STOPAYNE Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
STOPAYNE TABLETS, tablets.
2. Qualitative and quantitative composition
Each tablet contains: Meprobamate 150 mg Codeine phosphate 8 mg Paracetamol 320 mg Caffeine anhydrous 32 mg <u>Excipients with known effect:</u> Contains sugar (lactose monohydrate): 1 mg Contains the ...
3. Pharmaceutical form
Tablets. Light green, round biconvex tablets, scored on one side and RIO embossed on the other side.
4.1. Therapeutic indications
STOPAYNE TABLETS relieve mild to moderate pain and fever, and pain associated with tension.
4.2. Posology and method of administration
Posology DO NOT EXCEED THE RECOMMENDED DOSE. Adult dosage: Two tablets three or four times a day as required. Do not use continuously for more than ten days without consulting your doctor. Special populations ...
4.3. Contraindications
Hypersensitivity to any of the active ingredients or to any of the excipients of STOPAYNE TABLETS (see section 2 and section 6.1). STOPAYNE TABLETS should not be given to patients with acute intermittent ...
4.4. Special warnings and precautions for use
STOPAYNE TABLETS are not recommended for use by pregnant or breastfeeding women (see section 4.6). Do not use continuously for more than ten days without consulting your doctor. Consult your doctor if ...
4.5. Interaction with other medicinal products and other forms of interaction
No information available. Paediatric population No information available.
4.6. Fertility, pregnancy and lactation
Pregnancy STOPAYNE TABLETS is not recommended for use by pregnant women. Breastfeeding STOPAYNE TABLETS is not recommended for use by breastfeeding women. Fertility No information available.
4.7. Effects on ability to drive and use machines
The use of this medicine may cause drowsiness and care should be taken when driving or operating machinery. Reduce dosage if necessary.
4.8. Undesirable effects
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur. a. Summary of the safety profile No information available. b. Tabulated summary of adverse reactions Codeine SYSTEM ...
4.9. Overdose
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment ...
5.1. Pharmacodynamic properties
<b>Category and class:</b> A 2.8 Analgesic combinations. STOPAYNE TABLETS have analgesic, antipyretic and tranquilising properties.
6.1. List of excipients
Brilliant blue FCF (E133) Gelatine Lactose monohydrate Magnesium stearate Povidone Pregelatinized starch Purified talc Quinoline yellow (E104) Sodium starch glycolate Sunset yellow FCF (E110)
6.2. Incompatibilities
No data available.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store at or below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/PVDC/Aluminium blister strips in an outer carton. or White HDPE bottles with white HDPE screw caps in an outer carton. <u>Pack sizes:</u> 100 or 1 000 tablets. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Adcock Ingram Limited, Address, 1 New Road, Erand Gardens, Midrand, 1685
8. Marketing authorization number(s)
B 866 (Act 101/1965) Namibia NS3 14/2.8/0417 Botswana S1 B9300805
9. Date of first authorization / renewal of the authorization
Date of registration: 19 November 1986
10. Date of revision of the text
05 June 2021
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