Vastor 10 mg/20 mg/40 mg/80 mg Film-Coated Tablets

What VASTOR is: VASTOR belongs to a group of medicines known as lipid (fat) regulating medicines commonly known as statins.

What it is used for: VASTOR is used to lower lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. Remember to continue with your diet and lifestyle changes while you are taking VASTOR.

Do not take VASTOR

• If you are hypersensitive (allergic) to atorvastatin or to medicines of the same class (statins or lipid lowering medicines), or any of the other ingredients of VASTOR (listed in section 6).
• If you are receiving treatment for your immune system such as ciclosporin (see Other medicines and VASTOR).
• If you are pregnant, trying to become pregnant or breastfeeding your baby.
• If you have or ever had a disease which affects the liver.
• If you have had any unexplained abnormal blood test results for liver function.
• If you have any muscle disease.
• If you are taking the following:
• Rifampicin: an antibiotic used to treat several types of bacterial infections, including tuberculosis (TB).
• Diltiazem: medicine used to treat high blood pressure and to control angina (chest pain).
• Hepatitis C antivirals glecaprevir/pibrentasvir.
• If you drink grapefruit juice.

Warnings and precautions

Take special care with VASTOR:

• If you experience any of the following symptoms: unusual fatigue or weakness, loss of appetite, stomach pain, dark-coloured urine, or yellowing of the skin or the white of the eyes, you should notify your health care professional right away. Serious liver problems may occur. Your doctor will carry out a liver function test before treatment starts and if needed thereafter.
• If you have ever had any type of stroke. Tell your doctor will need to consider this in deciding the best treatment and dose for you.
• If you have any kidney disorders.
• If you have an under-active thyroid gland.
• If you have or had repeated or unexplained muscle aches or pains, or if you have a personal history or family history of muscle problems.
• If you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other statins or fibrate medicines).
• If you have diabetes or if you have a risk of developing diabetes and take VASTOR. Your doctor will monitor you on a regular basis.
• If you experience forgetfulness and confusion. Tell this to your doctor. These symptoms will disappear after stopping treatment with VASTOR.
• If you are taking any of the following medicines as the risk of muscle-related side effects is increased if taken together with VASTOR (see Other medicines and VASTOR):
• Colchicine (used to treat gout, a kind of arthritis).
• Fibric acid derivatives (a class of medicines also used to lower blood fat levels).
• Telaprevir or boceprevir (used to treat hepatitis C).
• Saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir and fosamprenavir plus ritonavir (combination of protease inhibitors used to treat HIV).
• Azole antifungal medication (used to treat fungal infections).
• Fusidic acid or erythromycin (antibiotics used to treat bacterial infections). If you are taking or have taken fusidic acid orally or by injection in the last 7 days. The combination of fusidic acid and VASTOR can lead to serious muscle problems (rhabdomyolysis).
• Protease inhibitors (a class of medicines used to treat or prevent infection by viruses).
• If you are taking medicine that contains statins, such as VASTOR, you might be at risk of developing weakness of skeletal muscles that control body movement (arms and legs) and breathing (myasthenia gravis) or weakness of the muscles that control eye and eyelid movement (ocular myasthenia).

Do not share medicines prescribed for you with any other person. You will be placed on a standard cholesterol-lowering diet before receiving VASTOR and should continue on this diet during treatment with VASTOR. Always take VASTOR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

• The usual starting dose is 10 mg once a day in adults and children aged 10 years and older.
• Your doctor will tell you how long your treatment with VASTOR will last.
• Doses will be individualised by your doctor according to your requirements and response.
• Adjustment of dosage should only be made by your doctor after an interval of 4 weeks or more.
• The maximum recommended dose is 40 mg once a day.
• Doses may be taken at any time of day, with or without food.
• Taking your tablet at the same time each day will have the best effect on your cholesterol levels. It will also help you remember when to take the tablet.

If you have the impression that the effect of VASTOR is too strong or too weak, tell your doctor or pharmacist.

Children

Treatment experience in paediatrics is limited.

If you take more VASTOR than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take VASTOR

If you missed a dose, take it as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

VASTOR can have side effects. Not all side effects reported for VASTOR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VASTOR, please consult your health care provider for advice.

If any of the following happens, stop taking VASTOR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.
• Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes or genitals, fever or skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
• Muscle weakness, tenderness, pain or rupture or red-brown discolouration of urine and particularly, if at the same time, you feel unwell or have a high temperature. It may be caused by an abnormal muscle breakdown (rhabdomyolysis). The abnormal muscle breakdown does not always go away, even after you have stopped taking VASTOR, and it can be life-threatening and lead to kidney problems. These are all very serious side effects. If you have them, you may have had a serious reaction to VASTOR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Abdominal pain and vomiting as this could be caused by inflammation of the pancreas.
• Your skin and whites of your eyes get yellow.
• Chest pain.
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Allergic reactions, skin rashes.
• Headache, dizziness, numbness or tingling in the fingers and toes.
• Nausea, diarrhoea, stomach pain, indigestion, constipation, wind, belching.
• Joint pain, muscle pain and back pain.
• Lack or loss of strength, infection.

The following side effects have been reported less frequently:

• Blood disorders (reduction of red blood cells, decrease in blood platelets).
• Weight gain, changes in blood sugar levels, loss of appetite.
• Change in sense of taste, loss of memory, forgetfulness, and confusion.
• Ringing in the ears or hearing loss.
• Purple skin lesions (signs of blood vessel inflammation, vasculitis).
• Fluid retention.
• Liver problems such as hepatitis, jaundice (yellowing of the skin).
• Hair loss, various skin disorders.
• Rash that may occur on the skin or sores in the mouth (lichenoid drug reaction).
• Disease of a muscle, inflammation of a muscle, muscle cramps.
• Sexual difficulties.
• Fatigue.
• Accidental injury, sore muscle tendons that may rupture.
• Noise bleed.
• Urine tests that are positive for white blood cells.
• Tendon injury.
• Gynaecomastia (breast enlargement in men).

The following side effects have been reported but the frequency is unknown:

• Sleeplessness.
• Reductions of sensation to pain or touch.
• Stuffy or runny nose due to inflammation, sore throat.
• Weakness of skeletal muscles that control body movement (arms and legs) and breathing (myasthenia gravis).
• Weakness of the muscles that control eye and eyelid movement (ocular myasthenia).

Possible side effects reported with some statins such as VASTOR (medicines of the same type):

• Blood tests may also show changes in your blood sugar levels and changes in your muscles and liver.
• Depression.
• Breathing problems including persistent coughing and/or shortness of breath or fever.
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Additional side effects reported after the marketing of VASTOR include:

• Cognitive impairment (e.g. memory loss, forgetfulness, memory impairment and confusion).

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, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of VASTOR.

Store all medicines out of reach of children.

• Store in a cool and dry place at or below 25 °C.
• Do not remove blisters from carton until required for use.
• The HDPE bottles must be kept tightly closed.
• Store in the original container/package.
• Keep the container in the outer carton.
• Do not store in a bathroom.