Label: information for theuser

PENTASA 1 gram suppositories

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 must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctororpharmacist, even if they are not listed in this label.See section 4.

1. What isPentasa suppositoriesand what is it used for

2. What you need to know before starting tousePentasa suppositories

3. How to usePentasa suppositories

4. Possible adverse effects

5. Storage ofPentasa suppositories

6. Contents of the package and additional information

Pentasa suppositories contain mesalazine. Mesalazine belongs to a group of medicines called anti-inflammatory intestinal agents.

Pentasa suppositories are indicated for the treatment of ulcerative proctitis.

Do not use Pentasa suppositories:

• if you are allergic to mesalazine or to any of the other components of this medication (listed in section 6).

• if you are allergic to acetylsalicylic acid.

• if you have liver or kidney impairment.Renal function should be monitored regularly, especially during the initial treatment phase.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Pentasa suppositories.

Inform your doctor before starting to use this medication:

• if you are allergic to sulfasalazine (risk of salicylate allergy).
• if you have current or past liver or kidney impairment.

• if you have a disease that may make you prone to bleedings

• if you are taking a treatment that may affect renal function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you have respiratory problems, particularly asthma.
• interrupt treatment immediately in case of cramps, abdominal pain, fever, severe headache, and rash.
• Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain 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.

Be particularly cautious 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 experience any symptoms related to these severe skin reactions described in section 4.

If you experience severe or recurring headaches, vision changes, or tinnitus, contact your doctor immediately.

While on treatment with this medication, your doctor will perform blood and urine tests to monitor your renal function, especially at the start of treatment.

Use in the elderly::

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

Use in children:

There is limited experience and documentation on the effect in children.

Pentasa suppositories interaction with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is limited experience with the use of mesalazine during pregnancy and breastfeeding.Haematological alterations have been observed in newborns of mothers treated with this medication. Newborns may develop allergic reactions through breastfeeding, such as diarrhea. If the newborn experiences diarrhea, breastfeeding should be interrupted.

Fertility:

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

Driving and operating machinery:

The treatment with Pentasa suppositories does not appear to have any influence on the ability to drive and/or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to use your medication.

Each Pentasa suppository1 gramis protected by an aluminum blister that must be opened immediately before use.

1. It is recommended to evacuate before administering the suppository.
2. Remove a suppository from the aluminum blister.
3. Insert the suppository until the resistance disappears.
4. If the suppository is expelled during the first 10 minutes, you must administer a new one.

Recommended dose:

Adults: 1 suppository one to two times a day rectally.

Children: There is limited experience and documentation on the effect in children.

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

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Pentasa suppositories.

If you use more Pentasa suppositories than you should

No cases of overdose have been reported in humans, but if you suspect an overdose, immediately consult your doctor or pharmacist.

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 forgot to use Pentasa suppositories:

Insert the suppository as soon as you remember and continue with the next one at the usual time.

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

If you interrupt treatment with Pentasa1 gramsuppositories

Your doctor will indicate the duration of your treatment with Pentasa1 gramsuppositories. Do not stop treatment before finishing, as symptoms may return if you stop treatment too soon. Follow the treatment strictly according to your doctor's instructions in the maintenance period established.

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

Like all medications, Pentasa suppositoriesmay 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. 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 common 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, , feeling 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, edema (swelling due to increased fluids)and increased blood pressure
• 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)
• 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 under the skin, including severe skin erosions and severe burning 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 Medicines 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 this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Deposit empty packaging and unused medications at the SIGRE collection point at the pharmacy. In case of doubt ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Composition ofPentasa 1 gram suppositories:

- The active ingredient is mesalazine. Each suppository of Pentasa contains 1 gram of mesalazine.

- The other components are: macrogol 6000, povidone, magnesium stearate, and talc.

Appearance of the product and contents of the packaging

Pentasa 1 gram suppositories are for rectal administration. The suppositories are white to light brown, speckled, and oval in shape.

They are presented in boxes of 28 suppositories or 56 suppositories.

Not all presentations are marketed.

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 GmbH

Wittland 11

D-24109 Kiel

Germany

Date of the last review of this leaflet in January 2025

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