Prospect: information for the user

TRANQUIGORsoft capsules

Valerian officinalis extract - Humulus lupulus extract

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

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

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.

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.

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.

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.

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/