Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Erdotin 300mg capsules

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Erdosteine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Erdosteine
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR Erdotin contains erdosteine, a mucolytic agent, which acts on the phlegm (mucus) in the respiratory tract or airways. Use: Erdotin is used to treat the symptoms associated with short, severe episodes of worsening of chronic bronchitis. It is also used as an expectorant. 2. BEFORE YOU TAKE ERDOTIN

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Do not take Erdotin if you are hypersensitive (allergic) to erdosteine or any of the other ingredients of Erdotin; if you suffer from severe liver failure; if you suffer from severe decreased kidney function; if you have a stomach ulcer.

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Take special care with Erdotin if you suffer from mild liver failure, you 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 taking or planning to take, including any obtained without a prescription.

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Taking Erdotin with food and drink Food and drink have no influence.

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Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. The use of erdosteine in pregnant or breast-feeding women is not recommended. 1.3.1 Package Leaflet

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Effects on the ability to drive or to use machines Erdotin has minor or negligible influence on the ability to drive and use machines.

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Important information about some of the ingredients of Erdotin Erdotin does not contain any ingredients which would influence the safe and effective use of the product.

How to take it

ERDOTIN Always take Erdotin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is: Elderly patients and adults above 18 years: one capsule (300 mg erdosteine) twice a day. For oral use. The capsule must be swallowed whole with a glass of water. The maximum duration of therapy is 10 days. If you take more Erdotin than you should If you take too many capsules, by mistake, contact your doctor immediately. 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.

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. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

ERDOTIN Keep this medicine out of the sight and reach 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 1.3.1 Package Leaflet

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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: Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK Manufacturer: Edmond Pharma S.r.l. Strada Statale dei Giovi 131 20037 Paderno Dugnano MI Italy 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 revised in June 2019 Erdotin is a trade mark.

1.3.1 Package Leaflet

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Frequently asked questions about Erdotin 300mg capsules

How do I take Erdotin 300mg capsules?

Erdotin 300mg capsules comes as capsule containing 300mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Erdotin 300mg capsules?

The active substance in Erdotin 300mg capsules is erdosteine.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Erdotin 300mg capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Erdotin 300mg capsules without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Erdosteine (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

As an expectorant.For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults.

4.2. Posology and method of administration

Elderly and adults above 18 years:300 mg twice daily for maximum 10 days.The capsules must be swallowed whole with a glass of water.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the other excipients.Since there are no data in patients with creatinine clearance <25ml/min, or with severe liver failure, the use of erdosteine is not recommended in these patients.Patients with active peptic ulcer.

4.4. Special warnings and precautions for use

No increase in adverse events has been observed with erdosteine in patients with mild liver failure; however these patients should not exceed a dose of 300 mg per day.

4.5. Interaction with other medicinal products and other forms of interaction

No adverse interactions have been reported.

4.6. Fertility, pregnancy and lactation

Pregnancy:There is no experience for the use of erdosteine in pregnant women.Lactation:Experience is missing.Therefore, the use of erdosteine in pregnant or breast-feeding women is not recommended.

4.7. Effects on ability to drive and use machines

Erdotin has minor or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Nervous system disorders

Uncommon (≥ 1/1,000 to <1/100)

Headache

Respiratory, thoracic and mediastinal disorders

Uncommon (≥ 1/1,000 to <1/100)

Cold, dyspnoea

Gastrointestinal disorders

Uncommon (≥ 1/1,000 to <1/100) Common (≥ 1/100 to <1/10)

Taste alterations, nausea, vomiting, diarrhoea

Epigastric pain

Skin and subcutaneous tissue disorders

Uncommon ((≥ 1/1,000 to <1/100)

Angioedema and cutaneous hypersensitivity reactions, such as urticaria, erythema, oedema and eczema

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card SchemeWebsite: www.mhra.gov.uk/yellowcard.

4.9. Overdose

No experience of acute overdosage is available.Symptomatic treatment and general supportive measures should be followed in all cases of overdosage.Gastric lavage may be beneficial, followed by observation.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • ERDOMED 300 mg prescriptionERDOSTEINUM · taken by mouth
  • ERDOMED 175 mg/5 ml prescriptionERDOSTEINUM · taken by mouth
  • ERDOMED 225 mg over the counterERDOSTEINUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • ErdomedErdosteinum · taken by mouth
  • Erdomed MukoErdosteinum · taken by mouth
  • AsterdanErdosteinum · taken by mouth
  • Erdosol RespiroErdosteinum · taken by mouth
  • Erdosol MucoErdosteinum · taken by mouth
  • ErdosolErdosteinum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Erdotin 300mg capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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