1. WHAT PAROXETIN NYCOMED IS AND WHAT IT IS USED FOR Therapeutic Group PAROXETIN NYCOMED 20 mg tablets belong to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Serotonin is normally present in the body. Low levels of serotonin are thought to be a cause of depression and other related conditions. Paroxetin Nycomed works by bringing the levels of serotonin back to normal. Indications Treatment and prevention of: - Depression. - Obsessive compulsive disorder. - Panic attacks in patients who may or may not also suffer from a fear of going into public places (agoraphobia). - Social anxiety disorder/social phobia. - Generalised anxiety disorder. - Post-traumatic stress disorder. 2. BEFORE YOU TAKE PAROXETIN NYCOMED Do not take Paroxetin Nycomed: - If you are hypersensitive (allergic) to paroxetin or any of the other ingredients of Paroxetin Nycomed 20 mg tablets - If you are taking medicines known as MAO inhibitors (another medicine used against depression) - If you are taking thioridazine (a major tranquilliser) - If you are taking pimozide (antipsychotic medicine) Treatment with paroxetine can be initiated: - two weeks after discontinuation of an irreversible MAO inhibitor, or - at least 24 hours after discontinuation of a reversible MAO inhibitor (e.g. moclobemide). At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAO inhibitor. 20 Take special care with Paroxetin Nycomed: - If your are under the age of 18 - If you have eye glaucoma, kidney, liver or heart disease - If you suffer from epilepsy or have a history of fits - If you have akathisia (an inability to sit or stand still usually associated with subjective distress) - If you have a history of mania (overactive behaviour or thoughts) - If you are having electro-convulsive therapy (ECT) - If you have a history of bleeding disorders - If you suffer from diabetes - If you have low blood sodium level Occasionally, the symptoms of your illness may include thoughts of harming yourself or committing suicide. Until the full effect of your medicine becomes apparent, it is possible that these symptoms may increase in the first few weeks of treatment. Tell your doctor immediately or go to the nearest hospital if you have any distressing thoughts or experiences during this initial period or at any other time. Use in children and adolescents under 18 years of age Paroxetin Nycomed 20 mg should normally not be used for children and adolescents under 18 years of age. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Paroxetin Nycomed 20 mg for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Paroxetin Nycomed 20 mg for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Sertralin Nycomed 20 mg. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Sertralin Nycomed 50 mg in this age group have not yet been demonstrated. Taking other medicines Paroxetin Nycomed can influence the effect of other medicines. Please inform your doctor if you are taking or have recently taken any other medicines even those not prescribed. You should also inform your doctor that you use Paroxetin Nycomed when another medicine is prescribed to you. It is especially important to inform your doctor if you are taking: - Medicines used to treat certain psychiatric disorders (anti-psychotics). - Medicines containing tryptophan (an amino acid that is transformed into serotonin in the body). - Triptans (medicines for the treatment of migraine). - Other antidepressants, lithium or medicines affecting the central nervous system (CNS). - Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD). - Cimetidine (medicine against peptic ulcers). - Phenytoin (against epilepsy) or other medicines used to prevent seizures. - Warfarin or other medicines used to prevent blood clotting. - Procyclidine (a medicine used to relieve tremor, especially in Parkinson’s disease). - Medicines containing dextromethorphan, a cough suppressant. - Medicines used to treat an irregular heartbeat (Type 1c antiarrhythmics) and metoprolol (a betablocker used to treat high blood pressure and heart disorders). - Acetyl salicylic acid or other painkillers known as “NSAIDs” (non-steroidal anti-inflammatory drugs). - A herbal remedy hypericum perforatum (St. John’s wort). Taking Paroxetin Nycomed with food and drink Taking Paroxetin Nycomed it is not allowed to drink alkohol. 