Condroitina sulfato rovi 400 mg capsulas duras

Package Leaflet: Information for the User

Chondroitin Sulfate Rovi 400 mg Hard Capsules

Chondroitin Sulfate Sodium

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Chondroitin Sulfate Rovi

3. How to take Chondroitin Sulfate Rovi

4. Possible side effects

5. Storage of Chondroitin Sulfate Rovi

6. Contents of the pack and additional information

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

Chondroitin sulfate Rovi capsules are indicated to relieve pain due to knee osteoarthritis. It should be taken in combination with other medications for acute or short-term pain treatment, as this medication takes time to become effective (6-8 weeks).

The effect generally lasts for 2 to 3 months after treatment has ended.

Do not take Condroitina sulfato Rovi

• if you are allergic to sodium chondroitin sulfate or any of the othercomponents of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

• if you have heart disease (heart failure) or kidney insufficiency. This medication may cause fluid retention and edema.
• if you have liver insufficiency.
• if you use medications that prevent blood coagulation (such as acetylsalicylic acid (aspirin), dipiridamol or clopidogrel).

Use of Condroitina sulfato Rovi with other medications

Inform your doctor or pharmacistif you are taking, have taken recently or may have to take any other medication.

This is especially important for medications that prevent blood coagulation, such as acetylsalicylic acid, dipiridamol, clopidogrel, ticlodipine and warfarin.

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

Taking Condroitina sulfato Rovi with food and drinks

Condroitina sulfato Rovi can be taken before, during or after meals. If you frequently experience stomach discomfort, it is recommended to take the medication 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 lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

There is no experience with the use of sodium chondroitin sulfate during pregnancy or lactation. Therefore, the product should not be used during pregnancy and lactation.

Driving and operating machines

No adverse effects on the ability to drive and use machines have been observed related to the use of sodium chondroitin sulfate.

Condroitina sulfato Rovi contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

In severe cases, the recommended dose is 1,200 mg, that is, 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, that is, 1 capsule three times a day.

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

Use in children

Condroitina Sulfate Rovi is not recommended for use in children.

If you take more Condroitina Sulfate 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Condroitina Sulfate Rovi

No particular effects are expected. Do not take a double dose to compensate for the missed dose and continue taking your medication the next day at the usual time.

If you interrupt treatment with Condroitina Sulfate Rovi

No particular effects are expected.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects that are rare and very rare (occur in fewer than 1 in 1,000 patients):

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

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

General disorders: Edema.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at your local pharmacy's SIGRE collection point.Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Chondroitin Sulphate Rovi

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

Appearance of the product and content of the packaging

Hard, white, and opaque capsules containing white powder.

Blister: 60 and 180 capsules

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Farmacéuticos Rovi, S.A.

Julián Camarillo, 35

28037 – Madrid

(Spain)

Responsible for manufacturing

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares 28805 – Madrid

(Spain)

This medicine is authorized in the member states of the European Economic Area with the following names:

Finland: Chondroitin Sulphate Rovi® 400 mg, hard capsules

Spain: Condroitina sulfato Rovi® 400 mg hard capsules

Italy: Condroitina Solfato Rovi

Last review date of this leaflet: June 2021

Further detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/)