Peglax Neutral

Active Ingredients

A powder for preparing an oral solutioncontains:

Polyethylene glycol 3350, 99.973% w/w

Indications

Therapeutic class:

Osmotic laxative.

Peglax Neutral powder for preparing an oral solution is intended for treatment of constipation. Peglax softens the stool by increasing the stool water content, causes normal intestinal activity and thus relieves constipation.

Instructions

Dissolve the daily dose in any beverage of choice, such as: water, juice, cold drinks, coffee, tea, milk, baby formula. Peglax Neutral dissolves completely and quickly in any beverage at any temperature.Drink the entire dose. It is advisable to take the dose in the morning.

The generally accepted dosage is:

Do not exceed the recommended dose.

A cup for precise dose measurement is enclosed with the product package. Gradations are marked on the sides of the cup to indicate the quantity of powder to be filled in the measuring cup to receive the required dose.

The effect of Peglax occurs within 24 to 48 hours of administration. With continuous treatment, the intestinal activity will be regular. Temporary improvement in intestinal activity as a result of the treatment, will be maintained through a healthy lifestyle and dietary measures.

If there is no improvement in your condition within a week, refer to the doctor. The medicine is usually intended for treatment lasting up to 2 weeks, unless otherwise instructed by the doctor. The duration of treatment in children must not exceed 3 months due to a lack of clinical data regarding more than 3 months of treatment.

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

Warnings

Do not use Peglax Neutral if you are sensitive (allergic) to the active ingredient (polyethylene glycol 3350) or to any of the other ingredients this medicine contains Do not use this medicine if you suffer from an intestinal or colon disease (such as ulcerative inflammation of the large intestine, Crohn’s disease).

Do not use this medicine if you suffer from abdominal pain of undetermined cause.

Do not use this medicine if youhave or suspect you may have gastrointestinal perforation.

Do not use this medicine if you have or suspect you may have bowel obstruction.

The medicine contains polyethylene glycol (Macrogol). Very few cases of hypersensitivity (rash, hives or edema) have been observed.

The absorption of other medicines may be decreased as a result of an increase in gastrointestinal activity that is caused by polyethylene glycol.

Before treatment with Peglax, tell your doctor if:

You have diarrhea and you are prone to electrolyte balance disorders (for example if you are elderly, if you suffer from impaired liver or kidney function or if you are using diuretics). The doctor will consider monitoring your electrolytes level. Important information before taking the medicine:

Occasional constipation

This constipation may be related to a recent change in your hygiene habits. There are medicines that can be used for short-term treatment of constipation. Consult a doctor in the case of constipation that recently started, which cannot be explained by changes in your lifestyle, or in the case of constipation accompanied by pain, fever or swelling of the abdomen.

Chronic constipation (long-term constipation)

May occur as a result of:

• Intestinal disease that requires medical consultation
• Impaired intestinal function (imbalance) as a result of eating habits and lifestyle

The treatment includes, amongst other things:

• Increasing the percentage of plant-based products in the diet (vegetables, bread, fruit)
• Increasing water intake, including fruit juices
• Increasing physical activity (sport, walking)
• Rehabilitation of defecation reflux (stool)

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

If you are taking or have recently taken other medicines, including non-prescription medicines and nutritional supplements, tell the doctor or the pharmacist. The absorption of other medicines may decrease while using Peglax. The therapeutic effect of medicines with a narrow therapeutic index may be especially affected (such as antiepileptic medicines, Digoxin and immunosuppressant medicines).

No effects are anticipated during pregnancy, since the systemic exposure to Peglax is negligible. Peglax can be used during pregnancy. No effects are anticipated on the breastfeeding newborn/infant since the systemic exposure of the breastfeeding mother is negligible. Peglax can be used during breastfeeding.

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.