Cletrova

Package leaflet: Information for the patient

Cletrova 500 mg prolonged-release granules

Mesalazine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.
Keep this leaflet. 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 give it to other people, even if their
symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Cletrova 500 mg granules is and what it is used for
2. What you need to know before taking Cletrova 500 mg granules
3. How to take Cletrova 500 mg granules
4. Possible side effects
5. How to store Cletrova 500 mg granules
6. Contents of the pack and other information

1. What Cletrova 500 mg granules is and what it is used for

Cletrova granules contain the active substance mesalazine, an anti-inflammatory agent used to
treat inflammatory bowel diseases.
Cletrova 500 mg granules are used for
the treatment of acute episodes and the prevention of further episodes (relapse) of ulcerative colitis,
a mild to moderate inflammatory disease of the large intestine (colon).

2. What you need to know before taking Cletrova 500 mg granules

Do not take Cletrova 500 mg granules
if you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g.
Aspirin), or to any of the other ingredients of this medicine (listed in
section 6);
if you have severe liver or kidney disease.

Warnings and precautions
Talk to your doctor before taking Cletrova 500 mg granules:
if you have a history of lung problems, particularly if you suffer from bronchial asthma;
if you have a history of allergy to sulfasalazine, a substance related to mesalazine;
if you suffer from liver problems;
if you suffer from kidney problems;
if you have ever developed a severe skin rash, skin peeling, blistering, and/or oral ulcers after taking mesalazine.

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

Additional precautions
During treatment, your doctor may wish to monitor you closely and carry out regular blood and urine tests.
Kidney stones may develop during treatment with mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Make sure to drink sufficient amounts of fluids during treatment with mesalazine.
Serious skin reactions have been reported in association with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Stop using mesalazine and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Other medicines and Cletrova 500 mg granules
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular:
Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune system disorders);
Some products that inhibit blood clotting (antithrombotic or anticoagulant medicines, such as warfarin);
Lactulose (a medicine used to treat constipation) or other preparations that may alter the acidity of stools.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. You may still be able to use Cletrova 500 mg granules, and your doctor will decide what is suitable for you.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use Cletrova 500 mg granules during pregnancy only if your doctor has instructed you to do so.
You should also use Cletrova 500 mg granules during breastfeeding only if your doctor has instructed you to do so, as this medicine may pass into breast milk.

Driving and using machines
Cletrova 500 mg granules has no effect or negligible effect on the ability to drive vehicles and use machinery.

Cletrova 500 mg granules contains aspartame, sucrose and sodium
This medicine contains 1 mg of aspartame per sachet of Cletrova 500 mg granules.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. it is essentially "sodium-free".

3. How to take Cletrova 500 mg granules

Take Cletrova 500 mg granules exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Method of administration
Cletrova 500 mg granules is for oral use only.
Cletrova 500 mg granules must not be chewed. You must take Cletrova 500 mg granules by placing the granules directly on the tongue and swallowing them with plenty of liquid without chewing.
Dosage

Adults and elderly
If not otherwise prescribed by your doctor, the recommended dose for the treatment of acute episodes
of ulcerative colitis is:
depending on individual clinical needs, from 3 to 6 sachets of Cletrova 500 mg granules
(equivalent to 1.5–3 g of mesalazine per day) once daily, preferably in the morning, or
1–2 sachets three times daily (in the morning, at midday, and in the evening).
For prevention of relapse of ulcerative colitis
The usual dosage for prevention of further episodes of ulcerative colitis is 1 sachet of Cletrova 500 mg
granules three times daily (equivalent to 1.5 g of mesalazine per day).
If, according to your doctor's assessment, you are at high risk of relapse, the dosage for prevention of
further episodes of ulcerative colitis is 6 sachets of Cletrova 500 mg granules once daily,
preferably in the morning (equivalent to 3 g of mesalazine per day).
In general, for recommended dosages exceeding 1.5 g of mesalazine up to 3 g of mesalazine,
Cletrova 1,000 mg, Cletrova 1.5 g, or Cletrova 3 g granules should be used, if possible.
Use in children
Data on efficacy in children (aged 6–18 years) are limited.
Children aged 6 years and older
Please consult your doctor for the exact dosage of Cletrova granules for your child.
In acute episodes
To be determined individually, starting with 30–50 mg of mesalazine per kg of body weight per
day, administered once daily, preferably in the morning, or in divided doses. The maximum dose is
75 mg of mesalazine per kg of body weight per day. The total dose must not exceed the maximum
dose for an adult.
For prevention of relapse
To be determined individually, starting with 15–30 mg of mesalazine per kg of body weight per
day, administered in divided doses. The total dose must not exceed the recommended dose for an
adult.
It is generally recommended to administer a dose equal to half the adult dose to children with a body
weight up to 40 kg, and the full adult dose to those with a body weight exceeding 40 kg.
Duration of treatment
Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how
long you should continue treatment with this medicine, depending on your condition.
To achieve the maximum benefit from this medicine, you must use Cletrova granules regularly and
consistently, both during acute episodes of inflammation and as long-term maintenance treatment, as
indicated.
If you think that Cletrova 500 mg granules is too strong or too weak, consult your doctor.
If you take more Cletrova 500 mg granules than you should
If in doubt, consult a doctor, so that appropriate measures can be taken.
If you take too much Cletrova 500 mg granules on one occasion, simply take the next dose as prescribed.
Do not take a lower amount.
If you forget to take Cletrova 500 mg granules
Do not take a double dose to make up for a forgotten dose.
If you stop taking Cletrova 500 mg granules
Do not stop treatment with this product before discussing it with your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cletrova 500 mg granules can cause side effects, although not everyone gets them.
If you experience any of the following symptoms after taking this medicine, contact your doctor and stop using Cletrova granules immediately:

