Active ingredients: sodium chondroitin sulphate
CONDROSULF 400 mg hard capsules
CONDROSULF 400 mg granules for oral solution
Indications Why is Condrosulf used? What is it for?
CONDROSULF is a medicine used for the treatment of deformations resulting from the degradation of the joints (osteoarthritis) of the knee and hip; its active ingredient is chondroitin-sulphate, which is the main component of cartilage.
CHONDROSULF relieves joint pain and improves joint mobility.
Contraindications When Condrosulf should not be used
Do not take CHONDROSULF if:
- you are allergic to the active substance or to other chemically similar substances, or to any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Condrosulf
CONDROSULF should be used with caution in individuals particularly at risk of allergies. Tell your doctor or pharmacist before taking this medicine if you have allergies. CHONDROSULF granules for oral solution contains:
- sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- orange yellow S (E 110). It can cause allergic reactions.
- sodium (1.59 mmol per dose). To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.
Children and adolescents
CONDROSULF is not recommended for children and adolescents under 18 years of age.
Interactions Which drugs or foods can modify the effect of Condrosulf
There are no known interactions between CHONDROSULF and other drugs. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
This medicine should be used during pregnancy or breastfeeding only when clearly needed and under strict medical supervision.
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, consult your doctor who will evaluate the benefits and risks of therapy with CONDROSULF.
Driving and using machines
CONDROSULF does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Condrosulf: Posology
Always take this medicine exactly as your doctor has told you, who will determine the dose and duration of treatment. If in doubt, consult your doctor or pharmacist.
Adults
Unless otherwise directed by your doctor, the usual dose is 2 - 3 capsules or sachets per day, for at least 3 weeks.
Take CHONDROSULF by mouth:
- if you use CONDROSULF capsules, swallow the capsules with water;
- if you use CHONDROSULF granules, dissolve the contents of the sachets in water before taking.
Do not change the dose recommended or prescribed by your doctor. If you do not notice any improvement or your symptoms are getting worse, please tell your doctor or pharmacist.
Overdose What to do if you have taken too much Condrosulf
There are no known cases of overdose. It is recommended not to exceed the suggested dosage. In case of accidental ingestion / intake of an excessive dose contact your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Condrosulf
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with CONDROSULF:
Rare side effects (may affect up to 1 in 1,000 people):
- stomach or bowel upset, abdominal pain, nausea, diarrhea;
- more or less sudden onset of skin lesions, for example spot or diffuse color changes (maculo-papular rash, erythema, rash);
- dizziness.
Very rare side effects (may affect up to 1 in 10,000 people):
- redness of the skin (eczema), hives, itching;
- swelling (edema).
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.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.
This medicinal product does not require any special storage conditions.
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.
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.
Other information
What CHONDROSULF contains
The active ingredient is: sodium chondroitin sulphate.
CONDROSULF hard capsules
- Each capsule contains 400 mg of sodium chondroitin sulfate.
- The other ingredients are: magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).
CHONDROSULF granules for oral solution
- Each sachet of granules contains 400 mg of sodium chondroitin sulphate.
- The other ingredients are: citric acid, orange flavor, sodium saccharin, orange yellow S (E 110), sorbitol, anhydrous colloidal silica (Aerosil 200).
Description of the appearance of CHONDROSULF and contents of the pack
CONDROSULF hard capsules are available in packs containing 20 capsules.
CHONDROSULF granules for oral solution is available in packs containing 20 sachets.
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
CONDROSULF 400 MG
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 mg of sodium chondroitin sulfate
Each sachet of granules contains 400 mg of sodium chondroitin sulphate
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Hard capsules.
Granules for oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of osteoarthritis of the knee and hip
04.2 Posology and method of administration
Adults
Unless otherwise prescribed, the following dosage schedule is recommended, to be followed for a period of not less than 3 weeks: from 2 to 3 capsules or sachets orally / day, according to the severity of the disease.
Children
There is no evidence to support the use of chondroitin sulfate in children 0 to 18. Therefore, the use of chondroitin sulfate in children is not recommended.
