Over-the-counter medication

SPASFON LYOC Phloroglucinol 160MG Sublingual Tablets

Name: Spasfon-Lyoc 160mg Douleurs abdominales 5 lyophilisats oraux
Brand: Téva Santé Laboratoire
SKU: 2502
Price: 3.99 EUR
Availability: InStock
Rating: 4.8333 (6 reviews)

Brand : Téva Santé Laboratoire

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Reference : 3400941686245

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Spasfon-Lyoc 160 mg belongs to a class of non-prescription medication called antispasmodics. It acts against spasms (involuntary contractions). Spasfon-Lyoc 160 mg is recommended in adults for the treatment of spasmodic pain in the intestines, biliary tract, bladder and uterus.

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SPASFON LYOC Phloroglucinol 160MG Sublingual tablets

For warnings, precautions for use and contraindications, please see the instructions for use of the drug without prescription Spasfon-Lyoc 160 mg.

Description

Spasfon-Lyoc 160 mg belongs to a class of non-prescription medicines called antispasmodics . It acts against spasms (contractions of the viscera). This medication is indicated for adults to treat spasmodic pain in the stomach, bile ducts, bladder, and uterus.

Spasmodic pain is pain due to spasms of the abdominal organs, either in connection with the digestive system or with the genitals in men as in women or the urinary system.

This medicine contains phloroglucinol which is used in the treatment of painful muscle spasms of digestive origin, in case of spasmodic colitis for example. It is also used to treat biliary spasms as one meets in the event of hepatic colic, spasms of urological origin (in case of renal colic in particular) and spasms of gynecological origin (painful periods, uterine contraction).

Dosage of Spasfon-Lyoc 160 mg Sublingual tablets

This non-prescription medication is for adults only.

Take 1 oral lyophilisate of spasfon at the time of the attack. Renew in case of significant spasms by respecting a minimum interval of 2 hours between each intake without exceeding 3 oral lyophilisates per day.

Method of administration of Spasfon-Lyoc 160 mg : oral

Oral lyophilisates dissolve easily in water or saliva
You can :

either dissolve the oral lyophilisate in a glass of water,
either let it melt under the tongue to get a quick effect

Composition of Spasfon-Lyoc 160 mg Sublingual tablets

The active substance in Spasfon-Lyoc 160 mg : the active substance is phloroglucinol (160 mg per lyophilisate).

The other ingredients of Spasfon-Lyoc 160 mg : Mannitol, dextran 70, sucralose, macrogol hydroxystearate 15.

Packaging of Spasfon-Lyoc 160 mg

5 oral lyophilisates. These are sublingual tablets, which means that these tablets are to be dissolved under the tongue or in a glass of water for faster absorption of the active ingredient, phloroglucinol, and thus, benefit from a rapid anti-spasmodic action. ).

Summary of the characteristics of Spasfon-Lyoc 160 mg (ANSM)

Warnings on drugs that treat digestive issues

Please note, the drug Spasfon-Lyoc 160 mg is not a product like any other. Read the package leaflet for Spasfon-Lyoc 160 mg carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
Click here to find the instructions for this drug Spasfon-Lyoc 160 mg on the website of the National Agency for the Safety of Medicines and Health Products.
Pharmacovigilance: Declare one or more undesirable effect (s) linked to the use of a Spasfon-Lyoc 160 mg drug.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 27/04/2017

Name of the medicinal product

SPASFON LYOC 160 mg oral lyophilisate

phloroglucinol

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or 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 talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is SPASFON LYOC 160 mg, oral lyophilisate and in which cases it is used?

2. What should I tell you before taking SPASFON LYOC 160 mg oral lyophilisate?

3. How to take SPASFON LYOC 160 mg oral lyophilisate?

4. What are the possible side effects?

5. How to store SPASFON LYOC 160 mg oral lyophilisate?

6. Package contents and other information.

1. WHAT IS SPASFON LYOC 160 mg, oral lyophilisate AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: ANTISPASMODIQUE MUSCULOTROPE, ATC code: A03AX12

(A: digestive system and metabolism) (G: genitourinary system )

SPASFON LYOC 160 mg belongs to a class of medications called antispasmodics. It acts against spasms (contractions).

