Valeriana Dispert - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Valerian (Valerian root dry extract)

VALERIANA DISPERT 45 mg coated tablets

Valeriana Dispert package inserts are available for packs:
  • VALERIANA DISPERT 45 mg coated tablets
  • VALERIANA DISPERT 125 mg coated tablets

Why is Valeriana Dispert used? What is it for?

What is it

Hypnotic-sedative.

Why is it used

Valeriana Dispert is used as a mild sedative, also to promote night rest.

Contraindications When Valeriana Dispert should not be used

When it should not be used

Hypersensitivity to the active substance or to any of the excipients.

Generally contraindicated in pregnancy and during lactation.

When it can be used only after consulting your doctor

Pregnancy and breastfeeding: (see What to do during pregnancy and breastfeeding)

What to do during pregnancy and breastfeeding

Since no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution. No adverse effects have been reported following the common use of valerian root as a medicine, but there are no adequate experimental data.

Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.

Precautions for use What you need to know before taking Valeriana Dispert

Do not exceed the recommended dose. Consult your doctor if symptoms persist for more than 2 weeks or if they worsen during treatment.

Interactions Which drugs or foods can modify the effect of Valeriana Dispert

No interactions were reported.

However, the patient is advised to ask the doctor for advice if he is taking other medications.

Warnings It is important to know that:

It is not recommended to take valerian preparations immediately before (up to two hours) driving or operating machinery.

The effect of valerian preparations can be enhanced by the consumption of alcohol.

The medicine is not contraindicated for people with celiac disease.

Dose, Method and Time of Administration How to use Valeriana Dispert: Posology

How many

Children: 1-2 coated tablets twice a day.

Adults: 1-3 coated tablets three times a day.

Warning: do not exceed the indicated doses without medical advice.

When and for how long

Warning: use only for short periods of treatment.

After a short attempt without appreciable results, consult your doctor.

Like

The tablets should be swallowed without chewing.

Overdose What to do if you have taken too much Valerian Dispert

In case of accidental ingestion / intake of an excessive dose of Valerian Dispert 45 mg coated tablets, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Valeriana Dispert

There are no known undesirable effects to be attributed to the use of Valeriana Dispert 45 mg coated tablets under recommended conditions and for short periods of time.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.

Request and fill in the Undesirable Effects report form available at the pharmacy (form B).

Expiry and Retention

Store at a temperature not exceeding 30 ° C.

See the expiration date indicated on the package.

Warning: do not use the medicine after the expiry date indicated on the package.

Keep this medicine out of the reach of children.

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Composition and pharmaceutical form

Composition

Active ingredient: Dry extract of Valerian root 45 mg prepared with 70% v / v ethanol (ratio of valerian root: extract equal to 3-6: 1).

Excipients: dextrin, microcrystalline cellulose, lactose monohydrate, macrogol 4000, colloidal anhydrous silica, magnesium stearate, lacquer, hypromellose, talc, light magnesium oxide, gum arabic, sucrose, povidone K25, macrogol 6000, titanium dioxide, carmellose sodium, white wax, carnauba wax.

How it looks

Valeriana Dispert comes in the form of coated tablets for oral use packed in a glass vial containing 30-60-100 tablets.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Valeriana Dispert is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VALERIANA DISPERT® 45 mg COATED TABLETS

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One coated tablet contains:

Active principle: dry extract of valerian root 45 mg prepared with 70% v / v ethanol (ratio of valerian root: extract equal to 3-6: 1).

For excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Coated tablets.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Mild sedative, also to promote night rest.

04.2 Posology and method of administration

Children: 1-2 coated tablets twice a day.

Adults: 1-3 coated tablets three times a day.

The coated tablets should be swallowed without chewing.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients. Generally contraindicated in pregnancy and during lactation.

04.4 Special warnings and appropriate precautions for use

Do not exceed the recommended dose. Consult your doctor if symptoms persist for more than 2 weeks or if they worsen during treatment.

Keep this medicine out of the reach of children.

04.5 Interactions with other medicinal products and other forms of interaction

No interactions were reported.

However, the patient is advised to ask the doctor for advice if he is taking other medications.

04.6 Pregnancy and breastfeeding

Since no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution. No adverse effects have been reported following the common use of valerian root as a medicine, but there are no adequate experimental data.

04.7 Effects on ability to drive and use machines

It is not recommended to take valerian preparations immediately before (up to two hours) driving or operating machinery. The effect of valerian preparations may be enhanced by the consumption of alcohol.

04.8 Undesirable effects

There are no known undesirable effects to be attributed to the use of the medicine under the recommended conditions and for short periods of time.

04.9 Overdose

Valerian root at a dose of about 20 g causes mild symptoms (fatigue, abdominal cramps, feeling lightly dizzy, chest tightness, hand tremors and mydriasis) which disappear within 24 hours. If symptoms appear, appropriate treatment should be instituted.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: hypnotics and sedatives, ATC code: N05CM09.

Dry extracts of valerian root, administered orally, such as Valerian Dispert® 45 mg coated tablets, have shown in humans the ability to reduce the sleep induction phase and improve sleep quality, although positive results are derived more from subjective evaluations that give statistically significant variations in sleep parameters.

05.2 Pharmacokinetic properties

No data are available.

05.3 Preclinical safety data

Acute and repeat-dose toxicity tests for periods of 4-8 weeks showed low toxicity of alcoholic extracts in rodents.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Dextrin, microcrystalline cellulose, lactose monohydrate, macrogol 4000, colloidal anhydrous silica, magnesium stearate, lacquer, hypromellose, talc, light magnesium oxide, gum arabic, sucrose, povidone K25, macrogol 6000, titanium dioxide, carmellose sodium, white wax, carnauba wax .

06.2 Incompatibility

Not relevant.

06.3 Period of validity

3 years.

06.4 Special precautions for storage

Store at a temperature not exceeding 30 ° C.

06.5 Nature of the immediate packaging and contents of the package

Carton containing a glass vial with 30 - 60 - 100 coated tablets of 45 mg.

06.6 Instructions for use and handling

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07.0 MARKETING AUTHORIZATION HOLDER

Representative for Italy: Vemedia Pharma SRL, Via S. Francesco d "Assisi 22 - Turin.

08.0 MARKETING AUTHORIZATION NUMBER

AIC n. 004853014 - vial of 30 coated tablets of 45 mg

AIC n. 004853026 - vial of 60 coated tablets of 45 mg

AIC n. 004853038 - vial of 100 coated tablets of 45 mg

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Vial of 30 coated tablets of 45 mg: 21/08/89 - 31/05/2005 - May 2008

Vial of 60 - 100 coated tablets of 45 mg: 18/10/99 - 31/05/2005 - May 2008

10.0 DATE OF REVISION OF THE TEXT

March 2010

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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