NOTICE
ANSM - Updated on : 23/11/2021
Product name
PHLOROGLUCINOL VIATRIS 80 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 VIATRIS 80 mg, orodispersible tablet and what is it used for?
2. What do I need to know before taking PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet?
3. How do I take PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet?
4. What are the possible side effects?
5. How do I keep PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet?
6. Package contents and other information.
1. WHAT IS PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Musculotropic antispasmodics - ATC code: A03AX12 (A: digestive system and metabolism) (G: genitourinary system).
PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet belongs to a class of medicines known as antispasmodics. It acts against spasms (contractions).
It is indicated for the treatment of spasmodic pain of the intestine, biliary tract, bladder and uterus.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet?
Never take PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet:
- if you are allergic to phloroglucinol or any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet.
Children and adolescents
Not applicable.
Other medicines and PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
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.
Pregnancy
This drug should be used during pregnancy only if necessary.
Breast-feeding
This drug should not be administered to nursing mothers.
Driving and use of machinery
PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet has no or negligible effect on the ability to drive and use machines.
PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet contains laspartam and lactose.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
This medicine contains 2 mg daspartam per tablet. Laspartam contains a source of phenylalanine. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by an accumulation of phenylalanine that cannot be properly eliminated.
3. HOW DO I TAKE PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet is a symptomatic treatment. The duration of treatment varies according to the indication. If symptoms persist, consult your doctor.
Dosage
For adults
Take 2 tablets 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 6 tablets per 24 hours.
Use in children
For children over 2 years of age, take 1 tablet at the time of the attack. Repeat in the event of severe spasms, with a minimum interval of 2 hours between each dose, not to exceed 2 tablets per 24 hours.
Method and route of administration
Oral administration.
Adults: tablets should be dissolved in a glass of water or left to melt under the tongue for a rapid effect.
In children: dissolve tablets in a glass of water.
If you have taken more PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet than you should have
Consult your doctor or pharmacist immediately.
If you forget to take PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking PHLOROGLUCINOL VIATRIS 80 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 product may cause undesirable effects, but these do not always occur in everyone.
In some cases, allergies may occur.
You will recognize the signs of an allergy:
- by pimples and/or redness on the skin, itching,
- by sudden swelling of the face and neck (angioedema),
- or sudden malaise due to a drop in blood pressure (anaphylactic shock).
With undetermined frequency, the following may occur
- an extensive scaly red rash with masses under the skin and blisters accompanied by fever when treatment is initiated (acute generalized exanthematous pustulosis).
If you develop these symptoms, stop using this medicine and contact your GP or consult a doctor immediately.
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: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C, away from moisture.
Do not dispose of any medicine in the sewer or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet contains
- The active substance is :
Phloroglucinol ....................................................................................................................... 80 mg
For one orodispersible tablet.
- The other components are :
Lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, aspartam (E951).
What PHLOROGLUCINOL VIATRIS 80 mg, orodispersible tablet is and what it contains
This medicine comes in the form of an orodispersible tablet. Box of 10 or 20 tablets.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
VIATRIS SANTE
360 AVENUE HENRI SCHNEIDER
69330 MEYZIEU
or
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
or
INPHARMASCI
ZI N°2 DE PROUVY-ROUVIGNIES
1 RUE DE NUNGESSER
59121 PROUVY
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.