This medicine is indicated in adults for the treatment of spasmodic pain in the intestine, biliary tract, bladder and uterus.

2. BEFORE YOU TAKE SPASFON LYOC 160 mg oral lyophilisate?

Do not take SPASFON LYOC 160 mg, oral lyophilisate:

If you are allergic to phloroglucinol or to any of the other ingredients of this medication mentioned in section 6.

Warnings and Precautions

Talk to your doctor or pharmacist before using SPASFON LYOC 160 mg oral lyophilisate .

Children and Youth

Not applicable.

Other medicines and SPASFON LYOC 160 mg oral lyophilisate

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

SPASFON LYOC 160 mg, oral lyophilisate with food and beverages

Not applicable.

Pregnancy and breast feeding

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of this medication should only be considered during pregnancy if necessary.

feeding

The use of SPASFON LYOC 160 mg is not recommended in breast-feeding women.

Driving and using machines

SPASFON has no or negligible effect on the ability to drive and use machines .

SPASFON LYOC 160 mg oral lyophilisate contains

Not applicable.

3. HOW TO TAKE SPASFON LYOC 160 mg oral lyophilisate?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Spasfon is a symptomatic treatment. The duration of treatment varies according to the indication. If symptoms persist, consult your doctor.

Reserved for adults only.

Dosage

Take 1 oral lyophilisate at the time of the crisis. Repeat in case of severe spasms within a minimum interval of 2 hours between each intake without exceeding 3 oral lyophilisates per day.

Use in children

This dosage is not suitable for the child.

Method and route of administration

Oral use.

Oral lyophilisates should be dissolved in a glass of water or allowed to melt under the tongue for a quick effect.

If you take more SPASFON LYOC 160 mg oral lyophilisate than you should:

Immediately consult your doctor or pharmacist.

If you forget to take SPASFON LYOC 160 mg oral lyophilisate:

Do not take a double dose to make up for the missed dose

If you stop taking SPASFON LYOC 160 mg oral lyophilisate:

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

In some cases an allergy may occur.

You will recognize the signs of an allergy:

· by pimples and / or redness on the skin, itching,

· by a sudden swelling of the face and neck (Quincke's edema),

· or a sudden discomfort due to a fall in blood pressure (anaphylactic shock).

Declaration of side effects

If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE SPASFON LYOC 160 mg oral lyophilisate?

Keep this medicine out of the reach and sight of children.

Do not use this medication after the expiry date indicated on the box. The expiry date refers to the last day of that month.

No special precautions for storage.

Do not use if you notice any visible signs of product degradation.

The surface of lyophilisates may not be smooth, but sometimes bumpy. This irregular appearance does not affect the quality and effectiveness of the product.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What SPASFON LYOC 160 mg contains, oral lyophilisate

· The active substance is:

Phloroglucinol dihydrate ................................................ ................................................ 160,000 mg

Corresponding amount of anhydrous phloroglucinol at ............................................ 124.466 mg

For an oral lyophilisate.

· The other components are:

Mannitol, dextran 70, sucralose, macrogol hydroxystearate 15.

What SPASFON LYOC 160 mg oral lyophilisate contains and contents of the pack

SPASFON LYOC 160 mg is in the form of oral lyophilisates white to creamy white and round. Oral lyophilisates are tablets that dissolve easily in water or saliva.

The oral lyophilisates are presented under platelets. In some countries, these platelets may be overwrapped in a sachet.

SPASFON LYOC 160 mg is presented in a box of 5 or 10 oral lyophilisates.

