Active ingredients: Antidiarrheal associations
STREPTOMAGMA ® Antidiarrheals
Why is Streptomagma used? What is it for?
WHAT IS IT
Streptomagma is an antidiarrheal product.
WHY IT IS USED
Streptomagma is used in the symptomatic treatment of non-specific diarrhea.
Contraindications When Streptomagma should not be used
Hypersensitivity to the components of the product. Kidney failure. Hypophosphatemia.
Precautions for use What you need to know before taking Streptomagma
What to do during pregnancy and breastfeeding
There are no contraindications if the product is used correctly.
Interactions Which drugs or foods can modify the effect of Streptomagma
It should be borne in mind that the product, due to the presence of aluminum, can interfere with the oral administration of other drugs, in particular the simultaneous administration of tetracyclines must be avoided, which can give rise to insoluble complexes with a reduction in absorption and in the activity of such antibiotics.
It is however advisable not to administer other drugs by mouth within 1 or 2 hours of using the product.
Warnings It is important to know that:
After a short period of treatment without appreciable results and in cases of diarrhea accompanied by high fever, blood in the stool, consult your doctor.
In children under 3 years of age, Streptomagma suspension should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Dosage and method of use How to use Streptomagma: Dosage
How much, how and for how long
Adults: 4 teaspoons (3 times a day) before meals.
Children over 3 years: according to weight, 1-2 teaspoons (3 times a day) before meals.
Children under the age of 3: according to medical opinion.
Keep the bottle tightly closed. Shake before using.
Warning: do not exceed the indicated doses without the advice of the doctor. Warning: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Overdose What to do if you have taken too much Streptomagma
In case of accidental ingestion / intake of an excessive dose of Streptomagma suspension, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Streptomagma
No particular undesirable effects are known.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.
Request and fill in the undesirable effects report form available at the pharmacy (Form B).
Expiry and Retention
Store the product at room temperature, in its original packaging.
Warning: do not use the medicine after the expiry date indicated on the package.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN.
Deadline "> Other information
COMPOSITION
100 ml contain:
- Active ingredients: aluminum hydroxide gel with 0,954 g of Al2 03; kaolin 10,000 g; pectin 0,900 g.
- Excipients: vaseline oil, glycerin, sodium benzoate, benzoic acid, saccharin, vanillin, methylparaben, propylparaben, butylparaben, monobasic sodium phosphate monohydrate, water q.s.
HOW IT LOOKS
Streptomagma comes in the form of a suspension, in a 90 ml bottle.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
STREPTOMAGMA
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
SUSPENSION
100 ml contain: ACTIVE INGREDIENTS. 2.5% aluminum hydroxide gel Al203 ml 36.000; kaolin 10,000 g; pectin g 0,900.
TABLETS
Each tablet contains: activated attapulgite 350,000 mg; pectin 45,000 mg; dried aluminum hydroxide gel at 50% of 70,000 mg Al203.
03.0 PHARMACEUTICAL FORM -
Suspension for oral use
Tablets
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Symptomatic treatment of diarrhea of a non-specific nature.
04.2 Posology and method of administration -
SUSPENSION:
Adults: 4 teaspoons 3 times a day or 2 sachets (3 times a day) before meals.
Children over 3 years: according to weight, 1-2 teaspoons (3 times a day) or 1-2 sachets (1 time a day) before meals.
Children under the age of 3: according to medical opinion.
Do not exceed the recommended dose.
Keep the bottle tightly closed. Shake before using.
TABLETS
Adults: 2 tablets to chew or dissolve in the mouth, followed by one tablet every 4-6 hours as needed.
Children over 3 years: half tablet every 6-8 hours as needed.
04.3 Contraindications -
Hypersensitivity to the components of the product. Kidney failure. Hypophosphatemia.
04.4 Special warnings and appropriate precautions for use -
In cases of diarrhea accompanied by high fever, blood in the stool or symptoms lasting more than 2 days, consult your doctor.
It is advisable not to administer other drugs by mouth within 1 or 2 hours of using the product. For children under the age of 3 years, STRATOMAGMA should only be given on medical advice.
04.5 Interactions with other medicinal products and other forms of interaction -
Due to the presence of aluminum, the product can interfere with the oral administration of other drugs, in particular the simultaneous administration of tetracyclines must be avoided, which can give rise to insoluble complexes with a reduction in the absorption and activity of these antibiotics.
It is however advisable not to administer other drugs by mouth within 1 or 2 hours of using the product.
04.6 Pregnancy and breastfeeding -
There are no contraindications if the product is used correctly.
04.7 Effects on ability to drive and use machines -
No effects on ability to drive and use machines have been reported after use of Streptomagma.
04.8 Undesirable effects -
No particular undesirable effects are known.
04.9 Overdose -
No overdose phenomena have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Streptomagma suspension is made up of the association of pectin, aluminum hydroxide gel and kaolin. Streptomagma tablets is made up of the association of pectin, dried aluminum hydroxide gel and attapulgite. Pectin, thanks to its hydrophilic properties, has an "absorbing action" on the water present in the diarrheal faeces; moreover it tends to form a protective layer on the surface of the intestinal mucosa. The aluminum hydroxide gel also carries out an absorbing action and also in the Streptomagma Sospensione also performs a dispersion function of the kaolin giving rise to a colloidal solution and allowing the kaolin to perform its activity in the best possible way. The kaolin, thanks due to its absorbent properties, it is used in intestinal infectious processes. Attapulgite, present in the tablet formulation, is a chemically inert and essentially neutral inorganic substance, with absorbent properties that remain unchanged even when the pH changes.
05.2 "Pharmacokinetic properties -
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05.3 Preclinical safety data -
TOXICOLOGY: Streptomagma contains natural substances, which have been present for a long time in all Pharmacopoeias and for which there are no data referring to acute, subacute or chronic toxicity. However, in established use, no teratogenic, mutagenic or carcinogenic effects have ever been reported.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
SUSPENSION: Vaseline oil; glycerine; sodium benzoate; benzoic acid; saccharin; vanillin; methylparaben; propylparaben; butylparaben; monobasic sodium phosphate monohydrate; water.
TABLETS: hydrated calcium silicate; methylcellulose; polacrilin potassium; magnesium stearate; sodium saccharin; saccharin; vanillin.
06.2 Incompatibility "-
No incompatibilities were observed.
06.3 Period of validity "-
Suspension: 2 years
Tablets: 4 years
06.4 Special precautions for storage -
Keep the bottle containing the suspension tightly closed.
06.5 Nature of the immediate packaging and contents of the package -
SUSPENSION:
- 90 ml glass bottle
TABLETS
blister (in PVC and aluminum) of 12 tablets
06.6 Instructions for use and handling -
None
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
WYETH LEDERLE SpA - Via Nettunense, 90 - Aprilia (LT)
under license from Wyeth-Ayerst Lab. USA
Dealer for Sale: WHITEHALL ITALIA SpA - Via G.Puccini n.3 - 20121 Milan
08.0 MARKETING AUTHORIZATION NUMBER -
90 ml BOTTLE of Suspension: AIC n.011068032
12 tablets: AIC n.011068044
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
90 ml bottle of Suspension: 12.1.1961 /31.5.2000
12 tablets: 13.7.1985 / 31.5.2000
6 single-dose sachets of suspension: 26.9.96 / 31.5.2000
10.0 DATE OF REVISION OF THE TEXT -
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