Ascivasc 5 mg Tablets

ASCIVASC contains the active substance amlodipine which belongs to a group of medicines called selective calcium channel blockers. ASCIVASC is used:

• To treat high blood pressure (hypertension)
• To treat angina pectoris, which is characterised by chest pain and discomfort.

Your doctor may prescribe you ASCIVASC together with other medicines used to lower your blood pressure.

Do not take ASCIVASC:

• If you are hypersensitive (allergic) to amlodipine, other calcium channel blockers or any of the other ingredients of ASCIVASC (listed in section 6).
• If you have severe low blood pressure
• If you have had shock or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
• If you have aortic stenosis (narrowing of the heart valve of the aorta)
• If you recently (within the past 28 days) suffered a heart attack.
• If you have unstable angina (chest pain which may occur when you are resting).
• If you are pregnant or breastfeeding.

Warnings and precautions

Tell your doctor before taking ASCIVASC:

• If you have severe liver problems. Your doctor may need to monitor your liver function and adjust your dose of ASCIVASC accordingly.
• If you suffer from heart failure.
• If you are 65 years or older.
• If you suffer from severe kidney problems.
• If you suffer from diabetes
• If you have porphyria (a group of disorders that result in a buildup of natural chemicals called porphyrins in your body)
• If you experience chest pain while taking ASCIVASC.
• If you have low blood pressure.

Children and adolescents

Do not give ASCIVASC to children and adolescents as safety and efficacy have not been established.

Other medicines and ASCIVASC

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist before you take ASCIVASC if you are taking:

• Azole anti fungals, such as ketoconazole or itraconazole (used to treat fungal infections).
• Protease inhibitors (used to treat human immunodeficiency virus (HIV)).
• Macrolide antibacterials, such as erythromycin or clarithromycin (used to treat bacterial infections).

Do not share medicines prescribed for you with any other person. Always take ASCIVASC exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet of ASCIVASC 5 mg or one tablet of ASCIVASC 10 mg once a day taken orally. ASCIVASC can be taken with or without food.

Your doctor will determine your dose based on your age, liver function or your response to ASCIVASC. Your doctor will tell you how long your treatment with ASCIVASC will last. If you have the impression that the effect of ASCIVASC is too strong or too weak, tell your doctor or pharmacist.

Taking your tablets at the same time each day will have the best effect on your blood pressure. It will also help you remember when to take the tablets.

If you take more ASCIVASC than you should

Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24 – 48 hours after intake. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take along any tablets that are left, including the carton, so that the hospital staff can easily tell what you have taken.

If you forget to take ASCIVASC

If you forget to take a dose of ASCIVASC, take one as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take the tablet or tablets at the usual time. Do not take a double dose to make up for the forgotten individual doses.

ASCIVASC can have side effects. Not all side effects reported for ASCIVASC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ASCIVASC, please consult your health care provider for advice.

If any of the following happens, stop taking ASCIVASC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, lips, mouth or throat which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to ASCIVASC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• painful, blistering or peeling skin rash;
• bleeding or bruising more easily than normal or abnormal blood test results;
• frequent infections such as fever, severe chills, sore throat or mouth ulcers;
• heart attack (severe chest pain) abnormal heartbeat;
• pancreatitis (nausea, vomiting, fever, pain in your stomach area radiating to your back);
• changes in the way your heart beats (irregular heart beats, beating slower or faster than usual) or heart attack;

Tell your doctor if you notice any of the following:

Frequent side effects

• water retention (causing swelling of your ankles, hands and feet);
• headache, dizziness, sleepiness (especially at the beginning of treatment);
• pain in your stomach area, feeling sick (nausea), feeling bloated (caused by excessive gas);
• changes in bowel movements, such as constipation or diarrhoea;
• visual disturbances, double vision;
• muscle cramps, physical weakness and lack of energy;
• flushing of your skin (blushing).

Less frequent side effects

• bleeding or small pin-sized purple spots on the skin
• feeling depressed or confused, mood changes, anxiousness, and insomnia;
• shaking (tremor);
• distortion of the sense of taste;

Side effects with an unknown frequency

• muscle spasms, slow movements and irregular, jerky movements.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za. By reporting side effects, you can help provide more information on the safety of ASCIVASC.

Store all medicines out of reach of children.

• Store in a cool, dry place at or below 25 °C.
• Store in the original container.
• Do not remove the blister from the carton until required for use.
• Do not use after the expiry date stated on the label / carton / bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).