NEURAPAS

NEURAPAS Balance film-coated tablets

Important notes (mandatory information)

Neurapas balance film-coated tablets. Areas of application: mild temporary depressive disorders with nervous restlessness.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Neurapas balance film-coated tablets
Active ingredients: St. John's wort dry extract, valerian root dry extract, passion flower herb dry extract
Herbal medicinal product

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information.

• Always take Neurapas balance exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.
• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve, you must see a doctor in any case.

What this package leaflet contains

1. WHAT IS NEURAPAS BALANCE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NEURAPAS BALANCE?
3. HOW TO TAKE NEURAPAS BALANCE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NEURAPAS BALANCE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NEURAPAS BALANCE AND WHAT IS IT USED FOR?

Neurapas balance is a herbal medicinal product for depressive mood with nervous restlessness. Areas of application: Mild temporary depressive disorders with nervous restlessness.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NEURAPAS BALANCE?

Contraindications

Do not use Neurapas balance if you are also being treated with another medicine that contains one of the following active ingredients or an active ingredient from one of the following groups of active ingredients

1. Medicines to suppress rejection reactions to transplants:
   • Ciclosporin,
   • Tacrolimus for internal use.
2. Medicines to treat HIV infections or AIDS:
   • Protease inhibitors such as indinavir and amprenavir.
3. Cytostatics such as irinotecan
4. Medicines to inhibit blood clotting:
   • Warfarin.
5. In addition, Neurapas balance must not be used:
   • if you are allergic to any of its ingredients.

What should be considered in children and adolescents?
There are no adequate studies on the use of Neurapas balance in children and adolescents. The medicine must therefore not be used in persons under 18 years of age.

Special warnings and precautions for use

Special care should be taken when taking Neurapas balance

Medicines that contain ingredients from St. John's wort (Hypericum), like Neurapas balance, can interact with other medicines: Active ingredients from Hypericum can accelerate the excretion of other medicines and thus reduce the effectiveness of these other active ingredients. However, active ingredients from Hypericum can also increase the concentration of a so-called "messenger substance" (serotonin) in the brain, so that this substance may have undesirable effects, especially when combined with other medicines that are effective against depression. If you are already taking Neurapas balance, you should inform your doctor about this if he prescribes another medicine for you or if you want to take another non-prescription medicine that is available in pharmacies. If it is considered necessary to use Neurapas balance at the same time as other medicines (see section 2), your doctor must consider the possible interactions.

In women who use hormonal contraceptives (e.g. the "pill") and take Neurapas balance at the same time, breakthrough bleeding may occur as a result of an interaction (see section 2); the safety of hormonal contraception may be reduced, so that additional contraceptive measures should be taken. Excessive exposure to UV radiation must be avoided during the use of Neurapas balance. Before planned surgical procedures with general or partial anaesthesia, you should talk to your doctor at least 1 - 2 weeks beforehand to identify possible interactions of the preparations used. In this case, Neurapas balance should be discontinued at least one week before the surgical procedure. If your liver function is impaired or you have elevated liver values, take Neurapas balance only after consulting your doctor!

Interactions with other medicines

Due to possible interactions, you must not take Neurapas balance with the medicines already listed in section 2

Neurapas balance can interact with numerous other medicines in the sense that the concentration of these substances in the blood is lowered and their effectiveness is thus reduced. These substances include the following active ingredients:

• Digoxin,
• Simvastatin,
• Fexofenadine,
• Benzodiazepines,
• Methadone,
• Finasteride,
• hormonal contraceptives (contraceptives, e.g. "pill"), and
• other antidepressants such as amitriptyline.

Neurapas balance can enhance serotonergic effects (such as nausea, vomiting, anxiety, restlessness, confusion) when Neurapas balance is combined with the following medicines: other antidepressants of the SRI or SSRI type such as:

• Paroxetine,
• Sertraline,
• Nefazodone as well as buspirone and triptans.

When used concomitantly with other medicines that have a photosensitising effect, phototoxic effects may be enhanced (see section 4).

When taking Neurapas balance with food and drink

The medicine should be taken independently of meals.

Pregnancy and breast-feeding

The medicine must not be used during pregnancy and breast-feeding due to insufficient studies. It should be noted that use in women of childbearing age who are not using contraception is also not recommended due to the risk of a possible early pregnancy, unless such a pregnancy is excluded. Hypericin, one of the ingredients contained in Neurapas balance, passes into the milk of rats and can reach higher concentrations there than in the maternal blood. It is not known whether Neurapas balance or its metabolites pass into breast milk. A risk to breast-fed infants cannot be ruled out.

Driving and using machines

Medicines with a sedative effect can basically, even when used as intended, alter the ability to react to such an extent that the ability to actively participate in road traffic or to operate machines is impaired. This applies to an even greater extent in conjunction with alcohol. Patients who perceive an impairment should not actively participate in road traffic or operate machines.

Important information about certain other ingredients of Neurapas balance

This medicine contains glucose and lactose. Therefore, please only take Neurapas balance after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE NEURAPAS BALANCE?

Always take Neurapas balance exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed, adults aged 18 and over should take 2 film-coated tablets 3 times a day without chewing, with liquid. The medicine should be taken independently of meals. The duration of use is basically not limited. However, if there is no improvement after 4 to 6 weeks, a doctor should check whether this form of therapy should be continued.

If you have taken more Neurapas balance than you should

In case of ingestion of considerable overdoses, the skin should be protected from sunlight and UV radiation for 1 - 2 weeks due to possible increased photosensitivity. The side effects described may be more pronounced. A doctor should be consulted.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Neurapas balance can have side effects, although not everybody gets them. When using Neurapas balance, especially in fair-skinned people, increased sensitivity of the skin to UV light (photosensitisation) can lead to sunburn-like reactions of the skin areas that are exposed to strong radiation (sun, solarium). In addition, allergic skin rashes, gastrointestinal complaints, fatigue or restlessness may occur during medication with Neurapas balance. The frequency is not known.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE NEURAPAS BALANCE?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and the blister pack after "Use by" or "use by". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Neurapas balance contains

The active ingredients are: One film-coated tablet contains: 60 mg dry extract of St. John's wort (4.6-6.5:1), extraction solvent: Ethanol 38% (m/m); 28 mg dry extract of valerian roots (3.8-5.6:1), extraction solvent: Ethanol 40% (m/m); 32 mg dry extract of passion flower herb (6.25-7.1:1), extraction solvent: Ethanol 60% (m/m). The other ingredients are: Povidone K 30, lactose monohydrate, glycerol 85%, spray-dried glucose syrup, highly dispersed silicon dioxide, maltodextrin, talc, magnesium stearate, croscarmellose sodium salt, basic butyl methacrylate copolymer (Eudragit E), macrogol 6000, titanium dioxide (E 171), indigo carmine (E 132).

What Neurapas balance looks like and contents of the pack

Blister pack with light blue film-coated tablets. Neurapas balance is available in original packs of 20, 60 and 100 film-coated tablets and as a bundle pack of 5 x 100 film-coated tablets.

Pharmaceutical entrepreneur and manufacturer

Pascoe pharmazeutische Präparate GmbH
Schiffenberger Weg 55
D-35394 Giessen or
Bulk recipient postcode D-35383 Giessen
Tel.: +49 (0)641/7960-0
Fax: +49 (0)641/7960-109
e-mail: info@ pascoe.de.

This package leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 02/2018
Areas of application: mild temporary depressive disorders with nervous restlessness.