Active ingredients: Glucosamine
DONATES 250 mg hard capsules
DONATES 250 mg coated tablets
DONATES 1500 mg powder for oral solution
DONATES 750 mg film-coated tablets
DONATES 400mg / 3ml concentrate for solution for injection and solvent for intramuscular use with lidocaine
Why is Dona used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Other non-steroidal anti-inflammatory / antirheumatic drugs.
THERAPEUTIC INDICATIONS
Relief of symptoms in mild / moderate forms of knee osteoarthritis.
Contraindications When Dona should not be used
Hypersensitivity to the active substance or to any of the excipients.
Dona must not be used in patients who are allergic to shellfish, since the active ingredient is obtained from shellfish.
The injectable form, due to its lidocaine content, is contraindicated in patients with conduction heart disorders, acute heart failure and in patients with lidocaine hypersensitivity.
Precautions for use What you need to know before you take Dona
Dona should not be used for the treatment of children and adolescents below 18 years due to a lack of data on safety and efficacy.
To exclude the presence of concomitant diseases, for which other type of treatment could be considered, a doctor should be consulted.
In patients with glucose intolerance problems it is recommended to check blood glucose levels and, if applicable, insulin requirements, before starting treatment and periodically during treatment.
Monitoring of blood lipid levels is recommended in patients at risk of cardiovascular disease, as hypercholesterolemia has been observed in some cases in patients treated with glucosamine.
An exacerbation of asthma symptoms triggered after initiation of glucosamine therapy has been reported, (a situation which resolved after discontinuation of glucosamine administration).
Asthma patients starting glucosamine treatment should therefore be aware that symptoms can worsen.
No studies have been performed in patients with hepatic or renal insufficiency. The pharmacokinetic and toxicological profiles of the product do not indicate limitations for these patients, however careful monitoring by the physician is recommended when administering to patients with severe hepatic or renal insufficiency.
Interactions Which drugs or foods can modify the effect of Dona
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
Data on possible interactions of glucosamine with other drugs are limited.
Oral Anticoagulants: An increase in INR values has been reported with coumarin-based anticoagulants (warfarin and acenocoumarol). Patients being treated with coumarin anticoagulants should therefore be closely monitored when starting or ending glucosamine treatment.
Tetracyclines: Concomitant administration of tetracyclines may affect serum tetracycline concentration, but the clinical relevance of this interaction is probably limited.
Given the limited documentation available regarding drugs that can interact with glucosamine, one should be aware that the therapeutic response or concentration of drugs simultaneously in use may be altered.
Warnings It is important to know that:
Pregnancy
The use of DONA is not recommended in women who are pregnant or planning to become pregnant.
DONA should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
The use of ampoules in the early months of pregnancy should be avoided.
Feeding time
There are no data on the excretion of glucosamine sulphate in human breast milk and on the safety for the newborn. Therefore, the use of DONA during breastfeeding is not recommended.
Driving and using machines
Because DONA can cause headache, drowsiness and visual disturbances, caution should be exercised when driving and operating machinery.
Altered liver and / or renal function
No studies have been conducted in patients with impaired renal and / or hepatic function. Close medical supervision is recommended when administering to patients with severe hepatic or renal insufficiency.
Important information about some of the ingredients
This medicinal product contains 151 mg of sodium per daily dose (1500 mg). To be taken into consideration in people with reduced kidney function and who follow a low sodium diet.
DONA 250 mg hard capsules contain lactose, DONA 250 mg coated tablets contain sucrose, DONA 1500 mg powder for oral solution contains sorbitol therefore if your doctor has diagnosed an intolerance to some sugars, you should contact him before taking this medicine.
DONNA 1500 mg powder for oral solution contains aspartame (a source of phenylalanine). It can be harmful in patients with phenylketonuria.
Dosage and method of use How to use Dona: Dosage
ORAL
The daily dosage of oral glucosamine sulphate is 1500 mg, regardless of the pharmaceutical form and method of administration.
Unless otherwise prescribed by the doctor, we therefore recommend 2 capsules or 2 coated tablets of 250 mg 3 times a day (in the morning, at lunchtime and in the evening), or the contents of 1 sachet of 1500 mg (dissolved in a glass of water) or 2 film-coated tablets of 750 mg per day.
BY THE INTRAMUSCULAR WAY
1 or 2 pairs of vials, intramuscularly, 3 times a week for 4-6 weeks. Draw the contents of the pair of vials A (brown) and B (colorless) into the same syringe.
A slight yellow coloring of the solution for injection of vial A does not affect the activity and tolerability of the product.
