Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
pregabalin, Quantity: 300 mg
NOUMED PHARMACEUTICALS PTY LTD
Capsule
Excipient Ingredients: purified talc; maize starch; pregelatinised maize starch; titanium dioxide; brilliant blue FCF; sunset yellow FCF; purified water; allura red AC; Gelatin; sodium lauryl sulfate
Oral
56, 14, 10
(S4) Prescription Only Medicine
NOUMED PREGABALIN (pregabalin) is indicated for the treatment of neuropathic pain in adults. NOUMED PREGABALIN (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Visual Identification: White to off white powder filled in size 0 hard gelatin orange opaque and white opaque capsule linear printed in black ink with Cipla 300 mg on the cap and 685 on the body.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-02-21
Noumed Pregabalin 1 NOUMED PREGABALIN CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before taking this medicine. 1. WHY AM I TAKING NOUMED PREGABALIN? Noumed Pregabalin belongs to a group of medicines called anticonvulsants. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. For more information, see Section 1. Why am I using Noumed Pregabalin? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE NOUMED PREGABALIN? Do not use if you have ever had an allergic reaction to pregabalin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take Noumed Pregabalin? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Noumed Pregabalin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE NOUMED PREGABALIN? • The usual dose range is 150 mg per day to 600 mg per day given in two divided doses. More instructions can be found in Section 4. How do I take Noumed Pregabalin? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING NOUMED PREGABALIN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking Noumed Pregabalin. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly unless you have discussed it with your doctor. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how Noumed Pregabalin affects you. DRINKING ALCOHOL • If you drink alcohol, symptoms such as dizziness and drowsiness may be worse LOOKING AFT Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION NOUMED PREGABALIN (PREGABALIN) CAPSULES WARNINGS MISUSE, ABUSE POTENTIAL OR DEPENDENCE Pregabalin is a potential drug of misuse, abuse, and dependence. Pregabalin poses risks of misuse, abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. Assess the patient’s risk of misuse, abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines (see Section 4.4 - Special warnings and precautions for use). 1. NAME OF THE MEDICINE Pregabalin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Noumed Pregabalin 25 mg hard gelatin capsules Each hard capsule contains 25 mg of pregabalin. Noumed Pregabalin 75 mg hard gelatin capsules Each hard capsule contains 75 mg of pregabalin. Noumed Pregabalin 150 mg hard gelatin capsules Each hard capsule contains 150 mg of pregabalin. Noumed Pregabalin 300 mg hard gelatin capsules Each hard capsule contains 300 mg of pregabalin. For the full list of excipients, see section 6.1. Description Pregabalin is a white to off-white solid, crystalline solid. It is sparingly soluble in water and basic and acidic aqueous solutions. 3. PHARMACEUTICAL FORM Hard capsules. Noumed Pregabalin 25 mg capsules: white to off white powder filled in size ‘4’ hard gelatin white opaque and white opaque capsule linear printed in black ink with 'Cipla 25 mg' on the cap and ‘677’ on the body. Noumed Pregabalin 75 mg capsules: white to off white powder filled in size ‘4’ hard gelatin orange opaque and white opaque capsule linear printed in black ink with 'Cipla 75 mg' on the cap and ‘679’ on the body. Noumed Pregabalin 150 mg capsules: white to off white powder filled in size ‘2’ hard gelatin white opaque and white opaque capsule linear printed in black ink with 'Cipla 150 mg' on the cap and ‘682’ on the body. Noumed Pregabalin 300 mg capsules: white Przeczytaj cały dokument