Pentasa

Patient Information Leaflet

PENTASA, 1 g/100 ml, rectal suspension
Mesalazinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor. See section 4.

Table of contents:

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, acts locally as an anti-inflammatory agent on the diseased wall of the sigmoid colon and rectum.
Pentasa is used in the treatment of ulcerative proctosigmoiditis.

2. Important information before using Pentasa

BEFORE STARTING MESALAZINE TREATMENT, INFORM YOUR DOCTOR IF:

• The patient has ever experienced the following after taking mesalazine: severe skin rash, skin peeling, blisters, or mouth ulcers.

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.
Use with 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, vision disturbances, or ringing or buzzing in the ears, they should immediately contact their doctor.
Mesalazine treatment may lead to kidney stone formation. Symptoms may include flank pain and haematuria. During treatment with mesalazine, an adequate fluid intake should be maintained.
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 these severe skin reactions occur, as described in section 4.
Rarely, mesalazine has been associated with hypersensitivity reactions affecting the heart (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.
Generally, 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 is due to a chemical reaction between mesalazine and the bleach and is harmless.

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

Pentasa and 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 into 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.
Recommended dose:
Adults
1 g (one enema) in the evening before bedtime.
Dosage adjustment is not required in elderly patients.
This medicine is for rectal use only.
Instructions for use:
Defecate immediately before using the enema.
Warm the bottle containing the suspension to approximately 37°C prior to administration.

1. Immediately before use, remove the bottle from the aluminum pouch and shake vigorously.
2. To break the seal, rotate the applicator one full turn clockwise (after rotation, the tip of the applicator should face the same direction as before turning).
3. Put on the plastic protective sleeve included in the package.
4. Hold the bottle as shown in the illustration.
5. To administer the suspension, lie on your left side with your left leg straight and your right leg bent forward for balance. Gently insert the applicator into the rectum. Administer the suspension by evenly squeezing the bottle with appropriate pressure. The entire contents of the bottle should be administered within no more than 30 to 40 seconds.
6. After emptying the bottle, withdraw the applicator tip from the rectum without releasing pressure on the bottle.
7. The suspension should be retained in the bowel. Remain in the same lying position for 5 to 10 minutes or until the urge to expel the suspension subsides.
8. Slide the plastic protective sleeve over the empty bottle. Dispose of it and wash your hands.

The medicine should be used immediately after opening the foil sachet.
Protect clothing from soiling with Pentasa medicine, as discoloration of the fabric may occur.
In case of accidental soiling, the fabric should be washed immediately.
Use of a higher than recommended dose of Pentasa medicine
In the event of an 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 experiences them.
Treatment with mesalazine should be discontinued and immediate medical help sought if the patient develops any of the following symptoms:

• Red, flat, disc-shaped or circular skin lesions on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes, 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 recurring 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. lung infiltration due to hypersensitivity with accompanying blood eosinophilia (increased number of eosinophils in blood), 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, increased 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: anaemia, aplastic anaemia, 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 count 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, i.e. non-epidermal blisters appearing on mucous membranes, mainly in the mouth 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pentasa

Keep 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 packaging after the EXP mark.
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. This will help protect the environment.

6. Contents of the pack and other information

What Pentasa contains
The active substance is mesalazine. 100 ml of the enema contains 1 g of mesalazine.
Other ingredients are: disodium edetate, sodium metabisulfite, sodium acetate, hydrochloric acid, purified water.

What Pentasa looks like and contents of the pack
Pentasa is available as a rectal enema suspension.
The suspension is white to slightly yellow in colour.
The pack contains 7 bottles of 100 ml enema suspension.

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

Manufacturer
Ferring-Léčiva a.s.
K Rybniku 475
252 42 Jesenice near Prague
Czech Republic

For further information, please contact the Marketing Authorisation Holder.
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