Normalax

Active Ingredients

A white to cream-white powder for oral solution contains:

Polyethylene Glycol 3350 100%.

Indications

Therapeutic group: Osmotic laxative.

The medicine is intended to treat constipation.

Normalax softens the stool by increasing the water content in the stool, promotes normal bowel activity, thereby relieving constipation.

Instructions

Normalax is free of flavor, smell and color. Normalax completely and rapidly dissolves

in any drink at any temperature.

Dissolve the daily dose in any beverage of choice, such as: water, juice, cold drinks, coffee, tea, milk, baby formula.

Drink the entire dose. It is preferable to take the dose in the morning.

If you forgot to take the medicine at the required time, do not take a double dose.

Take the next dose at the regular time and consult a doctor.

If otherwise wasn't referred by a doctor the usual dosage is:

A cup is provided on the bottle cap for exact measurement of the dose.

There are marked scales on both sides of the measuring cup.

The effect of Normalax occurs within 24 to 48 hours after administering. With continued treatment, intestinal activity will be regular.

Do not exceed the recommended dose.

Normalax can be taken with or without food.

No effects are anticipated during pregnancy, since systemic exposure to Normalax is

negligible. Normalax can be used during pregnancy.

No effects on the breastfeeding newborn/infant are anticipated since the systemic

exposure of the breastfeeding mother is negligible. Normalax can be used during

breastfeeding.

Essential information before taking the medicine

Occasional constipation

It may be related to a recent change in hygiene habits. There are medicines for short term treatment. Consult 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)

May occur as the result of :

• Intestinal disease that requires a doctor's advice.

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

The treatment includes, among others:

• Increasing the proportion of vegetable-based products in the diet and high-fiber foods (vegetables, bread, fruits).

• Increasing water and fruit juice intake.

• Increasing physical activity (sports, walking).

• Rehabilitation of defecation reflex (stool).

Transient improvement in intestinal activity will be maintained through a healthy lifestyle  and dietary measures.

Warnings

Do not use the medicine if:

• you are sensitive (allergic) to the active ingredient (Polyethylene Glycol 3350).

• you are suffering from intestinal obstruction, severe inflammatory intestinal diseases (e.g., Crohn's disease or colitis) or chronic intestinal dysfunction.

• you have suffered, or are suffering, from gastrointestinal perforation or from abdominal pain of unclear origin.

Consult your doctor before administering this treatment to your child, in order to rule out any organic cause of constipation. After 3 months of treatment, the doctor should evaluate your child's clinical condition.

In case of diarrhea, attention should be given to patients subject to electrolytic disorders (for example, elderly people, patients with impaired hepatic or renal

function, or patients using diuretics) and monitoring electrolytes should be considered.

The medicine contains Macrogol (P.E.G. = Polyethylene Glycol). Very few cases of hypersensitivity reactions (rash, hives or edema) have been observed.

If you accidentally took a higher dosage you may develop diarrhea, which will disappear after temporarily discontinuing the treatment or after reducing the dosage.

If you are taking, or have recently taken, other medicines, including non-prescription medicines and nutritional supplements, tell the doctor or pharmacist in order to prevent hazards or lack of efficacy arising from drug interactions.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.