• General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties, or generalized inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• A marked worsening of your general health, especially if accompanied by fever and/or sore throat and mouth. These symptoms may very rarely be due to a reduction in the number of white blood cells in the blood, which may make you more susceptible to developing a serious infection (agranulocytosis). A reduction in other blood cells (such as red blood cells or platelets, causing aplastic anaemia or thrombocytopenia) may also occur, which can lead to symptoms such as unexplained bleeding, pinpoint spots or purple patches under the skin, or anaemia (feeling tired and weak, and pale appearance, particularly of the lips and nails). A blood test can confirm whether these symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
• Severe skin rashes with flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These manifestations may be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
• Shortness of breath, chest pain or irregular heartbeat, or swelling of the limbs, which may indicate cardiac hypersensitivity reactions. These reactions are very rare.
• Kidney function problems (may occur very rarely), for example changes in the colour or amount of urine produced, or swelling of the limbs or sudden flank pain (caused by kidney stones) (occurring in an unknown number of patients (frequency not known)).

The following side effects have also been reported in patients using mesalazine:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Skin rash, itching

Uncommon side effects (may affect up to 1 in 100 people)

• Abdominal pain, diarrhoea, dyspepsia, flatulence, nausea and vomiting
• Severe abdominal pain due to acute inflammation of the pancreas
• Changes in liver function parameters, changes in pancreatic enzymes

Rare side effects (may affect up to 1 in 1,000 people)

• Dizziness
• Jaundice or abdominal pain due to liver or bile flow disorders
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Joint pain
• Feeling of weakness or fatigue

Very rare side effects (may affect up to 1 in 10,000 people)

• Numbness and tingling in the hands and feet (peripheral neuropathy)
• Shortness of breath, cough, wheezing, lung shadows on X-rays due to allergic and/or inflammatory conditions affecting the lungs
• Hair loss and development of baldness
• Muscle pain
• Reversible reduction in sperm production

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cletrova 500 mg granules

Keep this medicine out of the sight and reach of children.
Do not use Cletrova 500 mg granules after the expiry date which is stated on the carton and sachet
after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cletrova 500 mg granules contain
The active substance is mesalazine and one sachet of Cletrova 500 mg granules contains 500 mg of
mesalazine.
The other components are: aspartame (E951), sodium carmellose, microcrystalline cellulose, citric
acid, anhydrous colloidal silica, hypromellose, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methylcellulose, 40% polyacrylate dispersion
(Eudragit NE 40 D containing 2% nonoxinol 100), povidone K 25, simethicone, sorbic acid,
talc, titanium dioxide (E171), triethyl citrate, vanilla custard flavour (containing sucrose).
Description of the appearance of Cletrova 500 mg granules and contents of the pack
Cletrova 500 mg prolonged-release granules consist of rod-shaped or round granules, grey-white in colour.
Each sachet contains 930 mg of granules.
Cletrova 500 mg granules are available in packs of 50, 100 and 300 sachets.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
DR. FALK PHARMA GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761 / 1514-0
Fax: +49 (0) 761 / 1514-321
E-mail: [email protected]
Distributor for Italy:
DR. FALK PHARMA S.r.l.,
Via Lepetit 8 – 20124, Milan, Italy
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Denmark, Finland, Germany, Greece, Ireland, Latvia, Norway, Netherlands, Portugal, United Kingdom, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary: Salofalk.
Belgium, Luxembourg: Colitofalk.
Austria: Mesagran.
Italy: Cletrova
France: Osperzo.
[To be completed with national data]

Patient information leaflet

Cletrova 1.000 mg prolonged-release granules

mesalazine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cletrova 1.000 mg granules is and what it is used for
2. What you need to know before taking Cletrova 1.000 mg granules
3. How to take Cletrova 1.000 mg granules
4. Possible side effects
5. How to store Cletrova 1.000 mg granules
6. Contents of the pack and other information

1. What Cletrova 1,000 mg granules is and what it is used for

Cletrova 1,000 mg granules contains the active substance mesalazine, an anti-inflammatory agent used
to treat inflammatory bowel diseases.
Cletrova 1,000 mg granules is used for

• the treatment of acute episodes and the prevention of further episodes (relapse) of ulcerative colitis, a mild to moderate inflammatory disease of the large intestine (colon).

2. What you need to know before taking Cletrova 1,000 mg granules

Do not take Cletrova 1,000 mg granules

• if you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin), or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease.

Warnings and precautions
Talk to your doctor before taking Cletrova 1,000 mg granules

• if you have a history of lung problems, particularly if you suffer from bronchial asthma
• if you are allergic to sulfasalazine, a substance related to mesalazine
• if you suffer from liver problems
• if you suffer from kidney problems
• if you have ever developed a severe skin rash, skin peeling, blistering and/or oral ulcers after taking mesalazine.

Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite
contained in bleach present in toilet water. This is due to a harmless chemical reaction
occurring between mesalazine and bleach.
Additional precautions
During treatment, your doctor may wish to monitor you closely and carry out regular
blood and urine tests.
Kidney stones may develop during treatment with mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Make sure you drink adequate amounts of fluids during treatment with mesalazine.
Severe skin reactions have been reported in association 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 consult a doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Other medicines and Cletrova 1,000 mg granules
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular

• Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune system disorders)
• Some products that inhibit blood clotting (antithrombotic or anticoagulant medicines, such as warfarin)
• Lactulose (a medicine used to treat constipation) or other preparations that may alter the acidity of stools

Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those not requiring a prescription. You may still be able to use Cletrova 1,000
mg granules, and your doctor will decide what is appropriate for you.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
You should use Cletrova 1,000 mg granules during pregnancy only if your doctor has instructed you to do so.
You should also use Cletrova 1,000 mg granules during breastfeeding only if your doctor has instructed you to do so, as this medicine may pass into breast milk.
Driving and using machines
Cletrova 1,000 mg granules has no effect or negligible effect on the ability to drive and use machines.
Cletrova 1,000 mg granules contains aspartame, sucrose and sodium
This medicine contains 2 mg of aspartame per sachet of Cletrova 1,000 mg granules.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare
genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. it is essentially "sodium-free".

