Spasfon solution for injection ampoule spasmodic pain

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Spasfon solution for injection ampoule spasmodic pain

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Partners with: ERGYPROTECT COMFORT 60 capsules NUTERGIA

Used for : spasmodic pain

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For warnings, the precautions and cons-indications, please refer to the instructions for use of injectable ampoules Spasfon.

Description Spasfon injectable ampoules

Spasfon injectable solution in ampoule is a medicament for the treatment of spasmodic intestine, biliary tract, urinary bladder and uterus.

Spasfon dosage injectable ampoules  

Attack Treatment
1-3 phials per day by intravenous or intramuscular route.

Maintenance treatment
The tablets or suppositories will take over from the etching treatment in a dosage of 6 tablets per day or 3 suppositories.

Method and route of administration of injectable ampoules Spasfon   : Intravenous or intramuscular

Composition for injection ampoule Spasfon   :

- Phloroglucinol hydrated ............................................... .................................... 40.00 mg
- Correspndant amount of anhydrous phloroglucinol to ........................... 31.12 mg
- Triméthylphloroglucinol..............................................................................0.04 mg
To a dropping

Excipients Spasfon injectable ampoules   : Sodium chloride, water for injections.  

This medication should not be used if you are allergic to any component.

Precautions  
If in doubt do not hesitate to ask your doctor or pharmacist

Drug interactions and other interactions  

It is against inappropriate to mix in the same syringe injectable solution of phloroglucinol with noramidopyrine due to physico-chemical incompatibility (risk phlebothrombosis thrombosis).
To avoid possible interactions between multiple drugs should routinely report any ongoing treatment with your doctor or pharmacist

Pregnancy - Breastfeeding  

The use of this drug should be considered during pregnancy if necessary. The administration of this drug is not recommended in breastfeeding women.

In general, it is during pregnancy or breastfeeding always seek the advice of your doctor or pharmacist before using any medicine.
Packaging:   6 ampoules of 4 ml

Summary of characteristics of Spasfon injectable ampoules (MSNA)

Warnings on drugs

Warning, the injectable ampoules drug Spasfon is not a product like any other. Read the package leaflet injectable ampoules Spasfon before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find the instructions for this medicine injectable ampoules Spasfon on the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Declare one or effect (s) spam (s) connected (s) to the use of injectable ampoules drug Spasfon.

VIDAL OF THE FAMILY

Spasfon

antispasmodic

phloroglucinol

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

PRESENTATIONS (summary)

SPASFON: tablet (pink); box of 30.
Refunded at 15%. - price: 1,97 euro (s).

SPASFON: suppository; box of 10.
Refunded at 15%. - price: 2,01 euro (s).

SPASFON: solution for injection; box of 6 ampoules of 4 ml.
Refunded at 15%. - price: 2.59 euro (s).
List I

Laboratory Téva Santé

COMPOSITION (summary)
p cp p assumed p amp inj
phloroglucinol 62.2 mg 150 mg 40 mg
Trimethylphloroglucinol 80 mg 150 mg 40 μg
Lactose +
Sucrose +

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).
WARNING (Contents)
The injectable solution should not be mixed with another drug in the same syringe.
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 available data 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)
The mode of administration differs according to the case and the intensity of the disorders: the solution injectable acts in a few minutes but its effect is of short duration; the tablets are intended to take over the injectable solution, their action lasts longer; suppositories can be used in case of vomiting.
The injectable solution is administered by way intramuscular or intravenous .

Usual dosage:

Tablet :
6 tablets per day.
Injectable solution :
1 to 3 ampoules per day, in attack treatment. The tablets or suppositories are then taken in relay of the attack treatment.
Suppository :
3 suppositories per 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.
The injectable solution should be stored away from light.
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).


intramuscular
route or injectionInjection of a drug into a muscle, usually at the buttock. The effect of the drug, which only gradually passes into the bloodstream, is delayed but prolonged. A good prior disinfection of the skin is necessary, because this deep injection exposes to a risk of abscesses. The pain caused by the bite depends mainly on the nature of the product used. This route of administration is contraindicated in hemophiliacs and in people undergoing anticoagulant therapy because it exposes them to a risk of hematoma of the buttock.
Abbreviation: IM.


intravenous
route or injectionInjection of a drug into a vein, usually at the bend of the elbow, after disinfection of the skin. In the case of direct intravenous injection with a syringe, the effect of the drug is immediate, but brief. Conversely, perfusion allows continuous and controlled administration of the active substance, diluted in a vial of serum.
Abbreviation: IV.


