Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
[Invented Name] 20 mg gastro-resistant tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains: 20 mg of pantoprazole (equivalent to 22.6 mg pantoprazole sodium sesquihydrate)
Excipients with known effect: 38.425 mg maltitol, soya lecithin and maximum of 1.84 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant tablet Yellow, oval tablet.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
[Invented Name] is indicated for use in adults and adolescents 12 years of age and above for: Symptomatic gastro-oesophageal reflux disease. Long-term management and prevention of relapse in reflux oesophagitis.
[Invented Name] is indicated for use in adults for: Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4).
4.2 Posology and method of administration
Posology
Adults and adolescents 12 years of age and above Symptomatic gastro-oesophageal reflux disease The recommended oral dose is one [Invented Name] 20 mg gastro-resistant tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, taking one tablet when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis For long-term management, a maintenance dose of one [Invented Name] 20 mg gastro-resistant tablet per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. [Invented Name] 40 mg is available for this case. After healing of the relapse the dose can be reduced again to 20 mg pantoprazole.
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Adults Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment The recommended oral dose is one [Invented Name] 20 mg gastro-resistant tablet per day.
Hepatic Impairment A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment (see section 4.4).
Renal Impairment No dose adjustment is necessary in patients with impaired renal function (see section 5.2)..
Elderly No dose adjustment is necessary in elderly patients (see section 5.2).
Paediatric population [Invented Name] is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in this age group (see section 5.2).
Method of administration Tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.
4.3 Contraindications
Hypersensitivity to the active substance, substituted benzimidazoles, peanut, soya or to any of the other excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Hepatic Impairment In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use. In the case of a rise of the liver enzymes, the treatment with [Invented Name] should be discontinued (see section 4.2).
Co-administration with NSAIDs The use of [Invented Name] as a preventive of gastroduodenal ulcers induced by non-selective non- steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications. The increased risk should be assessed according to individual risk factors, e.g. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.
Gastric malignancy Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.
Further investigation is to be considered if symptoms persist despite adequate treatment.
Co-administration with HIV protease inhibitors Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).
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Influence on vitamin B12 absorption Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Long term treatment In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Gastrointestinal infections caused by bacteria Treatment with pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.
Hypomagnesaemia Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia (e.g., diuretics), health-care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Bone fractures Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Sub-acute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping pantoprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, [Product name] treatment should be stopped for at least five days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Soya lecithin This medicinal product contains soya lecithin. If the patient is allergic to peanut or soya, do not use this medicinal product (see section 4.3).
Maltitol This medicinal product contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
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Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
4.5 Interaction with other medicinal products and other forms of interaction
Medicinal products with pH-dependent absorption pharmacokinetics Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of other medicinal products where gastric pH is an important determinant of oral availability, e.g. some azole antifungals such as ketoconazole, itraconazole, posaconazole and other medicines such as erlotinib.
HIV protease inhibitors Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir due to significant reduction in their bioavailability (see section 4.4).
If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended. A pantoprazole dose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitor may need to be adjusted.
Coumarin anticoagulants (phenprocoumon or warfarin) Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or INR. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenprocoumon concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. Patients treated with pantoprazole and warfarin or phenprocoumon may need to be monitored for increase in INR and prothrombin time
Methotrexate Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors has been reported to increase methotrexate levels in some patients. Therefore in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of pantoprazole may need to be considered.
Other interactions studies Pantoprazole is extensively metabolized in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4. Interaction studies with medicinal products also metabolized with these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.
An interaction of pantoprazole with other medicinal products or compounds, which are metabolized using the same enzyme system, cannot be excluded.
Results from a range of interaction studies demonstrate that pantoprazole does not affect the metabolism of active substances metabolised by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) or does not interfere with p-glycoprotein related absorption of digoxin.
There were no interactions with concomitantly administered antacids.