Glucosamine is not indicated in the treatment of acute symptoms.
The reduction of symptoms (particularly the analgesic effect) may not occur before a few weeks of treatment and in some cases after an even longer period of time. If the analgesic effect is not achieved after 2-3 months, the continuation of glucosamine therapy should be reconsidered. Additional information for particular patient groups.
Use in children and adolescents
Dona should not be used for the treatment of children and adolescents under 18 years due to a lack of data on safety and efficacy.
Use in the elderly
No targeted studies have been performed in elderly patients, but according to clinical experience no dosage adjustment is required in the treatment of healthy elderly patients.
Patients with renal and / or hepatic impairment
For patients with renal and / or hepatic impairment it is not possible to suggest a dosage, as no studies have been conducted (see also section "Precautions for use").
Overdose What to do if you have taken too much Dona
No cases of overdose have been reported.
In case of accidental ingestion / intake of an overdose of DONA, notify your doctor immediately and contact the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE "USE OF DONATE, CONTACT YOUR DOCTOR OR PHARMACIST
Side Effects What are the side effects of Dona
Like all medicines, DONA can cause side effects, although not everybody gets them.
The side effects observed were the following:
- common (more than 1 out of 100 patients and less than 1 out of 10 patients): headache, somnolence, diarrhea, constipation, nausea, bloating, heaviness and pain in the stomach, dyspepsia;
- uncommon (more than 1 out of 1000 patients and less than 1 out of 100 patients): skin irritation, itching and redness of the skin. You may experience allergic reactions, visual disturbances, hair loss, bronchial asthma, increased blood glucose levels and injection site reactions
The injectable form, due to its lidocaine content, can sometimes cause nausea and very rarely even vomiting.
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package. The product must be kept away from heat sources.
Donate 250 mg hard capsules: store below 30 ° C.
Donate 1500 mg powder for oral solution: store below 30 ° C.
Donate 400 mg / 3 ml concentrate for solution for injection and solvent for intramuscular use with lidocaine,: store below 25 ° C.
Donate 750 mg film-coated tablets: this medicine does not require any special storage conditions.
Shelf life after opening the tablet container:
The period of validity after the first opening of the container of 60 tablets is 1 month, for the product stored at a temperature below 25 ° C. The shelf life after the first opening of the 180 tablet container is 3 months, for the product stored at a temperature below 25 ° C.
Do not use DONA if you notice obvious signs of deterioration of the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
COMPOSITION
DONATES 250 mg hard capsules
Each hard capsule contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 314.0 mg
equivalent to:
Glucosamine sulfate 250.0 mg Sodium chloride 64.0 mg
EXCIPIENTS
Corn starch, Lactose, Magnesium stearate, Talc.
COMPONENTS OF THE HARD JELLY CAPSULE
Titanium dioxide (E 171), Iron oxide (E 172), Erythrosine (E 127), Gelatin.
DONATES 250 mg coated tablets
Each coated tablet contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 314.0 mg
equivalent to:
Glucosamine sulfate 250.0 mg Sodium chloride 64.0 mg
EXCIPIENTS
Maize starch, Povidone, Microcrystalline cellulose, Sodium chloride, Macrogol glycerol ricinolate, Croscarmellose sodium, Magnesium stearate, Silicon dioxide, Sucrose, Talc, Triethyl citrate, Carmellose sodium, Copolymer methylacrylic acid ethyl acrylate 1: 1 ( 30 D), Colloidal silicon dioxide, Silicon fluid emulsion, titanium dioxide (E 171), Macrogol 6000, Kaolin, Glucose syrup, Montanglycol wax.
DONATES 1500 mg powder for oral solution
Each sachet contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 1884 mg
equivalent to
Glucosamine sulfate 1500 mg Sodium chloride 384 mg
EXCIPIENTS
Aspartame, Sorbitol, Citric acid, Macrogol 4000
DONATES 750 mg film-coated tablets
Each film-coated tablet contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 942.0 mg
equivalent to:
Glucosamine sulfate 750.0 mg Sodium chloride 192.0 mg
EXCIPIENTS
microcrystalline cellulose, Povidone, Croscarmellose sodium, Macrogol 6000, Magnesium stearate, Talc, Eudragit 12.5, Eudragit RL: 30 D, Titanium dioxide (E171), Triacetin.
DONATES 400mg / 3ml concentrate for solution for injection and solvent for intramuscular use with lidocaine
Each vial contains Vial A (brown)
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 502.5 mg
equivalent to:
Glucosamine sulfate 400.0 mg Sodium chloride 102.5 mg
EXCIPIENTS
Lidocaine hydrochloride, Water for injections.
