Baldrian-Dispert

BALDRIAN DISPERT Day coated tablets

Important notes (mandatory information)

Baldrian-Dispert Day for calming 125 mg, coated tablets Active ingredient: Valerian root dry extract. Areas of application: used for restlessness.

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

Patient information: Information for the user
Baldrian-Dispert Day 125 mg, coated tablets for calming. For use in adolescents over 12 years of age and adults.
Active ingredient: Valerian root dry extract

Read the entire package leaflet carefully as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Baldrian-Dispert Day for calming must be used as directed.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If your symptoms worsen or do not improve after 2 weeks, you must consult a doctor.
- If any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet includes:
1. WHAT IS BALDRIAN-DISPERT DAY FOR CALMING AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BALDRIAN-DISPERT DAY FOR CALMING?
3. HOW SHOULD BALDRIAN-DISPERT DAY FOR CALMING BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BALDRIAN-DISPERT DAY FOR CALMING BE STORED?
6. FURTHER INFORMATION

1. WHAT IS BALDRIAN-DISPERT DAY FOR CALMING AND WHAT IS IT USED FOR?

Baldrian-Dispert Day for calming is a herbal medicine for calming.
Baldrian-Dispert Day for calming is used for restlessness.
If these symptoms persist for more than 2 weeks or worsen, you must consult a doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BALDRIAN-DISPERT DAY FOR CALMING?

Baldrian-Dispert Day for calming must not be taken,
if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of Baldrian-Dispert Day for calming.

Special care should be taken when taking Baldrian-Dispert Day for calming,
in children: There are no sufficient studies on the use of this medicine in children. Therefore, it is not recommended for children under 12 years of age.

When taking Baldrian-Dispert Day for calming with other medicines:
No interactions with other medicines are known.
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

When taking Baldrian-Dispert Day for calming with food and drink:
You should avoid drinking alcohol while using this medicine.

Pregnancy and breastfeeding:
There is no evidence from the widespread use of valerian root as a medicine of any risks during pregnancy and breastfeeding. However, results of experimental studies are not available. You should therefore not take this medicine during pregnancy and breastfeeding.

Driving and operating machinery:
This medicine should not be used within 2 hours of actively participating in road traffic, operating machinery or working without a secure hold, as the ability to react can be impaired even when used as directed. This applies to an even greater extent in combination with alcohol.

Important information about certain other ingredients of Baldrian-Dispert Day for calming:
This medicine contains lactose and sucrose. Therefore, please only take Baldrian-Dispert Day for calming after consulting your doctor if you know that you suffer from a
sugar intolerance.

3. HOW SHOULD BALDRIAN-DISPERT DAY FOR CALMING BE TAKEN?

Always take Baldrian-Dispert Day for calming exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the usual dose for adults and children over 12 years of age is: For the treatment of restlessness, up to 3 times daily 4 coated tablets of Baldrian-Dispert Day for calming. The single dose corresponds to 2 to 3 g of valerian root.

Method of administration:
For oral use. Do not take Baldrian-Dispert Day for calming while lying down. Please take Baldrian-Dispert Day for calming unchewed with sufficient liquid (preferably a glass of drinking water).

Duration of use:
The duration of use of this medicine is in principle not limited. If the symptoms persist for more than 2 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 Day for calming is too strong or too weak.

If you have taken more Baldrian-Dispert Day for calming than you should:
If you have accidentally taken twice or three times the intended dosage (equivalent to 8-12 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.
Very rarely, taking valerian root in a dosage of over 20 g (equivalent to about 36 coated tablets) leads to the following symptoms: fatigue, abdominal cramps, tightness in the chest, emptiness in the head, trembling of the hands and dilation of the pupils.

If you forget to take Baldrian-Dispert Day for calming:
Do not take a double dose, but continue taking or using the medicine as described in this leaflet or as prescribed by your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Baldrian-Dispert Day for calming can have side effects, although not everybody gets them. 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
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
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:
Very rarely, hypersensitivity reactions of the skin (e.g. itching, rash, hives) may occur. If these reactions occur, Baldrian-Dispert Day for calming should no longer be taken and a doctor should be consulted if necessary.
Please inform your doctor or pharmacist if any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this leaflet.

5. HOW SHOULD BALDRIAN-DISPERT DAY FOR CALMING BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the blister/folding box after "Use by". The expiry date refers to the last day of the month.

Storage conditions: Do not store above 30°C.

6. FURTHER INFORMATION

The active ingredient is: Valerian root dry extract. One coated tablet contains: 125 mg dry extract of valerian root in a ratio of drug to extract of 3 to 6 to 1.
Extraction agent: Ethanol 70% (V/V). The other ingredients are: Dextrin, microcrystalline cellulose, lactose monohydrate, macrogol 4000, macrogol 6000, highly dispersed silicon dioxide, magnesium stearate, shellac, hypromellose, talc, light magnesium oxide, gum arabic, sucrose, povidone K 25, titanium dioxide (E 171), carmellose sodium, carnauba wax, bleached wax.

Carbohydrates: 1 coated tablet contains less than 0.1 BE.

What Baldrian-Dispert Day for calming looks like and contents of the pack:
Baldrian-Dispert Day for calming are coated tablets.
They are available in pack sizes of 40, 50, 75, 80 or 100 coated tablets.

Pharmaceutical entrepreneur and manufacturer

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

This leaflet was last revised in March 2011.

Source: Information from the package leaflet
Status: 11/2015
Active ingredient: Valerian root dry extract. Areas of application: used for restlessness.