Amlobloc Tablets

AMBLOBLOC belongs to a group of medicines called calcium antagonists. AMLOBLOC is used to treat high blood pressure (hypertension) and a type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina. AMLOBLOC is also used to reduce the risk of fatal and non-fatal heart disease or stroke. AMLOBLOC can be used alone or with other medicines to treat these conditions.

Do not take AMLOBLOC:

• If you are hypersensitive (allergic) to amlodipine or any of the ingredients of AMLOBLOC (listed in section 6).
• If you have had an allergic reaction to other medicines of this type.
• In combination with grapefruit juice.

Warnings and precautions

Take special care with AMLOBLOC:

• If you are taking other medicines such as anti-fungal medicines (ketoconazole, itraconazole) or protease inhibitors used to treat HIV (ritonavir). Using these medicines together with AMLOBLOC may decrease the blood pressure even further (see Other medicines and AMLOBLOC).
• If you are elderly.
• If you have severe kidney disease.
• If you have liver disease.
• If you have heart failure (a condition where the heart cannot pump blood well).

Other medicines and AMLOBLOC

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines).

Do not share medicines prescribed for you with any other person. Always take AMLOBLOC exactly as your doctor has told you. Check with doctor or pharmacist if you are not sure. The usual dose of AMLOBLOC is one 5 mg tablet once a day; however, sometimes one 10 mg tablet a day may be required. AMLOBLOC tablets may be taken with or without food. The usual starting dose for children aged 6 - 17 years is 2,5 mg increased to 5 mg once a day. Your doctor will tell you how long treatment with AMLOBLOC will last and will determine the dose that is best suited to you. If you have the impression that the effect of AMLOBLOC is too strong or too weak, tell your doctor or pharmacist. Continue taking AMLOBLOC until your doctor tells you to stop at which time it should be done gradually.

If you take more AMLOBLOC than you should

It is important not to take more AMLOBLOC tablets than you should. 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, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take AMLOBLOC

It is important to take your AMLOBLOC tablets regularly at the same time each day. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for forgotten individual doses.

AMLOBLOC can have side effects. Not all side effects reported for AMLOBLOC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AMLOBLOC, please consult your healthcare provider for advice. If any of the following happens, stop taking AMLOBLOC and tell your doctor immediately or go to the casualty department at your nearest hospital:

Allergic reaction including:

• Pruritus (severe itching of the skin)
• Rash
• Angiodema (swelling under the skin, often around your face and lips)
• Erythema multiforme (large, symmetrical red blotches that appear all over the skin in a circular pattern).

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

Tell your doctor if you notice any of the following:

Frequent side effects

• Headache, dizziness especially when standing up, sleepiness.
• Heart palpitations (very fast heartbeat), flushing (hot or warm feeling in your face).
• Stomach pain, nausea.
• Swelling of your legs or ankles, tiredness.

Less frequent side effects

• Too few white blood cells, too few blood platelets, too much sugar in the blood.
• Mood changes, sleeplessness.
• Tightening of the muscles, loss of pain sensation, numbness or tingling sensation, fainting, taste abnormalities, trembling, movement disorder.
• Visual disturbances.
• Ringing in the ears.
• Low blood pressure, inflammation of the blood vessels.
• Cough, shortness of breath, sneezing/running nose.
• Change in bowel habit, dry mouth, indigestion, swelling of the gums, inflammation of the pancreas, vomiting.
• Hair loss, increased sweating, itchy skin, red patches on skin.
• Joint or muscle pain, back pain, muscle cramps.
• Increased need to urinate especially at night, pain when urinating.
• Enlargement of male breasts, inability to obtain an erection.
• Feeling unwell, weakness, pain.
• Increase or decrease in weight.
• Itching, rash, swelling under the skin, red blotchy skin.
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increases which may have an effect on some medical tests.
• Heart attack, increase in heart rate, chest pain.

Should any of these symptoms occur, or 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 report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AMLOBLOC.

Store at or below 25 °C, in original packaging. Do not use this medicine after the expiry date stated on the label and carton. Return out of date or unused tablets to your pharmacist or nearest hospital. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets) STORE ALL MEDICINES OUT OF REACH OF CHILDREN.