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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Carbocisteine 375 mg Capsules, Hard

⚠ 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 Carbocisteine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Carbocisteine

Equivalent medicines (same active substance, strength and form)

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

What it is and what it is used for

for Carbocisteine 375 mg Capsules (called Carbocisteine Capsules in this leaflet) contain a medicine called carbocisteine. This belongs to a group of medicines called 'mucolytics'. It works by making mucus (phlegm) less sticky. This makes the mucus easier to cough up. Carbocisteine 375 mg Capsules are used for problems with the breathing passages (respiratory tract). These problems happen when too much mucus is made or the mucus is too sticky.

What you need to know before you take it

e Carbocisteine 375 mg Capsules Do not take Carbocisteine 375 mg Capsules and tell your doctor if: •

•

you are allergic (hypersensitive) to carbocisteine or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue. you have an ulcer in your stomach or gut.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Carbocisteine capsules.

Warnings and Precautions Talk to your doctor or pharmacist before taking Carbocisteine if: • • •

You are elderly Have had an ulcer in your stomach or gut You are taking other medicines known to cause bleeding in the stomach

Pregnancy and breast-feeding and fertility Carbocisteine is not recommended during pregnancy or breast-feeding Talk to your doctor before taking this medicine: Pregnancy: If you are pregnant, might become pregnant or think you may be pregnant. This medicine should not be taken during the first three months of your pregnancy. Breast-feeding:

  • If you are breast-feeding or planning to breast-feed. Fertility: Not Stated If you are pregnant or breastfeeding , think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Carbocisteine has no or negligible influence on the ability to drive and use machines. Important information about some of the ingredients of Carbocisteine Capsules. Carbocisteine 375 mg Capsules contains: Lactose. This medicine contains lactose. This is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take it

Carbocisteine 375 mg Capsules Always take Carbocisteine Capsules exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine

  • Take this medicine by mouth
  • If you feel that this medicine is too weak or too strong, do not change the dose yourself, but ask your doctor. How much to take Adults (including the elderly)

• •

Usual dose is two capsules, 3 times each day If your symptoms improve, your dose should be lowered to one capsule, 4 times, each day.

Use in Children

  • Carbocisteine capsules are not recommended for children. A syrup form of this medicine is available for use in children. If you take more Carbocisteine 375 mg Capsules than you should If you take more Carbocisteine capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. If you take too many Carbocisteine capsules, it is likely that you will get an upset stomach (gastrointestinal disturbance). If you forget to take Carbocisteine 375 mg Capsules If you forget a dose, do not worry. Just wait until the next dose is due. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Carbocisteine capsules can cause side effects, although not everybody gets them. Stop taking Carbocisteine capsules and see a doctor or go to a hospital straight away if: • •

•

You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue You have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called 'StevensJohnson syndrome' You have blood in your vomit or black tarry stools

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: • • •

Feeling sick (nausea) or being sick (vomiting) Diarrhoea Stomach pain

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

How to store it

Carbocisteine 375 mg Capsules Keep this medicine out of the sight and reach of children Do not use Carbocisteine capsules after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store below 30°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What Carbocisteine 375 mg Capsules contains Each gelatine capsule contains 375 mg of the active substance, Carbocisteine. The other ingredients are Magnesium stearate (E572), Anhydrous colloidal silica (E551), Lactose monohydrate, Sodium lauril sulphate. Capsule Shell contains Gelatin, Sodium lauryl sulphate, Size 1 golden yellow gelatin capsules containing iron oxide yellow (E172) , Titanium dioxide (E171). What Carbocisteine 375 mg Capsules look like and contents of the pack Carbocisteine 375 mg Capsules appear as golden yellow colored cap/ golden yellow colored body, size "1" hard gelatin capsule imprinted "6C1" on cap and "375" on body with black ink, containing white to off white granular powder. Polypropylene container with polypropylene screw cap, containing 30 or 100 capsules. PVC/PE/PVdC-Aluminium blister packs of 6, 18, 30 or 120 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Brown & Burk UK Limited 5 Marryat Close, Hounslow West Middlesex, TW4 5DQ United Kingdom Manufacturer Brown & Burk UK Limited 5 Marryat Close, Hounslow West Middlesex, TW4 5DQ United Kingdom

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in 10/2020

Frequently asked questions about Carbocisteine 375 mg Capsules, Hard

How do I take Carbocisteine 375 mg Capsules, Hard?

Carbocisteine 375 mg Capsules, Hard comes as capsule containing 375mg. 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 Carbocisteine 375 mg Capsules, Hard?

The active substance in Carbocisteine 375 mg Capsules, Hard is carbocisteine.

Are there equivalent medicines to Carbocisteine 375 mg Capsules, Hard?

Medicines with the same active substance, strength and form include: Carbocisteine 375 mg Capsules, Carbocisteine 375 mg Capsules, hard, Carbocisteine 375 mg Capsules, hard Milpharm Limited. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Carbocisteine 375 mg Capsules, Hard, 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 Carbocisteine 375 mg Capsules, Hard 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: Carbocisteine (12 medicines)
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

Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.

4.2. Posology and method of administration

Posology

Adults including the elderly:

Dosage is based upon an initial daily dosage of 2250mg Carbocisteine in divided doses, reducing to 1500mg daily in divided doses when a satisfactory response is obtained e.g. two capsules three times a day reducing to one capsule four times a day.

Paediatric population:

This formulation is not recommended for children. It is recommended that syrup formulation of this drug be administered at a normal daily dose of 20 mg/kg body weight in divided doses.

Method of administration

Carbocisteine 375 mg Capsules are for oral use.

4.3. Contraindications

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

• Use in patients with active peptic ulceration.

4.4. Special warnings and precautions for use

• Caution is recommended in the elderly, in those with a history of gastro duodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication.

• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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

None stated.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no available data on carbocisteine use in pregnant women. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during pregnancy. The use of carbocisteine in pregnant women is not recommended, especially during the first trimester.

Breast-feeding There are no available data on the presence of carbocisteine in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during breastfeeding. The use of carbocisteine in breastfeeding women is not recommended.

Fertility

There is no consistent evidence on the effects of this product on fertility in males or females.

4.7. Effects on ability to drive and use machines

Carbocisteine has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data).

Immune System Disorders

There have been reports of anaphylactic reactions, allergic skin eruption and fixed drug eruption.

Gastrointestinal disorders

There have been reports of diarrhoea, nausea, epigastric discomfort and gastrointestinal bleeding occurring during treatment with Carbocisteine.

Frequency not known: vomiting, gastrointestinal bleeding.

Skin and subcutaneous tissue disorders

There have been reports of skin rashes and allergic skin eruptions. Isolated cases of dermatitis bullous such as Stevens–Johnson syndrome and erythema multiforme have also been reported.

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 the national reporting system, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Carbocisteine Capsules overdose.

💬 Ask about this leaflet

Ask anything about Carbocisteine 375 mg Capsules, Hard. 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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