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Package leaflet: Information for the patient Dolestan® forte 50 mg Tablets Active substance: diphenhydramine hydrochloride 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 has 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 or pharmacist. 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. What is in this leaflet 1. 2. 3. 4. 5. 6. 1. What Dolestan® forte is and what it is used for What you need to know before you take Dolestan® forte How to take Dolestan® forte Possible side effects How to store Dolestan® forte Contents of the pack and other information What Dolestan® forte is and what it is used for Dolestan® forte is a soporific that belongs to the antihistamine group. Dolestan® forte is used for the short-term treatment of sleep disorders. 2. What you need to know before you take Dolestan® forte Do not take Dolestan® forte: - if you are allergic to diphenhydramine hydrochloride, other antihistamines or any of the other ingredients of this medicine (listed in section 6), - if you suffer from acute asthma, - if you suffer from angle-closure glaucoma, - if you suffer from a specific tumour of the medulla of the adrenal glands (phaeochromocytoma), - if you have an enlarged prostate with postvoid residual urine, - if you suffer from epilepsy, - if you suffer from potassium or magnesium deficiency, 1 - if you have a slow heartbeat (bradycardia), - if you suffer from specific heart disorders (congenital QT syndrome or other clinically significant heart defects, in particular coronary heart disease, conduction disorders, arrhythmia), - if you at the same time take medicines that also prolong the so-called QT interval in the ECG or cause hypokalaemia (see "Other medicines and Dolestan® forte"), - if you consume alcohol or take so-called MAO inhibitors (medicines used to treat depression) at the same time, - during pregnancy or breast-feeding. Warnings and precautions Talk to your doctor or pharmacist before taking Dolestan® forte. Take special care with Dolestan® forte if you suffer from one of the following diseases: - impaired liver function, - chronic lung diseases or asthma, - specific forms of stomach dysfunction (pylorostenosis or achalasia of the cardia). When soporifics are taken over a longer period of time, you may experience a loss of efficacy (tolerance). Like with other soporifics, taking Dolestan® forte may result in physical and psychological dependence. The risk of a dependency increases with the dose and duration of treatment. This risk is also increased in patients with a history of alcohol or (recreational) drug dependency. When treatment with Dolestan® forte is terminated, stopping it suddenly may cause sleep disorders to temporarily recur. It is therefore recommended to terminate treatment by gradually tapering the dose if required. Children and adolescents Dolestan® forte is not recommended for the treatment of children and adolescents under 14 years. A low-dose dosage form is available for adolescents. Other medicines and Dolestan® forte Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. Diphenhydramine hydrochloride must not be given at the same time as so-called "MAO inhibitors" (specific medicines used to treat depression). Taking Dolestan® forte at the same time as other medicines that also contain diphenhydramine, including ones for external use, should be avoided. When used at the same time as other CNS depressants such as soporifics, painkillers or anaesthetic drugs, tranquillisers (anxiolytics), medicines used to treat depression or medicines used to treat seizures (antiepileptic drugs), the medicines may enhance the effect of one another. 2 The so-called "anticholinergic" effect of diphenhydramine may be enhanced by substances with a similar effect such as atropine, biperiden, tricyclic antidepressants or monoamine oxidase inhibitors. An increase in intraocular pressure, urinary retention or a possibly life-threatening bowel paralysis may occur. Use of diphenhydramine at the same time as medicines decreasing blood pressure may cause increased tiredness. Using this medicine at the same time as medicines that also prolong the so-called QT interval in the ECG, e.g. medicines used to treat hearth rhythm disorders (class IA or III antiarrhythmic agents), specific antibiotics (e.g. erythromycin), cisapride, antimalarials, medicines used to treat allergies or stomach/intestinal ulcers (antihistamines) or medicines used to treat specific mental health disorders (neuroleptic medications) or substances that may cause potassium deficiency (e.g. specific diuretic medications) should be avoided. Diphenhydramine may distort results of allergy tests and should therefore not be taken for at least 3 days before an allergy test. Dolestan® forte with food, drink and alcohol No alcohol may be consumed during treatment with Dolestan® forte since this will unpredictably alter and enhance the effect of diphenhydramine. Pregnancy and breast-feeding 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. Dolestan® forte must not be taken during pregnancy and breast-feeding. Driving and using machines You must not drive or operate dangerous machines after taking Dolestan® forte. Residual tiredness and slowed reaction time may adversely affect the ability to drive and use machines even on the day after taking the medicine, in particular if you have not slept enough. 