Dimetindene SmPC_LAB_PIL Day 206 210617
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
[Product name] 1 mg/ml oral drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains dimetindene maleate 1 mg (1 ml = 20 drops).
Excipients with known effect 1 ml contains 100 mg propylene glycol and 1 mg benzoic acid. For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral drops, solution. Clear, colourless and odourless solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
‒ Symptomatic treatment of allergic diseases: • Skin: Urticaria, pruritus of various etiology, endogenous eczema with previous medical diagnosis. • Respiratory system: Seasonal (hay fever) and perennial rhinitis with previous medical diagnosis. ‒ Relieve of itching associated with infectious diseases (e.g. chickenpox) with previous medical diagnosis or after an insect bite or stings. [Product name] is indicated in adults, adolescents and children aged 1 year and older. [Product name] is indicated in allergic rhinitis in adults, adolescents and children aged 6 years and older.
Dimetindene SmPC_LAB_PIL Day 206 210617
4.2 Posology and method of administration
Posology The recommended dose should not be exceeded.
Adults and adolescents 12 years of age and older The recommended daily dose is 3 – 6 mg of dimetindene maleate divided into 3 doses, i.e. 20 – 40 drops 3× a day. The recommended dose in patients with tendency toward somnolence is 40 drops at night and 20 drops in the morning.
Paediatric population The recommended daily dose for children 1 – 11 years is 0.1 mg dimetindene maleate/kg body weight, i.e. 2 drops/kg/day divided into 3 doses. See the dosage table below. Weight Single dose Daily dose (kg) (number of drops) (total number of drops) 7 – 8 5 15 9 6 18 10 – 11 7 21 12 8 24 13 – 14 9 27 15 10 30 16 – 17 11 33 18 12 36 19 – 20 13 39 21 14 42 22 – 23 15 45 24 16 48 25 – 26 17 51 27 18 54 28 – 29 19 57 30 20 60
Elderly (over 65 years) The same dosage as for adults can be used.
Duration of treatment [Product name] should not be used longer than 14 days without consulting a doctor.
Dimetindene SmPC_LAB_PIL Day 206 210617
Method of administration To drip, hold the bottle with the dropper vertically downwards. In case of dripping difficulties, tap the bottom of the bottle several times with your finger. The drops are taken undiluted (for example with a teaspoon). [Product name] should not be exposed to high temperatures. If a child is spoon-fed, the product can be administered undiluted on a teaspoon.
4.3 Contraindications
‒ Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. ‒ Infants and children under 1 year of age.
4.4 Special warnings and precautions for use
As with other antihistamines, increased caution is recommended in case of administration to patients with glaucoma or urinary bladder neck obstruction (e.g. prostatic hypertrophy). As with all H1-receptor antagonists and some H2-antihistamines, increased caution is needed in patients with epilepsy.
Elderly Elderly patients are more predisposed to development of adverse anticholinergic effects or agitation and fatigue. Therefore, dimetindene should be used with caution in these patients. Do not use it in elderly patients manifesting confusion.
Paediatric population Induction of excitability by administration of antihistamines has been observed in small children.
Excipients ‒ This medicine contains 200 mg of propylene glycol in a single dose (40 drops), which is equivalent to 100 mg/ml. ‒ This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium free”. ‒ This medicine contains 2 mg benzoic acid in a single dose (40 drops), which is equivalent to 1 mg/ml.
4.5 Interaction with other medicinal products and other forms of interaction
In concurrent use of 2 or more medicines suppressing the CNS, increase of the suppressive effect on the CNS can be expected. This can have adverse and life-threatening consequences. These
Dimetindene SmPC_LAB_PIL Day 206 210617
medicines include opioid analgesics, anticonvulsives, antidepressants (tricyclic and monoaminooxidase inhibitors), antihistamines, antiemetics, antipsychotics, anxiolytics, hypnotics, scopolamine. Alcohol has the same effect. Tricyclic antidepressants and anticholinergics (e.g. bronchodilators, spasmolytics acting on smooth musculature of the gastrointestinal tract, mydriatics, antimuscarinic parasympatolytics used in urology) can have additive antimuscarinic effect when administered together with antihistamines, which can increase the risk of worsening glaucoma or urinary retention. Procarbazine and antihistamines should be administered concurrently with caution because of possible augmenting effect and to minimize CNS suppression.