Marketing Authorization Holder

TEVA HEALTH

100-110 ESPLANADE OF GENERAL DE GAULLE

92931 PARIS LA DEFENSE CEDEX

Marketing Authorization Operator

TEVA HEALTH

100-110 ESPLANADE OF GENERAL DE GAULLE

92931 PARIS LA DEFENSE CEDEX

Maker

GALIEN LPS

22 RUE EDME LABORDE

NEVERS SAINT ELOI ACTIVITY PARK

58000 NEVERS

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Vidal file

VIDAL OF THE FAMILY

SPASFON LYOC

antispasmodic

. Presentations . Composition . Indications . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS ^(summary)

SPASFON-LYOC 80 mg: oral lyophilisate (white); box of 10.
Refunded at 15%. - price: 1,33 euro (s).

SPASFON-LYOC 160 mg: oral lyophilisate (white); box of 5.
Refunded at 15%. - price: 1.47 euro (s).

Laboratory Téva Santé

COMPOSITION ^(summary)

	p cp	p cp
Phloroglucinol hydrate	80 mg	160 mg

INDICATIONS ^(summary)

This medication is an antispasmodic . He struggles against abnormal and painful contractions of the intestine, the bile ducts , the way urinary and uterus.
It is used in the treatment of painful spasms of digestive origin (spasmodic colitis ), biliary (hepatic colic), urological ( renal colic ) and gynecological (painful periods and contractions of the uterus during pregnancy).

PREGNANCY AND BREAST-FEEDING ^(summary)

Pregnancy :
The scientific data currently available have not revealed any particular problem when using this medication during pregnancy at the recommended dose. Nevertheless, do not use it without medical advice.

Breastfeeding:
The data currently available do not indicate whether this drug passes into breast milk: it is not recommended during breast-feeding without medical advice.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

Lyophilisates can be dissolved in a glass of water or placed under the tongue for a faster effect.
160 mg lyophilisates are reserved for adults.

Usual dosage:

Adults: 2 lyophilisates with 80 mg or 1 lyophilisate with 160 mg to be taken at the time of the crisis and to be renewed if necessary in case of important spasms. Do not exceed 3 lyophilisates at 160 mg per day.
Child: 1 lyophilisate with 80 mg dissolved in a glass of water, 2 times a day.

TIPS ^(summary)

In cases of nephritic colic , it is generally advisable to drink plenty between crises to fight against the formation of calculations. However, during a crisis, fluid absorption should be limited so as not to increase pain.
In the case of painful contractions of the uterus during pregnancy, rest is an integral part of the treatment.

POSSIBLE ADVERSE EFFECTS ^(summary)

Rash, rarely urticaria, itching. Exceptionally: angioedema , anaphylactic shock .

GLOSSARY ^(summary)

antispasmodic
Medication that fights against spasms. Antispasmodics generally act by preventing the contraction of muscle fibers present in the wall of the intestine or urinary tract.

anaphylactic shock
Shock of allergic origin manifested by a sudden drop in blood pressure, due to extreme dilation of the blood vessels. It occurs after contact with an allergenic substance (food, insect bites, injection or drug absorption).

renal colic
Acute pain in the abdomen or back caused by a calculation that obstructs the urinary tract. These are usually calculations of uric acid or calcium salts.

colitis
Inflammation of part or all of the colon. It can be caused by a bacterial or parasitic infection, an inflammatory disease (Crohn's disease) or a bowel disorder (spastic colitis).

lyophilisate
Powder resulting from rapid drying (at low temperature and under vacuum) of a substance dissolved in water (eg soluble coffee). As medicaments, lyophilisates may be dissolved in a solvent for the preparation of an injectable, atrial, nasal, etc. solution. or be presented as a tablet to be dissolved in a glass of water, sucked or allowed to melt under the tongue.

angioedema
Allergy edema usually affects the face. Quincke edema results in a sometimes spectacular swelling. Eyelids are often the first to be affected. In rare cases where edema affects the throat, respiratory problems may occur and urgent treatment is required.

way

Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
Set of hollow organs allowing the passage of air (respiratory tract), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

Biliary
Excretory pathways leading the bile of the liver to the duodenum. They include the bile duct and the gall bladder, which stores excess bile between meals.

Pharmacist's advice

used for :

spasms, stomach problems, stomach pains, upset stomach, muscle contractions