Valerin max

Package Leaflet: Information for the Patient

Valerin max

360 mg, coated tablets
Valerianae radicis extractum hydroalcoholicum siccum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 14 days, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Valerin max and what is it used for
• 2. Important information before taking Valerin max
• 3. How to take Valerin max
• 4. Possible side effects
• 5. How to store Valerin max
• 6. Contents of the pack and other information

1. What is Valerin max and what is it used for

Valerin max is a herbal medicine with a calming effect.

Indications for use

Mild states of nervous tension and feelings of anxiety.
If there is no improvement or the patient feels worse after 14 days, a doctor should be consulted.

2. Important information before taking Valerin max

When not to take Valerin max

• if the patient is allergic to valerian root extract or any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age.

Warnings and precautions

Before starting to take Valerin max, the doctor or pharmacist should be consulted.
It is not recommended to take the medicine by people who may experience malaise after taking dry hydroalcoholic extract of valerian root.
If symptoms worsen while taking the medicine, a doctor or nurse should be consulted.

Children

Valerin max should not be taken by children under 12 years of age.

Valerin max and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
The patient should tell the doctor if they are taking:

• barbiturates (sleeping pills and those used to treat epilepsy);
• sleeping pills from the benzodiazepine group;
• other synthetic sedatives.

It is not recommended to take these medicines at the same time as Valerin max due to their similar mechanism of action.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Due to the lack of data confirming the safety of the medicine during pregnancy and breastfeeding, it is not recommended to take the medicine.

Driving and using machines

The medicine may impair the ability to drive and operate machines, so it is not recommended to take the medicine by people driving vehicles or operating other machines.

Valerin max contains lactose monohydrate, sodium, and brown HT

Lactose monohydrate

If the patient has previously been found to have an intolerance to some sugars, they should consult a doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Brown HT

The medicine may cause allergic reactions.

3. How to take Valerin max

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.

Recommended dose

Adults and adolescents over 12 years of age:
1 tablet up to 3 times a day.
Maximum 4 times a day, 1 tablet at a time. Do not take more than 4 tablets per day.

Method of administration

The medicine should be taken orally.
Due to the gradual effect of valerian root, it is not indicated for emergency treatment of acute nervous tension states. It is recommended to continue treatment for 2 to 4 weeks to achieve the best effect.
If symptoms worsen or do not improve after 2 weeks, a doctor should be consulted.

Use in children

Do not use in children under 12 years of age.

Taking a higher dose of Valerin max than recommended

In case of taking a higher dose of the medicine than recommended, a doctor should be consulted.
In case of overdose (more than 7 tablets), mild symptoms such as:
fatigue, abdominal cramps, dizziness, pupil dilation, feeling of pressure in the chest, hand tremors may occur.
These symptoms usually resolve within 24 hours. If symptoms persist, a doctor should be consulted.

Missing a dose of Valerin max

A double dose should not be taken to make up for a missed dose.
If a dose is missed and symptoms persist, the next dose should be taken at the scheduled time.
In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects
Frequency not known(cannot be estimated from the available data)

• gastrointestinal disorders, such as nausea, abdominal cramps.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor or pharmacist should be informed.
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, Medical Devices, and Biocidal 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Valerin max

Keep out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Valerin max contains

• -The active substance of the medicine is dry hydroalcoholic extract of valerian root (Valerianae radicis extractum hydroalcoholicum siccum). One coated tablet contains 360 mg of hydroalcoholic extract (as dry extract) from Valeriana officinalisL., radix (valerian root) (8-11:1). Extractant: ethanol 60% (V/V).
• -The other ingredients are: mannitol, corn starch, calcium hydrogen phosphate, sodium lauryl sulfate, lactose monohydrate, colloidal silica anhydrous, magnesium stearate, hypromellose, hydroxypropyl cellulose, brown HT (E155), Capol 1295 (White wax and Carnauba wax).

What Valerin max looks like and contents of the pack

Valerin max is a biconvex, film-coated tablet, oval in shape, brown in color.
The tablets are packaged in Al/PVC/PVDC blisters of 10 tablets.
The pack contains 10 tablets, 20 tablets in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: