Active ingredients: Rhubarb, Cascara, Genziana, Boldo
AMARO MEDICINAL GIULIANI 3.77 mg / ml + 1.28 mg / ml + 1.18 mg / ml + 1.06 mg / ml oral solution
AMARO MEDICINAL GIULIANI 71.2 mg + 24.2 mg + 22.2 mg + 20 mg oral solution
Why is Amaro medicinal giuliani used? What is it for?
AMARO MEDICINALE GIULIANI contains the active ingredients Rhubarb, Gentian and Boldo as soft extracts and Cascara as dry extract.
This medicine stimulates digestion and appetite and is also used as a laxative. AMARO MEDICINALE GIULIANI is used in adults and children (over 10 years of age) in case of:
- Digestive difficulties (such as a feeling of heaviness in the stomach, sleepiness after meals).
- Lack of appetite.
- Short-term treatment of occasional constipation.
Talk to your doctor if you do not feel better or if you feel worse after the treatment period prescribed by your doctor, while in the case of use as a laxative after 7 days.
Contraindications When Amaro medicinal giuliani should not be used
Do not take AMARO GIULIANI MEDICINAL
- If you are allergic to the active substances or any of the other ingredients of this medicine
- If you experience acute abdominal pain of unknown origin.
- If you feel sick or vomit.
- If you are subject to intestinal stenosis (narrowing of the intestine) or intestinal obstruction (impeding the normal progression of semiliquid, gaseous and solid material, in the various parts of the intestine).
- If you have rectal bleeding (from the last part of the intestine) of unknown origin
- If you are severely dehydrated (excessive fluid loss).
Precautions for use What you need to know before taking Amaro medicinal giuliani
Talk to your doctor or pharmacist before taking AMARO MEDICINALE GIULIANI, in particular:
- If you are elderly or in poor health.
- If you are pregnant or breastfeeding.
- In case of children under the age of 10.
Constipation
First of all you must keep 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 bowel movements are reduced compared to your personal habits and are associated with the emission of hard stools.
Consult your doctor:
- If episodes of constipation occur repeatedly.
- When the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks.
- When the use of the laxative produces no effects.
It is important to know that the abuse of laxatives (frequent or prolonged use or excessive doses of drugs with a purgative, evacuating, anti-constipation action) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other factors essential nutrients (see section "If you take more GIULIANI AMARO MEDICINAL PRODUCT than you should"). In severe cases it is possible the onset of dehydration or hypokalaemia (potassium deficiency) which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides (drugs used for heart diseases), diuretics (drugs used to increase the production of urine) or corticosteroids (anti-inflammatory drugs). 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).
Children and adolescents
In children under the age of 10, the medicine can only be used after consulting your doctor.
Interactions Which drugs or foods can modify the effect of Amaro medicinal giuliani
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid taking laxatives and other drugs at the same time, as laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally (by mouth).
Before taking AMARO MEDICINALE GIULIANI, if you have taken an antacid, leave an interval of at least one hour, as antacids can modify the effect of the medicine; two hours, in case he had taken another medicine.
AMARO MEDICINALE GIULIANI with food and drink
Milk can modify the effect of AMARO MEDICINALE GIULIANI. If you have taken milk, leave an interval of at least one hour before taking the medicine.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. . Only take this medicine when needed and under the direct supervision of your doctor, who will carefully weigh the expected benefit to you in relation to the possible risk to your baby.
Driving and using machines
AMARO MEDICINALE GIULIANI has no effect on driving and using machines.
AMARO MEDICINALE GIULIANI contains paraidoxybenzoates which can cause allergic reactions, even delayed ones.
AMARO MEDICINALE GIULIANI contains ethyl alcohol.
This medicinal product contains 10 vol% ethanol (alcohol), i.e. up to 1.5 g of alcohol per dose, equivalent to 38 ml of beer or 16 ml of wine per dose.
It can be harmful to alcoholics.
To be taken into consideration for pregnant or lactating women, children and high-risk groups such as people with liver disease (especially those with chronic alcoholism) or epilepsy.
Furthermore, for those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine a positive anti-doping test in relation to the alcohol concentration limits indicated by some sports federations.
AMARO MEDICINALE GIULIANI contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, contact your doctor before taking this medicinal product.
AMARO MEDICINALE GIULIANI contains 1.12 mmol sodium per dose (in the case of vials 1.06 mmol per dose). To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.
Dose, Method and Time of Administration How to use Amaro medicinal giuliani: Dosage
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. You can take AMARO MEDICINALE GIULIANI as it is or diluted in water. In any case, take a large glass of water after taking the medicine. Take into account that a diet rich in liquids favors the effect of the medicine.
Adults
To aid digestion by stimulating biliary function:
- in the case of GIULIANI AMARO MEDICINALE in bottle: take a measuring cup (equal to 20 ml, measurable with the dispenser included) after the two main meals
- in the case of AMARO MEDICINALE GIULIANI in a vial: take a single-dose vial after the two main meals.
