THERASAL

REMOTIV 250MG X 30 FILM-COATED TABLETS

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Composition.

The active substance is the dry extract of Hyperici herba (St. John's wort) Ze 117. The other components are: Core - microcrystalline cellulose, lactose monohydrate, macrogol 6000, magnesium stearate; Film - hypromellose, titanium dioxide (E 171), macrogol 400, red iron oxide (E 172), macrogol 20000, propylene glycol

Therapeutic indications.

Remotiv is a herbal medicine used in the treatment of mood disorders. This medicine contains dry extract of Hyperici herba (St. John's wort) Ze 117, corresponding to 0.5 mg of total hypericin. The extraction solvent is 50% ethanol (m/m); ratio of plant product/extract: 4- 7/1.

Remotiv is indicated for the short-term treatment of symptoms of mild depressive disorders in adults over 18 years of age.

Dosage and method of administration.

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Talk to your doctor or pharmacist if you are not sure.

Remotiv is a medicine intended for adults. The recommended dose is 1 film-coated tablet twice a day, morning and evening, administered with a quantity of liquid (a large glass of water), preferably during or after a meal. The tablets should not be crushed. No dose reduction is necessary for elderly patients.

Precautions.

Before using Remotiv, talk to your doctor or pharmacist.

- because there are interactions with other groups of substances, it is not recommended to administer Remotiv in combination with other medicines except on the recommendation of a doctor.

- if you have sensitive skin or light-coloured skin, avoid excessive exposure to UV radiation (sun exposure, artificial tanning). In very rare cases, skin reactions such as skin redness similar to sunburn or eye reactions may occur.

- if you have renal or hepatic impairment, caution is recommended when administering Remotiv, as there are no clinical studies on the administration of the medicine to this category of patients.

Special warnings.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Animal studies have shown equivocal results. The potential risk to humans is unknown. Due to insufficient clinical data, use during pregnancy or breastfeeding is not recommended. The decision to administer Remotiv during pregnancy or breastfeeding belongs to the specialist doctor after analysing the ratio: maternal therapeutic benefit / potential risk to the foetus or infant.

Driving and using machines

A study conducted on 19 volunteers showed that Remotiv has no influence on the ability to drive and use machines. However, these abilities may be affected by the disease for which you are being treated with it. The decision on whether to start treatment should be made by your doctor.

Packaging. Box with 2 blisters of Al/PVC/PE/PVDC foil, each containing 15 film-coated tablets.

Page updated on: 06.08.2021