Like all medicines, Vastatifix can cause side effects, although not everybody gets them. Generally, these are mild and transient. However, the following side effects may occur in some patients during treatment.
The frequencies of side effects are ranked according to the following:
Very common: in more than 1 in 10 patients
Common: between 1 in 10 and 1 in 100
Uncommon: between 1 in 100 and 1 in 1000
Rare: between 1 in 1000 and 1 in 10,000
Very rare: less than 1 in 10,000
1 Nervous system disorders:
Uncommon: dizziness, headache, sleep disturbances, lack of sufficient sleep.
Very rare: problems with touch including burning/tingling sensation, numbness or pins and needles [paresthesia] may occur which may be a sign of damage to the nerve endings (peripheral polyneuropathy).
Unknown frequency: nightmares, memory loss, depression.
2 Respiratory, thoracic and mediastinal disorders:
Unknown frequency: breathing problems including persistent cough and/or shortness of breath or fever.
1 Eye problems:
Uncommon: vision disturbance (blurred vision or double vision).
1 Gastrointestinal disorders:
Uncommon: digestive problems or slow digestion (dyspepsia)/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, wind.
Very rare: inflammation of the pancreas (pancreatitis).
1 Skin disorders:
Uncommon: itching, rash, hives, scalp and hair problems (inclusive of hair loss).
1 Kidney and urinary tract problems:
Uncommon: abnormal urination, e.g. pain, frequency, frequent urination at night (dysuria).
1 Reproductive system disorders: Uncommon: disturbed sexual functions.
1 General disorders: Uncommon: tiredness.
1 Skeleton, muscle and connective tissue disorders:
Common: tender muscles and bones, painful joints (athralgia), muscle cramps, muscle pain and muscle weakness. Very rare: inflammation of a muscle, destruction of fibres in skeletal muscle (rhabdomyolysis) that may be associated with acute kidney failure.
In some cases tendon disorders, sometimes associated with tearing.
Contact your doctor immediately if you develop one of these symptoms during the use of Vastatifix, because muscle disorders may be serious in rare cases (see also 2. Before you take Vastatifix).
1 Liver disorders:
Common: increased production of liver enzymes.
Very rare: yellowish discoloration of the skin (jaundice), tissues and body fluids, liver inflammation (hepatitis), sudden rapid destruction of all liver tissue (hepatitis necrosis).
1 Immune system disorders:
Very rare: Hypersensitivity reactions (angiooedema, anaphylaxis) such as serious allergic reactions with swelling of the face, tongue and wind pipe [oedema] which can cause great difficulty in breathing. This is a very rare reaction which can be serious if it occurs.
You should see a doctor immediately if this occurs.
A certain type of chronic skin disorder (lupus like syndrome).
2 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.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
