CLAVERSAL 500 mg SUPPOSITORIES

2. What you need to know before you start using Claversal 500 mg Suppositories

Do not use Claversal

• if you are allergic to mesalazine or any of the other ingredients of this medicine (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

Talk to your doctor or pharmacist before you start using Claversal 500 mg Suppositories.

• if you are or might become pregnant.
• if you are breast-feeding.
• if you have liver or kidney problems.
• if you have any lung disease, for example asthma.
• if you have been allergic to sulfasalazine in the past.
• if you have a stomach or intestinal ulcer.
• if you have previously had an inflammation of the heart (which could be a consequence of a heart infection).
• if you have ever suffered from a severe skin rash, peeling, or blisters in the mouth after using mesalazine.

If you experience severe headache or recurrent headache, vision disturbances, or ringing or buzzing 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 the course of treatment, do not use Claversal suppositories anymore 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 reactions, 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 medicine in children and adolescents is limited.

Do not administer to children under 5 years of age.

Other medicines and Claversal 500 mg Suppositories

In general, you can continue treatment with other medicines while using Claversal. However, inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine, including those obtained without a prescription.

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

In particular:

• medicines to lower blood sugar levels (antidiabetics).
• medicines to lower blood pressure (antihypertensives/diuretics).
• medicines for the treatment or prevention of gout attacks.
• medicines that help with bowel movements (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 to treat pain and inflammation (anti-inflammatory agents).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

The use of Claversal is not recommended in pregnant or breast-feeding women unless the doctor indicates otherwise.

Driving and using machines

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

3. How to use Claversal 500 mg Suppositories

Follow the instructions for administration of Claversal 500 mg Suppositories exactly as indicated by your doctor regarding the method and time of administration; otherwise, you may not benefit fully from its 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 stop treatment before, even if you feel better, as symptoms may return if treatment is stopped too soon.

Strictly follow the treatment according to your doctor's instructions, both in the acute inflammatory phase and in the maintenance time 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 in 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 of age.

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.

Method of administration:

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

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

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

The suppositories should be inserted deeply into the anus and should be kept 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 Toxicology Information Service, phone: 915620420, indicating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget 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 make up for forgotten doses.

If you stop using Claversal 500 mg Suppositories

It is important that you use Claversal suppositories every day, even when you do not have symptoms of ulcerative colitis. Always finish the treatment that has been prescribed for you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 be due, very rarely, to a 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, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and enlarged lymph nodes. These severe skin reactions are often preceded by fever or flu-like symptoms.
• if you experience severe headache or recurrent headache, vision disturbances, or ringing or buzzing 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 using 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 an effect on the heart;
• 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 medicine at the intestinal level;

• 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 of the hands and feet (peripheral neuropathy).
• reversible decrease in semen production;
• blood count disorders.

Side effects of unknown frequency(cannot be estimated from the 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 continue or become more severe, consult your doctor.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Claversal 500 mg Suppositories

Keep this medicine 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 stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Claversal

• The active ingredient is mesalazine (500 mg per suppository).
• The other ingredients (excipients) are: semi-synthetic solid glycerides.

Appearance of the product and packaging contents

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

Packaging with 100 suppositories of 500 mg.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

2700-327 Amadora

Portugal

Date of the last revision of this package leaflet:January 2025

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