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Spasfon-Lyoc 160 mg is a medication used to alleviate spasms or contractions. It belongs to the class of antispasmodic drugs. It's commonly used in adults to treat spasmodic pain in the intestines, bile ducts, bladder, and uterus.
The active ingredient in this medication is phloroglucinol, dosed at 160 mg per oral lyophilisate. Other ingredients in Spasfon-Lyoc 160 mg include mannitol, dextran 70, sucralose, and macrogol 15 hydroxystearate.
Dosage Instructions for Spasfon Lyoc 160 mg, a Medication for Stomach Pain: This stomach pain medication is intended for adult use only. The generally recommended dosage is 1 oral lyophilisate, to be taken during a spasm episode. If severe spasms continue, the dosage can be repeated, but it is important to maintain at least a 2-hour gap between each dosage and not to exceed 3 oral lyophilisates per day.
The lyophilisates easily dissolve in water or saliva, so they can either be mixed into a glass of water or allowed to dissolve under the tongue.
Contradictions for the use of Spasfon Lyoc 160 mg: Please consult your doctor or pharmacist before taking Spasfon-Lyoc 160 mg. This medication should not be used if you are allergic or hypersensitive to phloroglucinol or any of the other ingredients in its formula.
If you are currently taking or have recently taken any other medication, it's important to inform your doctor or pharmacist before using Spasfon-Lyoc 160 mg.
If you are pregnant or breastfeeding, you should seek advice from your doctor or pharmacist before taking any medication. Spasfon-Lyoc 160 mg should only be considered during pregnancy if absolutely necessary and is not recommended during breastfeeding.
Packaging: 5 oral lyophilisates.
In case of gastroenteritis, stomach pain may be accompanied or followed by nausea and vomiting. In such instances, Teva Laboratories offers Vogalib tablets, which are to be dissolved under the tongue.
Please read the following full disclosure.
SUMMARY OF PRODUCT CHARACTERISTICS
ANSM - Updated on: 03/10/2019
- NAME OF THE MEDICINE
SPASFON LYOC 160 mg, oral lyophilisate
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrated phloroglucinol ............................................................................................... 160.000 mg
Quantity corresponding in anhydrous phloroglucinol to ...................................................... 124.466 mg
For an oral lyophilisate.
For the full list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Oral lyophilisate.
White to cream white, round oral lyophilisate.
- CLINICAL DATA
4.1. Therapeutic indications
· Symptomatic treatment of pain associated with 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. If symptoms persist, the patient's condition should be re-evaluated.
For adults only.
Dosage
The usual dosage is 1 oral lyophilisate, to be taken at the onset of the crisis, to be renewed in case of significant spasms respecting a minimum interval of 2 hours between each intake without exceeding 3 oral lyophilisates per day.
Pediatric population
This dosage is not suitable for children.
Method of administration
Oral route.
The oral lyophilisates are to be dissolved in a glass of water or allowed to melt under the tongue for a rapid effect.
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 interaction
The data available to date do not suggest the existence of clinically significant interactions.
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, substances causing malformations in the human species have been found to be teratogenic in animals in well-conducted studies on two species.
In clinical practice, the relatively widespread use of phloroglucinol has apparently not revealed any risk of malformation 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 your doctors advises it is 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 and use machines
SPASFON has no or negligible effect on the ability to drive vehicles and use machines.
4.8. Adverse effects
Class of organ system disorders
Adverse effect-preferred term
Frequency
Skin and subcutaneous tissue disorders
Rash, rarely urticaria, itching, exceptionally Quincke's edema, anaphylactic shock (low blood pressure), acute generalized exanthematous pustulosis
Undetermined frequency
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicine is important. It allows for continuous monitoring of the benefit/risk balance of the medicine. Health professionals report any suspected adverse reactions 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 group: MUSCULOTROPIC ANTISPASMODIC, ATC code: A03AX12 (A: digestive system and metabolism) (G: genito-urinary system)
Mechanism of action
Phloroglucinol has a spasmolytic activity on smooth muscles and a visceral anti-nociceptive effect, particularly following episodes of acute pain.
5.2. Pharmacokinetic properties
Absorption
After oral administration, the peak plasma level is reached between 15 and 20 minutes.
Distribution
The tissue distribution of phloroglucinol is rapid and extensive.
Biotransformation
Phloroglucinol is metabolized in the liver by glucuroconjugation.
Elimination
Elimination occurs through the urinary tract in the form of glucuroconjugated and through the bile duct in free and conjugated form. The half-life of elimination is about 1h40.
5.3. Preclinical safety data
Non-clinical data from conventional studies on repeated-dose toxicity, genotoxicity and reproductive functions have not revealed any particular risk for humans.
- PHARMACEUTICAL DATA
6.1. List of excipients
Mannitol, dextran 70, sucralose, macrogol 15 hydroxystearate.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of outer packaging
5 or 10 oral lyophilisates in blister packs (PVC/TE/PVDC/Aluminium).
5 or 10 oral lyophilisates in blister packs (PVC/TE/PVDC/Aluminium) overpackaged in a sachet (PET/Aluminium/PE).
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
- MARKETING AUTHORIZATION HOLDER
TEVA SANTE
100-110 ESPLANADE DU GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
- NUMBER(S) OF MARKETING AUTHORIZATION
· 34009 416 862 4 5: 5 oral lyophilisates in blister packs (PVC/TE/PVDC/Aluminium).
· 34009 416 863 0 6: 10 oral lyophilisates in blister packs (PVC/TE/PVDC/Aluminium).
- DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed later by the holder]
- DATE OF TEXT UPDATE
[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.
