Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Carbocisteine 375mg 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 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.
Do not take this medicine and tell your doctor if: • You are allergic to carbocisteine or any of the other ingredients of carbocisteine capsules (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 apply 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 this medicine 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 Talk to your doctor before taking this medicine 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.
• You are breast-feeding or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Carbocisteine capsules contain: • 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, talk to your doctor before taking this medicine.
• Sunset yellow (E110): May cause allergic reactions. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
Always take carbocisteine capsules exactly as your doctor or pharmacist has told you.
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
Children
• Carbocisteine capsules are not recommended for use in children less than 2 years of age. A paediatric syrup is available for use in children
If you take more carbocisteine 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 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 medicine, ask your doctor or pharmacist.
Like all medicines, carbocisteine capsules can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.
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, skin eruptions, 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 'Stevens-Johnson syndrome'
• Blood in your vomit or black tarry stools.
Other side effects (frequency not known): • Being sick (vomiting), nausea, diarrhoea and discomfort in the upper abdomen (epigastric discomfort).
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 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.
Keep this medicine out of 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 25°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 capsules contains: • Each capsule contains 375mg of the active substance, carbocisteine.
• The other ingredients are magnesium stearate (E572), anhydrous colloidal silica (E551, lactose monohydrate, sodium lauril sulphate, gelatin, quinoline yellow (E104), sunset yellow (E110) and titanium dioxide (E171)
What carbocisteine capsules look like and contents of the pack Carbocisteine capsules are yellow and printed 'Mucodyne 375' in black.
They are available in blister packs containing 6, 18, 30 or 120 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
Manufacturer:
Famar Health Care Services Madrid, S.A.U.
Avda. Leganés
62, Alcorcón 28923
Madrid
Spain
This leaflet was last revised in July 2021
'Zentiva' is a registered trademark © 2021 Zentiva
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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.
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. Children: This formulation is not recommended for children. The normal daily dosage is 20mg/kg body weight in divided doses. It is recommended that this is achieved with Paediatric Syrup. Method of Administration Carbocisteine capsules are for oral use. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
Hypersensitivity to carbocisteine or to any of the excipients (listed in section 6.1). Use in patients with active peptic ulceration. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication. Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
None stated. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Although tests in mammalian species have revealed no teratogenic effects, carbocisteine is not recommended during the first trimester of pregnancy.
Use in lactation: Effects not known.
None stated.
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 allergic skin eruptions, anaphylactic reactions and fixed drug eruption. Gastrointestinal disorders There have been reports of gastrointestinal bleeding occurring during treatment with carbocisteine, however the frequency is not known. Epigastric discomfort, vomiting, nausea and diarrhoea have also been observed, though the frequency of this occurrence is not known. Skin and subcutaneous tissue disorders There have been reports of skin rashes and allergic skin eruptions. Isolated cases of bullous dermatitis 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of carbocisteine over dosage.
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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