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Danlax Suspension

Patient Information Leaflet 075-0463-APIL



Danlax Suspension

Co-Danthramer

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

-    Please 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 becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Danlax Suspension is and what it is used for

2.    Before you take Danlax Suspension

3.    Howto take Danlax Suspension

4.    Possible side effects

5.    How to store Danlax Suspension

6.    Further information

1.    WHAT DANLAX SUSPENSION IS AND WHAT IT IS USED FOR

The name of your medicine is Danlax Suspension. The active ingredients are Dantron and Poloxamer.

Dantron and Poloxamer are both laxatives.

Danlax Suspension is used to prevent or treat constipation during serious illnesses, as constipation may be caused by certain serious medical conditions or may be a side effect of certain pain relieving medicines.

2.    BEFORE YOU TAKE DANLAX SUSPENSION Do not take this medicine if:

•    you have ever had an allergic reaction to any of the ingredients of Danlax Suspension (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);

•    you have or have you recently experienced stomach pain where the cause is unknown;


•    you had a blockage of the bowel which is not due to constipation;

•    you are pregnant, you think that you may be pregnant or are you breast-feeding.

•    Danlax Suspension must not be given to an infant in nappies.

Take special care with Danlax Suspension

Danlax Suspension should be used with care in incontinent patients.

Taking other medicines

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

Pregnancy and breast-feeding

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

Driving and using machines

There have been no reported effects on the ability to drive or operate machinery while taking this medicine.

Important information about some of the ingredients of Danlax Suspension

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars.

This is because Danlax Suspension contains sucrose, a type of sugar.

Danlax Suspension includes benzoic acid which can cause mild irritation of the skin, eyes and mucous membranes of some patients.

Danlax Suspension can cause staining and shedding of the skin on the buttocks of incontinent or bedridden patients, so should be administered with care.

3. HOW TO TAKE DANLAX SUSPENSION

Always take your medicine 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 use until any sediment is dispersed.

The usual doses of Danlax Suspension are as follows: Adults

One or two 5 ml spoonfuls, taken at bedtime.

The dose may be reduced for elderly patients to half to one 5 ml spoonful, taken at bedtime.

Children

A half to one 5 ml spoonful, taken at bedtime.

If the dose is less than a 5 ml spoonful it may be convenient to use an oral syringe (obtainable from your pharmacist) to measure and give the dose. Rinse the syringe thoroughly after use in accordance with the manufacturer’s instructions.

If you are not sure about how much medicine to take, please speak to your doctor or pharmacist.

If you take more solution than you should

If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.

If you forget to take your medicine

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Danlax Suspension can cause side effects, although not everybody gets them.

You are unlikely to get any of the following, but if you do, tell your doctor immediately:

• Skin reddening, itching, difficulty in breathing or swelling. These could be signs of an allergic reaction and might not happen immediately - they may be experienced at the beginning of treatment or they may be delayed;

If you notice any side effects mentioned above, please tell your doctor or pharmacist.


A few people find that they get a pink or red tint in their urine and staining of the anal skin. This is due to the Dantron in Danlax Suspension and is not a cause for concern.

If any of the side effects becomes severe, of if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

5.    HOW TO STORE DANLAX SUSPENSION

Do not use after the expiry date that is stated on the bottle label.

Store the solution so that it is protected from light. Do not store above 25°C.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION What Danlax Suspension contains:

Each 5 ml of solution contains 200 mg of Poloxamer and 25 mg of Dantron the active substances of Danlax Suspension.

The other ingredients are: sucrose, xanthan gum, colloidal anhydrous silica, citric acid monohydrate, benzoic acid, lemon spirit, vanillin and purified water.

What Danlax Suspension looks like and the contents of the pack:

Danlax Suspension is an orange suspension with the odour of lemons, which is available in amber glass bottles with tamper-evident caps. Each bottle contains either 300 ml or 100 ml of Suspension,

Marketing Authorisation Holder and Manufacturer

Waymade Pic trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.

Remember: This medicine is for you and has been prescribed foryou byadoctor. Never give it to anybody else, even if their symptoms are the same as yours.

This leaflet does not contain all the available information about your medicine.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet applies only to Danlax Suspension.


^SOVEREIGN

■Mb medical


Date of preparation of leaflet: May 2008