ABTEI

ABTEI Night Rest Valerian Sleeping Tablets N

Important notes (mandatory information)

Nighttime Valerian Sleep-Dragees N, coated tablets. Active ingredient: Valerian root dry extract. Areas of application: for improving well-being in case of nervous strain and for supporting sleep.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Nighttime Valerian Sleep-Dragees N, coated tablets for use in adults and adolescents aged 12 and over
Active ingredient: 150 mg 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, Nighttime Valerian Sleep-Dragees N must be used as directed in order to achieve the best possible treatment results.

• 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 see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE NIGHTTIME VALERIAN SLEEP-DRAGEES N AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NIGHTTIME VALERIAN SLEEP-DRAGEES N?
3. HOW SHOULD NIGHTTIME VALERIAN SLEEP-DRAGEES N BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD NIGHTTIME VALERIAN SLEEP-DRAGEES N BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE NIGHTTIME VALERIAN SLEEP-DRAGEES N AND WHAT ARE THEY USED FOR?

Nighttime Valerian Sleep-Dragees N are a traditional herbal medicinal product for improving well-being in case of nervous strain and for supporting sleep. The medicine is a traditional herbal medicinal product that is registered exclusively on the basis of long-standing use for the area of application.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NIGHTTIME VALERIAN SLEEP-DRAGEES N?

Nighttime Valerian Sleep-Dragees N must not be taken if you are known to be hypersensitive (allergic) to the active ingredient or any of the other ingredients of the medicine.

Special care should be taken when taking Nighttime Valerian Sleep-Dragees N

If symptoms of illness persist or if side effects other than those mentioned in the package leaflet occur, a doctor or other qualified person in a healthcare profession should be consulted.

The following should be noted when taking Nighttime Valerian Sleep-Dragees N with other medicines

Interactions with other medicines are not known. Studies on interactions with other medicines have not been conducted. 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.

The following should be noted when taking Nighttime Valerian Sleep-Dragees N with food and drink

No interactions with food and drink are known. You should avoid drinking alcohol while using this medicine.

Pregnancy and breastfeeding

The safety during pregnancy and breastfeeding has not been sufficiently studied. Nighttime Valerian Sleep-Dragees N are not recommended for pregnant and breastfeeding women.

Children

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

Driving and operating machinery

Nighttime Valerian Sleep-Dragees N can impair the ability to drive and operate machinery, even when used as intended. In this case, you must not drive vehicles, operate machinery or perform work without a secure hold. This applies to an even greater extent in combination with alcohol.

Important information about certain other ingredients of Nighttime Valerian Sleep-Dragees N

This medicine contains lactose and sucrose. Please only take Nighttime Valerian Sleep-Dragees N after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD NIGHTTIME VALERIAN SLEEP-DRAGEES N BE TAKEN?

Always take Nighttime Valerian Sleep-Dragees N 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 over 12 years of age:

• To improve well-being in case of nervous strain: Up to 3 times a day, 3 coated tablets.
• To support sleep: 3 coated tablets half to one hour before bedtime. If necessary, you can also take an additional 3 coated tablets earlier in the evening.
• Use in children under 12 years of age is not intended.

Maximum daily dose

4 times a day, 3 coated tablets.

There is insufficient data for specific dosage recommendations in case of impaired renal function/hepatic function.

Method of administration

Please take the coated tablets whole with sufficient liquid, preferably a glass of water.

Duration of use

If the symptoms persist for more than 2 weeks or worsen, you must see a doctor in any case.

Please talk to your doctor or pharmacist if you have the impression that the effect of Nighttime Valerian Sleep-Dragees N is too strong or too weak.

If you have taken more Nighttime Valerian Sleep-Dragees N than you should

If you have accidentally taken twice or three times the single dose, this will generally not have any adverse effects. In this case, stop taking the medicine immediately, 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 Nighttime Valerian Sleep-Dragees N

Do not take double the dose the next time, but continue taking the medicine immediately, as stated in this package leaflet or as prescribed by your doctor.

If you stop taking Nighttime Valerian Sleep-Dragees N

Interrupting or prematurely ending treatment is generally harmless.

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, Nighttime Valerian Sleep-Dragees N can have side effects, although not everybody gets them. After taking preparations made from valerian root, gastrointestinal complaints (e.g. nausea, abdominal cramps) may occur. The frequency of these possible side effects 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 about the safety of this medicine.

5. HOW SHOULD NIGHTTIME VALERIAN SLEEP-DRAGEES N BE STORED?

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

Storage conditions

Do not store above 30°C.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. FURTHER INFORMATION

What Nighttime Valerian Sleep-Dragees N contain

The active ingredient is valerian root dry extract. 1 coated tablet contains 150 mg dry extract from valerian root (5.3-6.6:1) Extraction agent: Methanol 45% (m/m). The other ingredients are: Maltodextrin, highly dispersed silicon dioxide, lactose monohydrate, povidone K25, croscarmellose sodium, precipitated silicon dioxide, calcium stearate, bleached dewaxed shellac, native castor oil, talc, sucrose, gum arabic, titanium dioxide {E171), calcium carbonate, white clay, macrogol 6000, iron (III) hydroxide oxide (E172), beeswax, carnauba wax

Bread units per dosage form

0.01 BE.

Available pack sizes

Original packs with 40 or 90 coated tablets.

Pharmaceutical entrepreneur

Omega Pharma Deutschland GmbH
Benzstraße 25
71083 Herrenberg

Registration holder

Aenova IP GmbH
Temmlerstraße 2
35039 Marburg

Manufacturer

Swiss Caps GmbH
Grassingerstraße 9
83043 Bad Aibling

This leaflet was last revised in June 2019.

Source: Information from the package leaflet
Status: 02/2021
Active ingredient: Valerian root dry extract. Areas of application: for improving well-being in case of nervous strain and for supporting sleep.