The active substance is amlodipine. Each tablet contains 5 mg of amlodipine (as amlodipine besilate).
Excipients/Inactive Ingredients: The other ingredients are Microcrystalline cellulose; Anhydrous Calcium Hydrogen Phosphate; Sodium starch glycolate (type A) and magnesium stearate.
Afiten belongs to a group of medicines called calcium-channel blockers.
If the patient suffers from high blood pressure, Afiten works by relaxing blood vessels, so that blood passes through them more easily.
If the patient suffers from angina, Afiten works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Afiten does not provide immediate relief of chest pain from angina.
Afiten is used to treat: high blood pressure; chest pain due to narrowing of the coronary arteries of the heart muscle (angina pectoris) or the more rare form of chest pain caused by cramping of the coronary arteries of the heart muscle (vasospastic angina).
Always take this medicine exactly as the doctor has told. Check with the doctor or pharmacist if the patient is not sure.
Adults: The recommended dose is 5 mg daily. If necessary the dose can be raised to 10 mg once daily after 2-4 weeks.
Elderly: The dose must be adjusted. Follow the doctor's instructions. Any increase in dose requires caution.
Impaired liver function: The dose must be reduced. Follow the doctor's instructions.
The tablet should be taken with a glass of water.
If the patient takes more Afiten than they should: If the patient accidentally takes too many tablets, the following symptoms may be appeared: extreme dizziness and/or very light feeling in the head, difficulty in breathing, increased urine output. Contact the nearest hospital accident and emergency department or tell the doctor immediately.
If the patient forgets to take Afiten: If the patient has forgotten to take a tablet, they can still take it up to 12 hours after they usually take the tablet. If it is more than 12 hours after the time that they should have taken the tablet, they should not take the missed dose and they should take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.
If the patient stops taking Afiten: The treatment must only be changed or stopped in consultation with the doctor.
If the patient has any further questions on the use of this product, ask the doctor or pharmacist.
Do not take Afiten: if the patient is allergic to amlodipine or any of the other ingredients of this medicine (listed in Description); if the patient has very low blood pressure; in states of shock; if the patient has haemodynamically unstable heart failure after acute myocardial infarction; if the patient has narrowing of the aorta (aortic stenosis).
Talk to the doctor before taking Afiten if the patient: has poor heart function (e.g. heart failure); has impaired liver function; is undergoing dialysis; is elderly and increase of the dosage is needed.
Driving and using machines: Use of Afiten may possibly give side effects, such as dizziness, headache, fatigue or nausea, that to a greater or lesser degree may affect safety at work and in traffic.
Use in Children: Children and adolescents: As experience is insufficient, use of Afiten in children and adolescents (below 18 years old) is not recommended.
Pregnancy, breastfeeding and fertility: If the patient is pregnant, or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: The patient must only take Afiten on the doctor's instructions.
Breastfeeding: If the patient is breastfeeding she must not take Afiten.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the doctor immediately if the patient experiences any of the following side effects: Very rare (may affect up to 1 in 10,000 people): Serious skin reactions, e.g. inflammation and ulceration of the skin, and swelling of the face, larynx, arms, legs and breathing problems (angio-oedema).
Chest pain or an assumed heart attack.
Yellowing of the eye whites or skin (jaundice).
Unexplained fever, flu-like symptoms such as sore throat. These may be signs of a decreased white blood cell count (leucopenia).
Increased tendency to develop bruises or nasal bleeding. These may be signs of decreased blood platelets (thrombocytopenia).
If any of these side effects appears the patient must see the doctor immediately.
Other side effects: Common (may affect up to 1 in 10 people): Headache (especially at the start of treatment), somnolence, dizziness, nausea, stomach pains, red face with sensation of warmth, swollen ankles and generalized swelling (oedema) and weakness (fatigue).
Uncommon (may affect up to 1 in 100 people): Breast development in men, dyspepsia, dry mouth, tingling in the skin, decreased skin sensitivity (hypoesthesia), increased sweating, visual disturbances, tinnitus (ringing in the ears), sleeplessness, mood changes (including anxiety), depression, tremor, fainting, abnormal heartbeat (palpitation), pain.
Low blood pressure, shortness of breath, running nose, vomiting, diarrhoea, taste distortion, constipation, skin rash, itching, hair loss, skin discoloration, purpura, cramp, back pain, muscle and joint pain, increased need to urinate (increased micturition frequency), passing abnormally large quantity of urine during the night, increased urinary frequency, impotence, weight gain or weight loss, generally feeling unwell.
Rare (may affect up to 1 in 1,000 people): Confusion.
Very rare (may affect up to 1 in 10,000 people): High blood sugar, nerve disease (peripheral neuropathy), increased muscle stiffness (hypertonia), cough, inflammation of the pancreas, liver or of the stomach lining, increased liver enzyme level in the blood, swollen gums, inflammation of blood vessels, abnormal or irregular heart rhythm; increased sensitivity of the skin to the sun.
Not known: Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. By reporting side effects the patient can help provide more information on the safety of this medicine.
Tell the doctor or the pharmacist if the patient is taking, has recently taken or might take any other medicines. Always tell the doctor or pharmacist if the patient is using or receiving any of the following medicines in addition to Afiten: ketoconazole, itraconazole (against fungal infections) or ritonavir (an AIDS drug), as the amlodipine concentration may be raised; rifampicin, as the amlodipine concentration may be reduced; natural remedies that contain St. John's wort (Hypericum perforatum), as the amlodipine concentration may be reduced; other blood pressure lowering drugs and diuretics, as amlodipine may strengthen their action; tacrolimus (used to control the body's immune response, enabling the body to accept the transplanted organ); clarithromycin (for infections caused by bacteria).
Afiten with food, drink and alcohol: The patient can take Afiten with food and drink.
Store below 25°C.
Do not throw away any medicine via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Tab 5 mg (round, white) x 3 x 10's.
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