TANNACOMP

TANNACOMP film-coated tablets

Important notes (mandatory information)

Tannacomp Film-coated tablets. Areas of application: Treatment of acute non-specific diarrhoea and for the prevention and treatment of traveller's diarrhoea.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tannacomp 500mg/50mg Film-coated tablets for use in children over 5 years of age, adolescents and adults
Active ingredients: Tannin albuminate/ethacridine lactate monohydrate

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 - 4 days, contact your doctor.

What this package leaflet contains

1. WHAT IS TANNACOMP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TANNACOMP?
3. HOW TO TAKE TANNACOMP?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE TANNACOMP?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS TANNACOMP AND WHAT IS IT USED FOR?

Tannacomp is a gastrointestinal medicine/antidiarrhoeal. Areas of application: Treatment of acute non-specific diarrhoea and for the prevention and treatment of traveller's diarrhoea. Note: In the case of severe diarrhoea, especially if it is accompanied by fever and/or bloody stools, a doctor should be consulted, as specific treatment may be required.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TANNACOMP?

Tannacomp must not be taken if you are allergic to tannin albuminate (contains egg white), ethacridine lactate monohydrate or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Tannacomp.

Taking Tannacomp with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Iron-containing preparations should not be taken at the same time as Tannacomp, but should be taken several hours apart, as otherwise the effect of the iron preparation may be reduced.

Taking Tannacomp with food and drink

The effect of Tannacomp is supported by diet. In addition to ensuring an adequate fluid intake, it is particularly important to avoid high-fibre and highly seasoned food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. During pregnancy, especially in the first three months, and during breast-feeding, Tannacomp should only be taken on the express instructions of a doctor.

3. HOW TO TAKE TANNACOMP?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The dose and frequency depend on the severity of the diarrhoeal disease.

Unless otherwise prescribed by your doctor, the usual dose is:

• Children 5 – 14 years: 1 film-coated tablet 3–4 times a day.
• Adults: 1 – 2 film-coated tablets 4 times a day.
• Adults for prevention: 1 film-coated tablet 2 times a day.

The film-coated tablets are taken before or with meals with sufficient liquid. If necessary, you can also crush the film-coated tablets and mix them with food or drinks. In children and the elderly, diarrhoea, especially in combination with vomiting, can lead to dangerous water and electrolyte loss in a very short time. Therefore, special attention must be paid to adequate replacement of water and electrolytes. Tannacomp should be taken regularly until the diarrhoea has subsided. Do not take Tannacomp for more than 3 - 4 days without medical advice.

If you have taken more Tannacomp than you should

Tannacomp does not cause constipation even in case of overdose. Serious health problems as a result of overdose are not known to date.

If you forget to take Tannacomp

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Tannacomp

In this case, the symptoms may recur.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Immune system disorders

Rare: In rare cases, allergic reactions (hypersensitivity reactions) to tannin albuminate and ethacridine lactate monohydrate have been observed.

Gastrointestinal tract

Note: The intestinal contents may turn yellowish after taking Tannacomp due to the ethacridine lactate monohydrate content.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TANNACOMP?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the folding box after "Use by:". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 30°C. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tannacomp contains

The active ingredients are: 1 film-coated tablet contains: Tannin albuminate 500 mg, Ethacridine lactate monohydrate 50 mg. The other ingredients are: Microcrystalline cellulose (Ph. Eur.), Sodium carboxymethyl starch (type A) (Ph. Eur.), Highly dispersed silicon dioxide, Talc (Ph. Eur.), Magnesium stearate [vegetable] (Ph. Eur.), Poly(vinyl alcohol), Macrogol 3350, Titanium dioxide, Iron(III) hydroxide oxide x H2O, Iron(III) oxide.

What Tannacomp looks like and contents of the pack

Orange-brown, oblong film-coated tablet with a break score on both sides. Original packs of 20 film-coated tablets and 50 film-coated tablets.

Pharmaceutical entrepreneur and manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
D-58638 Iserlohn,
Telephone: 02371/937-0
Telefax: 02371/937-106
www.medice.de
e-mail: info@medice.de

This package leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: Treatment of acute non-specific diarrhoea and for the prevention and treatment of traveller's diarrhoea.