Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metoclopramide hydrochloride; Paracetamol
DE Pharmaceuticals
N02BE51
Metoclopramide hydrochloride; Paracetamol
5mg ; 500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401
PACKAGE LEAFLET: INFORMATION FOR THE USER PARAMAX® 500MG/5MG TABLETS (paracetamol/metoclopramide hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet WHAT IS IN THIS LEAFLET: 1. What Paramax is and what it is used for 2. What you need to know before you take Paramax 3. How to take Paramax 4. Possible side effects 5. How to store Paramax 6. Contents of the pack and other information 1. WHAT PARAMAX IS AND WHAT IT IS USED FOR The name of your medicine is Paramax 500mg/5mg Tablets (called Paramax in this leaflet). WHAT PARAMAX CONTAINS Paramax contains two different medicines. These are called: • METOCLOPRAMIDE HYDROCHLORIDE: this belongs to a group of medicines called antiemetics. It works on muscles in the upper part of the digestive system causing your stomach to empty. It also works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting) • PARACETAMOL: this belongs to a group of medicines called painkillers (analgesics). It works by stopping substances that naturally occur in your body called prostaglandins from being made. Prostaglandins cause pain. If they are blocked, pain is relieved WHAT PARAMAX IS USED FOR Paramax is used to treat the signs of migraine, such as headache, feeling sick (nausea) or being sick (vomiting) in adults 18 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARAMAX DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: • You are allergic to the active substances or any of the other ingredients (listed in section 6) Signs of an allergic reaction include: Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paramax 500mg/5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg paracetamol with 5mg metoclopramide hydrochloride (calculated with reference to anhydrous substance). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adult population Paramax is indicated for the symptomatic treatment of migraine 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Paramax should be taken at the first warning of an attack. If symptoms persist, further doses may be taken at four-hourly intervals. Total dosage in any 24- hour period should not exceed the quantity stated. The dosage recommendations given below should be strictly adhered to if side- effects of the dystonic type are to be avoided. USUAL RECOMMENDED DOSAGE (NUMBER OF TABLETS) Initial dose at first Maximum warning of attack dosage in any 24-hour period Adults (including elderly patients) 2 6 Treatment should not exceed 3 months due to the presence of metoclopramide (see also sections 4.4 and 4.8). Paediatric population including adolescents Use in children less than 1 year of age is contra-indicated due to increased risk of extrapyramidal disorders (see section 4.4). Use in children and adolescents between the ages of 1 and 18 years is not recommended. METHOD OF ADMINISTRATION For oral administration only. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Gastrointestinal haemorrhage, obstruction or perforation, since stimulation of gastrointestinal motility constitutes a risk in these situations. History of neuroleptic or metoclopramide-induced tardive dyskinesia. Confirmed epilepsy, since the frequency and severity of seizures may be increased. Confirmed or suspected phaeochromocytoma, because of the risk of hypertensive crisis. Combination with levodopa because of a mutual antagonism. Metoclopramide should be not be used in the imm Read the complete document