TREVIGO Tablet Ref.[50542] Active ingredients: Betahistine

Source: Marketing Authorisation Holder  Revision Year: 2014  Publisher: Novagen Pharma (Pty) Ltd., Office 2, 100 Sovereign Drive, Route 21 Corporate Park, Nellmapius Drive, Irene Pretoria, South Africa

4.1. Therapeutic indications

TREVIGO TABLETS are used to treat vertigo (dizziness) associated with Ménière’s syndrome. Vertigo is a condition that causes sufferers to have a sensation of rotation or movement of themselves or their surroundings. TREVIGO TABLETS work by improving blood flow in the inner ear. This lowers the build-up of pressure.

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 is too strong or too weak, talk to your doctor or pharmacist. Do not share medicines prescribed for you with any other person.

Adults (including the elderly)

  • TREVIGO TABLETS are preferably taken with meals.
  • Dosage is determined according to the individual patient’s response. Depending on the severity of your complaints, your doctor will determine the necessary dose for the treatment of your disease.
  • The usual starting dose is 16 mg three times a day.
  • Thereafter, the usual recommended dose is 24-48 mg daily, taken in divided doses.

Children

  • TREVIGO TABLETS should not be used in children.

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. If neither is available, contact the nearest hospital or poison control centre.

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: 30’s – Each carton contains 3 blisters of 10 tablets each.

HDPE Container Pack: Tablets are packed in 40 ml HDPE containers with polypropylene closures with induction sealing wad, containing cotton coil. Each container contains 30 tablets.

Pack size: 30’s – One HDPE container contains 30 tablets.

TREVIGO 16 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: 30’s – Each carton contains 3 blisters of 10 tablets each.

HDPE Container Pack: Tablets are packed in 40 ml HDPE containers with polypropylene closures with induction sealing wad, containing cotton coil. Each container contains 30 tablets.

Pack size: 30’s – One HDPE container contains 30 tablets.

TREVIGO 24 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: 20’s – Each carton contains 2 blisters of 10 tablets each.

HDPE Container Pack: Tablets are packed in 40 ml HDPE containers with polypropylene closures with induction sealing wad, containing cotton coil. Each container contains 30 tablets.

Pack size: 20’s – One HDPE container contains 20 tablets.

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).

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