GLYCILAX

GLYCILAX Suppositorien für Erwachsene

Important notes (mandatory information)

Glycilax for adults. Active ingredient: Glycerol 85%. Areas of application: for laxative use in case of 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 adults
Active ingredient: Glycerol 85%/1 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 ADULTS AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING GLYCILAX FOR ADULTS?
3. HOW TO USE GLYCILAX FOR ADULTS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GLYCILAX FOR ADULTS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Glycilax for adults belongs to the group of laxatives (medicines for constipation). Glycilax for adults is used for laxative use in case of 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 ADULTS?

Glycilax for adults must not be used:

• if you are allergic to the active substance or any of the other ingredients listed in section 6.
• if you have an intestinal obstruction.

Warnings and precautions

Please talk to your doctor or pharmacist before using Glycilax for adults. If you have unclear abdominal pain (e.g. if you suspect appendicitis), you should consult a doctor. If Glycilax for adults and condoms are used at the same time, the tear resistance may be reduced and thus the safety of condoms may be impaired.

Further information on the use of Glycilax for adults

Constipation can be the result of incorrect dietary or lifestyle habits (e.g. too little exercise, lack of fluid intake, low-fibre diet). Medicinal treatment of constipation should only be used if dietary measures or lifestyle changes have not been sufficiently successful.

Use of Glycilax for adults together with other medicines

The absorption of other drugs that are used rectally during the same period may be reduced by Glycilax for adults. 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. Reports of harmful effects when used as directed during pregnancy and breast-feeding are not known in humans.

Driving and using machines

No special precautions are required.

3. HOW TO USE GLYCILAX FOR ADULTS?

Always use this medicine exactly as described in this 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. Adults insert 1 - 2 suppositories (corresponding to 1 - 2 g glycerol 85%) into the anus as needed. In case of persistent constipation, another suppository can be inserted. The suppositories should be stored cool or, if necessary, kept briefly 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 are no data on efficacy and safety for a period of use exceeding 10 days. Please talk to your doctor or pharmacist if you have the impression that the effect of Glycilax for adults is too strong or too weak.

If you have used more Glycilax for adults than you should

Increased urge to defecate up to diarrhoea and possibly irritation in the anal area may occur.

If you forget to use Glycilax for adults

Glycilax for adults 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 forgotten application and continue the therapy as discussed.

If you stop using Glycilax for adults

Please follow the instructions for use, otherwise Glycilax for adults may 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 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 ADULTS?

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

What Glycilax for adults looks like and contents of the pack

The suppositories are white and smooth and have a torpedo shape. Glycilax for adults is available in packs of 6 (N 1) and 12 (N 2) suppositories.

Pharmaceutical entrepreneur and manufacturer

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

This leaflet was last revised in March 2014.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Glycerol 85%. Areas of application: for laxative use in case of constipation and painful bowel movements.