Vial B (colorless) (solvent)
EXCIPIENTS Diethanolamine, Water for injections.
PHARMACEUTICAL FORM AND CONTENT
Hard capsules: Box of 10 hard capsules of 250 mg. Coated tablets: Box of 30 coated tablets of 250 mg. Powder for oral solution: Box of 20 sachets of 1500 mg. Concentrate for solution for injection and solvent for intramuscular use with lidocaine: Box of 6 concentrated ampoules of 2 ml + 6 ampoules of 1 ml solvent with 3.3% lidocaine Film-coated tablets: container for 60 and 180 tablets.
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
DONATE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
DONATES 250 mg hard capsules
Each hard capsule contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 314.0 mg
equivalent to: Glucosamine sulfate 250.0 mg
Sodium chloride 64.0 mg
Excipients: Lactose
For the full list of excipients, see section 6.1
DONATES 250 mg coated tablets
Each coated tablet contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 314.0 mg
equivalent to: Glucosamine sulfate 250.0 mg
Sodium chloride 64.0 mg
Excipients: glucose syrup, sucrose
For the full list of excipients, see section 6.1
DONATES 1500 mg powder for oral solution
Each sachet contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 1884 mg
equivalent to: Glucosamine sulfate 1500 mg
Sodium chloride 384 mg
Excipients: aspartame and sorbitol
For the full list of excipients, see section 6.1
DONATES 750 mg film-coated tablets
Each film-coated tablet contains:
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 942.0 mg
equivalent to: Glucosamine sulfate 750.0 mg
Sodium chloride 192.0 mg
DONATE with lidocaine 400 mg / 3 ml concentrate and solvent for solution for injection for intramuscular use
For the full list of excipients, see section 6.1
DONATES 400mg / 3ml concentrate for solution for injection and solvent for intramuscular use with lidocaine
Each vial contains
Vial A (brunette)
ACTIVE PRINCIPLE
Glucosamine sulfate sodium chloride 502.5 mg
equivalent to: Glucosamine sulfate 400.0 mg
Sodium chloride 102.5 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Hard capsules - coated tablets - powder for oral solution - film coated tablets - concentrate for solution for injection and solvent for intramuscular use with lidocaine
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Relief of symptoms in mild / moderate forms of knee osteoarthritis.
04.2 Posology and method of administration
ORAL
The daily dosage of oral glucosamine sulfate is 1500 mg, regardless of the pharmaceutical form and method of administration.
Unless otherwise prescribed by the doctor, we therefore recommend 2 capsules or 2 coated tablets of 250 mg 3 times a day (in the morning, at lunchtime and in the evening), or the contents of 1 sachet of 1500 mg (dissolved in a glass of water) or 2 film-coated tablets of 750 mg per day.
BY THE INTRAMUSCULAR WAY
1 or 2 pairs of vials, intramuscularly, 3 times a week for 4-6 weeks.
Draw the contents of the pair of vials A (brown) and B (colorless) into the same syringe.
A slight yellow coloring of the solution for injection of vial A does not affect the activity and tolerability of the product.
Glucosamine is not indicated for the treatment of acute symptoms.
The reduction of symptoms (particularly the analgesic effect) may not occur before a few weeks of treatment and in some cases after an even longer period of time. If the analgesic effect is not achieved after 2-3 months, the continuation of glucosamine therapy should be reconsidered.
Additional information for particular patient groups.
Use in children and adolescents
Dona is not to be used for the treatment of children and adolescents under the age of 18.
Use in the elderly
No targeted studies have been performed in elderly patients, but according to clinical experience no dosage adjustment is required in the treatment of healthy elderly patients.
Patients with renal and / or hepatic impairment
For patients with renal and / or hepatic impairment it is not possible to suggest a dosage as no studies have been conducted (see also section 4.4).
04.3 Contraindications
Hypersensitivity to glucosamine or to any of the excipients.
Dona must not be used in patients who are allergic to shellfish, since the active ingredient is obtained from shellfish.
The injectable form, due to its lidocaine content, is contraindicated in patients with conduction heart disorders, acute heart failure and in patients with lidocaine hypersensitivity.
04.4 Special warnings and appropriate precautions for use
Dona should not be used for the treatment of children and adolescents below 18 years due to a lack of data on safety and efficacy.
To exclude the presence of concomitant diseases, for which other type of treatment could be considered, a doctor should be consulted.
In patients with glucose intolerance problems it is recommended to check blood glucose levels and, if applicable, insulin requirements, before starting treatment and periodically during treatment.
