Spasfon Lyoc 80 mg for Stomach Aches 10 Oral Tablets

Dosage of Spasfon Lyoc against stomach ache

In adults, take 2 tablets at the time of pain, to be renewed if necessary after 2 hours and without exceeding 6 per day. To melt under the tongue or in a little water.

In children from 2 years old, 1 Spasfon Lyoc at the time of the crisis to be renewed if necessary after 2 hours without exceeding 2 tablets per day. To be dissolved in a little water before making it drink.

Please read the following full disclosure.

Contraindications of Spasfon Lyoc 

It is preferable not to use this antispasmodic drug during breastfeeding. During pregnancy, only your doctor will decide whether or not to take Spasfon Lyoc.

Allergy to one of the compounds constitutes a contraindication to taking Spasfon Lyoc .

Packaging : box of 10 oral lyophilisates

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 10/03/2019

1. NAME OF THE MEDICINE

SPASFON LYOC 80 mg, oral lyophilisate

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrated phloroglucinol ................................................................................................. 80.00 mg

Amount corresponding to anhydrous phloroglucinol ...................................................... 62.25 mg

For an oral lyophilisate.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral lyophilisate.

4. CLINICAL DATA

4.1. Therapeutic indications

· Symptomatic treatment of pains related to functional disorders of the digestive tract and bile ducts.

· Treatment of acute spasmodic and painful manifestations of the urinary tract: renal colic.

· Symptomatic treatment of painful spasmodic manifestations in gynecology.

· Adjuvant treatment of contractions during pregnancy in combination with rest.

4.2. Dosage and method of administration

SPASFON is a symptomatic treatment. In case of persistence of symptoms, it is necessary to reassess the patient's condition.

Dosage

In adults

The usual dosage is 2 oral lyophilisates, to be taken at the time of the crisis, to be renewed in case of significant spasms, respecting a minimum interval of 2 hours between each intake without exceeding 6 oral lyophilisates per 24 hours.

Pediatric population

In children over 2 years of age, the usual dosage is 1 oral lyophilisate, to be taken at the time of the crisis, to be renewed in case of significant spasms, respecting a minimum interval of 2 hours between each intake without exceeding 2 oral lyophilisates per 24 hours.

The efficacy of SPASFON LYOC 80 mg in children under 2 years of age has not been established.

Method of administration

Oral route.

In adults, the oral lyophilisates are to be dissolved in a glass of water or left to dissolve under the tongue for a rapid effect.

In children, the oral lyophilisate is to be dissolved in a glass of water.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

The combination of phloroglucinol with major analgesics such as morphine or its derivatives should be avoided due to their spasmogenic effect.

4.5. Interactions with other medicines and other forms of interactions

Not applicable.

4.6. Fertility, pregnancy and lactation

Pregnancy

Studies conducted in animals have not shown any teratogenic effect of phloroglucinol. In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have proven to be teratogenic in animals in well-conducted studies on two species.

In clinical practice, the relatively widespread use of phloroglucinol has apparently revealed no malformative risk to date. However, epidemiological studies are necessary to verify the absence of risk.

Therefore, the use of phloroglucinol should only be considered during pregnancy if necessary.

Breastfeeding

In the absence of data, it is advised to avoid the use of this medicine during breastfeeding.

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

Organ System Class

Adverse effect-preferred term

Frequency

Skin and subcutaneous tissue disorders

Rash, rarely urticaria, pruritus, exceptionally Quincke's edema anaphylactic shock (hypotension), acute generalized exanthematous pustulosis

Undetermined frequency

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals report any suspected adverse reactions via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

Cases of overdose have been reported without specific symptoms.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: MUSCULOTROPIC ANTISPASMODIC, ATC code: A03AX12 (A: digestive system and metabolism) (G: genitourinary system)

Mechanism of action

Phloroglucinol has a spasmolytic activity on smooth muscles and an anti-nociceptive visceral effect, particularly after episodes of acute pain.

5.2. Pharmacokinetic properties

Absorption

After oral administration, the plasma peak is reached between 15 and 20 minutes.

Distribution

The tissue distribution of phloroglucinol is rapid and significant.

Biotransformation

Phloroglucinol is metabolized in the liver by glucuroconjugation.

Elimination

Elimination is via the urinary route in glucuroconjugated form and via the biliary route in free and conjugated form. The elimination half-life is approximately 1h40.

5.3. Preclinical safety data

Non-clinical data from conventional repeated-dose toxicity, genotoxicity, and reproductive function studies have not revealed any particular risk to humans.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Dextran 70, mannitol.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Blister packs (PVC/Aluminium):

Store away from heat and moisture.

Over-wrapped blister packs (PVC/Aluminium) (Aluminium):

Store at a temperature not exceeding 30°C.

6.5. Nature and contents of outer packaging

10, 16 or 20 oral lyophilisates in blister packs (PVC/Aluminium).

10 or 20 oral lyophilisates in over-wrapped blister packs (PVC/Aluminium) in an aluminium sachet.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. MARKETING AUTHORISATION HOLDER

TEVA SANTE

100-110 ESPLANADE DU GENERAL DE GAULLE

92931 PARIS LA DEFENSE CEDEX

8. MARKET AUTHORIZATION NUMBER(S)

· 34009 318 630 1 4: 10 oral lyophilisates in blisters (PVC/Aluminium).

· 34009 370 549 7 3: 16 oral lyophilisates in blisters (PVC/Aluminium).

· 34009 318 629 3 2: 20 oral lyophilisates in blisters (PVC/Aluminium).

· 34009 363 419 4 4: 10 oral lyophilisates in overwrapped blisters (PVC/Aluminium/Aluminium).

· 34009 363 420 2 6: 20 oral lyophilisates in overwrapped blisters (PVC/Aluminium/Aluminium).

9. DATE OF FIRST AUTHORIZATION/OF AUTHORIZATION RENEWAL

[to be completed later by the holder]

10. DATE OF TEXT UPDATE

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicine not subject to medical prescription.