Claversal 500 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Claversal 500 mg gastro-resistant tablets

mesalazine

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Claversal 500 mg gastro-resistant tablets are and what they are used for
2. What you need to know before taking Claversal 500 mg gastro-resistant tablets
3. How to take Claversal 500 mg gastro-resistant tablets
4. Possible side effects
5. How to store Claversal 500 mg gastro-resistant tablets
6. Contents of the pack and other information

1. What Claversal 500 mg enteric-coated tablets is and what it is used for

Claversal contains mesalazine (also known as 5-aminosalicylic acid), which belongs to a group of medicines called intestinal anti-inflammatory agents.

Claversal is indicated for the treatment of ulcerative colitis, an inflammatory bowel disease.

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 to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid or to any other salicylate
• if you have a medical condition that may make you prone to bleeding
• if you have severe renal and/or hepatic impairment

Warnings and precautions

Consult your doctor before starting to take Claversal

• if you are pregnant or planning to become pregnant
• if you are breastfeeding
• if you have liver or kidney problems
• if you suffer from any lung disease, for example, asthma
• if you have previously had an allergy to sulfasalazine
• if you have a stomach or intestinal ulcer
• if you have previously had inflammation of the heart (which could be a consequence of a heart infection)
• if you have ever experienced severe skin rash, skin peeling, blisters, or mouth sores after taking mesalazine.

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

If any allergic reaction occurs (e.g., skin rash, itching) or cramps, abdominal pain, severe headache, or fever during treatment, stop taking the tablets and inform your doctor immediately.

Before and during treatment, your doctor may want to carry out regular blood and urine tests to monitor the function 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 you drink an adequate amount of fluids during treatment with mesalazine.

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

Mesalazine may cause a harmless reddish-brown discoloration of the urine 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

Safety information regarding the use of this medicine in children and adolescents is limited.

Do not administer to children under 5 years of age.

Other medicines and Claversal 500 mg gastro-resistant tablets

In general, you may continue treatment with other medicines while taking Claversal. However, inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Claversal may interact with certain medicines when taken at the same time.

In particular:

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

Pregnancy and breastfeeding

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

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 discontinued.

The use of Claversal during pregnancy or breastfeeding is not recommended unless otherwise directed by your doctor.

Driving and using machines

No adverse effects of Claversal on the ability to drive or operate machinery have been reported.

Claversal 500 mg gastro-resistant tablets contain sodium

This medicine contains 49 mg of sodium (main component of table/cooking salt) per gastro-resistant tablet. This corresponds to 2.5% of the maximum daily sodium intake recommended 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 (sodium) diet.

3. How to take Claversal 500 mg gastro-resistant tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long your treatment with this medicine should last. Do not stop treatment earlier, even if you feel better, as symptoms may return if treatment is stopped too soon.

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

The recommended dose for adults is:

• To treat an acute episode of colitis, your doctor will usually prescribe a daily dose between 1.5 grams (3 gastro-resistant tablets) and 4 grams (8 gastro-resistant tablets) of mesalazine, which may be administered in one or several doses.
• To help prevent further episodes of colitis, your doctor may prescribe a daily dose between 1.5 grams (3 gastro-resistant tablets) and 3 grams (6 gastro-resistant tablets) of mesalazine, which may be administered in one or several doses.

Claversal 500 mg gastro-resistant tablets are to be administered orally.

Gastro-resistant tablets must be taken before meals and should be swallowed whole with liquid. They must not be divided, chewed, or crushed.

Use in children and adolescents

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

Do not administer to children under 5 years of age.

Use in elderly patients

The use of Claversal in elderly patients should be done with caution and is only recommended for patients with normal renal function.

If you take more Claversal 500 mg gastro-resistant tablets than you should

Contact your doctor if you have taken more than prescribed. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet 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 taking Claversal 500 mg gastro-resistant tablets

It is important that you take Claversal 500 mg gastro-resistant tablets every day, even when you do not have symptoms of ulcerative colitis. Always complete the prescribed course of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

All medicines can cause allergic reactions, although severe allergic reactions are very rare. If you experience any of the following symptoms after using this medicine, 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 medicine and contact your doctor immediately. These symptoms may, very rarely, be due to a decrease in the number of white blood cells in the blood (a condition called agranulocytosis).

Serious adverse effects:

Stop taking mesalazine and seek immediate medical help if you experience any of the following symptoms:

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

The following adverse effects have also been reported in patients using mesalazine:

Rare adverse effects (may affect up to 1 in 1,000 patients/people)

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

Very rare adverse effects (may affect fewer than 1 in 10,000 patients)

• kidney function problems, sometimes with swelling of the limbs or flank pain;
• severe abdominal pain due to acute inflammation of the pancreas;
• worsening of colitis symptoms;
• fever, sore throat, or nausea due to changes in blood cell count;
• breathing difficulty, cough, wheezing, lung shadows on chest X-ray due to allergic and/or inflammatory conditions in the lungs;
• diarrhoea and severe abdominal pain due to an allergic reaction to the medicine in the intestine;
• skin rash or inflammation;
• muscle and joint pain;
• jaundice or abdominal pain due to disorders of bile or hepatic flow;
• hair loss and development of baldness;
• erythema multiforme;
• numbness and tingling in the fingers of the hands and feet (peripheral neuropathy);
• reversible decrease in semen production;
• blood cell count disorders.

Adverse effects with unknown frequency (cannot be estimated from available data)

• kidney stones and associated kidney pain (see also section 2).
• serious skin reactions: drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), 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 of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Claversal 500 mg gastro-resistant tablets

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Claversal

• The active substance is mesalazine (500 mg per tablet).
• The other components (excipients) are: anhydrous sodium carbonate, glycine, povidone, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, calcium stearate, methacrylic acid and ethyl 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 pack contents

Claversal 500 mg is presented as orange, oblong, gastro-resistant tablets.

Claversal 500 mg is available in OPA/Al/PVC//Al blisters contained in packaging 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

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent review of this leaflet: January 2025

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