País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate; Caffeine; Paracetamol
Omega Pharma Ltd
N02BE51
Codeine phosphate; Caffeine; Paracetamol
8mg ; 30mg ; 500mg
Oral capsule
Oral
Schedule 5 (CD Inv)
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 5000347062681
children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome. Use in children with BREATHING PROBLEMS: Codeine is not recommended in children with BREATHING PROBLEMS, since the symptoms of morphine toxicity may be worse in these children. PREGNANCY AND BREAST FEEDING TALK TO YOUR DOCTOR before taking Solpadeine Plus Capsules if you are PREGNANT. DO NOT TAKE Solpadeine Plus Capsules while you are BREAST-FEEDING. Codeine and morphine passes into breast milk. DRIVING AND USING MACHINES This medicine can affect your ability to drive as it may make you SLEEPY or DIZZY. DO NOT DRIVE while taking this medicine UNTIL YOU KNOW HOW IT AFFECTS YOU. It is an OFFENCE to drive if this medicine affects your ability to drive. However, you would NOT be committing an offence if: • The medicine has been taken to treat a MEDICAL or DENTAL problem and • You have taken it ACCORDING TO THE INFORMATION PROVIDED with the medicine and • It was NOT AFFECTING your ability to drive safely. TALK TO YOUR DOCTOR or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Details regarding a NEW DRIVING OFFENCE concerning driving after drugs have been taken IN THE UK may be found here: www.gov.uk/drug-driving-law 3. How to take Solpadeine Plus Capsules ADULTS: SWALLOW 2 CAPSULES EVERY 4-6 HOURS AS NEEDED. Do not take more than 8 CAPSULES IN 24 HOURS. FOR THE ELDERLY A REDUCED DOSE MAY BE REQUIRED. CHILDREN AGED 16 – 18 YEARS: SWALLOW 1-2 CAPSULES EVERY 6 HOURS AS NEEDED. CHILDREN AGED 12-15 YEARS: SWALLOW 1 CAPSULE EVERY 6 HOURS AS NEEDED. Do not take more than 4 CAPSULES IN 24 HOURS. • Do not take MORE THAN THE RECOMMENDED DOSE • AVOID TOO MUCH CAFFEINE IN DRINKS LIKE COFFEE AND TEA. High caffeine intake can cause DIFFICULTY SLEEPING, SHAKING and an UNCOMFORTABLE FEELING IN THE CHEST • Solpadeine Plus Capsules should not be taken by children BELOW THE AGE OF 12 YEARS, due to the risk of severe breathing problems • This medicine should not be ta Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solpadeine Plus Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Paracetamol Ph Eur. 500 mg, Codeine Phosphate Hemihydrate Ph Fur 8 mg and Caffeine Ph Eur 30.0 mg. 3. PHARMACEUTICAL FORM Hard gelatin capsules, size”0” with convex hemispherical ends. Opaque red cap and opaque white body, plain on both halves. Capsules contain white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Codeine is indicated in patients older than 12 years for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone. Solpadeine Plus Capsules are recommended for the relief of migraine, headache, backache, rheumatic pain, period pains, dental pain, strains & sprains and sciatica. 4 CLINICAL PARTICULARS 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults 2 capsules every 4-6 hours, up to four times a day. The minimum dosing interval is 4 hours. No more than 4 doses (8 capsules) in 24 hours. Paediatric population: Adolescents aged 16-18 years: 1-2 capsules every 6 hours up to 4 times a day . The minimum dosing interval is 6 hours. No more than 4 doses(8 capsules) should be given in 24 hours. Adolescents aged 12 – 15 years: 1 capsule every 6 hours up to 4 times a day. The minimum dosing interval is 6 hours. No more than 4 doses (4 capsules) should be given in 24 hours. Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). Elderly patients: Elderly patients, especially those who are frail or immobile, may require a reduced dose or frequency of dosing. Renal impairment: Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication. It is recommended, when giving paracetamol to patients with renal failure, to reduce the Leia o documento completo