NOTICE
ANSM - Last updated: 03/08/2017
Name of the medicinal product
SEDORRHOIDE CRISIS HEMORROIDAIRE, rectal cream
Dodeclonium bromide, esculoside sesquihydrate, enoxolone, benzocaine
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 7 days.
What is in this leaflet?
1. What is SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream and in which cases is it used?
2. What should I know before using SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream?
3. How to use SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream?
4. What are the possible side effects?
5. How to keep SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream?
6. Package contents and other information.
1. WHAT IS SEDORRHOIDE CRISIS HEMORROIDAIRE, rectal cream AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: TOPIC IN PROCTOLOGY (C: cardiovascular system) - ATC code: C05A - Medicines for the treatment of hemorrhoids and anal fissures for topical use.
This medication is recommended in the hemorrhoidal crisis.
2. WHAT TO DO ABOUT BEFORE USING SEDORRHOIDE HEMORROID CRISIS, rectal cream?
Never use SEDORRHOIDE HEMORROIDAIRE CRISIS, rectal cream:
· Allergy known to benzocaine (anesthetic).
Warnings and Precautions
Special warnings
Treatment should be short-term. If the pain does not give up quickly, consult your doctor immediately.
It is necessary to seek medical advice before use in children.
The presence of benzocaine in this medication can cause methemoglobinemia (excessive amount of certain pigments making up red blood cells, altering blood oxygenation).
This medicinal product contains cetostearyl alcohol and may cause local skin reactions (eg eczema).
NEVER LEAVE TO CHILDREN'S SCOPE
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
children
Not applicable.
Other medicines and SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
SEDORRHOIDE HEMORROIDAIRE CRISIS, rectal cream with food and beverages
Not applicable.
Pregnancy and breast feeding
It is best not to use this medication during pregnancy and lactation. If you discover that you are pregnant, consult your doctor, alone can judge the need to continue treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
SEDORRHOIDE HEMORROIDAIRE CRISIS, rectal cream contains cetostearyl alcohol.
3. HOW TO USE SEDORRHOIDE HEMORROIDAIRE CRISIS, rectal cream?
Dosage
2 to 3 applications per day.
Method and route of administration
Rectal route.
Duration of treatment
Treatment should be short-term (maximum 7 days).
If you used more SEDORRHOIDE HEMORROIDAIRE CRISIS, rectal cream than you should have
No cases of overdose have been reported, however excessive use may lead to exacerbation of adverse effects.
If you forget to use SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream
Not applicable.
If you stop using SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all drugs, SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream is likely to have unwanted effects, although not everyone is subject to:
· Possible allergic reactions to any of the components, and especially local skin reactions.
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 via 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 SEDORRHOIDE HEMORROID CRISIS, rectal cream?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require special precautions for storage.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What SEDORRHOIDE contains HEMORROIDAIRE CRISIS, rectal cream
· The active substances are:
Dodeclonium bromide ............................................... .................................................. 0.40 g
Esculoside sesquihydrate ................................................ ................................................. 0.46 g
Enoxolone ................................................. .................................................. .................... 0.93 g
Benzocaine ................................................. .................................................. ................... 2.40 g
For 100 g of rectal cream.
· The other components are: Emulgade F *, Octyldodecanol (Eutanol G), purified water.
* Composition of emulgade F: cetostearyl alcohol, sodium cetostearylsulfate, emulgator (ethoxylated fatty acids of vegetable origin).
What is SEDORRHOIDE CRISE HEMORROIDAIRE, rectal cream and contents of the pack
This medication is in the form of a rectal cream.
Tube of 30 g.
Marketing Authorization Holder
FRENCH PHARMACEUTICAL COOPERATION
Place Lucien Auvert
77020 MELUN CEDEX
Marketing Authorization Operator
FRENCH PHARMACEUTICAL COOPERATION
Place Lucien Auvert
77020 MELUN CEDEX
Maker
FRENCH PHARMACEUTICAL COOPERATION
Place Lucien Auvert
77020 MELUN CEDEX
or
FRENCH PHARMACEUTICAL COOPERATION
2 rue de la Saussaie
77310 SAINT FARGEAU PONTHIERRY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
July 2017
Other
Detailed information on this medicine is available on the ANSM website (France).
ADVICE / HEALTH EDUCATION
What is Hemorrhoids and the Hemorrhoid Crisis?
Hemorrhoids are veins located at the level of the anal area (anus, rectum, and surrounding tissue). They are normal and painless anatomical structures, which have a pathological aspect only when they evolve towards a haemorrhoidal disease.
Problems arise when a hemorrhoidal attack occurs, caused by abnormal dilation of these veins.
These dilated hemorrhoids can then be externalized to form a kind of "ball" at the level of the anus. This hemorrhoidal crisis results in a greater or lesser discomfort. Itching, irritation, and small bleeding during or after stools (found on toilet paper or underwear) are the trio of symptoms common to hemorrhoids. Generally, the hemorrhoidal crisis is not of a serious nature and must be regressed within a few days.
Warning :
If symptoms persist, it is necessary to consult. Pain and bleeding can be signs of complications or even a more serious illness that only your doctor will be able to diagnose and treat.
To avoid :
In general, any excessive pressure exerted on the haemorrhoidal veins may cause congestion. It is therefore necessary to avoid:
· Disorders of the intestinal transit: constipation leads to repeated pushing efforts; diarrhea or irritant laxatives cause irritation of the mucous membranes;
· Foods that can promote congestion of the hemorrhoid veins and therefore the onset of the crisis: alcohol, spices.