Tranquigor 125/27,8 mg capsulas blandas
Introduction
Prospect: information for the user
TRANQUIGORsoft capsules
Valerian officinalis extract - Humulus lupulus extract
Read this prospect carefully before starting to take this medication, as it contains important information for you.
- This medication can be purchased without a prescription. However, for the best results, it should be used properly.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
1. What isTranquigorand for what it is used
2. What you need to know before starting to takeTranquigor
3. How to takeTranquigor
4. Possible adverse effects
5. Storage ofTranquigor
6. Contents of the package and additional information
1. What is Tranquigor and what is it used for
Tranquigor belongs to a group of medications known as “other hypnotics and sedatives” and contains a combination of valerian and hop extracts, with a sedative effect on the nervous system.
Tranquigor is indicated for the treatment of temporary and mild states of nervousness, and occasional difficulty in falling asleep.
Consult a doctor if symptoms worsen or do 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 components of this medication.
- This medication contains soy oil. Do not use in case of an allergy to peanuts or soy.
Warnings and precautions
Children
- Do not administer to children under 12 years old without consulting a doctor.
Use of Tranquigor with other medications
Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.
Due to its activity, it is possible that this medication may enhance the effects of other sedative, tranquilizing, or sleeping medications, so if you are being treated with any of them, consult your doctor before taking this medication.
Taking Tranquigor with food, drinks, and alcohol
Alcohol may potentiate its sedative effect, so it should not be taken with alcoholic beverages.
Pregnancy and breastfeeding
As a general precaution, and due to the lack of data on its use during pregnancy and breastfeeding, its use is not recommended in these situations.
If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.
The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.
Driving and operating machinery
Tranquigor is a medication that can cause drowsiness. Do not drive or operate machinery if you feel drowsy or notice that your attention and reaction time are reduced.
Important information about some of the components of Tranquigor
This medication contains lactose and sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.
3. How to Take Tranquigor
Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Tranquigor is administered orally.
The recommended dose is:
Adults and children over 12 years:
Anxiety: take 1 or 2 capsules of1 to3 times every 24 hours.
For sleep: take 1 or 2 capsules 30 minutes to 1 hour before bedtime, and if necessary, take 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, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 91.562.04.20 indicating the medication and the amount taken.
If you forget to take Tranquigor
Do not take a double dose to compensate for the missed doses.
If you interrupt treatment with Tranquigor
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications,this medicationmay cause adverse effects, although not all people will experience them.
After ingestion of valerian root preparations, gastrointestinal discomfort (e.g. nausea, abdominal cramps) may appear. Its frequency is unknown.
If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist..
Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
5. Preservation of Tranquigor
Keep this medication out of the sight and reach of children.
No special storage conditions are required.
Expiration Date
Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.
Do not dispose of medications through drains or trash.Deposit empty containers and unused medications at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.
6. Content of the packaging and additional information
Composition of Tranquigor
The active principles are:
-Methanolic dry extract 45% V/V of Valeriana officinalis root, (equivalent to 500 mg of Valeriana root)125,00 mg
-Methanolic dry extract 40% V/V of Humulus lupulus cones, (equivalent to 139 mg of Hops cones)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), chlorophyllin-Na-Cu water-soluble (E141).
Appearance of the product and content of the packaging
Packages with 30 soft gelatin capsules.
Holder of the marketing authorization and Responsible for the manufacturing
Holder of the marketing authorization
Laboratorios Tegor, S.L.
Polígono Industrial Ugaldeguren 1,
48170 Zamudio (Vizcaya)
Spain
Responsible for the manufacturing
HC CLOVER PRODUCTS AND SERVICES
C/ Alicante, 8-10
28500 Arganda del Rey, Madrid
Spain
Laboratorios Tegor S.L.
Pol. Ind. Ugaldeguren, 1
48170 Zamudio, Vizcaya
Last review date of this prospectus: June 2014
The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/
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