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Medicinal products that inhibit or induce CYP2C19: Inhibitors of CYP2C19 such as fluvoxamine could increase the systemic exposure of pantoprazole. A dose reduction may be considered for patients treated long-term with high doses of pantoprazole, or those with hepatic impairment. Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St John´s wort (Hypericum perforatum) may reduce the plasma concentrations of PPIs that are metabolized through these enzyme systems.
4.6 Fertility, pregnancy and lactation
Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of pantoprazole. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of pantoprazole during pregnancy.
Breast-feeding Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore a decision on whether to discontinue breast-feeding or to discontinue/abstain therapy with pantoprazole should take into account the benefit of breast-feeding for the child and the benefit of pantoprazole therapy for the woman.
Fertility There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
4.7 Effects on ability to drive and use machines
Pantoprazole has no or negligible influence on the ability to drive and use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machines.
4.8 Undesirable effects
Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1 % of patients.
The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). For all adverse reactions reported from post-marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
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Frequency Common Uncommon Rare Very rare Not known
System Organ Class
Blood and Agranulocyto- Thrombocyto- lymphatic system sis penia; disorders Leukopenia, Pancytopenia
Immune system Hypersensiti- disorders vity (including anaphylactic reactions and anaphylactic shock) Metabolism and Hyperlipid- Hyponatr-aemia nutrition aemias and lipid Hypomagnes- disorders increases aemia (see (triglycerides, section 4.4) cholesterol); Hypocalc-aemia Weight changes in association with hypomagnes- aemia; Hypokalaemia
Psychiatric Sleep disorders Depression (and Disorientation Hallucination; disorders all (and all Confusion aggravations) aggravations) (especially in predisposed patients, as well as the aggravation of these symptoms in case of preexistence) Nervous system Headache; Taste disorders Parasthesia disorders Dizziness
Eye disorders Disturbances in vision / blurred vision
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System Organ Class
Gastrointestinal Fundic gland Diarrhoea; Microscopic disorders polyps Nausea/vomit- colitis (benign) ing; Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort Hepatobiliary Liver enzymes Bilirubin Hepatocellular disorders increased increased injury; (transaminases, Jaundice; γ-GT) Hepatocellular failure Skin and sub- Rash / Urticaria; Stevens- cutaneous tissue exanthema / Angioedema Johnson disorders eruption; syndrome; Lyell Pruritus syndrome; Erythema multiforme; Photosensitivi- ty; Subacute cutaneous lupus erythematosus (see section 4.4). Musculoskeletal Fracture of the Arthralgia; Muscle and connective hip, wrist or Myalgia spasm as a tissue disorders spine (see consequence of section 4.4) electrolyte disturbances Renal and urinary Interstitial disorders nephritis (with possible progression to renal failure) Reproductive Gynaecoma-stia system and breast disorders General disorders Asthenia, Body and fatigue and temperature administration malaise increased; site conditions Oedema peripheral
CONFIDENTIAL Module 1 Page 7 Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
4.9 Overdose
There are no known symptoms of overdose in man. Systemic exposure with up to 240 mg administered intravenously over 2 minutes were well tolerated. As pantoprazole is extensively protein bound, it is not readily dialysable.
In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: proton pump inhibitors ATC code: A02 BC 02
Mechanism of action Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most patients, freedom from symptoms is achieved within 2 weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.
Pharmacodynamic effects The fasting gastrin values increase under pantoprazole. On short-term use, in most cases they do not exceed the upper limit of normal. During long-term treatment, gastrin levels double in most cases. An excessive increase, however, occurs only in isolated cases. As a result, a mild to moderate increase in the number of specific endocrine (ECL) cells in the stomach is observed in a minority of cases during long-term treatment (simple to adenomatoid hyperplasia). However, according to the studies conducted so far, the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids as were found in animal experiments (see section 5.3) have not been observed in humans.
An influence of a long term treatment with pantoprazole exceeding one year cannot be completely ruled out on endocrine parameters of the thyroid according to results in animal studies.
During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.