3. How to take Cletrova 1,000 mg granules

Take Cletrova 1,000 mg granules exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Cletrova 1,000 mg granules is for oral use only.
Cletrova granules must not be chewed. You must take Cletrova granules by placing the granules directly on the tongue and swallowing them with plenty of liquid without chewing.
Dosage

Adults and elderly
If not otherwise prescribed by your doctor, the recommended dose for the treatment of acute episodes
of ulcerative colitis is:
depending on clinical needs in the individual case, 3 sachets of Cletrova 1,000 mg granules (equivalent
to 3 g of mesalazine per day) once daily, preferably in the morning, or 1 sachet of Cletrova 1,000 mg
granules three times daily (in the morning, at midday, and in the evening).
To prevent a relapse of ulcerative colitis
The usual dosage to prevent further episodes of ulcerative colitis is 1 sachet of Cletrova 500 mg
granules three times daily (equivalent to 1.5 g of mesalazine per day).
If, according to your doctor's opinion, you are at high risk of relapse, the dosage for preventing
further episodes of ulcerative colitis is 3 sachets of Cletrova 1,000 mg granules once daily,
preferably in the morning (equivalent to 3 g of mesalazine per day).
Use in children
Data on efficacy in children (aged 6–18 years) are limited.
Children aged 6 years and older
Ask your doctor for the exact dosage of Cletrova granules for your child.
In acute episodes:
To be determined individually, starting with 30–50 mg of mesalazine per kg of body weight per
day, administered once daily, preferably in the morning, or in divided doses. The maximum dose is
75 mg of mesalazine per kg of body weight per day. The total dose must not exceed the maximum dose for an adult.
To prevent a relapse:
To be determined individually, starting with 15–30 mg of mesalazine per kg of body weight per
day, administered in divided doses. The total dose must not exceed the recommended dose for an adult.
It is generally recommended to administer half the adult dose to children weighing up to 40 kg, and the full adult dose to children weighing more than 40 kg.
Duration of treatment
The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you should continue treatment with this medicine. This will depend on your condition.
To achieve the maximum benefit from this medicine, you must use Cletrova granules regularly and consistently, both during the acute episode of inflammation and as long-term treatment, as indicated.
If you think that Cletrova 1,000 mg granules is too strong or too weak, consult your doctor.
If you take more Cletrova 1,000 mg granules than you should
If in doubt, consult a doctor so that appropriate measures can be taken.
If you take too much Cletrova 1,000 mg granules on one occasion, simply take the next dose as prescribed. Do not use a lower amount.
If you forget to take Cletrova 1,000 mg granules
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Cletrova 1,000 mg granules
Do not stop treatment with this product before discussing it with your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cletrova 1,000 mg granules can cause side effects, although not everybody gets
them.
If you experience any of the following symptoms after taking this medicine, consult your doctor and
stop using Cletrova granules immediately:

• General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties, or generalized inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• A marked worsening of your general health, especially if accompanied by fever, and/or sore throat and mouth. These symptoms may very rarely be due to a reduced number of white blood cells in the blood, which may make you more susceptible to developing a serious infection ( agranulocytosis ). A reduction in other blood cells (such as red blood cells or platelets, leading to aplastic anaemia or thrombocytopenia ) may also occur, which could cause symptoms such as unexplained bleeding, purple spots or bruises under the skin, or anaemia (feeling tired and weak, pale appearance, especially of lips and nails). A blood test can confirm whether symptoms are due to this medicine's effect on the blood. These reactions are very rare.
• Severe skin rashes with flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth ulcers, sores in the throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These symptoms may be preceded by fever and flu-like symptoms. The frequency of these reactions is unknown.
• Shortness of breath, chest pain or irregular heartbeat, or swelling in the limbs, which may indicate cardiac hypersensitivity reactions . These reactions are very rare.
• Kidney function problems (may occur very rarely), e.g. changes in colour or amount of urine produced, swelling in the limbs or sudden flank pain (caused by kidney stones) (occurring in an unknown number of patients (frequency not known)).

The following side effects have also been reported in patients using mesalazine:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Skin rash, itching

Uncommon side effects (may affect up to 1 in 100 people)

• Abdominal pain, diarrhoea, dyspepsia, flatulence, nausea and vomiting
• Severe abdominal pain due to acute inflammation of the pancreas
• Changes in liver function tests, changes in pancreatic enzymes

Rare side effects (may affect up to 1 in 1,000 people)

• Dizziness
• Jaundice or abdominal pain due to liver and bile flow disorders
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Joint pain
• Feeling weak or tired

Very rare side effects (may affect up to 1 in 10,000 people)

• Numbness and tingling in hands and feet (peripheral neuropathy)
• Shortness of breath, cough, wheezing, lung shadows on X-rays due to allergic and/or inflammatory conditions of the lungs
• Hair loss and development of baldness
• Muscle pain
• Reversible reduction in sperm production

