PegLax 10 g powder for oral solution in sachet

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse have 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1. What PEGLAX is and what it is used for
2. What you need to know before you take PEGLAX
3. How to take PEGLAX
4. Possible side effects
5. How to store PEGLAX
6. Contents of the pack and other information

Occasional constipation may be related to a recent change in your lifestyle. There are medicines that can be used for short term treatment. Ask the opinion of your doctor in the case of recent constipation which cannot be explained by changes in your lifestyle, or in the case of constipation associated with pain, fever or abdominal swelling.

Chronic constipation may be caused by:

• Intestinal disease that requires a physician´s advice.
• Intestinal dysfunction (imbalance) due to dietary habits and lifestyle.

The treatment includes among others:

• An increase in the proportion of fibre in the diet (vegetables, wholegrain bread and fruit);
• Increase water and fruit juice intake;
• Increase physical activity (sports, walking ...)
• Rehabilitation of defecation reflex.

• If you are allergic to Macrogol (P.E.G. = polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
• If you have any intestine or colon disease (such as ulcerative colitis, Crohn's disease).
• If you have abdominal pain of undetermined cause.
• If you have or suspect a gastrointestinal perforation.
• If you have or suspect a bowel obstruction

Talk to your doctor, pharmacist or nurse before taking PEGLAX.

If you develop diarrhoea following treatment with PEGLAX you may be at risk of developing electrolytec disorders (a decrease in certain salts in the blood). You are more likely to be at risk if you are an older person, or have liver or kidney problems, or are taking diuretics (water tablets). If you are one of these people and you develop diarrhoea you should see your doctor to have your electrolyte levels checked with a blood test.

Ask your doctor´s opinion before administering this treatment to your child, in order to exclude any organic cause of constipation. After 3 months of treatment, your doctor should evaluate your child clinical condition.

PEGLAX may delay the absorption of other medicines, making them less effective or ineffective especially those with a narrow therapeutic index (e.g antiepileptics, digoxin and immunosuppressive agents). Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Pregnancy

PEGLAX can be used during pregnancy.

Breast-feeding

PEGLAX can be used during breast-feeding.

PEGLAX has no influence on ability to drive and use machines.

This medicine may rarely cause severe hypersensitivity reactions and bronchospasm (difficulty breathing) because of its sulphur dioxide content.

This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially “sodium- free”.

PEGLAX contains a non-significant amount of sugar or polyol and thus may be prescribed to diabetic patients or patients on a galactose-free diet.

For children, the treatment must not exceed 3 months due to a lack of clinical data from more than 3 months treatments.

Treatment should be stopped gradually and resumed if constipation recurs.

You can develop diarrhoea, abdominal pain and vomiting which disappears when treatment is temporarily interrupted or the dose is reduced.

If you suffer from severe diarrhoea or vomiting you should contact a doctor as soon as possible as you may require treatment to prevent loss of salts (electrolytes) from fluid loss.

Do not take a double dose to make up for a forgotten dose.

Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system. These side effects include:

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Abdominal distension
• Diarrhoea
• Nausea

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Urgency to defecate
• Faecal incontinence

Not known (frequency cannot be estimated from available data)

• Electrolyte disorders (low blood levels of sodium and potassium: hyponatremia, hypokalemia)
• Dehydration, caused by severe diarrhoea especially in elderly patients
• Erythema

As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system. These side effects include:

Common (may affect up to 1 in 10 people)

• Abdominal pain
• Diarrhoea (may cause perianal soreness)

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Bloating
• Nausea

Excessive doses can cause diarrhoea, abdominal pain and vomiting which disappears generally when the dose is reduced or treatment temporarily interrupted.

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 via the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

The active substance is: Macrogol 4000

Each sachet contains 10g of macrogol 4000.

The other ingredients are: Saccharin sodium (E954) and Apple flavour (Natural flavour, maltodextrine, gum arabic E414, sulphur dioxide E220, alpha tocopherol E307). See section 2 “Casenlax contains sulphur dioxide”

PEGLAX is an almost white powder in a sachet for making up a solution.

It is available in packs of 8, 10, 20, 30, 50, 60 or 100 sachets.

Not all pack sizes may be marketed.

This medicine is authorized in the Member States of EEA under the following names:

Bulgaria: Касенлакс 10 g прах за перорален разтвор в саше

Belgium: Transilax 10 g

Cyprus: Macrogol 4000 Casen Recordati 10 g κόνις για πόσιμο διάλυμα σε φακελίσκο

Denmark: Casenlax 10g pulver til oral opløsning i brev

Estonia: Proctolax

Finland: Casenlax 10g jauhe oraaliliuosta varten, annospussi

France: Casenlax 10g poudre pour solution buvable

Germany: Laxbene 10 g Pulver zur Herstellung einer Lösung zum Einnehmen, in Beuteln, für

Kinder ab 8 Jahren und Erwachsene

Greece: Cleenlax forte 10 g κόνις για πόσιμο διάλυμα σε φακελίσκο

Ireland: PEGLax 10g Powder for oral solution in sachet

Italy: Casenlax 10g polvere per soluzione orale in bustina

Latvia: Proctolax 10 g pulveris iekšķīgi lietojama šķīduma pagatavošanai paciņā

Lithuania: Macrogol 4000 Casen Recordati 10 g milteliai geriamajam tirpalui paketėlyje

Netherlands: Casenlax 10 g poeder voor drank

Norway: Casenlax 10g pulver til mikstur, oppløsning i dosepose

Portugal: Casenlax 10g pó para solução oral em saquetas

Romania: Proctolax 10g, pulbere pentru soluție orală, in plic

Spain: Casenlax 10g polvo para solución oral en sobre

Sweden: Casenlax 10g pulver till oral lösning i dospåse

United Kingdom (Northern Ireland): PEGLax 10g Powder for oral solution in sachet