GLYCERINE GIFRER 25 SUPPOSITORIES ADULT

NOTICE

ANSM - Last updated: 12/11/2013

Name of the medicinal product

SUPPLEMENTARY TO GLYCERINE GIFRER ADULTS, suppository

Glycerol

framed

Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist, consult a physician.

· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Review summary

In this notice :

1. WHAT SUPPOSITORY TO GLYCERINE GIFRER ADULTS, suppository AND WHAT IT IS USED FOR?

2. BEFORE YOU USE SUPPOSITORY FOR GLYCERINE GIFRER ADULTS, suppository?

3. HOW TO USE SUPPOSITORY WITH GLYCERIN GIFRER ADULTS, suppository?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE SUPPOSITORY FOR GLYCERINE GIFRER ADULTS, suppository?

6. ADDITIONAL INFORMATION

1. WHAT SUPPOSITORY TO GLYCERINE GIFRER ADULTS, suppository AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

Laxative rectally.

(A: Digestive System and Metabolism)

Therapeutic indications

This medication is recommended in certain forms of constipation and as preparation for certain examinations (rectoscopy).

2. BEFORE YOU USE SUPPOSITORY FOR GLYCERINE GIFRER ADULTS, suppository?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not use SUPPOSITORY WITH GLYCERINE GIFRER ADULT, suppository:

· If you are allergic to glycerol or any of the other ingredients in the suppository;

· If you have obstructive colopathy, given the laxative effect of the drug.

· If you have abdominal pain syndrome of indeterminate and inflammatory cause (ulcerative colitis, Crohn's disease, ...).

Precautions for use; special warnings

Take special care with GLYCERINE GIFRER ADULT SUPPOSITORY, suppository:

Take special precautions with GLYCERINE GIFRER ADULT SUPPOSITORY, suppository:

Special warnings

NO PROLONGED USE WITHOUT MEDICAL ADVICE.

Occasional constipation:

It may be related to a recent change in lifestyle (travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.

Chronic constipation (long-term constipation):

It can be linked to two causes:

· a disease of the intestine that requires treatment by the physician,

· or an imbalance in intestinal function due to dietary habits and lifestyle.

Treatment includes:

· an increase in dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruit ...),

· an increase in the consumption of water and fruit juices,

· an increase in physical activities (sports, walking ...),

· a rehabilitation of the defecation reflex,

· sometimes, adding sound to the diet.

It is helpful to seek advice from your doctor or pharmacist.

Precautions for use

· If you have a colic disease, an anal fissure or a hemorrhagic ulcer;

· When you have a hemorrhoidal attack.

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

NEVER LEAVE TO CHILDREN

Interaction with other medicines

Use of other medicines

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your pharmacist.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

This medication should be used with caution during pregnancy and lactation.

In general, you should seek advice from your doctor or pharmacist before taking any medication.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Not applicable.

3. HOW TO USE SUPPOSITORY WITH GLYCERIN GIFRER ADULTS, suppository?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

· Treatment of low constipation:
1 to 2 suppositories per day to get one saddle per day.

· Preparation for endoscopic examination of the rectum:
1 suppository 5 to 30 minutes before the time chosen for the exemption.

Method and route of administration

The suppository can be soaked in cold water to facilitate its introduction.

Symptoms and Instructions for Overdose

If you used more SUPPOSITORY TO GLYCERINE GIFRER ADULT, suppository you should have:

Risk of proctitis and / or diarrhea.

Decrease the dose or discontinue your treatment. Consult your doctor or pharmacist.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines SUPPOSITORY TO GLYCERINE GIFRER ADULT, suppository is likely to have undesirable effects, although not everybody is subject to it: sensation of anal burns.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system : National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE SUPPOSITORY FOR GLYCERINE GIFRER ADULTS, suppository?

Keep this medicine out of the reach and sight of children.

Expiration date

Do not use SUPPOSITORY WITH GLYCERINE GIFRER ADULT, suppository after the expiry date stated on the outer packaging.

Storage conditions

Store at a temperature not exceeding 25 ° C.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What contains SUPPOSITORY FOR GLYCERINE GIFRER ADULT, suppository?

The active substance is:

Glycerol ................................................. .................................................. ......................................... 1.98 g

For suppository

The other components are:

Gelatin, purified water.

Pharmaceutical form and content

What is GLYCERINE GIFRER ADULT, suppository and contents of the outer packaging?

This medication is in the form of a suppository. Bags (Polyester / PE) of 25, 50 and 100 suppositories. Blister pack (PVC / PE): box of 10, 20, 60 and 100 suppositories.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

GIFRER BARBEZAT

8 to 10 rue Paul Bert

69150 Décines-CHARPIEU

exploiting

GIFRER BARBEZAT

8 - 10 rue Paul Bert

69153 Décines CEDEX

Maker

GIFRER BARBEZAT

8 - 10 rue Paul Bert

69153 Décines CEDEX

or

PHARMACEUTICAL PRODUCTION AND HYGIENE PRODUCTION COMPANY - SPPH

7, impasse of the Boussenots

21800 QUETIGNY LES DIJON

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the Ansm website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

VIDAL OF THE FAMILY

GLYCERINE GIFRER SUPPOSITORIES