Patient Information Leaflet

Claversal 1 g Rectal Foam

Mesalazine

Please read this leaflet carefully before you start to use this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have similar symptoms to 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.

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

Claversal rectal foam 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 wish to become pregnant
• if you are breastfeeding your child
• 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 an ulcer in the stomach or intestine
• if you have previously had an inflammation of the heart (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 eruptions, 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 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.

Other Medications and Claversal 500 mg Gastrorresistant 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 acquired 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 Machines

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

Claversal 500 mg Gastrorresistant Tablets contain Sodium

This medication contains 49 mg of sodium (main component of table salt/for cooking) in each gastrorresistant 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 gastrorresistant tablets daily for a prolonged period, especially if you have been recommended a low-sodium diet.

Follow exactly the administration instructions for Claversal indicated by your doctor regarding the method and timing of when to use the rectal foam; otherwise, you will not be able to fully benefit from its effects.

If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with Claversal rectal foam. Do not discontinue treatment before finishing it, even if you are feeling better, as symptoms may return 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:

One to two applications per day (1 to 2 g), for four to six weeks.

Use in children and adolescents

Administration of Claversal is not recommended in children and adolescents under 18 years of age due to a 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 always limited to those patients with normal renal function.

Claversal 1 g rectal foam is used rectally.

If you use more Claversal than you should

Consult your doctor if you have used 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 used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Claversal

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

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 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, red 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 limb swelling 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 development;
• Multi-form erythema;
• Numbness and tingling of 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 prospectus. 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.

Do not store at a temperature above 30°C.

This container is a pressurized aerosol that contains a flammable propellant. It should be kept away from any heat source, flames, or embers, including cigarettes. It should be protected from direct sunlight and should not be destroyed or burned, even when empty.

Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Claversal 1 g rectal foam

• The active ingredient is mesalazine (1g per application)
• The other components (excipients) are: mono-oleate of sorbitan, polisorbate 20, emulsifying wax, anhydrous colloidal silica, sodium metabisulphite (E-223), disodium edetate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), dodecahydrate of sodium hydrogen phosphate, dihydrate of sodium dihydrogen phosphate, glycerol, polyethylene glycol 300, purified water, propano, isobutane, and n-butane.

Appearance of the product and contents of the packaging

Rectal foam enema for administration. The foam is white to light brown in color.

The case includes:

• 1 aerosol dispenser that delivers 14 applications,
• a kit consisting of a base or grid with 14 compartments (which contain a small amount of vaseline), and in which 14 disposable applicators are introduced. The purpose of the vaseline is to facilitate the introduction of the applicators into the rectum,
• 14 disposable plastic bags,
• a leaflet.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

SOFAR

Via Firenze, 40

20060 Trezzano Rosa, Milan

Italy

Last review date of this prospectus:January 2023

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