Granmesa

Patient Information Leaflet

GRANMESA, 1 g, prolonged-release granules in sachet
GRANMESA, 2 g, prolonged-release granules in sachet
Mesalazinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents:

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

1. What GRANMESA is and what it is used for

Mesalazine, the active substance in GRANMESA, acts locally as an anti-inflammatory agent on the diseased intestinal wall of both the small and large intestine. Mesalazine is continuously released from the granules along the entire length of the intestine, independently of pH values.
GRANMESA is used in the treatment of mild to moderate ulcerative colitis and Crohn's disease.

2. Important information before using GRANMESA

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 GRANMESA

• 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. acetylsalicylic acid,
• 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
Before starting treatment with GRANMESA, discuss this with your doctor. 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 (an immunosuppressive agent), 6-mercaptopurine (an antineoplastic and immunosuppressive agent), or thioguanine (an antineoplastic agent),
• if the patient has lung disorders, especially bronchial asthma,
• if the patient experiences severe or recurring headache, vision disturbances, or tinnitus (ringing or buzzing in the ears), contact your doctor immediately,
• Mesalazine treatment may lead to kidney stone formation. Symptoms may include flank pain and haematuria (blood in urine). 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). Treatment with mesalazine must be discontinued immediately and medical help sought if any of the symptoms of these severe skin reactions (listed in section 4) occur.

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 should be stopped immediately and a 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 when it comes into 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
GRANMESA should not be used in children under 6 years of age. Clinical data on use in children (aged 6 to 18 years) are limited.

GRANMESA and other medicines
Inform 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 particularly includes: sulfasalazine, azathioprine, 6-mercaptopurine, thioguanine, and 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 human milk.

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

GRANMESA contains sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use GRANMESA

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
Recommended dosage:
Ulcerative colitis, treatment of active phase of the disease:
Adults: the physician determines the dosage individually, up to 4 g once daily or in divided doses.
Children aged 6 years and older: the physician determines the dosage individually; usually 30 to
50 mg/kg body weight per day in divided doses. Maximum dose: 75 mg/kg body weight per day in
divided doses. Total daily dose should not exceed 4 g per day (maximum adult dose). GRANMESA should not be used in children under 6 years of age.
Ulcerative colitis, maintenance treatment:
Adults: the recommended dose is 2 g once daily.
Children aged 6 years and older: the physician determines the dosage individually; usually 15 to
30 mg/kg body weight per day in divided doses. Total daily dose should not exceed 2 g per day. GRANMESA should not be used in children under 6 years of age.
Crohn's disease, treatment of active phase of the disease:
Adults: the physician determines the dosage individually, up to 4 g per day in divided doses.
Children aged 6 years and older: the physician determines the dosage individually; usually 30 to
50 mg/kg body weight per day in divided doses. Maximum dose: 75 mg/kg body weight per day in
divided doses. Total daily dose should not exceed 4 g per day (maximum adult dose). GRANMESA should not be used in children under 6 years of age.
Crohn's disease, maintenance treatment:
Adults: the physician determines the dosage individually, up to 4 g per day in divided doses.
Children aged 6 years and older: the physician determines the dosage individually; usually 15 to
30 mg/kg body weight per day in divided doses. Total daily dose should not exceed 2 g per day. GRANMESA should not be used in children under 6 years of age.
For treatment with doses lower than 2 g, the available GRANMESA prolonged-release granules 1 g product should be used.
In patients with active Crohn's disease who do not respond adequately to treatment with 4 g per day within 6 weeks, and in patients with Crohn's disease who experience relapse during maintenance treatment with 4 g per day, alternative treatment should be considered.
Dosage adjustment is not required in elderly patients.
The medicine is taken orally.
Do not chew or crush the granules.
Empty the contents of the sachet onto the tongue and swallow with water or juice.
Alternatively, the entire contents of the sachet may be mixed with yogurt and consumed immediately, without chewing the granules. To achieve the desired therapeutic effect, the recommended doses should be taken regularly and consistently.
Use of a higher than recommended dose of GRANMESA
In case of overdose, symptomatic treatment in hospital is indicated, with monitoring of kidney function.
Missed dose of GRANMESA
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Severe adverse effects:
Mesalazine treatment should be discontinued immediately and medical help sought if the patient develops any of the following symptoms:

• Flat, target-shaped or circular red patches on the trunk, often with blisters in the centre, skin peeling, ulceration in the mouth, throat, nose, genital organs and around the eyes, extensive rash, fever and swollen lymph nodes. Such severe skin rashes may be preceded by fever and flu-like symptoms.

If during treatment any of the following occur:

• Acute intolerance symptoms such as colicky abdominal pain, acute abdominal pain, fever, severe headache or rash,
• 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); treatment should be stopped immediately and a doctor contacted.

Common (may occur in 1 to 10 out of 100 patients treated):

• Diarrhoea
• Nausea
• Abdominal pain
• Headache
• Vomiting
• Flatulence
• Rash
• Urticaria

Uncommon (may occur in 1 to 10 out of 10,000 patients treated):

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

Very rare (may occur in less than 1 out of 10,000 patients treated):

• Muscle pain
• Joint pain
• Transient alopecia
• Allergic alveolitis, allergic reactions and fibrotic changes in the lungs (including dyspnoea, cough, bronchospasm), pulmonary eosinophilia – i.e. lung infiltrate due to hypersensitivity with accompanying blood eosinophilia (increased number of acidophilic 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, harmful effects on the liver (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 colon
• Transient oligospermia (low sperm count in male semen)
• Hypersensitivity reactions, including allergic rash, anaphylactic reaction, erythema multiforme
• Drug fever.

Frequency unknown (frequency 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-transient blisters appearing on mucous membranes, mainly in the oral cavity and genital organs.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store GRANMESA

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine GRANMESA contains

• The active substance is mesalazine. Each prolonged-release sachet contains either 1 g or 2 g of mesalazine.
• Other ingredients are: sucrose, granules (sucrose, corn starch, povidone K 30), polymethacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, triethyl citrate, ethylcellulose N 20, povidone K 30, dibutyl sebacate, talc.

What GRANMESA looks like and contents of the pack
GRANMESA is available as a prolonged-release granulate. Spherical pellets ranging in colour from light to dark beige.
Packaging: paper/LDPE/aluminium/LDPE sachets containing prolonged-release granulate, placed in a cardboard box.
GRANMESA 1 g is available in the following pack sizes: 50, 100, 150 sachets.
GRANMESA 2 g is available in the following pack sizes: 60, 120 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Recordati Polska Sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel.: +48 22 206 84 50

Importer
Inpharmasci
Z.I. n°2 Prouvy-Rouvignies,
1 Rue de Nungesser
59121 Prouvy
France