VALDISPERT 125 mg FILM-COATED TABLETS
How to use VALDISPERT 125 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Valdispert 125 mg coated tablets
Dry ethanolic extract of Valeriana officinalis root (Valerian)
Read the entire leaflet carefully because it contains important information for you.
This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If symptoms worsen or persist after 2 weeks, you should consult a doctor.
- If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
Contents of the package leaflet:
- What is Valdispert 125 mg and what is it used for
- Before taking Valdispert 125 mg
- How to take Valdispert 125 mg
- Possible side effects
- Storage of Valdispert 125 mg
- Additional information
1. What is VALDISPERT 125 mg and what is it used for
Valdispert 125 mg is a herbal medicine, belonging to a group of medicines called hypnotics and sedatives (to help you fall asleep and relax).
It is indicated for the relief of mild nervous tension and sleep disorders.
2. BEFORE TAKING VALDISPERT 125 mg
Do not take Valdispert 125 mg
If you are allergic (hypersensitive) to valerian root extract or to any of the other components of Valdispert 125 mg.
Be careful with Valdispert 125 mg
It is not recommended to administer this medication to children under 12 years of age.
Use of other medications
Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.
This medication may enhance the effect of other sedative, tranquilizing, or sleeping medications, so if you are being treated with any of them, consult your doctor before taking it.
Taking Valdispert 125 mg with food and drinks
Alcohol may potentiate its sedative effect, so excessive consumption should be avoided.
Pregnancy and breastfeeding
Safety during pregnancy and breastfeeding has not been established. As a precautionary measure, its administration is not recommended to women during pregnancy and breastfeeding.
Consult your doctor or pharmacist before using any medication.
Driving and using machines
This medication may cause drowsiness. Do not drive or use machinery if you feel drowsy or if you notice that your attention or reaction capacity is reduced.
Important information about some of the components of Valdispert 125 mg
This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor or pharmacist before taking this medication.
3. HOW TO TAKE VALDISPERT 125 mg
Valdispert 125 mg is administered orally.
Follow these instructions unless your doctor or pharmacist has given you different instructions. Consult your doctor or pharmacist if you have any doubts.
Adolescents over 12 years of age, adults, and elderly:
- Nervousness: 1-3 tablets 3 times a day.
- Sleep disorders: 2 tablets, 30 to 60 minutes before bedtime. If necessary, 1 more tablet can be administered in the afternoon.
The tablets should be taken whole, without chewing, after meals, and with plenty of liquid.
Due to the gradual appearance of the effects of valerian root, its use is not suitable for the acute treatment of cases of nervousness and insomnia. A treatment duration of 2-4 weeks is recommended to achieve the expected effect.
If symptoms persist or worsen after 2 weeks of continuous use, you should consult a doctor.
If you take more Valdispert 125 mg than you should
If you have taken more Valdispert 125 mg than you should, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, go to a medical center indicating the product and the amount ingested, or call the Toxicology Information Service, phone 91 562 04 20.
If you forget to take Valdispert 125 mg
Do not take a double dose to make up for forgotten doses.
If you have any other doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, Valdispert 125 mg can cause side effects, although not everyone experiences them.
Adverse reactions are rare, but the most frequent ones are migraines or headaches and gastrointestinal symptoms, such as nausea and abdominal cramps, which can occur after ingestion of valerian root preparations. The frequency is unknown.
If you notice any other adverse reaction not described in this leaflet, consult your doctor or pharmacist.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications. Website: www.notificaRAM.es By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of VALDISPERT 125 mg
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use Valdispert 125 mg after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Valdispert 125 mg
- The active ingredient is the dry ethanolic extract of Valeriana officinalis root (Valerian). Each coated tablet contains 125 mg of dry ethanolic extract of Valeriana officinalis root (Valerian), equivalent to 375-750 mg of valerian root.
- The other components are dextrin, microcrystalline cellulose (E-460), lactose monohydrate, macrogol 4,000, colloidal anhydrous silica (E-551), magnesium stearate (E-572), shellac (E-904), hypromellose (E-464), talc (E-553b), magnesium oxide (E-530), arabic gum (E-414), sucrose, povidone K25, macrogol 6,000, titanium dioxide (E 171), sodium carmellose, beeswax, and carnauba wax.
Appearance of the product and packaging content
White coated tablets packaged in blisters, contained in boxes of 30 or 50 tablets.
Marketing authorization holder and manufacturer
Marketing authorization holder
Vemedia Pharma Hispania S.A.
C/ Aragón, 182 5ª Planta
08011 Barcelona
Manufacturer
Vemedia Manufacturing BV.
Verrijn Stuartweg, 60. P.O Box 171 (Diemen)-110 BC
Netherlands
This leaflet was approved in April 2012
Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to VALDISPERT 125 mg FILM-COATED TABLETSDosage form: TABLET, 500 mgActive substance: Valerianae radixManufacturer: TilmanPrescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, 94.2 MG/ML valerian rootActive substance: Valerianae radixManufacturer: Vemedia Pharma Hispania S.A.Prescription not requiredDosage form: TABLET, 200 mg/68 mgActive substance: Valerianae radixManufacturer: Vemedia Manufacturing B.V.Prescription not required
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