To stimulate the appetite:
- in the case of GIULIANI AMARO MEDICINALE in bottle: take a measuring cup (equal to 20 ml, measurable with the dispenser included) before the two main meals,
- in the case of AMARO MEDICINALE GIULIANI in a vial: take a single-dose vial, before the two main meals.
As a laxative:
- in the case of GIULIANI AMARO MEDICINALE in bottle: take 1-2 measuring glasses (equal to 20-40 ml, measurable with the included dispenser) preferably in the evening, before going to bed,
- in the case of GIULIANI AMARO MEDICINALE in a vial: take 1-2 single-dose vials, preferably in the evening, before going to bed.
Laxatives should be used as infrequently as possible and for no more than 7 days. The use for longer periods of time requires a doctor's prescription, after adequate evaluation of the individual case.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Use in children and adolescents
Consult your doctor before administering AMARO MEDICINALE GIULIANI to children under 10 years of age.
The use of AMARO MEDICINALE GIULIANI in children over 10 years of age requires that the doses be halved and that the product is diluted in water. The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces.
It is advisable to initially use the minimum doses provided.
When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Warning: do not exceed the indicated doses without medical advice.
If you forget to take AMARO MEDICINALE GIULIANI
Do not take a double dose to make up for a forgotten dose, but resume your normal dose schedule as directed.
If you stop using AMARO MEDICINALE GIULIANI
No effects were found due to discontinuation of treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken an overdose of Amaro medica giuliani
Excessive doses of this medicine can cause abdominal pain and diarrhea resulting in loss of fluids and electrolytes which must be replaced.
In case of accidental ingestion of an excessive dose of AMARO MEDICINALE GIULIANI, contact your doctor or the nearest hospital immediately.
Side Effects What are the side effects of Amaro medicinal giuliani
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Occasionally, following the use of AMARO MEDICINALE GIULIANI, side effects may occur such as pains such as isolated cramps or abdominal colic, more frequent in cases of severe constipation.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month and to the unopened, correctly stored product. After first opening the bottle, use the medicine within 18 months.
No special storage precautions are required.
Do not use this medicine if you notice visible signs of deterioration.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment. It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Other Information
What contains AMARO MEDICINALE GIULIANI 100 g of solution contain:
Active principles:
Rhubarb soft extract 356 mg
Cascara dry extract 121 mg
Gentian soft extract 111 mg
Boldo soft extract 100 mg
Other components: Natural flavors, Glycerin, Caramel, Sodium bicarbonate, Esters of hydroxybenzoic acid, sodium salt, Alcohol, Essences, Sucrose, Water.
Description of the appearance of AMARO MEDICINALE GIULIANI and contents of the pack
AMARO MEDICINALE GIULIANI in bottle:
Oral solution contained in a bottle of 200 g, 400 g, 450 g, 500 g, 750 g. Amber glass bottle, closed with an aluminum cap, pilfer-proof (screw cap with tamper-proof pre-breaking), equipped with plastic sub-cap and a 20 ml measuring cup.
AMARO MEDICINALE GIULIANI in vials:
Oral solution contained in 6 single-dose vials of 20g of amber glass, closed with an aluminum cap, equipped with a plastic cap.
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
AMARO MEDICINAL GIULIANI ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of solution contain:
Active principles:
Rhubarb soft extract 356 mg
Cascara dry extract 121 mg
Gentian soft extract 111 mg
Boldo soft extract 100 mg
Excipients with known effects: parahydroxybenzoates, ethyl alcohol, sucrose, sodium
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Solution for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
AMARO MEDICINALE GIULIANI is used in adults and children (over 10 years of age) in case of:
• Digestive difficulties (such as a feeling of heaviness in the stomach, sleepiness after meals).
• Lack of appetite.
• Short-term treatment of occasional constipation.
04.2 Posology and method of administration
Dosage
Adults
To aid digestion by stimulating biliary function:
• in the case of GIULIANI AMARO MEDICINALE in bottle: a measuring cup (equal to 20 ml, measurable with the dispenser included) after the two main meals,
• in the case of GIULIANI AMARO MEDICINALE in a vial: a single-dose vial after the two main meals.
To stimulate the appetite:
• in the case of GIULIANI AMARO MEDICINALE in bottle: a measuring cup (equal to 20 ml, measurable with the dispenser included) before the two main meals,
• in the case of GIULIANI AMARO MEDICINALE in a vial: a single-dose vial, before the two main meals.
As a laxative:
• in the case of GIULIANI AMARO MEDICINAL in a bottle: 1-2 measuring cups (equal to 20-40 ml, measurable with the included doser in the evening, before going to bed,
• in the case of GIULIANI AMARO MEDICINALE in a vial: 1-2 single-dose vials, preferably in the evening, before going to bed.
Laxatives should be used as infrequently as possible and for no more than 7 days.
The use for longer periods of time requires a doctor's prescription, after adequate evaluation of the individual case.
Pediatric population
The use of AMARO MEDICINALE GIULIANI in children over 10 years of age requires that the doses be halved and that the product is diluted in water. The correct dose is the minimum sufficient to produce an evacuation of soft faeces.
