Aspavor Side Effects

Home › Medicine Side Effects › Aspavor

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

Part of cardiovascular side effects.

What is Aspavor?

Aspavor contains the active ingredient Atorvastatin.

• Active ingredient — Atorvastatin
• Registration number — 43/7.5/0837; A39/7.5/0017; A39/7.5/0018; A39/7.5/0019
• Registration holder — Viatris South Africa (Pty) Ltd

It is approved for:

• ASPAVOR belongs to a group of medicines known as lipid or cholesterol (fat) regulating medicines commonly known as statins
• ASPAVOR lowers cholesterol in your blood
• It lowers the LDL-C (“bad” cholesterol) and triglycerides in your blood
• It can raise your HDL-C (“good” cholesterol) as well

Common side effects of Aspavor

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.

Reported side effects

• Muscle problems ASPAVOR can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with ASPAVOR
• Liver problems Your doctor may do blood tests to check your liver before you start taking ASPAVOR and if you have symptoms of liver problems while you take ASPAVOR. Symptoms of liver problems include:
• Feeling tired or weak
• Loss of appetite
• Upper belly pain
• Dark amber-coloured urine
• Yellowing of your skin or the whites of your eyes. Call your doctor immediately if you have:
• Muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. This may be an early sign of a muscle problem
• Muscle problems that do not go away even after your doctor has advised you to stop taking ASPAVOR. Your doctor may do further tests to diagnose the cause of your muscle problems
• Allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing which may require treatment right away
• Nausea and vomiting
• Passing brown or dark-coloured urine
• Loss of appetite
• You feel more tired than usual
• Your skin and whites of your eyes get yellow
• Stomach pain
• Allergic skin reactions. Other side effects include: Infection, headache, accidental injury, flu-like syndrome, back pain, constipation, diarrhoea, dyspepsia, flatulence, sinusitis, pharyngitis, rash, joint pain. Other frequent side effects which have been reported include the following: Diarrhoea, constipation, wind, indigestion, headache, pain in joints, chest pain, inability to sleep, back pain, numbness, tingling, reduced sensitivity to touch, dizziness and itching. Other less frequent side effects which have been reported are: Ringing in the ears, feeling unwell, loss of memory, impotence, loss of hair, and change in sense of taste, inflammation of the pancreas, inflammation of the liver, too few blood platelets, tendon problems, low blood sugar, high blood sugar, anorexia (eating disorder), weight gain, nerve disease affecting the extremities of the body, change in sense of taste, swelling of hands and feet and muscle cramps. Additional side effects reported after the marketing of ASPAVOR include: Cognitive impairment (e.g. memory loss, forgetfulness, memory impairment and confusion). Should any of these symptoms occur or

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

• You are allergic to any of the ingredients of ASPAVOR
• You are pregnant, trying to fall pregnant or breastfeeding
• You are able to have children and are not using adequate contraceptive measures
• You have or have had any liver disease or any unexplained abnormal blood tests for liver function
• You are taking rifampicin, an antibiotic, for an infection
• You are taking diltiazem, a calcium channel blocker, for angina or high blood pressure
• You drink grapefruit juice

Use with care, and tell your doctor, if

• You have kidney problems
• You have an underactive thyroid gland (hypothyroidism)
• You have muscle disorders or if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other “statins” or “fibrate” medicines)
• You drink excessive amounts of alcohol and/or have a history of liver disease
• You have an intolerance to some sugars
• You are taking any of the following medication as the risk of muscle-related side effects are increased if taken together with ASPAVOR:
• Colchicine (used to treat gout, a kind of arthritis)
• Vitamin B3
• Fibric acid derivatives (a class of medicines also used to lower blood fat levels)
• Telaprevir and boceprevir (used to treat hepatitis C)
• Saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, atazanavir plus ritonavir and fosamprenavir plus ritonavir (combination of protease inhibitors used to treat HIV)
• Immunosuppressive medicines (medicines that inhibit or prevent activity of the immune system)
• Azole antifungal medication (used to treat fungal infections)
• Fusidic acid or erythromycin (antibiotics used to treat bacterial infections)
• You have diabetes as ASPAVOR can lead to high blood sugar. Tell your doctor if you have ever had any type of stroke; your doctor will need to consider this in deciding the best treatment and dose for you. Tell your doctor if serious liver injury or jaundice (yellow discolouration of skin or whites of the eyes) occurs. If you experience unexplained muscle pain, tenderness or weakness especially if accompanied by fever or a general feeling of being unwell, tell your doctor. Your doctor may need to carry out a blood test before and possibly during your ASPAVOR treatment to predict your risk of muscle-related side effects. Taking ASPAVOR with food and drink: Grapefruit juice should be avoided when taking ASPAVOR as this combination can result in an undesirable interaction

Pregnancy and breastfeeding

• Do not take ASPAVOR if: • You are pregnant, trying to fall pregnant or breastfeeding
• • You are able to have children and are not using adequate contraceptive measures
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other health care professional for advice before taking ASPAVOR
• Important information about some of the ingredients of ASPAVOR: ASPAVOR contains lactose
• You should not take ASPAVOR and should contact your doctor if you have rare hereditary problems, or a history of lactose or galactose intolerance (the body is unable to absorb certain sugars), Lapp lactase deficiency (the body is unable to digest milk and milk products due to lack of an enzyme) or glucose-galactose malabsorption (the body is unable to absorb certain sugars)

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines used to modulate immune response e.g. ciclosporin
• Certain antibiotics or antifungal medicines e.g. erythromycin, clarithromycin, clotrimazole, rifampicin and itraconazole
• Other medicines to regulate lipid (fat) levels e.g. fibric acid derivatives, colestipol, niacin (nicotinic acid)
• Some calcium channel blockers used for angina or high blood pressure e.g. diltiazem
• Medicines to regulate your heart rhythm e.g. digoxin
• Protease inhibitors used in the treatment of HIV e.g. nelfinavir, saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir and atazanavir plus ritonavir
• Efavirenz used in the treatment of HIV
• Other medicines known to interact with ASPAVOR include warfarin (which reduces blood clotting), oral contraceptives, antacids (indigestion products containing aluminium or magnesium) and fusidic acid
• Telaprevir and boceprevir (used to treat hepatitis C)
• Colchicine (used to treat gout, a kind of arthritis)

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.

Related pages

• amlodipine side effects

← Back to more medicine side effects.