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Nervosol ® TABS

coated tablets, OTC drugs

Nervosol TABS is a traditional herbal medicinal product for use in specified indications resulting exclusively from its long-term use.

Indications of use:
It is traditionally used in mild states of nervous tension and difficulties in falling asleep.

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How to use Nervosol TABS

Use orally.

Adults and adolescents over 12 years of age:
– in mild states of nervous tension 2 tablets coated 3 times a day,
– in case of difficulty in falling asleep as a sleeping aid, 2 coated tablets an hour before going to bed.

The maximum daily dose of the drug is 6 tablets.

Important information before use

If a patient is allergic to the active ingredients (dry extracts from the root of Valeriana officinalis and hop cones), the plants of Valerianaceae family and the cannabis family (Cannabaceae) or any of the other ingredients of the medicine.

 Warnings and precautions
If you have previously been diagnosed with intolerance to certain sugars, discuss this with your doctor before taking Nervosol TABS.

Children
Do not administer Nervosol TABS to children younger than 12 years of age.

Nervosol TABS and other medicines
Tell your doctor or pharmacist about all the medicines you are currently or recently taking, as well as the medicines you plan to take.

Data on pharmacological interactions with other drugs are limited. No clinically significant interactions with drugs metabolised by CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 cytochrome P450 isoenzymes were observed.

The concomitant use of medicinal product Nervosol TABS and synthetic sedatives is not recommended.

Taking Nervosol TABS with food and drink
Take the tabs with water.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or breast-feeding, think you may be pregnant, or if you are planning to have a baby.

Driving vehicles and operating machines
Nervosol TABS may interfere with the ability to drive vehicles and operate machines.
Patients should not drive or operate machines after taking this medicine.

The drug contains spray-dried liquid glucose, soya lecithin and allura red colouring AC aluminium lacquer (E129).
If you have previously been diagnosed with intolerance to certain sugars, discuss this with your doctor before taking Nervosol TABS.

The drug may cause allergic reactions.

Possible side effects

Like all medicines, Nervosol TABS can cause side effects, although not everyone gets them.
Side effects of the drug are presented according to the classification of organs and systems according to MedDRA and frequency of occurrence: unknown (cannot be determined on the basis of available data).

While taking Nervosol TABS, you may experience stomach and intestinal disorders: nausea, abdominal cramps – the frequency is unknown.

If you notice any other adverse effects not described above, please consult your doctor or pharmacist.

Composition

The active substances of the drug are water-alcoholic dry extract from the valerianae extractum hydroalcoholicum siccum and dry extract from hop cones (Lupuli floris extractum siccum).

One coated tablet contains:
100 mg of water-alcoholic extract (as dry extract) of Valeriana officinalis L.s.l., radix (valerian root) (3 – 6 : 1), extractant: ethanol (70% V/V) and 32 mg of extract (as dry extract) from Humulus lupulus L., floss (hop cones) (4 – 8 : 1 ), Extractant: ethanol (40% V/V).

Known excipients: spray-dried liquid glucose, soya lecithin, allura red AC aluminium lacquer (E129).
Other ingredients are: colloidal anhydrous silica, maltodextrin, microcrystalline cellulose with the addition of colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, Opadra II coating (polyvinyl alcohol, talcum powder, titanium dioxide E171, macrogol 3350, indigotin alumina (E132)).

Packaging: 1 blister of 30 coated tablets each.

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