In this manual :
1. WHAT IS SEDORRHOIDE HEMORROIDIC CRISIS, suppository AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING SEDORRHOID HEMORROID CRISIS, suppository
3. HOW TO USE SEDORRHOID HEMORROID CRISIS, suppository?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE SEDORRHOIDE HEMORROID CRISIS, suppository?
6. ADDITIONAL INFORMATION
1. WHAT IS SEDORRHOIDE HEMORROID CRISIS, suppository AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is an anti-inflammatory and a local anaesthetic.
This medicine is recommended in certain anal pathologies accompanied by pain and/or itching and in particular in the hemorrhoidal crisis.
2. WHAT YOU SHOULD KNOW BEFORE USING SEDORRHOIDE HEMORRHOIDARY CRISIS, suppository
List of information needed before taking the medicine
Not applicable.
Never use SEDORRHOID HEMORROIDIC CRISIS suppository in the following cases:
- allergy to benzocaine.
Precautions for use; special warnings
Be careful with SEDORRHOID HEMORROIDIC CRISIS, suppository:
Cautionary note
Treatment should be short-term. If the pain does not subside quickly, consult your doctor immediately.
Interactions with other medicines
Taking or using other medications
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
It is better not to use this medicine during pregnancy and breastfeeding. If you discover that you are pregnant, consult your doctor.
In general, it is advisable to ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
This medicine contains an active substance (benzocaine, a local anaesthetic) which may cause a positive reaction in tests carried out during doping controls.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO USE SEDORRHOIDE HEMORRHOIDIC CRISIS, suppository
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 suppositories per day.
Method and route of administration
Rectal route.
Symptoms and instructions in case of overdose
If you have used more SEDORRHOIDE HEMORROIDIC CRISIS suppository than you should have:
Excessive use may result in worsening of 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, suppository is likely to have undesirable effects, although not everyone is subject to them, including
- possible allergic reactions to any of the components.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE SEDORRHOIDE HEMORROIDIC CRISIS, suppository
Keep out of the reach and sight of children.
Do not use SEDORRHOID HEMORROIDIC CRISIS after the expiry date stated on the outer packaging.
No special storage conditions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does SEDORRHOIDE HEMORROIDIC CRISIS, suppository contain?
The active substances are:
Dodeclonium bromide ................................................................................................................... 1.3 mg
Esculoside sesquihydrate .................................................................................................................. 6.0 mg
Enoxolone ...................................................................................................................................... 23.0 mg
Benzocaine .................................................................................................................................... 50.0 mg
For one suppository.
Other components are:
Solid hemi-synthetic glycerides.
Pharmaceutical form and content
What is SEDORRHOIDE HEMORROIDIC CRISIS, suppository and what does it contain?
This medicine is in the form of a suppository. Box of 8 suppositories.
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 CEDEX
Manufacturer
HAUPT PHARMA LIVRON
1, RUE COMTE DE SINARD
26250 LIVRON
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the Afssaps website (France).
Information for health professionals only
Not applicable.