Spasmovax ORO tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

phloroglucinol (phloroglucinol dihydrate), 1,3,5-trimethoxybenzene

Available from:

Doppel Farmaceutici S.r.l.

ATC code:

A03AX12

INN (International Name):

phloroglucinol (phloroglucinol dihydrate), 1,3,5-trimethoxybenzene

Dosage:

80mg+ 80mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-07-26

Summary of Product characteristics

SCHARPER S.P.A.
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
SPASMOVAX® ORO 80 mg + 80 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS:
_Active ingredients_
1,3,5-Trihydroxybenzene dihydrate (phloroglucinol dihydrate) 102.850
mg (equivalent to
anhydrous phloroglucinol 80 mg) + 1,3,5-Trimethoxybenzene 80 mg.
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of pain related to functional disorders of the
digestive tract and
bile ducts.
Treatment of acute spasmodic painful disorders of the urinary tract:
renal colic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In urology and hepatology: 6 tablets per day.
PATIENTS WITH RENAL/HEPATIC IMPAIRMENT
No data is available on the use of Spasmovax ORO on this patient
population.
PAEDIATRIC POPULATION
No studies on the use of Spasmovax ORO have been carried out on this
patient population.
4.3 CONTRAINDICATIONS
Hypersensitivity to active ingredients or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings
Avoid associating the use of Spasmovax ORO with potent analgesics like
morphine or its
derivatives due to their spasmogenic effect.
Precautions for use
To date there have been no reports of precautions that need to be
taken.
Spasmovax ORO tablets contain lactose and are therefore not suitable
for patients suffering
from lactase deficiency, galactosaemia or glucose/galactose
malabsorption syndrome.
Spasmovax ORO tablets contain sucrose and are therefore not suitable
for patients suffering
from rare hereditary fructose intolerance problems, from
glucose/galactose malabsorption
syndrome or from sucrase-isomaltase insufficiency.
2
4.5
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
Avoid associating the use of Spasmovax ORO with potent analgesics like
morphine or its
derivatives due to their spasmogenic effect.
4.6
PREGNANCY AND LACTATION
PREGNANCY
Tests on laboratory animals have not shown any teratogenic effects due
to the use