Baldrian-Dispert

BALDRIAN DISPERT Night to help you fall asleep, tablets.

Important notes (mandatory information)

Baldrian-Dispert Nacht zum Einschlafen, coated tablets. Areas of application: for nervous sleep disorders.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Baldrian-Dispert Nacht zum Einschlafen, coated tablets for use in adolescents over 12 years of age and adults
Active ingredients: Valerian root dry extract 200 mg/coated tablet, hop cone dry extract 68 mg/coated tablet

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. See section 4.
• If you do not feel better or even worse after 4 weeks, contact your doctor.

What this package leaflet contains

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

1. WHAT IS BALDRIAN-DISPERT NACHT ZUM EINSCHLAFEN AND WHAT IS IT USED FOR?

Baldrian-Dispert Nacht zum Einschlafen is a herbal medicine for calming. Baldrian-Dispert Nacht zum Einschlafen is used for nervous sleep disorders. If you do not feel better or even worse after 4 weeks, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BALDRIAN-DISPERT NACHT ZUM EINSCHLAFEN?

Baldrian-Dispert Nacht zum Einschlafen must not be taken if you are allergic to valerian root dry extract or hop cone dry extract or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Baldrian-Dispert Nacht zum Einschlafen.

Children and adolescents under 12 years of age

There are no sufficient studies on the use of Baldrian-Dispert Nacht zum Einschlafen in children. Therefore, taking Baldrian-Dispert Nacht zum Einschlafen is not recommended for children and adolescents under 12 years of age.

Taking Baldrian-Dispert Nacht zum Einschlafen with other medicines

There is only limited data on interactions with other medicines. Clinically relevant interactions have not been observed so far. Because an increased effect cannot be ruled out when taken together with other sedatives, simultaneous intake should only be done on medical advice and under medical supervision. Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Taking Baldrian-Dispert Nacht zum Einschlafen with food, drinks and alcohol

You should avoid drinking alcohol while using this medicine.

Pregnancy and breast-feeding

The safety during pregnancy and breast-feeding has not been sufficiently studied. Taking Baldrian-Dispert Nacht zum Einschlafen 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

The use of Baldrian-Dispert Nacht zum Einschlafen up to 2 hours before actively participating in road traffic, operating machinery or working without a safe hold is not recommended, as the reaction time can be impaired even when used as intended. This applies to an even greater extent in combination with alcohol.

Baldrian-Dispert Nacht zum Einschlafen contains lactose and sucrose (sugar)

Therefore, please only take Baldrian-Dispert Nacht zum Einschlafen after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE BALDRIAN-DISPERT NACHT ZUM EINSCHLAFEN?

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 adults and adolescents over 12 years of age is: For the treatment of nervous sleep disorders, one coated tablet ½ to 1 hour before bedtime. If necessary, you can also take an additional coated tablet earlier in the evening. The single dose corresponds to 50 to 75% of 2 to 3 g of valerian root and 50 to 75% of 0.5 g of hop cones.

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 Nacht zum Einschlafen while lying down.

Duration of use

The duration of use of Baldrian-Dispert Nacht is in principle not limited. If the symptoms persist for more than 4 weeks or worsen, you should consult a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Baldrian-Dispert Nacht zum Einschlafen is too strong or too weak.

If you have taken more Baldrian-Dispert Nacht zum Einschlafen than you should

If you accidentally take twice or three times the intended dosage (equivalent to 2 or 3 coated tablets of this medicine), this will usually have no 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 18 coated tablets) caused the following symptoms: fatigue, 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 Nacht zum Einschlafen

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Baldrian-Dispert Nacht zum Einschlafen

Taking Baldrian-Dispert Nacht zum Einschlafen can be interrupted or stopped at any time.

If you have any further questions about taking 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 take if you are affected

Gastrointestinal disorders

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

Skin diseases

Very rare: Allergic skin reactions or hypersensitivity reactions (e.g. itching, rash, hives).

If these reactions occur, Baldrian-Dispert Nacht zum Einschlafen should no longer be taken and a doctor should be consulted if necessary. As a rule, it is sufficient to discontinue the medicine in order for the side effects to disappear again.

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, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE BALDRIAN-DISPERT NACHT ZUM EINSCHLAFEN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton/container after "Use by". The expiry date refers to the last day of the month indicated. Storage condition: Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Baldrian-Dispert Nacht zum Einschlafen contains

The active ingredients are: Valerian root dry extract and hop cone dry extract. One coated tablet contains: 200 mg dry extract from valerian root in a drug to extract ratio of (4-7:1). The extraction agent is ethanol 70% (V/V). 68 mg dry extract from hop cones in a drug to extract ratio of (4-8:1). The extraction agent is ethanol 40% (V/V). The other ingredients are: Lactose monohydrate, dextrin, highly dispersed silicon dioxide, microcrystalline cellulose, cellulose powder, poly (O-carboxymethyl) starch, sodium salt (2.8 - 4.2 % Na), stearic acid (Ph.Eur.) [vegetable], magnesium stearate (Ph. Eur.) [vegetable], basic butyl methacrylate copolymer (Ph.Eur.) ((MW: approx. 150000)), sucrose, talc, calcium carbonate, gum arabic, tragacanth, poly (O-acetyl) starch, montan glycol wax, titanium dioxide. One coated tablet corresponds to 0.02 BE.

What Baldrian-Dispert Nacht zum Einschlafen looks like and contents of the pack

Baldrian-Dispert Nacht zum Einschlafen are white, sugar-coated tablets. They are available in pack sizes of 25, 40, 50, 60, 80 or 100 coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

CHEPLAPHARM Arzneimittel GmbH
Bahnhofstraße 1a
17498 Mesekenhagen
Tel.: 038351 / 5369-0
Fax: 038351 / 5369-25
Email: info@cheplapharm.de
www.cheplapharm.com

This package leaflet was last revised in August 2013.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for nervous sleep disorders.