Tranquigor 125/27.8 mg soft capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
TRANQUIGOR soft capsules
Valeriana officinalis extract - Humulus lupulus extract
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Tranquigor is and what it is used for
- What you need to know before taking Tranquigor
- How to take Tranquigor
- Possible adverse effects
- How to store Tranquigor
- Contents of the pack and other information
1. What Tranquigor is and what it is used for
Tranquigor belongs to a group of medicines called "other hypnotics and sedatives" and contains a combination of valerian and hop extracts, which have a sedative effect on the nervous system.
Tranquigor is indicated for the treatment of temporary and mild states of nervousness, and for occasional difficulty in falling asleep.
You should consult a doctor if your condition worsens or does not improve after 14 days.
2. What you need to know before starting to take Tranquigor
Do not take Tranquigor:
- If you are allergic (hypersensitive) to valerian, hops, or any of the other ingredients of this medicine.
- This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.
Warnings and precautions
Children
- Do not administer to children under 12 years of age without consulting a doctor.
Use of Tranquigor with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Due to its activity, this medicine may enhance the effects of other sedative, tranquilizing, or sleep-inducing drugs. Therefore, if you are undergoing treatment with any of these, consult your doctor before taking this medicine.
Taking Tranquigor with food, drinks, and alcohol
Alcohol may enhance its sedative effect; therefore, alcoholic beverages should not be consumed while taking this medicine.
Pregnancy and breastfeeding
As a general precaution, and due to the lack of data regarding its use during pregnancy and breastfeeding, its use is not recommended in these situations.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.
Driving and using machines
Tranquigor is a medicine that may cause drowsiness. Do not drive or operate machinery if you feel sleepy or notice that your attention and reaction ability are reduced.
Important information about some of the components of Tranquigor
This medicine contains lactose and sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Tranquigor
Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
Tranquigor is administered orally.
The recommended dose is:
Adults and children over 12 years of age:
Nervousness: take 1 or 2 capsules 1 to 3 times every 24 hours.
To help sleep: take 1 or 2 capsules half to one hour before going to bed, and if necessary, an equal dose in the afternoon.
Instructions for correct administration: the capsules must be swallowed whole, without chewing, after meals and with plenty of liquid.
If you take more Tranquigor than you should
If you have taken more Tranquigor than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount taken.
If you forget to take Tranquigor
Do not take a double dose to make up for missed doses.
If you stop taking Tranquigor
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
After taking valerian root preparations, gastrointestinal disturbances (e.g. nausea, abdominal cramps) may occur. The frequency of these is unknown.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tranquigor
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Expiry
Do not use this medicine after the expiry date stated on the packaging after "Exp." The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of medicines and packaging that you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Tranquigor
The active substances are:
- 45% V/V methanolic dry extract of Valeriana officinalis root, (equivalent to 500 mg of Valerian root) 125.00 mg
- 40% V/V methanolic dry extract of Humulus lupulus strobili, (equivalent to 139 mg of Hops strobili) 27.80 mg
The other excipients are: rapeseed oil, yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, soy lecithin, dextrin, highly dispersed silicon dioxide, lactose, gelatin, glycerol (E422), sorbitol, titanium dioxide (E171), water-soluble chlorophyllin-Na-Cu (E141).
Appearance of the medicine and contents of the pack
Packs containing 30 soft capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LABORATORIOS TEGOR, S.L.
Polígono Industrial Ugaldeguren 1,
48170 Zamudio (Vizcaya)
Spain
Manufacturer
HC CLOVER PRODUCTOS Y SERVICIOS
C/ Alicante, 8-10
28500 Arganda del Rey, Madrid
Spain
Laboratorios Tegor S.L.
Pol. Ind. Ugaldeguren, 1
48170 Zamudio, Vizcaya
Date of the most recent review of this leaflet: June 2014
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/