LYRICA Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Lyrica 25 mg hard capsules. Lyrica 50 mg hard capsules. Lyrica 75 mg hard capsules. Lyrica 100 mg hard capsules. Lyrica 150 mg hard capsules. Lyrica 200 mg hard capsules. Lyrica 225 mg hard capsules. ...
Qualitative and quantitative composition
Lyrica 25 mg hard capsules: Each hard capsule contains 25 mg of pregabalin. Lyrica 50 mg hard capsules: Each hard capsule contains 50 mg of pregabalin. Lyrica 75 mg hard capsules: Each hard capsule contains ...
Pharmaceutical form
Hard capsules. <u>Lyrica 25 mg hard capsules:</u> White marked Pfizer on the cap and PGN 25 on the body with black ink. <u>Lyrica 50 mg hard capsules:</u> White marked Pfizer on the cap and PGN 50 on the ...
Therapeutic indications
Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without ...
Posology and method of administration
Posology The dose range is 150 to 600 mg per day given in either two or three divided doses. Neuropathic pain Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Diabetic patients In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products. Hypersensitivity reactions ...
Interaction with other medicinal products and other forms of interaction
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential. Pregnancy There ...
Effects on ability to drive and use machines
Lyrica may have minor or moderate influence on the ability to drive and use machines. Lyrica may cause dizziness and somnolence and therefore may influence the ability to drive or use machines. Patients ...
Undesirable effects
The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebo controlled trials. The most commonly reported adverse reactions were ...
Overdose
In the postmarketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. Seizures ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16 The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)3(aminomethyl)-5-methylhexanoic acid]. Mechanism ...
Pharmacokinetic properties
Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain. Absorption Pregabalin is rapidly absorbed ...
Preclinical safety data
In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses. In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including ...
List of excipients
Lyrica 25 mg, 50 mg, 150 mg hard capsules Capsules content: Lactose monohydrate Maize starch Talc Capsules shell: Gelatin Titanium dioxide (E171) Sodium laurilsulphate Silica, colloidal anhydrous Purified ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Lyrica 25 mg hard capsules: PVC/Aluminium blisters containing 14, 21, 56, 84, 100 or 112 (2 56) hard capsules. 100 1 hard capsules in PVC/Aluminium perforated unit dose blisters. HDPE bottle containing ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
Lyrica 25 mg hard capsules: EU/1/04/279/001-005 EU/1/04/279/026 EU/1/04/279/036 EU/1/04/279/046 Lyrica 50 mg hard capsules: EU/1/04/279/006-010 EU/1/04/279/037 Lyrica 75 mg hard capsules: EU/1/04/279/011-013 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 06 July 2004 Date of last renewal: 06 July 2009
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