3. How to take Dolestan® forte Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless prescribed otherwise by your doctor, the usual dose for adults is 1 tablet (equivalent to 50 mg diphenhydramine hydrochloride). This dose should not be exceeded. 3 Patients with impaired liver or kidney function should receive lower doses. In elderly or weakened patients, who may possibly react sensitively, it is recommended to adjust the dose if required. Use in children and adolescents Dolestan® forte is not recommended for the treatment of children and adolescents under 14 years. A low-dose dosage form is available for adolescents. Method of administration Take the tablets 30 minutes before going to bed in the evening with some liquid (water), without chewing. Ensure that you will be able to sleep for long enough after taking the medicine (7-8 hours). Duration of administration The duration of treatment should be as short as possible. It should in general only be a few days and not exceed 2 weeks. If your sleep disorder persists, please consult a doctor! Talk to your doctor or pharmacist if you think that the effect of Dolestan® forte is too strong or too weak. If you take more Dolestan® forte than you should Diphenhydramine overdoses can be dangerous, in particular for children and toddlers. For that reason, a doctor must be consulted immediately if an overdose or poisoning is suspected (e.g. poisons information service)! The forms in which diphenhydramine overdoses manifest primarily depend on the amount taken, and they are characterised by disorders affecting the central nervous system (confusion, agitation to the point of seizures, clouding of consciousness to the point of coma, breathing problems to the point of apnoea) and cardiovascular system. Furthermore, increased muscle reflexes, fever, dry mucosa, visual disturbances, constipation and urinary disorders may occur. Rhabdomyolysis (severe muscular damage) has also been observed. If you forget to take Dolestan® forte Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The stated frequencies of the side effects are based on the following categories: Very common: Common: Uncommon: Rare: Very rare: Not known: may affect more than 1 in 10 treated may affect 1 to 10 in 100 treated may affect 1 to 10 in 1,000 treated may affect 1 to 10 in 10,000 treated may affect less than 1 in 10,000 treated cannot be estimated from the available data Possible side effects: Nervous system disorders: Common: drowsiness, lightheadedness and problems concentrating on the day after taking the medicine, in particular if the patient has not slept enough, dizziness, headache. Eye disorders: Common: visual disturbances. Cardiac disorders: specific heart rhythm disorders (prolonged QT interval in the ECG) may occur during treatment with Dolestan® forte. Gastrointestinal disorders: Common: gastrointestinal complaints such as feeling and being sick or diarrhoea and so-called "anticholinergic effects" such as dry mouth, constipation, heartburn. Musculoskeletal and connective tissue disorders: Common: muscle weakness. Renal and urinary disorders: Common: complaints when passing water. Furthermore, hypersensitivity reactions, increased sensitivity of the skin to light, blood count changes, increased intraocular pressure, jaundice (cholestatic icterus) and socalled "paradoxical reactions" such as restlessness, nervousness, agitation, anxiety, trembling or sleep disorders have been reported. 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 5. How to store Dolestan® forte 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 carton and container after "EXP". The expiry date refers to the last day of that month. Storage conditions: Do not store above 30 °C. Store in the original package in order to protect from moisture. 6. Contents of the pack and other information What Dolestan® forte contains The active substance is diphenhydramine hydrochloride. One tablet contains 50 mg diphenhydramine hydrochloride. The other ingredients are: microcrystalline cellulose, cellulose granules, powdered cellulose, potato starch, magnesium stearate, talc, colloidal silica. What Dolestan® forte looks like and contents of the pack Dolestan® forte are white tablets with one-sided score line and "Dolestan forte" embossed on one side. Dolestan® forte is available in packs of 20 tablets (N2). Marketing Authorisation Holder and Manufacturer Krewel Meuselbach GmbH Krewelstr. 2 53783 Eitorf tel: +49 (0)2243 / 87-0 fax: +49 (0)2243 / 87-175 e-mail: [email protected] This leaflet was last revised in March 2014. 6