Label: Information for the Patient

Claversal 500 mg Suppositories

Mesalamine

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

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

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 have previously had heart inflammation (which could be a consequence of a heart infection)
• if you have ever had a severe skin rash or peeling of the skin, 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 reactions, 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 using 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

Generally, 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:

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

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 for Claversal 500 mg suppositories as indicated by your doctor regarding the manner and time in which you should insert the suppositories; otherwise, you will not be able to fully benefit from their effects. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of your treatment with Claversal 500 mg suppositories. 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:

• A maximum of 3 suppositories of 500 mg per day, in three separate administrations, with the last one to be administered at bedtime.

Use in children and adolescents

The administration of Claversal suppositories is not recommended for children and adolescents under 18 years of age due to the lack of data on their safety and efficacy.

Do not administer to children under 5 years old.

Use in elderly patients

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

Method of administration:

This medication can only be used rectally, so it must be inserted through the anus. DO NOT take orally.

It is recommended to go to the bathroom and empty the intestines before using the suppository.

It is advisable to insert the suppository while lying on the left side and remain in this position for approximately 1 hour.

The suppositories should be inserted deeply into the anus and should be retained in the rectum for 1 to 3 hours to increase efficacy.

If you use more Claversal 500 mg suppositories than you should

If you have used more Claversal 500 mg suppositories than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915620420 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Claversal 500 mg suppositories

Insert the suppository as soon as you remember and continue with the next one at the usual time.

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

If you interrupt treatment with Claversal 500 mg suppositories

It is essential to use Claversal suppositories 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 can 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 rash;
• 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, red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers, generalised rash, 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)

• kidney 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 X-ray 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 duct disorders;
• hair loss and baldness;
• erythema multiforme;
• 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 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.

Store in the original packaging to protect it from light.

Store below 30°C.

Do not use Claversal after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Claversal

-The active principle is mesalazine (500 mg per suppository)

-The other components (excipients) are: solid semisynthetic glycerides

Appearance of the product and contents of the packaging

Claversal is presented in the form of torpedo-shaped suppositories, white-gray to light reddish-violet in color.

Packaging with 100 suppositories of 500 mg.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsibleformanufacturing

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

2700-327 Amadora

Portugal

Last review date of this prospectus:January 2023

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