4.6 Fertility, pregnancy and lactation
Pregnancy There are no data about the use of dimetindene maleate during pregnancy. Dimetindene studies conducted in animals did not demonstrate direct or indirect harmful effects on pregnancy, development of the embryo or foetus, delivery or postnatal development (see section 5.3). Dimetindene maleate should not be used in pregnant women unless the benefit of treating the mother outweighs the risk for the foetus; it should be taken under medical supervision only.
Breast-feeding There is a well-founded presumption that dimetindene can be excreted in human milk. Taking [Product name] while breast-feeding is not recommended.
Fertility Data concerning the effect on fertility in humans are not available. No effects on fertility were observed in animal studies (see section 5.3).
4.7 Effects on ability to drive and use machines
Like other antihistamines, dimetindene can reduce the level of mental concentration in some patients. If this occurs, patients should avoid driving motor vehicles, using machines or other activities requiring increased concentration. This applies in particular in combination with alcohol.
4.8 Undesirable effects
Summary of the safety profile Adverse effects include somnolence particularly at the beginning of treatment. Allergic reactions can occur in very rare cases.
Dimetindene SmPC_LAB_PIL Day 206 210617
Tabulated list of adverse reactions Adverse effects are listed below according to the system organ class classification and frequency of occurrence. Frequencies are defined as follows: 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) or not known (cannot be estimated from the available data). Undesirable effects in every group are ordered by decreasing severity. System organ class Frequency Adverse effect Immune system Very rare Anaphylactic reactions including swelling of the face, disorders swelling of the larynx, rash, muscular spasms and dyspnoea Psychiatric disorders Rare Restlessness Nervous system Very common Fatigue disorders Common Somnolence, nervousness Rare Headache, dizziness Gastrointestinal Rare Digestive problems, nausea, dry mouth and throat disorders
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
Symptoms Symptoms and signs of H1-antihistamine overdose can include: CNS suppression with somnolence (predominantly in adults), CNS stimulation and anticholinergic effects (particularly in children and the elderly), such as excitation, ataxia, hallucinations, tremor, spasms, urinary retention and fever. Hypotension, coma and cardio-respiratory collapse may follow.
Treatment There is no specific antidote for antihistamine overdose. The usual emergency measures must be adopted, including administration of activated charcoal, saline laxatives and the usual cardio- respiratory supportive measures. Stimulant use is inappropriate, vasoconstrictive agents may be administered to treat hypotension.
Dimetindene SmPC_LAB_PIL Day 206 210617
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines for systemic application, ATC code: R06AB03.
Mechanism of action and pharmacodynamic properties Dimetindene maleate is a competitive histamine inhibitor on H1-receptors. At low concentrations, it stimulates histamine methyltransferase, which leads to histamine deactivation. It exhibits strong affinity to H1 receptors and is a strong stabilizer of mast cells. It also has a local anaesthetic effect. It does not have any effect on H2-receptors. Dimetindene maleate also acts as a bradykinin, serotonin and acetylcholine antagonist. It is a racemic mixture, in which the R-(-)-dimetindene has higher H1-antihistamine effect. It significantly reduces capillary permeability, which is associated with immediate hypersensitivity reaction. Together with H2-antihistamines, dimetindene maleate suppresses practically all circulatory effects of histamine. In a study of histamine-induced skin oedema and erythema, the effect of a single 4 mg dose of dimetindene in the form of drops continued to be measurable up to 24 hours after administration.
5.2 Pharmacokinetic properties
Absorption Systemic biological availability of dimetindene administered in the form of drops is approximately 70%. The onset of effect is expected within 30 minutes, and its peak is expected to last 5 hours. Administration of an oral solution or coated tablets containing 1 mg yielded peak plasma levels in 2 hours.
Distribution At levels ranging from 0.09 ‒ 2 μg/ml in humans, approximately 90% of dimetindene is bound to blood plasma proteins.
