Spasfon Stomach Ache Tablets 30 Tablets

Dosage of Spasfon tablet

In adults, take 2 tablets of Spasfon per dose, 3 times a day, respecting a minimum interval of 2 hours between each dose and without exceeding 6 per day.

In children over 6 years old, give 1 tablet of Spasfon per dose, twice a day, respecting a minimum interval of 2 hours between each dose without exceeding 2 per day.

The tablets are simply swallowed with a little water. If the symptoms persist despite taking Spasfon, it will be necessary to see your doctor.

Please read the following full disclosure.

Precautions with Spasfon stomach ache

ANSM - Updated on: 25/09/2020

1. NAME OF THE MEDICINE

SPASFON, coated tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrated Phloroglucinol ............................................................................................................ 80.000 mg

Quantity corresponding to anhydrous phloroglucinol ............................................................. 62.233 mg

Trimethylphloroglucinol .......................................................................................................... 80.000 mg

For one coated tablet.

Notable excipients: Each tablet contains 23.77 mg of wheat starch, 140 mg of monohydrated lactose, and 206.5 mg of sucrose.

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Coated tablet, round in shape with convex faces, smooth and shiny, pink in color.

4. CLINICAL DATA

4.1. Therapeutic indications

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

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

· Symptomatic treatment of spasmodic painful manifestations in gynecology.

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

4.2. Dosage and method of administration

SPASFON is a symptomatic treatment. If symptoms persist, the patient's condition should be reassessed.

Dosage

In adults

The usual dosage is 2 tablets per dose, three times a day, respecting a minimum interval of 2 hours between each dose, not exceeding 6 tablets per 24 hours.

The tablets can be used as a relay of an attack treatment by injectable route.

Pediatric population

This presentation is not suitable for children under 6 years of age.

The usual dosage is 1 coated tablet per dose, twice a day, respecting a minimum interval of 2 hours between each dose, not exceeding 2 tablets per 24 hours.

In children over 6 years of age, it will be necessary to ensure that the tablets can be swallowed, otherwise, the Spasfon Lyoc 80 mg form will be preferred.

Method of administration

Oral route.

The tablets should be swallowed with a glass of water.

4.3. Contraindications

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

SPASFON tablet is contraindicated in patients with a wheat allergy (other than celiac disease).

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.

Excipient(s)

Wheat starch

This medication contains a very low gluten content (from wheat starch). It is considered "gluten-free" and is therefore unlikely to cause problems in case of celiac disease. One tablet does not contain more than 2.4 micrograms of gluten. Patients allergic to wheat should not take this medication.

Lactose

Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome (rare hereditary diseases) should not take this medication.

Sucrose

Patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase/isomaltase deficiency (rare hereditary diseases) should not take this medication.

4.5. Interactions with other medicines and other forms of interactions

Not applicable.

4.6. Fertility, pregnancy, and breastfeeding

Pregnancy

Studies in animals have not revealed a teratogenic effect of phloroglucinol. In the absence of a teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been found to be teratogenic in animals during well-conducted studies on two species.

Clinically, the relatively widespread use of phloroglucinol has apparently not revealed any malformative risk to date. However, epidemiological studies are necessary to verify the absence of risk.

As a result, 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 the ability to drive vehicles and use machines

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

4.8. Adverse effects

System Organ 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

Declaration of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk balance of the medicine. Health professionals report any suspected adverse effect via the national reporting system: 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 symptomatology.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: MUSCULOTROPIC ANTISPASMODIC, ATC code: A03AX12. (A: digestive system and metabolism) (G: genito-urinary system)

Mechanism of action

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

5.2. Pharmacokinetic properties

Absorption

After oral administration, the plasma peak is reached between 40 and 60 minutes.

Distribution

The tissue distribution of phloroglucinol is rapid and substantial.

Biotransformation

Phloroglucinol is metabolized in the liver by glucuroconjugation.

Elimination

Elimination occurs via the urinary route in glucuroconjugated form and via the biliary route in free and conjugated form. The elimination half-life is about 1 hour and 40 minutes.

5.3. Preclinical safety data

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

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Monohydrated lactose, sucrose, polyvinyl acetate, wheat starch, stearic acid, magnesium stearate.

Coating: polyvinyl acetate, talc, sucrose, gum arabic, gelatin, titanium dioxide (E171), erythrosine (E127), carnauba wax.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store at a temperature not exceeding 30°C.

6.5. Nature and contents of outer packaging

20, 30, or 500 tablets in blister packs (PVC/Aluminum).

All presentations may not be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. MARKETING AUTHORIZATION HOLDER

TEVA SANTE

100-110 ESPLANADE DU GENERAL DE GAULLE

92931 PARIS LA DEFENSE CEDEX

8. MARKETING AUTHORIZATION NUMBER(S)

· 34009 379 934 0 1: 20 tablets in blister packs (PVC/Aluminium).

· 34009 309 860 8 0: 30 tablets in blister packs (PVC/Aluminium).

· 34009 352 432 4 9: 500 tablets in blister packs (PVC/Aluminium).

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[to be completed later by the holder]

10. DATE OF REVISION OF THE TEXT

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND SUPPLY CONDITIONS

Over-the-counter medicine. Not subject to a medical prescription.