Package leaflet: Information for the patient
[Invented Name] 60 mg capsules, hard
Acemetacin
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 or pharmacist. - 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 or pharmacist. 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] is a medicine for the relief of inflammation and pain, and belongs to the group of the so-called non-steroidal anti-inflammatory medicinal products (NSAID).
[Invented Name] is used to relieve pain and inflammation in patients suffering from acute arthritis (including gout) chronic arthritis, particularly in rheumatoid arthritis (chronic polyarthritis) ankylosing spondylitis (Bechterew’s Disease) and other inflammatory rheumatic spinal disorders osteoarthritis soft tissue inflammatory rheumatic disorders painful inflammation and swelling due to trauma
2. What you need to know before you
Do not take [Invented Name] - if you are allergic to acemetacin, indometacin or any of the other ingredients of this medicine (listed in section 6). if you have a history of wheezing or asthma attacks, swelling of the nasal mucosa (hayfever) or hives in response to acetylsalicylic acid or other NSAIDs. if you suffer from unexplained disturbance of formation of blood cells. if you suffer from active peptic ulcer/haemorrhage, or if you have a history of recurrent peptic ulcer/haemorrhage (at least two or more different episodes of proven ulceration or bleeding). if you have a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. if you suffer from cerebrovascular or other active bleeding. if you suffer from severe heart failure. if you suffer from kidney or liver impairment
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if you are pregnant in the third trimester.
Warnings and precautions
Talk to your doctor or pharmacist before taking [Invented Name].
You should avoid the use of [Invented Name] in combination with other NSAIDs, including cyclooxygenase-2 selective inhibitors.
Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, in patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease) and in elderly patients.
If you belong to one of these patient groups your doctor may decide to prescribe medicinal products which help to protect the tissue of your stomach and intestine.
Please report any unusual abdominal symptoms (especially gastrointestinal bleeding) to your doctor.
If you experience gastrointestinal bleeding or ulceration during the treatment with [Invented Name], the treatment should be withdrawn.
Please inform your doctor if you receive concomitant medications, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid, which could increase the risk of ulceration or bleeding.
The use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a slightly increased risk of arterial blood clots (for example heart attack or stroke). There are insufficient data to exclude such a risk for [Invented Name].
If you suffer from uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease you should only be treated with acemetacin after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Serious skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson-Syndrome and toxic epidermal necrolysis) are very rare during the use of NSAIDs. You must discontinue the use of [Invented Name] at the first appearance of any sign of severe hypersensitivity, skin rash, mucosal lesions or any other sign of allergic reaction.
Headache may occur as a result of long-term treatment with analgesics. You should not treat this headache with higher doses of analgesics.
In general, habitual use of analgesics, especially the combination of different analgesic substances, may lead to irreversible kidney impairment with the risk of kidney insufficiency (analgesic induced nephropathy). Further information:
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You should [Invented Name] only use after careful consideration of the risk-benefit ratio if you suffer from - acute porphyria - systemic lupus erythematosus (SLE) or mixed connective tissue disease.
Particular supervision by a doctor is necessary - if you suffer from kidney impairment - if you suffer from severe liver impairment - immediately after major surgical intervention - if you suffer from hayfever, nasal polyps or chronic obstructive pulmonary disease because of a higher risk for allergic reactions, such as acute asthma attack (analgesic induced asthma), Quincke’s edema or hives - if you have a history of allergic reaction to other substances because of a higher risk for an allergic reaction to [Invented Name].
Severe allergic reactions, e.g. anaphylactic shock, are very rare. You must discontinue the use of [Invented Name] at the first appearance of any sign of severe hypersensitivity and immediately seek for medical advice.
[Invented Name] can induce transitory inhibition of the function of platelets (blood components involved in clotting). If you suffer from blood clotting disturbances your doctor will induce measures for monitoring.
During long-term treatment with [Invented Name], changes to the retina of the eye (pigmentary degeneration) and cataract were occasionally observed. Please report any sign of blurred vision to your doctor as it may be a sign of this and requires a thorough ophthalmological examination.