Biotransformation Metabolic reactions of dimetindene include hydroxylation and methoxylation.
Elimination Elimination half-life is approximately 6 hours. Dimetindene and its metabolites are excreted through bile and through urine.
Dimetindene SmPC_LAB_PIL Day 206 210617
5.3 Preclinical safety data
Preclinical data of the active substance based on conventional pharmacological studies of safety, toxicity with repeated administration and genotoxicity do not demonstrate any particular risk for humans. No teratogenic effects were observed in laboratory rats or in rabbits. Dimetindene administered to laboratory rats in doses 250 times exceeding the doses used in humans did not affect fertility, perinatal or postnatal development of offspring.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene glycol (E 1520) Disodium phosphate dodecahydrate Citric acid monohydrate Benzoic acid (E 210) Disodium edetate Saccharin sodium (E 954) Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years. After first opening: 6 months.
6.4 Special precautions for storage
Store below 25 °C. Keep the bottle in the outer carton in order to protect from light.
6.5 Nature and contents of container
Dimetindene SmPC_LAB_PIL Day 206 210617
Amber type III glass bottle, with a white PP screw cap, fitted with neutral LDPE child resistant cap and a neutral LDPE dropper. Pack size: 20, 50, 3×20 ml. Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
[To be completed nationally]
8. MARKETING AUTHORISATION NUMBER
[To be completed nationally]
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Date of first authorisation: [To be completed nationally]
10. DATE OF REVISION OF THE TEXT
[To be completed nationally]
Dimetindene SmPC_LAB_PIL Day 206 210617
LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Paper box
1. NAME OF THE MEDICINAL PRODUCT
[Product name] 1 mg/ml oral drops, solution dimetindene maleate
2. STATEMENT OF ACTIVE SUBSTANCE
1 ml contains dimetindene maleate 1 mg (1 ml = 20 drops).
3. LIST OF EXCIPIENTS
Excipients: Propylene glycol (E 1520), disodium phosphate dodecahydrate, citric acid monohydrate, benzoic acid (E 210), disodium edetate, saccharin sodium (E 954), purified water.
4. PHARMACEUTICAL FORM AND CONTENTS
Oral drops solution. 20 ml 50 ml 3×20 ml
5. METHOD AND ROUTE OF ADMINISTRATION
For oral use. Read the package leaflet before use.
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.
Dimetindene SmPC_LAB_PIL Day 206 210617
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP Use within 6 months after first opening.
9. SPECIAL STORAGE CONDITIONS
Store below 25 °C. Keep the bottle in the outer carton in order to protect from light.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Return the unused medicine to pharmacy.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
12. MARKETING AUTHORISATION NUMBER(S)
Reg. No.
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
[To be completed nationally]
Dimetindene SmPC_LAB_PIL Day 206 210617
15. INSTRUCTIONS ON USE
‒ For treatment of signs of allergic diseases such as hives, eczema, allergic rhinitis only after previous medical diagnosis. ‒ For relief of itching associated with infectious diseases (only after previous medical diagnosis) or after insect bites or stings. [Product name] is indicated in adults, adolescents and children aged 1 year and older. [Product name] is indicated in allergic rhinitis in adults, adolescents and children aged 6 years and older.
Adults and adolescents over 12 years: 20 – 40 drops 3× a day. Children 1 – 12 years: 2 drops/kg body weight/day, divided into 3 doses. Read the package leaflet for further information about dosage.
16. INFORMATION IN BRAILLE
[Product name]
17. UNIQUE IDENTIFIER – 2D BARCODE
Not applicable.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
Not applicable.
Dimetindene SmPC_LAB_PIL Day 206 210617
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Bottle label
1. NAME OF THE MEDICINAL PRODUCT
[Product name] 1 mg/ml oral drops, solution dimetindene maleate
1 ml contains dimetindene maleate 1 mg (1 ml = 20 drops).
2. METHOD OF ADMINISTRATION
For oral use.
3. EXPIRY DATE
EXP Use within 6 months after first opening.
