Claversal rectal foam

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Claversal 1 g rectal foam

mesalazine

Read the entire leaflet carefully before you start using 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; do not give it 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Claversal rectal foam is and what it is used for
2. What you need to know before using Claversal rectal foam
3. How to use Claversal rectal foam
4. Possible adverse effects
5. Storage of Claversal rectal foam
6. Contents of the pack and other information

1. What Claversal rectal foam is and what it is used for

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

Claversal rectal foam is indicated for the treatment of ulcerative colitis, an inflammatory bowel disease.

2. What you need to know before using Claversal rectal foam

Do not use 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 salicylate
• 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 using Claversal

• if you are pregnant or planning to become pregnant
• if you are breastfeeding your child
• if you have liver or kidney problems
• if you have a lung disease, for example, asthma
• if you have previously been allergic 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 had a severe skin rash or skin peeling, blisters, or mouth sores after using mesalazine.

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

If any allergic reaction occurs (e.g., skin rash, itching) or if you develop fever during treatment, stop using Claversal rectal foam and inform your doctor immediately.

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

Mesalazine may cause a reddish-brown discoloration of the urine 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

Safety information on 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 rectal foam

In general, you may continue treatment with other medicines while using 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 other medicines if 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 that help bowel evacuation (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 for pain and inflammation (anti-inflammatory drugs)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 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 indicated by your doctor.

Driving and using machines

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

Claversal rectal foam contains sodium metabisulfite, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and glycerol

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite.

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medicine may cause a mild laxative effect because it contains glycerol.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; hence, it is essentially sodium-free.

3. How to use Claversal rectal foam

Follow exactly your doctor's instructions on how and when to use Claversal rectal foam; otherwise, you may not fully benefit from its effects.

If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with Claversal rectal foam. Do not stop treatment prematurely, even if you feel better, as symptoms may return if treatment is ended too early.

Strictly adhere to the treatment regimen prescribed by your doctor, both during the acute inflammatory phase and the maintenance period established by your physician.

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 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 limited to those patients with normal renal function.

Claversal 1 g rectal foam is administered by the rectal route.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and amount used. It is recommended to bring the medication container and package leaflet to the healthcare professional.

If you forget to use Claversal

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

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 immediately and contact your doctor right away:

• Allergic skin rash;
• fever;
• difficulty breathing.

If you develop 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 severe skin rashes are often preceded by fever or flu-like symptoms.
• 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 using mesalazine:

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

• abdominal pain, diarrhoea, flatulence, nausea, and vomiting;
• headache, dizziness;
• chest pain, difficulty breathing, or swollen extremities 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 extremities or flank 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;
• breathing difficulty, cough, wheezing, or spots on chest X-ray due to allergic and/or inflammatory conditions in the lungs;
• diarrhoea 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 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 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 it is a possible adverse effect 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 Rectal Foam

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

Do not store above 30°C.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be handed over to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Claversal 1 g rectal foam

• The active substance is mesalazine (1 g per application).
• The other components (excipients) are: sorbitan monooleate, polysorbate 20, emulsifying wax, anhydrous colloidal silica, sodium metabisulfite (E-223), disodium edetate, methylparaben (E-218), propylparaben (E-216), disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, glycerol, polyethylene glycol 300, purified water, propane, iso-butane, and n-butane.

Nature of the product and contents of the package

Enema foam for rectal administration. The foam is white to light brown in color.

The carton contains:

• 1 aerosol that dispenses 14 applications,
• a kit consisting of a base or tray with 14 compartments (containing a small amount of vaseline), each holding a disposable applicator. The purpose of the vaseline is to facilitate insertion of the applicators into the rectum,
• 14 disposable plastic bags,
• a package leaflet.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

SOFAR

Via Firenze, 40

20060 Trezzano Rosa, Milan

Italy

Date of the most recent review of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/