NOTICE
ANSM - Updated on : 05/04/2023
Product name
PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet
Phloroglucinol
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. 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.
What does this leaflet contain?
1. What is PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet and what is it used for?
2. What do I need to know before taking PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet?
3. How do I take PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet?
4. What are the possible side effects?
5. How do I keep PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet?
6. Package contents and other information.
1. WHAT IS PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: A03AX12.
PHLOROGLUCINOL BIOGARAN belongs to a class of drugs known as antispasmodics. It acts against spasms (contractions).
It is indicated in adults for the treatment of spasmodic pain of the bowel, biliary tract, bladder and luteus.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet?
Never take PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet:
- if you are allergic to phloroglucinol or any of the other ingredients listed in section 6.
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of daspartam.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking PHLOROGLUCINOL BIOGARAN.
Children and adolescents
This medicine is intended for adults only.
Other medicines and PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore taking this medicine.
Use of this drug during pregnancy should be considered only if necessary.
This drug should not be used by women who are breast-feeding.
Driving and use of machinery
PHLOROGLUCINOL BIOGARAN has no or negligible effect on the ability to drive and use machines.
PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet contains laspartam and glucose.
Laspartam contains a source of phenylalanine. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by the accumulation of phenylketonuria which cannot be eliminated properly.
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
3. HOW DO I TAKE PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
PHLOROGLUCINOL BIOGARAN is a symptomatic treatment. The duration of treatment varies according to the indication. If symptoms persist, consult your doctor.
Take 1 orodispersible tablet at the time of the attack. Repeat in the event of severe spasms, observing a minimum interval of 2 hours between each dose, without exceeding 3 orodispersible tablets per day.
Oral administration.
Orodispersible tablets dissolve easily in water or saliva.
You can either :
- or dissolve the orodispersible tablet in a glass of water,
- or let it melt under the tongue for a rapid effect.
Use in children and adolescents
This dosage is not suitable for children.
If you have taken more PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet than you should have
Consult your doctor or pharmacist immediately.
If you forget to take PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Undetermined frequency:
- an extensive scaly red rash with masses under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).
If you develop these symptoms, stop using this medicine and contact your GP or consult a doctor immediately.
In some cases, an allergy may occur.
You'll recognize the signs of an allergy:
- by pimples and/or redness of the skin, itching,
- by sudden swelling of the face and neck (angioedema),
- or sudden malaise due to a drop in blood pressure (anaphylactic shock).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box or blister.
No special storage precautions are required.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PHLOROGLUCINOL BIOGARAN 160 mg orodispersible tablet contains
- The active substance is :
Phloroglucinol..................................................................................................................... 160 mg
For 1 orodispersible tablet.
- The other components are :
Microcrystalline cellulose, mannitol, crospovidone, aspartam (E 951), orange flavouring (orange bark extract and other flavouring substances, glucose, maltodextrin and gum arabic), magnesium stearate.
What PHLOROGLUCINOL BIOGARAN 160 mg, orodispersible tablet is and what it contains
This medicine comes in the form of an orodispersible tablet.
Box of 5 or 10 tablets.
Not all presentations may be marketed.
Marketing authorization holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
LABORATOIRES BTT
Z.I. DE KRAFFT
67150 ERSTEIN
Product 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].
Other
Detailed information on this drug is available on the ANSM (France) website.