LIPANOR

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

CIPROFIBRATE

Tilgjengelig fra:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC-kode:

C10AB08

Legemiddelform:

CAPSULES

Sammensetning:

CIPROFIBRATE 100 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Terapeutisk gruppe:

CIPROFIBRATE

Terapeutisk område:

CIPROFIBRATE

Indikasjoner:

For the treatment of primary hyperlipidaemia resistant to appropriate dietary management, including hypercholesterolaemia, hypertriglyceridaemia and combined hyperlipidaemia.

Autorisasjon dato:

2022-04-30

Informasjon til brukeren

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حصلا ةرازول ة
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يبناج ضارعأ نع غي

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
LIPANOR 100 mg, capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg ciprofibrate as the active ingredient.
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Capsules.
Each capsule contains an opaque olive green cap and an opaque cream
body, containing white
to off-white odourless powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of primary hyperlipidaemia resistant to appropriate
dietary management,
including hypercholesterolaemia, hypertriglyceridaemia and combined
hyperlipidaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults_: _The recommended dosage is one capsule (100 mg ciprofibrate)
per day. This dose
should not be exceeded (See Precautions)
Elderly patients:_ _As for adults, but see Precautions and Warnings.
Use in Case of impaired renal function_:_ In moderate renal impairment
(creatinine clearance
30-80 ml/min/1.73m2) it is recommended that dosage be reduced to one
capsule every
other day. Patients should be carefully monitored. Ciprofibrate should
not be used in
severe renal impairment (creatinine clearance
˂
30 ml/min/1.73m2)
Use in Children:_ _Not recommended since safety and efficacy in
children have not been
established.
For oral administration only
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1

Severe hepatic impairment

Severe renal impairment (creatinine clearance
˂
30 ml/min/1.73m2)

Pregnancy and lactation, or when pregnancy is suspected.

Concurrent use with another fibrate.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Patients with rare hereditary problems of galactose intolerance, total
lactase deficiency or
glucose-galactose malabsorption should not take this medicine.
_Myalgia/myopathy: _
- Patients should be advised to report unexplained muscle pain,
tenderness or weakness
immediately.
CPK levels should be assessed immediately in patients reporting these
symptoms.
Therapy s