Pentasa 1 g suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PENTASA 1 gram suppositories

Mesalazine

Read the entire leaflet carefully before you start using this medicine, because 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 only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Pentasa suppositories are and what they are used for
2. What you need to know before using Pentasa suppositories
3. How to use Pentasa suppositories
4. Possible adverse effects
5. How to store Pentasa suppositories
6. Contents of the pack and other information

1. What Pentasa suppositories are and what they are used for

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

Pentasa suppositories are indicated for the treatment of ulcerative proctitis.

2. What you need to know before using Pentasa suppositories

Do not use Pentasa suppositories:

• 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.

• if you have impaired renal or hepatic function. Renal function should be routinely monitored, especially during the initial phase of treatment.

Warnings and precautions

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

Before starting to use this medicine, inform your doctor:

• if you are allergic to sulfasalazine (risk of salicylate allergies).

• if you currently have or have previously had impaired liver or kidney function.

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

• if you are taking treatment that may affect kidney function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin

• if you have respiratory problems, particularly asthma.

• treatment must be stopped immediately if cramps, abdominal pain, fever, severe headache, or rash occur.

• 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 to drink an adequate amount of fluid during treatment with mesalazine.

• if you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mesalazine.

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

Take special care 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.

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

While being treated with this medicine, your doctor will perform blood and urine tests to monitor your kidney function, especially at the beginning of treatment.

Use in the elderly:

Should be used with caution in elderly patients and only in those with normal renal function.

Use in children:

Limited experience and insufficient documentation exist regarding the effect in children.

Interaction of Pentasa suppositories with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

• 6-mercaptopurine or thioguanine (chemotherapeutic agents used to treat leukemia)

• certain drugs that inhibit blood clotting (medicines for thrombosis or blood thinners).

Pregnancy, breastfeeding, and fertility

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.

Experience with the use of mesalazine during pregnancy and breastfeeding is limited. Blood abnormalities have been observed in newborns of mothers treated with this medicine. Newborns may develop allergic reactions during breastfeeding, for example, diarrhea. If the newborn develops diarrhea, breastfeeding should be discontinued.

Fertility:

Animal data on mesalazine show that it has no effect on male or female fertility.

Driving and using machines:

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

3. How to use Pentasa suppositories

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

Remember to use your medicine.

Each Pentasa 1 gram suppository is protected by an aluminum blister, which must be opened immediately before use.

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

Recommended dose:

Adults: 1 suppository one to two times daily by rectal route.

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

Dosage should be adjusted according to the patient's response.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Your doctor will advise you on the duration of your treatment with Pentasa suppositories.

If you use more Pentasa suppositories than you should

Cases of overdose in humans have not been reported; however, if an overdose is suspected, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Pentasa suppositories:

Use the missed suppository as soon as you remember, then continue with the next dose at the usual time.

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

If you stop treatment with Pentasa 1 gram suppositories

Your doctor will advise you on the duration of your treatment with Pentasa 1 gram suppositories. Do not stop treatment prematurely, even if you feel better, as symptoms may return if treatment is ended too early. Strictly follow the treatment regimen as instructed by your doctor, including the recommended maintenance period.

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

4. Possible adverse effects

Like all medicines, Pentasa suppositories can produce adverse effects, although not everyone experiences them.

Serious adverse effects:

Very few cases of severe allergic reaction (including severe skin erosions that may affect the skin as the body's protective barrier) have been reported. 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 recurrent headache, changes in vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

Stop taking mesalazine and seek immediate medical help if you develop any of the following symptoms:

• reddish non-elevated patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever, and swollen lymph nodes. These serious skin rashes are often preceded by fever or flu-like symptoms.

The following common adverse effects occur in between 1 and 10 out of every 100 patients treated:

• headache
• diarrhoea
• abdominal pain
• nausea
• vomiting
• skin rash
• flatulence (gas)
• local reactions such as pruritus, rectal discomfort, and urgency to defecate

Anal discomfort and irritation at the site of administration, itching, sensation of needing to defecate.

The following rare adverse effects, occurring in between 1 and 10 out of every 10,000 patients treated:

• inflammation of certain areas of the heart (myocarditis and pericarditis), which may cause difficulty breathing, chest pain, or palpitations (rapid or irregular heartbeat)
• inflammation of the pancreas (including symptoms of back and/or stomach pain) and increased amylase levels
• dizziness
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

The following very rare adverse effects, occurring in fewer than 1 out of every 10,000 patients treated:

• eosinophilia (as part of an allergic reaction) and blood disorders such as reduction in red blood cells (anaemia), white blood cells (leucopenia), or platelets (thrombocytopenia), which may increase the likelihood of infections or bleeding
• liver disorders (hepatitis) characterized by symptoms including jaundice (yellowing of the skin and/or eyes) and/or pale stools
• inflammatory kidney disorders (nephritis) including the following signs and symptoms: blood in the urine, oedema (swelling due to fluid retention), and increased blood pressure
• peripheral neuropathy (a condition affecting nerves in the hands and feet, including symptoms of tingling and numbness)
• pulmonary and fibrotic allergic reactions (symptoms include cough, difficulty breathing, bronchospasm, bloody and/or excessive sputum)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation that may affect various parts of the body such as the joints, skin, kidneys, heart, etc. (symptoms include painful joints, fatigue, fever, abnormal or unexplained bleeding (e.g. nosebleeds), bruising, purplish skin discolouration, spots under the skin (including severe skin erosions and severe burning that may affect the skin as the body's protective barrier))
• low sperm concentration in semen (oligospermia) (this is reversible)
• allergic reactions and fever may occasionally occur

Frequency not known (cannot be estimated from available data)

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

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

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pentasa suppositories

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

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

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

Medicines should not be disposed of via drains or in household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of packaging and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pentasa 1 gram suppositories:

• The active substance is mesalazine. Each Pentasa suppository contains 1 gram of mesalazine.

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

Nature and contents of the container

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

They are available in packs of 28 suppositories or 56 suppositories.

Not all presentations are marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Ferring S.A.U.

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Manufacturing Responsible Party:

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

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/