Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
PAHANG PHARMACY SDN. BHD.
PREGABALIN
60capsule Capsules
KRKA, d.d., Novo mesto
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ REWISCA HARD CAPSULES Pregabalin (50 mg, 75 mg, 150 mg) 1 WHAT IS IN THIS LEAFLET 1. What _Rewisca _is used for 2. How _Rewisca_ works 3. Before you use _Rewisca_ 4. How to use _Rewisca_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Rewisca_ Product Description 8. Manufacturer and Product Registration Holder 9. Date of revision WHAT _REWISCA_ IS USED FOR _Rewisca_ belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults. PERIPHERAL AND CENTRAL NEUROPATHIC PAIN: _Rewisca_ is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life. EPILEPSY: _Rewisca_ is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe _Rewisca_ for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take _Rewisca_ in addition to your current treatment. _Rewisca_ is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment. GENERALISED ANXIETY DISORDER: _Rewisca_ is used to treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, and having muscle tension or sleep disturbance. This is different to the stresses and strains of everyday life Leggi il documento completo
1.3.1 Pregabalin SPC, Labeling and Package Leaflet MY SmPCPIL133311_3 03.06.2019 – Updated: 08.07.2019 Page 1 of 11 REWISCA _Pregabalin_ NAME OF THE MEDICINAL PRODUCT Rewisca 50 mg hard capsules Rewisca 75 mg hard capsules Rewisca 150 mg hard capsules COMPOSITION Each hard capsule contains 50 mg, 75 mg or 150 mg pregabalin. For the full list of excipients, see section List of excipients. PRODUCT DESCRIPTION 50 mg hard capsules (capsules): The body of the capsule is white colour, the cap of the capsule is bright yellow colour. Capsule cap is imprinted with black mark P50. The content of the capsule is white to off white powder. Capsule size No. 3. 75 mg hard capsules: The body of the capsule is brownish yellow colour, the cap of the capsule is brownish yellow colour. Capsule cap is imprinted with black mark P75. The content of the capsule is white to off white powder. Capsule size No. 4. 150 mg hard capsules: The body of the capsule is white colour, the cap of the capsule is yellowish brown colour. Capsule cap is imprinted with black mark P150. The content of the capsule is white to off white powder. Capsule size No. 2. THERAPEUTIC INDICATIONS _Neuropathic pain_ Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults. _Epilepsy_ Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. _Generalised Anxiety Disorder_ Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. _Fibromyalgia_ Pregabalin is indicated for the treatment of fibromyalgia. 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. Based on individual patient response 1.3.1 Pregabalin SPC, Labeling and Package Leaflet MY SmPCPIL133311_3 03.06.2019 – Updated: 08.07.2019 Page 2 of 11 and tolerability, the dose may be increased to 300 mg per day after an in Leggi il documento completo