LOPID Film-coated tablet (2019)
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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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