Pentasa 4 g rectal suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pentasa 4 g rectal suspension

Mesalazine

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Pentasa rectal suspension is and what it is used for
2. What you need to know before using Pentasa rectal suspension
3. How to use Pentasa rectal suspension
4. Possible side effects
5. How to store Pentasa rectal suspension
6. Contents of the pack and other information

1. What Pentasa rectal suspension is and what it is used for

Pentasa rectal suspension is indicated for the treatment of ulcerative colitis localized in the rectum and sigmoid colon.

Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine is inflamed and develops numerous tiny breaks on its surface (ulcers) that may bleed.

Pentasa contains the active substance mesalazine. It belongs to a group of medicines called intestinal anti-inflammatory agents, which help reduce inflammation and painful symptoms.

2. What you need to know before using Pentasa rectal suspension

Do not use PENTASA rectal suspension:

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

Warnings and precautions

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

• if you are allergic to sulfasalazine (risk of allergy to salicylates)
• 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 receiving 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 acute intolerance symptoms occur, such as cramps, abdominal pain, fever, severe headache, or rash.
• 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 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 a red-brown color when it comes into contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Take special care with mesalazine:

Severe skin reactions have been observed with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Stop taking mesalazine and seek immediate medical attention if you notice any 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 carry out blood and urine tests to monitor your kidney function, especially at the beginning of treatment.

Use in children:

There is limited data available on the effect in children (6–18 years of age).

Use in elderly:

Pentasa should be used with caution in elderly patients and only in those with normal kidney function.

Use of Pentasa 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 (medications for thrombosis or blood thinners)

Pentasa 4 gram rectal suspension with food and drink

Not applicable.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning 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 disorders have been observed in newborns of mothers treated with this medicine.

Newborns may develop allergic reactions after breastfeeding, for example, diarrhoea. If the newborn develops diarrhoea, breastfeeding should be discontinued.

Fertility:

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

Driving and use of machines:

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

3. How to use Pentasa 4 grams rectal suspension

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again. Remember to use your medicine.

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

It is recommended to empty the bowel before administering the rectal suspension.

Instructions for use

Note: It is recommended to protect bed linens from possible spillage, as Pentasa rectal suspension may discolor fabrics. If Pentasa rectal suspension is accidentally spilled onto fabric, soak it immediately.

Recommended dose:

Adults: 1 bottle of 100 milliliters (4 grams) rectal suspension 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 minimal documented evidence regarding use in children.

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

If you use Pentasa rectal suspension and more than you should

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

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 the amount ingested.

If you stop treatment with Pentasa rectal suspension

Your doctor will determine the duration of your treatment with Pentasa rectal suspension. Do not discontinue treatment prematurely, even if you feel better, as symptoms may reappear if treatment is stopped too early. Strictly follow the treatment regimen as instructed by your doctor, including the prescribed maintenance period.

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

4. Possible adverse effects

Like all medicines, Pentasa rectal suspension may cause 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 cause 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 recurrent headache, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension).

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

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

The following are common adverse effects, affecting between 1 and 10 in 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 are rare adverse effects, affecting between 1 and 10 in 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
• dizziness
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

The following are very rare adverse effects, affecting fewer than 1 in 10,000 patients treated:

• eosinophilia (as part of an allergic reaction) and blood disorders such as reduction in red blood cells (anemia), 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, edema (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 allergic and fibrotic 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 discoloration, 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 color
• If you experience severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension).

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

If these symptoms persist or worsen, consult your doctor.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 rectal suspension

Keep out of the sight and reach of children.

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

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 or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pentasa rectal suspension:

• The active substance is mesalazine.
• The other components are: disodium edetate, sodium metabisulphite, sodium acetate trihydrate, hydrochloric acid and purified water q.s. 100 millilitres.

Nature of the product and pack contents

Pentasa rectal suspension is a white to slightly yellowish suspension for rectal administration, 100 millilitres.

Each carton contains 7 bottles of 100 millilitres of rectal suspension.

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 Léciva a.s

Address: K Rybníku 475, 252 42

Jesenice, Prague, Czech Republic

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

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