Label: information for the user

Pentasa 4 g rectal suspension

Mesalamine

Read this label carefully before starting to use this medication,because 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 only for you and should not be given to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experienceadverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6.Contents of the package and additional information

Rectal Pentasa Suspension,is indicated for the treatment of localized ulcerative colitis in the rectum and sigmoid colon.

Ulcerative colitis is an inflammatory intestinal disease in which the intestinal lining is inflamed and develops many small breaks in its surface (ulcers) that can bleed.

Pentasa contains the active ingredient mesalazine,which belongs to a group ofmedications calledintestinal anti-inflammatory agentsthat help reduce inflammation and painful symptoms.

No use PENTASA suspensión rectal:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)
• if you are allergic to salicylates, for example aspirin
• if you have severe kidney and/or liver problems

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use Pentasa suspension rectal:

• if you are allergic to sulfasalazine (risk of salicylate allergy)
• if you currently have or have had liver or kidney function deterioration
• if you have a disease that may make you prone to bleeding
• if you are undergoing treatment that may affect renal function, for example non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin
• if you have respiratory problems, particularly asthma
• immediately discontinue treatment in case of acute intolerance symptoms, for example cramps, abdominal pain, fever, severe headache, and rash.
• Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain on one or both sides and presence of blood in the urine. Ensure you drink a sufficient amount of liquid during treatment with mesalazine.
• If you have ever experienced a severe skin rash or skin peeling, blisters, or mouth sores after using mesalazine

Mesalazine may produce a brown-red discoloration of the urine after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and the bleach and is harmless.

Tenga especial cuidado con la mesalazina:

Se han observado erupciones cutáneas graves, como reacción al medicamento con eosinofilia y síntomas sistémicos (DRESS), síndrome de Stevens-Johnson (SSJ) y necrólisis epidérmica tóxica (NET), con el tratamiento a base de mesalazina. Deje de tomar mesalazina y solicite atención médica inmediatamente si observa alguno de los síntomas relacionados con estas reacciones cutáneas graves descritos en la sección 4.

Si experimenta dolor de cabeza fuerte o recurrente, alteraciones de la visión o pitidos o zumbidos en los oídos contacte inmediatamente con su médico.

Mientras esté en tratamiento con este medicamento, su médico le realizará análisis de sangre y orina para controlar su función renal, especialmente al inicio del tratamiento.

Uso en niños:

Existe documentación limitada sobre el efecto en niños (6-18 años).

Uso en ancianos:

Se debe utilizar con cuidado en ancianos y solamente en pacientes con la función renal normal.

Uso de Pentasa conotros medicamentos:

Informe a su médico o farmacéutico si está utilizando o ha utilizado recientementeo podría tener que utilizar cualquierotro medicamento.

Esto es especialmente importante si usted está tomando cualquiera de los siguientes medicamentos:

• azatioprina(used after transplants or to treat autoimmune diseases)

• 6-mercaptopurinaor tioguanina (chemotherapy, used to treat leukemia)
• certain medications that inhibit blood coagulation (medications for thrombosis or to thin the blood)

Pentasa 4 gramos suspensión rectal con alimentos y bebidas

No procede.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, o cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Existe una experiencia limitada con el uso de mesalazinadurante el embarazo y la lactancia.

Se han observado alteraciones sanguíneas en recién nacidos de madres tratadas con este medicamento.

Los recién nacidos pueden desarrollar reacciones alérgicas tras la lactancia, por ejemplo, diarrea.En caso de que el recién nacido presente diarrea, se deberá interrumpir la lactancia.

Fertilidad:

Los datos de mesalazina en animales muestran que no tiene efecto sobre la fertilidad masculina o femenina

Conducción y uso de máquinas:

El tratamiento con Pentasa suspensión rectal no parece ejercer ninguna influencia en la capacidad de conducir y/o utilizar máquinas.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be used as directed by your doctor.In case of doubt, consult your doctor or pharmacist again.Remember to use your medication.

The rectal suspension containers are protected by an aluminum bag and should be used immediately after opening.

It is recommended to evacuate before administering the rectal suspension.

Usage Instructions

Nota. It is recommended to protect the bedding from a possible spill since Pentasa rectal suspension may discolor fabrics. If Pentasa rectal suspension accidentally spills onto fabric, immediately soak it.