It is advisable to initially use the minimum doses provided.
When necessary, the dose can then be increased, but without ever exceeding the maximum indicated.
Method of administration
AMARO MEDICINALE GIULIANI can be taken as such or diluted in water.
In any case, swallow the medicine together with an adequate quantity of water (a large glass). A diet rich in liquids promotes the effect of the medicine.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the other ingredients of this medicinal product listed in section 6.1.
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.
04.4 Special warnings and appropriate precautions for use
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).
If episodes of constipation occur repeatedly, a doctor should be consulted.
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) lasting more than two weeks or when the use of the laxative fails to produce effects.
It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine.
Pediatric population
In children under the age of 10, the medicine can only be used after consulting your doctor.
Important information about some of the excipients
The product contains sucrose, this should be taken into account in case of diabetes or low calorie diets. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
The product contains parahydroxybenzoates. It can cause allergic reactions (even delayed).
This medicinal product contains 10 vol% ethanol (alcohol), i.e. up to 1.5 g of alcohol per dose, equivalent to 38 ml of beer or 16 ml of wine per dose.
It can be harmful to alcoholics.
To be taken into consideration for pregnant or lactating women, children and high-risk groups such as people with liver disease (especially those with chronic alcoholism) or epilepsy.
This medicinal product contains 1.12 mmol sodium per dose (in the case of vials 1.06 mmol per dose). To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.
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 modify the effect of the medicine; leave an interval of at least 1 hour 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, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.
04.7 Effects on ability to drive and use machines
AMARO MEDICINALE GIULIANI has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicine is important as it allows for continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. website: http://www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose
Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced.
See also what is reported in the paragraph " Special warnings and precautions for "use" about the abuse of laxatives.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
GIULIANI MEDICINAL AMARO promotes digestive activity. The bitter taste components of the product, Rhubarb and Gentian, tend to stimulate the appetite, promoting an increase in the secretion of gastric juices with a consequent improvement in digestion. The presence of Boldo tends to increase bile flow favoring the digestion of fats. The mildly laxative effect of Cascara confers greater motility to the intestine.
The various natural components of AMARO MEDICINALE GIULIANI therefore exert an overall eupeptic, digestive and regulating activity of the intestine.
The preparation has highlighted a series of pharmacodynamic activities that document its efficacy and usability in the therapeutic field in various functional affections of the digestive system; in particular, the stimulating effects of salivary secretion and gastric secretion with acceleration of gastric emptying and intestinal transit.
From the hepatobiliary point of view, a choleretic and cholagogue effect has been documented.
05.2 Pharmacokinetic properties
The active components of Rhubarb are anthracenic derivatives partly free and partly glycosylated.
The active components of Cascara (Cascarosides) are also glycosylated oxygenated anthracenic derivatives. They arrive unaltered in the large intestine where they are transformed into Aloin and Aloemodina and finally into Reina. All of these metabolites are predominantly excreted in the faeces.
Boldina is the active component of Boldo which, after exerting its choleretic action, passes into the colon where it is absorbed for about 10%. The remaining 90% approx. it is eliminated in the faeces.
The active component of Gentian is Amarogentina, which carries out its action in the oral cavity and in the stomach, then passes into the intestine where it is inactivated and largely eliminated with the faeces.
05.3 Preclinical safety data
The product, tested on the most common laboratory animals, has very low acute toxicity, so it is still well tolerated from a general point of view for the administration routes recommended in human medicine (i.e. the oral route) even in doses many times higher than those recommended or in any case achievable in clinical practice (LD50 greater than 39.96 g / kg).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Natural flavors, Glycerin, Caramel, Sodium bicarbonate, Esters of p-hydroxy-benzoic acid, sodium salt, Alcohol, Essences, Sucrose, Water.
06.2 Incompatibility
This medicinal product must not be mixed with other medicinal products, in particular with antacids and milk (see section 4.5).
06.3 Period of validity
24 months in intact packaging.
18 months after first opening the bottle.
06.4 Special precautions for storage
No special storage precautions.
For storage conditions after first opening see section 6.3.
06.5 Nature of the immediate packaging and contents of the package
Oral solution contained in a bottle 200g, 400g, 450g, 500g or 750g of amber glass, closed with pilfer-proof aluminum capsule with plastic cap and a 20ml measuring cup.
Oral solution contained in 6 single-dose vials of 20 g of amber glass, closed with an aluminum cap, equipped with an undercap in plastic material.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions for disposal.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
GIULIANI S.p.A. via Palagi, 2 - 20129, Milan
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. 002427223 - "solution for oral use" Bottle 200 g
A.I.C. 002427274 - "solution for oral use" Bottle 400 g
A.I.C. 002427209 - "solution for oral use" Bottle 450 g
A.I.C. 002427173 - "solution for oral use" Bottle 500 g
A.I.C. 002427033 - "solution for oral use" Bottle 750 g
A.I.C. 002427161 - "solution for oral use" 6 single-dose containers g 20
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 12 September 1949
Date of most recent renewal: November 2009
10.0 DATE OF REVISION OF THE TEXT
September 2015
