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

4.3. 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 (a tumour on the adrenal gland).

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 if you are taking any other medicine. (This includes complementary or traditional medicines).

Taking TREVIGO TABLETS with food and drink:

  • TREVIGO TABLETS are preferably taken with meals.

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 professional for advice before taking TREVIGO TABLETS.

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.
  • A red skin rash, inflamed itchy skin; hives

Other side effects include: Headache, itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking TREVIGO TABLETS during meals or lowering the dose can help reduce any stomach problems.

Tell your doctor as soon as possible if any of the above side effects are severe, bothersome, do not go away or about any concerns you have while taking TREVIGO TABLETS.

Not all side-effects reported for TREVIGO TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TREVIGO TABLETS, please consult your doctor, pharmacist or other healthcare professional for advice.

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