CONDROITIN SULFATE ROVI 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Chondroitin Sulphate Rovi 400 mg Hard Capsules

Chondroitin Sulphate Sodium

Read all of this leaflet carefully before you 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 or pharmacist.
• 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Chondroitin Sulphate Rovi and what is it used for
2. What you need to know before you take Chondroitin Sulphate Rovi
3. How to take Chondroitin Sulphate Rovi
4. Possible side effects
5. Storage of Chondroitin Sulphate Rovi
6. Contents of the pack and further information

1. What is Chondroitin Sulphate Rovi and what is it used for

The active substance of Chondroitin Sulphate Rovi capsules, chondroitin sulphate sodium, is produced naturally in the human body. It is one of the components of articular cartilage.

Chondroitin Sulphate Rovi capsules are indicated for the relief of pain due to knee osteoarthritis. You should take other medications for the treatment of acute or short-term pain, as this medication takes effect (6-8 weeks).

The effect generally lasts from 2 to 3 months after treatment has finished.

2. What you need to know before you take Chondroitin Sulphate Rovi

Do not take Chondroitin Sulphate Rovi

• if you are allergic to chondroitin sulphate sodium or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine

• if you have heart disease (heart failure) or kidney failure. This medicine may cause fluid retention and edema.
• if you have liver failure.
• if you are taking medications that prevent blood clotting (such as acetylsalicylic acid (aspirin), dipyridamole or clopidogrel).

Using Chondroitin Sulphate Rovi with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important for medicines that prevent blood clotting, such as acetylsalicylic acid, dipyridamole, clopidogrel, ticlodipine and warfarin.

If you are taking warfarin, your doctor may request more frequent monitoring of INR values after starting treatment with this medicine and after stopping treatment.

Taking Chondroitin Sulphate Rovi with food and drinks

Chondroitin Sulphate Rovi can be taken before, during or after meals. If you often suffer from stomach upset, it is recommended to take the medicine after a meal.

The capsules should not be chewed; they should be swallowed whole with a sufficient amount of liquid (e.g. a glass of water).

Pregnancy and breast-feeding

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.

There is no experience with the use of chondroitin sulphate sodium during pregnancy or breast-feeding. Therefore, the product should not be used during pregnancy and breast-feeding.

Driving and using machines

No harmful effects on the ability to drive and use machines have been observed in relation to the use of chondroitin sulphate sodium.

Chondroitin Sulphate Rovi contains sodium

This medicine contains 36.54 mg of sodium (main component of cooking/table salt) in each capsule (as part of the active substance). This is equivalent to 1.83% of the maximum recommended daily intake of sodium for an adult.

3. How to take Chondroitin Sulphate Rovi

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The capsules should not be chewed; they should be swallowed whole with a sufficient amount of liquid (e.g. a glass of water).

The recommended dose is 800 mg, i.e. 2 capsules per day in a single dose for three months.

In more severe cases, the recommended dose is 1,200 mg, i.e. 3 capsules per day, for the first 4 to 6 weeks of treatment, followed by 800 mg per day until the end of the three-month treatment period. The daily dose of 1,200 mg can be taken in a single dose or divided into three doses, i.e. 1 capsule three times a day.

Treatment consists of repeated periods of three months of treatment, followed by a two-month period without treatment.

Use in children

Chondroitin Sulphate Rovi is not recommended for use in children.

If you take more Chondroitin Sulphate Rovi than you should

No cases of overdose have been reported. According to studies, no symptoms or harmful effects are expected. However, in case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Chondroitin Sulphate Rovi

No particular effects are expected. Do not take a double dose to make up for the forgotten dose and continue taking your medicine the next day at the usual dose.

If you stop taking Chondroitin Sulphate Rovi

No particular effects are expected.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare and very rare side effects (occurring in less than 1 in 1,000 patients):

Gastrointestinal system: alterations in the digestive system (such as pain in the upper abdomen, nausea or diarrhea).

Skin and subcutaneous tissue: redness, spots, irritative dermatitis, urticaria, eczema, itching.

General disorders: Edema.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Chondroitin Sulphate Rovi

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Chondroitin Sulphate Rovi

• The active substance is chondroitin sulphate sodium. Each capsule contains 400 mg of chondroitin sulphate sodium.
• The other ingredients are: magnesium stearate, gelatin and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Hard capsules, white and opaque, containing white powder.

Blister: 60 and 180 capsules

Some pack sizes may only be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Farmacéuticos Rovi, S.A.

Julián Camarillo, 35

28037 – Madrid

(Spain)

Manufacturer

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares 28805 – Madrid

(Spain)

This medicine is authorised in the Member States of the European Economic Area under the following names:

Finland: Chondroitin Sulphate Rovi 400 mg, hard capsules

Spain: Condroitina sulfato Rovi 400 mg hard capsules

Italy: Condroitina Solfato Rovi

Date of last revision of this leaflet: June 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)