BALDRIPARAN

BALDRIPARAN Strong coated tablets for the night.

Important notes (mandatory information)

Baldriparan Stark für die Nacht, coated tablets. Active ingredient: Valerian root dry extract. Areas of application: for the relief of sleep disorders caused by nervousness. Warning: Contains sucrose.

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


PACKAGE LEAFLET: INFORMATION FOR USERS

Baldriparan Stark für die Nacht, coated tablets for adults and adolescents aged 12 and over
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, Baldriparan Stark für die Nacht must be taken 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 14 days, you must see a doctor.

This package leaflet contains

1. WHAT IS BALDRIPARAN STARK FÜR DIE NACHT AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING BALDRIPARAN STARK FÜR DIE NACHT?
3. HOW TO TAKE BALDRIPARAN STARK FÜR DIE NACHT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BALDRIPARAN STARK FÜR DIE NACHT?
6. FURTHER INFORMATION

1. WHAT IS BALDRIPARAN STARK FÜR DIE NACHT AND WHAT IS IT USED FOR?

Baldriparan Stark für die Nacht is a herbal medicine for calming. Baldriparan Stark für die Nacht is used to relieve sleep disorders caused by nervousness.

2. WHAT YOU NEED TO KNOW BEFORE TAKING BALDRIPARAN STARK FÜR DIE NACHT?

Baldriparan Stark für die Nacht must not be taken if you are hypersensitive (allergic) to the active substance valerian or any of the other ingredients. There are no sufficient studies on the use of Baldriparan Stark für die Nacht in patients with impaired liver function. If you suffer from impaired liver function, you should consult your doctor before taking it.

Children

There are no sufficient studies on the use of Baldriparan Stark für die Nacht in children. Therefore, taking Baldriparan Stark für die Nacht is not recommended for children under 12 years of age.

Interactions with other medicines

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. No studies have been conducted with Baldriparan Stark für die Nacht. There is only limited data on the pharmacological interactions of valerian preparations with other medicines. The combination with synthetic sedatives requires a medical diagnosis and monitoring.

When taking Baldriparan Stark für die Nacht together with food and drink

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 Baldriparan Stark für die Nacht is not recommended for pregnant and breast-feeding women.

Driving and using machines

Baldriparan Stark für die Nacht can impair the ability to drive and use machines, even if used as intended. You should therefore not drive, operate machinery or perform other hazardous activities as long as you feel impaired. This applies to an even greater extent in combination with alcohol.

Important information about certain other ingredients of Baldriparan Stark für die Nacht

This medicine contains sucrose (sugar). Therefore, please only take Baldriparan Stark für die Nacht after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE BALDRIPARAN STARK FÜR DIE NACHT?

Always take Baldriparan Stark für die Nacht exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

For adults and adolescents aged 12 and over for the treatment of sleep disorders caused by nervousness, 1 coated tablet 1/2 to 1 hour before bedtime. If necessary, you can also take 1 coated tablet earlier in the evening. There is insufficient data for specific dosage recommendations in the case of impaired renal function. Patients with impaired liver function should consult their doctor before taking this medicine. Use in children under 12 years of age is not intended.

Method of administration

For oral use. Do not take coated tablets while lying down. Please take the coated tablets whole with sufficient liquid (preferably a glass of drinking water).

Please talk to your doctor or pharmacist if you have the impression that the effect of this medicine is too strong or too weak.

How long should you take Baldriparan Stark für die Nacht?
Due to its gradual onset of action, valerian root is not suitable for the acute treatment of sleep disorders caused by nervousness. To achieve optimal treatment success, it is recommended to take it continuously for 2 - 4 weeks. If symptoms persist or worsen after two weeks of continuous use of the medicine, a doctor or pharmacist should be consulted.

If you have taken more Baldriparan Stark für die Nacht than you should

If you have accidentally taken twice or three times the intended dosage (equivalent to 2 - 3 coated tablets of this medicine), this will generally not have any adverse effects. 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.

If you forget to take Baldriparan Stark für die Nacht

Do not take a double dose, but continue taking or using the medicine as described in this package leaflet or as prescribed by your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

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, 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 on the safety of this medicine.

5. HOW TO STORE BALDRIPARAN STARK FÜR DIE NACHT?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton or container. Please do not store Baldriparan Stark für die Nacht above +25°C.

6. FURTHER INFORMATION

What does Baldriparan Stark für die Nacht contain?
1 coated tablet contains: 441.35 mg dry extract of valerian root in a ratio of drug to extract as (6.0-7.4 :1). The extraction solvent is ethanol 70% (VA/). The other ingredients are: maltodextrin, microcrystalline cellulose, magnesium stearate (Ph. Eur.) [vegetable], highly dispersed silicon dioxide, sucrose, gum arabic, talc, macrogol 6000, povidone K 25, potassium dihydrogen phosphate, carnauba wax, calcium carbonate, shellac, refined castor oil, bleached wax and dyes E 171 and E 132.

Note for diabetics

A single dose of Baldriparan Stark für die Nacht (1 coated tablet) corresponds to 0.015 BE.

Baldriparan Stark für die Nacht is available in packs of 30, 60, 90 and 120 coated tablets.

Pharmaceutical entrepreneur:
PharmaSGP GmbH
Am Haag 14
82166 Gräfelfing
Telephone: 089/85 89 639- 150,
Telefax: 089/85 89 639- 201,
E-mail: info@pharmasgp.com

Manufacturer

Pfizer Consumer Manufacturing Italy Srl
Via Nettunense 90
04011 Aprilia
Italy

This package leaflet was last revised in September 2021.

Source: Information from the package leaflet
Status: 08/2023
Active ingredient: Valerian root dry extract. Areas of application: for the relief of sleep disorders caused by nervousness. Warning: Contains sucrose.