Children and adolescents
[Invented Name] is not recommended for use in children and adolescents as there are no sufficient data on safety and efficacy in this patient-group.
Other medicines and [Invented Name]
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Acemetacin, the active substance of [Invented Name], should – like other NSAIDs – only be used with caution concomitantly with the following substances:
Concomitant use of more than one NSAID may increase the risk for gastrointestinal ulceration and bleedings due to synergistic effects. Therefore you should avoid concomitant use of [Invented Name] with other NSAIDs.
Concomitant use of [Invented Name] with digoxin, phenytoin or lithium may increase the plasma levels of these compounds.
NSAIDs may diminish the effect of diuretics and antihypertensives (e.g. ACE-inhibitors and angiotensin 2 antagonists). In patients with impaired kidney function (e.g. dehydrated patients or elderly patients) concomitant intake of ACE-inhibitors or angiotensin-2- antagonists with a NSAID may lead to further impairment of kidney function including potential acute kidney failure (usually reversible). Therefore, this combination should be used with caution, especially by elderly patients. If you use such a combination please be careful to ensure adequate liquid intake. Your doctor may wish to check your renal parameters regularly.
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Concomitant intake of [Invented Name] and potassium-sparing diuretics may lead to hyperkalaemia (elevated blood potassium levels).
Concomitant use of Glucocorticosteroids, platelet aggregation inhibitors (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (SSRIs) may increase the risk of gastrointestinal ulceration or bleeding.
When taken within 24 hours before or after administration of methotrexate, [Invented Name] may increase methotrexate blood concentration and therefore increase the toxic effects of methotrexate.
The risk of kidney damage due to cyclosporine is increased by concomitant administration of certain NSAIDs. This effect can also not be excluded for the combination of cyclosporine and acemetacin.
NSAIDs such as [Invented Name] may increase the effects of anti-coagulants (anti-clotting medicinal products, e.g. warfarin)
Interactions between certain NSAIDs and oral antidiabetic agents have been observed. Although such interactions have not been described for acemetacin and sulfonylureas your f blood glucose should be monitored during concomitant use.
Medicinal products containing probenecid or sulfinpyrazone may delay the elimination of acemetacin.
Furosemide (a diuretic agent) accelerates the elimination of acemetacin.
[Invented Name] should not be administered together with triamterene (a diuretic agent). Cases of acute kidney failure were observed due to additional administration of triamterene during treatment with [Invented Name].
[Invented Name] should not be used concomitantly with diflunisal (also an NSAID) because this may lead to an increase of the occurrence of side effects.
Acemetacin may delay the elimination of penicillin antibiotics.
Concomitant intake of [Invented Name] and other centrally acting medicinal products or alcohol requires special caution.
[Invented name] with alcohol
Concomitant intake of [Invented Name] and alcohol may increase the risk of the occurrence of acemetacin-related side effects, particularly side effects involving the gastrointestinal tract or the central nervous system.
Pregnancy, breast-feeding and fertility
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.
Pregnancy: During the first and second trimester of pregnancy [Invented Name] should not be given unless clearly necessary as it may adversely affect the pregnancy and/or the embryo/foetal development.
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If you attempt to conceive, or you are pregnant in the first and second trimester, the dose of [Invented Name] should be kept as low as possible and the duration of treatment as short as possible. [Invented Name] must not be used during the third trimester of pregnancy.
Breast-feeding: Treatment with [Invented Name] should be avoided during the breast-feeding period as small amounts of [Invented Name] are detectable in the breast milk.
Fertility:
Acemetacin may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems falling pregnant.
Driving and using machines
[Invented Name] has influence on the ability to drive and use machines due to the fact that [Invented Name] in high dosages may cause central nervous system side effects, such as sleepiness and dizziness. Concomitant use of alcohol increases these effects.
[Invented Name] contains lactose and azorubine (E122)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Azorubine (E122) may cause allergic reactions.
3. How to take [Invented Name]
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. [Invented Name] is dosed according to the severity of the disease.
