GLYCILAX

GLYCILAX Suppositories for children

Important notes (mandatory information)

Glycilax for children, suppositories. Active ingredient: Glycerol. Areas of application: for relieving constipation and painful bowel movements.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Glycilax for children, suppositories
Active ingredient: Glycerol 85%/0.75 g per suppository

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 10 days, contact your doctor or pharmacist.

What this package leaflet contains

1. WHAT IS GLYCILAX FOR CHILDREN AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING GLYCILAX FOR CHILDREN?
3. HOW TO USE GLYCILAX FOR CHILDREN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GLYCILAX FOR CHILDREN?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS GLYCILAX FOR CHILDREN AND WHAT IS IT USED FOR?

Glycilax for children belongs to the group of laxatives (medicines for constipation). Glycilax for children is used to relieve constipation and painful bowel movements. If you do not feel better or even worse after 10 days, contact your doctor.

2. WHAT YOU NEED TO KNOW BEFORE USING GLYCILAX FOR CHILDREN?

Glycilax for children must not be used:

• if your child is hypersensitive (allergic) to the active ingredient or any of the other ingredients listed in section 6.
• if there is an intestinal obstruction.

Warnings and precautions

Please talk to your doctor or pharmacist before using Glycilax for children. If you have unclear abdominal pain (e.g. if you suspect appendicitis), you should consult a doctor. Further instructions for using Glycilax for children Constipation can be the result of incorrect dietary or lifestyle habits (e.g. too little exercise, lack of fluid intake, low-fibre diet). Constipation should only be treated with medication if dietary measures or lifestyle changes have not been sufficiently successful.

Using Glycilax for children together with other medicines

The absorption of other medicines that are used rectally at the same time may be reduced by Glycilax for children. Therefore, use other suppositories or enemas at different times. Please inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before using this medicine. There are no known reports of harmful effects in humans when used as directed during pregnancy and breast-feeding.

Driving and using machines
No special precautions are necessary.

3. HOW TO USE GLYCILAX FOR CHILDREN?

Always use this medicine exactly as described in the package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Insert 1 - 2 suppositories as needed.

Method of administration

For rectal use. If necessary, infants are given 1 suppository (corresponding to 0.75 g glycerol 85%) inserted into the anus. Children are given 1 - 2 suppositories (corresponding to 0.75 - 1.5 g glycerol 85%) inserted into the anus. In cases of persistent constipation, one additional suppository can be inserted at a time. The suppositories should be stored cool or, if necessary, briefly held under cold water in the foil before use.

1. Separate one suppository strip from the foil.
2. To remove, pull the foil sheets apart above the tip of the suppository.
3. Insert the suppository with the pointed end as deeply as possible into the anus and leave it in place for at least 1 hour.

Duration of use

In case of persistent or prolonged constipation, it is advisable to consult a doctor who will then decide on further treatment. There is no data on efficacy and safety for use beyond 10 days. Please talk to your doctor or pharmacist if you have the impression that the effect of Glycilax for children is too strong or too weak.

If you have used more Glycilax for children than you should

Increased urge to defecate, possibly diarrhoea and, if necessary, irritation in the anal area may occur.

If you forget to use Glycilax for children

Glycilax for children is normally used as needed. Long-term or regular use should only be done after consultation with a doctor. In this case, you should make up for a missed application and continue the therapy as discussed.

If you stop using Glycilax for children

Please follow the instructions for use, otherwise Glycilax for children will not work properly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Gastrointestinal disorders

Very rarely, irritation of the rectal mucosa may occur in particularly sensitive persons or in the case of damaged mucosa.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GLYCILAX FOR CHILDREN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of the month indicated. Do not store above 25°C!

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What is Glycilax for children?
The active ingredient is glycerol 85%. 1 suppository contains 0.75 g glycerol 85%. The other ingredients are: Light basic magnesium carbonate, hard fat, bleached wax, cetomacrogol 1000.

What Glycilax for children looks like and contents of the pack

The suppositories are white, smooth and torpedo-shaped. Glycilax for children is available in packs of 6 (N 1) and 12 (N 2) suppositories.

Pharmaceutical entrepreneur and manufacturer

Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3
61138 Niederdorfelden
Tel.: 06101 / 539 - 300
Fax: 06101 / 539 - 315
Internet: www.engelhard-am.de
E-Mail: info@engelhard-am.de

This package leaflet was last revised in March 2014.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: Glycerol. Areas of application: for relieving constipation and painful bowel movements.