Pentasa

Patient Information Leaflet

PENTASA, 1 g, suppositories
Mesalazinum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor. See section 4.

Contents of the leaflet:

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

1. What Pentasa is and what it is used for

Mesalazine, the active substance in Pentasa, exerts a local anti-inflammatory action on the diseased wall of the rectum.
Pentasa is used in the treatment of ulcerative proctitis.

2. Important information before using Pentasa

BEFORE STARTING MESALAZINE TREATMENT, INFORM YOUR DOCTOR IF:

• The patient has ever experienced severe skin rash, skin peeling, blisters or oral ulcers after taking mesalazine.

When not to use Pentasa
if the patient is allergic to mesalazine or any of the other ingredients of this medicine
(listed in section 6),
if the patient is allergic to salicylates, e.g. aspirin,
if the patient has severe liver and/or kidney function disorders,
if the patient has peptic ulcer of the stomach or duodenum,
if the patient has a bleeding tendency.

Warnings and precautions
Discuss this with your doctor before starting treatment with Pentasa.
Exercise caution:
if the patient is allergic to sulfasalazine,
if there are liver and/or kidney function disorders,
if the patient is concurrently treated with medicines that may impair kidney function,
if the patient is concurrently treated with azathioprine (a medicine that suppresses the immune system),
6-mercaptopurine (a medicine with antineoplastic and immunosuppressive effects), or thioguanine (a medicine with antineoplastic effects),
if the patient has lung disorders, especially bronchial asthma,
if the patient experiences severe or recurring headache, visual disturbances, or ringing or buzzing in the ears, they should contact the doctor immediately.

Mesalazine treatment may lead to the formation of kidney stones. Symptoms may include flank pain and haematuria. Adequate fluid intake is recommended during mesalazine therapy.

Severe skin reactions have been reported with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Mesalazine must be discontinued immediately and medical help sought without delay if any of the symptoms of these severe skin reactions, listed in section 4, occur.

Rarely, mesalazine has been associated with cardiac hypersensitivity reactions (myocarditis and pericarditis).
Very rarely, serious blood disorders have been reported.

If acute intolerance symptoms occur during treatment, such as colicky abdominal pain, acute abdominal pain, fever, severe headache or rash, treatment must be stopped immediately and the doctor contacted.

Usually, before starting and during treatment, the doctor will order blood and urine tests to monitor liver, kidney, or haematopoietic system function.

Mesalazine may cause a reddish-brown discoloration of urine upon contact with sodium hypochlorite bleach present in toilet water. This results from a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents
Experience with use in children is limited and clinical data are scarce.

Pentasa with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is particularly important for the following medicines:
sulfasalazine, azathioprine, 6-mercaptopurine or thioguanine, warfarin.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Mesalazine crosses the placenta.
Mesalazine is excreted in breast milk.

Driving and operating machinery
No effects of Pentasa on the ability to drive and operate machinery have been observed.

3. How to use Pentasa

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
The recommended dose is:
Adults
1 g (one suppository) 1-2 times daily.
In elderly patients, no dosage adjustment is necessary.
The medicine is administered rectally.
Instructions for use of the medicine:

1. It is recommended to empty the bowels immediately before inserting the suppository.
2. For hygiene purposes, a protective cover may be placed on the finger before inserting the suppository.
3. Insert the suppository into the rectum. To facilitate insertion, the suppository may be moistened with water.
4. If the suppository is expelled within 10 minutes, another one should be inserted.

Use of a higher than recommended dose of Pentasa
In case of overdose, symptomatic treatment in hospital is indicated, with monitoring of kidney function.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with mesalazine should be discontinued immediately and medical help should be sought urgently if the patient develops any of the following symptoms:

• Red, flat, disc-shaped or circular spots on the trunk, often with blisters in the center, peeling skin, oral, throat, nasal, genital or ocular ulcers, extensive rash, fever and swollen lymph nodes. Such severe skin reactions may be preceded by fever and flu-like symptoms.

Serious adverse reactions of unknown frequency (cannot be estimated from available data)
Seek immediate medical help if:

• The patient experiences severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension).

The following adverse reactions occur commonly (may occur in 1 to 10 out of 100 treated patients):

• Diarrhea
• Nausea
• Abdominal pain
• Headache
• Vomiting
• Flatulence
• Rash
• Urticaria
• Discomfort and irritation around the anus
• Itching of the anus
• Painful urge to defecate

The following adverse reactions occur rarely (may occur in 1 to 10 out of 10,000 treated patients):

• Dizziness
• Myocarditis
• Pericarditis
• Increased amylase activity
• Acute pancreatitis
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity)

The following adverse reactions occur very rarely (may occur in less than 1 out of 10,000 treated patients):

• Muscle pain
• Joint pain
• Transient alopecia
• Allergic alveolitis, allergic reactions and fibrotic changes in the lungs (including dyspnea, cough, bronchospasm), pulmonary eosinophilia – i.e. pulmonary infiltrate due to hypersensitivity with accompanying blood eosinophilia (increased number of eosinophilic white blood cells), interstitial lung disease, pulmonary infiltrate, pneumonia
• Kidney function disorders (acute and chronic interstitial nephritis, nephrotic syndrome – i.e. a syndrome of disease symptoms caused by excessive loss of protein in urine, renal failure), discoloration of urine
• Increased liver enzyme activity, elevated cholestasis markers (substances indicating bile stasis in the liver) and bilirubin levels, hepatotoxic effects (including hepatitis, cholestatic hepatitis, cirrhosis, liver failure)
• Blood disorders such as: anemia, aplastic anemia, agranulocytosis – i.e. very low granulocyte count, neutropenia – i.e. low neutrophil count, leukopenia – i.e. low white blood cell count (including granulocytopenia – i.e. low granulocyte count), pancytopenia – i.e. low counts of all blood cells, thrombocytopenia – i.e. low platelet count, and eosinophilia (as part of an allergic reaction)
• Lupus-like reactions
• Peripheral neuropathy – i.e. dysfunction of peripheral nerves
• Pancolitis – i.e. severe form of ulcerative colitis affecting the entire large intestine
• Transient oligospermia (low sperm count in male semen)
• Hypersensitivity reactions, including allergic rash, anaphylactic reaction, erythema multiforme
• Drug fever

Frequency unknown (cannot be estimated from available data):

• Kidney stones and associated kidney pain (see also section 2)
• Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) – severe skin reactions characterized by transient blisters on mucous membranes, mainly in the oral cavity and genital organs.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pentasa

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Pentasa contains
The active substance is mesalazine. Each suppository contains 1 g of mesalazine.
The other ingredients are: povidone, macrogol 6000, magnesium stearate, talc.

What Pentasa looks like and contents of the pack
Pentasa is available as rectal suppositories.
The suppository is elongated, mottled, white to light brown in colour.
The pack contains 14 or 28 suppositories.

Marketing Authorisation Holder:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For further information, please contact the representative of the Marketing Authorisation Holder.
Poland
Ferring Pharmaceuticals Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81