Rebalance Filmtablet 250 mg 120 pcs

Herbal medicinal product

What is Rebalance 250 and when is it used?

Rebalance 250 is a herbal medicine based on St. John's wort. Rebalance 250 contains the quantified dry extract of St. John's wort (Hypericum perforatum L.). Rebalance 250 has a calming and balancing effect on: depressed mood, mood lability, inner restlessness, anxiety, states of tension and the associated difficulties falling asleep and sleeping through the night.

What should be considered?

If your symptoms last longer than a month, you should seek medical help. This medicinal product contains approximately 180 mg of digestible carbohydrates per single dose. The drug is suitable for diabetics.

When should Rebalance 500 not be taken or only with caution?

If you are known to be hypersensitive to St. John's wort extracts or other components of the drug (see "What does Rebalance 250 contain ?») or if you are known to be hypersensitive to light, Rebalance 250 must not be used. St. John's wort preparations may not be used in children under the age of 6 and in children from 6 to 12 years of age only if expressly instructed to do so by a doctor. St. John's wort preparations can affect the effects of other medications! Rebalance 250 must therefore not be used with the following medicines:

• Certain antidepressants (medicines against depression) or other serotonergic active ingredients (e.g. amitriptyline, fluoxetine, buspirone, triptans, etc.)

Rebalance 250 must be discontinued at least 5 days before any operations and should only be taken again after consultation with a doctor. In very rare cases, and especially in light-skinned people, skin reactions such as skin reddening similar to sunburn can occur after taking St. John's wort preparations and subsequent exposure to sunlight. People who are sensitive to light should therefore protect their skin and eyes from prolonged direct sunlight during the time of application and should refrain from visiting solariums. Please only take Rebalance 250 after consulting your doctor if you know that you suffer from a sugar intolerance. If, in addition to Rebalance 250, you are taking other medicines, especially those prescribed by your doctor, please discuss this with your doctor. Tell your doctor, pharmacist or druggist if you

• suffer from other diseases,have allergies ortake other medicines (including those you bought yourself!)!

Can Rebalance 250 be taken during pregnancy or breastfeeding?

Based on previous experience, there is no known risk for the child when used as directed. However, systematic scientific investigations have never been carried out. As a precaution, you should avoid taking medicines during pregnancy and breastfeeding or ask your doctor, pharmacist or druggist for advice.

How do you use Rebalance 250?

Adults and adolescents from the age of 12 take one film-coated tablet with a little liquid in the morning and evening, preferably with or after food. The recommended maximum dosage of 500 mg must not be exceeded to ensure the low risk of drug interactions. Rebalance 250 should not be used in children under 6 years of age and in children from 6 to 12 years of age only if specifically directed by a doctor. The preparation should be taken for a maximum of 1 month without a break. Any treatment longer than this should only be carried out under medical supervision. Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Rebalance 250 have?

The following side effects can occur when using Rebalance 250:

Common (affects 1 to 10 users in 100)

Stomach upset, headache, sweating and weakness.

Uncommon (affects 1 to 10 users in 1000)

Dizziness, tiredness, restlessness, allergic skin reactions.

Rare (affects 1 to 10 users in 10,000)

Skin reactions when exposed to sunlight. In the literature, adverse reactions in the eyes have been associated with the administration of St. John's wort preparations and simultaneous exposure to sunlight. In the event of adverse reactions on the skin or eyes, stop taking the film-coated tablets and have the symptoms clarified by a doctor. In a single case, seizures and confusion have been reported after a massive overdose of a medicinal product containing St. John's wort. If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage Instructions

Store at room temperature (15-25°C) in the original packaging. Keep out of the reach of children.

Further information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Rebalance 250 contain?Active ingredients

Rebalance 250 contains 250 mg of the quantified dry extract per film-coated tablet St. John's wort (Hypericum perforatum L., herba), corresponds to 0.25 - 0.75 mg total hypericin (calculated as hypericin) and a maximum of 0.5 mg hyperforin, drug-extract ratio 4-7:1, extractant ethanol 57.9% ( V/V).

Excipients

Microcrystalline cellulose, lactose monohydrate 122 mg, macrogol 6'000, hypromellose, titanium dioxide (E 171), magnesium stearate, colloidal silicon dioxide, macrogol 400, propylene glycol ( E 1520), macrogol 20,000, iron(III) oxide red (E 172).

Approval number

53924 (Swissmedic)

Where can you get Rebalance 250? What packs are available?

In pharmacies and drugstores, without a doctor's prescription, in blister packs of 30, 60 and 120 film-coated tablets.

Authorization holder

Zeller Medical AG, CH-8590 Romanshorn This leaflet was last checked by the drug authority (Swissmedic) in September 2019.