Valeriana Dispert
Italy
Table of Contents
Package leaflet: Information for the user
VALERIANA DISPERT 45 mg coated tablets
Dry extract of valerian root
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks of treatment.
Contents of this leaflet:
- What Valeriana Dispert is and what it is used for
- What you need to know before taking Valeriana Dispert
- How to take Valeriana Dispert
- Possible side effects
- How to store Valeriana Dispert
- Contents of the pack and other information
1. What Valeriana Dispert is and what it is used for
Valeriana Dispert contains an active ingredient called dry extract of valerian root. It
is a hypnotic-sedative medicinal product, that is, capable of inducing sleep (hypnotic) and having a calming effect
(sedative).
Valeriana Dispert is used as a mild sedative, also to promote night-time rest.
2. What you need to know before taking Valeriana Dispert
Do not take Valeriana Dispert:
- if you are allergic to valerian or to any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding, unless specifically advised by your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valeriana Dispert.
Other medicines and Valeriana Dispert
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Valeriana Dispert and other medicines have been reported.
Valeriana Dispert with food, drinks and alcohol
No interactions between Valeriana Dispert and food have been reported.
Do not take Valeriana Dispert together with alcohol. Alcohol may enhance the effect of Valeriana Dispert.
Pregnancy, breastfeeding and fertility
Do not use valerian during pregnancy or while breastfeeding. There is insufficient data on the safety of valerian use during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine may impair your ability to drive or operate machinery. Do not take Valeriana Dispert immediately before (up to two hours) driving or operating machinery.
Valeriana Dispert contains lactose and sucrose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.
Valeriana Dispert contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e. essentially ‘sodium-free’.
3. How to take Valeriana Dispert
Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: 1-3 coated tablets three times a day.
Swallow the tablets whole, without chewing.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 2 weeks of continuous treatment with Valeriana Dispert.
Use in children
The recommended dose for children is: 1-2 coated tablets twice a day.
If you take more Valeriana Dispert than you should
Consult your doctor or go to the nearest hospital if you have taken more than the recommended dose.
Symptoms of overdose include fatigue, abdominal cramps, mild dizziness, chest tightness, hand tremors, and pupil dilation (mydriasis).
If you forget to take Valeriana Dispert
It is not important if you have forgotten to take a tablet. Do not take a double dose to make up for the missed dose.
If you stop treatment with Valeriana Dispert
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No side effects are known to be associated with the use of Valeriana Dispert 45 mg film-coated tablets under the recommended conditions and for short periods of time.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Valeriana Dispert
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the bottle after
"Exp.". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Valeriana Dispert contains
- The active substance is: dried valerian root extract. Each coated tablet contains 45 mg of extract (as dried extract) of valerian root, prepared with 70% v/v ethanol (valerian root:extract ratio of 3-6:1).
- The other components are: dextrin, microcrystalline cellulose, monohydrate lactose, macrogol 4000, anhydrous colloidal silica, magnesium stearate, lake, hypromellose, talc, light magnesium oxide, arabic gum, sucrose, povidone K25, macrogol 6000, titanium dioxide, sodium carmellose, white wax, carnauba wax.
Description of the appearance of Valeriana Dispert and contents of the pack
Valeriana Dispert 45 mg coated tablets are oral coated tablets.
Packaged in a glass bottle containing 30, 60 or 100 coated tablets.
Marketing Authorization Holder and Manufacturer
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
The Netherlands
Marketing Authorization Holder for sales
Vemedia Pharma S.r.l – Parma
Patient Information Leaflet: Information for the user
VALERIANA DISPERT 125 mg film-coated tablets
Dry extract of valerian root
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 2 weeks of treatment.
Contents of this leaflet:
- What Valeriana Dispert is and what it is used for
- What you need to know before taking Valeriana Dispert
- How to take Valeriana Dispert
- Possible side effects
- How to store Valeriana Dispert
- Contents of the pack and other information
1. What Valeriana Dispert is and what it is used for
Valeriana Dispert contains an active substance called dry extract of valerian root.
It is a hypnotic-sedative medicine, meaning it is capable of inducing sleep (hypnotic) and has a calming effect
(sedative).
Valeriana Dispert is used for the treatment of mild and temporary states of nervous tension and for temporary
difficulty in falling asleep.
Valeriana Dispert is indicated for use in adults and adolescents over 12 years of age.
2. What you need to know before taking Valeriana Dispert
Do not take Valeriana Dispert:
- if you are allergic to valerian or to any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding, unless specifically advised by your doctor after careful evaluation.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valeriana Dispert.
Children
The use of Valeriana Dispert is not recommended in children under 12 years of age, as there is insufficient data available on efficacy and safety in this age group.
Other medicines and Valeriana Dispert
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Valeriana Dispert and other medicines have been reported.
Valeriana Dispert with food, drinks and alcohol
No interactions between Valeriana Dispert and food have been reported.
Do not take Valeriana Dispert together with alcohol. Alcohol may enhance the effect of Valeriana Dispert.
Pregnancy, breastfeeding and fertility
Do not use valerian during pregnancy or while breastfeeding. There is insufficient data on the safety of valerian use during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine may impair your ability to drive or operate machinery. Do not take Valeriana Dispert immediately before (up to two hours) driving or operating machinery.
Valeriana Dispert contains lactose and sucrose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.
Valeriana Dispert contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e. essentially 'sodium-free'.
3. How to take Valeriana Dispert
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults, elderly, and adolescents over 12 years of age:
Single dose: 4 coated tablets.
For nervous tension: up to three times a day.
As an aid to help sleep: a single dose taken half an hour to one hour before bedtime, and, if necessary, an additional single dose earlier in the evening.
Swallow the tablets whole, without chewing.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 2 weeks of continuous treatment with Valeriana Dispert.
Use in children and adolescents
Valeriana Dispert is not recommended for children under 12 years of age.
The recommended dose for adolescents over 12 years of age is:
Single dose: 4 coated tablets.
For nervous tension: up to three times a day.
As an aid to help sleep: a single dose taken half an hour to one hour before bedtime, and, if necessary, an additional single dose earlier in the evening.
If you take more Valeriana Dispert than you should
Consult your doctor or go to the nearest hospital if you have taken more than the recommended dose.
Symptoms of overdose include fatigue, abdominal cramps, mild dizziness, chest tightness, hand tremors, and pupil dilation (mydriasis).
If you forget to take Valeriana Dispert
It is not important if you have forgotten to take a tablet. Do not take a double dose to make up for the missed dose.
If you stop taking Valeriana Dispert
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
No side effects are known to be associated with the use of Valeriana Dispert 125 mg film-coated tablets under the recommended conditions and for short periods of time.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Valeriana Dispert
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Scad." and on the
blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Valeriana Dispert contains
- The active substance is: dried valerian root extract. Each coated tablet contains 125 mg of extract (as dried extract) of valerian root, prepared with 70% v/v ethanol (valerian root:extract ratio of 3-6:1).
- The other components are: dextrin, microcrystalline cellulose, monohydrate lactose, macrogol 4000, anhydrous colloidal silicon dioxide, magnesium stearate, lake, hypromellose, talc, light magnesium oxide, arabic gum, sucrose, povidone K25, macrogol 6000, titanium dioxide, sodium carmellose, white wax, carnauba wax.
Description of the appearance of Valeriana Dispert and contents of the pack
Valeriana Dispert 125 mg coated tablets are presented as coated tablets for oral use, packed in blisters.
Pack contents: 20 or 50 coated tablets.
Marketing Authorization Holder and Manufacturer
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
The Netherlands
Concessionaire for sale
Vemedia Pharma S.r.l – Parma