Macrolax

Italy
Brand name Macrolax
Form solution, rectal
Active substance / Dosage
SORBITOL
DOCUSATE SODICUM
Prescription type Over-the-counter
ATC code
A06AG10
Registration number 028271
Manufacturer LABORATORIO FARMACEUTICO SIT SPECIALITA IGIENICO TERAPEUTICHE S.R.L.
Macrolax solution, rectal

Table of Contents

Package leaflet: Information for the user

Macrolax 36 g + 0.24 g rectal solution

liquid non-crystallizable sorbitol + sodium docusate
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

  • Keep this leaflet. You may need to read it again.
  • If you want more information or advice, consult your pharmacist.
  • If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  • Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

  1. What Macrolax is and what it is used for
  2. What you need to know before using Macrolax
  3. How to use Macrolax
  4. Possible side effects
  5. How to store Macrolax
  6. Contents of the pack and other information

1. What Macrolax is and what it is used for

Macrolax is a rectal solution containing two active substances: non-crystallizable liquid sorbitol and sodium docusate.
These two substances belong to the class of laxatives and work by softening the stools and stimulating the bowel to expel them.
This medicine is used for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse after a few days.

Health education notes:
Many people believe they suffer from constipation if they are unable to defecate every day.
This is a mistaken belief, as this condition is completely normal for a large number of individuals.
Constipation instead refers to a situation in which bowel movements are reduced compared to one's usual habits and are associated with the passage of hard stools.
In most cases, a balanced diet rich in water and fibre (bran, vegetables, and fruit) can provide a long-term solution to constipation.
If episodes of constipation occur repeatedly, you should consult your doctor.

2. What you need to know before using Macrolax

Do not use Macrolax

  • if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
  • if you have problems in the final portion of the intestine called the “rectum” (rectal bleeding of unknown origin);
  • if you have abdominal pain, nausea and vomiting;
  • if you have intestinal problems (intestinal obstruction or stenosis);
  • if you are dehydrated;
  • if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
  • if you are under 12 years of age (see section “Warnings and precautions”).

Warnings and precautions
Consult your doctor before using Macrolax:

  • if you have persistent constipation. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications and monitoring during therapy;
  • if you have noticed a sudden change in your bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks;
  • if you are elderly or in poor general health. Consult your doctor also if, after a short period of treatment with this medicine, you do not achieve satisfactory results.

Do not use this medicine for prolonged treatments.
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause:

  • dependence, leading to the possible need to progressively increase the dose;
  • chronic constipation;
  • loss of normal intestinal function (intestinal atony);
  • persistent diarrhoea, which may result in loss of water, mineral salts (especially potassium), and other essential nutrients. In more severe cases, dehydration or low blood potassium levels (hypokalaemia) may occur, which can lead to heart dysfunction or to disorders of the nerves controlling muscles. The risk is increased if you are simultaneously being treated with medicines for the heart (cardiac glycosides), medicines used for high blood pressure (diuretics), or medicines used for allergies and inflammation (corticosteroids).

Children
In children under 12 years of age, this medicine should be used only after consulting a doctor.
Other medicines and Macrolax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially if you are taking mineral oil-based medicines used for constipation.
Laxatives may reduce the intestinal transit time, and thus the absorption, of other medicines taken simultaneously by mouth. Therefore, avoid taking laxatives and other medicines at the same time: wait at least 2 hours after taking another medicine before taking the laxative.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no adequate studies on the use of this medicine during pregnancy or breastfeeding.
Therefore, during pregnancy and breastfeeding, use this medicine only if considered necessary, under the direct supervision of a doctor, after evaluating with him the risk/benefit ratio in your individual case.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
Macrolax contains methyl parahydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Macrolax

Use this medicine exactly as stated in this leaflet or according to the instructions provided by your doctor or pharmacist.
The correct dose is the lowest effective dose required to produce easy evacuation of soft stools.
The recommended dose for an enema is the entire contents of the bottle, preferably administered in the evening.
Initially, use the recommended dose. Do not exceed the advised dose.
If in doubt, consult your doctor or pharmacist.
A diet rich in fluids enhances the effect of the medicine.

Method of administration
For correct use of the product, it is recommended to administer Macrolax by introducing it into the rectum while lying on your side (see below).

Medical illustration showing two steps: removing the cannula cap from the vial and inserting the vial into the rectum by pressing to expel the contents

Duration of treatment
This medicine, like all laxatives, should be used as infrequently as possible and for no longer than seven days. Use for longer periods requires appropriate medical evaluation and prescription by a doctor.

If you use more Macrolax than you should
Excessive doses may cause abdominal pain and diarrhoea, which can lead to loss of water and electrolytes (see information in section “Warnings and precautions” regarding laxative abuse). If diarrhoea occurs, drink plenty of fluids.
In case of accidental ingestion or overdose of Macrolax, contact your doctor immediately or go to the nearest hospital. Bring this leaflet with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Occasionally, cramp-like or colicky abdominal pain may occur, which is more frequent in cases of severe constipation.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the website: http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Macrolax

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.

6. Package contents and other information

What Macrolax contains
In 120 ml of Macrolax rectal solution 36 g + 0.24 g:

  • The active substances are liquid non-crystallizable sorbitol 36 g and sodium docusate 0.24 g.
  • The other components are methyl p-hydroxybenzoate, purified water.

Description of Macrolax and package contents
Macrolax is a rectal solution supplied in 1 bottle of 120 ml made of low-density polyethylene, with an attached cannula.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
DMS Farmaceutici S.p.A. - Via Provinciale per Lecco, 78 - 22038 Tavernerio (CO)