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5.2 Pharmacokinetic properties
Absorption Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 20 mg oral dose. On average at about 2.0 h – 2.5 hours p.a. the maximum serum concentrations of about 1 – 1.5 µg/ml are achieved, and these values remain constant after multiple administration. Pharmacokinetics does not vary after single or repeated administration. In the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole is linear after both oral and intravenous administration. The absolute bioavailability from the tablet was found to be about 77 %. Concomitant intake of food had no influence on AUC, maximum serum concentration and thus bioavailability. Only the variability of the lag-time will be increased by concomitant food intake.
Distribution Pantoprazole serum protein binding is about 98 %. Volume of distribution is about 0.15 l/kg
Biotransformation The substance is almost exclusively metabolized in the liver. The main metabolic pathway is demethylation by CYP2C19 with subsequent sulphate conjugation, other metabolic pathway includes oxidation by CYP3A4.
Elimination Terminal half-life is about 1 hour and clearance is about 0.1 l/h/kg. There were a few cases of subjects with delayed elimination. Because of the specific binding of pantoprazole to the proton pumps of the parietal cell the elimination half-life does not correlate with the much longer duration of action (inhibition of acid secretion). Renal elimination represents the major route of excretion (about 80 %) for the metabolites of pantoprazole, the rest is excreted with the faeces. The main metabolite in both the serum and urine is desmethylpantoprazole which is conjugated with sulphate. The half-life of the main metabolite (about 1.5 hours) is not much longer than that of pantoprazole.
Special populations Poor metabolisers Approximately 3 % of the European population lack a functional CYP2C19 enzyme and are called poor metabolisers. In these individuals the metabolism of pantoprazole is probably mainly catalysed by CYP3A4. After a single-dose administration of 40 mg pantoprazole, the mean area under the plasma concentration-time curve was approximately 6 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations were increased by about 60 %. These findings have no implications for the posology of pantoprazole.
Renal impairment No dose reduction is recommended when pantoprazole is administered to patients with impaired renal function (including dialysis patients). As with healthy subjects, pantoprazole´s half-life is short. Only very small amounts of pantoprazole are dialyzed. Although the main metabolite has a moderately delayed half-life (2 - 3h), excretion is still rapid and thus accumulation does not occur.
Hepatic impairment Although for patients with liver cirrhosis (classes A and B according to Child) the half-life values increased to between 3 and 6 h and the AUC values increased by a factor of 3 - 5, the maximum serum concentration only increased slightly by a factor of 1.3 compared with healthy subjects.
Elderly A slight increase in AUC and Cmax in elderly volunteers compared with younger counterparts is also not clinically relevant.
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Paediatric population Following administration of single oral doses of 20 or 40 mg pantoprazole to children aged 5 - 16 years AUC and Cmax were in the range of corresponding values in adults. Following administration of single i.v. doses of 0.8 or 1.6 mg/kg pantoprazole to children aged 2 - 16 years there was no significant association between pantoprazole clearance and age or weight. AUC and volume of distribution were in accordance with data from adults.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
In the two-year carcinogenicity studies in rats neuroendocrine neoplasms were found. In addition, squamous cell papillomas were found in the forestomach of rats. The mechanism leading to the formation of gastric carcinoids by substituted benzimidazoles has been carefully investigated and allows the conclusion that it is a secondary reaction to the massively elevated serum gastrin levels occurring in the rat during chronic high-dose treatment. In the two-year rodent studies an increased number of liver tumours was observed in rats and in female mice and was interpreted as being due to pantoprazole´s high metabolic rate in the liver.
A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the highest dose (200 mg/kg). The occurrence of these neoplasms is associated with the pantoprazole- induced changes in the breakdown of thyroxine in the rat liver. As the therapeutic dose in man is low, no harmful effects on the thyroid glands are expected.
