Label: information for theuser

PENTASA1 gramsuspensionrectal

Mesalazine

Read this label carefully before starting to usethis 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 yourdoctororpharmacist.
• This medication has been prescribed to you alone,and you should not give it to others who 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.

1. What isPENTASA rectal suspensionand what is it used for

2. What you need to know before starting tousePENTASA rectal suspension

3. How to usePENTASA rectal suspension

4. Possible adverse effects

5. Storage ofPENTASA rectal suspension

6. Contents of the package and additional information

PENTASA rectal 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 ofmedicines calledintestinal anti-inflammatory agentsthat help to reduce inflammation and painful symptoms.

No use PENTASA suspensión rectal:

• if you are allergic to the active ingredient or 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 currently undergoing treatment that may affect kidney function, for example nonsteroidal 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.
• kidney stones may occur with the use of mesalazine. Symptoms include abdominal pain on one side and blood in the urine. Ensure you drink a sufficient amount of liquid during mesalazine treatment.
• if you have ever experienced intense skin rash or skin peeling, blisters, or mouth sores after using mesalazine

Mesalazine may cause urine discoloration to a reddish-brown color after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Tenga especial cuidado con la mesalazina:

severe skin eruptions, 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 notice any of the symptoms related to these severe skin reactions described in section 4.

if you experience severe or recurring headaches, vision changes, or ringing or buzzing in the ears, contact your doctor immediately.

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:

there is limited documentation on the effect in children (6-18 years).

Uso en ancianos:

use with caution in the elderly and only in patients with normal renal function.

Uso de Pentasaconotros medicamentos:

inform your doctor or pharmacist if you are using or have used recentlyor may have to use anyother medication.

This is especially important if you are taking any of the following medications:

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

• 6-mercaptopurine or thioguanine (chemotherapy, used to treat leukemia)
• certain medications that inhibit blood clotting (blood thinners or medications to thin your blood)

Pentasa1 gramosuspensión rectal con alimentos y bebidas

No procede.

Embarazo,lactanciay fertilidad

if you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctororpharmacist before usingthismedication.

there is limited experience with the use of mesalazineduring pregnancy and lactation.

blood disorders have been observed in newborns of mothers treated with this medication.

newborns may develop allergic reactions after breastfeeding, for example, diarrhea.in case the newborn experiences diarrhea, breastfeeding should be discontinued.

Fertilidad:

mesalazine data in animals show that it has no effect on male or female fertility

Conducción y uso de máquinas:

Pentasa suspension rectal treatment does not appear to exert any influence on the ability to drive and/or use machines.

Followexactly the administration instructionsfor this medicationas indicated 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 must be used immediately after opening.

It is recommended to evacuate before administering the rectal suspension.

Usage Instructions

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

The recommended dose is:

Adults:1 rectal suspension container of 100 milliliters (1 gram) at bedtime for 2-3 weeks. The dose may be reduced based 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 based on the patient's response.

If you use more PENTASA 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,telephone: 91 562 04 20indicating the medication and the amount ingested.

If you interrupt treatment with Pentasa suspension rectal

Your doctor will indicate the duration of your treatment with Pentasa suspension rectal. Do not stop treatment prematurely, even if you feel better, as symptoms may recur if treatment is stopped too soon. Follow your doctor's instructions strictly for the maintenance period they establish.

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

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

Severe side effects:

There have been very few reported cases of severe allergic reaction (including severe skin erosions that can affect the skin as a protective barrier of the body). 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 within your skull (idiopathic intracranial hypertension).

Stop taking mesalazine and seek medical help immediately if you experience any of the following symptoms:

• flat, non-elevated 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 pale 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 coughing, 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, and/or subcutaneous nodules)
• 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 within 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 the 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.

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

Composition ofPENTASA rectal suspension:

- The active ingredient is mesalazine.

- The other components are: disodium edetate, sodium metabisulphite (E-223), sodium acetate, hydrochloric acid and purified water q.s. 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 rectal suspension containers 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 near Prague, Czech Republic

Date of the last review of this leaflet in January 2025

The 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/