PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 PACKAGE LEAFLET 1

2 PACKAGE LEAFLET: INFORMATION FOR THE USER Vasexten 10, 10 mg modified release capsules Vasexten 20, 20 mg modified release capsules barnidipine hydrochloride Read all of this leaflet carefully before you start taking this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - 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. In this leaflet: 1. What Vasexten is and what it is used for 2. Before you take Vasexten 3. How to take Vasexten 4. Possible side effects 5. How to store Vasexten 6. Further information 1. WHAT VASEXTEN IS AND WHAT IT IS USED FOR The active substance of Vasexten belongs to the group of medicines called calcium antagonists. Vasexten causes blood vessels to dilate thereby lowering blood pressure. Vasexten capsules are made in a prolongedrelease form. This means that the active substance gets absorbed into your system gradually and has a longer lasting effect. That is why taking the dose once daily is sufficient. Vasexten is used to treat high blood pressure. 2. BEFORE YOU TAKE VASEXTEN Do not take Vasexten - if you are allergic (hypersensitive) to barnidipine or any of the other ingredients of Vasexten. - if you are allergic (hypersensitive) to dihydropyridines (found in medicines to treat high blood pressure) - if you suffer from liver disease. - if you suffer from severe kidney disease. - if you suffer from these specific heart diseases: untreated heart failure, certain forms of pain on the chest (unstable angina pectoris) or acute cardiac arrest. - if you use one of the following other medicines: protease blockers (medicines used to treat AIDS), ketoconazole or itraconazole (medicines to treat yeast infections), erythromycin or claritromycin (antibiotics). Take special care with Vasexten - if you suffer from a kidney disease. - if you suffer from a heart disease. Vasexten is not to be used in children or adolescents under 18 years. Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Vasexten starts. 2

3 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. This is especially important if you use one of the following medicines as they MUST not be used together with Vasexten: - protease blockers (medicines used to treat AIDS), - ketoconazole or itraconazole (medicines to treat yeast infections), - erythromycin or claritromycin (antibiotics). Also inform your doctor if you are taking: - other medicines to treat high blood pressure as they may cause your blood pressure to fall even more. - cimetidine (medicine against stomach problems) as they may increase the effect of Vasexten. - phenytoin or carbamazepine (medicines used to treat epilepsy), or rifampicin (an antibiotic) as higher dose of Vasexten may be needed. If you stop treatment with these medicines, your doctor may lower the dose of Vasexten. Taking Vasexten with food and drink Take special care when drinking alcohol or grapefruit juice, as these may cause an increase in the effect of Vasexten. Take Vasexten preferable with a glass of water. You can take the capsules before, during and after a meal. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You should not use Vasexten during pregnancy unless clearly necessary. Do not use Vasexten if you breast feed. Barnidipine may get into your breast milk. Driving and using machines There is no information to suggest that Vasexten affects your ability to drive or use machines. However Vasexten may cause dizziness, so make sure you know how this medicine affects you before you drive or use machines Important information about some of the ingredients of Vasexten Vasexten capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine. 3. HOW TO TAKE VASEXTEN Instructions for proper use - Take the capsule once daily, in the morning. It is advisable to associate taking the capsule with something you do on a daily basis, like brushing your teeth or having breakfast - Swallow the capsules whole, preferably with a glass of water. You can take Vasexten before, during or after a meal, according to your preference. - Even though you may not feel any signs or symptoms of high blood pressure, it is important to continue to take Vasexten every day to get the full benefits of blood pressure reduction. Dosage Always take Vasexten exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is 1 capsule Vasexten 10 mg once daily. Your doctor may increase this dose to 1 capsule of Vasexten 20 mg, once daily or 2 capsules of Vasexten 10 mg, once daily. If you are older you can use the normal dosage. Your doctor will most likely monitor you more closely at the start of the treatment. 3

4 If you take more Vasexten than you should If you have accidentally taken a large amount of capsules at once, you should immediately contact your doctor or have someone bring you to the hospital emergency room. Possible symptoms followed by an overdose are weakness, slow heart rate, drowsiness, confusion, nausea, vomiting and convulsions. If you forget to take Vasexten If you forget to take Vasexten at your usual time take the capsule as soon as possible on that same day. If you only remember the following day do not take a double dose to make up for the forgotten capsule,. Simply continue with your regular daily dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Vasexten can cause side effects, although not everybody gets them.. Vasexten may cause the following: Very common side effects (likely to affect more than 1 in 10 patients): - headache - facial redness - fluid accumulation (edema) in arms or legs Common side effects (likely to affect more than 1 in 100 and less than 1 in 10 patients): - dizziness - palpitations These side effects usually lessen or disappear during treatment (within one month for fluid accumulation and within two weeks for facial redness, headache and palpitations). 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 VASEXTEN Keep out of the reach and sight of children. Store Vasexten capsules below 25 ºC. Do not use Vasexten after the expiry date which is stated on the packaging after EXP. 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 Vasexten contains - The active substance is 10 mg or 20 mg barnidipine hydrochloride equivalent to 9.3 and 18.6 mg barnidipine per capsule, respectively. - Other ingredients are capsule content: carboxymethylethylcellulose, polysorbate 80, sucrose, ethylcellulose and talc. capsule case: titanium dioxide (E171), yellow iron oxide (E172) and gelatine. print ink: shellac, industrial-methylated alcohol, propylene glycol (E1520), purified water, n-butanol, isopropyl alcohol and black iron oxide (E172). 4

5 What Vasexten looks like and contents of the pack The capsules are yellow. Vasexten 10 carries the code Vasexten 20 carries the code Vasexten capsules are packaged in aluminium-aluminium blister packs (with PVC and polyamide coating) in cardboard boxes of 10, 14, 20, 28, 30, 50, 56, 98 or 100. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Astellas Pharma Europe B.V. Elisabethhof EW Leiderdorp. The Netherlands Telephone: This medicinal product is authorised in the Member States of the EEA under the following names:> Belgium, Greece, Italy, Netherlands, Luxemburg, Portugal, Spain: Vasexten This leaflet was last revised/approved on 20 February