CLAVERSAL 500 mg GASTRO-RESISTANT TABLETS

2. What you need to know before taking Claversal 500 mg Gastro-Resistant Tablets

Do not take Claversal

• if you are allergic to mesalazine or any of the other components of this medication (listed in section 6)
• if you are allergic to acetylsalicylic acid or any other salicylate
• if you have a medical condition that may make you prone to bleeding
• if you have severe kidney and/or liver impairment

Warnings and precautions

Consult your doctor before starting to take Claversal

• if you are or plan to become pregnant
• if you are breastfeeding
• if you have liver or kidney problems
• if you suffer from any lung disease, such as asthma
• if you have had an allergy to sulfasalazine in the past
• if you have an ulcer in the stomach or intestine
• if you have previously had inflammation of the heart (which could be a consequence of a heart infection)
• if you have ever suffered from severe skin rash, peeling, or blisters in the mouth after using mesalazine.

If you experience severe headache or recurrent headache, vision changes, or ringing in the ears, contact your doctor immediately.

In case of appearance of any allergic manifestation (e.g., skin rash, itching) or cramps, abdominal pain, severe headache, and fever during treatment, do not take more tablets and inform your doctor immediately.

Before and during treatment, your doctor may want to perform regular blood and urine tests to check the functioning of your liver, kidneys, blood, and lungs.

Kidney stones may occur with the use of mesalazine. Symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink enough liquid during treatment with mesalazine.

Severe skin rashes, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN), have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents

Information on safety in the use of this medication in children and adolescents is limited.

Do not administer to children under 5 years of age.

Other medications and Claversal 500 mg Gastro-Resistant Tablets

In general, you can continue treatment with other medications while taking Claversal. However, inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

Claversal may interact with some medications if taken at the same time.

In particular:

• medications to lower blood sugar (antidiabetics)
• medications to lower blood pressure (antihypertensives/diuretics)
• medications for the treatment or prevention of gout attacks
• medications that aid in intestinal evacuation (laxatives containing lactulose)
• medications to prevent blood clotting (anticoagulants)
• medications to reduce immune system activity (e.g., azathioprine, 6-mercaptopurine, or thioguanine)
• medications to treat pain and inflammation (anti-inflammatory agents)

Pregnancy and breastfeeding

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

There is limited experience with the use of mesalazine during pregnancy and breastfeeding. The newborn may develop allergic reactions after breastfeeding, such as diarrhea. If the newborn develops diarrhea, breastfeeding should be interrupted.

Mesalazine is not recommended during pregnancy or breastfeeding unless your doctor advises otherwise.

Driving and using machines

No adverse effects of Claversal on the ability to drive or use machines have been reported.

Claversal 500 mg Gastro-Resistant Tablets contain sodium

This medication contains 49 mg of sodium (main component of table salt) per gastro-resistant tablet. This is equivalent to 2.5% of the maximum recommended daily intake of sodium for an adult.

Consult your doctor or pharmacist if you need to take 8 or more gastro-resistant tablets daily for a prolonged period, especially if you have been advised to follow a low-salt diet.

3. How to take Claversal 500 mg Gastro-Resistant Tablets

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment before completing the prescribed course, as symptoms may return if treatment is stopped too soon.

Strictly follow the treatment as instructed by your doctor, both in the acute inflammatory phase and during the maintenance period.

The recommended dose for an adult is:

• To treat an acute episode of colitis,your doctor will normally prescribe a dose of 1.5 grams (3 gastro-resistant tablets) to 4 grams (8 gastro-resistant tablets) of mesalazine per day, which can be taken in one or several doses.
• To help prevent further episodes of colitis,your doctor may prescribe a dose of 1.5 grams (3 gastro-resistant tablets) to 3 grams (6 gastro-resistant tablets) of mesalazine per day, which can be taken in one or several doses.

Claversal 500 mg Gastro-Resistant Tablets should be taken orally.

The gastro-resistant tablets should be taken before meals and swallowed whole, with the help of liquid. They should not be divided, chewed, or crushed.

Use in children and adolescents

Administration of Claversal to children and adolescents under 18 years of age is not recommended due to lack of safety and efficacy data.

Do not administer to children under 5 years of age.

Use in elderly patients

Use of Claversal in elderly patients should be done with caution and limited to those patients with normal renal function.

If you take more Claversal 500 mg Gastro-Resistant Tablets than you should

Consult your doctor if you have taken more than prescribed. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and leaflet of the medication to the healthcare professional.

If you forget to take Claversal 500 mg Gastro-Resistant Tablets

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Claversal 500 mg Gastro-Resistant Tablets

It is important to take Claversal 500 mg Gastro-Resistant Tablets every day, even when you do not have symptoms of ulcerative colitis. Always complete the prescribed treatment course.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

All medications can cause allergic reactions, although severe allergic reactions are very rare. If you experience any of these symptoms after using this medication, stop using it and contact your doctor immediately:

• Allergic skin rash;
• fever;
• difficulty breathing.

If you experience fever or irritation of the throat or mouth, stop using this medication and contact your doctor immediately. These symptoms may be due to a rare decrease in the number of white blood cells in the blood (a condition called agranulocytosis).

Severe side effects:

Stop taking mesalazine and seek medical attention immediately if you experience any of the following symptoms:

• red patches, or circular or coin-shaped patches on the chest, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and swollen lymph nodes. These severe skin rashes are often preceded by fever or flu-like symptoms.
• if you experience severe headache or recurrent headache, vision changes, or ringing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

The following side effects have also been reported in patients taking mesalazine:

Rare side effects(may affect up to 1 in 1,000 patients)

• abdominal pain, diarrhea, flatulence, nausea, and vomiting;
• headache, dizziness;
• chest pain, difficulty breathing, or swollen limbs due to a heart effect;
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

Very rare side effects(may affect less than 1 in 10,000 patients)

• kidney problems, sometimes with swelling of the limbs or pain in the side;

• severe abdominal pain due to acute pancreatitis;
• worsening of colitis symptoms;
• fever, sore throat, or nausea due to changes in blood count;

• difficulty breathing, cough, wheezing, spots on the lung X-ray due to allergic and/or inflammatory conditions in the lungs;
• diarrhea and severe abdominal pain due to an allergic reaction to the medication in the intestine;

• skin rash or inflammation;
• muscle and joint pain;
• jaundice or abdominal pain due to liver or biliary disorders;
• hair loss and development of baldness;
• erythema multiforme;
• numbness and tingling of the fingers and toes (peripheral neuropathy)
• reversible decrease in semen production;
• blood count disorders.

Side effects of unknown frequency(cannot be estimated from available data).

• kidney stones and associated kidney pain (see also section 2).
• severe skin reactions: drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN).

Photosensitivity

More severe reactions have been reported in patients with pre-existing skin conditions, such as atopic dermatitis and atopic eczema.

If these symptoms persist or worsen, consult your doctor.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Claversal 500 mg Gastro-Resistant Tablets

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Packaging contents and additional information

Composition of Claversal

• The active ingredient is mesalazine (500 mg per tablet).
• The other ingredients (excipients) are: anhydrous sodium carbonate, glycine, povidone, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, calcium stearate, ethyl acrylate and methyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), dibutyl sebacate, talc, titanium dioxide (E-171), macrogol, yellow iron oxide (E-172), red iron oxide (E-172), isopropyl alcohol.

Appearance of the product and packaging contents

Claversal 500 mg is presented in the form of orange, oblong, gastro-resistant tablets.

Claversal 500 mg is presented in OPA/Al/PVC//Al blisters contained in packages with 100 gastro-resistant tablets.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

O

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of last revision of this leaflet: January 2025

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