In a peri-postnatal rat reproduction study designed to assess bone development, , signs of offspring toxicity (mortality, lower mean body weight, lower mean body weight gain and reduced bone growth) were observed at exposures (Cmax) approximately 2x the human clinical exposure. By the end of the recovery phase, bone parameters were similar across groups and body weights were also trending toward reversibility after a drug-free recovery period. The increased mortality has only been reported in pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 years old. The relevance of this finding to the paediatric population is unclear. A previous peri- postnatal study in rats at slightly lower doses found no adverse effects at 3 mg/kg compared with a low dose of 5 mg/kg in this study.
Investigations revealed no evidence of impaired fertility or teratogenic effects.
Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation. As a result, concentration of pantoprazole in the foetus is increased shortly before birth.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core maltitol (E 965) crospovidone type B carmellose sodium sodium carbonate, anhydrous (E 500) calcium stearate
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6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years After first opening of the bottle use the medicinal product within three months.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Alu-Alu blisters HDPE bottles with PP closure and desiccant
Pack sizes: 7, 14, 15, 28, 30, 50, 56, 60, 90, 98*, 100, 140, 140 (10x14) (5x28), 280 (20x14) (10x28), 500, 700 (5x140) gastro-resistant tablets (blister packs)
*only use for Germany
14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 140 (10x14) (5x28), 280 (20x14) (10x28), 500, 700 (5x140) gastro-resistant tablets (HDPE bottles)
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
[To be completed nationally] {Name and address} {tel} {fax} {e-mail}
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[To be completed nationally]
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[To be completed nationally]
10. DATE OF REVISION OF THE TEXT
{MM/YYYY}
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PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
1. NAME OF THE MEDICINAL PRODUCT
[Invented Name] 20 mg gastro-resistant tablets pantoprazole
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg pantoprazole (as pantoprazole sodium sesqiuhydrate).
3. LIST OF EXCIPIENTS
Contains maltitol, soya lecithin and sodium. See the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Gastro-resistant tablet. blister packs: 7 tablets 14 tablets 15 tablets 28 tablets 30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 98 tablets** 100 tablets 140 tablets 140 tablets (10x14) (5x28) 280 tablets (20x14) (10x28) 500 tablets 700 tablets (5x140) * Samples with 7 gastro-resistant tablets (*doctors pack) ** only use for Germany
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HDPE bottles: 14 tablets 15 tablets 28 tablets 30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 100 tablets 140 tablets 140 tablets (10x14) (5x28) 280 tablets (20x14) (10x28) 500 tablets 700 tablets(5x140) * Samples with 7 gastro-resistant tablets (*doctors pack)
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use. Swallow whole, do not chew.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP: Bottles: After first opening: Use within 3 months.
9. SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
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11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally] {Name and address} {tel} {fax} {e-mail}
12. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally.]
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
[To be completed nationally.]
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
[Invented Name] 20 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: SN: NN:
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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
1. NAME OF THE MEDICINAL PRODUCT
[Invented Name] 20 mg gastro-resistant tablets pantoprazole sodium 1.5 H2O
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally.]
3. EXPIRY DATE
EXP:
4. BATCH NUMBER
Lot:
5. OTHER
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PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle Label
1. NAME OF THE MEDICINAL PRODUCT
[Invented Name] 20 mg gastro-resistant tablets pantoprazole
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate).
3. LIST OF EXCIPIENTS
Contains maltitol, soya lecithin and sodium. See the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Gastro-resistant tablet
2 tablets (starter pack) 14 tablets 15 tablets 28 tablets 30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 100 tablets 140 tablets 140 tablets (10x14) (5x28) 280 tablets (20x14) (10x28) 500 tablets 700 tablets (5x140)
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use. Swallow whole, do not chew.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
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7. OTHER SPECIAL WARNING(S), IF NECESSARY
Not applicable.
8. EXPIRY DATE
EXP: After first opening: Use within 3 months.
9. SPECIAL STORAGE CONDITIONS
Not applicable.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Not applicable.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally] {Name and address} {tel} {fax} {e-mail}
12. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally.]
