TANAGEL 250 mg POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Tanagel 250 mg Powder for Oral Suspension

Tanate Gelatine

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist or nurse, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the Package Leaflet:

1. What is Tanagel and what is it used for
2. What you need to know before taking Tanagel
3. How to take Tanagel
4. Possible side effects
5. Storage of Tanagel
6. Package Contents and Additional Information

1. What is Tanagel and what is it used for

It belongs to the group of medicines called antidiarrheals.

Tanagel contains the active ingredient gelatine tanate, and is indicated for the treatment of symptoms of acute non-specific diarrhea in adults and adolescents over 14 years of age, when dietary measures and oral rehydration are not sufficient.

You should consult a doctor if it worsens or does not improve after 2 days.

2. What you need to know before taking Tanagel

Do not take Tanagel:

• if you are allergic to gelatine tanate, tannic acid, gelatine or any of the other components of this medicine (listed in section 6),
• if you have a bacterial infection in the intestine and have an ulcer and gastrointestinal inflammation,
• if you have blood in your stool,
• if you have a high fever,
• if you have liver problems (liver failure),
• if you experience sudden changes in bowel habits that persist for more than two weeks.

Warnings and Precautions

Consult your doctor or pharmacist before taking Tanagel if:

• you have kidney disease or are an elderly patient
• you have nausea, vomiting, abdominal pain or fever

If you do not see improvement in 2 days, consult your doctor.

Patients with diarrhea should drink plenty of fluids to avoid dehydration, which is characterized by dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. This is especially important in elderly people.

Since the treatment of diarrhea with Tanagel is only symptomatic, the diarrhea should be treated taking into account its cause, when possible.

Children and Adolescents

Tanagel should not be used in children and adolescents under 14 years of age.

Using Tanagel with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Do not take Tanagel with other antidiarrheal medicines. It is also not recommended to take Tanagel with medicines that contain iron salts, bismuth compounds, alkaline hydroxides or carbonates, as this would decrease their absorption.

Pregnancy, Breastfeeding, and Fertility

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

Taking Tanagel with Food and Drinks

While taking Tanagel, it is recommended to drink plenty of water and other fluids.

Tanagel can be taken mixed with milk, yogurt, juices, or mush, preferably fruit-based.

Driving and Using Machines

Tanagel does not affect your ability to drive or operate machinery.

3. How to Take Tanagel

Follow the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and adolescents over 14 years of age is: 2 sachets (500 mg of gelatine tanate) every 4-6 hours, up to a maximum of 12 sachets (3000 mg of gelatine tanate) per day.

Method of Administration

This medicine is taken orally.

Dissolve the contents of the sachet in water or milk.

It can also be ingested as a powder mixed with food, yogurt, juices, or mush, preferably fruit-based.

While taking Tanagel, it is recommended to drink plenty of water and other fluids.

If symptoms worsen or persist after 2 days, the patient's clinical situation should be evaluated.

If you take more Tanagel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service: Phone: 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Tanagel

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed with an unknown frequency (cannot be estimated from the available data):

• Constipation, intestinal obstruction, and abdominal pain, local damage to the intestinal villi
• Allergic reactions.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tanagel

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Tanagel after the expiry date stated on the carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tanagel

Each Tanagel sachet contains as active ingredient, and only component, Gelatine tanate, 250 mg.

Appearance of the Product and Package Contents

Tanagel is presented in boxes containing 20 sachets with 250 mg of white powder for oral suspension.

Marketing Authorization Holder and Manufacturer

Laboratorios Francisco Durbán, S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

This package leaflet was approved on 23/09/2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.