Active ingredients: Cassia angustifolia, Cassia fistula
TAMARINE® JAM 8% + 0.39% LAXATIVE
Tamarine package inserts are available for pack sizes:- TAMARINE® JAM 8% + 0.39% LAXATIVE
- TAMARINE® SORBITOL SYRUP
Why is Tamarine used? What is it for?
WHAT IS IT:
TAMARINE jam is a laxative.
WHY IT IS USED:
TAMARINE is used for the short-term treatment of occasional constipation.
Contraindications When Tamarine should not be used
Diabetes and hypersensitivity to the active substances or to any of the excipients.
Laxatives are contraindicated in subjects with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.
Contraindicated in children under 10 years of age.
Generally contraindicated during pregnancy and breastfeeding.
Precautions for use What you need to know before taking Tamarine
The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.
Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that the subjects elderly or in poor health conditions consult your doctor before using the medicine.
Interactions Which drugs or foods can modify the effect of Tamarine
If you are using other medicines ask your doctor or pharmacist for advice.
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally.
Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.
Milk or antacids can change the effect of the medicine; allow an interval of at least one hour to elapse before taking the laxative.
Warnings It is important to know that:
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors.
In severe cases, the onset of dehydration or hypokalaemia (decrease in potassium in the blood) is possible, which can cause cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
NOTES ON HEALTH EDUCATION
First of all it must be borne in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can permanently solve the problem of constipation.
Many people think they suffer from constipation if they fail to evacuate every day. This is a mistaken belief as this situation is completely normal for a large number of individuals.
Consider, instead, that constipation occurs when the bowel movements are reduced compared to your personal habits and are associated with the emission of hard stools. If the episodes of constipation occur repeatedly, the doctor must be consulted.
What to do during pregnancy and breastfeeding:
There are no adequate and well-controlled studies on the use of the medicine in pregnancy. Therefore, Tamarine should only be used in pregnancy after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Tamarine should not be used while breastfeeding.
Dose, Method and Time of Administration How to use Tamarine: Posology
How many
The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to use the minimum doses initially. When necessary, the dose can then be increased, but never exceed the indicated one.
Adults: 1 teaspoon after the evening meal.
Children over 10 years: 1/4 teaspoon after the evening meal.
When, how and for how long
Take preferably in the evening. Swallow with an adequate amount of water (a large glass). A diet rich in liquids promotes the effect of the medicine.
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Overdose What to do if you have taken too much Tamarine
Excessive doses can cause abdominal pain and diarrhea; the resulting loss of fluids and electrolytes must be replaced with fluid intake.
In case of accidental ingestion / intake of an excessive dose of Tamarine jam, notify your doctor immediately or go to the nearest hospital.
See also the information in the "It's important to know" section about laxative abuse.
Side Effects What are the side effects of Tamarine
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
With use of the product, the urine sometimes turns slightly yellow-brown or red. This coloration is simply due to the presence of senna components in the urine and is not clinically significant.
Compliance with the instructions given here reduces the risk of unwanted effects. However, when they occur, it is advisable to consult your doctor or pharmacist. 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 at a temperature not exceeding 25 ° C, in its original packaging.
Keep container tightly closed.
Warning: do not use the medicine after the expiry date indicated on the package.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN
It is important to always have the information on the medicine available, so keep the package leaflet.
Deadline "> Other information
COMPOSITION:
100 g of product contain:
Active ingredients: Cassia Angustifolia (dry extract 1: 5) g 8; Cassia Fistula (dry extract 1: 4) g 0.39.
Excipients: tamarindus indica soft extract, coriandrum sativum powder, glycyrrhiza glabra dry extract, sodium methyl paraoxybenzoate, potassium sorbate, fruit, sugar, water.
HOW IT LOOKS:
TAMARINE comes in the form of jam contained in a 260 g jar.
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 -
TAMARINE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Jam: per 100 g of product:
Active ingredients: Cassia Angustifolia (dry extract 1: 5) g 8 - Cassia fistula (dry extract 1: 4) g 0.39.
Syrup: for 100 g of product:
Active ingredients: Cassia angustifolia purified soft extract g 8, corresponding to g 0.20 of sennosides - Cassia fistula (dry extract 1: 4) g 0.39.
For excipients see 6.1
03.0 PHARMACEUTICAL FORM -
Marmalade
Syrup
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Short-term treatment of occasional constipation
04.2 Posology and method of administration -
The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to use the minimum doses initially. When necessary, the dose can then be increased, but never exceed the indicated one. Take preferably in the evening.
