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1. Peglax 10 G Powder For Oral Solution In Sachet
2. Peglax 10 G Powder For Oral Solution In Sachet

PEGLax 10 g Powder for oral solution in sachet Macrogol 4000

PACKAGE LEAFLET: INFORMATION TO THE USER

In this leaflet:

1.    What PEGLax 10 g is and what it is used for

2.    What information is to be known before taking PEGLax 10 g

3.    How to take PEGLax 10 g

4.    What are the possible side effects

5.    How to store PEGLax 10 g

6.    Further information

1. WHAT PEGLax 10 g IS AND WHAT IT IS USED FOR

The name of this medicine is PEGLax 10 g, powder for oral solution in sachet.

PEGLax 10 g is considered as osmotic laxative.

PEGLax 10 g is indicated for the symptomatic treatment of constipation in adults and children 8 years old and over and regarded as temporary adjunctive therapy in an appropriate lifestyle and in dietary measures.

In the case of constipation, the maximum treatment period in children is 3 months.

2. WHAT INFORMATION IS TO BE KNOWN BEFORE TAKING PEGLax 10 g

List of information necessary before taking the medicine.

Occasional constipation:

It may be related to a recent change in hygiene 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 can not be explained by changes in your lifestyle, or in the case of constipation associated with pain, fever or abdominal distension.

Chronic constipation (long term constipation):

It may come from:

•    Intestinal disease that requires a physician advice.

•    Intestinal dysfunction (imbalance) due to diet habits and hygiene lifestyle.

The treatment includes among others:

•    Increase the proportion of vegetal source products in the diet (vegetables, bread, fruits).

•    Increase water and juice fruit intake.

•    Increase physical activity (sports, walking ...).

•    Rehabilitation of defecation reflex.

Do not take PEGLax 10 g if:

•    You are allergic (hypersensitive) to Macrogol (= P.E.G. = polyethylene glycol) or any of the other excipients.

•    You have any intestine or colon disease (such as ulcerative colitis, Crohn’s disease).

•    You have abdominal pain of undetermined cause.

•    You have or suspect a gastrointestinal perforation.

•    You have or suspect a bowel obstruction (Ileus)

Take special care with PEGLax 10 g:

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's clinical condition.

In case of diarrhoea, attention should be given to patients subject to electrolytic disorders (for example elderly people or patients with impaired hepatic or renal function (patients using diuretics)) and an electrolytic check up should be considered.

This medicine contains Macrogol (=P.E.G. = polyethylene glycol).Very few cases of hypersensitivity reactions (rash, hives or oedema) have been notified.

Taking other medicines

If you use or have recently used another medicine, including medicines obtained without a prescription, tell your doctor or your pharmacist.

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor if you are pregnant or expect to be or if you are breastfeeding your child.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to PEGLax 10 g in negligible. PEGLax 10 g can be used during pregnancy.

Lactation

No effects on the breast-feeding newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to macrogol 4000 is negligible; PEGLax 10 g can be used during breast-feeding.

Driving vehicles and using machines

PEGLax 10 g does not affect the ability to drive or use machines.

Important information regarding some components of PEGLax 10 g

PEGLax 10 g does not contain a significant quantity of sugar or polyol; it may be prescribed to diabetics or galactose-free diet patients.

3. HOW TO TAKE PEGLax 10 g

Always take PEGLax 10 g as your doctor has told you if in doubt ask your doctor or your pharmacist. For oral use.

The usual dose is:

1 to 2 sachets per day, preferably taken as a single dose in the morning.

The daily dose should be adjusted according to the clinical effects obtained and may range from one sachet every other day (especially in children) to up to a maximum of 2 sachets per day.

The effect of PEGLax 10 g occurs within 24 to 48 hours after administering.

Instructions for administering

Each sachet is, before the intake, to be dissolved in a glass of water.

Treatment duration

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

Intestinal transient improvement will be maintained through a healthy lifestyle and dietary measures.

If you take more PEGLax 10 g than you should

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

Excessive liquid loss by diarrhoea or vomiting may require rebalancing electrolytic disorders (i.e. sodium and potassium low blood levels).

If you forget to take PEGLax 10 g

Do not take a double dose to compensate the forgotten dose.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS

Like all medicines, PEGLax 10 g may cause undesirable side effects, but they do not sistematically occur

with everybody.

•    Hypersensitivity reactions: pruritus, urticaria, rash, face oedema, Quincke oedema and an isolated case of anaphylactic shock. You should go straight to hospital if you have difficulty in breathing, start to look flushed, or have any other symptom that you think might mean you are having a serious allergic reaction.

•    Diarrhoea, urgent need to go to the toilet or faecal incontinence.

•    Abdominal distension and/or pain

•    Nausea and vomiting.

•    Cases of diarrhoea leading to electrolytes disordes (low blood levels of sodium and potassium: hyponatremia, hypokalemia) and/or dehydration have been reported especially in elderly patients.

Excessive doses can cause diarrhoea, which disappears generally when the dose is reduced or treatment temporarily interrupted. Diarrhoea may cause perianal soreness.

If you feel seriously one of the effects mentioned or if undesirable effects not mentioned in this leaflet arise

please advise your doctor or pharmacist.

5. HOW TO STORE PEGLax 10 g

Keep this medicine out of the reach and sight of children.

This medicine does not require special storage conditions.

Do not take PEGLax 10 g after the expiry date which is printed on the sachet.

The expiry date refers to the last day of that month.

Medicines should not be thrown away into the sewers or into the household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

Do not use PEGLax 10 g Powder for Oral Solution if you notice any visible signs of deterioration.

6. FURTHER INFORMATION

What PEGLax 10 g contains

The active substance is: Macrogol 4000.

The other ingredients are Saccharin sodium (E954) and Apple flavour.

What PEGLax 10 g looks like and contents of the pack

PEGLax 10 g is an almost white powder in a sachet for making up a solution. It is available in packs of 10, 20, 50 or 100 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Laboratorios Casen-Fleet, S.L.U. Autovia de Logrono, Km 13,300. 50180 UTEBO - Zaragoza (Spain)

Manufacturer

Casen Recordati, S.L. Autovia de Logrono, Km 13,300. 50180 UTEBO - Zaragoza (Spain)

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

Denmark:    Casenlax 10 g pulver til oral oplosning

Finland:    Casenlax 10 g jauhe oraaliliuosta varten

France:    Casenlax 10 g poudre pour solution buvable

Germany:    Casenlax 10 g pulver zur Herstellung einer losung zum einnehmen

Ireland:    PEGLax 10 g powder for oral solution

Italy:    Casenlax 10 g polvere per soluzione orale

Netherlands: Casenlax 10 g poeder voor drank

Norway:    Casenlax 10 g pulver til mikstur, opplosning

Portugal:    Casenlax 10 g po para solupao oral

Spain:    Casenlax 10 g polvo para solucion oral

Sweden:    Casenlax 10 g pulver till oral losning

UK:    PEGLax 10 g powder for oral solution

The last date on which this leaflet has been approved is: May 2015

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