Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol; ORPHENADRINE CITRATE
Hovid Nutriworld Sdn Bhd
Paracetamol; ORPHENADRINE CITRATE
100 Tablets
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ BIOWELL PENSIC TABLET 450 MG / 35 MG Paracetamol 450mg, Orphenadrine Citrate 35mg 1 WHAT IS IN THIS LEAFLET 1. What Pensic is used for 2. How Pensic works 3. Before you use Pensic 4. How to use Pensic 5. While you are using it 6. Side effects 7. Storage and Disposal of Pensic 8. Manufacturer 9. Product Registration Holder 10. Date of Revision 11. Serial Number WHAT PENSIC IS USED FOR Pensic is used to treat tension headache and headaches caused by spasm of the muscles in the back of your head and neck. It is also used to help relax certain muscles in your body and to relieve the pain and discomfort caused by sprains, strains or other injuries such as whiplash injuries, acute torticollis (twisting of the neck), slipped disc to your muscles. Your doctor may have prescribed Pensic for another purpose. Ask your pharmacist or doctor if you have any questions about this medicine. HOW PENSIC WORKS Paracetamol has analgesic and antipyretic actions that is used to reduce pain and fever. Orphenadrine Citrate is a skeletal muscle relaxant. BEFORE YOUR USE PENSIC _ _ _- When you must not use it_ Do not take this medicine if: • You are / may be allergic to Paracetamol or Orphenadrine Citrate or other ingredients in Pensic tablet • You have glaucoma (high pressure in the eyes) • Enlarged prostate or bladder obstruction • Myasthenia gravis (a disease of the muscles causing dropping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms and legs) If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor. _- Before you start to use it_ Tell your doctor/pharmacist if: • You have allergies to any other medicines, foods, preservatives or dyes. • you have heart problems. • You have any liver or kidney problems. • You have alcohol abuse problems. This preparation contains PARACETAMOL. Do not take any other paracetamol containing medicines at the same time. Pensic is not recommen Baca dokumen lengkap
DESCRIPTION Round, white uncoated tablet, bevel-edged, flat faces, "HD" embossed and scored on the same face. The tablet is not meant to be split and should be swallowed whole as the break line is solely for identification purposes. COMPOSITION Each tablet contains: Paracetamol 450 mg Orphenadrine citrate 35 mg PHARMACODYNAMICS Orphenadrine is a skeletal muscle relaxant. Paracetamol is an analgesic and antipyretic. PHARMACOKINETICS Orphenadrine is readily absorbed from the gastrointestinal tract and is almost completely metabolised to at least eight metabolites. Orphenadrine and its metabolites are excreted from the body in the urine, with a half life of 14 hours. Paracetamol is also readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. It has a half life of between 1 to 3 hours. INDICATIONS Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc. CONTRAINDICATIONS Orphenadrine shows some anticholinergic activity and should not be used in patients with glaucoma, prostatic hypertrophy or obstruction at the bladder neck, or myasthenia gravis. WARNING AND PRECAUTIONS Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly. Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias. Safety of continuous long-term therapy with orphenadrine has not been established. Therefore if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function is recommended. ALLERGY ALERT: Paracetamol may cause severe skin re Baca dokumen lengkap