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ERDOTIN 300 MG CAPSULES

Active substance(s): ERDOSTEINE / ERDOSTEINE / ERDOSTEINE

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Take special care with Erdotin
PACKAGE LEAFLET:
INFORMATION FOR THE USER - if you suffer from mild liver failure, you

ERDOTIN®
300 mg CAPSULES

should only take one capsule per day.

Taking other medicines
Erdotin does not usually interfere with
other medicines.
However, you should always tell your doctor
or pharmacist about all medicines you are
Read all of this leaflet carefully before
taking or planning to take, including any
you start taking this medicine.
- Keep this leaflet. You may need to read it obtained without a prescription.
again.
- Taking Erdotin with food and drink
- If you have any further questions, ask
Food and drink have no influence.
your doctor or pharmacist.
- This medicine has been prescribed for
you. Do not pass it on to others. It may
- Pregnancy and breast-feeding
harm them, even if their symptoms are
Ask your doctor or pharmacist for advice
the same as yours.
before taking any medicine.
- If any of the side effects gets serious, or if The use of erdosteine in pregnant or breastyou notice any side effects not listed in
feeding women is not recommended.
this leaflet, please tell your doctor or
pharmacist.
- Effects on the ability to drive or to use
machines
In this leaflet:
Erdotin has minor or negligible influence on
1. What Erdotin is and what it is used for
the ability to drive and use machines.
2. Before you take Erdotin
3. How to take Erdotin
4. Possible side effects
- Important information about some of
5. How to store Erdotin
the ingredients of Erdotin
6. Further information
Erdotin does not contain any ingredients
1. WHAT ERDOTIN IS AND WHAT IT which would influence the safe and effective
use of the product.
IS USED FOR
Erdotin contains erdosteine, a mucolytic
agent, which acts on the phlegm (mucus) in 3. HOW TO TAKE ERDOTIN
the respiratory tract or airways.
Always take Erdotin exactly as your doctor
Use:
has told you. You should check with your
Erdotin is used to treat the symptoms doctor or pharmacist if you are not sure.
associated with short, severe episodes of
The usual dose is:
worsening of chronic bronchitis. It is also
Elderly patients and adults above 18 years:
used as an expectorant.
one capsule (300 mg erdosteine) twice a day.
For oral use.
2. BEFORE YOU TAKE ERDOTIN
The capsule must be swallowed whole with
Do not take Erdotin
a glass of water.
- if you are hypersensitive (allergic) to
erdosteine or any of the other ingredients The maximum duration of therapy is 10
of Erdotin;
days.
- if you suffer from severe liver failure;
- if you suffer from severe decreased kidney If you take more Erdotin than you should
If you take too many capsules, by mistake,
function;
contact your doctor immediately.
- if you have a stomach ulcer.

Erdosteine

If you forget to take Erdotin
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Erdotin
If you have any further questions on the use
of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Erdotin can cause side
effects, although not everybody gets them.
Uncommon (from 1 in 1000 to 1 in 100):
headache; cold and difficulty in breathing;
taste alterations, nausea, vomiting and
diarrhoea; swelling of the blood vessels
below the skin and mucosal tissues due to
allergic reaction (angioedema); other skin
allergic reactions, such as itching and
redness of the skin, oedema and eczema.
Common (from 1 in 100 to 1 in 10):
stomach pain (heartburn)
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE ERDOTIN
Keep out of the reach and sight of children.
Do not use Erdotin after the expiry date
which is stated on the carton and on the
blister after “EXP”.
The expiry date refers to the last day of that
month.
Do not store above 25°C
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Erdotin contains
- The active ingredient is erdosteine.
- The other ingredients are: microcrystalline
cellulose, povidone, magnesium stearate.
- The ingredients of the capsule shell are:
gelatin, titanium dioxide (E171), iron
oxide, yellow (E172), indigotine (E132).

What Erdotin looks like and contents of
the pack
Erdotin is a capsule with a green cap and
yellow body and is packed in
PVC/PVdC/Aluminium blister packs.
Pack sizes: box of 20 and 60 capsules.
Not all these packs may be marketed.
Marketing Authorisation Holder:
Edmond Pharma S.r.l.
Via dei Giovi 131
20037 Paderno Dugnano MI
Italy
Phone: +39 02910011.1
Fax: +39 02910011352
Manufacturer:
Edmond Pharma S.r.l.
Via dei Giovi 131
20037 Paderno Dugnano MI
Italy
Phone: +39 02910011.1
Fax: +39 02910011352
Representative in the United Kingdom
and Ireland:
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Phone: +44 (0) 28 3833 4974
Fax: +44 (0) 28 3835 0206
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Denmark: Erdotin
United Kingdom: Erdotin
Ireland: Erdotin
This leaflet was last approved in
February 2012
Erdotin is a trade mark.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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