Valerin max
Poland
Table of Contents
Package leaflet: Information for the patient
Valerin max
360 mg, coated tablets
Valerianae radicis extractum hydroalcoholicum siccum
Please read the entire leaflet carefully 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 a physician or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, 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 max is and what it is used for
- Important information before taking Valerin max
- How to take Valerin max
- Possible side effects
- How to store Valerin max
- Contents of the package and other information
1. What Valerin max is and what it is used for
Valerin max is a herbal medicinal product with sedative properties.
Indications
Mild states of nervous tension and feelings of anxiety.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.
2. Important information before taking Valerin max
When not to take Valerin max
- if you are 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 treatment with Valerin max, discuss it with your doctor or pharmacist.
Use of this medicine is not recommended in individuals who may experience discomfort after taking a dry hydroalcoholic extract of valerian root.
If your symptoms worsen during treatment, consult your doctor or nurse.
Children
Valerin max should not be used in children under 12 years of age.
Valerin max and other medicines
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to take.
You should inform 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 sedative medicines.
Concomitant use of the above-mentioned medicines with Valerin max is not recommended due to similar mechanisms of action.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think 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
This medicine may impair the ability to drive or operate machinery. Therefore, its use is not recommended in individuals who drive or operate machinery.
Valerin max contains monohydrate lactose, sodium, and Brown HT
Monohydrate lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
Brown HT
This medicine may cause allergic reactions.
3. How to take Valerin max
This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years of age:
1 tablet up to 3 times daily.
Maximum of 4 times daily, 1 tablet each time. Do not take more than 4 tablets per day.
Method of administration
The medicine should be taken orally.
Due to the gradual action of valerian root, this medicine is not intended for immediate treatment of acute nervous tension. For optimal effect, it is recommended to continue treatment for a period of 2 to 4 weeks.
If symptoms worsen or do not improve after 2 weeks, consult your doctor.
Use in children
Do not use in children under 12 years of age.
Taking more Valerin max than recommended
If you have taken more than the recommended dose, contact your doctor.
In case of overdose (more than 7 tablets), mild symptoms may occur such as:
fatigue, abdominal cramps, dizziness, pupil dilation, feeling of chest pressure, hand tremors.
These symptoms usually resolve within 24 hours. If symptoms persist, seek medical advice.
Missed dose of Valerin max
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 doubts concerning 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 everybody gets them.
Possible adverse reactions
Frequency unknown (cannot be estimated from the available data)
- Gastrointestinal disorders, e.g. nausea, abdominal cramps.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 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 the medicine.
5. How to store Valerin max
Keep out of sight and reach of children.
Store 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 stated month.
Medicines must 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 max contains
- The active substance in Valerin max is dried hydroalcoholic extract of valerian root (Valerianae radicis extractum hydroalcoholicum siccum). One coated tablet contains 360 mg of hydroalcoholic extract (as dry extract) from Valeriana officinalis L., radix (valerian root) (8-11:1). Extraction solvent: ethanol 60% (V/V).
- Other ingredients are: mannitol, corn starch, calcium hydrogen phosphate, sodium lauryl sulfate, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose, hydroxypropylcellulose, Brown HT (E155), Capol 1295 (White wax and Carnauba wax).
What Valerin max looks like and contents of the pack
Valerin max is an oval-shaped, brown, film-coated, biconvex tablet.
Tablets are packed in Al/PVC/PVDC blisters containing 10 tablets.
Pack sizes: 10 tablets, 20 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