STILPANE Tablet

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Περιεχόμενα

1. Name of the medicinal product

STILPANE (tablets).

2. Qualitative and quantitative composition

Each STILPANE tablet contains: Meprobamate 150 mg Codeine phosphate 8 mg Paracetamol 320 mg Caffeine anhydrous 32 mg Preservatives: Nipastat 0,02% m/m Sugar free.

3. Pharmaceutical form

Green, biconvex tablet, debossed C26 on the one side and bisected on the other side.

4.1. Therapeutic indications

STILPANE is indicated for short term use (no longer than 5 days) in mild to moderate pain associated with anxiety or tension.

4.2. Posology and method of administration

For short term use only. Do not use STILPANE for longer than 5 days. Not recommended for children under 12 years of age. Take two tablets three or four times a day as required. DO NOT EXCEED THE RECOMMENDED ...

4.3. Contraindications

STILPANE is contraindicated in: Hypersensitivity to any of the active ingredients or excipients of STILPANE (see COMPOSITION). Porphyria (including acute forms of porphyria, especially variegate porphyria, ...

4.4. Special warnings and precautions for use

STILPANE contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital ...

4.5. Interaction with other medicinal products and other forms of interaction

Caffeine Caffeine undergoes extensive metabolism by hepatic microsomal cytochrome P450 isoenzyme CYP1A2, and is subject to interactions with other medicines which enhance or reduce its metabolic clearance. ...

4.6. Pregnancy and lactation

The safety of STILPANE in pregnancy and lactation has not been established. STILPANE should not be used during pregnancy and lactation (see CONTRAINDICATIONS).

4.7. Effects on ability to drive and use machines

The use of STILPANE may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or central nervous system depressants. Affected patients should not drive ...

4.8. Undesirable effects

Paracetamol Blood and the lymphatic system disorders Frequency unknown: Neutropenia, pancytopenia, leucopenia, thrombocytopenia and agranulocytosis Skin and subcutaneous tissue disorders Less ...

4.9. Overdose

Prompt treatment is essential. In the event of overdosage, consult a doctor immediately, or take the patient to the nearest hospital immediately. A delay in starting treatment may mean that antidote ...

5.1. Pharmacodynamic properties

Pharmacological classification: A 2.9 Other analgesics STILPANE tablets act as an analgesic in pain-tension states.

6.1. List of excipients

Dye lake green (C.I Nos: 47005, 42090, 15985), magnesium stearate, nipastat, povidone K25, sodium starch glycollate, starch, talc.

6.4. Special precautions for storage

Store at or below 25°C, in a well-closed container. Protect from light. Keep in original packaging until required for use. KEEP OUT OF REACH OF CHILDREN.

6.5. Nature and contents of container

100 tablets are packed in aluminium/PVC blister strips. The strips are packed, together with a leaflet into a unit carton. 500 tablets are packed into a white polypropylene (PP) securitainer, together ...

7. Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

8. Marketing authorization number(s)

M/2.9/2

9. Date of first authorization / renewal of the authorization

Date of registration: 23 November 1979 Date of the most recent amendment to the professional information as approved by the Authority: 20 April 2012

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