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
[To be completed nationally.]
15. INSTRUCTIONS ON USE
Not applicable.
16. INFORMATION IN BRAILLE
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Not applicable.
CONFIDENTIAL Module 1 Page 19 Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR Package leaflet: Information for the user
[Invented Name] 20 mg gastro-resistant tablets pantoprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What [Invented Name] is and what it is used for 2. What you need to know before you take [Invented Name] 3. How to take [Invented Name] 4. Possible side effects 5. How to store [Invented Name] 6. Contents of the pack and other information
1. What [Invented Name] is and what it is used for
[Invented Name] contains the active substance pantoprazole. [Invented Name] is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.
[Invented Name] is used
To treat adults and adolescents 12 years of age and above for: symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro- oesophageal reflux disease caused by reflux of acid from the stomach.
long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return.
[Invented Name] is used to treat adults for: Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.
2. What you need to know before you take [Invented name]
Do not take [Invented Name] If you are allergic to pantoprazole, peanut, soya or any of the other ingredients of this medicine listed in section 6. If you are allergic to medicines containing other proton pump inhibitors.
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking [Invented Name] If you have severe liver problems. Please tell your doctor if you have ever had problems with your liver. He will check your liver enzymes more frequently, especially when you are taking
CONFIDENTIAL Module 1 Page 20 Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR [Invented Name] as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped. If you need to take medicines called NSAIDs continuously and receive [Invented Name] because you have an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to your own personal risk factors such as your age (65 years old or more), a history of stomach or duodenal ulcers or of stomach or intestinal bleeding. If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin B12. If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice. Taking a proton pump inhibitor like [Invented Name], especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis). If you are on [Invented Name] for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium. If you have ever had a skin reaction after treatment with a medicine similar to [Invented Name] that reduces stomach acid. If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with [Invented Name]. Remember to also mention any other ill-effects like pain in your joints. If you are due to have a specific blood test (chromogranin A)
Tell your doctor immediately before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight - vomiting particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools: which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.
If you take [Invented Name] on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Children and adolescents [Invented Name] is not recommended for use in children as it has not been proven to work in children below 12 years of age.
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Other medicines and [Invented Name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. This is because [Invented Name] may influence the effectiveness of other medicines, so tell your doctor if you are taking medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because [Invented Name] may stop these and other medicines from working properly. warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks. medicines used to treat HIV-infection such as atazanavir methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer), serious forms of and).– if you are taking methotrexate your doctor may temporarily stop your [Invented Name] treatment because pantoprazole can increase levels of methotrexate in the blood. fluvoxamine (used to treat depression and other psychiatric diseases) – if you are taking fluvoxamine your doctor may reduce the dose. Rifampicin (used to treat infections). St John’s wort (Hypericum perforatum) (used to treat mild depression).
Pregnancy, breast-feeding and fertility There are no adequate data from the use of pantoprazole in pregnant women.Excretion into human milk has been reported. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.
Driving and using machines [Invented Name] has no or negligible influence on the ability to drive and use machines. If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
[Invented Name] contains soya lecithin, maltitol and sodium If you are allergic to peanut or soya, do not use this medicine. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
3. How to take [Invented name]
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
When and how you should take [Invented Name] Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.
The recommended dose is:
CONFIDENTIAL Module 1 Page 22 Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR Adults and adolescents 12 years of age and above
To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro- oesophageal reflux disease The usual dose is one tablet a day.This dose usually brings relief within 2 - 4 weeks – at most after another 4 weeks. Your doctor will tell you how long to continue taking the medicine. After this any recurring symptoms can be controlled by taking one tablet daily, when required.
For long-term management and for preventing the return of reflux oesophagitis The usual dose is one tablet a day. If the illness returns, your doctor can double the dose, in which case you can use [Invented Name] 40 mg instead, one a day. After healing, you can reduce the dose back again to one tablet 20 mg a day.
