Tanagel 250 mg powder for oral suspension
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Tanagel 250 mg Powder for oral suspension
Cholestyramine gelatin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for taking this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse.
- Keep this leaflet as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve within 2 days.
Contents of the leaflet:
- What Tanagel is and what it is used for
- What you need to know before taking Tanagel
- How to take Tanagel
- Possible side effects
- How to store Tanagel
- Contents of the pack and other information
1. What Tanagel is and what it is used for
It belongs to a group of medicines called antidiarrheals.
Tanagel contains the active substance tannic acid gelatin. It is indicated for the treatment of symptoms of acute nonspecific 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 your condition 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 tannic gelatin, tannic acid, gelatin, or any of the other ingredients of this medicine (listed in section 6),
- if you have a bacterial infection in the intestine and have gastrointestinal ulcer or inflammation,
- if you have blood in your stools,
- if you have high fever,
- if you have any liver problems (hepatic insufficiency),
- if you experience sudden, persistent changes in bowel habits lasting 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 there is no improvement within 2 days, consult your doctor.
Patients with diarrhea should drink plenty of fluids to prevent dehydration, which may present as dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. This is especially important in elderly individuals.
Since the treatment of diarrhea with Tanagel is purely symptomatic, the underlying cause of diarrhea should be considered and addressed whenever possible.
Children and adolescents
Tanagel must not be used in children and adolescents under 14 years of age.
Use of Tanagel with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take Tanagel together with other anti-diarrheal medicines. It is also not recommended to take Tanagel with medicines containing iron salts, bismuth compounds, or alkaline hydroxides or carbonates, as this may reduce their absorption.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Taking Tanagel with food and drinks
During treatment, it is advisable to drink plenty of water and other fluids.
Tanagel may be taken mixed with milk, yogurt, fruit juices, or fruit purees.
Driving and using machines
Tanagel does not affect your ability to drive or operate machinery.
3. How to take Tanagel
Follow exactly the instructions for use of this medicine as provided 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 tannic acid gelatin) every 4–6 hours, up to a maximum of 12 sachets (3,000 mg of tannic acid gelatin) per day.
Method of administration
This medicine is taken orally.
Dissolve the contents of the sachet in water or milk.
The powder may also be mixed with food, yoghurt, fruit juices, or purees, preferably fruit-based.
During treatment, it is advisable to drink plenty of water and other fluids.
If symptoms worsen or persist for more than 2 days, the patient's clinical condition should be reassessed.
If you take more Tanagel than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service: Tel.: 91.562.04.20, stating the medicine and the amount ingested.
If you forget to take Tanagel
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed with unknown frequency (cannot be estimated from the available data):
- Constipation, intestinal obstruction and abdominal pain, local damage to intestinal villi
- Allergic reactions.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tanagel
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use Tanagel after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tanagel
Each Tanagel sachet contains, as the active ingredient and sole component, Gelatin tannate, 250 mg.
Appearance of the product and contents of the pack
Tanagel is packaged 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 leaflet was approved on 23/09/2015
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es.