Document: leaflet FOCUS PHARMACEUTICALS_PL 36301-0019 change

• leaflet FOCUS PHARMACEUTICALS_PL 36301-0019
• leaflet MAH BRAND_PL 36301-0019

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Read all of this leaflet carefully

because it contains important

information for you.

•    This medicine is available without prescription. However, you still need to use Micralax carefully to get the best results from it.

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

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

•    You must contact a doctor if your symptoms worsen or do not improve after a few days.

•    In this leaflet Micralax 450 mg/45mg/5ml Rectal Solution will be called Micralax.

In this leaflet:

1.    What Micralax is for

2.    Before you use Micralax

3.    How to use Micralax

4.    Possible side effects

5.    How to store Micralax

6.    Further information

1. What Micralax is for

Micralax belongs to a group of medicines called laxatives.

It contains two active ingredients, sodium citrate and sodium alkylsulphoacetate. These work together in the medicine.

Micralax works by causing water to be drawn into the lower bowels. This makes more water in the stools. This means your stools are softer. It is then much easier to empty your bowels. Micralax is used to:

•    Treat constipation especially in bedridden patients, the elderly, children, women giving birth or those deliberately not passing stools

•    Empty your bowels before an X-ray or other examination.

Micralax is an enema. An enema is an injection of liquid into your back passage (anus) which makes your bowels easy to empty.

2. Before you take Micralax

Do not use Micralax if:

•    You are allergic to sodium citrate or sodium alkylsulphoacetate

•    You are allergic to any of the other ingredients in Micralax (see section 6)

•    You have an inflammatory bowel disease.

If any of the above applies to you talk to your doctor or pharmacist.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Micralax.

3. How to use Micralax

Always use Micralax exactly as your doctor or pharmacist has told you.

IMPORTANT:

Your doctor or pharmacist will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Adults and Children aged 3 years and over:

•    Micralax usually works within 5 to 15 minutes, so make sure you are near a toilet before using it

•    Always use a fresh tube of Micralax every time.

•    The usual dose is one tube. Remember: if after a few days treatment you are still constipated, you must see your doctor.

You should not use laxatives for a long time.

How to use Micralax

•    Lie down on your side with your knees drawn up towards your tummy. If you prefer you can sit on the toilet

•    Pull or twist the cap off the tube

•    You can lubricate the nozzle to make it easier to put in. Squeeze a drop of medicine out onto the nozzle

•    Put the full length of the nozzle into your back passage

•    Gently squeeze the tube until it is empty

•    Keep squeezing the tube as you pull the nozzle out. This is to stop the medicine being drawn back into the tube

•    Wait for the laxative to work. This takes 5-15 minutes.

If you use more Micralax than you should

If you accidentally use too much Micralax, contact the nearest hospital casualty department or your doctor as soon as possible.

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

4. Possible side effects

Like all medicines Micralax can cause side effects, although not everybody gets them. Most people find that using this medicine causes no side effects, provided it is used correctly.

If you use Micralax too much it may cause diarrhoea or loss of fluid.

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 Yellow Card Scheme on the MHRA website (www.mhra.gov.uk/yel-lowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Micralax

Keep out of the reach and sight of children. Do not use Micralax after the expiry date on the pack. The expiry date refers to the last day of that month.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

What Micralax contains

The active substances are 450 mg sodium citrate and 45 mg sodium alkylsulphoacetate.

The other ingredients are sorbitol solution, glycerol, sorbic acid and purified water.

What Micralax looks like

Micralax is a colourless liquid that comes in disposable plastic 5ml tube with 5 - 6 cm long flexible nozzle.

Micralax comes in cartons containing 12 tubes.

Marketing Authorisation Holder RPH Pharmaceuticals AB, Lagervagen 7, 136 50 Haninge, Sweden.

Manufacturer

Recipharm Limited,

Vale of Bardsley,

Ashton-under-Lyne,

OL7 9RR, UK

Distributed by

Focus Pharmaceuticals Ltd.

This leaflet was last updated July 2014.