4. BATCH NUMBER
Batch
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
20 ml 50 ml
6. OTHER
Dimetindene SmPC_LAB_PIL Day 206 210617
PACKAGE LEAFLET: INFORMATION FOR THE USER
[Product name] 1 mg/ml oral drops, solution dimetindene maleate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. ‒ Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. ‒ Keep this leaflet. You may need to read it again. ‒ Ask your pharmacist if you need more information or advice. ‒ If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. ‒ You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Content of the pack and other information
1. What [Product name] is and what it is used for
[Product name] contains the active substance dimetindene maleate. It belongs to a group of medicines called antihistamines. It blocks the effect of histamine, which is a substance released by the body during allergic reactions. [Product name] relieves itching and irritation caused by skin rash, reduces swelling and relieves symptoms of allergic rhinitis, such as runny nose, sneezing, itching of the nose and itching and watering eyes.
[Product name] is used to treat signs of allergic diseases: ‒ Skin: Hives, pruritus of various origins, endogenous eczema if your doctor has diagnosed you with these conditions previously.
Dimetindene SmPC_LAB_PIL Day 206 210617
‒ Respiratory system: Seasonal allergic rhinitis (hay fever) and perennial rhinitis (e.g. allergy to house dust, animal dander, feathers) if your doctor has diagnosed you with these conditions previously. [Product name] relieves of itching associated with infectious diseases (e.g. chickenpox) if your doctor has diagnosed you with these conditions previously or after an insect bite or stings.
[Product name] is indicated in adults, adolescents and children aged 1 year and older. [Product name] is indicated in allergic rhinitis in adults, adolescents and children aged 6 years and older.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know before you take [Product name]
Do not take [Product name] ‒ if you are allergic to dimetindene maleate or any of the other ingredients of this medicine (listed in section 6). Do not give [Product name] to infants younger than one year.
Warnings and precautions Talk to your doctor or pharmacist before using [Product name], if you ‒ have glaucoma. ‒ have problems with urination (e.g. due to enlarged prostate). ‒ suffer from epilepsy.
Elderly patients should check with their physician before using this medicine because they are more likely to experience side effects such as increased heart rate, dry mouth, blurry vision, constipation, agitation or tiredness. These patients should therefore take [Product name] drops with caution. [Product name] should not be used in elderly patients if they show signs of confusion.
Children and adolescents Do not use [Product name] in children younger than 1 year. It has been noted that antihistamines can induce excitability (getting excited easier) in younger children. Check with your doctor about children younger than 12 years taking [Product name].
Dimetindene SmPC_LAB_PIL Day 206 210617
Other medicines and [Product name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Unless under doctor’s recommendation, you should not take [Product name] if you take any of the following medicines: ‒ Antidepressants (for treatment of depression). ‒ Anticholinergics, for example bronchodilators (medicines for treatment of asthma and bronchospasm, that is constriction of the bronchial tubes), products for treatment of alimentary tract spasms (stomach or abdominal cramps), mydriatics (medicines for dilation of the pupil of the eye), medicines used to treat symptoms of urinary incontinence or irritable urinary bladder. The concomitant use of tricyclic antidepressants or anticholinergics may increase the risk of worsening glaucoma or urinary retention. ‒ Sedatives, anxiolytics (calming medicines) or hypnotics (medicines for sleeping). ‒ Anticonvulsives (medicines for epilepsy). ‒ Opioid analgesics (pain killers). ‒ Antihistamines (medicines for treatment of various allergy symptoms). ‒ Antiemetics (medicines against vomiting). ‒ Procarbazine (medicine for treatment of tumours). ‒ Scopolamine (medicine for prevention of motion sickness). ‒ Antipsychotics (medicines for treatment of mental disorders). ‒ Alcohol.
[Product name] with food, drink and alcohol Like many other antihistamines, [Product name] can boost the effect of alcohol.
Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant, take [Product name] only on your doctor’s recommendation. Taking [Product name] while breast-feeding is not recommended.
Driving and using machines Like other antihistamines, [Product name] can induce tiredness, reduce concentration and slow down reactions in some people. This applies in particular in combination with alcohol. If this occurs, you should avoid driving, using machines or other activities requiring increased concentration.