The recommended dose is:

Adults:1 rectal suspension container of 100 milliliters (4 grams) at bedtime for 2-3 weeks. The dose may be reduced depending on the patient's body weight.

Children (6-18 years):There is limited experience and documentation on the effect in children.

The dosage should be adjusted according to the patient's response.

If you use morePentasa rectal suspension than you should

No cases of overdose have been reported in humans, but if an overdose is suspected, consult your doctor.

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 ingested.

If you interrupt treatment with Pentasa rectal suspension

Your doctor will indicate the duration of your treatment with Pentasa rectal suspension. Do not stop treatment before you feel better, as symptoms may recur if you stop treatment too soon. Follow the treatment strictly according to your doctor's instructions in the maintenance time established.

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

Like all medications, Pentasa rectal suspensionmay cause side effects, although not everyone will experience them.

Severe side effects:

Few cases of severe allergic reaction (including severe skin erosions that can affect the skin as a protective barrier of the body) have been reported. The allergic reaction could lead to swelling of the face and neck and/or difficulty breathing or swallowing (Quincke's edema). If this occurs, contact your doctor or emergency services immediately.

Inform your doctor immediately if you experience severe or recurring headaches, vision changes, or ringing or buzzing in your ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

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 ulcers, throat, nose, genital, and eye ulcers, generalized rash, fever, and swollen lymph nodes. These severe skin eruptions are often preceded by fever or flu-like symptoms.

The following frequent side effectsaffect between 1 and 10 of every 100 patients treated:

• headache
• diarrhea
• abdominal pain
• nausea
• vomiting
• skin rash
• flatulence (gas)
• local reactions such as itching, rectal discomfort, and urgency to defecate
• anal discomfort and irritation at the site of administration, itching, and sensation of needing to defecate.

The following rare side effects,affect between 1 and 10 of every 10,000 patients treated:

• inflammation of some areas of the heart (myocarditis and pericarditis) that can cause difficulty breathing and chest pain or palpitations (rapid or irregular heartbeats)
• pancreatitis (including symptoms of back and/or stomach pain) and increased amylase
• dizziness
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)

The following very rare side effects,affect fewer than 1 of every 10,000 patients treated:

• eosinophilia (as part of an allergic reaction) and blood disorders such as reduced red blood cells (anemia), white blood cells (leucopenia), and platelets (thrombocytopenia), which can increase the risk of infections or bleeding.
• liver disorders (hepatitis) characterized by symptoms that include jaundice (yellowing of the skin and/or eyes) and/or white stools.
• inflammatory kidney disorders (nephritis) that include the following signs and symptoms: blood in the urine, swelling (edema), and increased blood pressureand
• peripheral neuropathy (condition affecting the nerves of the hands and feet, including symptoms of tingling and numbness)
• allergic and fibrotic lung reactions (symptoms include cough, difficulty breathing, bronchospasm, bloody or excessive sputum, and/or hemoptysis)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation that can affect various parts of the body, such as joints, skin, kidneys, heart, etc. (symptoms include painful joints, fatigue, fever, abnormal bleeding or bruising, contusion, purple discoloration of the skin, skin lesions, and severe skin erosions and burns that can affect the skin as a protective barrier of the body)
• semen with low sperm concentration (oligospermia) (this is reversible)
• occasionally, allergic reactions and fever may occur

Unknown frequency(cannot be estimated from available data)

• kidney stones and associated renal pain (see also section 2)
• change in urine color
• If you experience severe or recurring headaches, vision changes, or ringing or buzzing in your ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

Some of these adverse reactions may also be attributed to the underlying disease itself.

If these symptoms persist or worsen, consult your doctor.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication..

Keep out of sight and reach of children.

Do not store above 25°C. Do not refrigerate or freeze. Store in the original packaging to protect it from light.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of 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 ofPentasa rectal suspension:

- The active ingredient is mesalazine.

- The other components are: sodium edetate, sodium metabisulphite, sodium acetate trihydrate, hydrochloric acid and purified water c.s.p. 100 milliliters.

Appearance of the product and contents of the packaging

Pentasa rectal suspension is a white to slightly yellowish suspension of 100 milliliters for rectal administration.

Each box contains 7 bottles of rectal suspension of 100 milliliters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Ferring S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Responsible for manufacturing:

Ferring Léciva a.s

Address: K Rybníku 475, 252 42

Jesenice, Prague, Czech Republic

Last review date of this leaflet: January 2025

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