Monitoring of blood lipid levels is recommended in patients at risk of cardiovascular disease, as hypercholesterolemia has been observed in some cases in patients treated with glucosamine.
An exacerbation of asthma symptoms triggered after initiation of glucosamine therapy has been reported, (a situation which resolved after discontinuation of glucosamine administration).
Asthma patients starting glucosamine treatment should therefore be aware that symptoms can worsen.
No studies have been performed in patients with hepatic or renal insufficiency. The pharmacokinetic and toxicological profiles of the product do not indicate limitations for these patients, however careful monitoring by the physician is recommended when administering to patients with severe hepatic or renal insufficiency.
The sodium content of the oral formulations (151 mg in total at a daily dose of 1500 mg) should be taken into consideration in patients requiring sodium intake restriction (eg patients with impaired renal function or on a low-fat diet). sodium content).
There powder for oral solution it must not be taken by patients with rare hereditary problems of fructose intolerance due to its sorbitol content. Furthermore, due to the presence in the composition of aspartame (source of phenylalanine) it is contraindicated in case of phenylketonuria.
The capsules, due to their lactose content, should not be taken by patients with rare hereditary problems of galactose intolerance, lactase deficiency and glucose-galactose malabsorption.
The coated tablets , due to their sucrose content, they should not be taken by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, sucrase isomaltase insufficiency.
04.5 Interactions with other medicinal products and other forms of interaction
Data on possible interactions of glucosamine with other drugs are limited.
Oral anticoagulants:
An increase in INR values has been reported with coumarin-based anticoagulants (warfarin and acenocoumarol). Patients being treated with coumarin anticoagulants should therefore be closely monitored when starting or ending glucosamine treatment.
Tetracyclines:
Concomitant administration of tetracyclines may affect serum tetracycline concentration, but the clinical relevance of this interaction is probably limited.
Given the limited documentation available regarding drugs that can interact with glucosamine, one should be aware that the therapeutic response or concentration of drugs simultaneously in use may be altered.
04.6 Pregnancy and lactation
Pregnancy
There are no adequate data on the use of glucosamine in pregnant women. There are insufficient data available from animal studies. Therefore glucosamine should not be used during pregnancy and its administration should be discontinued in women who have fertility problems. or who are undergoing fertility investigations.
Feeding time
No data are available on the excretion of glucosamine sulfate in breast milk. The use of glucosamine during breastfeeding is therefore not recommended as there are no data on safety for the newborn.
04.7 Effects on ability to drive and use machines
No studies on the effect of glucosamine on the ability to drive and use machines have been performed. If you experience dizziness, somnolence, headache or visual disturbances you should avoid driving and using machines.
04.8 Undesirable effects
The most common adverse reactions associated with glucosamine treatment are nausea, abdominal pain, indigestion, constipation, diarrhea, dyspepsia, bloating, heaviness and stomach pain.
Skin irritation, itching and redness may occur uncommonly
Increased blood glucose levels, visual disturbances, hair loss, bronchial asthma and injection site reactions have also been reported with unknown frequency (not estimable from available data).
Adverse reactions reported are usually mild in intensity and transient.
The injectable form, due to its lidocaine content, can sometimes cause nausea and very rarely even vomiting.
In the following table, within each frequency class, the undesirable effects are listed in descending order of severity.
* whose frequency cannot be estimated from the available data
Sporadic cases of hypercholesterolemia have been reported from spontaneous reports, but a cause-and-effect relationship has not been established.
04.9 Overdose
No cases of overdose have been reported.
However, if overdose occurs, treatment should be symptomatic.
In such cases it is necessary to re-establish the hydro-electrolytic balance
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other anti-inflammatory and antirheumatic active ingredients, non-steroidal anti-inflammatory drugs. ATC code: M01AX05.
Glucosamine is an endogenous substance, a normal component of the polysaccharide chains of the glucosaminoglycans of the cartilage matrix and of the synovial fluid. In vitro and in vivo studies have shown that glucosamine stimulates the synthesis of glycosaminoglycans and proteoglycans by chondrocytes and hyaluronic acid by synoviocytes.
The mechanism of action of glucosamine in humans is not known.
It was not possible to establish the time period leading to the onset of the therapeutic response.
05.2 Pharmacokinetic properties
Glucosamine is a relatively small molecule (molecular weight 179), easily soluble in water and soluble in hydrophilic organic solvents.
There is limited information available on the pharmacokinetics of glucosamine. The absolute bioavailability in humans is unknown. The volume of distribution is approximately 5 liters and the half-life following intravenous administration is approximately 2 hours. Approximately 38% of an intravenous dose is eliminated by renal excretion as unchanged substance.
