Valerin

Patient Information Leaflet

Valerin
200 mg, coated tablets
Valerianae radix extractum siccum
Please read carefully all the information in this leaflet before taking this medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Table of Contents

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

1. What Valerin is and what it is used for

Valerin is a herbal medicinal product with a calming effect that facilitates sleep.
Valerin is indicated for:

• mild states of nervous tension and anxiety,
• sleep onset difficulties.

If there is no improvement after 14 days, or if you feel worse, consult your doctor.

2. Important information before taking Valerin

When not to take Valerin

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

Warnings and precautions
Children
Valerin must not be used in children under 12 years of age.
Valerin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
The patient should inform the doctor if they are taking synthetic sedative medicines such as:

• barbiturates (sleeping medicines and those used in epilepsy treatment);
• benzodiazepine sleeping medicines;
• other sleeping medicines.

Concomitant use of synthetic sedatives with Valerin is not recommended due to a 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, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Due to lack of data confirming the safety of Valerin during pregnancy and breastfeeding, its use is not recommended.
Driving and operating machinery
Due to increased tendency to drowsiness, the product is not recommended for people driving at night or for people experiencing fatigue.
Driving and operating machinery should be avoided for up to two hours after taking the medicine.
Valerin contains lactose and sucrose
This medicine contains lactose and sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Valerin

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

Recommended dose
Adults, adolescents over 12 years of age, and elderly patients
For mild states of nervous tension and anxiety: 1–2 effervescent tablets three times daily.
For difficulty falling asleep: 2–3 effervescent tablets taken \1/2\ hour before planned bedtime.
The recommended duration of treatment is a period of 2 to 4 weeks.
If symptoms worsen or do not improve after 2 weeks, consult a doctor.

Method of administration
The medicine should be taken orally.
If the effect of the medicine appears too strong or too weak, consult a doctor.

Taking more medicine than recommended (Valerin overdose)
In case of taking more than the recommended dose, contact a doctor.
Following ingestion of a dose higher than recommended, mild symptoms may occur, such as fatigue, abdominal cramps, dizziness, pupil dilation, chest pressure, hand tremors, which resolve within 24 hours.

Missed dose of Valerin
Do not take a double dose to make up for a missed dose.
If a dose is missed and symptoms persist, take the next dose at the scheduled time.

If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Frequency unknown (cannot be estimated from the available data):

• gastrointestinal disorders, e.g. nausea, abdominal cramps.

In some individuals, other adverse reactions may occur during treatment with Valerin.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your 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, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of this medicine to be collected.

5. How to store Valerin

Keep the medicine out of the 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 stated month.
Information on the blister:
Lot – batch number
EXP – expiry date
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Valerin contains

• The active substance in Valerin is dried extract of valerian root (Valerianae radix extractum siccum).
• One coated tablet contains 200 mg of extract (as dry extract) from Valeriana officinalis L., 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 silicon dioxide, sucrose, talc, gum arabic, brown HT (E 155), carnauba wax.

What Valerin looks like and contents of the pack
Valerin is a round, biconvex coated tablet of dark brown colour.
Tablets are packed in blisters of 15 tablets. The pack sizes are 15, 30, 60 and 90 tablets in a cardboard box.

Marketing Authorisation 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