Package Insert: Information for the User

Tanagel 250 mg Powder for Oral Suspension

Tannate Gelatin

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

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist or nurse.

- Keep this package insert, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this package insert. See section 4.

- You should consult a doctor if you worsen or do not improve after 2 days.

1. What is Tanagel and for what it is used

2. What you need to know before starting to take Tanagel

3. How to take Tanagel

4. Possible adverse effects

5. Storage of Tanagel

6. Contents of the package and additional information

It belongs to the group of medications known as anti-diarrheals.

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

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

Do not take Tanagel:

• if you are allergic to tannate, tannic acid, gelatin, or any of the other components of this medication (listed in section 6),
• if you have an intestinal bacterial infection and have gastrointestinal ulcers and inflammation,
• if you have blood in your stool,
• if you have a high fever,
• if you have any liver problems (hepatic insufficiency),
• if you experience sudden changes in bowel habits that persist for more than two weeks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 liquids to avoid dehydration, which manifests as dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. This is especially important in elderly individuals.

Since Tanagel treatment for diarrhea is only symptomatic, diarrhea should be treated by addressing its underlying cause, if possible.

Children and adolescents

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

Use of Tanagel with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Tanagel with other anti-diarrheal medications. Also, do not take Tanagel with medications that contain iron salts, bismuth compounds, hydroxides, or alkaline carbonates, as it would decrease their absorption.

Pregnancy, breastfeeding, and fertility

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 Tanagel with food and drinks

It is recommended to drink plenty of water and other liquids during the administration period.

Tanagel can be taken mixed with milk, yogurt, juices, or fruit purees, preferably from fruits.

Driving and operating machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults and adolescents over 14 years old is: 2 packets (500 mg of gelatin tanato) every 4-6 hours, up to a maximum of 12 packets (3,000 mg of gelatin tanato) per day.

Administration Form

This medication is taken orally.

Dissolve the contents of the packet in water or milk.

It can also be ingested mixed with food, yogurt, juices, or purees, preferably of fruits.

While the administration lasts, it is advisable to drink a large amount of water and other liquids.

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 Toxicological Information Service: Tel.: 91.562.04.20, indicating the medication and the amount ingested.

If You Forget to Take Tanagel

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects of unknown frequency (cannot be estimated from available data) have been observed:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use Tanagel after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Tanagel Composition

Each Tanagel packet contains gelatin tannate, 250 mg, as the active ingredient and sole component.

Product appearance and packaging contents

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

Marketing authorization holder and manufacturer responsible

Laboratorios Francisco Durbán, S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

This leaflet was approved on 23/09/2015

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es.