Symptomatic treatment of constipation in adults, adolescents and children aged 8 years and over.
Before starting treatment, an organic condition should be ruled out. PROCTOLAX should remain a temporary adjunctive treatment, together with an appropriate lifestyle and diet in case of constipation, and the duration of treatment in children should be a maximum of 3 months. If symptoms persist despite associated dietary measures, an underlying condition should be suspected and treated appropriately.

Contraindications:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic strictures,
Digestive perforation or risk of digestive perforation, Ileus or suspected intestinal obstruction,
Painful abdominal syndromes of unspecified etiology.

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

Pregnancy, lactation and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Task:
PROCTOLAX can be used during pregnancy.
Breastfeeding:
PROCTOLAX can be used during breastfeeding.

Driving and using machines:
PROCTOLAX has no influence on the ability to drive or use machines.

PROCTOLAX contains sulfur dioxide:
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm (difficulty breathing) due to its sulfur dioxide content.

PROCTOLAX contains sodium
PROCTOLAX contains less than 1 mmol sodium (23 mg) per sachet, i.e. essentially “sodium-free”.
PROCTOLAX contains an insignificant amount of sugar or polyol and can therefore be recommended for patients with diabetes or patients following a galactose-free diet.

Oral administration:
Dosage:
1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125 ml of liquid (e.g. water) after each dose.
The effect of PROCTOLAX becomes apparent within 24 to 48 hours after administration.
The daily dose should be adjusted according to clinical effects and may vary from one sachet every other day (especially in children) to 2 sachets per day.
Treatment should be stopped gradually and resumed if constipation recurs.

Children and adolescents:
1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to consume
125 ml of fluids (e.g. water) after each dose.
In children, treatment should not exceed 3 months due to the lack of clinical data on therapy lasting longer than 3 months. The recovery of bowel movements induced by treatment will be maintained
through an appropriate lifestyle and dietary measures.

Method of administration:
Each sachet should be dissolved in a glass of water (approximately 125 ml) just before use.
The resulting solution should be clear and transparent like water.

- The active substance is: Macrogol 4000
Each sachet contains 10 g of macrogol 4000.
Excipients with known effect:
Sulfur dioxide (E-220) 0.0000018 mg per sachet and sodium less than 1 mmol per sachet.
Sodium saccharin (E954), apple flavor*
* Composition of apple flavor: flavors identical to nature substances, natural flavors, flavoring preparations, maltodextrin, gum arabic (E414), sulfur dioxide (E220), alpha tocopherol (E307)

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

8 envelopes