Valdix Forte

Leaflet attached to the packaging: patient information

VALDIX FORTE

355 mg, coated tablets,

Valerianae extractum hydroalcoholicum siccum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Valdix Forte and what is it used for?
• 2. Important information before using Valdix Forte.
• 3. How to use Valdix Forte?
• 4. Possible side effects.
• 5. How to store Valdix Forte?
• 6. Contents of the packaging 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 falling asleep and improving the quality of sleep. It is used to alleviate moderate nervous tension and 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

The use of this medicine is not recommended in children under 12 years of age.

Valdix Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is not recommended to use this preparation with synthetic medicines with a calming effect.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The safety of use during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

Driving and operating machinery

Valdix Forte, 2024.10.18
1/3
This medicine may impair the ability to drive and operate machinery, so it is not recommended to use this product while driving or operating machinery.

3. How to use Valdix Forte?

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
Oral administration. Adolescents over 12 years of age, adults, elderly:

• in cases of moderate nervous tension - 2 tablets up to 3 times a day,
• in sleep disorders - 2 tablets 30 minutes to 1 hour before sleep or, if necessary, an additional 2 tablets in the evening. Maximum daily dose: 8 tablets. Recommended treatment period: 2-4 weeks. If symptoms do not improve or worsen after 2 weeks of use, the patient should consult a doctor.

Using a higher dose of Valdix Forte than recommended

A dose of about 20 g of valerian root may cause mild symptoms: fatigue, painful abdominal cramps, feeling of pressure in the chest, dizziness, hand tremors, pupil dilation.
Symptoms disappear within 24 hours. If symptoms persist, supportive treatment should be undertaken. A dose of 20 g of valerian root corresponds to 14-19 tablets of the Valdix Forte medicinal product.

Missing a dose of Valdix Forte

A double dose should not be used to make up for a missed dose.

4. Possible side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Mild gastrointestinal symptoms (nausea, cramps) may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49 21 301, fax 22 49 21 309. Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information on the safety of the medicine can be collected.

5. How to store Valdix Forte?

The medicine should be stored in a closed packaging, at a temperature not exceeding 25°C, out of sight and reach of children.
This medicine should not be used after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information.

What does Valdix Forte contain?

• The active substance of the medicine is 355 mg of dry hydroalcoholic extract from valerian root (Valeriana officinalis L., radix) (3-4:1), extractant: ethanol 60% (V/V).

Valdix Forte, 2024.10.18
2/3

• Excipients: microcrystalline cellulose (type 102 and type 12), magnesium stearate, anhydrous colloidal silica, Opadry 03B90571 Blue coating (composition: titanium dioxide (E 171), hydroxypropyl methylcellulose, polyethylene glycol, aluminum indigo pigment).

What does Valdix Forte look like and what does the packaging contain?

The tablets are round, biconvex, blue in color.
Immediate packaging: PP container with PE cap or PE container with PE cap labeled with a label or label-leaflet containing 30, 60, or 90 tablets or PVC/Aluminum blister pack containing 10 tablets.
Outer packaging: cardboard box containing 10 to 100 tablets.
Containers may be labeled with a label and packed in a cardboard box or labeled with a label-leaflet.
Not all types of packaging may be on the market.

Marketing authorization holder and manufacturer:

Labofarm sp. z o.o.
ul. Lubichowska 176B
83-200 Starogard Gdański
tel. 58 561 20 08
e-mail: poczta@labofarm.com.pl

Date of the last update of the leaflet:

Valdix Forte, 2024.10.18
3/3