Patient Information Leaflet

VALDIX FORTE
355 mg, coated tablets,
Valerianae extractum hydroalcoholicum siccum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as prescribed by
your doctor.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any that are not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 weeks, or if you feel worse, you should consult your doctor.

Table of Contents

What is Valdix Forte and what is it used for?
Important information before taking Valdix Forte.
How to take Valdix Forte.
Possible side effects.
How to store Valdix Forte.
Contents of the pack and other information.

1. What is Valdix Forte and what is it used for?

Valdix Forte is a herbal medicinal product with a calming effect, facilitating sleep onset and improving sleep quality. It is used to relieve mild to moderate nervous tension and for sleep disorders.

2. Important information before using Valdix Forte

When not to use Valdix Forte:

if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Children
Use in children under 12 years of age is not recommended.
Valdix Forte and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Valdix Forte with synthetic sedative drugs is not recommended.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult a doctor or pharmacist before using this medicine.
The safety of use during pregnancy and lactation has not been established. Due to lack of data, use during pregnancy and lactation is not recommended.
Driving and operating machinery
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This medicine may impair the ability to drive or operate machinery. Therefore, use of this product is not recommended for people driving vehicles or operating machinery.

3. How to use Valdix Forte?

This medicine should always be taken exactly as described in the patient leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral administration. Adolescents over 12 years of age, adults, elderly patients:

in cases of moderate nervous tension – 2 tablets up to 3 times daily,
in sleep disorders – 2 tablets half an hour to one hour before bedtime, or, if necessary, additionally 2 tablets in the evening. Maximum daily dose: 8 tablets. Recommended duration of use: 2–4 weeks. If symptoms do not improve or worsen after 2 weeks of treatment, consult a doctor.

Use of a higher than recommended dose of Valdix Forte
Valerian root in a dose of approximately 20 g may cause mild symptoms: fatigue, painful abdominal cramps, chest pressure, dizziness, hand tremor, and pupil dilation.
Symptoms resolve within 24 hours. If symptoms persist, supportive treatment should be initiated. A dose of 20 g of valerian root corresponds to 14–19 tablets of the medicinal product Valdix Forte.
Missed dose of Valdix Forte
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Mild gastrointestinal symptoms (such as nausea, cramping discomfort) may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Valdix Forte?

Keep the medicine in its tightly closed container, at a temperature not exceeding 25°C, in a place
invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What does Valdix Forte contain?

The active substance is 355 mg of a dry aqueous-alcoholic extract from valerian root (Valeriana officinalis L., radix) (3-4:1), extracted with 60% (V/V) ethanol as extraction solvent.

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Excipients: microcrystalline cellulose (type 102 and type 12), magnesium stearate, colloidal anhydrous silica, Opadry 03B90571 Blue coating (composition: titanium dioxide (E 171), hydroxypropylmethylcellulose, polyethylene glycol, aluminium indigotine pigment).

What Valdix Forte looks like and contents of the pack
Tablets are round, biconvex, blue in colour.
Primary packaging: PP container with PE lid or PE container with PE lid, labelled with a label or label-leaflet, containing 30, 60 or 90 tablets; or PVC/Aluminium blister pack containing 10 tablets.
Outer packaging: cardboard box containing 10 to 100 tablets.
Containers may be labelled with a label and packed into a cardboard box, or labelled with a label-leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Labofarm sp. z o.o.
ul. Lubichowska 176B
83-200 Starogard Gdański
tel. 58 561 20 08
e-mail: [email protected]
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