TRANQUIGOR 125/27.8 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

TRANQUIGORsoft capsules

Valeriana officinalis extract - Humulus lupulus extract

Read the entire package leaflet carefully before starting to take this medication, as 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 package leaflet, 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 adverse effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Tranquigor is and what it is used for
2. What you need to know before taking Tranquigor
3. How to take Tranquigor
4. Possible adverse effects
5. Storage of Tranquigor
6. Package contents and additional information

1. What Tranquigor is and what it is used for

Tranquigor belongs to a group of medications called "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 nervousness, and occasional difficulty falling asleep.

You should consult a doctor if it worsens or does not improve after 14 days.

2. What you need to know before taking Tranquigor

Do not take Tranquigor:

• If you are allergic (hypersensitive) to valerian, hop, or any of the other components of this medication.
• This medication contains soybean oil. It should not be used in case of peanut or soy allergy.

Warnings and precautions

Children

• Do not administer to children under 12 years old without consulting a doctor.

Using Tranquigor with other medications

Inform your doctor or pharmacist if you are using or have recently used 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 sleep-inducing medications. If you are being treated with any of these, consult your doctor before taking this medication.

Taking Tranquigor with food, beverages, 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 since there are no data on its use during pregnancy and breastfeeding, its use is not recommended in these situations.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

Tranquigor is a medication that can cause drowsiness. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced.

Important information about some of the components of Tranquigor

This medication contains lactose and sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Tranquigor

Follow the administration instructions for this medication exactly 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 old:

Nervousness: take 1 or 2 capsules 1 to 3 times every 24 hours.

To 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 should 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, or call the Toxicology 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 make up for forgotten doses.

If you interrupt treatment with Tranquigor

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

After ingestion of valerian root preparations, gastrointestinal disorders (e.g., nausea, abdominal cramps) may appear. The frequency is not known.

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 package leaflet, 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage 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 shown on the packaging after "EXP". 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 any unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tranquigor

The active ingredients 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 strobiles, (equivalent to 139 mg of Lupulus strobiles) 27.80 mg

The other excipients are: rapeseed oil, yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, soybean lecithin, dextrin, highly dispersed silicon dioxide, lactose, gelatin, glycerol (E422), sorbitol, titanium dioxide (E171), chlorophyllin-Na-Cu hydrosoluble (E141).

Appearance of the product and package contents

Packages 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 last revision of this package leaflet: June 2014

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.es/