Austell amlodipine Side Effects

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Answer the side-effect intent for austell amlodipine without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of cardiovascular side effects.

What is Austell amlodipine?

Austell-Amlodipine contains the active ingredient Amlodipine.

• Active ingredient — Amlodipine
• Registration number — A39/7.1/0545; A39/7.1/0546
• Registration holder — Austell Pharmaceuticals (Pty) Ltd

It is approved for:

• AUSTELL AMLODIPINE contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists
• AUSTELL AMLODIPINE 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
• AUSTELL AMLODIPINE is also used to reduce the risk of fatal and non-fatal heart disease or stroke
• AUSTELL AMLODIPINE can be used alone or with other medicines to treat these conditions

Common side effects of Austell amlodipine

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• headache, dizziness especially when standing up, sleepiness (especially at the beginning of treatment)
• very fast heartbeat (heart palpitations), hot or warm feeling in your face (flushing)
• stomach pain, feeling sick (nausea)
• swelling of your legs or ankles, tiredness

Less frequent side effects

• too few white blood cells, too few blood platelets, which may result in unusual bruising or easy bleeding
• too much sugar in the blood (hyperglycaemia)
• mood changes, anxiety, depression, sleeplessness
• tightening of the muscles, loss of pain sensation, numbness or tingling sensation, fainting, taste abnormalities, a disorder of the nerves which can cause muscular weakness, tingling or numbness, a disorder combining rigidity, trembling and/or movement disorder
• visual disturbances
• ringing in the ears
• low blood pressure, inflammation of the blood vessels
• cough, shortness of breath, sneezing/running nose (rhinitis)
• change in bowel habits, dry mouth, indigestion, swelling or bleeding of the gums, inflammation of the pancreas, vomiting
• hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
• joint or muscle pain, back pain, muscle cramps
• increased need to urinate especially at night, pain when urinating, increased number of times of passing urine
• inability to obtain an erection, discomfort or enlargement of the breasts in men
• pain, feeling unwell, weakness, chest pain
• increase or decrease in weight
• confusion
• itching, rash, swelling under the skin, red blotchy skin
• abdominal bloating (gastritis)
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests
• sensitivity to light

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are sensitive (allergic) to amlodipine or any of the other ingredients of AUSTELL AMLODIPINE (listed in section 6)
• If you have had an allergic reaction to other medicines of this type
• In combination with grapefruit juice
• 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 suffer from heart failure after a heart attack

Use with care, and tell your doctor, if

• If you are taking other medicines such anti-fungal medicines (ketoconazole, itraconazole) or protease inhibitors used to treat HIV (ritonavir). Using these medicines together with AUSTELL AMLODIPINE may decrease the blood pressure even further
• If you are elderly and if your doctor needs to increase your dose, this should happen with care
• If you have severe kidney disease
• If you have liver disease and if your doctor needs to increase your dose. You will be closely monitored by your doctor if you have severe liver failure
• If you have heart failure (a condition where the heart cannot pump blood well). Children and adolescents AUSTELL AMLODIPINE has not been studied in children under the age of 6 years. AUSTELL AMLODIPINE should only be used for hypertension in children and adolescents from 6 years to 17 years of age

Pregnancy and breastfeeding

• 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 health care provider for advice before taking AUSTELL AMLODIPINE
• If you are a woman of childbearing potential, you and your partner should ensure you are both using adequate contraception
• The safety of AUSTELL AMLODIPINE in human pregnancy has not been established
• AUSTELL AMLODIPINE has been shown to pass into breast milk
• There is insufficient information regarding the potential effect of AUSTELL AMLODIPINE on fertility

Interactions and medicines to check

The approved leaflet names these interactions.

• Cholesterol-lowering medicine (simvastatin)
• Heart medicines (diltiazem)
• Anti-fungal medicines (ketoconazole, itraconazole)
• Antibiotics (erythromycin, clarithromycin, rifampicin)
• Protease inhibitors used to treat HIV (ritonavir)
• St. John’s Wort (hypericum perforatum)
• Immunosuppressive medicines (tacrolimus, sirolimus, temsirolimus, everolimus and ciclosporin)
• Dantrolene (infusion for severe body temperature abnormalities) AUSTELL AMLODIPINE may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure. AUSTELL AMLODIPINE with food and drink Do not eat grapefruit or drink grapefruit juice with AUSTELL AMLODIPINE

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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