Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
PREGABALIN
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N03AX16
CAPSULES
PREGABALIN 300 MG
PER OS
Required
PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY
PREGABALIN
PREGABALIN
Lyrica is indicated for the:- Treatment of peripheral and central neuropathic pain in adults. - Management of Fibromyalgia.- Treatment of Generalised Anxiety Disorder (GAD) in adults..
2020-06-30
Lyrica PIL CC 110822 Pfleet 2022-007662, 2022-0077909 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only LYRICA ® 25 MG LYRICA ® 50 MG LYRICA ® 75 MG LYRICA ® 100 MG LYRICA ® 150 MG LYRICA ® 200 MG LYRICA ® 225 MG LYRICA ® 300 MG CAPSULES ACTIVE INGREDIENT: PREGABALIN 25, 50, 75, 100, 150, 200, 225, 300 MG Inactive ingredients and allergens: see section 2 under "Important information about some of this medicine's ingredients" and section 6 “Further information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others, it may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is not intended for treatment of children and adolescents under 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? For treatment of neuropathic (neural) pain in adults, for treatment of fibromyalgia and for treatment of generalised anxiety disorder in adults. THERAPEUTIC GROUP: A gamma-aminobutyric acid analog. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to the active ingredient or to any of the other ingredients contained in this medicine (listed in section 6). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE REFER TO YOUR DOCTOR BEFORE TAKING THE MEDICINE. • Some patients taking Lyrica have reported allergic effects. These effects include swelling of the face, lips, tongue and throat, as well as diffuse skin rash. If you experience one or more of these effects, refer to a doctor immediately. Lyrica PIL CC 110822 Pfleet 2022-007662, 2022-0077909 • Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with Lyrica. Stop using the medicine and refer to a doctor imm Perskaitykite visą dokumentą
Lyrica LPD CC 070722 Page 1 of 14 Pfleet 2022-0075766, 2021-0069599 1. NAME OF THE MEDICINAL PRODUCT LYRICA ® 25 mg LYRICA ® 50 mg LYRICA ® 75 mg LYRICA ® 100 mg LYRICA ® 150 mg LYRICA ® 200 mg LYRICA ® 225 mg LYRICA ® 300 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin. _ _ Excipients with known effect: [25mg] Each capsule contains 35 mg lactose monohydrate. [50mg] Each capsule also contains 70 mg lactose monohydrate. [75mg] Each capsule also contains 8.25 mg lactose monohydrate. [100mg] Each capsule also contains 11 mg lactose monohydrate. [150mg] Each capsule also contains 16.50 mg lactose monohydrate. [200mg] Each capsule also contains 22 mg lactose monohydrate. [225mg] Each capsule also contains 24.75 mg lactose monohydrate. [300mg] Each capsule also contains 33 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule 25 mg capsule: White hard gelatin capsule, marked “Pfizer” on the cap and “PGN 25” on the body with black ink. 50 mg capsule: White hard gelatin capsule, marked “Pfizer” on the cap and “PGN 50” on the body with black ink. The body is also marked with a black band. 75 mg capsule: White and orange hard gelatin capsule, marked “Pfizer” on the cap and “PGN 75” on the body with black ink. 100 mg capsule: Orange hard gelatin capsule marked “Pfizer” on the cap and “PGN 100” on the body with black ink. 150 mg capsule: White hard gelatin capsule, marked “Pfizer” on the cap and “PGN 150” on the body with black ink. 200 mg capsule: Light orange hard gelatin capsule, marked “Pfizer” on the cap and “PGN 200” on the body with black ink. 225 mg capsule: White and light orange hard gelatin capsule, marked “Pfizer” on the cap and “PGN 225” on the body with black ink. 300 mg capsule: White and orange hard gelatin capsule, marked “Pfizer” on the cap and “PGN 300” on the body with black ink. 4. CLINIC Perskaitykite visą dokumentą