REGULAX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

POLYETHYLENE GLYCOL 3350

Available from:

NEOPHARM CONSUMER PRODUCTS LTD, ISRAEL

ATC code:

A06AD15

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

POLYETHYLENE GLYCOL 3350 99.973 %W/W

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

BEN SHIMON FLORIS LTD, ISRAEL

Therapeutic group:

MACROGOL

Therapeutic area:

MACROGOL

Therapeutic indications:

Treatment of constipation.

Authorization date:

2017-04-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed
without a doctor’s prescription
REGULAX
Powder for preparing an oral solution
ACTIVE INGREDIENT AND ITS CONCENTRATION:
polyethylene glycol 3350, 99.973% w/w.
INACTIVE INGREDIENTS:
See section 6 of this leaflet: “
ADDITIONAL INFORMATION
”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
Use the preparation according to the instructions in the section on
dosage in this leaflet.
If you need further information, consult with the pharmacist. You must
contact a doctor if your symptoms worsen or do not improve.
Regulax does not contain sugar, and is therefore suitable for
diabetics.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of constipation. Regulax
softens the stool by increasing the water content in the stool,
and promotes normal bowel activity, thereby relieving constipation.
THERAPEUTIC GROUP:
Osmotic laxative.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient
(polyethylene glycol 3350) or to the additional ingredient (sucralose)
contained
in the medicine.
• 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.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE TREATMENT WITH REGULAX, TELL YOUR DOCTOR IF:
• You have diarrhea and are prone to electrolytic disorders (for
example, if you are elderly, have
impaired hepatic or renal function, or
use diuretics). The doctor will consider monitoring electrolyte level.
• The medicine contains polyethylene glycol (Macrogol). Very few
cases of hypersensitivity reactions (rash, urticaria or edema) have
been