Package leaflet: Information for the patient

Erdotin 300 mg hard capsules, 300 mg dispersible tablets, 225 mg granules for oral suspension

erdosteine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Erdotin is and what it is used for
What you need to know before taking Erdotin
How to take Erdotin
Possible side effects
How to store Erdotin
Contents of the pack and other information

1. What Erdotin is and what it is used for

Erdotin contains the active substance erdosteine, a mucolytic agent, which facilitates the removal of mucus from the respiratory tract.
Erdotin is indicated for the treatment of exacerbations of chronic obstructive bronchopneumopathy (a disease that makes it difficult to empty air from the lungs) and chronic bronchitis (persistent inflammation of the bronchi accompanied by cough with sputum).
Erdotin is indicated as supportive therapy in acute respiratory infections (of recent onset).

2. What you should know before taking Erdotin

Do not take Erdotin

if you are allergic to erdosteine or to any of the other ingredients of this medicine (listed in section 6).
if you have active peptic ulcer.
if you have renal failure with creatinine clearance <25 ml/min or severe hepatic insufficiency.
if you have hepatic cirrhosis and cystathionine-synthase deficiency, due to the probable interference of the product's metabolites with methionine metabolism.

Warnings and precautions
Talk to your doctor or pharmacist before taking Erdotin.
Patients with mild hepatic impairment should not exceed a daily dose of 300 mg of Erdotin.

Other medicines and Erdotin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other drugs have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of erdosteine during human pregnancy and breastfeeding has not been established.
Therefore, the use of Erdotin in pregnant or breastfeeding women is not recommended.

Driving and using machines
Erdotin has a minor or negligible influence on the ability to drive vehicles or operate machinery.

Erdotin granules for oral suspension (sachets) contain sucrose and sodium.
Sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Erdotin dispersible tablets contain monohydrate lactose, sodium and sunset yellow (E110)
Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Sunset yellow (E110)
May cause allergic reactions.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Erdotin

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
ERDOTIN 300 MG HARD CAPSULES and ERDOTIN 300 MG ORAL DISPERSIBLE TABLETS
The recommended dose is 1 capsule or 1 tablet 2-3 times a day.
The maximum daily dose is 900 mg (equivalent to 3 capsules or 3 tablets per day).
Do not exceed the recommended maximum dose.
ERDOTIN 225 MG GRANULES FOR ORAL SUSPENSION
The recommended dose is 225 mg (equivalent to 1 sachet) 2-3 times a day.
The maximum daily dose is 675 mg (equivalent to 3 sachets per day). Do not exceed the recommended maximum dose.
Method of administration
For oral use.
Hard capsules must be swallowed whole with a glass of water.
Oral dispersible tablets and granules for oral suspension must be dissolved in a glass of water. The solution should be taken immediately.
Duration of treatment
Do not use for more than 10 days. Your doctor will assess whether a longer treatment duration is necessary.
If you take more Erdotin than you should
With doses higher than those recommended (1200 mg/day), sweating, dizziness, and hot flushes have been reported.
In case of accidental ingestion or overdose of Erdotin, inform your doctor immediately or go to the nearest hospital.
If you forget to take Erdotin
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Fewer than 1 in 1000 patients may report gastrointestinal side effects.
The frequency listed below is described using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated based on available data).

Uncommon nervous system disorders	Headache
Uncommon respiratory, thoracic and mediastinal disorders	Shortness of breath (dyspnea)
Uncommon gastrointestinal disorders	Altered taste, nausea, vomiting, diarrhoea, epigastric pain
Uncommon skin and subcutaneous tissue disorders	Angioedema and cutaneous hypersensitivity reactions such as urticaria, erythema, oedema and eczema

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report adverse reactions directly
through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse
reactions, you can help provide more information on the safety of this
medicinal product.

5. How to store Erdotin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging, correctly stored.
The possible presence of a sulfurous odour does not indicate any deterioration of the product, but is characteristic of the active substance it contains.
Erdotin 300 mg hard capsules: store below 30°C.
Erdotin 300 mg dispersible tablets: store below 25°C.
Erdotin 225 mg granules for oral suspension: store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Erdotin contains
Erdotin 300 mg hard capsules
The active substance is erdosteine.
Each capsule contains 300 mg of erdosteine.
The other components are: povidone, microcrystalline cellulose, magnesium stearate, gelatin,
titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).
Erdotin 300 mg dispersible tablets
The active substance is erdosteine.
Each tablet contains 300 mg of erdosteine.
The other components are lactose, microcrystalline cellulose, sucralose, sodium croscarmellose,
talc, magnesium stearate, mango flavour, Sunset Yellow (E110), povidone, colloidal silicon dioxide.
Erdotin 225 mg granules for oral suspension
The active substance is erdosteine.
Each sachet contains 225 mg of erdosteine.
The other components are sucrose, malic acid, sodium starch glycolate, orange flavour,
sucralose, silicon dioxide.

Description of the appearance of ERDOTIN and contents of the pack
Erdotin 300 mg hard capsules, box containing 20 capsules
Erdotin 300 mg dispersible tablets, box containing 20 tablets
Erdotin 225 mg granules for oral suspension, box containing 20 sachets
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
Hard capsules, dispersible tablets and granules for oral suspension:
EDMOND PHARMA S.r.l.
Strada Statale dei Giovi, 131
20037 Paderno Dugnano (MI)
Italy

Hard capsules:
Astrea Fontaine S.A.S
Rue des Prés Potets
21121 - Fontaine-les-Dijon – France
FAMAR ITALIA S.p.A.
Via Zambeletti, 25 – 20021 Baranzate (MI) - Italy

Granules for oral suspension:
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano, 43
24041 Brembate (BG)
Italy