Each film-coated tablet contains:
Active ingredient:
| Phloroglucinol hydrate |
80 mg |
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SPASBOSTON
202206-0224 • 560 Views • Box of 03 blisters x 10 film-coated tablets.
COMPOSITION
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: renal colic.
Symptomatic treatment of painful spasmodic manifestation in gynaecology.
Adjuvant treatment of contractions during pregnancy in combination with rest.
DOSAGE AND ADMINISTRATION
Dosage
Adult
The usual dosage is 2 tablets per dose, three times a day, with a minimum interval of 2 hours between each dose, do not exceed 6 tablets in a 24 hour period.
The tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with injectable dosage form.
Pediatric
This dosage form is not suitable for children under 6 years of age.
In children over 6 years of age, the usual dosage is 1 tablet per dose, twice a day, with a minimum interval of 2 hours between each dose, do not exceed 2 tablets in a 24 hour period.
It should be ensured that the tablets can be swallowed.
Administration
Oral administration. This product should be swallowed with enough water.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
WARNINGS AND PRECAUTIONS
The combination of phloroglucinol with major analgesics such as morphine or its derivatives should be avoided due to their spasmogenic effect.
This product contains erythrosine, it may cause allergic reactions.
PREGNANCY AND LACTATION
Pregnancy
Studies conducted in animals have not demonstrated any teratogenic effects. In the absence of teratogenic effects in animals, malformation in humans is not expected. Substances responsible for malformations in humans have, to date, proved teratogenic in animals during correctly conducted studies in two species.
The relatively widespread use of phloroglucinol in clinical practice has not revealed any risk of malformative effects until now. However, epidemiological studies would be necessary to confirm the absence of risk.
Consequently, as a precaution, this medicinal product should only be used during pregnancy if necessary.
Lactation
In the absence of data, the administration of phloroglucinol is not recommended during lactation.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
SPASBOSTON has no or negligible effect on the ability to drive and use machines.
STORAGE CONDITION
In a dry place, below 30°C, protect from light.
SHELF-LIFE
36 months from the manufacturing date. Do not use after the expiry date.
Aluminum/PVC blister.
Box of 10 blisters x 10 film-coated tablets.
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