The contents of the sachets must be dissolved in water before taking.
04.3 Contraindications
Hypersensitivity to the active substance or to other closely related substances from a chemical point of view and / or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The use of the medicine is not recommended in subjects particularly prone to allergies.
CHONDROSULF granules for oral solution contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not receive this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions or incompatibilities with other medicines.
No interaction studies have been performed.
04.6 Pregnancy and breastfeeding
In pregnant and lactating women, the product should be administered only in cases of real need and under the direct supervision of the doctor.
Pregnancy: No clinical data on exposure during pregnancy are available for the product.
Animal studies do not indicate direct or indirect harmful effects related to pregnancy, embryo-fetal development, parturition and postnatal development.
Prescribe the drug with caution in pregnancy.
Feeding time: It is not known whether the product is excreted in human milk nor has its excretion in milk been studied in animals. The decision whether to continue or discontinue breastfeeding or to continue or discontinue therapy with CONDROSULF must be made considering the benefit of breastfeeding. maternal for the child and the benefit of therapy with the product for the mother.
04.7 Effects on ability to drive and use machines
CONDROSULF does not affect the ability to drive or use machines.
04.8 Undesirable effects
Adverse reactions are rare (nausea, diarrhea, pain, abdominal discomfort, and skin reactions may appear with initiation of therapy but are usually rare and mild in severity.
Adverse reactions observed during post-marketing surveillance are presented in the following table.
In each category, adverse reactions are ranked according to frequency of onset and severity, using the following convention: very common (> 1/10); common (> 1/100, 1 / 1,000, 1 / 10,000,
The most appropriate MedDRA term has been used to describe the reactions listed above. Synonyms or related conditions are not listed but should still be considered.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs for diseases of the musculoskeletal system. ATC code: M09AX.
Chondroitin sulfate, active ingredient of CHONDROSULF, belongs to the class of polysaccharides, more precisely of glycosamino-glycans. They are one of the main constituent elements of cartilage where they are found bound to proteins to form the so-called proteoglycans, which ensure the mechanical-elastic properties of the cartilage itself. In articular degenerative processes of the arthritic type, a decrease in the content of cartilaginous chondroitin sulphate is observed with a consequent reduction in the fixing power of water and subsequent progressive deterioration of joint function due to degeneration of the cartilage itself.
The supply of exogenous chondroitin sulphate compensates for the cartilage deficit, allowing an arrest or slowing down of the degenerative process and an optimal realization of the spontaneous reparative processes.
At the level of the articular cartilage, in fact, chondroitin sulphate is able to antagonize joint degenerative processes, above all through the inhibition of cartilaginous lytic enzymes and the stimulation of the biosynthesis of proteoglycans.
In the experimental animal the main effects of the active principle were the action on bone repair and the anti-arthritic activity.
05.2 Pharmacokinetic properties
From the pharmacokinetic point of view, after single oral administration in man, plasma concentrations of chondroitin sulphate were highlighted, evaluated as lipoprotein-lipase activity, already after 15 "from administration, with a detectable peak around 30" and persisting another 12 hours after administration. administration.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Hard capsules:
Capsule contents
Magnesium stearate
Capsule shell
Jelly
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Indigo carmine (E 132)
Granules for oral solution:
Citric acid
Orange aroma
Sodium saccharin
Orange yellow S (E 110)
Sorbitol
Anhydrous colloidal silica (Aerosil 200)
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Conservation in normal environmental conditions.
06.5 Nature of the immediate packaging and contents of the package
Hard capsules: Aluminum / PVDC blister. Cardboard box containing 20 capsules.
Granules for oral solution: heat-sealed paper-aluminum-polythene sachets.
Cardboard box containing 20 sachets.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi
08.0 MARKETING AUTHORIZATION NUMBER
400 mg hard capsules - 20 capsules: AIC n. 028784039
400 mg granules for oral solution - 20 sachets: AIC n. 028784041
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 29 October 1994
Date of last renewal: 15.11.2009
10.0 DATE OF REVISION OF THE TEXT
April 2011