05.3 Preclinical safety data
The acute toxicity of D-glucosamine is low.
There are no animal experimental data on repeated dose toxicity, reproductive toxicity, mutagenicity and carcinogenic potential available for glucosamine.
Results from in vitro and in vivo animal studies have shown that glucosamine reduces insulin secretion and induces insulin resistance, possibly through inhibition of glucokinase in beta cells. The clinical relevance is unknown.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
DONATES 250 mg hard capsules
Corn starch, Lactose, Magnesium stearate, Talc, Pure gelatin, erythrosine (E127), titanium dioxide (E171), iron oxide (E172)
DONATES 250 mg coated tablets:
Maize starch, Povidone, Microcrystalline cellulose, Sodium chloride, Macrogol glycerol ricinolate, Croscarmellose sodium, Magnesium stearate, Silicon dioxide, Sucrose, Talc, Triethyl citrate, Carmellose sodium, 1: 1 methylacrylic acid-ethylacrylate copolymer ( Eudragit L 30 D), Colloidal silicon dioxide, Silicon fluid emulsion, titanium dioxide (E 171), Macrogol 6000, Kaolin, Glucose syrup, Montanglycol wax.
DONATES 1500 mg powder for oral solution:
Aspartame, Sorbitol, Citric acid, Macrogol 4000
DONATE film-coated tablets:
Microcrystalline cellulose, Povidone, Croscarmellose sodium, Macrogol 6000, Magnesium stearate, Talc, Eudragit 12.5, Eudragit RL 30 D, Titanium dioxide (E171), Triacetin.
Donate 400mg / 3ml concentrate for solution for injection and solvent for intramuscular use with lidocaine
Vial A (brown): Lidocaine hydrochloride, Water for injections.
Vial B (colorless) (solvent): Diethanolamine, Water for injections.
06.2 Incompatibility
There are no known pharmaceutical incompatibilities regarding the oral form.
It is not recommended to use DONA as a "mixed" solution for injection.
06.3 Period of validity
DONATE 250 mg hard capsules: 5 years
DONATE 250 mg coated tablets: 5 years
DONATES 1500 mg powder for oral solution: 3 years
DONATES 750 mg film-coated tablets: 3 years
Shelf life after opening the tablet container:
The shelf life after first opening the container of 60 tablets is 1 month, for the product stored at a temperature below 25 ° C. The shelf life after first opening the 180 tablet container is 3 months, for the product stored at a temperature below 25 ° C.
DONATES 400mg / 3ml concentrate for solution for injection and solvent for intramuscular use with lidocaine: 2 years
The expiry date indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
DONA 250 mg coated tablets - 250 mg hard capsules The product should be kept away from heat sources.
Donate 1500 mg powder for oral solution: store below 30 ° C.
Dona 400mg / 3ml concentrate for solution for injection and solvent for intramuscular use with lidocaine store below 25 ° C.
Donate 750 mg film-coated tablets: this medicine does not require any special storage conditions
06.5 Nature of the immediate packaging and contents of the package
- Box of 10 hard capsules
- Box of 30 coated tablets
- Box of 20 sachets
- Tablet container of 60 film-coated tablets
- Tablet container of 180 film-coated tablets
- Box of 6 concentrated vials of 2 ml + 6 solvent vials of 1 ml with 3.3% lidocaine
06.6 Instructions for use and handling
Before using the solution for injection, mix the contents of ampoule A (brown), which contains glucosamine sulphate and lidocaine, and ampoule B (colorless), which contains the solvent, by drawing them into the same syringe (see section 4.2 posology and method of administration).
07.0 MARKETING AUTHORIZATION HOLDER
08.0 MARKETING AUTHORIZATION NUMBER
Donate 250 mg hard capsules, 10 capsules Code 026023010
Donate 250 mg coated tablets, 30 tablets Code 026023046
Donate 1500 mg powder for oral solution, 20 sachets Code 026023061
Donate 750 mg film-coated tablets, 60 tablets Code 026023085
Donate 750 mg film-coated tablets, 180 tablets Code 026023097
Donate 400mg / 3ml concentrate for solution and solvent for intramuscular use with lidocaine:
Code 026023059
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Hard capsules, coated tablets, concentrate and solvent for solution for injection and solvent for intramuscular use:
Date of first authorization: October 1985
Renewal date: May 2005
Powder for oral solution:
Date of first authorization: March 1991
Renewal date: May 2005
Donate film-coated tablets
Date of first authorization: March 2009
Renewal date: May 2010
10.0 DATE OF REVISION OF THE TEXT
March 2011
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