KAPAKE Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Kapake 30mg/500mg Tablets / Co-Codamol 30mg/500mg Tablets.
2. Qualitative and quantitative composition
<b>Per tablet:</b> Paracetamol 500mg Codeine Phosphate 30mg For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Oblong, white uncoated tablets marked Kapake and bearing a scoreline on one side, the other side is plain and unmarked. The score line is only to facilitate breaking for ease of swallowing and ...
4.1. Therapeutic indications
For the relief of severe pain in adults. 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 ...
4.2. Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with codeine in order to minimise the risk of addiction and drug withdrawal ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. This product is contraindicated in patients with raised intracranial pressure or head injury, respiratory depression, ...
4.4. Special warnings and precautions for use
CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect ...
4.5. Interaction with other medicinal products and other forms of interaction
Kapake/Co-Codamol 30mg/500mg Tablets are contraindicated in patients receiving monoamine oxidase inhibitors or who have received these agents within the previous two weeks (see section 4.3). The concomitant ...
4.6. Pregnancy and lactation
Pregnancy This product should not be used during pregnancy. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. Administration during labour ...
4.7. Effects on ability to drive and use machines
Codeine may impair mental and/or physical abilities, therefore it may affect the ability to drive and operate machinery. This medicine can impair cognitive function and can affect a patients ability to ...
4.8. Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including ...
4.9. Overdose
Paracetamol Overdose Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below). ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Opioids in combination with non-opioid analgesics <b>ATC code:</b> N02AJ06 Paracetamol has analgesic and antipyretic effects that do not differ significantly from that ...
5.2. Pharmacokinetic properties
Paracetamol is readily absorbed from the GI tract with peak plasma concentrations occurring about 30 minutes to two hours after oral administration. 90-100% of administered drug can be recovered in the ...
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Microcrystalline cellulose Sodium starch glycolate (type A) Magnesium stearate Povidone
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
High density polypropylene containers with low density polyethylene caps and/or PVC/aluminium blisters and/or PVC/child-resistant aluminium blisters: 3 years. Cold-form aluminium blisters: 2 years.
6.4. Special precautions for storage
Store below 25°C in a dry place protected from light.
6.5. Nature and contents of container
High density polypropylene containers with low density polyethylene caps and/or cold-form aluminium blisters and/or PVC (250um)/aluminium (20um) blisters and/or PVC/child-resistant aluminium blisters. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK
8. Marketing authorization number(s)
PL 27827/0009
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 03 March 1993 Date of latest renewal: 23 February 2009
10. Date of revision of the text
15 May 2020
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