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LOPID Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lopid 600 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 600 mg of gemfibrozil. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Description Lopid 600 mg: white, biconvex, oval, film-coated tablets

Therapeutic indications

Lopid is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. ...

Posology and method of administration

Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Hepatic impairment Severe renal impairment History of/or pre-existing gall bladder or biliary tract disease, including ...

Special warnings and precautions for use

Muscle disorders (myopathy/rhabdomyolysis) There have been reports of myositis, myopathy and markedly elevated creatine phosphokinase associated with gemfibrozil. Rhabdomyolysis has also been reported ...

Interaction with other medicinal products and other forms of interaction

The interaction profile of gemfibrozil is complex. In vivo studies indicate that gemfibrozil and its metabolite gemfibrozil 1-O-β-glucuronide are potent inhibitors of CYP2C8 (an enzyme important for the ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data on use of Lopid in pregnant women. Animal studies are insufficiently clear to allow conclusions to be drawn on pregnancy and foetal development (see section 5.3). The ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. In isolated cases dizziness and visual disturbances can occur which may negatively influence driving.

Undesirable effects

Most commonly reported adverse reactions are of gastrointestinal character and are seen in approximately 7% of the patients. These adverse reactions do not usually lead to discontinuation of the treatment. ...

Overdose

Overdose has been reported. Symptoms reported with overdosage were abdominal cramps, abnormal LFTs, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. The patients fully recovered. Symptomatic ...

Pharmacodynamic properties

Pharmacotherapeutic group: Serum-lipid lowering agent Chemical subgroup: Fibrates ATC code: C10AB04 Gemfibrozil is a non-halogenated phenoxypentanoic acid. Gemfibrozil is a lipid regulating agent which ...

Pharmacokinetic properties

Absorption Gemfibrozil is well absorbed from the gastro-intestinal tract after oral administration with a bioavailability close to 100%. As the presence of food alters the bioavailability slightly gemfibrozil ...

Preclinical safety data

In a 2-year study of gemfibrozil, subcapsular bilateral cataracts occurred in 10%, and unilateral in 6.3%, of male rats treated at 10 times the human dose. In a mouse carcinogenicity study at dosages corresponding ...

List of excipients

Core tablet: Microcrystalline cellulose Pregelatinised starch Colloidal silica (anhydrous) (E551) Polysorbate 80 (E433) Sodium starch glycollate Magnesium stearate Tablet coating: Hydroxypropylmethylcellulose ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Film-coated tablets: PVC/Aluminium blisters with 14, 20, 28, 30, 50, 56, 60, 98, 100, 196, 500 and 600 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/0535

Date of first authorization / renewal of the authorization

Renewal of authorization: 04 April 2010

Date of revision of the text

01/2019

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