NOTICE
ANSM - Updated on : 05/07/2023
Name of medicinal product
DOMILA, suppository
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided 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 after 3 days.
What does this leaflet contain?
1. What is DOMILA suppository and what is it used for?
2. What do I need to know before using DOMILA, suppository?
3. How do I use DOMILA suppository?
4. What are the possible side effects?
5. How should DOMILA suppositories be stored?
6. Package contents and other information.
1. WHAT IS DOMILA, suppository AND WHAT IS IT USED FOR?
DOMILA suppository is a homeopathic medicine traditionally used to treat teething troubles (pain, fever, restlessness) in infants and children aged 3 months and over.
2. WHAT DO I HAVE TO KNOW BEFORE USING DOMILA, suppository?
Never use DOMILA, suppository:
- If your child is allergic to any of the active ingredients or to any of the other ingredients listed in section 6.
- If your child is less than 3 months old.
- If your child has a recent history of lesions of the anus or rectum, due to the route of administration.
Warnings and precautions
Talk to your doctor or pharmacist before using DOMILA suppository.
- A single bout of teething rarely causes a temperature above 38°C. In the event of fever (temperature above 38°C), it is advisable to consult a doctor:
o if the fever persists for more than 2 days in a child aged between 3 months and 2 years,
o if fever persists for more than 3 days in children over 2 years of age.
- This medicine is intended to relieve fever and pain, and is not intended to significantly lower body temperature, nor to treat the condition that may be causing the fever. If the fever persists for more than 2 or 3 days, depending on your child's age (see section 3 "HOW TO USE DOMILA, suppository"), or if there is no improvement or any other sign, consult a doctor.
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- In case of diarrhea, the suppository form is not suitable.
Children and adolescents
This medicine is intended for infants and children aged 3 months and over.
Other medicinal products and DOMILA, suppository
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines.
DOMILA, suppository with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
Not applicable.
Driving and use of machinery
Not applicable.
DOMILA suppository contains solid hemisynthetic glycerides, powdered cellulose and lactose monohydrate (dilution vehicle).
3. HOW TO USE DOMILA, suppository?
DOMILA, suppository is indicated for infants and children aged 3 months and over.
The recommended dose is 1 to 2 suppositories per day.
The duration of treatment should not exceed 3 days without medical advice.
This medicine is to be administered rectally.
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Detach suppository
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Open by pulling apart the two edges
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Insert the suppository through the flat end (to avoid rejection)
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If you have used more DOMILA suppository than you should have
Consult your doctor or pharmacist immediately.
If you forget to use DOMILA, suppository
Do not use a double dose to make up for the one you have forgotten.
If you stop using DOMILA, suppository
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE DOMILA, suppository?
Keep out of sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiration date indicated on the packaging and the blister. The expiration date refers to the last day of that month.
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. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DOMILA suppository contains
- The active ingredients are :
Argentum metallicum 19DH......................................................................................... 20 mg
Belladonna 3DH......................................................................................................... 20 mg
Chamomilla vulgaris, radix, decocted 2DH..................................................................... 20 mg
Echinacea angustifolia TM........................................................................................ 270 mg
Gelsemium sempervirens, decocted 4DH...................................................................... 20 mg
For a 1 g suppository.
- Other ingredients: solid hemi-synthetic glycerides, powdered cellulose, lactose monohydrate (dilution vehicle).
What DOMILA suppository is and what it contains
This medicine comes in suppository form.
Box of 6 suppositories.
Marketing authorization holder
LABORATOIRE WELEDA SA
9 RUE EUGENE JUNG
68330 HUNINGUE
Marketing authorization holder
LABORATOIRE WELEDA SA
9 RUE EUGENE JUNG
68330 HUNINGUE
Manufacturer
LABORATOIRE WELEDA SA
9 RUE EUGENE JUNG
68330 HUNINGUE
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{MM/YYYY}
Other
Detailed information on this drug is available on the ANSM (France) website.