GEN-PAYNE Capsule, hard (2021)
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Περιεχόμενα
1. Name of the medicinal product
GEN-PAYNE CAPSULES, 10 mg/200 mg/250 mg, capsules.
2. Qualitative and quantitative composition
Each capsule contains: Codeine phosphate 10 mg Ibuprofen 200 mg Paracetamol 250 mg Sugar free. For full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsules. The cap is opaque green, and the body is opaque red. ADCO is printed on both the cap and body. Contents of the capsule are fine white granular powder.
4.1. Therapeutic indications
GEN-PAYNE CAPSULES are indicated for the relief of mild to moderate pain of inflammatory origin with or without fever.
4.2. Posology and method of administration
Posology Use the lowest effective dose for the shortest possible duration of treatment. Adults and children over 12 years One to two capsules four to six hourly and not more than six capsules per twenty-four ...
4.3. Contraindications
Impaired hepatic and renal function. Heart failure. History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including GEN-PAYNE CAPSULES. Active or history of ...
4.4. Special warnings and precautions for use
The safety of continuous administration of GEN-PAYNE CAPSULES has not been established for a period greater than four weeks. Codeine phosphate <b>Exceeding the prescribed dose, together with prolonged ...
4.5. Interaction with other medicinal products and other forms of interaction
Codeine phosphate The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines. Ibuprofen Lithium, ...
4.6. Fertility, pregnancy and lactation
GEN-PAYNE CAPSULES are not recommended for use by pregnant or breastfeeding women (see section 4.3). Regular use of non-steroidal anti-inflammatory drugs during the third trimester of pregnancy, may result ...
4.7. Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by dizziness or sedation. This medicine can impair cognitive function and can affect a patients ability to drive safely. Patients ...
4.8. Undesirable effects
a. Summary of the safety profile The most commonly observed adverse events are gastrointestinal in nature. b. Tabulated summary of adverse reactions Codeine phosphate SYSTEM ORGAN CLASS FREQUENCY ADVERSE ...
4.9. Overdose
Paracetamol <b>Prompt treatment is essential.</b> In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that antidote ...
5.1. Pharmacodynamic properties
<b>Category and class:</b> A 2.8 Analgesic combinations GEN-PAYNE CAPSULES have an analgesic, anti-inflammatory and anti-pyretic action.
6.1. List of excipients
<u>Capsule fill:</u> Colloidal silica Magnesium stearate Maize starch Potassium sorbate <u>Capsule shell:</u> Opaque Green Cap Opaque Red Body Printing ink <u>Capsule shell colourants:</u> Brilliant blue ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store at or below 25°C in well-closed containers.
6.5. Nature and contents of container
A white high density polypropylene (HDPP) securitainer with a low density polyethylene (LDPE) snap on lid or a white high density polyethylene container with a high density polyethylene (HDPE) screw cap ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Private Bag X69, Bryanston 2021
8. Marketing authorization number(s)
South Africa (S2): 35/2.8/0046 Botswana (S3): BOT1001644A Namibia (NS2): 04/2.8/1571 Zimbabwe (P): 2016/2.2/5239
9. Date of first authorization / renewal of the authorization
21 May 2002
10. Date of revision of the text
30 July 2021
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