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cletrova 1.000 mg granules

Keep this medicine out of the sight and reach of children.
Do not use Cletrova 1.000 mg granules after the expiry date stated on the carton and sachet after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cletrova 1,000 mg granules contains
The active substance is mesalazine. One sachet of Cletrova 1,000 mg granules contains 1,000 mg of
mesalazine.
The other components are: aspartame (E951), sodium carmellose, microcrystalline cellulose, citric
acid, anhydrous colloidal silica, hypromellose, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methylcellulose, 40% polyacrylate dispersion
(Eudragit NE 40 D containing 2% nonoxinol 100), povidone K 25, simethicone, sorbic acid,
talc, titanium dioxide (E171), triethyl citrate, vanilla custard flavour (containing sucrose).
Description of the appearance of Cletrova 1,000 mg granules and contents of the pack
Cletrova 1,000 mg prolonged-release granules consist of rod-shaped or round granules, greyish-white in colour.
Each sachet contains 1.86 g of granules.
Cletrova 1,000 mg granules are available in packs of 20, 50, 60, 100 and 150 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
DR. FALK PHARMA GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761 / 1514-0
Fax: +49 (0) 761 / 1514-321
E-mail: [email protected]
Sole distributor for sale in Italy:
DR. FALK PHARMA S.r.l.,
Via Lepetit 8 – 20124, Milan, Italy
This medicinal product is authorised in the European Economic Area countries under the
following names:
Bulgaria, Denmark, Finland, Germany, Greece, Ireland, Latvia, Norway, Netherlands, Poland,
Portugal, United Kingdom, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary: Salofalk.
Belgium, Luxembourg: Colitofalk.
Austria: Mesagran.
Italy: Cletrova.
France: Osperzo.
[To be completed with national data]

Patient information leaflet

Cletrova 1.5 g prolonged-release granules

mesalazine
Please read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cletrova 1.5 g granules is and what it is used for
2. What you need to know before taking Cletrova 1.5 g granules
3. How to take Cletrova 1.5 g granules
4. Possible side effects
5. How to store Cletrova 1.5 g granules
6. Contents of the pack and other information

1. What Cletrova 1.5 g granules is and what it is used for

Cletrova 1.5 g granules contains the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel diseases.
Cletrova 1.5 g granules is used for

• the treatment of acute episodes and the prevention of further episodes (relapse) of ulcerative colitis, a mild to moderate inflammatory disease of the large intestine (colon).

2. What you need to know before taking Cletrova 1.5 g granules

Do not take Cletrova 1.5 g granules

• if you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin), or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease.

Warnings and precautions
Talk to your doctor before taking Cletrova 1.5 g granules

• if you have a history of lung problems, particularly if you suffer from bronchial asthma
• if you have a history of allergy to sulfasalazine, a substance related to mesalazine
• if you suffer from liver problems
• if you suffer from kidney problems
• if you have ever developed a severe skin rash, skin peeling, blistering, and/or mouth ulcers after taking mesalazine.

Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite
contained in bleach present in toilet water. This is due to a harmless chemical reaction
occurring between mesalazine and bleach.
Additional precautions
During treatment, your doctor may wish to monitor you closely and carry out regular
blood and urine tests.
Kidney stones may develop during treatment with mesalazine. Symptoms may include pain in the sides
of the abdomen and blood in the urine. Make sure to drink sufficient fluids during
treatment with mesalazine.
Serious skin reactions have been reported in association with mesalazine treatment, including
drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS),
and toxic epidermal necrolysis (TEN). Stop using mesalazine and consult your doctor
immediately if you notice any of the symptoms related to these serious skin reactions
described in section 4.
Other medicines and Cletrova 1.5 g granules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. In particular

• Azathioprine, 6-mercaptopurine, or thioguanine (medicines used to treat immune system disorders)
• Some products that inhibit blood clotting (antithrombotic or anticoagulant medicines, such as warfarin)
• Lactulose (a medicine used to treat constipation) or other preparations that may alter stool acidity

Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those not requiring a prescription. You may still be able to use Cletrova 1.5 g
granules, and your doctor will be able to decide what is suitable for you.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
You should only use Cletrova 1.5 g granules during pregnancy if your doctor has instructed you to do so.
You should also only use Cletrova 1.5 g granules during breastfeeding if your doctor has instructed you to do so,
as this medicine may pass into breast milk.
Driving and using machines
Cletrova 1.5 g granules does not affect or has a negligible effect on the ability to drive vehicles and use
machinery.
Cletrova 1.5 g granules contains aspartame, sucrose, and sodium
This medicine contains 3 mg of aspartame per sachet of Cletrova 1.5 g granules.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare
genetic disorder causing accumulation of phenylalanine because the body cannot properly metabolize it.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking
this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. it is essentially "sodium-free".

3. How to take Cletrova 1.5 g granules

Take Cletrova granules exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Method of administration
Cletrova 1.5 g granules are for oral use only.
Cletrova 1.5 g granules must not be chewed. You must take Cletrova 1.5 g granules by placing the granules directly on the tongue and swallowing them with plenty of liquid without chewing.

Dosage

| Age and body weight | Single dose | Total daily dose | |-------------------------|-----------------|----------------------| | Adults, elderly, and children
weighing over 40 kg | Acute episode treatment
Up to 2 sachets of Cletrova 1.5 g granules once daily (1–2 sachets)

Prevention of further episodes
(for patients at higher risk of relapse)
2 sachets of Cletrova 1.5 g granules once daily | 1–2 sachets (equivalent to 1.5–3 g of mesalazine daily)

1 x 2 sachets (equivalent to 3 g of mesalazine daily) |

Adults and elderly
Unless otherwise prescribed by the doctor, the recommended dose for the treatment of acute episodes of ulcerative colitis is:
1–2 sachets of Cletrova 1.5 g granules once daily, preferably in the morning (equivalent to 1.5–3 g of mesalazine daily), depending on the individual clinical needs.

