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AMLOPIN table. 5 mg. 30 tablets

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AMLOPIN table. 5 mg. 30 tablets

WHAT AMLOPIN AND WHAT IT IS USED FOR ? Amlopin belongs to a group of medicines called calcium channel blockers . Amlopin administered for the treatment of: • high blood pressure • chest pain due to narrowing of the coronary arteries of the heart muscle ( angina) or the rarest form of chest pain caused by spasm of the coronary arteries of the heart muscle ( vasospastic angina ) If you suffer from high blood pressure. acting through Amlopin relaxation of the blood vessels as a result of which the blood flow more easily through them. If you suffer from angina pectoris, Amlopin works by improving blood flow to the heart muscle. which receives more oxygen and as a result prevent chest pain. Amlopin not provide immediate relief of chest pain in angina pectoris . 2. BEFORE YOU TAKE AMLOPIN Do not take Amlopin ® • if you are allergic to amlodipine or similar calcium channel blockers ( also called dihydropyridine derivatives) or any of the other ingredients ( for a full list of excipients, see section 6) • If you have very low blood pressure • if you suffer from insufficient blood supply to your tissues with symptoms such as low blood pressure. weakened pulse, heart rate increased (shock. including cardiogenic shock). Cardiogenic shock is shock caused by serious heart problems. • if you have heart failure after a heart attack within the last four weeks • if you suffer from a narrowing of the aorta (aortic stenosis) • if you have heart-related chest pain at rest or with minimal effort ( unstable angina) . Take special care with Amlopin Tell your doctor before starting treatment : • if you have heart failure • If you have reduced liver function • If you have reduced kidney function . Children and adolescents ( under 18 years) Amlopin should not be used in children because of lack of experience. Taking other medicines Some medicines (including medicines obtained without a prescription. herbal or natural products ) can interact with Amlopin. This means that the effect of each drug can be altered . Therefore, it is important to tell your doctor if you are taking any of these medicines: • Drugs that can lower blood pressure. for example. beta - blockers, ACE inhibitors, alpha 1 blockers, and diuretics. Amlopin may enhance the blood pressure lowering effect of these drugs. • Diltiazem (heart medicine) may increase the effects of Amlopin ®. • Ketoconazole and itraconazole ( anti - gybichkovi drugs ) may enhance the effect of Amlopin . • HIV protease inhibitors (antiviral medication for the treatment of infection with the AIDS virus, for example. Ritonavir) may enhance the effect of Amlopin . • clarithromycin, erythromycin and telithromycin (antibiotics) may enhance the effect of Amlopin . • Nefazodone (a medicine used to treat depression ) may increase the effects of Amlopin . • Rifampicin and rifabutin (antibiotics) may reduce the effect of Amlopin . • St. John's wort (a herbal medicine used to treat depression) may reduce the effect of Amlopin . • Dexamethasone ( cortisone ) may decrease the effect of Amlopin . • phenobarbital, phenytoin and carbamazepine (medicines for epilepsy ) may decrease the effect of Amlopin . • Nevirapine ( antiviral drug) may reduce the effect of Amlopin . Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Amlopin with food and drink Amlopin must be taken with a glass of liquid (e. g. water glass ), with or without food. Concomitant intake of grapefruit or grapefruit juice does not affect the effect of amlodipine. Pregnancy and lactation If you are pregnant or if you become pregnant during treatment. do not take Ampopin. unless specifically prescribed by your doctor. There are insufficient data to assess the risk to the baby amlodipine in Ask your doctor or pharmacist before taking any drug . Driving and using machines Be careful when driving or operating machinery when taking this medicine. Amlopin may not directly affect your ability to drive or operate machinery. Some patients, however. experience side effects such as dizziness or drowsiness associated with a decrease in blood pressure (see section 4 of this leaflet ). Such side effects are more likely to occur at the beginning of treatment or after Amlopin2 increasing dose. If you experience these side effects. you should refrain from driving and other activities requiring alertness . H. HOW TO TAKE AMLOPIN ? Always take Amlopin ® exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist. dosage: adults The usual starting dose is 5 mg once daily. If necessary. your doctor may increase the dose to 10 mg once daily. Children and adolescents (under 18 years) Amlopin ® should not be used in children and adolescents. Elderly No specific dose in the elderly. it is necessary. however. careful dose escalation . If you have kidney problems normal recommended dose. Amlopin can not be removed from the blood by dialysis ( artificial kidney ). Amlopin ® should be used with caution in patients on dialysis. If you have liver problems dose required for patients with liver problems has not been determined. If you have liver problems Amlopin ® should be administered with caution (see also section " Take special care with Amlopin " ) . How to take your medicine ? Swallow the tablets with a glass of water. You can take it with or without food. If you take more dose Amlopin If you or someone else may have taken too much Amlopin. contact your doctor. emergency room or poison center immediately. Person to whom this applies must be placed in a supine position with your hands and feet ( on several pillows, for example). Symptoms of overdose may include: severe dizziness and / or vertigo, breathing problems, frequent urination. If you forget to take Amlopin ® If you forget to take a tablet. you can still take it within 12 hours after the usual time that you take. If it's been more than 12 hours after the time of _ intake, skip the missed dose and take the next tablet at the usual time. Never take a double dose Amlopin ®, to make up the missed dose. If you stop taking Amlopin Your doctor has told you how long you should take Amlopin *. If you suddenly stop treatment your symptoms may recur. Do not stop treatment earlier than recommended without discussing it with your doctor. Amlopin ® is typically used for long-term treatment . If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Amlopin ® can cause side effects, although not everybody gets them . If any of the side effects gets serious. or you notice other effects not listed in this leaflet. please tell your doctor or pharmacist.