The recommended doses are
Adults: The recommended daily dose range is 60 – 180 mg Acemetacin, divided into 1 to 3 single doses.
Acute gout: For the treatment of acute gout a daily dose of 180 mg Acemetacin is recommended until symptoms subside.
Elderly patients: Because elderly are at increased risk of serious consequences of adverse reactions the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during treatment with [Invented Name].
Patients with impaired kidney function or liver disease should be carefully monitored during treatment with [Invented Name].
Children and adolescents: [Invented Name] is not recommended for use in children and adolescents due to insufficient data on safety and efficacy in this patient group.
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Method of administration Oral use. Please swallow [Invented Name] unchewed and with a sufficient amount of liquid. You should not take [Invented Name] on an empty stomach.
If you have a sensitive stomach you should take [Invented Name] during a meal.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms.
Your doctor should decide on the duration of treatment. Treatment of rheumatic diseases may require intake of < invented name > over a longer period.
Treatment with a daily dose higher than 180 mg Acemetacin should only occur under the close supervision of the prescribing physician..
If you take more [Invented Name] than you should
Symptoms of overdose include central nervous system disturbances, such as headache, dizziness, sleepiness, disorientation, lethargy, decreased seizure threshold, unconsciousness up to coma, abdominal pain, nausea, vomiting, gastro-intestinal bleeding, sweating, disturbances of electrolytes (blood salts), high blood pressure, swelling of the ankles, reduced urine volume, blood in the urine, depressed respiration (breathing) as well as liver and kidney dysfunction.
In case of an overdosage please contact your doctor who will decide if symptomatic therapy and general supportive measures are necessary.
If you forget to take [Invented Name] Do not take a double dose to make up for a forgotten dose.
If you stop taking using [Invented name]
If you stop taking [Invented Name] you can put the success of your treatment at risk. Do not stop your treatment without first consulting your doctor.
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.
You can minimize the occurrence of side effects by using the lowest effective dose for the shortest duration necessary to control your symptoms.
For the occurrence of the following side effects it should be considered that they are predominantly dose dependent and vary individually.
The most commonly observed side effects are: - gastrointestinal side effects, such as peptic ulcers, perforation or gastrointestinal bleeding which can sometimes be fatal especially in elderly patients.Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena (black, tarry bowel motions),
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vomiting blood, mouth ulcers, worsening of colitis and Crohn’s disease. Less frequently gastritis. - fluid retention (edema), high blood pressure, heart failure - small increased risk of arterial blood clots (e.g. heart attack or stroke)
Very common: (may affect more than 1 in 10 people) Gastrointestinal Disorders: gastrointestinal symptoms such as nausea, vomiting, abdominal pain, diarrhoea, minor gastrointestinal blood loss (can cause anaemia in exceptional cases)
Common: (may affect up to 1 in 10 people) Immune System Disorders: hypersensitivity (allergic) reactions such as skin rash and itching Psychiatric Disorders: excitation Nervous System Disorders: central nervous system disturbances, such as headache, fatigue, sleepiness, dizziness Gastrointestinal Disorders: dyspepsia, flatulence, abdominal cramps, lack of appetite, gastric or intestinal ulcers (in certain circumstances with bleeding and perforation) Hepatobiliary disorders: increase in liver enzymes (transaminases)
Uncommon: (may affect up to 1 in 100 people) Immune System Disorders: hives Eye Disorders: double vision, pigmentary degeneration of the retina and cataract during long-term treatment, blurred vision Gastrointestinal Disorders: vomiting blood, melena (black, tarry bowel motions) or bloody diarrhoea Hepatobiliary disorders: liver damage (toxic hepatitis with or without jaundice) Skin and Subcutaneous Tissue Disorders: loss of hair Renal and urinary disorders: fluid retention (edema e.g. swelling of the ankles) especially in patients with high blood pressure or impaired kidney function)
