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Spasfon
Spasfon suppositories are a type of medicine used to treat pain caused by spasms (sudden, involuntary muscle contractions) in areas such as your intestines, bile ducts, bladder, and uterus. This medicine is only meant for adults.
Each Spasfon suppository contains a substance called hydrated phloroglucinol, which helps to relax these spasms and relieve pain.
If you're experiencing stomach aches, the usual dose is one suppository, three times a day, with at least two hours between each one. But remember, don't use more than three in a day. This medicine isn't for kids.
Keep in mind that Spasfon suppositories treat symptoms, so if your pain continues, you should get in touch with your doctor.
You shouldn't use Spasfon suppositories if you're allergic to any ingredients in them. Signs of an allergic reaction could include itching, skin rashes, swelling of your face or neck, sudden discomfort, or a red, scaly rash with fever. If you notice any of these signs, stop using the suppositories and contact a doctor right away.
While this medicine can be used during pregnancy if needed, it's not recommended for breastfeeding women. Always seek advice from a healthcare professional before taking any new medicine. And if you forget a dose, don't double up on the next one.
The Spasfon suppositories come in a box of 10.
If you're pregnant and having contractions, your gynecologist might prescribe Spasfon suppositories and advise you to rest. A special cushion shaped like a banana or half-moon, like the Sissel cushion, can help you rest more comfortably.
are a type of medicine used to treat pain caused by spasms (sudden, involuntary muscle contractions) in areas such as your intestines, bile ducts, bladder, and uterus. This medicine is only meant for adults.
Each Spasfon suppository contains a substance called hydrated phloroglucinol, which helps to relax these spasms and relieve pain.
If you're experiencing stomach aches, the usual dose is one suppository, three times a day, with at least two hours between each one. But remember, don't use more than three in a day. This medicine isn't for kids.
Keep in mind that Spasfon suppositories treat symptoms, so if your pain continues, you should get in touch with your doctor.
You shouldn't use Spasfon suppositories if you're allergic to any ingredients in them. Signs of an allergic reaction could include itching, skin rashes, swelling of your face or neck, sudden discomfort, or a red, scaly rash with fever. If you notice any of these signs, stop using the suppositories and contact a doctor right away.
While this medicine can be used during pregnancy if needed, it's not recommended for breastfeeding women. Always seek advice from a healthcare professional before taking any new medicine. And if you forget a dose, don't double up on the next one.
The Spasfon suppositories come in a box of 10.
If you're pregnant and having contractions, your gynecologist might prescribe Spasfon suppositories and advise you to rest. A special cushion shaped like a banana or half-moon, like the Sissel cushion, can help you rest more comfortably.
Please read full disclosure.
PRODUCT CHARACTERISTICS SUMMARY
ANSM - Updated on: 20/09/2022
- NAME OF THE MEDICINE
SPASFON, suppository
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrated Phloroglucinol ................................................................................................. 150.0 mg
Quantity corresponding to anhydrous Phloroglucinol ..................................................... 116.7 mg
Trimethylphloroglucinol ................................................................................................ 150.0 mg
Per suppository.
For the complete list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Suppository.
- 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: kidney colic.
· Symptomatic treatment of painful spasmodic manifestations in gynecology.
· Adjuvant treatment of contractions during pregnancy in association with rest.
4.2. Dosage and method of administration
Spasfon is a symptomatic treatment. If symptoms persist, the patient's condition should be reassessed.
Reserved for adults.
Dosage
The usual dosage is 1 suppository per intake, three times a day, maintaining a minimum interval of 2 hours between each intake without exceeding 3 suppositories per 24 hours.
Pediatric Population
This dosage is not suitable for children.
Method of Administration
Rectal route.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1.
4.4. Special warnings and precautions for use
The association 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 breastfeeding
Pregnancy
Studies carried out in animals have not shown any 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 proven to be teratogenic in animals during well-conducted studies on two species.
In clinical practice, 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.
Consequently, the use of phloroglucinol should only be considered during pregnancy if advised by your doctor to be 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. Adverse effects
The following adverse effects are classified according to the organ system class and their frequency: indeterminate frequency (cannot be estimated based on the available data).
Organ System Class
Adverse Effect-Preferred Term
Frequency
Skin and Subcutaneous Tissue Disorders
Rash, rarely urticaria, pruritus, exceptionally Quincke's edema, acute generalized exanthematous pustulosis
Indeterminate Frequency
Immune System Disorders
Anaphylactic shock (low blood pressure)
Indeterminate Frequency
Declaration of Suspected Adverse Effects
The declaration of suspected adverse effects after the authorization of the medicine is important. It allows for continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
Cases of overdose have been reported without specific symptomatology.
- 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 and trimethylphloroglucinol have a spasmolytic activity on smooth muscles and a visceral anti-nociceptive effect, particularly in the aftermath of episodes of acute pain.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
Non-clinical data from conventional studies of repeated dose toxicity, genotoxicity and reproductive functions have not revealed any particular risk for humans.
- PHARMACEUTICAL DATA
6.1. List of Excipients
Semi-synthetic solid glycerides.
6.2. Incompatibilities
Not applicable.
6.3. Shelf Life
3 years.
6.4. Special Precautions for Storage
Keep away from heat.
6.5. Nature and Contents of Outer Packaging
10 or 100 suppositories in blister packs (Opaque PVC).
6.6. Special Precautions for Disposal and Handling
No special requirements for disposal.
- MARKETING AUTHORIZATION HOLDER
ACINO FRANCE SAS
76-78, AVENUE DU MIDI
63800 COURNON-D’AUVERGNE
- MARKETING AUTHORIZATION NUMBER(S)
· 34009 309 861 4 1: 10 suppositories in blister packs (Opaque PVC).
· 34009 352 431 8 8: 100 suppositories in blister packs (Opaque PVC).
- DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
[To be completed later by the holder]
- DATE OF UPDATE OF THE TEXT
[To be completed later by the holder]
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
PRESCRIPTION AND SUPPLY CONDITIONS
Medicine not subject to medical prescription.