Package leaflet: Information for the user

Laxadear 5.9 g, powder for oral solution

Macrogol 3350

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

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you.

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

•    Ask your pharmacist if you need more information or advice.

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

•    If your symptoms of constipation worsen, you must talk to a doctor immediately.

•    Talk to a doctor if your symptoms do not improve after 5 days of using Laxadear.

What is in this leaflet

1.    What Laxadear is and what it is used for

2.    What you need to know before you use Laxadear

3.    How to use Laxadear

4.    Possible side effects

5.    How to store Laxadear

6.    Contents of the pack and other information

1.    What Laxadear is and what it is used for

Laxadear contains an ingredient called'Macrogol 3350' (or 'polyethylene glycol') and a mixture of salts.

It comes as a powder that you dissolve in water to make a drink.

Laxadear is used as a laxative for short-term relief of constipation. It can be used in adults, adolescents over 12 years of age and the elderly.

Constipation can often be relieved by eating fresh fruit and vegetables, drinking plenty of water and exercising.

If these do not work, then Laxadear can be used.

You must talk to a doctor immediately if your symptoms of constipation worsen.

2.    What you need to know before you use Laxadear Do not use Laxadear if:

•    you are allergic to Macrogol 3350 ('polyethylene glycol') or any of the other ingredients of this medicine (listed in Section 6)

•    you have severe inflammatory bowel disease like'ulcerative colitis' or'Crohn's disease'

•    you have severe bloating of your gut ('toxic megacolon')

•    you have a hole or tear in your gut wall

•    you have a blockage in your gut (ileus)

•    you have'phenylketonuria', a rare inherited condition.

Do not use Laxadear if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions

Talk to your pharmacist before using Laxadear if:

•    you are on a low sodium diet (for heart failure or high blood pressure)

•    you are on a low potassium diet or have kidney problems

If any of the above apply to you (or you are not sure), talk to your pharmacist before using Laxadear.

Children under 12 years of age

Do not use this medicine in children under 12 years of age.

Other medicines and Laxadear

Tell your pharmacist if you are using, have recently used or might use any other medicines. Some medicines may not work as effectively during use with Laxadear.

Laxadear with food and drink

This medicine can be taken at any time, with or without food or drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think that you might be pregnant or are planning to have a baby, ask your pharmacist for advice before using this medicine.

Driving and using machines

Laxadear will not affect you being able to drive, cycle or use any tools or machines.

Laxadear contains sodium, potassium, aspartame and sulphur dioxide

This medicine contains:

•    sodium (12.5 mmol per sachet) - if you are on a low sodium diet (for heart failure or high blood pressure), you need to take this into account

•    potassium (1 mmol per sachet) - if you are on a low potassium diet or have kidney problems, you need to take this into account

•    aspartame (E951), a source of'phenylalanine'- this may be harmful for people with 'phenylketonuria'

•    sulphur dioxide (E220) - this may rarely cause severe allergic reactions, difficulty breathing or wheezing.

3.    How to use Laxadear

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you.

Check with your pharmacist if you are not sure.

Using this medicine

•    Empty the contents of one sachet into a small glass. Add about 100 ml of water to the glass.

•    Stir well until all the powder has dissolved. The solution should be clear or slightly cloudy and have a mild vanilla flavour.

•    Try and drink the solution straight away. If you cannot drink it straight away, you can keep it at room temperature for up to 2 hours.

•    If you use more than one sachet, you must use more water. Use about 100 ml for each sachet.

How much to use

•    The usual dose is 1 to 2 sachets each day, taken at the same time.

•    Laxadear usually takes between 24 and 48 hours to start working.

•    If the medicine is not working after this time, you can use more sachets. Do not use more than 4 sachets each day. How long to continue treatment

You should continue using Laxadear until your constipation is relieved. However, talk to a doctor if symptoms do not improve after 5 days of using Laxadear.

If you use more Laxadear than you should

If you use more Laxadear than you should, this may cause diarrhoea. The diarrhoea will usually stop when you stop using the medicine. If your diarrhoea is severe, talk to your doctor or pharmacist.

If you forget to use Laxadear

If you forget to use a dose of Laxadear, use it as soon as you remember.

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

4.    Possible side effects

Like all medicines, Laxadear can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop using Laxadear and see your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment

•    Serious allergic reaction - the signs may include difficulty breathing or swelling of the face, lips, tongue or throat.

Other side effects Stomach or gut reactions

•    bloating, wind, mild diarrhoea or feeling or being sick

•    indigestion, stomach ache or rumbling

•    soreness of the anus.

These side effects will usually get better if you reduce the amount of Laxadear you use.

Mild allergic reactions

•    skin reactions such as rash, itching or redness.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Ireland

HPRA Pharmacovigilance, Earlsfbrt Terrace, IRL- Dublin 2; Tel: +35316764971; Fax: +35316762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

United Kingdom

Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

5.    How to store Laxadear

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 sachet and carton after'Exp'. The expiry date refers to the last day of that month.

Do not store Laxadear above 25°C. The mixed Laxadear solution can be stored at room temperature for up to 2 hours or in the fridge for up to 24 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Laxadear contains

•    The active ingredient is Macrogol 3350. Each sachet contains 5.9 g Macrogol 3350.

•    The other ingredients are Sodium Sulphate Anhydrous, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride, Aspartame (E951) and Vanilla flavour (containing Caramel Color (E150), Maltodextrin (maize),

Gum Arabic/Acacia Gum (E414), Benzyl alcohol and Sulphur Dioxide (E220)).

What Laxadear looks like and contents of the pack

•    Laxadear is a white or almost white powder to be dissolved in water. The powder dissolves completely to give a clear or slightly cloudy solution with a flavour of vanilla.

•    Laxadear is available as 10 or 20 sachets packed in a box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland.

This leaflet was last revised in March 2016.