MARMALADE:
Adults: 1 teaspoon.
Children over 10 years: ¼ of a coffee spoon.
SYRUP:
Adults: from ½ teaspoon to 3 teaspoons after the evening meal. Start with a teaspoon and adjust the dosage according to the result obtained.
Children over 10 years: half the dose.
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Swallow with an adequate amount of water (a large glass). A diet rich in liquids promotes the effect of the medicine.
04.3 Contraindications -
Diabetes.
Hypersensitivity to the active substances or to any of the excipients.
Laxatives are contraindicated in subjects with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.
Contraindicated in children under 10 years of age.
Generally contraindicated during pregnancy and lactation (see p. 4.6).
04.4 Special warnings and appropriate precautions for use -
Warnings
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors.
In severe cases, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
Precautions for use
The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.
Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that the subjects elderly or in poor health conditions consult your doctor before using the medicine.
04.5 Interactions with other medicinal products and other forms of interaction -
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally.
Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.
Milk or antacids can change the effect of the medicine; allow an interval of at least one hour to elapse before taking the laxative.
04.6 Pregnancy and breastfeeding -
There are no adequate and well-controlled studies on the use of the drug in pregnancy or lactation. Therefore, since anthraquinone laxatives can be excreted in breast milk, nursing mothers should avoid taking Tamarine.
04.7 Effects on ability to drive and use machines -
No known effects on ability to drive and use of machines.
04.8 Undesirable effects -
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
With use of the product, the urine sometimes turns slightly yellow-brown or red. This coloration is simply due to the presence of senna components in the urine and is not clinically significant.
04.9 Overdose -
Excessive doses can cause abdominal pain and diarrhea; the resulting loss of fluids and electrolytes must be replaced with fluid intake.
Treatment: discontinuation of the drug.
See also the information in the section "Special warnings and precautions for use" regarding the abuse of laxatives.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: laxatives - ATC code: A06AB56.
The active ingredients (sennosides) contained in TAMARINE are obtained from the Cassia Fistula and Cassia Angustifolia plants.
The action of the sennosides present in TAMARINE has been studied in mice at doses between 9.4 and 14.1 mg / kg at 3 and 6 hours. The laxative effect, which is a function of the dose administered, is produced after about 6 hours, given that the sennosides, thanks to the protective action of the carbohydrate fraction, are not absorbed in the upper gastrointestinal tract and carry out their action in the colon.
05.2 "Pharmacokinetic properties -
In humans, TAMARINE was studied in the elderly at a dose of 5 g as a single administration in the evening and the effect was observed over a period of one week. There were no changes in blood sodium and potassium levels following treatment; TAMARINE was generally well tolerated.
The sennosides present in TAMARINE are eliminated in the faeces as metabolites; they are found unchanged for less than 5% in the faeces and for less than 5% in the urine.
05.3 Preclinical safety data -
The safety of TAMARINE has been studied in mice for up to 16 weeks at doses up to 250 mg / kg of weight against a control group. The drug proved to be well tolerated and did not cause histological changes and did not affect the general welfare conditions of the animal.
The LD50 value in mice is> 5000 mg / kg per os.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Marmalade:
Tamarindus indica soft extract, coriandrum sativum powder, glycyrrhiza glabra dry extract, sodium methyl paraoxybenzoate, potassium sorbate, fruit, sugar, water.
Syrup:
Tamarindus indica dry extract, coriandrum sativum fluid extract, glycyrrhiza glabra dry extract, sodium methyl paraoxybenzoate, potassium sorbate, sorbitol syrup, water.
06.2 Incompatibility "-
There are no chemical incompatibilities with other drugs.
06.3 Period of validity "-
2 years.
06.4 Special precautions for storage -
Store at a temperature not exceeding 25 ° C. Keep container tightly closed.
06.5 Nature of the immediate packaging and contents of the package -
- 260g glass jar with cap and undercap in non-toxic plastic material.
- Yellow glass bottle.
06.6 Instructions for use and handling -
See section 4.2 "Posology and method of administration".
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Pfizer Italia S.r.l. - Consumer Healthcare Division, Via Isonzo 71, 04100 Latina
08.0 MARKETING AUTHORIZATION NUMBER -
TAMARINE laxative jam (260 g) AIC n ° 021528157
TAMARINE sorbitol syrup AIC n ° 021528106
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
January 1979/31 May 2010
10.0 DATE OF REVISION OF THE TEXT -
May 2011
