দেশ: দক্ষিণ আফ্রিকা
ভাষা: ইংরেজি
সূত্র: South African Health Products Regulatory Authority (SAHPRA)
Viatris Healthcare (Pty) Ltd
See ingredients
CAPSULES
EACH CAPSULE CONTAINS PREGABALIN 25,0 mg
Registered
2009-06-11
Viatris Healthcare (Pty) Ltd Page 1 of 5 Lyrica 25 mg, 75 mg, 150 mg capsule Final approved PIL – 21 December 2022 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S5 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: LYRICA ® 25 MG CAPSULE LYRICA ® 75 MG CAPSULE LYRICA ® 150 MG CAPSULE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE LYRICA • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or pharmacist. • LYRICA has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 1. WHAT LYRICA CONTAINS: The active substance of LYRICA is pregabalin. Each capsule contains 25 mg, 75 mg or 150 mg of pregabalin active substance. The other ingredients that make up the capsule core are lactose monohydrate, maize starch and talc. 2. WHAT LYRICA IS USED FOR: LYRICA is used in adults to treat long lasting pain caused by damage to the nerves, as in diabetes mellitus and shingles (Herpes zoster). Pain from damaged nerves is called neuropathic pain. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc. If you have diabetes, the pain can be in your arms, hands, fingers, legs, feet or toes. If you have shingles, the pain is in the area of the rash. 3. BEFORE YOU TAKE LYRICA: BEFORE BEING TREATED WITH LYRICA, TELL YOUR DOCTOR IF: Viatris Healthcare (Pty) Ltd Page 2 of 5 Lyrica 25 mg, 75 mg, 150 mg capsule Final approved PIL – 21 December 2022 • You have had any allergic reaction to other medicines of this type (e.g. gabapentin or Neurontin) • You are pregnant, trying to become pregnant or breastfeeding • You are suffering from or have ever suffered from any kidney conditions. If so, your doctor may prescribe a lower dose of LYRICA • You have any family problems of galactose intolerance • You have heart problems including heart failure HAVE YOU EVER HAD AN ALLER সম্পূর্ণ নথি পড়ুন
Viatris Healthcare (Pty) Ltd Page 1 of 13 Lyrica 25 mg, 75 mg, 150 mg capsule Final approved PI – 21 December 2022 SCHEDULING STATUS: S5 PROPRIETARY NAME AND DOSAGE FORM: LYRICA ® 25 MG CAPSULE LYRICA ® 75 MG CAPSULE LYRICA ® 150 MG CAPSULE COMPOSITION: Each hard capsule contains 25 mg, 75 mg or 150 mg of pregabalin. Excipients: Lactose monohydrate, maize starch, talc. PHARMACOLOGICAL CLASSIFICATION: A 2.5 Central nervous system depressants – Anticonvulsants, including anti-epileptics PHARMACOLOGICAL ACTION: PHARMACODYNAMIC PROPERTIES: The active substance, pregabalin, is a gamma-aminobutyric acid (GABA) analogue ((S)-3- (aminomethyl)-5-methylhexanoic acid). _Mechanism of action: _ _In vitro_ studies show that pregabalin binds to an auxiliary subunit ( 2 - protein) of voltage-gated calcium channels in the central nervous system, potently displacing [ 3 H]-gabapentin. Two lines of evidence indicate that binding of pregabalin to the 2 - site is required for analgesic activity in animal models: (1) Studies with the inactive R-enantiomer and other structural derivatives of pregabalin and (2) Studies of pregabalin in mutant mice with defective drug binding to the 2 - protein. In addition, pregabalin reduces the release of several neurotransmitters, including glutamate, noradrenaline, and substance P. The significance of these effects for the clinical pharmacology of pregabalin is not known. Pregabalin does not interact with either GABA A or GABA B receptors; it is not converted metabolically into GABA or a GABA agonist; it is not an inhibitor of GABA uptake or degradation. Viatris Healthcare (Pty) Ltd Page 2 of 13 Lyrica 25 mg, 75 mg, 150 mg capsule Final approved PI – 21 December 2022 Pregabalin prevents pain-related behaviours in animal models of neuropathic and post-surgical pain, including hyperalgesia and allodynia. _Clinical experience: _ _Neuropathic pain: _ The effectiveness of pregabalin for the management of neuropathic pain was investigated in 10 double-blind, placebo-contro সম্পূর্ণ নথি পড়ুন