Chondromel 400 mg Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chondroitin sulfate

Available from:

IBSA Farmaceutici Italia S.r.l

ATC code:

M01

INN (International Name):

Chondroitin sulfate

Dosage:

400 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Not marketed

Authorization date:

2005-12-22

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE USER
CHONDROMEL, 400 MG CAPSULES
Chondroitin Sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TO START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any of the side effects talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Chondromel is and what it is used for
2. What you need to know before you take Chondromel
3. How to take Chondromel
4. Possible side effects
5. How to store Chondromel
6. Contents of the pack and other information
1. WHAT CHONDROMEL IS AND WHAT IT IS USED FOR
The name of your medicine is Chondromel, 400 mg Capsules and its
active ingredient is
chondroitin sulphate.
Chondromel is used to treat the symptoms of osteoarthritis.
2. BEFORE YOU TAKE CHONDROMEL
DO NOT USE CHONDROMEL:
•
If you have previously suffered an allergic reaction to a medicine
containing chondroitin
sulphate.
•
If you are allergic to any of the other ingredients in this medicine
(listed in the section 6).
•
If you are suffering from liver failure.
TAKE SPECIAL CARE WITH CHONDROMEL:
•
If you are being treated for heart, liver or kidney problems
•
If you are pregnant, planning to become pregnant or breast-feeding
This medicine contains 36.5 mg sodium (main component of cooking/table
salt) in each
capsule. This is equivalent to 1.8% of the recommended maximum daily
dietary intake of
sodium for an adult.
TAKING OTHER MEDICINES
There are no reports of interactions between chondroitin and other
medicines at normal doses.
However, please let your doctor or pharmacist know if you are taking
any medicines that
affect blood clotting, for instance aspirin, dipyridamole,
clopidogrel, ditazole, triflusal and
ticlopidin

Summary of Product characteristics

Health Products Regulatory Authority
20 September 2021
CRN00CKNM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chondromel 400 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH HARD CAPSULE CONTAINS CHONDROITIN SULFATE 400MG AS CHONDROITIN
SULFATE SODIUM.
EXCIPIENT WITH KNOWN EFFECTS: SODIUM.
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Transparent green and blue gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chondromelis indicated for the symptomatic treatment of
osteoarthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly):
The recommended dose of Chondromel is 800 mg/day as a single-dose (2
capsules at a time) for 3 months at least.
For symptoms of severe inflammation, the recommend starting dose is
1200 mg/day as a single (3 capsules at a time) or
divided dose (1 capsule 3 times a day) for 4-6 weeks, followed by 800
mg for up to 3 months. Therapy comprises repeatable
courses of treatment; each course comprises 3 months intake at least,
followed by a 2 month treatment-free interval.
The clinical effect will usually be seen in 4 weeks.
Clinical trials have only assessed the efficacy of the product over a
two year treatment period.
Children:
The use of Chondromel is not recommended for children.
Kidney failure:
There is little experience available on the use of Chondromel by
patients suffering from kidney failure. Therefore, these patients
must be treated with special attention (see section 4.4).
Liver failure:
There is no experience available on the use of Chondromel by patients
suffering from liver failure. Therefore, it is not
recommended for use in this group (see section 4.4).
Chondromel can be taken before, during or after a meal. Patients with
a history of gastric intolerance to medicines are
recommended to take it after a meal.
The capsules must be swallowed, not chewed, with sufficient liquid.
Health Products Regulatory Authority
20 September 2021
CRN00CKNM
Page 2 of 4
4.3 CON