Ciplavasc Side Effects

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

Part of cardiovascular side effects.

What is Ciplavasc?

Ciplavasc contains the active ingredient Amlodipine.

• Active ingredient — Amlodipine
• Registration number — A39/7.1/0117; A39/7.1/0120
• Registration holder — CIPLA MEDPRO (PTY) LTD

It is approved for:

• S3 CIPLAVASC contains amlodipine, which belongs to a group of medicines called calcium channel blocker that affects the movement of calcium into the cells of the heart and blood vessels
• As a result, it relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload
• CIPLAVASC is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina
• CIPLAVASC can be used alone or with other medicines to treat these conditions

Common side effects of Ciplavasc

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

• fizziness, headache, drowsiness/sleepiness
• flushing/red coloration of the skin
• muscle cramps
• increased tightness of muscle tone, tremor

Less frequent side effects

• increased blood sugar levels, causing blurry vision, frequent urination and fatigue
• depression, sleeplessness, mood changes (including anxiety), confusion
• distortion of the sense of taste (taste perversion)
• ringing or buzzing sound in the ears
• visual disturbances, including double vision
• coughing, runny nose
• nausea, stomach pain, indigestion, altered bowel habits including diarrhoea/loose stools and constipation
• vomiting, dry mouth, thickening of the gums
• raised liver enzymes
• hair loss, skin discolouration, increased sweating, itching, rash, hives, redness and scaling/crusting of the skin (exfoliative dermatitis), skin rash on areas exposed to sunlight (photosensitivity), red patches on skin
• pain in the joints, back pain, pain in the muscles
• increased urinary frequency, increased urination during the night
• impotence, enlargement of breast tissue in men
• fatigue, lack or loss of strength/energy
• pain, weight increase/decrease, chest pain, general feeling of being unwell

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 allergic (hypersensitive) to amlodipine, other dihydropyridines (such as nifedipine, felodipine, isradipine) or any of the other ingredients of CIPLAVASC listed in section 6
• if you have severe low blood pressure (hypotension)
• In combination with grapefruit juice
• if you are in shock (including cardiogenic shock), that causes your heart to not supply enough blood to your body
• if you have been diagnosed with narrowing of the aortic valve (aortic stenosis)
• if you have been diagnosed with heart failure after suffering a heart attack (acute myocardial infarction)

Use with care, and tell your doctor, if

• if you are taking other medicines, such as antifungal medicines (ketoconazole, itraconazole) or protease inhibitors used to treat HIV (ritonavir), using these medicines together with CIPLAVASC may decrease your blood pressure even further
• if you have impaired liver or kidney function
• if you have heart failure problems as there is a small chance that
• CIPLAVASC may make this condition worse
• if you have a severe increase in blood pressure (hypertensive crisis). Use in elderly The clearance of CIPLAVASC from the body is decreased in the elderly. Therefore, if you are elderly your doctor will start CIPLAVASC therapy at a lower dose and will increase your dose with care. Use in children The safety and efficacy of CIPLAVASC in children has not been established

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 this medicine
• Women who are capable of falling pregnant should use contraceptive whilst on taking CIPLAVASC
• CIPLAVASC is excreted in breast milk
• The effect of CIPLAVASC in breastmilk to the baby is not known

Interactions and medicines to check

The approved leaflet names these interactions.

• sublingual nitroglycerin, long-acting nitrates, beta blockers or other antianginal medicine, as these may produce additive effects of lowering the blood pressure and treating the angina
• protease inhibitors for the treatment of HIV-infection (such as saquinavir, ritonavir, indinavir, nelfinavir)
• azole antifungals for the treatment of fungal infections (such as fluconazole, ketoconazole)
• antibiotics, such as erythromycin or clarithromycin
• verapamil or diltiazem (for the treatment of high blood pressure, angina, or heart rhythm disorders)
• rifampicin, for the treatment of tuberculosis (TB)
• St John’s wort (hypericum perforatum), a herbal preparation used for the treatment of mild depression
• dantrolene intravenous injection, a muscle relaxant used for treating increased body temperature
• tacrolimus or ciclosporin, immune suppressants
• simvastatin, for lowering of blood cholesterol levels
• cholesterol-lowering medicine (simvastatin)
• immunosuppressive medicines (tacrolimus, sirolimus, temsirolimus, everolimus and ciclosporin. CIPLAVASC with food and drink and alcohol Do not consume grapefruit or grapefruit juice while taking CIPLAVASC, as this may increase the product’s blood pressure-lowering effect, leading to low blood pressure

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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