For prevention of ulcerative colitis relapse
The usual dosage for preventing further episodes of ulcerative colitis is 1 sachet of Cletrova 500 mg granules three times daily (equivalent to 1.5 g of mesalazine daily).
However, if your doctor considers you to be at higher risk of relapse, the dosage for prevention of further episodes of ulcerative colitis is 2 sachets of Cletrova 1.5 g granules once daily, preferably in the morning (equivalent to 3 g of mesalazine daily).

Use in children
Data on efficacy in children (aged 6–18 years) are limited.

Children aged 6 years and older
Ask your doctor for the exact dosage of Cletrova granules for your child.

During acute episodes
Dosage should be determined individually, starting at 30–50 mg of mesalazine per kg of body weight daily, administered once daily (preferably in the morning) or in divided doses. The maximum dose is 75 mg of mesalazine per kg of body weight daily. The total dose must not exceed the maximum adult dose.

Generally, it is recommended to administer a dose half that of an adult to children weighing up to 40 kg, and the full adult dose to those weighing over 40 kg.

Due to its high active substance content, Cletrova 1.5 g granules are not suitable for children weighing less than 40 kg. Use Cletrova 500 mg granules or 1,000 mg instead.

Duration of treatment
Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you should continue treatment with this medicine, depending on your condition.

To achieve the maximum benefit from this medicine, you must take Cletrova granules regularly and consistently, both during acute inflammatory episodes and as long-term maintenance treatment, as indicated.

If you think that Cletrova 1.5 g granules is too strong or too weak, consult your doctor.

If you take more Cletrova 1.5 g granules than you should
If in doubt, consult a doctor for advice on what to do.
If you take too much Cletrova 1.5 g granules on a single occasion, simply take the next dose as prescribed. Do not reduce the dose.

If you forget to take Cletrova 1.5 g granules
Do not take a double dose to make up for a missed dose.

If you stop taking Cletrova 1.5 g granules
Do not stop treatment with this product before discussing it with your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cletrova 1.5 g granules can cause side effects, although not everybody gets
them.
If you experience any of the following symptoms after taking this medicine, consult your doctor
immediately and stop using Cletrova granules straight away:

• General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties, or general inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• A marked worsening of your general health, especially if accompanied by fever and/or sore throat and mouth. These symptoms may very rarely be due to a reduction in the number of white blood cells in the blood, which may make you more susceptible to developing a serious infection ( agranulocytosis ). A reduction in other blood cells (such as red blood cells or platelets, causing aplastic anaemia or thrombocytopenia ) may also occur, which could lead to symptoms such as unexplained bleeding, purple spots or dots under the skin, or anaemia (feeling tired and weak, and pale appearance, especially of the lips and nails). A blood test can confirm whether the symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
• Severe skin rashes with flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital or eye sores, widespread rash, fever and swollen lymph nodes. These manifestations may be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
• Shortness of breath, chest pain or irregular heartbeat, or swelling of the limbs, which may indicate cardiac hypersensitivity reactions . These reactions are very rare.

Problems with kidney function (may occur very rarely), for example changes in the colour or amount of urine produced, and swelling of the limbs or sudden pain in the side (caused by kidney stones) (occurring in an unknown number of patients (frequency not known)).
The following side effects have also been reported in patients taking mesalazine:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Skin rash, itching

Uncommon side effects (may affect up to 1 in 100 people)

• Abdominal pain, diarrhoea, indigestion, flatulence, nausea and vomiting
• Severe abdominal pain due to acute inflammation of the pancreas
• Changes in liver function test parameters, changes in pancreatic enzymes

Rare side effects (may affect up to 1 in 1,000 people)

• Dizziness
• Jaundice or abdominal pain due to liver and bile flow disorders
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Joint pain
• Feeling of weakness or fatigue

Very rare side effects (may affect up to 1 in 10,000 people)

• Numbness and tingling in the hands and feet (peripheral neuropathy)
• Shortness of breath, cough, wheezing, lung shadows on X-rays due to allergic and/or inflammatory conditions affecting the lungs
• Hair loss and development of baldness
• Muscle pain
• Reversible reduction in sperm production

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cletrova 1.5 g granules

Keep this medicine out of the sight and reach of children.
Do not use Cletrova 1.5 g granules after the expiry date stated on the carton and on the sachet
after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Cletrova 1.5 g granules contains
The active substance is mesalazine; one sachet of Cletrova 1.5 g granules contains 1.5 g of mesalazine.
The other components are: aspartame (E951), sodium carmellose, microcrystalline cellulose, citric acid, anhydrous colloidal silica, hypromellose, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methylcellulose, 40% polyacrylate dispersion (Eudragit NE 40 D containing 2% nonoxynol 100), povidone K 25, simethicone, sorbic acid, talc, titanium dioxide (E171), triethyl citrate, vanilla custard flavour (containing sucrose).

Description of the appearance of Cletrova 1.5 g granules and package contents
Cletrova 1.5 g prolonged-release granules consist of rod-shaped or round granules, white-grey in colour.
Each sachet contains 2.79 g of granules.
Cletrova 1.5 g granules are available in packages containing 20, 30, 35, 45, 50, 60, 70, 90, 100 and 150 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
DR. FALK PHARMA GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761 / 1514-0
Fax: +49 (0) 761 / 1514-321
E-mail: [email protected]

Marketing Authorisation Holder in Italy:
DR. FALK PHARMA S.r.l.,
Via Lepetit 8 – 20124, Milan, Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark, Finland, Germany, Greece, Ireland, Latvia, Norway, Netherlands, Poland, Portugal, United Kingdom, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary: Salofalk.
Belgium, Luxembourg: Colitofalk.
Austria: Mesagran.
Italy: Cletrova
France: Osperzo.
[To be completed with national information]

Patient information leaflet

Cletrova 3 g prolonged-release granules

mesalazine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cletrova 3 g granules is and what it is used for
2. What you need to know before taking Cletrova 3 g granules
3. How to take Cletrova 3 g granules
4. Possible side effects
5. How to store Cletrova 3 g granules
6. Contents of the pack and other information

1. What Cletrova 3 g granules is and what it is used for

Cletrova 3 g granules contains the active substance mesalazine, an anti-inflammatory agent used
for the treatment of inflammatory bowel diseases.
Cletrova 3 g granules is used for

• the treatment of acute episodes and the prevention of further episodes (relapse) of ulcerative colitis, a mild to moderate inflammatory disease of the large intestine (colon).

