Full description:
Simva-Denk 20 is a medicine used to lower high cholesterol levels. Simva-Denk 20 lowers total cholesterol, the levels of “bad” LDL cholesterol and other fats known as triglycerides in the blood. Simva-Denk 20 also increases the levels of “good” HDL cholesterol. Simva-Denk 20 belongs to the class of medicines known as “statins”, which block the body’s production of cholesterol in the liver. You should continue your low cholesterol diet during treatment.
What Simva-Denk 20 contains:
The active substance is simvastatin. Each filmcoated tablet contains 20 mg simvastatin. The other ingredients are: Tablet core: butylhydroxyanisole (Ph.Eur), lactose monohydrate, pregelatinised starch (maize starch), ascorbic acid, citric acid monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate (Ph.Eur). Film coating: hyprolose, hypromellose, titanium dioxide (E171), talc, iron (III) oxide (E172), iron (II, III) oxide (E172), iron (III) hydroxide oxide (E172).
Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects may occur at various frequencies, which are defined as follows:
Very common: more than 1 in 10 patients is affected
Common: 1 to 10 patients in 100 are affected
Uncommon: 1 to 10 patients in 1,000 are affected
Rare: 1 to 10 patients in 10,000 are affected
Very rare: less than 1 in 10,000 patients is affected
Not known: cannot be estimated from the available data
The following serious side effects have been reported rarely:
If any of the following serious side effects occur, stop taking this medicine and contact your doctor immediately or go to the emergency department of your nearest hospital.
- Muscle disease with pain, tenderness, weakness or muscle cramps. Muscle disorders can be serious in rare cases, which can lead to a breakdown in skeletal muscle cells followed by kidney failure; very rarely, such cases have even been fatal.
- hypersensitivity (allergic) reactions with:
– swelling of the face, tongue and throat, which may cause problems in breathing or swallowing
– severe muscle pain, usually in the shoulders and pelvic region
– rash with weakness of limbs and neck muscles
– joint pain or inflammation (polymyalgia rheumatica)
– inflammation of the blood vessels (vasculitis)
– unusual bruises, rashes and swelling of the skin (dermatomyositis), itchy rash (hives), skin sensitivity to light, fever, facial flushing
– shortness of breath (dyspnoea) and malaise
– syndrome with rash, joint disorders and changes in blood count (lupus-like syndrome)
- hepatitis or jaundice with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare)
- inflammation of the pancreas, often associated with severe abdominal pain
The following side effects have also been reported rarely:
- low red blood cell count (anaemia)
- numbness or weakness in the arms and legs
- headache, abnormal skin sensations, dizziness
- digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
- rash, itching, hair loss
- weakness
- insomnia (very rare)
- memory impairment (very rare), memory loss, confusion
The following side effects have also been reported, but their frequency cannot be estimated from the available data (frequency not known):
- erectile dysfunction
- depression
- inflammation of the lungs causing breathing problems, including prolonged coughing and/or shortness of breath or fever
- tendon disorders and even tendon rupture in some cases
Possible side effects that have been reported with some statins (medicines of the same type):
- sleep disorders, including nightmares
- sexual function disorders
- blood sugar disorder (diabetes mellitus):
The risk of developing a blood sugar disorder is greater if you have increased blood sugar and blood fat levels, are overweight and have high blood pressure. Your doctor will monitor you during treatment with Simva-Denk 20.
- muscle pain, tenderness, or weakness that is constant that may not go away after stopping
Simva-Denk 20 (frequency not known).
Laboratory results:
Increases in certain liver enzyme levels and increased levels of a muscle enzyme (creatine phosphokinase) have been observed.
How to take:
Take the tablet with a glass of water in the evening (as the body’s cholesterol production in the liver takes place mainly at night). It can be taken with or without food. The film-coated tablet can be divided into equal doses. Take Simva-Denk 20 for as long as your doctor prescribes it.
If your doctor has prescribed you Simva- Denk 20 to be taken with another cholesterollowering agent containing the active substance cholestyramine or with other medicines containing anion exchangers, take Simva-Denk 20 at least 2 hours before or at least 4 hours after the anion exchanger.
