Baldrian-Dispert

BALDRIAN DISPERT 45 mg coated tablets

Important notes (mandatory information)

Baldrian-Dispert 45 mg coated tablets. Active ingredient: Valerian root dry extract. Areas of application: for mild restlessness and sleep disorders.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Baldrian-Dispert 45 mg coated tablets for use in adolescents over 12 years of age and adults
Active ingredient: Valerian root dry extract
Herbal medicinal product

Read the entire package leaflet carefully before you start taking this medicine, because 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 notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after two weeks, contact your doctor.

What this package leaflet contains

1. WHAT IS BALDRIAN–DISPERT 45 MG COATED TABLETS AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BALDRIAN–DISPERT 45 MG COATED TABLETS?
3. HOW TO TAKE BALDRIAN–DISPERT 45 MG COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BALDRIAN–DISPERT 45 MG COATED TABLETS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BALDRIAN-DISPERT 45 MG COATED TABLETS AND WHAT IS IT USED FOR?

Baldrian-Dispert 45 mg coated tablets is a herbal medicinal product for use in mild restlessness and sleep disorders.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BALDRIAN-DISPERT 45 MG COATED TABLETS?

Baldrian-Dispert 45 mg coated tablets must not be taken if you are allergic to the active ingredient or any of the other ingredients of Baldrian-Dispert 45 mg coated tablets listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Baldrian-Dispert 45 mg coated tablets.

Children and adolescents under 12 years of age

This medicine should not be taken by children under 12 years of age.

Taking Baldrian-Dispert 45 mg coated tablets together with other medicines

There is only limited data on interactions with other medicines. Clinically relevant interactions have not been observed to date. Because an increase in effect cannot be ruled out when taken together with other sedatives, simultaneous use should only take place on the advice of a doctor and under medical supervision. Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Taking Baldrian-Dispert 45 mg coated tablets together with food, drink and alcohol

Do not drink alcohol while using this medicine.

Pregnancy and breast-feeding

The safety during pregnancy and breast-feeding has not been sufficiently studied. Taking Baldrian-Dispert 45 mg coated tablets is not recommended for pregnant and breast-feeding women. If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Baldrian-Dispert 45 mg coated tablets can impair driving and the ability to use machines. This applies to an increased extent in combination with alcohol. Impaired patients should not drive or operate machinery.

Baldrian-Dispert 45 mg coated tablets contains lactose and sucrose (sugar)

Therefore, please only take Baldrian-Dispert 45 mg coated tablets after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE BALDRIAN-DISPERT 45 MG COATED TABLETS?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adolescents over 12 years of age and adults is:

• for the treatment of mild restlessness 1 to 3 times daily 10 to 12 coated tablets (equivalent to approx. 2 g valerian root).
• for the treatment of sleep disorders 10 to 12 coated tablets (equivalent to approx. 2 g valerian root) V2 to 1 hour before bedtime. If necessary, you can also take an additional 10 to 12 coated tablets (equivalent to approx. 2 g valerian root) earlier in the evening.

Maximum daily dose: 48 coated tablets.

Method of administration

Swallow the coated tablets whole after meals with plenty of liquid (preferably a glass of drinking water). Do not take Baldrian-Dispert 45 mg coated tablets while lying down.

Duration of use

The duration of use is not limited in principle. Due to the gradual onset of action, valerian root is not suitable for the acute treatment of mild restlessness and sleep disorders. To achieve optimal treatment success, it is recommended to adhere to a continuous treatment over 2 - 4 weeks. If the symptoms persist or worsen after two weeks of continuous use of the medicine, a doctor or pharmacist should be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Baldrian-Dispert 45 mg coated tablets is too strong or too weak.

If you have taken more Baldrian-Dispert 45 mg coated tablets than you should

If you have accidentally taken twice or three times the intended dosage, 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 this medicine, you should consult a doctor. Taking valerian root in a dosage of over 20 g (equivalent to about 100 coated tablets) caused the following symptoms: tiredness, abdominal cramps, tightness in the chest, emptiness in the head, trembling of the hands and dilation of the pupils, which disappeared after 24 hours. If symptoms occur, appropriate treatment should be given.

If you forget to take Baldrian-Dispert 45 mg coated tablets

Do not take double the amount to make up for a forgotten dose.

If you stop taking Baldrian-Dispert 45 mg coated tablets

Taking Baldrian-Dispert 45 mg coated tablets can be interrupted or stopped at any time.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate 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.

Significant side effects or signs to watch out for, and measures to be taken if affected

Gastrointestinal disorders

Not known: Gastrointestinal intolerances (e.g. nausea, abdominal cramps).

Skin disorders

Very rare: Hypersensitivity reactions of the skin (e.g. itching, rash, hives).

If these reactions occur, Baldrian-Dispert 45 mg coated tablets should no longer be taken and a doctor should be consulted if necessary.

Reporting of side effects

If you get 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, Department of Pharmacovigilance, 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 BALDRIAN-DISPERT 45 MG COATED TABLETS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label/carton after "Use by". The expiry date refers to the last day of the month indicated. Note on shelf life after opening: Shelf life after opening: 12 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Baldrian-Dispert 45 mg coated tablets contains

The active ingredient is: Valerian root dry extract. One coated tablet contains 45 mg dry extract from valerian root (3-6:1) Extraction agent: Ethanol 70% (V/V). The other ingredients are: Arabic gum, carmellose sodium, carnauba wax, dextrin, bleached wax, hypromellose, lactose monohydrate, highly dispersed silicon dioxide, light magnesium oxide, macrogol 4000, macrogol 6000, magnesium stearate (Ph. Eur.), microcrystalline cellulose, povidone K 25, sucrose, shellac, talc, titanium dioxide (E 171).

Carbohydrates

One coated tablet contains less than 0.1 BE.

What Baldrian-Dispert 45 mg coated tablets looks like and contents of the pack

Baldrian-Dispert 45 mg coated tablets are white coated tablets. They are available in pack sizes of 50 or 100 coated tablets.

Pharmaceutical entrepreneur and manufacturer

CHEPLAPHARM Arzneimittel GmbH
Bahnhofstraße 1a
17498 Mesekenhagen
Tel.: 03834/8539-0
Fax.: 03834/8539-119

This package leaflet was last revised in May 2016.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Valerian root dry extract. Areas of application: for mild restlessness and sleep disorders.