2. What you need to know before taking Cletrova 3 g granules

Do not take Cletrova 3 g granules

• if you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin) or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease.

Warnings and precautions
Talk to your doctor before taking Cletrova 3 g granules

• if you have a history of lung problems, particularly if you suffer from bronchial asthma
• if you have a history of allergy to sulfasalazine, a substance related to mesalazine
• if you suffer from liver problems
• if you suffer from kidney problems
• if you have ever developed a severe skin rash, peeling of the skin, blistering and/or mouth ulcers after taking mesalazine.

Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction occurring between mesalazine and bleach.
Additional precautions
During treatment, your doctor may wish to monitor you closely and carry out regular blood and urine tests.
Kidney stones may develop during treatment with mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Make sure you drink sufficient fluids during treatment with mesalazine.
Serious skin reactions have been reported with mesalazine use, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Stop using mesalazine and consult a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Other medicines and Cletrova 3 g granules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular

• Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune system disorders)
• Some products that inhibit blood clotting (antithrombotic or anticoagulant medicines, such as warfarin)
• Lactulose (a medicine used to treat constipation) or other preparations that may alter faecal acidity

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. You may still be able to use Cletrova 3 g granules, and your doctor will be able to decide what is suitable for you.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use Cletrova 3 g granules during pregnancy only if your doctor has instructed you to do so.
You should also use Cletrova 3 g granules during breastfeeding only if your doctor has instructed you to do so, as this medicine may pass into breast milk.
Driving and using machines
Cletrova 3 g granules has no or negligible effect on the ability to drive or use machinery.
Cletrova 3 g granules contains aspartame, sucrose and sodium
This medicine contains 6 mg of aspartame per sachet of Cletrova 3 g granules. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. it is essentially "sodium-free".

3. How to take Cletrova 3 g granules

Take Cletrova 3 g granules exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Method of administration
Cletrova 3 g granules are for oral use only.
Cletrova 3 g granules must not be chewed. You must take Cletrova 3 g granules by placing the granules directly on the tongue and swallowing them with plenty of liquid, without chewing.

Dosage

| Age and body weight | Single dose | Total daily dose | |-------------------------|-----------------|------------------------| | Adults, elderly, and children
weighing over 40 kg | 1 sachet of Cletrova 3 g granules | 1 x 1 sachet | | Acute episode treatment
and prevention of further episodes
(for patients at higher risk of relapse) | | |

Adults and elderly
Unless otherwise prescribed by your doctor, the recommended dose for the treatment of acute episodes
of ulcerative colitis is 1 sachet of Cletrova 3 g granules once daily, preferably in the morning
(equivalent to 3 g of mesalazine per day).

For prevention of relapse of ulcerative colitis
The usual dosage for preventing further episodes of ulcerative colitis is 1 sachet of Cletrova 500 mg granules three times daily (equivalent to 1.5 g of mesalazine per day).
If, according to your doctor’s judgment, you are at higher risk of relapse, the dosage for prevention of further episodes of ulcerative colitis is 1 sachet of Cletrova 3 g granules once daily, preferably in the morning (equivalent to 3 g of mesalazine per day).

Use in children
Data on efficacy in children (aged 6–18 years) are limited.

Children aged 6 years and above
Ask your doctor for the exact dosage of Cletrova granules for your child.
Generally, it is recommended to administer half the adult dose to children with body weight up to 40 kg, and the full adult dose to those weighing more than 40 kg.
Due to the high content of active substance, Cletrova 3 g granules are not suitable for children weighing less than 40 kg. Use Cletrova 500 mg granules or 1,000 mg instead.

Duration of treatment
Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you should continue treatment with this medicine, depending on your condition.
To obtain the maximum benefit from this medicine, you must take Cletrova granules regularly and consistently, both during acute inflammatory episodes and as long-term treatment, as indicated.

If you think that Cletrova 3 g granules is too strong or too weak, consult your doctor.

If you take more Cletrova 3 g granules than you should
If in doubt, consult a doctor to determine the appropriate course of action.
If you take too much Cletrova 3 g granules on a single occasion, simply take the next dose as prescribed. Do not reduce the dose.

If you forget to take Cletrova 3 g granules
Do not take a double dose to make up for the missed dose.

If you stop taking Cletrova 3 g granules
Do not stop treatment with this product before speaking to your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cletrova 3 g granules can cause side effects, although not everybody gets them.
If you experience any of the following symptoms after taking this medicine, contact your doctor
immediately and stop using Cletrova granules straight away:

• General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties, or general inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• A marked worsening of your general health, especially if accompanied by fever and/or sore throat and mouth. These symptoms may very rarely be due to a reduction in the number of white blood cells in the blood, which may make you more susceptible to developing a serious infection (agranulocytosis). A reduction in other blood cells may also occur (such as red blood cells or platelets, causing aplastic anaemia or thrombocytopenia), which may lead to symptoms such as unexplained bleeding, spots or purple patches under the skin, or anaemia (feeling tired and weak, pale appearance, especially of the lips and nails). A blood test can confirm whether these symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
• Severe skin rashes with flat, reddish spots, target-like or circular in shape, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These symptoms may be preceded by fever and flu-like symptoms. The frequency of these reactions is unknown.
• Shortness of breath, chest pain or irregular heartbeat, or swelling of the limbs, which may indicate cardiac hypersensitivity reactions. These reactions are very rare. Kidney function problems (may occur very rarely), e.g. changes in the colour or amount of urine produced, swelling of the limbs or sudden flank pain (caused by kidney stones) (frequency unknown).