Dimetindene SmPC_LAB_PIL Day 206 210617
[Product name] contains propylene glycol, sodium and benzoic acid ‒ This medicine contains 200 mg of propylene glycol in a single dose (40 drops), which is equivalent to 100 mg/ml. ‒ This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium free”. ‒ This medicine contains 2 mg benzoic acid in a single dose (40 drops), which is equivalent to 1 mg/ml.
3. How to take [Product name]
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. Do not exceed the recommended dose. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. [Product name] should not be used longer than 14 days without consulting a doctor.
Adults and adolescents older than 12 years 20 – 40 drops 3× a day. The recommended dose in patients with tendency toward sleepiness is 40 drops at night and 20 drops in the morning.
Children Children 1 – 12 years The recommended daily dose is 2 drops/kg body weight/day, divided into 3 doses (e.g. 8 drops 3× daily for a 2-year-old child weighing 12 kg). See the dosage table below for details. Weight Single dose Daily dose (kg) (number of drops) (total number of drops) 7 – 8 5 15 9 6 18 10 – 11 7 21 12 8 24 13 – 14 9 27 15 10 30 16 – 17 11 33 18 12 36 19 – 20 13 39 21 14 42 22 – 23 15 45 24 16 48 25 – 26 17 51
Dimetindene SmPC_LAB_PIL Day 206 210617
27 18 54 28 – 29 19 57 30 20 60
Elderly (over 65 years) The same dosage as for adults can be used.
How to take [Product name] To drip, hold the bottle with the dropper vertically downwards. In case of dripping difficulties, tap the bottom of the bottle several times with your finger. The drops are taken undiluted (for example with a teaspoon). [Product name] drops should not be exposed to high temperatures. If a child is spoon-fed, [Product name] drops are administered undiluted on a teaspoon.
If you take more [Product name] than you should In case of overdose or accidental ingestion of the product by a child, contact your doctor immediately.
If you forget to take [Product name] If you forgot to take a dose, take it as soon as you remember, unless it is less than 2 hours before the next dose. Then continue with your usual dosing schedule. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, which can be signs of allergic reaction, STOP TAKING [Product name] and seek medical help immediately. ‒ Shortness of breath or problems swallowing. ‒ Swelling of the face, lips, tongue or throat. ‒ Intense itching of the skin with red rash or pimples, muscle spasms. These side effects are very rare (may affect up to 1 in 10,000 people).
Other side effects that can occur are usually mild and temporary. Side effects are more common at the beginning of treatment. Very common (may affect in more than 1 in 10 people): ‒ Tiredness.
Dimetindene SmPC_LAB_PIL Day 206 210617
Common (may affect up to 1 in 10 people): ‒ Sleepiness, nervousness.
Rare (may affect up to 1 in 1,000 people): ‒ Restlessness. ‒ Headache, dizziness. ‒ Digestive problems, feeling sick, dry mouth and throat.
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 [Product name]
Keep this medicine out of the sight and reach of children. Store below 25 °C. Keep the bottle in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the pack after “EXP”. The expiry date refers to the last day of that month. Shelf life after first opening is 6 months.
6. Content of the pack and other information
What [Product name] contains ‒ The active substance is: Dimetindene maleate. 1 ml of [Product name] drops contains 1 mg dimetindene maleate. ‒ The excipients are: Propylene glycol (E 1520), disodium phosphate dodecahydrate, citric acid monohydrate, benzoic acid (E 210), disodium edetate, saccharin sodium (E 954), purified water.
What [Product name] looks like and contents of the pack [Product name] oral drops, solution is a clear, colourless and odourless solution. [Product name] oral drops is packed in amber type III glass bottle, with a white PP screw cap, fitted with neutral LDPE child resistant cap and a neutral LDPE dropper.
Dimetindene SmPC_LAB_PIL Day 206 210617
Pack size: 20, 50, 3×20 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer [To be completed nationally]
This medicine is authorised in the Member States of European Economic Area under the following names: Portugal, Poland: Zidenac Germany: Dimetinden Zentiva Czech Republic: Moniret
This leaflet was last revised on