5031427 MCT LEAFLET.qxp_148 x 295 mm_black 23/01/2015 16:42 Pagel

PACKAGE LEAFLET: INFORMATION FOR THE USER

Microcat 50 mg/mL, oral suspension

Barium sulphate

In this leaflet:

1.    What Microcat is and what it is used for

2.    Before you use Microcat

3.    How to use Microcat

4.    Possible side effects

5.    How to store Microcat

6.    Further information

1. WHAT MICROCAT IS AND WHAT IT IS USED FOR

This medicine is for diagnostic use only.

Microcat is an X-ray contrast media used to highlight areas of your body. It is most commonly used in Computerised axial Tomography (CT scans) or similar medical examinations to help the doctor diagnose problems in your digestive system (throat, stomach and bowels).

This medicine is for the use of children, adults and the elderly.

2. BEFORE YOU USE MICROCAT

Do not use Microcat

•    if you are allergic (hypersensitive) to the active substance (barium sulphate) or any of the other ingredients (refer to the end of this leaflet);

•    if you suffer from stomach ulcers, or any other stomach or bowel problem (perforation, obstruction, etc);

•    if you have had a surgery or an examination (endoscopy) of the digestive tract within the 7 previous days;

•    if you have had a radiotherapy of the digestive tract within the 4 previous weeks.

Tell your doctor if you are suffering from any of these

problems.

Take special care with Microcat

This medicinal product must not be injected.

Like with all products containing barium sulphate, there is a risk of side effects; they are usually minor but can also be life-threatening. Possible allergic-like reactions may occur in the hours following administration, up to 7 days after administration. They are unforeseeable but the risk of occurrence is increased if you have already had a reaction following previous administration of product containing barium sulphate (see section 4 “Possible side effects”). If this is the case, you should inform your doctor.

Inform your doctor:

•    if you have already experienced a reaction following the administration of the same type of medicinal product;

•    if you suffer from asthma;

•    in case of constipation or any other problem of the digestive system;

•    if you have any difficulty to swallow or to breath;

•    if your kidneys do not work properly;

•    in case of Hirschsprung's disease (very rare bowel problem affecting the children);

•    if you are to undergo other radiological examination in the next few days.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, may become pregnant, or are breast-feeding.

Ask your doctor of pharmacist for advice before taking any medicine.

Important information about some of the

ingredients of Microcat

This medicinal product contains:

•    Sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    Sodium (208.5 mg per 150 mL suspension). Please take this into consideration if you are on a low salt diet.

•    Potassium (55 mg per 150 mL suspension). Please take this into consideration if you have a reduced kidney function or are on a controlled potassium diet.

•    "Parahydroxybenzoate” and may cause allergic reactions (possibly delayed).

3. HOW TO USE MICROCAT

Always use Microcat exactly as your doctor has told you. You should check with him/her if you are not sure.

Dosage

The dose will be decided by the doctor depending on the type of examination.

Method of administration

The doctor will usually give you this medicine orally (by mouth) as a drink.

This medicine will be diluted for you and you will be given about half a litre (one pint) to drink.

It is particularly important to take this medicine exactly as told to do so. You should finish all that you have been given.

Adults:

The usual recommended dose is 150 mL of Microcat diluted to 500 mL (about 1 pint) with water and swallowed at the beginning of the examination. Your doctor may adjust this dose or volume to suit the examination.

In the Elderly:

No special dosage regimen is required, but care should be taken to observe the contra-indications and warnings.

Children:

No particular children's dose is recommended as such investigations in children are rare and specialised. The dosage will therefore be tailored by the radiologist to suit the special requirements in each case

You should check with your doctor if you are not sure. If you see other doctors, let them know what medicines you have taken.

If you use more Microcat than you should

Although you will be given Microcat in a hospital, and there will be little chance of an overdose, if you think a child or anyone else has swallowed any of it, let the emergency department or hospital staff know immediately.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Side effects can occur at some frequencies which are detailed below:

•    very common: affects more than 1 user in 10

•    common: affects 1 to 10 users in 100

•    uncommon: affects 1 to 10 users in 1,000

•    rare: affects 1 to 10 users in 10,000

•    very rare: affects less than 1 user in 10,000

•    not known: frequency cannot be estimated from the available data

Most side effects are not serious. Side effects reported for Microcat are mentioned below. Their frequency is not known.

•    sudden skin rash, breathing difficulties and fainting (within minutes or days) due to allergic reactions;

•    vomiting, diarrhoea, abdominal pain, constipation, feeling bloated, flatulence;

•    breathing difficulties;

•    dizziness and feeling of imminent loss of consciousness (pre-syncope);

•    urticaria (patches of red skin, severely itching), rash.

In very rare cases the administration of this type of medicinal product can cause the formation of a plug of faeces and barium in the bowel.

In case of perforation of the bowel, barium could leak into the abdomen, and cause potentially abscesses, inflammation or peritonitis. This could require surgery; however, it is an extremely rare complication.

The passage of barium into the blood may be responsible for blockage of blood vessels, shock, important difficulties to breathe and multiple formation of clots in the blood vessels.

If you get any of the side effects, talk to your doctor or health professional. This includes any side effects not listed in this leaflet.

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, website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MICROCAT

Keep out of the reach and sight of children.

This medicine should be stored below 25°C. Do not freeze it.

The suspension should be used within 2 hours of dilution.

Do not use Microcat after the expiry date which is stated on the container. The expiry date refers to the last day of that month. If you have any medicines that are out of date, return them to your pharmacist or hospital for safe disposal.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist or hospital how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Microcat contains

-The active substance is barium sulphate (50 mg/mL) -The other ingredients are sorbitol, xanthan gum, citric acid anhydrous, sodium citrate, simethicone emulsion, potassium sorbate, sodium methyl parahydroxybenzoate, saccharin sodium, apricot flavour and purified water.

What Microcat looks like and contents of the pack

Microcat is a white, thick liquid with an apricot smell. Microcat is available in bottles of 150 mL or 500 mL. Each contains 150 mL of Microcat, for dilution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Guerbet B.P 57400

95943 Roissy CdG Cedex FRANCE

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Guerbet Laboratories Ltd Avon House 435 Stratford road Shirley, Solihull Birmingham B90 4AA Phone: + 44 1217 338 542

This leaflet was last approved in March 2015.

5031427

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