The following side effects have also been reported in patients taking mesalazine:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Skin rash, itching

Uncommon side effects (may affect up to 1 in 100 people)

• Abdominal pain, diarrhoea, dyspepsia, flatulence, nausea and vomiting
• Severe abdominal pain due to acute inflammation of the pancreas
• Changes in liver function test parameters, changes in pancreatic enzymes

Rare side effects (may affect up to 1 in 1,000 people)

• Dizziness
• Jaundice or abdominal pain due to liver and bile flow disorders
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Joint pain
• Feeling weak or tired

Very rare side effects (may affect up to 1 in 10,000 people)

• Numbness and tingling in the hands and feet (peripheral neuropathy)
• Shortness of breath, cough, wheezing, lung shadows on X-rays due to allergic and/or inflammatory conditions of the lungs
• Hair loss and development of baldness
• Muscle pain
• Reversible reduction in sperm production

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cletrova 3 g granules

Keep this medicine out of the sight and reach of children.
Do not use Cletrova 3 g granules after the expiry date stated on the packaging and sachet after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cletrova 3 g granules contain
The active substance is mesalazine; one sachet of Cletrova 3 g granules contains 3 g of mesalazine.
The other components are: aspartame (E951), sodium carmellose, microcrystalline cellulose, citric acid, anhydrous colloidal silica, hypromellose, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methylcellulose, 40% polyacrylate dispersion (Eudragit NE 40 D containing 2% nonoxinol 100), povidone K 25, simethicone, sorbic acid, talc, titanium dioxide (E171), triethyl citrate, vanilla custard flavour (containing sucrose).

Description of the appearance of Cletrova 3 g granules and pack contents
Cletrova 3 g prolonged-release granules consist of rod-shaped or round granules, white-grey in colour.
Each sachet contains 5.58 g of granules.
Cletrova 3 g granules are available in packs of 10, 15, 20, 30, 50, 60, 90 and 100 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
DR. FALK PHARMA GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761 / 1514-0
Fax: +49 (0) 761 / 1514-321
E-mail: [email protected]

Marketing Authorisation Holder in Italy:
DR. FALK PHARMA S.r.l.,
Via Lepetit 8 – 20124, Milan, Italy

This medicinal product is authorised in the European Economic Area Member States under the
following names:
Bulgaria, Denmark, Finland, Germany, Greece, Ireland, Latvia, Norway, Netherlands, Poland, Portugal, United Kingdom, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary: Salofalk.
Belgium, Luxembourg: Colitofalk.
Austria: Mesagran.
Italy: Cletrova
France: Osperzo.
[To be completed with national data]

Patient information leaflet

Cletrova 1g gastro-resistant tablets

mesalazine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. 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 give it to other people, even if their
symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

19. What Cletrova 1g tablets are and what they are used for
20. What you need to know before taking Cletrova 1g tablets
21. How to take Cletrova 1g tablets
22. Possible side effects
23. How to store Cletrova 1g tablets
24. Contents of the pack and other information

4. What Cletrova 1g tablets are and what they are used for

Cletrova 1g tablets contain the active substance mesalazine, an anti-inflammatory agent used
to treat inflammatory bowel diseases.
Cletrova 1g tablets are used for the treatment of mild to moderate acute episodes of an inflammatory disease of the large intestine (colon), called ulcerative colitis.

5. What you need to know before taking Cletrova 1g tablets

Do not take Cletrova 1g tablets
if you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g.
Aspirin), or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver or kidney disease.

Warnings and precautions
Talk to your doctor before taking Cletrova 1g tablets:
if you have a history of lung problems, particularly if you suffer from bronchial asthma;
if you have a history of allergy to sulfasalazine, a substance related to mesalazine;
if you suffer from liver problems;
if you suffer from kidney problems;
if you have ever developed a severe skin rash, skin peeling, blistering, and/or oral ulcers after taking mesalazine.

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

Additional precautions
During treatment, your doctor may wish to monitor you closely and carry out regular blood and urine tests.
In patients who have undergone certain intestinal surgeries, Cletrova 1g tablets may be excreted undissolved in the faeces. Inform your doctor if you notice this.
Kidney stones may develop during treatment with mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Make sure to drink sufficient fluids during treatment with mesalazine.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine therapy. Discontinue use of mesalazine and consult a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Other medicines and Cletrova 1g tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Cletrova 1g tablets may affect how other medicines work, and other medicines may affect how Cletrova 1g tablets work.
In particular, inform your doctor or pharmacist if you are taking:
Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune system disorders);
Certain products that inhibit blood clotting (antithrombotic or anticoagulant medicines, such as warfarin).
You may still be able to use Cletrova 1g tablets, and your doctor will decide what is appropriate for you.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should only use Cletrova 1g tablets during pregnancy if your doctor has told you to do so.
You should only use Cletrova 1g tablets while breastfeeding if your doctor has told you to do so, as this medicine may pass into breast milk.

Driving and using machines
Cletrova 1g tablets do not affect or have negligible effect on the ability to drive vehicles or operate machinery.

