Claversal 1 g gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Claversal 1 g 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may 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.

Leaflet contents

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

1. What Claversal 1 g gastro-resistant tablets are and what they are 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 1 g 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 salicylates
• 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

Talk to your doctor or pharmacist before taking 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 allergic reaction 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 using mesalazine.

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

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

Before and during treatment, your doctor may want to perform 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 symptoms related to these serious skin reactions described in section 4.

Mesalazine may cause a reddish-brown discoloration of urine upon 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 data on the use of this medicine in children and adolescents are limited.

Do not administer to children under 5 years of age.

Other medicines and Claversal 1 g 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 to aid bowel evacuation (laxatives containing lactulose)
• medicines to prevent blood clotting (anticoagulants)
• medicines that suppress 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.

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 1 g gastro-resistant tablets contain sodium

This medicine contains 98 mg of sodium (the main component of table/cooking salt) per gastro-resistant tablet. This corresponds to 5% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need to take 4 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 1 g gastro-resistant tablets

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. 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 early, even if you feel better, as symptoms may return if treatment is ended too soon.

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

The recommended dose for an adult is:

• To treat an acute episode of colitis, your doctor will usually prescribe a daily dose of between 1.5 grams and 4 grams of mesalazine, which may be administered in one or several doses.

• To help prevent further episodes, your doctor may prescribe a daily dose of between 1.5 grams and 3 grams of mesalazine, which may be administered in one or several doses.

In both cases, it may be necessary to use Claversal 500 mg tablets to provide the most appropriate dose for you.

Use in children and adolescents

The 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.

Claversal 1 g gastro-resistant tablets must be administered orally.

The tablets should be taken before meals and must be swallowed whole with liquid.

If you take more Claversal 1 g gastro-resistant tablets than you should

Consult 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 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 1 g gastro-resistant tablets

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

If you stop treatment with Claversal 1 g gastro-resistant tablets

It is important that you take Claversal 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 experiences 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 recurring 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 taking mesalazine:

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

• Abdominal pain, diarrhea, 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 side 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 count;
• Difficulty breathing, cough, wheezing, spots on chest X-ray due to allergic and/or inflammatory conditions in the lungs;
• Diarrhea 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 count disorders.

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

• Kidney stones and associated kidney pain (see also section 2).

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 they are possible adverse effects not listed in this leaflet. You may 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 1 g 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 a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Claversal 1 g gastro-resistant tablets

• The active substance is mesalazine (1 g per tablet).
• The other components (excipients) are: anhydrous sodium carbonate, glycine, povidone, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, calcium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) 30% dispersion, 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 contents of the pack

Claversal 1 g is presented as orange-colored, oblong tablets.

Claversal 1 g is available in AquaBa® 130/AL blisters, packed in containers of 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 revision of this leaflet: January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/