Cedur

Cedur

"Bezafibrat? contains the active substance bezafibrate, a drug from the group of so-called fibrates (lipid sinks).

Fibrates are used to lower blood lipids. One of these fats is triglycerides.

Bezafibrate is used in addition to a low-fat diet and other non-drug therapies (e.g. exercise, weight loss) to lower blood fat levels.

Bezafibrate is prescription-only and may only be used on doctor's instructions.

as a support?corrosive treatment in addition to a Di?t or other non-medication?these therapies (e.g. sporty bet?weight loss) f?r following diseases:

- severe hypertriglyceride?mie with or without low HDL cholesterol,

- mixed hyperlipid?mie, if a statin is not to be used or is not tolerated.

The before the drug?sen treatment initiated di?tetischen Ma?should w?during therapy.

Take " Bezafibrat? always exactly according to the doctor's instructions. Please check with your doctor or pharmacist if you are not sure. Please adhere to the application rules, because " Bezafibrat? otherwise can not work properly!

For dosage forms with 200 mg Bezafibrate:

Please take Filmtabletten morning or evening without chewing with sufficient liquid (e.g. a glass of water)to or after a meal. If you prescribe 3 tablets a day, take one tablet each morning, noon and evening; if you prescribe 2 tablets a day, take 1 tablet each morning and evening.

For dosage forms with 400 mg bezafibrate:

Please take the prolonged forms in the morning or evening without chewing with sufficient liquid (e.g. a glass of water) or after a meal.

Treatment with " Bezafibrate? is usually required over a longer period of time. Please take " Bezafibrat? regularly and in the duration determined by the doctor.

As with any long-term treatment, ongoing monitoring is also necessary here: blood fat levels are to be checked repeatedly and regularly, at the same time attention is to be paid to possible side effects and the necessity of continuing the drug treatment is to be checked.

3.2. a. 1. Adults

take 1 film-coated tablet/dragee 3 times a day (equivalent to 600 mg bezafibrate per day).

If you suffer from a sensitive stomach, the treatment can be started gradually with 1 film-coated tablet/dragee (equivalent to 200 mg bezafibrate) once a day. After 3 to 4 days take 1 film-coated tablet/dragee twice a day (equivalent to 400 mg bezafibrate) and after another 3 to 4 days take 1 film-coated tablet/dragee three times a day (equivalent to 600 mg bezafibrate).

If the treatment is successful, your doctor may reduce the daily dose to 2 film-coated tablets/dragees (equivalent to 400 mg bezafibrate), 1 film-coated tablet/dragee in the morning and evening, especially for certain metabolic disorders (hypertriglyceridemia).

3.2.a.2.Impaired renal function and elderly patients

The doctor determines the required dose based on the result of a specific blood test (serum creatinine levels to be monitored regularly) or determination of creatinine clearance according to the following scheme:

- up to 1.5 mg/dl or 135 µmol/l serum creatinine or more than 60 ml/min creatinine clearance: 3 film-coated tablets / dragees / day

up to 1.6 to 2.5 mg/dl or 136 to 225 µmol/l serum creatinine or 60 to 40 ml / min creatinine clearance: 2 film-coated tablets / dragees / day

up to 2.6-6 mg/dl or 226 to 530 µmol/l Serum creatinine, or 40 to 15 ml/min creatinine Clearance: 1 film-coated tablet/caplet/day

- over 6 mg/dl or over 530 µmol/l serum creatinine or less than 15 ml/min creatinine clearance: 1 film-coated tablet / dragee every 1 to 2 days

Please pay attention to a sufficient and regular hydration!

3.2.a.3.With significant Hypoalbuminemia (a lack of a certain protein in the blood), such as the nephrotic syndrome

The doctor may reduce the dose to 1 film-coated tablet/dragee (200 mg) every 3rd day. In order to avoid overdoses and severe muscle damage (rhabdomyolysis), the doctor will perform precise dose-finding examinations to determine the concentration of bezafibrate in the blood (plasma).

If you suffer from a sensitive stomach, the treatment can be started insidiously. For this purpose, dosage forms with a lower content of bezafibrate are available.

3.2. b. 1. Adults

take 1 prolonged-release form (equivalent to 400 mg bezafibrate per day) once a day.

3.2. b.2. Renal dysfunction

up to 1.5 mg/dl or up to 135 µmol/l serum creatinine or more than 60 ml/min creatinine clearance: 1 prolonged form / day

(over 1.5 mg/dl or over 135 µmol/l serum creatinine or less than 60 ml/min creatinine clearance: the active substance content of 400 mg is too high for one application!)

Overdoses can lead to severe muscle damage (rhabdomyolysis), especially in patients with impaired renal function. If an overdose is suspected, please inform a doctor so that measures can be taken, if necessary, to accelerate the excretion of the active substance from the body.

If you are taking "Bezafibrate? do not take a double dose if you forget to take the previous dose. Continue treatment with the prescribed amount at the next time of intake.

Do not stop the treatment without consulting your doctor.

- if you are hypersensitive (allergic) to bezafibrate or any of the other ingredients of "Bezafibrate? have,

- severe liver dysfunction,

- for gallbladder diseases with or without gallstones (since the possibility of liver involvement cannot be excluded),

- in case of known hypersensitivity of the skin to light (photoallergic or phototoxic reactions) after taking a drug with an active substance from the group of fibrates (certain lipid sinks),

- if you are a dialysis patient,

- For dosage forms with 200 mg bezafibrate: for severe renal impairment (serum creatinine levels above 6 mg / dl or creatinine clearance below 15 ml / min).

- For dosage forms with 400 mg bezafibrate: with impaired renal function (serum creatinine values above 1.5 mg / dl or creatinine clearance below 60 ml / min).

Like all medicines, can Bezafibrate"? Have side effects, but do not have to occur with everyone.

The following frequency data are used for the evaluation of side effects:

- very common: more than 1 in 10 patients

- common: less than 1 in 10 but more than 1 in 100 patients

- occasionally: less than 1 in 100, but more than 1 in 1 000 treated

- rare: less than 1 in 1 000, but more than 1 in 10 000 treated

- very rare: less than 1 in 10,000 treated, including isolated cases

- unknown: Frequency cannot be estimated based on available data