Adults
To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously The usual dose is one tablet a day.
Patients with liver problems If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.
Use in children and adolescents These tablets are not recommended for use in children below 12 years.
If you take more [Invented Name] than you should Tell your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take [Invented Name] Do not take a double dose to make up for the forgotten dose. Take your next normal dose at the usual time.
If you stop taking [Invented Name] Do not stop taking these tablets without first talking to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital:
Serious allergic reactions (frequency rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke’s oedema / angioedema), severe dizziness with very fast heartbeat and heavy sweating. Serious skin conditions (frequency not known: frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light. Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with
CONFIDENTIAL Module 1 Page 23 Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR painful urination and lower back pain (serious inflammation of the kidneys), possibly leading to kidney failure.
Other side effects are:
Common (may affect up to 1 in 10 people) - benign polyps in the stomach
Uncommon (may affect up to 1 in 100 people) - headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders; fracture in the hip, wrist or spine
Rare (may affect up to 1 in 1,000 people) - distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
Very Rare (may affect up to 1 in 10,000 people) - disorientation.
Not known (frequency cannot be estimated from the available data) - hallucination; confusion (especially in patients with a history of these symptoms); decreased sodium level in blood; decreased magnesium level in blood (see section 2 “Warnings and precaution”); feeling of tingling, prickling, pins and needles, burning sensation or numbness; rash, possibly with pain in the joints; inflammation in the large bowel, that causes persistent watery diarrhoea.
Side effects identified through blood tests: Uncommon (may affect up to 1 in 100 people) - an increase in liver enzymes.
Rare (may affect up to 1 in 1,000 people) - an increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever.
Very Rare (may affect up to 1 in 10,000 people) - a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store [Invented name]
Keep this medicine out of the sight and reach of children.
CONFIDENTIAL Module 1 Page 24 Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR Do not use this medicine after the expiry date which is stated on the blister and outer carton after EXP. The expiry date refers to the last day of that month.
For tablets packed in plastic bottles: [Invented Name] can be used for three months after first opening of the container.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What [Invented Name] contains: The active substance is: pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The other ingredients are: Tablet core Maltitol (E 965), crospovidone type B, carmellose sodium, sodium carbonate, anhydrous (E 500), calcium stearate
Tablet coating Poly(vinyl alcohol), talc (E 553b), titanium dioxide (E 171), macrogol 3350, soya lecithin, iron oxide yellow (E 172), sodium carbonate anhydrous (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505)
What [Invented Name] looks like and contents of the pack: [Invented Name] are oval, yellow, gastro-resistant tablets.
[Invented Name] is available in the following pack sizes: [Invented Name] are available in blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98*, 100, 140, 140 (10x14) (5x28), 280 (20x14) (10x28), 500, 700 (5x140) gastro-resistant tablets and in bottles of 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 140 (10x14) (5x28), 280 (20x14) (10x28), 500, 700 (5x140) gastro-resistant tablets. * only use for Germany Not all pack sizes may be marketed.
Marketing authorisation holder [To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Manufacturer [To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names: DE (RMS): Pantoprazol Winthrop 20 mg magensaftresistente Tabletten ES: Pantoprazol Zentiva 20 mg comprimidos gastrorresistentes EFG FR: Pantoprazole Zentiva 20 mg, comprimé gastro-résistant
CONFIDENTIAL Module 1 Page 25 Drug Product: Pantoprazole 20 mg DCP-946 Name of Document: 1.3.1 SPC and Labelling and Package Leaflet DE/H/0946 Pantoprazole 20 mg EN TXT – 06/2019 PRAC (+excipients and minor editorial changes)+ 08/2019 EPAR IT: Pantoprazolo Zentiva Italia PT: Pantoprazol Zentiva
This leaflet was last revised in {MM/YYYY}.
Remark; Shaded text is to be deleted/replaced in national translations according to the Product name and local administrative data (MAH).
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