Rare: (may affect up to 1 in 1,000 people) Psychiatric disorders: irritability
Very rare: (may affect up to 1 in 10,000 people) Infections and Infestations: deterioration of infectious inflammations (e.g. development of necrotizing fasciitis) If during the treatment with [Invented Name] signs of infections appear or worsen, please contact your doctor immediately. Blood and Lymphatic System Disorders: anemia due to haemolysis (destruction of red blood cells) or impaired blood formation (including red blood cells, white blood cells, platelets, or all of these), fever, sore throat, mouth ulcers, flu-like symptoms, abnormal fatigue, nosebleeds, bruising Influence on the aggregation of thrombocytes and increased risk of bleeding is possible. In these cases, the medicinal product should be discontinued immediately, and a doctor should be consulted. Immune system disorders: severe hypersensitivity reactions, such as face and eyelid edema (swelling), swollen tongue, edema of the larynx with airway constriction (angioneurotic edema), breathlessness up to asthma attack, tachycardia (rapid heartbeat), drop in blood pressure which may be life-threating These conditions, which can already occur after the first administration, require immediate medical intervention. Allergic inflammation of small blood vessels and/or airways. Endocrine disorders: elevated blood glucose (sugar), glucose in the urine Psychiatric disorders: psychological disorders, disorientation, anxiety, nightmares, trembling, psychosis, hallucinations, depression and transient unconsciousness up to coma Nervous system disorders: altered sensation, muscle weakness, hyperhidrosis, taste disturbances, impaired memory, insomnia, seizures Ear and Labyrinth Disorders: tinnitus (ringing in the ears), transient auditory disturbances Cardiac disorders: palpitations, chest pain (similar to angina pectoris), heart insufficiency
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Vascular disorders: high blood pressure Gastrointestinal Disorders: inflammation of the mouth or tongue, esophageal lesions, complaints of the lower abdomen (e.g. bleeding non-specific colitis, worsening of Crohn’s disease or ulcerative colitis), constipation, narrowing or blockage of the intestines, pancreatitis
You must immediately stop intake of this medicine and seek medical advice in case of severe abdominal pain, melena or hematemesis.
Hepatobiliary disorders: fulminant liver failure, also without early symptoms Skin and Subcutaneous Tissue Disorders: rashes or redness of the skin and mucous membranes, including eczema, photosensitivity, bruising, bleeding of the skin (also caused by hypersensitivity), serious skin reactions (blistering and/or peeling reactions including Stevens-Johnson-Syndrome, toxic epidermal necrolysis and Lyell’s syndrome). Renal and urinary disorders: disorders of passing urine, increase in blood urea levels, acute kidney failure, increased protein in the urine, blood in the urine or kidney damage Reproductive System and Breast Disorders: vaginal bleeding
Not known: frequency cannot be estimated from the available data Nervous system disorders: During therapy with [Invented Name] detoriation of symptoms of epilepsy and Parkinson’s disease may be possible. Psychiatric Disorders The symptoms of psychiatric diseases may increase during the treatment with [Invented Name].
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.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30C.
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: acemetacin Each capsule, hard contains 60 mg acemetacin The other ingredients are: Capsule content: Lactose monohydrate, sodium laurilsulfate, talc, magnesium stearate, Silica colloidal anhydrous,
Capsule shell Gelatine, titan dioxide (E171), azorubine (E122), Patent blue V (E131) iron oxide yellow (E172)
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What [Invented Name] looks like and contents of the pack
[Invented Name] is a hard gelatine capsule size 4 (14,3 mm x 53 mm) with an opaque ivory- coloured body and an opaque violet cap.
[Invented Name] is packed into blisters
[Invented Name] is available in packs of 20, 50 and 100 capsules, hard. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
DE/H/3936/001/DC: DE: Ziloxicum 60 mg Hartkapseln EL: Ziloxicum 60 mg καψάκιο, σκληρό HU: Ziloxicum 60 mg kemény kapszula LU: Ziloxicum 60 mg Hartkapseln MT: Ziloxicum 60 mg capsule, hard
DE/H/3937/001/DC: DE: Ziloxicum 60 mg Hartkapseln LU: Acemetax 60 mg Hartkapseln
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>. [To be completed nationally]
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