Amloc Side Effects

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

What is Amloc?

Amloc contains the active ingredient Amlodipine.

• Active ingredient — Amlodipine
• Registration number — 46/7.1/0565; 46/7.1/0566
• Registration holder — Smart Pharmaceuticals (Pty) Ltd

It is approved for:

• VASLOC contains the active substance amlodipine which belongs to a group of medicines called selective calcium channel blockers
• S3 VASLOC is used to treat high blood pressure (hypertension) and to treat chest pain or discomfort called angina pectoris
• Your doctor may prescribe you VASLOC together with other medicines used to lower your blood pressure

Common side effects of Amloc

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

• water retention (causing swelling of your ankles, hands and feet)
• visual disturbances (seeing double)
• sleepiness, dizziness or headaches (especially when you first start taking VASLOC)
• pain in your stomach area, nausea (feeling sick), feeling bloated (caused by excessive gas) and indigestion
• changes in bowel movements, such as constipation or diarrhoea
• 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
• increased blood sugar levels
• changes in test results when your doctor monitors your liver function
• a decrease in blood pressure (causing light-headedness, clammy skin, nausea and dizziness)
• vasculitis (fever, headache, fatigue, weight loss, general aches and pains, night sweats, nerve problems such as numbness or weakness)
• changes in the frequency or control of urination, urinating more at night
• feeling depressed or confused, changes in your mood, anxiousness and insomnia
• shaking (tremor)
• ringing in the ears
• numbness, a loss of sensation, tingling or numbness in your hands or feet, feeling of weakness or heaviness in your arms and legs
• stiffness of your muscles and joint, muscle or back pain, pain in a joint and feeling unwell
• vomiting (being sick), a dry mouth or gastritis (causing pain, nausea, vomiting, vomiting blood, blood in the stool)
• overgrowth of the gums (causing pain, swelling and bad breath)
• distortion of the sense of taste
• coughing or a runny nose
• breast enlargement in men
• problems with sexual performance
• hair loss or excessive sweating
• discolouration of the skin or sensitivity to the sun
• gaining or losing weight. Side effects with an unknown frequency
• muscle spasms, slow movement and irregular, jerky movements

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 hypersensitive (allergic) to amlodipine, other calcium-channel blockers or any of the other ingredients of VASLOC
• 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 suffered a heart attack (within the past 28 days)
• if you have been diagnosed with unstable angina (chest pain occuring while resting)
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if

• if you suffer from heart failure
• if you have been diagnosed with aortic stenosis (narrowing of the aortic heart valve)
• if you have severe liver problems. Your doctor may need to monitor your liver function and adjust your dose of VASLOC accordingly
• 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 build-up of natural chemicals called porphyrins in your body)
• if you experience chest pain while taking VASLOC
• if you have low blood pressure. Children and adolescents Do not give VASLOC to children and adolescents as safety and efficacy have 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 VASLOC
• You should not take VASLOC if you are pregnant or breastfeeding

Interactions and medicines to check

The approved leaflet names these interactions.

• Protease inhibitors (used to treat human immunodeficiency virus (HIV))
• Azole antifungals, such as itraconazole or ketoconazole (used to treat fungal infections)
• Macrolide antibacterials, such as erythromycin or clarithromycin (used to treat bacterial
• infections)
• Verapamil (used to treat high blood pressure and heart pain) or any medicine that may lower your blood pressure
• Diltiazem (used to treat chest pain)
• Rifampicin (used to treat tuberculosis (TB) or certain other bacterial infections)
• St. John’s Wort (herbal medicine)
• Carbamazepine, phenobarbitone, phenytoin or valproate (used to treat seizures (fits))
• Dantrolene (used to treat severe body temperature abnormalities)
• Medicines for treating angina (chest pains), such as nitro-glycerine or beta-blockers
• Tacrolimus (used to treat eczema or during organ transplants)
• Mammalian target of rapamycin (mTOR) inhibitors, such as temsirolimus, everolimus and
• sirolimus (used to treat cancer)
• Simvastatin (used to lower fat in your blood)
• Quinidine or procainamide (used to treat heart rhythm disorders)
• Lithium (used to treat some types of depression). Tell your doctor or pharmacist before you take VASLOC if you have had a kidney transplant and are taking ciclosporin (used to treat cancer, rheumatoid arthritis or organ transplants). Your doctor may need to monitor your blood and adjust your dose of ciclosporin according to the test results. VASLOC with food and drink While taking VASLOC you should avoid consuming grapefruit juice or grapefruits as it may increase the risk of your blood pressure lowering more than expected

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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