Co-Danthramer 75mg/1000mg per 5ml Oral Suspension

(75mg Dantron, 1000mg Poloxamer 188/5ml)

Each 5 ml contains:

75mg Dantron, 1000mg Poloxamer 188.

It also contains sorbitol (E420), ethanol, methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216). This product contains 6.2% v/v of ethanol, see leaflet. Suspension for oral administration.

Keep out of the sight and reach of children. Dosage: As directed by physician.

Shake the bottle well before use.

Do not store above 25°C. Store in the original container. Read the package leaflet before use.

MA Holder and Manufacturer:    fPOMl

Pinewood Laboratories Ltd.,

Ballymacarbry, Clonmel, Co. Tipperary,

Ireland. PL 04917/0026

23LL04954PW

CO-DANTHRAMER

75mg/1000mg

Page 1 83. mm

Page 2    31 5 _mm

Page 3 80.5 mm

Page 4 78. mm

Page 5 78. mm

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PATIENT INFORMATION LEAFLET Co-Danthramer 75mg/1000mg per 5ml Oral Suspension 75mg Dantron and 1000mg Poloxamer 188/5ml

Read all of this leaflet carefully before you start taking this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Co-Danthramer is and what it is used for

2.    Before you take Co-Danthramer

3.    How to take Co-Danthramer

4.    Possible side effects

5.    How to store Co-Danthramer

6.    Further information

1.    WHAT CO-DANTHRAMER IS AND WHAT IT IS USED FOR

Co-Danthramer 75mg/1000mg per 5ml Oral Suspension (”Co-Danthramer”) belongs to a group of laxatives called stimulant laxatives. It works by encouraging normal bowel movements between 6 and 12 hours after taking it. Co-Danthramer is used for the prevention and treatment of constipation in seriously ill patients.

2.    BEFORE YOU TAKE CO-DANTHRAMER Do not take Co-Danthramer if you:

•    are allergic to dantron, poloxamer 188 or any of the other ingredients of Co-Danthramer (see Section 6 and end of Section 2).

•    are pregnant or are breast-feeding.

•    suffer from intestinal obstruction - bowel blockage.

•    have signs of appendicitis or inflamed bowel (severe pain in your side).

Co-Danthramer is not suitable for children under 12.

Take special care with Co-Danthramer

Before you take Co-Danthramer, tell your doctor if you:

•    suffer from incontinence as prolonged contact with the skin can cause irritation and peeling of the skin, or staining.

•    have hereditary fructose intolerance.

•    suffer from liver disease, alcoholism or epilepsy.

•    have ever had kidney-related problems.

Taking other medicines

You must tell your doctor if you are taking or have recently taken any other medicines, including other laxatives and medicines obtained without a prescription. Co-Danthramer may modify or increase the effects of other medicines.

Pregnancy and breast-feeding

Do not take Co-Danthramer if you are, or are likely to become pregnant, or are breast-feeding.

Driving and using machines

Co-Danthramer may cause unusual tiredness or weakness and, if affected, you should not drive or operate machinery.

Important information about some of the ingredients of Co-Danthramer:

The product contains:

•    sorbitol (E420): If you have an intolerance to some sugars contact your doctor before taking this medicinal product.

•    ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218): may cause allergic reactions, which may be delayed.

•    Ethanol: Each dose contains up to 0.25g of alcohol, equivalent to 5.9ml beer, 2.5ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

3. HOW TO TAKE CO-DANTHRAMER

Always take Co-Danthramer exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Shake the bottle well before taking Co-Danthramer, but avoid contact with skin to prevent staining.

The effects of Co-Danthramer are usually seen 6 to 12 hours after you have taken it.

The usual dose is :

Your doctor may advise you to take your medicine in a different way, so you must always follow your doctor's advice about when and how to take Co-Danthramer. Check with your doctor if you are unsure.

If you take more Co-Danthramer than you should:

Co-Danthramer can cause diarrhoea if you take too much at once. If it is used for long periods of time, you may get diarrhoea which may lower the salt levels in the blood, causing weakness, dehydration, faintness and tiredness. If this occurs, eat a balanced diet containing foods rich in potassium and drink plenty of water. If you are unsure contact your doctor or pharmacist who will recommend what action you should take.

If you forget to take Co-Danthramer:

If you forget to take a dose, then miss that dose and take it at the next convenient time.

If you have any questions on the use of this product, ask your doctor or pharmacist for advice.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Co-Danthramer can cause side effects, although not everybody gets them.

Possible side effects are:

•    abdominal cramps    •    rash

•    urine may be coloured red    •    stomach upset

•    irritation and peeling or staining of the skin e.g. in incontinence

•    unusual tiredness or weakness

With prolonged use, the following may occur:

•    discolouration of the lining of your stomach

•    kidney stones - failure

•    bowels may stop working normally - stopping salt and nutrients being absorbed into the blood

In animals, dantron can cause growths in the bowel and liver. There may be a possible, but very small risk of this happening in humans.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any

possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at 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 CO-DANTHRAMER

Keep this medicine out of the sight and reach of children. Do not use Co-Danthramer after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not store above 25^lC, and store in the original container.

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

6.    FURTHER INFORMATION What Co-Danthramer contains

Each 5ml of Co-Danthramer contains:

•    Active ingredients : 75mg Dantron and 1000mg Poloxamer 188.

•    Other ingredients : aluminium magnesium silicate, xanthan gum, glycerol (E422), sorbitol (E420), saccharin sodium, propylene glycol, ethanol, methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), citric acid monohydrate, sodium citrate, purified water and peach flavour liquid (contains propylene glycol).

What Co-Danthramer looks like and contents of the pack:

Co-Danthramer is a yellow, peach-flavoured oral suspension, and is

available in 100ml, 150ml, 200ml, 300ml, 500ml and 1 litre amber

glass bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary,

Ireland. PL 04917/0026

Revision Date: March 2016

Co-Danthramer 75m^l00unp p er 5ml Oral Suspension

(75mg Dantron, 1000mg Po^a^e' 188'5ml

Sugar Free • 300 ml

©

HEALTHCARE

Clonmel, Ireland.

Each 5 ml contains:

75mg Dantron, 1000mg Poloxamer 188.

It also contains sorbitol (E420), ethanol, methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216). This product contains 6.2% v/v of ethanol, see leaflet. Suspension for oral administration.

IKeep out of tfe sight and r#ch of children. Dosage: As directed by physician.

Shake the bottle well before use.

Do not t#e above 25°C. Store in the original container. Read the package leaflet before use.

MA Holder and Manufacturer:    [pOMI

Pinewood Laboratories Ltd.,    I-1

Ballymacarbry, Clonmel, Co. Tipperary,

Ireland. PL 04917/0026

23LL04954PW

Page 9 78. mm

Page 8 78. mm

Page 7 80.5 mm

Page 6 81.5 mm

Front page 83. mm