SNIP Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Snip tablets.
2. Qualitative and quantitative composition
Each tablet contains 325mg paracetamol, 15mg pseudoephedrine hydrochloride and 1mg clorpheniramine maleate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White, round, flat, scored tablets embossed Snip. The score line is not intended for breaking the tablet.
4.1. Therapeutic indications
Snip is indicated for: Relief of symptoms associated with cold and flu, such as: nasal congestion, rhinitis, sneeze, fever, mild to moderate pain of different origin. Additional, for alleviating symptoms ...
4.2. Posology and method of administration
Posology Adults Two tablets up to four times daily as required for relief of symptoms. The dose should not be repeated more frequently than every four hours nor should more than four doses be given in ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Not to be used by patients taking monoaminoxidase inhibitors (MAOIs) or for two weeks after stopping the MAOI ...
4.4. Special warnings and precautions for use
Ischaemic colitis Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or ...
4.5. Interaction with other medicinal products and other forms of interaction
The co-administration of Snip with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants), or with monoamine oxidase inhibitors ...
4.6. Fertility, pregnancy and lactation
Do not use Snip if pregnant or breast-feeding without medical advice.
4.7. Effects on ability to drive and use machines
Chlorpheniramine can cause drowsiness; if affected patients should not drive or operate machinery.
4.8. Undesirable effects
The frequencies of the adverse reactions are defined as follows: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known ...
4.9. Overdose
Paracetamol Symptoms Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> paracetamol, combinations without psycholeptics <b>ATC code:</b> N02BE51 The analgesic and antipyretic actions of paracetamol are believed to be due, at least in part, ...
5.2. Pharmacokinetic properties
Paracetamol is rapidly and completely absorbed from the gastro-intestinal tract with peak plasma levels occurring about 0.25‑2 hours after dosing. The absolute bioavailability is about 80% and is independent ...
5.3. Preclinical safety data
Preclinical safety data on paracetamol, pseudoephedrine and chlorpheniramine in the literature have not revealed findings which are of relevance to the recommended dosage and use of the product and which ...
6.1. List of excipients
Microcrystalline cellulose Croscarmellose sodium Powdered cellulose Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
Packs containing 10, 20 and 30 tablets in PVC/Alu blisters are available.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
20113
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 22/06/2006 Date of first renewal of authorisation: 11/02/2015
10. Date of revision of the text
25/06/2020
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