NUROFEN PLUS Film-coated tablet (2023)
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Περιεχόμενα
1. Name of the medicinal product
Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg.
2. Qualitative and quantitative composition
Each tablet contains Ibuprofen 200.0 mg and Codeine Phosphate Hemihydrate 12.8 mg. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated Tablet (Tablet). Nurofen Plus is a white film-coated, biconvex capsule-shaped tablet embossed with the logo N+ on one side.
4.1. Therapeutic indications
For the relief of pain in such conditions as: rheumatic and muscular pain, backache, migraine, dental pain, dysmenorrhoea, feverishness, symptoms of cold and flu. This product is indicated in patients ...
4.2. Posology and method of administration
Posology Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken up to 4 times daily at intervals of not less than 6 hours. The maximum daily dose should ...
4.3. Contraindications
Hypersensitivity to the active substances or any of the excipients listed in section 6.1. Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema ...
4.4. Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms. <u>Elderly:</u> The elderly have an increased frequency of adverse reactions ...
4.5. Interaction with other medicinal products and other forms of interaction
If you are elderly or particularly if you are receiving regular treatment from your doctor, consult your doctor before taking this medicine. The following drug-drug interactions are known to occur in association ...
4.6. Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
4.7. Effects on ability to drive and use machines
Patients may become dizzy and sedated with Nurofen Plus Tablets. Rare side effects may include convulsions, hallucinations, blurred or double vision and orthostatic hypotension (see section 4.8). If affected, ...
4.8. Undesirable effects
The list of the following adverse effects relates to those experienced with Ibuprofen and Codeine at OTC doses (maximum 1200mg ibuprofen per day), in short-term use. In the treatment of mild to moderate ...
4.9. Overdose
In children, ingestion of more than 400 mg/kg ibuprofen may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours. Ingestion of more than 350mg ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Ibuprofen combinations <b>ATC Code:</b> N02AJ08 Ibuprofen is an NSAID which acts peripherally, inhibiting prostaglandin synthesis and the action of chemical mediators ...
5.2. Pharmacokinetic properties
The combination of the two drugs is appropriate from a pharmacokinetic viewpoint; the tablet exhibits normal release characteristics for both active substances. Ibuprofen is rapidly absorbed from the gastrointestinal ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Sodium starch glycolate Type A Hypromellose Pregelatinised maize starch <u>Film coating:</u> Hypromellose Talc Opaspray white M-1-7111B (containing: Hypromellose ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
6.5. Nature and contents of container
Blister packs (250 micron PVC/40gsm PVDC heat sealed to aluminium foil) containing 6, 12 or 24 tablets (OTC pack sizes). Blister packs (250 micron PVC/40gsm PVDC heat sealed to aluminum foil) containing ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA0979/034/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 21 March 1997 Date of last renewal: 21 March 2007
10. Date of revision of the text
July 2023
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