Dicynone 250mg 6 vials is an injectable solution indicated in case of bleeding caused by the fragility of small blood vessels , gynecological bleeding or in case of surgery to reduce blood loss .
This medicine is indicated in the treatment of bleeding caused by the fragility of small blood vessels , it is also indicated in gynecological bleeding, in the event of surgery to reduce blood loss .
It is an antihaemorrhagic and vasculoprotective.
The active substance of this drug is etamsylate dosed at 250 mg for one ampoule.
The formula also contains a dilute solution of monosodium sulphite corresponding to 0.8 mg of sulfur dioxide, sodium bicarbonate, water for injections, for one 2 ml ampoule.
For adults, the recommended dosage is:
For infants and children, the dosage observes the same therapeutic scheme as the adult, decreasing it by half.
This injectable solution can be used orally (diluted in half a glass of water), but also locally in tamponades.
In all cases, it is necessary to strictly respect the indications of the prescription provided by the doctor concerning the dosage, the frequency of administration as well as the duration of the treatment.
Comment on the advice for use and dosage of Dicynone 250mg 6 vials with our partner Avis checked after your purchase .
Etamsylate.............. 250.00 mg
Diluted solution of monosodium sulphite, sodium bicarbonate, water for injections.
What are the side effects and contraindications ?
This injectable solution should not be used in case of intolerance or allergy to etamsylate or any of its components.
It contains sulphites which can cause a generalized allergic reaction.
If a fever is felt, treatment should be stopped, and you should consult your doctor immediately.
Inform your doctor or pharmacist of any other current or recent treatment, in order to avoid possible drug interactions.
Inform your doctor in case of pregnancy.
This treatment is not recommended during breastfeeding.
Always seek the advice of a healthcare professional before taking any medication, especially if you are pregnant or breastfeeding.
The excipient knowledge of which is important for safe use in some patients is sodium sulphite.
Presentation - Packaging
Dicynone 250 mg is available in our online pharmacy in a box of 6 vials.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 29/01/2025
Product name
DICYNONE 250 mg/2 ml, solution for injection
etamsylate
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and 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 do not feel any improvement or if you feel less well.
Keep out of the reach of children.
What does this leaflet contain?
1. What is DICYNONE 250 mg/2 ml, solution for injection and what is it used for?
2. What do I need to know before using DICYNONE 250 mg/2 ml, solution for injection?
3. How do I use DICYNONE 250 mg/2 ml, solution for injection?
4. What are the possible side effects?
5. How do I keep DICYNONE 250 mg/2 ml, solution for injection?
6. Package contents and other information.
1. WHAT IS DICYNONE 250 mg/2 ml, solution for injection AND WHAT IS IT USED FOR?
OTHER SYSTEMIC HEMOSTATIC - ATC code: B02BX01
This drug is an antihaemorrhagic and vasculoprotective agent.
It is recommended:
- in the treatment of bleeding due to fragility of small blood vessels and in gynecological bleeding,
- to reduce blood loss during surgery.
2. WHAT DO I HAVE TO KNOW BEFORE USING DICYNONE 250 mg/2 ml, solution for injection?
Never use DICYNONE 250 mg/2 ml, solution for injection:
- If you are allergic (hypersensitive) to the active substance (etamsylate) or to any of the other components of this medicine, as listed in section 6.
Warnings and precautions
- This medicine contains "sulfite" and may cause severe allergic reactions and respiratory discomfort.
- If you develop a fever or skin reaction, stop taking this medicine and consult your doctor immediately.
- This drug is generally not recommended in cases of blood disorders affecting hemoglobin (acute porphyria).
- Blood tests: tell your doctor if you are taking Dicynone and need to have a blood test, as it may cause your blood creatinine level to be lower than usual.
- Please inform your doctor or pharmacist if you are going to undergo any medical examinations: during treatment with detamsylate, the sample (e.g. blood test) required for laboratory tests should be taken before the first daily administration of the drug to minimize any potential interaction of detamsylate with laboratory tests.
Other drugs and DICYNONE 250 mg/2 ml, solution for injection
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DICYNONE 250 mg/2 ml, solution for injection with food and drink
Not applicable.
Pregnancy and breast-feeding
Data on the use of Dicynone in pregnant women are limited. As a precautionary measure, Dicynone should not be used during pregnancy.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding is not recommended during treatment.
Sportsmen
Not applicable.
Driving and use of machinery
Not applicable.
DICYNONE 250 mg/2 ml, solution for injection contains: sodium sulfite.
3. HOW TO USE DICYNONE 250 mg/2 ml, solution for injection
Dosage
Adults:
- in emergencies: 2 to 3 ampoules, three times a day, I.V. or I.M.
- pre-operatively: 1 hour before surgery, 2 vials I.V. or I.M.
- intra-operatively: on demand.
- post-operatively: 1 ampoule I.V. or I.M., 2 times a day.
Use in children
Infants and children: same treatment regimen as for adults, reducing dosage by half.
N.B.: the injectable solution can be used:
- orally: diluted in half a glass of water,
- locally: as dabs.
Method of administration
By injection.
To open the ampoule: Hold the ampoule firmly, with the coloured dot facing you (diagram 1). Grasp the ampoule head between thumb and forefinger (thumb over colored dot), then press backwards (diagrams 2 and 3).
If you have taken more DICYNONE 250 mg/2 ml, solution for injection than you should have :
Not applicable.
If you forget to take DICYNONE 250 mg/2 ml, solution for injection :
Not applicable.
If you stop taking DICYNONE 250 mg/2 ml, solution for injection :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- nausea, vomiting, diarrhea,
- rash of pimples and/or patches on the skin,
- fever,
- headache,
- severe decrease in the number of white blood cells (agranulocytosis)
- decrease in the number of white blood cells (neutropenia)
- allergic reactions, ranging from a rash of pimples and/or patches on the skin to a more severe reaction (anaphylactic shock) with malaise and severe drop in blood pressure and/or breathing difficulties (bronchospasm).
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE DICYNONE 250 mg/2 ml, solution for injection?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
After opening: use immediately.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DICYNONE 250 mg/2 ml, solution for injection contains
- The active substance is :
Etamsylate..................................................................................................................... 250 mg
for one ampoule.
- The other excipient components are :
Diluted monosodium sulfite solution, sodium bicarbonate, water for injection.
What DICYNONE 250 mg/2 ml solution for injection is and what it contains
This medicine comes in the form of a solution for injection in ampoules.
Box of 6 or 50 ampoules.
Marketing authorization holder
OMEDICAMED Unipessoal Lda
Avenida António Augusto de Aguiar nº 19 4º
1050-012 Lisboa
Portugal
Marketing authorization holder
FOSUN PHARMA SAS
ZONE DACTIVITE LA BALME
2 RUE DES PYRENEES
31450 BELBERAUD
FRANCE
Manufacturer
DELPHARM DIJON
6, BOULEVARD DE L'EUROPE
21800 QUETIGNY
FRANCE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is :
to be completed subsequently by the holder
Other
Not applicable.
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