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Mylan Viatris Phloroglucinol 80mg tablets Mylan Viatris Phloroglucinol 80mg tablets
Mylan Viatris Phloroglucinol 80mg tablets Mylan Viatris Phloroglucinol 80mg tablets
Over-the-counter medication

Mylan Viatris Phloroglucinol 80mg tablets

Brand : Mylan Viatris Mylan Viatris

Phloroglucinol 80mg Mylan Conseil 20 tablets is an antispasmodic drug.

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What is Phloroglucinol 80mg Mylan advice used for?

Phloroglucinol Mylan Conseil 80mg is an antispasmodic drug developed to soothe spasmodic pains of the intestine , bile ducts, bladder and uterus.

Each orodispersible tablet consists of phloroglucinol which is dosed at 80 mg. This medicine also contains lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K90, magnesium and aspartame. Excipients with known effect: lactose and aspartame.

How to properly use Phloroglucinol 80mg Mylan advice 20 tablets?

The Phloroglucinol Mylan Conseil 80 mg orodispersible tablet is taken orally, to be dissolved under the tongue for a rapid effect or to be dissolved in a glass of water if swallowed.

For adults, the recommended dose of Phloroglucinol Mylan Conseil is 2 tablets, to be taken at the time of the crisis. You can renew this dose in case of severe spasms. While in children, the dosage is 2 tablets per day, to be taken twice. For the child, this medicine is only to be dissolved in water. If the symptoms worsen or still persist after taking the tablet, it is best to get closer to a health professional.

It is advisable to consult your doctor or pharmacist if you feel that the effect of the medicine is too strong or too weak.

Comment on the recommendations for use and dosage of Phloroglucinol 80mg Mylan Conseil 20 tablets with our partner Avis checked after your purchase .

What is the composition of this Antispasmodic?

Phloroglucinol 80mg Mylan Conseil is formulated based on: The active substance is: Phloroglucinol 80 mg. For an orodispersible tablet. The other ingredients are:

Lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, aspartame (E951).

What are the side effects and contraindications?

  • Internal use
  • Store in a clean, dry place away from heat, light and moisture
  • Always keep out of reach of children
  • Pregnant and breastfeeding women seek advice from a healthcare professional
  • Not recommended for patients with galactose intolerance and Lapp lactase deficiency
  • Taking this medication is also prohibited for people with rare hereditary diseases such as glucose or galactose malabsorption syndrome
  • Containing a source of phenylalanine, this drug proves dangerous for patients with phenylketonuria
  • To avoid dangerous interactions of this drug, take the advice of your doctor before taking in case you are under treatment with other drugs.
  • In case of known hypersensitivity to phloroglucinol or another composition of this medicine, avoid taking it
  • With its formula containing aspartame, this orodispersible tablet is strongly discouraged in case of phenylketonuria or hereditary disease detected at birth.

Presentation - Packaging

Phloroglucinol 80 mg Mylan Conseil comes in the form of a box containing 20 tablets.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

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.

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