PONSTAN FORTE Film-coated tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Ponstan Forte Tablets 500 mg.
Qualitative and quantitative composition
Each tablet contains 500 mg mefenamic acid. <u>Excipients with known effect:</u> Each tablet contains 22.73 mg lactose monohydrate, and 0.067 mg sunset yellow (E110). For the full list of excipients, see ...
Pharmaceutical form
Film-coated tablet. Yellow, biconvex elliptical film coated tablet, inscribed Ponstan Forte on one side.
Therapeutic indications
Mefenamic acid is a non-steroidal anti-inflammatory agent with analgesic properties, and a demonstrable antipyretic effect. It has been shown to inhibit prostaglandin activity. <u>Indications:</u> 1. As ...
Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Do not exceed the stated dose. Posology Adults 1 tablet ...
Contraindications
Hypersensitivity to mefenamic acid or any of the other ingredients. Inflammatory bowel disease. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history ...
Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks below). Patients on prolonged ...
Interaction with other medicinal products and other forms of interaction
Concurrent therapy with other plasma protein binding drugs may necessitate a modification in dosage. Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). ...
Fertility, pregnancy and lactation
Pregnancy Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of ...
Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
Undesirable effects
The most frequently reported side effects associated with mefenamic acid involve the gastrointestinal tract. Diarrhoea occasionally occurs following the use of mefenamic acid. Although this may occur soon ...
Overdose
It is important that the recommended dose is not exceeded and the regime adhered to since some reports have involved daily dosages under 3g. Symptoms Symptoms include headache, nausea, vomiting epigastric ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-inflammatory and anti- rheumatic products, non-steroids, fenamates <b>ATC code:</b> M01AG01 Mechanism of action Mefenamic acid is non-steroidal anti-inflammatory ...
Pharmacokinetic properties
Absorption and Distribution Mefenamic acid is absorbed from the gastro intestinal tract. Peak levels of 10 mg/l occur two hours after the administration of a 1g oral dose to adults. Biotransformation ...
Preclinical safety data
Preclinical safety data does not add anything of further significance to the prescriber.
List of excipients
<u>Tablet core:</u> Lactose monohydrate Pregelatinized starch Maize starch Povidone Colloidal anhydrous silica Talc Magnesium stearate Croscarmellose sodium type A Sodium laurilsulfate <u>Coating (Opadry ...
Incompatibilities
Not applicable.
Shelf life
<u>Amber polystyrene bottle:</u> 3 years. <u>Blister and HDPE DUMA and polypropylene container:</u> 4 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
a) Aluminium foil/pvc blister pack in cardboard carton. Pack sizes: 28 and 100 tablets. b) HDPE DUMA and polypropylene container. Pack sizes: 100 and 500 tablets. c) Amber polystyrene bottle with a high ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom
Marketing authorization number(s)
PL 17736/0007
Date of first authorization / renewal of the authorization
10/10/2005
Date of revision of the text
25/02/2021
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