Package leaflet: information for the patient

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

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any 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

What Valerin ultramax is and what it is used for
Important information before taking Valerin ultramax
How to take Valerin ultramax
Possible side effects
How to store Valerin ultramax
Contents of the pack and other information

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

Valerin ultramax is a herbal medicine with a calming effect.
Indications
Herbal medicinal product used in mild states of nervous tension.
If symptoms persist or worsen after 2 weeks of treatment, consult your doctor.

2. Important information before taking Valerin ultramax

When not to take Valerin ultramax

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

Warnings and precautions
Before starting treatment with Valerin ultramax, consult your doctor or pharmacist.
If symptoms worsen during treatment, consult your doctor or pharmacist.
Children
The use of Valerin ultramax in children under 12 years of age is contraindicated.
Valerin ultramax and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
You should tell your doctor if you are taking any of the following medicines:

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

Concomitant use of the above medicines with Valerin ultramax is not recommended due to similar mechanisms of action. Simultaneous use of Valerin ultramax with synthetic sedatives requires medical supervision.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Due to lack of data confirming safety during pregnancy and breastfeeding, use of this medicine is not recommended.
Driving and operating machinery
Valerin ultramax has a moderate effect on the ability to drive and operate machinery. Use of this medicine is not recommended for people who drive vehicles or operate machinery.
Valerin ultramax contains isomalt and sodium
Isomalt
This medicine should not be used in patients with rare hereditary fructose intolerance.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Valerin ultramax

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Recommended dose:
Adults, adolescents over 12 years of age, and elderly patients:

For mild states of nervous tension: 1 tablet up to 3 times daily. Maximum 4 times daily, 1 tablet each time. Do not take more than 4 tablets per day.

Due to the gradual effect of valerian root, this medicine is not intended for immediate relief of mild nervous tension. For optimal treatment results, it is recommended to continue treatment for a period of 2 to 4 weeks.
If symptoms persist or worsen after 2 weeks of use, consult your doctor.
Use in children
The use of this medicine in children under 12 years of age is contraindicated.
Taking more than the recommended dose of Valerin ultramax
If you have taken more than the recommended dose, contact your doctor.
In case of overdose (more than 8 tablets), mild symptoms may occur, such as:
fatigue, abdominal cramps, dizziness, pupil dilation, chest pressure sensation, hand tremors.
These symptoms usually resolve within 24 hours. If symptoms persist, consult your doctor.
Missed dose of Valerin ultramax
Do not take a double dose to make up for a missed dose.
If you miss a dose and your symptoms persist, take the next dose at the scheduled time.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions:
gastrointestinal disorders, e.g. nausea, abdominal cramps. Frequency unknown (frequency cannot
be estimated from the available data).
If any other adverse reactions not listed above occur, consult a doctor or pharmacist.
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, 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 helps to provide more information on the safety of this medicine.

5. How to store Valerin ultramax

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the stated month.
Store below 30ºC.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Valerin ultramax contains

The active substance is dry hydroalcoholic extract of valerian root (Valerianae radicis extractum hydroalcoholicum siccum). Each coated tablet contains 600 mg of hydroalcoholic extract (as dry extract) from Valeriana officinalis L., radix (valerian root) (3-4:1), extraction solvent: ethanol 60% (V/V).
Other ingredients are: anhydrous colloidal silicon dioxide, microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, hypromellose, calcium carbonate, isomalt, iron oxide yellow (E172), hydroxypropylcellulose, medium-chain triglycerides, riboflavin (E101), brilliant blue FCF (E133), indigotine (E132).

What Valerin ultramax looks like and contents of the pack
The medicine is in the form of elongated, biconvex oval green tablets.
The tablets are packed in PVC/PVDC/Aluminium blisters.
The pack contains 10 tablets in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: + 48 42 22 53 100
Manufacturer:
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów