EMCOZIN Tablet (2018)

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Περιεχόμενα

1. Name of the medicinal product

Emcozin 30/500mg Tablets. Co-codamol 30/500 mg Tablets.

2. Qualitative and quantitative composition

Each tablet contains: Paracetamol 500 mg and Codeine Phosphate Hemihydrate 30 mg. For excipients, see 6.1.

3. Pharmaceutical form

Tablets. Off-white, capsule-shaped tablets. Embossed on one side with CO COD 30 and plain on the reverse.

4.1. Therapeutic indications

For the relief of severe pain. Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol ...

4.2. Posology and method of administration

For oral administration. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Adults ...

4.3. Contraindications

Known hypersensitivity to paracetamol, codeine or other opioid analgesics or to any of the excipients. Moderate to severe renal failure. Moderate to severe liver disease. Acute respiratory depression and ...

4.4. Special warnings and precautions for use

Caution is advised in the administration of both paracetamol and codeine to patients with impaired kidney or liver function. The hazard of overdose with paracetamol is greater in those with alcoholic liver ...

4.5. Interaction with other medicinal products and other forms of interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced ...

4.6. Fertility, pregnancy and lactation

Pregnancy Codeine crosses the placenta. There is no adequate evidence of safety in human pregnancy and a possible association with respiratory and cardiac malformations has been reported. Regular use during ...

4.7. Effects on ability to drive and use machines

Codeine may cause drowsiness, changes in vision, including blurred or double vision. If affected patients should be advised not to drive or operate machinery. The effects of alcohol are enhanced by opioid ...

4.8. Undesirable effects

The information below lists reported adverse reactions, ranked using the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 ...

4.9. Overdose

Paracetamol Symptoms Symptoms of paracetamol overdosage in the first 24 hours are sweating, pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ...

5.1. Pharmacodynamic properties

Paracetamol has analgesic and antipyretic actions. Codeine phosphate is an analgesic of the opioid class. Opioid analgesics bind with stereospecific receptors at many sites within the CNS to alter processes ...

5.2. Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma levels occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine ...

5.3. Preclinical safety data

Both actives have been in clinical use separately and in combination products for many years. Preclinical data has therefore been superseded by clinical data.

6.1. List of excipients

Maize starch Colloidal anhydrous silica Povidone Potassium sorbate Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5. Nature and contents of container

Blister pack strips, constructed from 250 micron PVC film lidded with aluminium foil containing 10, 20, 30, 50 or 100 tablets per strip.

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

M & A Pharmachem Ltd, Allenby Laboratories Wigan, Road, Westhoughton, Bolton BL5, 2AL

8. Marketing authorization number(s)

PL 04077/0224

9. Date of first authorization / renewal of the authorization

05/06/2006

10. Date of revision of the text

01/08/2018

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