Amtas Tablets

AMTAS belongs to a group of medicines known as calcium - channel blockers (calcium antagonists). Calcium - channel blockers lower blood pressure by relaxing the blood vessel walls. AMTAS is used to treat mild to moderate high blood pressure (hypertension). AMTAS is also used to treat a certain type of chest pain called angina and to reduce the risk of heart disease and stroke.

Do not take AMTAS :

• If you are hypersensitive (allergic) to amlodipine, calcium - channel blockers (dihydropyridine derivatives), or to any of the other ingredients of AMTAS (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have severe low blood pressure (hypotension).
• If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
• If you have suffered from heart failure after a heart attack.
• If you are having grapefruit juice.
• In cases of shock (where the body is not getting enough blood flow).

Take special care with AMTAS :

• If you are elderly, your doctor may start you on a lower dose of AMTAS.
• If you have kidney or liver problems, your doctor may start you on a lower dose of AMTAS.
• If you have heart problems such as heart failure, please inform your doctor.
• If you have porphyria (an inherited disease of certain enzymes), please inform your doctor.

Children and adolescents

If you are under 18 years of age, since the safety and effectiveness of AMTAS has not been established in children.

Other medicines and AMTAS

Always tell your healthcare provider if you are taking any other medicines. (This includes all complementary or traditional medicines.) AMTAS may affect or be affected by other medicines, such as:

• Medicines used to treat high blood pressure and angina (chest pain) known as sublingual nitroglycerine, long acting nitrates or beta blockers, which may lower your blood pressure even further.
• Ciclosporin (an immune suppressant used after organ transplant) when used for kidney transplants; a decrease in ciclosporin dose might be required.
• The following medicines may lead to an increase in blood concentrations of amlodipine resulting in an increase in blood pressure lowering effect:
• Protease inhibitors used to treat HIV infection (such as ritonavir, indinavir, nelfinavir).
• Anti - fungal medicines such as ketoconazole or itraconazole.
• Antibiotics such as erythromycin or clarithromycin.
• Verapamil or diltiazem (heart medicines).
• Rifampicin (used to treat tuberculosis) – may reduce the effect of AMTAS.
• Hypericum perforatum (St. John’s Wort – a herbal antidepressant) - may reduce the effect of AMTAS.
• Dantrolene (infusion for severe body temperature abnormalities) – may cause an increase in blood potassium levels.
• Tacrolimus, everolimus, sirolimus (an immune suppressant used after organ transplant) – a dose adjustment might be required as AMTAS can cause tacrolimus levels to increase.
• Simvastatin (cholesterol lowering medicine); doses of simvastatin should be limited to 20 mg daily AMTAS may further lower your blood pressure if you are already taking other medicines to treat your high blood pressure.

AMTAS with food and drink:

You should not consume grapefruit or grapefruit juice if you are taking AMTAS, because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of AMTAS.

Pregnancy and Breastfeeding:

The safety of AMTAS in pregnancy has not been established. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine.

Driving and using machines:

AMTAS may cause dizziness, headache, tiredness, or make you feel sick. If you have any of these side - effects, you should keep in mind that this can affect your ability to drive and/or use machinery. It is not always possible to predict to what extent AMTAS may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which AMTAS affects you.

Always take AMTAS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is AMTAS 5mg once daily, which may be increased by your doctor to a maximum dose of 10 mg depending on your response after 10 - 14 days of treatment. AMTAS can be taken before or after a meal. You should take AMTAS at the same time each day with a glass of water. Your doctor will tell you how long your treatment with AMTAS will last. If you have the impression that AMTAS is too strong or too weak, tell your doctor or pharmacist.

Do not share medicines prescribed for you with any other person.

If you take more AMTAS than you should:

Overdosage may cause your blood pressure to become very low. You may experience extreme dizziness, feel light - headed, faint or weakness. Your skin could feel cool and clammy and you could lose consciousness. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take AMTAS:

Take the missed dose as soon as possible. However, if it is almost time for your next dose, continue to take the next tablet at the usual time. Do not take a double dose to make up for the forgotten individual doses.

AMTAS can have side effects. If any of the following happens, stop taking AMTAS, and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the tongue or throat, which may cause difficulty in swallowing or breathing
• sudden wheeziness, chest pain, shortness of breath or difficulty in breathing
• swelling of the eyelids, face or lips
• severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to AMTAS. 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:

• heart attack (severe chest pain), irregular heartbeat
• pancreatitis (upper abdominal pain that radiates into the back which may be aggravated by eating foods high in fat, accompanied with feeling unwell, nausea and vomiting)
• unexplained bleeding or bruising

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• drowsiness, dizziness, headache
• palpitations (feeling like your heart is pounding, racing or fluttering)
• flushing
• stomach pain, nausea (feeling sick) and vomiting
• ankle swelling, tiredness

Less frequent side effects:

• increased thirst, dry mouth, tiredness, blurred vision – may indicate high blood sugar levels
• mood changes, depression, difficulty sleeping, confusion
• trembling, taste abnormalities, a sensation of tingling, tickling, pricking, or burning of your skin, feeling tired, pain in the hands and feet, fainting
• visual disturbances
• ringing in the ears
• low blood pressure
• shortness of breath, cough, runny or congested nose
• change in bowel habits (diarrhoea or constipation), heartburn, dry mouth, mouth ulcers, stomach pain and indigestion
• yellowing of the skin and eyes, also called jaundice
• hair loss, purple bruises on the skin, discolouration of the skin, increased sweating, itchy skin rash, skin sensitivity to light exposure
• muscle or joint pain, back pain, muscle cramps
• increased urinary frequency, increased need to urinate at night
• inability to develop or maintain an erection, enlargement of the breasts in men
• weakness or feeling unwell
• weight increase or decrease

Not all side effects reported for AMTAS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AMTAS, please consult your doctor, pharmacist or other healthcare professional for advice. 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, pharmacist or nurse. You can also report side effects to SAHPRA via the “Adverse drug reaction and quality problem reporting form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/document/adverse-drug-reactions-and-quality-problem-reporting-form/ By reporting side effects, you can help provide more information on the safety of AMTAS.

Store at or below 25 °C. Protect from light. Keep blister in outer carton until before use. Store all medicines out of reach of children. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).