Leaflet: information for the patient

Claversal 1 g gastro-resistant tablets

mesalazine

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Claversal 1 g gastro-resistant tablets and what it is used for

2. What you need to know before you start taking Claversal 1 g gastro-resistant tablets

3. How to take Claversal 1 g gastro-resistant tablets

4. Possible side effects

5. Storage of Claversal 1 g gastro-resistant tablets

6. Contents of the pack and additional information

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.

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 renal and/or hepatic insufficiency

Warnings and precautions

Consult your doctor before starting to take Claversal

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

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

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

Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain on the sides and presence of blood in the urine. Make sure to drink a sufficient amount of liquid during treatment with mesalazine.

Severe skin eruptions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (NET), 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 brownish-red discoloration of the urine after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and the bleach and is harmless.

Children and adolescents

The information on the safety of this medication in children and adolescents is limited.

Do not administer to children under 5 years old.

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 used recently, 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.

Particularly:

• blood sugar-lowering medications (antidiabetics)
• blood pressure-lowering medications (anti-hypertensives/diuretics)
• medications for the treatment or prevention of gout attacks
• laxatives containing lactulose
• blood-thinning medications (anticoagulants)
• immunosuppressive medications (e.g., azathioprine, 6-mercaptopurine, or thioguanine)
• anti-inflammatory medications

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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.

Claversal is not recommended for use during pregnancy or breastfeeding unless your doctor advises otherwise.

Driving and operating machinery

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

Claversal 500 mg gastro-resistant tablets contain sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with this medication. Do not discontinue treatment before, even if you feel better, as symptoms may recur if you stop treatment too soon.

Follow the treatment strictly according to your doctor's instructions, both in the acute inflammatory phase and in the maintenance period established.

The recommended dose for an adult is:

• For treating an acute episode of colitis,Your doctor will usually prescribe a dose between 1.5 grams and 4 grams of mesalazine per day, which can be administered in one or several doses.

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

In both cases, it may be necessary to use Claversal 500 mg tablets to provide the dose that best suits you.

Use in children and adolescents

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

Do not administer to children under 5 years old.

Use in elderly patients

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

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

The tablets should be taken before meals and should be swallowed whole, with the help of a 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Claversal 1 g gastro-resistant tablets

Do not take a double dose to compensate for the missed doses.

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

It is essential to take Claversal gastro-resistant tablets every day, even when you do not have symptoms of ulcerative colitis. Always complete the treatment prescribed.

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

Like all medicines, this medicine may cause side 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 this medicine and contact your doctor immediately:

• Allergic skin eruption;
• Fever;
• Difficulty breathing.

If you experience fever or throat or mouth irritation, stop using this medicine 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 help immediately 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, mouth, throat, nose, genital, and eye ulcers, general eruption, fever, and swollen lymph nodes. These severe skin eruptions are often preceded by fever or flu-like symptoms.

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

Rare side 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 heart effects;
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)

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

• Renal function problems, sometimes with swelling of the limbs or side pain;

• Severe abdominal pain due to acute pancreatitis inflammation;
• Worsening of colitis symptoms;
• Fever, sore throat, or nausea due to changes in blood counts;

• Difficulty breathing, cough, wheezing, and lung radiograph spots due to allergic and/or inflammatory conditions in the lungs;
• Severe diarrhea and abdominal pain due to an allergic reaction to the medication in the intestines;

• Skin eruption or inflammation;
• Muscle and joint pain;
• Jaundice or abdominal pain due to liver or bile flow disorders;
• Hair loss and baldness;
• Multi-form erythema;
• Numbness and tingling in the hands and feet (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 renal pain (see also section 2).

Severe skin reactions: pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (NET).

• Increased pressure inside your skull (idiopathic intracranial hypertension)

Photosensitivity

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

If these symptoms continue or worsen, consult your doctor.

Reporting of side effects:

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

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

This medication does not require special storage conditions.

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 trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Claversal 1 g gastro-resistant tablets

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

Claversal 1 g is presented in the form of orange-colored oval-shaped tablets.

Claversal 1 g is presented in AquaBa®130/AL blisters contained in 100 gastro-resistant tablets packaging.

Marketing authorization holder

Faes Farma, S.A.

Maximo Aguirre, 1448940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: January 2023

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