NEURAPAS® balance

80025095

Film-coated tablets

1 film-coated tablet contains:

Dry extract (4.6-6.5:1) of St. John`s wort ................................................................... 60 mg

Dry extract (3.8-5.6:1) of valerian root ........................................................................ 28 mg

Dry extract (6.25-7.1:1) of passion flower herb........................................................  32 mg

Adults, children (≥ 12 years): 2 tablets 2-3 times daily.

Children (6-11 years): 1 tablet 1-3 times daily.

Tablets should be swallowed whole with a little water.

Do not use:

• If you are allergic (hypersensitive) to St John's wort, Passionflower, Valerian or any of the non-medicinal ingredients.
• If you are pregnant or breastfeeding.
• If you are takingg any of the medicines mentioned under interactions, prior to consulting you doctor.
• If your skin is hypersensitive to light or if you are undergoing phototherapy or any photodiagnostic procedures.
• In children under 6 years of age.

Cautions:

• Do not exceed the recommended dose.
• Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.
• If you are a light-skinned or photosensitive person, please pay attention to the side effects. Persons using this product should avoid excessive sunbathing or the use of sunbeds or solariums.
• This product should be discontinued at least 10 days prior to elective surgery due to the potential for interactions with medicines used during general and regional anaesthesia.
• You must contact a health care practitioner if your symptoms worsen or do not improve after 14 days.
• Consumption with alcohol, other drugs or natural health products with sedative properties is not recommended.
• Consult a health care practitioner if sleeplessness persists continously for more than 3 weeks (chronic insomnia).
• Consult a health care practitioner if symptoms persist or worsen or if you experience sleep disturbances.
• Exercise caution if operating heavy machinery or driving a motor vehicle or participating in activities requiring mental alertness within 2 hours of consumption.

No adverse reactions to NEURAPAS™ balance have been reported over the past three decades.

Use of high-dose St John's Wort extract may, especially in fair-skinned individuals, lead to increased sensitivity to sunlight (photosensitization) and therefore produce sunburn-like reactions of skin areas exposed to intense sunlight. There have been rare reports of gastrointestinal symptoms, allergic reactions, fatigue or restlessness.

If you experience any side effects, please make sure to inform your health care practitioner.

Medications containing St. John's wort have been observed to interact with the following medicines, reducing their effects:

• oral anticoagulants (blood thinning medicines) of the coumarin type (warfarin and phenprocoumon)
• drugs that suppress transplant rejection reactions: such as cyclosporin, tacrolimus for internal use, sirolimus
• digoxin (drug for heart failure)
• drugs for the treatment of HIV infections and AIDS
• protease inhibitors such as indinavir
• non-nucleoside reverse transcriptase inhibitors such as nevirapine
•  cytotoxic drugs such as imitanib, irinotecan, except for monoclonal antibodies
• verapamil (drug for the treatment of heart rhythm disorders, coronary heart disease, high blood pressure, cluster headaches, heart muscle disease)
• cholesterol-lowering drugs of the statin type, such as simvastatin
• triptans (migraine therapies)
• antiepileptic drugs
• various drugs for depression, such as amitriptyline, nortriptyline, midazolam. Patients taking this medicine together with antidepressants, which inhibit serotonin re-uptake (such as paroxetine, sertraline, trazodone), may experience more pronounced serotonergic effects (such as nausea, vomiting, anxiety, restlessness, confusion)

Patients taking NEURAPAS® balance together with any medication that contains any of the above mentioined drugs should ask their doctor for advice.

Women taking hormonal birth control pills may experience intermenstrual bleeding. Also, patients are recommended to use additional non-hormonal methods of birth control while taking NEURAPAS® balance.

Patients taking this medicine together with other medications that increase the skin's sensitivity to light may experience increased injury from light exposure (see 'Possible side effects').

60 tablets or 100 film-coated tablets.