Carbocisteine 375 Mg Capsules Hard

Document: leaflet MAH GENERIC_PL 00289-1500 change

150 mm



Carbocisteine 375 mg Capsules, hard


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects,talk to your doctor or pharmacist.,This includes any possible side effects not listed in this leaflet. See section 4.

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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carbocisteine. Caution is recommended in patients with peptic ulcers.

Children and adolescents

Carbocisteine capsules should not be used in children.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine .

What is in this leaflet:


1.    What Carbocisteine is and what it is used for

2.    What you need to know before you take Carbocisteine

3.    How to take Carbocisteine

4.    Possible side effects

5.    How to store Carbocisteine

6.    Contents of the pack and other information

What Carbocisteine is and what it is used for

Carbocisteine contains lactose

Patients who are intolerant to lactose (milk sugar) should note that Carbocisteine contains a small amount of lactose. 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 Carbocisteine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Carbocisteine 375 mg Capsules,hard contain the active substance 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 is used for problems with the breathing passages (respiratory tract).These problems happen when too much mucus is made or the mucus is too sticky.

The recommended dose is Adults (including the elderly)

The usual dose is 2 capsules, 3 times a day. If your symptoms improve, your dose should be lowered to 1 capsule, 4 times a day

Use in children and adolescents

Carbocistine is not recommended for children.

What you need to know before you take Carbocisteine

Do not take Carbocisteine if you - are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Carbocisteine (see list of ingredients in section 6). An allergic reaction may include rash, swallowing or

Route(s) and/or method of administration

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.

If you take more Carbocisteine than you should

If you take more Carbocisteine than you should, tell a doctor or go to a hospital





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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

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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Carbocisteine and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:

•    an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, severe skin rash or hives

•    blood in your vomit or black tarry stools.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

The following side effects have also been reported at the approximate frequencies shown:

Rare :may affect up to 1 in 1,000 people

•    nausea, diarrhoea.

Very rare : may affect up to 1 in 10,000 people

•    allergic skin reactions such as pruritus, urticaria and rash

•    abdominal pain.

•    Severe illness with blistering of the skin, mouth, eyes and genitals

•    Inflamatory skin eruption

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: .By reporting side effects you can help provide more information on the safety of this medicine.

How to store Carbocisteine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister or label after the abbreviation EXRThe expiry date refers to the last day of that month.

Do not store above 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 protect the environment.

Q Contents of the pack and other information

What Carbocisteine contains

The active substance is carbocisteine. Each capsule contains 375 mg carbocisteine.

The other ingredients are:

Lactose monohydrate Sodium laurilsulfate Silica, colloidal anhydrous Magnesium stearate Capsule cap/body:


Sodium laurilsulfate Iron oxide yellow (E172)

Titanium dioxide (E171)

Printing ink:

Shellac, Black iron oxide (E172), Propylene glycol. Potassium hydroxide

What Carbocisteine looks like and contents of the pack

Carbocisteine capsules are yellow, size 1 hard capsules, imprinted "6C1" on the cap and "375" on the body, containing a white or off-white granular powder.They are available in tubs containing 100 capsules, or in blister packs of 30, 100 & 120 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Brampton Road,

Hampden Park, Eastbourne, BN22 9AG, United Kingdom.

This leaflet was last revised in 04/2016

PL 00289/1500




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