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Remotiv®

Extract of Hypericum (St John’s wort) Ze 117


Consumer Medicine Information

What is in this leaflet?

The information in this leaflet will answer some of the questions you may have about Remotiv tablets.

What Remotiv tablets are used for?

Remotiv tablets are recommended for the relief of anxiety, nervous tension, irritability and are helpful during times of stress. Remotiv tablets also help to relieve sleeplessness and insomnia.

Before using Remotiv tablets you should consider the following:

  • Increased sensitivity to the sun
    Very large doses of Remotiv may potentially cause photosensitisation (increased sensitivity to the sun and sunburn).
  • Pregnancy and breast feeding
    There is no data on the use of Remotivduring pregnancy or in breast-feeding mothers.
    Remotiv tablets should only be taken during pregnancy and used by breast-feeding mothers under medical supervision.
  • Kidney and liver disease
    Due to absence of clinical data, Remotiv should not be used in patients with severe renal impairment (kidney problems), or hepatic impairment (liver problems).
  • Severe depressive illness
    Remotiv is not recommended in these patients.
  • Possible Interactions between Remotiv tablets and other medicines
    St John’s wort affects the way some prescription medicines work. Please consult your doctor.
    When St John’s wort is taken together with certain other drugs, the speed at which the other drugs in the body are broken down by could possibly be increased. This may result in lower levels of the other drugs being present and could affect the action of these drugs. Drugs definitely affected in this way are indinavir and cyclosporin. Other drugs that maybe affected are warfarin, digoxin, theophylline, anticonvulsants and psychotropic reuptake inhibitors. You should discuss this with your health care professional.

How to take Remotiv tablets

Adults take one tablet morning and evening or as directed by your doctor or health care professional. The effect of Remotiv tablets is usually seen within 10 to 14 days of starting treatment, and a duration of therapy of four to six weeks is recommended. Treatment beyond this period may be suggested by your health care professional. If symptoms persist, you should seek the advice of your doctor or health care professional.

If too many Remotiv tablets are taken (overdose)

Photosensitisation has been reported only at high doses, typical symptoms included rash, itching and redness 24 hours after exposure to ultraviolet light. Treatment consists of avoiding exposure to sunlight. There are however no reports of photosensitisation at the recommended dosage.

While you are taking Remotiv tablets

You should remind all health care professionals that you are taking Remotiv tablets, especially if you are currently taking or intend starting any other medicine.

Effects on ability to drive and use machines

Remotiv tablets have no known adverse effects in these situations.

Side Effects

The incidence of undesirable effects during Remotiv treatment is similar to that of placebo (dummy sugar tablets). Undesirable effects reported with an incidence of <5% are: gastro-intestinal disturbances, fatigue and nervousness.

Storage

Remotiv tablets should be stored in their original packaging, be protected from moisture and sunlight and kept in a cool place that stays below 25°C.

Product Description

Each Remotiv tablet contains extracts equivalent to dry:

Hypericum perforatum herb 1.375 g
(Standardised to hypericin 500mcg)

Manufacturer

Remotiv tablets are made in Switzerland by Zeller AG and are marketed in Australia by
herbal medicines
Level 5, 156 Pacific Highway
St. Leonards NSW 2065 Australia
Telephone: 02 9431 7200
Fax: 02 9431 7272
www.flordis.com.au

Published by MIMS October 2010

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