CLARANTIN Hard capsule Ref.[50022] Active ingredients: Naftidrofuryl

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: Medochemie Ltd, 1-10 Constantinopoleos Street, 3011 Limassol, Cyprus

4.3. Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Patients with a history of hyperoxaluria or recurrent calcium containing stones; they should not use Clarantin either.

4.4. Special warnings and precautions for use

A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.

Clarantin contains carmoisine which may cause allergic reactions.

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

None known.

There is no information on potential interactions with other drugs or other forms of interaction.

4.6. Pregnancy and lactation

Pregnancy

There is inadequate evidence of the safety of naftidrofuryl oxalate in human pregnancy, although it has been in wide use for many years without apparent ill consequence. Animal studies having shown no hazard. If drug therapy is required during pregnancy, Clarantin could be used if there is no safer alternative.

Breast-feeding

There is no information available and Clarantin should not be used during lactation.

4.7. Effects on ability to drive and use machines

Clarantin has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Naftidrofuryl oxalate is normally well tolerated in the dosage recommended:

Rare: Nausea, hepatitis, epigastric pain and rashes.

Very rare: Calcium oxalate kidney stones.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

6.2. Incompatibilities

No known incompatibilities.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.