Valerin

Package Leaflet: Information for the Patient

Valerin

200 mg, chewable tablets
Valerianae radix extractum 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 the package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, 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 there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Valerin and what is it used for

Valerin is a herbal medicine with a calming effect, facilitating sleep.
Valerin is indicated for:

• mild nervous tension and anxiety ,
• difficulty falling asleep.

If there is no improvement after 14 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Valerin

When not to take Valerin

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

Warnings and precautions

Children

Valerin should not be used in children under 12 years of age.

Valerin 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.
The patient should tell their doctor if they are taking synthetic sedatives such as:

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

The simultaneous use of synthetic sedatives with Valerin is not recommended due to the similar mechanism of action.
If the patient is unsure whether they are taking any of the above-mentioned medicines, they should consult their doctor or pharmacist.

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 taking this medicine.
Due to the lack of data confirming the safety of using the medicine during pregnancy and breastfeeding, it is not recommended to use the medicine.

Driving and operating machinery

Due to the increased tendency to fall asleep, it is not recommended to use the product by people driving vehicles at night and by people feeling tired.
Driving vehicles and operating machinery is not recommended for up to two hours after taking the medicine.

Valerin contains lactose and sucrose

The medicine contains lactose and sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Valerin

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose

Adults, adolescents over 12 years of age, and the elderly

For mild nervous tension and anxiety: 1-2 chewable tablets 3 times a day.
For difficulty falling asleep: 2-3 chewable tablets 1/2 hour before planned sleep.
The recommended treatment duration is 2 to 4 weeks.
If symptoms worsen or do not improve after 2 weeks, the patient should consult their doctor.

Method of administration

The medicine should be taken orally.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Valerin than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor.
In case of taking a higher dose than recommended, mild symptoms such as fatigue, abdominal cramps, dizziness, pupil dilation, chest pressure, hand tremors may occur, which disappear within 24 hours.

Missing a dose of Valerin

The patient should not take a double dose to make up for a missed dose.
In case of missing a dose and persistence of symptoms, the patient should take the next dose at the scheduled time.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• gastrointestinal disorders, such as nausea, abdominal cramps.

In some people, other side effects may occur during the use of Valerin.

Reporting side effects

If any side effects occur, including any side effects not listed in the 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, 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Valerin

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature not exceeding 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 given month.
Markings on the blister pack
Lot - batch number
EXP - expiry date
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. Package contents and other information

What Valerin contains

• The active substance of the medicine is dry extract of valerian root (Valerianae radix extractum siccum).
• One chewable tablet contains 200 mg of extract (as dry extract) from Valeriana officinalisL, radix (valerian root) (3-6:1).Extraction solvent: ethanol 70% (V/V).
• Other ingredients are:lactose monohydrate, potato starch, mannitol (E 421), magnesium stearate ,sodium lauryl sulfate, colloidal silica, sucrose, talc, arabic gum, brown HT (E 155), carnauba wax.

What Valerin looks like and what the package contains

Valerin is a round, biconvex, chewable tablet with a dark brown color.
The tablets are packaged in blisters of 15 pieces. The product packaging is 15, 30, 60, 90 tablets in a cardboard box.

Marketing authorization holder

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

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of last update of the leaflet:22.06.2020