Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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.
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:
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
• •
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
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.
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.
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
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.
The active substance in Carbocisteine 375 mg Capsules, Hard is carbocisteine.
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.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
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.
• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
• Use in patients with active peptic ulceration.
• 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.
None stated.
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.
Carbocisteine has no or negligible influence on the ability to drive and use machines.
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.
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Carbocisteine Capsules overdose.
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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