BALDRIVIT

BALDRIVIT 600 mg coated tablets

Important notes (mandatory information)

Baldrivit 600 mg, coated tablets Active ingredient: Valerian root dry extract. Areas of application: for mild nervous tension and sleep disorders.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Baldrivit 600 mg, coated tablets, for use in adults and adolescents aged 12 and over
Active ingredient: Valerian root dry extract

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet.
• If you do not feel better or if you feel worse after 2 weeks, talk to your doctor.

What this package leaflet contains

1. WHAT IS BALDRIVIT 600 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BALDRIVIT 600 MG?
3. HOW TO TAKE BALDRIVIT 600 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BALDRIVIT 600 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BALDRIVIT 600 MG AND WHAT IS IT USED FOR?

Baldrivit 600 mg is a herbal medicine for calming. Baldrivit 600 mg is used for mild nervous tension and sleep disorders.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BALDRIVIT 600 MG?

Baldrivit 600 mg must not be taken if you are hypersensitive (allergic) to valerian or any of the other ingredients of Baldrivit 600 mg.

Special care must be taken when taking Baldrivit 600 mg

Children: There are no adequate studies on the use of this medicine in children. It should therefore not be taken by children under 12 years of age.

Taking Baldrivit 600 mg with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. No studies have been conducted with Baldrivit 600 mg. There is only limited data on pharmacological interactions of valerian preparations with other medicines. The combination with synthetic sedatives requires a medical diagnosis and monitoring.

Taking Baldrivit 600 mg with food and drink

You should avoid drinking alcohol while using Baldrivit 600 mg.

Pregnancy and breast-feeding

The safety during pregnancy and breast-feeding has not been adequately studied. Baldrivit 600 mg is not recommended for pregnant and breast-feeding women. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Even when used as intended, Baldrivit 600 mg can impair the ability to drive, operate machinery or perform work without a secure hold. In this case, you must not drive, operate machinery or perform other hazardous activities. This applies to an even greater extent in combination with alcohol.

Important information about certain other ingredients of Baldrivit 600 mg

This medicine contains glucose and sucrose. Please only take Baldrivit 600 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE BALDRIVIT 600 MG?

Always take Baldrivit 600 mg exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not quite sure. Use in children under 12 years of age is not intended. Unless otherwise prescribed by your doctor, the usual dose for adults and adolescents over 12 years of age is:

• for the treatment of mild nervous tension up to 3 times a day 1 coated tablet,
• for the treatment of sleep disorders 1 coated tablet Vi to 1 hour before going to bed. If necessary, you can also take 1 coated tablet earlier in the evening.

For people with kidney or liver disease

There is no sufficient data for specific dosage recommendations in case of impaired kidney/liver function.

Method of administration

Please take the coated tablet unchewed with sufficient liquid (preferably a glass of drinking water). Do not take tablets while lying down.

Duration of use

Due to its gradual onset of action, valerian root is not suitable for the acute treatment of mild nervous tension and sleep disorders. To achieve an optimal treatment success, it is recommended to adhere to a continuous use over 2-4 weeks. If the symptoms persist or worsen after two weeks of continuous use of the medicine, a doctor should be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Baldrivit 600 mg is too strong or too weak.

If you have taken more Baldrivit 600 mg than you should

If you have accidentally taken 1 or 2 coated tablets more than intended, this will generally not have any adverse consequences. In this case, continue taking the medicine as described in the dosage instructions or as prescribed by your doctor. If you have significantly overdosed on Baldrivit 600 mg, you should consult a doctor.

If you forget to take Baldrivit 600 mg

Do not take a double dose to make up for a forgotten dose. Continue taking or using the medicine as described in this package leaflet or as prescribed by your doctor.

If you stop taking Baldrivit 600 mg

An interruption or premature termination of treatment is harmless.

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Baldrivit 600 mg can have side effects, although not everybody gets them.

Possible side effects

After taking preparations made from valerian roots, gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur. The frequency is not known.

The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BALDRIVIT 600 MG?

Keep medicine out of reach of children. Do not use the medicine after the expiry date which is stated on the carton and blister after "usable until". The expiry date refers to the last day of the month.

Storage conditions

Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Baldrivit 600 mg contains

The active ingredient is valerian root dry extract. 1 coated tablet contains: 600 mg valerian roots dry extract (3-6:1) Extraction agent: Ethanol 70% (V/V). The other ingredients are: Sucrose (saccharose), talc, glucose syrup, cellulose powder, calcium carbonate, highly dispersed silicon dioxide, crospovidone type A, titanium dioxide (E 171), white clay, gum arabic, hypromellose, vegetable magnesium stearate, macrogol 6000, microcrystalline cellulose, stearic acid, glycerol 85%, iron(III) hydroxide oxide x H20 (E 172), montanglycol wax.

Note: One coated tablet corresponds to approx. 0.034 bread units (BE).

What Baldrivit 600 mg looks like and contents of the pack

Baldrivit 600 mg is available in original packs of 20, 50 and 100 coated tablets. The packs contain blister strips with cream-coloured, oblong dragees.

Pharmaceutical entrepreneur and manufacturer

Rodisma-Med Pharma GmbH
Kölner Str. 48
51 149 Cologne

This package leaflet was last revised in June 2015.

Source: Information from the package leaflet
Status: 03/2016
Active ingredient: Valerian root dry extract. Areas of application: for mild nervous tension and sleep disorders.