During treatment with Amlopin the following adverse reactions : Blood and Lymphatic ( Blood and lymphatic system ) Very rare: - A reduced number of white blood cells. which can cause an unexplained fever. sore throat. and flu-like symptoms ( leucopenia) - Reduced number of platelets in the blood, which can cause easy bruising or bleeding from the nose (thrombocytopenia) Hormones ( endocrine system) Uncommon: breast enlargement in men Metabolism Very rare: increase the level of blood sugar Psychiatric disorders Uncommon: sleep disturbances. irritability. depression Rare: confusion, mood changes, including anxiety Nervous System Disorders Common: headache ( especially at the beginning of treatment). somnolence, dizziness. weakness Uncommon: malaise, dry mouth, uncontrolled trembling ( tremor). feeling the prick of needles (paraesthesia), increased sweating Rare: changes in taste Very rare: pain or numbness in the hands and feet ( peripheral neuropathy) Eye disorders Uncommon: vision problems Ear and labyrinth Uncommon: ringing or buzzing in the ears ( tinnitus) Heart ( heart disease) Common: rapid or irregular heartbeat ( palpitations) Uncommon: seizures. increased heart rate (tachycardia). chest pain, early treatment may deteriorate angina in isolated cases have occurred following side effects. but the relationship to treatment with Amlopin ® is not sure. heart attack (myocardial infarction ). irregular heartbeat and chest pain ( angina pectoris ) vascular disorders Uncommon: low blood pressure. inflammation of the blood vessels Lungs, breathing and chest (respiratory. thoracic and mediastinal disorders) Uncommon: difficulty breathing. inflammation of the nasal mucosa ( rhinitis). Very rare. cough Gastrointestinal Disorders Common: nausea, digestive problems. stomach pain Uncommon. vomiting, diarrhea. constipation. swelling of the gums ( gingival hyperplasia) Very rare: inflammation of the lining of the stomach ( gastritis ), inflammation of the pancreas ( pancreatitis) Liver and bile ( hepatobiliary disorders) Rare: elevation of certain liver enzymes. yellowing of the skin or whites of the eyes. this could be a result of impaired liver function or liver inflammation Skin ( Skin and subcutaneous tissue) Very common: swollen ankles Common: flushing and feeling of warmth ( especially at the beginning of treatment) Uncommon: pinprick sensation and tingling of the skin ( exanthema ). pruritus, rash nettle. hair loss, change in skin color. purpura Very rare. allergic reaction with swelling of the face or extremities, swelling of the lips or tongue. swelling of the mucous membranes of the mouth and throat. leading to shortness of breath and difficulty swallowing - ( angioedema) - If this occurs immediately contact emergency room or doctor. In isolated cases occurred allergic skin rash with irregular red spots caused by drugs ( erythema multiforme exudativum ) or severe allergic reactions with blistering of the skin and mucous membranes ( Collagenist - liativen dermatitis

Muscles and bones ( Musculo - skeletal ) Uncommon: muscle cramps. back pain. pain in muscles and joints Kidney ( Renal and urinary ) Uncommon: increased need to urinate ( high frequency) Genitals and breasts ( Reproductive system and breast ) Uncommon: impotence General disorders Uncommon: increase or decrease in body weight. 5. HOW TO STORE AMLOPIN Keep out of reach of children. Amlopin not use after the expiry date stated on the pack. The expiry date refers to the last

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 ADDITIONAL INFORMATION What does Amlopin ? Amlopin 5 mg tablets • The active ingredient is amlodipine. Each tablet contains 5 mg of amlodipine (in the form of amlodipine besylate). • The other ingredients are microcrystalline cellulose. calcium hidrogenfrsfat anhydrous. sodium starch glycolate (type A ) and magnesium stearate. Amlopin 10 mg tablets • The active ingredient is amlodipine. Each tablet contains 10 mg of amlodipine (in the form of amlodipine besylate). • The other ingredients are microcrystalline cellulose. calcium hydrogen phosphate anhydrous. sodium starch glycolate (type A ) and magnesium stearate. Amlopin6 looks like and contents of pack " Amlopin 5 mg tablets White or almost white. oblong tablet with bevelled edges. scored on one side and marked with " 5 "on the other side. The score line is only to facilitate breaking of the tablet for easy swallowing and not to separate the same two equal doses. The separation of the tablet, one side should be taken immediately after the other. . Amlopin 10 mg tablets White or almost white. oblong tablet with bevelled edges. scored on one side and marked " 10 ° on the other side . The tablet can be divided into two equal halves. Your tablets are available in : • Packaging perforated unit dose blisters 10. 14, 20, 28. 30, 50. 60, 1 00, 1 20 and tablets 50 x 1 tablet • Plastic bottles of 20. 30, 50. 60, Not all pack sizes may be marketed.

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