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 (airways), 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.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 23/05/2017

Name of the medicinal product

SPASFON, solution for injection in ampoule

phloroglucinol / trimethylphloroglucinol

framed

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

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

· If you have any further questions, ask your doctor, pharmacist or nurse.

· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.

· 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.

What is in this leaflet?

1. What is SPASFON, an injectable ampoule solution and in which cases is it used?

2. What should I know before using SPASFON, an injectable solution?

3. How to use SPASFON, injectable solution in ampoule?

4. What are the possible side effects?

5. How to preserve SPASFON, solution for injection in ampoule?

6. Package contents and other information.

1. WHAT IS SPASFON, solution for injection in ampules AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group: ANTISPASMODIQUE MUSCULOTROPE - ATC code: A03AX12

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

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

This medication is indicated for the treatment of spasmodic pain in the intestine, bile ducts, bladder and uterus.

2. BEFORE YOU USE SPASFON, solution for injection in ampules?

Never use SPASFON, solution for injection in bulbs:

· if you are allergic to phloroglucinol, trimethylphloroglucinol or any of the other ingredients of this medication mentioned in section 6.

Warnings and Precautions

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

Children and Youth

Not applicable.

Other medicines and SPASFON, solution for injection in ampoule

It is contraindicated to mix the injectable solution of phloroglucinol with noramidopyrin in the same syringe because of a physico-chemical incompatibility (risk of phlebothrombosis).

This medication should not be mixed with other medicines.

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

SPASFON, solution for injection in ampoules with food and drinks

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

Administration of this medication is not recommended for nursing mothers.

Driving and using machines

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

SPASFON, solution for injection in ampoule contains

Not applicable.

3. HOW TO USE SPASFON, solution for injection in ampules?

Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.

Diagram of opening of the bulb:

Dosage

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

In the adult

Attack processing

1 ampoule will be administered at the time of the crisis, renewed in case of major spasms, not exceeding 3 ampoules per 24 hours.

Maintenance treatment

Tablets or suppositories will take over the treatment of attack in a dosage of 6 tablets or 3 suppositories per day.

For further details, refer to the dosage and method of administration of coated tablets or suppositories (SPASFON, coated tablet or SPASFON, suppository).

Use in children

No data available

Method and route of administration

Injectable route.

Administration can be done either intravenously or intramuscularly.

This medication should not be mixed with other medicines.

If you used more SPASFON, injectable ampoule than you should:

Immediately consult your doctor or pharmacist.

If you forget to use SPASFON, solution for injection in ampoules:

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

If you stop using SPASFON, bulking solution for injection:

Not applicable.

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

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, 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: 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, a solution for injection in ampules?

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.

This medication should be stored in a dark place.

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 contains, solution for injection in ampoule

· The active substances are:

Phloroglucinol hydrate ................................................ .................................................. ... 40.00 mg

Corresponding amount of anhydrous phloroglucinol at ............................................ .............. 31.12 mg

Trimethylphloroglucinol ................................................. .................................................. ... 0.04 mg

For a light bulb.

· The other components are:

Sodium chloride, water for injections.

What is SPASFON, solution for injection in ampoules and contents of the pack

This medication is in the form of an injectable ampoule. Box of 6, 12, 18 or 60 ampoules.

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

RENAUDIN LABORATORY

ARTISANAL AREA ERROBI

64250 ITXASSOU

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).

Cheap Spasfon in your medicine approved Ars  

Spasfon is a medicament spastic pain of the intestine, biliary tract, urinary bladder and uterus.

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