Cletrova 1g tablets contain sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

6. How to take Cletrova 1g tablets

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Take one Cletrova 1g tablet three times daily (morning, midday, and evening), or as directed
by your doctor.
Method of administration
Cletrova 1g tablets are for oral use only.
Take the tablets one hour before meals. The tablets must be swallowed whole, without
chewing, to ensure the integrity of the gastro-resistant coating, and taken with plenty of
fluid.
If you have difficulty swallowing the tablet, use another mesalazine formulation (e.g. granules).
Use in children
Data on efficacy in children (aged 6–18 years) are limited.
Children aged 6 years and older with body weight equal to or above 40 kg
Ask your doctor for the exact dosage of Cletrova 1g tablets for your child. The dosage depends
on the severity of the disease and the child's body weight.
The dose should be individually determined, starting at 30–50 mg of mesalazine per kg of
body weight per day, administered in divided doses. The maximum dose is 75 mg of mesalazine
per kg of body weight per day. The total dose must not exceed the maximum dose for an adult.
Children aged 6 years and older with body weight below 40 kg
Generally, a dose equal to half the adult dose is recommended for children weighing up to 40 kg, and the full adult dose for those weighing more than 40 kg.
Due to the size of Cletrova 1g tablets and the recommended dosage, formulations with lower dosages (e.g. products containing 500 mg of mesalazine) should be used in children.
Duration of treatment
Treatment of acute episodes of ulcerative colitis generally lasts 8 weeks. The duration of
treatment will depend on your condition. Your doctor will decide how long you should continue
taking this medicine.
To achieve the desired therapeutic effects, you must take Cletrova 1g tablets regularly and consistently during the acute inflammatory episode.
For maintenance of remission in ulcerative colitis, your doctor will prescribe another mesalazine-based product.
If you think that the effect of Cletrova 1g tablets is too strong or too weak, consult your doctor.
If you take more Cletrova 1g tablets than you should
If in doubt, consult your doctor, so that they can decide on the appropriate action.
If you take too many Cletrova 1g tablets at one time, take the next dose as prescribed. Do not reduce the dose.
If you forget to take Cletrova 1g tablets
If you miss a dose, continue treatment at the prescribed dosage. Do not take a double dose to make up for the missed dose.
If you stop taking Cletrova 1g tablets
Do not stop treatment with this product before discussing it with your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

6. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following symptoms after taking this medicine, contact your doctor and stop using Cletrova 1g tablets immediately:

• General allergic reactions such as skin rash, fever, joint pain and/or breathing difficulties, or general inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• A marked worsening of your general health, especially if accompanied by fever and/or sore throat and mouth. These symptoms may very rarely be due to a reduced number of white blood cells in the blood, which may make you more susceptible to developing a serious infection ( agranulocytosis ). A reduction in other blood cells (such as red blood cells or platelets, causing aplastic anaemia or thrombocytopenia ) may also occur, which could lead to symptoms such as unexplained bleeding, purple spots or bruises under the skin, or anaemia (feeling tired and weak, and pale appearance, especially of lips and nails). A blood test can confirm whether the symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
• Severe skin rashes with flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These manifestations may be preceded by fever and flu-like symptoms. The frequency of these reactions is unknown (frequency not known).
• Shortness of breath, chest pain or irregular heartbeat, or swelling in the limbs, which may indicate cardiac hypersensitivity reactions . These reactions are very rare.
• Kidney function problems (may occur very rarely), for example changes in the colour or amount of urine produced, swelling in the limbs, or sudden flank pain (caused by a kidney stone) (occurring in an unknown number of patients (frequency not known)).

In patients using medicines containing mesalazine, the active substance in Cletrova 1g tablets, the following side effects have also been reported:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Skin rash, itching

Uncommon side effects (may affect up to 1 in 100 people)

• Abdominal pain, diarrhoea, dyspepsia, flatulence, nausea and vomiting
• Severe abdominal pain due to acute inflammation of the pancreas
• Changes in liver function test parameters, changes in pancreatic enzymes

Rare side effects (may affect up to 1 in 1,000 people)

• Dizziness
• Jaundice or abdominal pain due to liver and bile flow disorders
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Joint pain
• Feeling of weakness or fatigue

Very rare side effects (may affect up to 1 in 10,000 people)

• Numbness and tingling in the hands and feet (peripheral neuropathy)
• Shortness of breath, cough, wheezing, lung shadows on X-rays due to allergic and/or inflammatory conditions affecting the lungs
• Hair loss and development of baldness
• Muscle pain
• Reversible reduction in sperm production

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

7. How to store Cletrova 1g tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cletrova 1g tablets contain

• The active substance is mesalazine. Each Cletrova 1g tablet contains 1 g of mesalazine.
• The other components are: microcrystalline cellulose, povidone K 25, sodium croscarmellose, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methacrylic acid-methyl methacrylate copolymer (1:2) (Eudragit S 100), calcium stearate [of vegetable origin], talc, Macrogol 6000, hypromellose, anhydrous colloidal silica, iron oxide yellow (E172), titanium dioxide (E171).

Description of the appearance of Cletrova 1g tablets and contents of the pack
Cletrova 1g tablets are gastro-resistant, oblong (20–21 mm), biconvex tablets, yellow to yellow-ochre in colour, with a smooth surface and rounded edges.
Cletrova 1g tablets are available in packs containing 20, 50, 60, 90, 100 and 150 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
DR. FALK PHARMA GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: +49 (0) 761 / 1514-0
Fax: +49 (0) 761 / 1514-321
E-mail: [email protected]

Marketing Authorisation Holder in Italy:
Dr. Falk Pharma S.r.l.
Via Roberto Lepetit 8
20124 Milano, Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Cyprus, Denmark, Finland, Germany, Greece, Hungary, Norway, Sweden and United Kingdom: Salofalk
France: Osperzo
Italy: Cletrova