21 Pregnancy and breast-feeding Epidemiological studies suggest a small increased risk of cardiovascular malformations associated with the use of paroxetine during the first trimester of pregnancy. Paroxetin may be used during pregnancy only if specifically prescribed by the doctor. Paroxetin Nycomed is known to be excreted in breast milk. Its effects on the nursing infant have not been established, ask your doctor for advice before you take any medicine. Driving and using machines Take care when driving and using machinery until you know how this medication affects you. Important information about some of the ingredients of Paroxetin Nycomed If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE PAROXETIN NYCOMED Always take Paroxetin Nycomed exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Note that the doctor could have prescribed this medicine for another indication and/or dosage than indicated on this leaflet. Adults (18-65 years) The dose is individual, and is determined by your doctor. The normal dose is usually between 10 mg (1/2 tablet) and 60 mg (3 tablets) per day depending upon the medical condition being treated. Your doctor may decide that you are beginning with a lower dose or that the dose is increased. It is recommended to take tablets once daily in the morning with food. Tablets (or half tablets) must be swallowed whole and not chewed. Elderly The maximum dose for elderly patients is 40 mg per day. Patients with liver or kidney disease If you have liver or kidney disease, your doctor may prescribe a lower dose of Paroxetin Nycomed than usual. If you have the impression that the effects of Paroxetin Nycomed is too strong or too weak, talk with your doctor. For how long should you take Paroxetin Nycomed Paroxetin Nycomed will not relieve your symptoms straightaway. You should start to feel better after a week or two, although it may take longer. Even after you start to feel better it is important to continue to take your tablets for as long as your doctor recommends If you take more Paroxetin Nycomed than you should If you have accidentally taken to many Paroxetin Nycomed tablets, consult your doctor or nearest hospital. Remember to take your tablets with you. If you forget to take Paroxetin Nycomed Leave of that dose completely. Take your next dose normally. If you stop taking Paroxetin Do not stop taking Paroxetin Nycomed until your doctor tells you to. Your doctor will usually advise you to slowly reduce the dose over a number of weeks. When you stop taking Paroxetin Nycomed, 22 especially if you do so suddenly, you may have side-effects. Please see the next section of this leaflet called “Possible side-effects”. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Paroxetin Nycomed can cause side effects, although not everybody gets them. Very common adverse effects (more than 1 in 10 people) Nausea and sexual disturbances. Common adverse effects (more than 1 in 100 people) Decreased appetite, somnolence, insomnia, agitation, dizziness, tremor, blurred vision, yawning, constipation, diarrhoea, dry mouth, sweating, asthenia, gain in bodyweight. Uncommon side effects (more than 1 in 1000 people) Abnormal bleeding of the skin and mucous membranes (ecchymosis), confusion, hallucinations, skin rashes, pruritus, urinary retention. Your doctor is informed about rare adverse effects (less 1 in 1000 people) and very rare adverse effects (less than 1 in 10.000 people). Some adverse effects listed above may be also caused by your disease, not Paroxetin Nycomed. People may experience side effects also after stopping the treatment. For the majority of people, symptoms go away on their own within 2 weeks. Please see your doctor if you are worried about side-effects when taking or stopping the use of Paroxetin Nycomed. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE PAROXETIN NYCOMED Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions Do not use after the expiry date stated on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Paroxetin Nycomed contains - The active substance is paroxetin (as anhydrous paroxetine hydrochloride). One film-coated tablet contains paroxetine hydrochloride anhydrous 22,2 mg equivalent to 20 mg paroxetin. - The other ingredients are: magnesium stearate, sodium starch glycolate (Type A), anhydrous lactose, hyprolose (Type LF), hypromellose, macrogol 8000 and titanium dioxide (E171). What Paroxetin Nycomed looks like and contents of the pack 23 White, oval-shaped, biconvex, film-coated tablets. The tablets are engraved “20” with a breakline on one side, the reverse side is plain. Packsize: 4, 12, 14, 20, 28, 30, 50, 56, 60, 100 tablets in blister and in outer carton Not all pack sizes may be marketed.