In this manual :
1. WHAT IS SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING SEDORRHOIDE HEMORROID CRISIS, rectal cream
3. HOW DO I USE SEDORRHOID HEMORROIDIC CRISIS, rectal cream?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE SEDORRHOIDE HEMORROID CRISIS, rectal cream?
6. ADDITIONAL INFORMATION
1. WHAT IS SEDORRHOIDE HEMORROID CRISIS, rectal cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
TOPICAL IN PROCTOLOGY
(C: Cardiovascular system)
This medicine is an anti-inflammatory and a local anesthetic. This medicine is recommended in certain anal pathologies accompanied by pain and/or itching and in particular in haemorrhoidal crisis.
2. WHAT YOU SHOULD KNOW BEFORE USING SEDORRHOIDE HEMORRHOIDARY CRISIS, rectal cream
List of information needed before taking the medicine
Not applicable.
Never use SEDORRHOID HEMORROIDIC CRISIS, rectal cream in the following cases:
- Known allergy to benzocaine (anesthetic)
IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Use caution with SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream:
Special Warnings
Treatment should be short-term. If the pain does not subside quickly, consult your doctor immediately.
This medicine contains cetostearyl alcohol and may cause local skin reactions (e.g. eczema).
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
It is preferable not to use this medicine during pregnancy and breastfeeding. If you discover that you are pregnant, consult your doctor, who is the only person who can decide whether you should continue treatment.
Ask your doctor or pharmacist for advice before taking any medication.
This medicine contains an active substance which may cause a positive reaction in tests carried out during doping controls.
Effects on the ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: cetostearyl alcohol.
3. HOW TO USE SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
2 or 3 applications per day.
Method and route of administration
Rectal route.
Symptoms and instructions in case of overdose
If you have used more SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream than you should have
No cases of overdose have been reported, however, excessive use may result in an exacerbation of the adverse effects.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream may have adverse reactions, although not everyone is susceptible:
- possible allergic reactions to any of the components, and in particular local skin reactions.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream
Keep out of the reach and sight of children.
Do not use SEDORRHOIDE HEMORROIDIC CRUISE rectal cream after the expiry date stated on the outer packaging.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream contain?
The active ingredients are
Dodeclonium bromide .................................................................................................................... 0.40 g
Esculoside sesquihydrate ................................................................................................................... 0.46 g
Enoxolone ......................................................................................................................................... 0.93 g
Benzocaine ....................................................................................................................................... 2.00 g
Per 100 g of rectal cream.
Other components are:
Emulgade F(1), Octyldodecanol (Eutanol G), purified water.
(1)Composition of Emulgade F: Cetostearyl alcohol, Sodium ketostearyl sulphate, Emulgator (ethoxylated fatty acids of vegetable origin).
Pharmaceutical form and content
What is SEDORRHOIDE HEMORROIDIC CRISIS, rectal cream and what does it contain?
This medicine is presented as a rectal cream.
Tube of 30 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Operator
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN
Manufacturer
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
or
COOPERATION PHARMACEUTIQUE FRANCAISE
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.