TREVIGO Tablet (2014)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

TREVIGO 8 mg TABLETS. TREVIGO 16 mg TABLETS. TREVIGO 24 mg TABLETS. Betahistine dihydrochloride.

2. Qualitative and quantitative composition

The active substance is betahistine dihydrochloride. TREVIGO 8 mg tablets: Each uncoated tablet contains betahistine dihydrochloride 8 mg. TREVIGO 16 mg tablets: Each uncoated tablet contains ...

3. Pharmaceutical form

TREVIGO 8 mg TABLETS: White to off–white round, flat, uncoated tablets debossed with X on one side and 87 on the other side. TREVIGO 16 mg TABLETS: White to off–white round, uncoated tablets, debossed ...

4.1. Therapeutic indications

TREVIGO TABLETS are used to treat vertigo (dizziness) associated with Ménières syndrome. Vertigo is a condition that causes sufferers to have a sensation of rotation or movement of themselves or their ...

4.2. Posology and method of administration

Always take TREVIGO TABLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of TREVIGO TABLETS ...

4.3. Contraindications

Do not take TREVIGO TABLETS: If you are hypersensitive (allergic) to betahistine dihydrochloride, or any of the other ingredients of TREVIGO TABLETS. If you have a stomach ulcer. If you suffer from phaeochromocytoma ...

4.4. Special warnings and precautions for use

Take special care with TREVIGO TABLETS: If you have asthma. If you have ever had a stomach ulcer.

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

Taking other medicines with TREVIGO TABLETS: Do not take TREVIGO TABLETS together with antihistamine medicines i.e. medicines used for the treatment of allergy. Always tell your healthcare professional ...

4.6. Pregnancy and lactation

The safe use of TREVIGO TABLETS during pregnancy and breastfeeding has not been determined. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare ...

4.7. Effects on ability to drive and use machines

TREVIGO TABLETS do not appear to make one sleepy or drowsy, so you can drive or operate machinery, if necessary. Please consult your doctor or pharmacist for advice.

4.8. Undesirable effects

TREVIGO TABLETS can have side effects. Get emergency medical help immediately if you have any of these signs of an allergic reaction: Difficulty breathing; swelling of your face, lips, tongue, or throat. ...

4.9. Overdose

The symptoms of overdose include nausea, vomiting and headache. Low blood pressure may occur. Treatment may include emptying the stomach. In the event of overdosage, consult your doctor or pharmacist. ...

6.1. List of excipients

Cellulose microcrystalline Citric acid Crospovidone Mannitol Povidone Silica colloidal anhydrous Stearic acid Talc

6.4. Special precautions for storage

Store at or below 25°C (room temperature). Do not remove the blisters from the carton until required for use. Keep the containers tightly closed. Keep all medicines out of reach of children.

6.5. Nature and contents of container

TREVIGO 8 mg TABLETS Blister Pack: Tablets are packed in blister packs (composed of OPA / aluminium foil / PVC film and printed aluminium foil). Each blister contains 10 tablets. Pack size: 30s – Each ...

6.6. Special precautions for disposal and other handling

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

7. Marketing authorization holder

Novagen Pharma (Pty) Ltd., Office 2, 100 Sovereign Drive, Route 21 Corporate Park, Nellmapius Drive, Irene Pretoria, South Africa

8. Marketing authorization number(s)

TREVIGO 8 mg TABLETS: 45/5.6/0577 TREVIGO 16 mg TABLETS: 45/5.6/0578 TREVIGO 24 mg TABLETS: 45/5.6/0579

9. Date of first authorization / renewal of the authorization

Date of Registration: 6 March 2014

10. Date of revision of the text

6 March 2014

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