ASAMAX 400 mg Enteric-Coated Tablet

Зміст інструкції

1. ASAMAX 400 mg gastro-resistant tablets, 800 mg gastro-resistant tablets
   1. What is ASAMAX and what is it used for
   2. What you need to know before you take/give ASAMAX to a child
   3. How to take/give ASAMAX to the child
   4. Possible side effects
   5. How to store ASAMAX
   6. Package contents and other
2. ASAMAX 400 mg is presented in packaging containing 50 gastro-resistant 400 mg tablets
3. ASAMAX 500 mg suppositories suppositories
   1. What is ASAMAX and what is it used for
   2. What you need to know before you use/give ASAMAX to the child
   3. How to use/give ASAMAX to a child
   4. Possible side effects
   5. How to store ASAMAX
   6. Package contents and other
4. ASAMAX 2 g/50 ml rectal suspension
   1. What is ASAMAX and what is it used for
   2. What you need to know before you use/give ASAMAX to the child
   3. How to use/give ASAMAX to a child
   4. Possible side effects
   5. How to store ASAMAX
   6. Package contents and other

ASAMAX 400 mg gastro-resistant tablets, 800 mg gastro-resistant tablets

Mesalazine

Read this leaflet carefully before you take/give this medicine to your child, 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 only for you/your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ASAMAX is and what it is used for
• 2. What you need to know before you take/give ASAMAX to your child
• 3. How to take/give ASAMAX to your child
• 4. Possible side effects
• 5. How to store ASAMAX
• 6. Contents of the pack and other information

1. What is ASAMAX and what is it used for

ASAMAX is a medicine containing mesalazine, which belongs to the class of
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), medicines used to treat
inflammation.
ASAMAX is indicated in adults and children over 6 years of agefor the treatment of
intestinal inflammation (ulcerative colitis and Crohn's disease) and in the prevention of relapses.

2. What you need to know before you take/give ASAMAX to a child

Do not take/give ASAMAX to a child

• if you are allergic to mesalazine, or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to any medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), in particular to salicylates
• if you suffer from a severe liver disease
• if you suffer from severe kidney diseases (severe nephropathies and renal insufficiency)
• if you have ongoing lesions of the stomach or intestine (gastric or duodenal ulcers)
• if you have a blood disorder that makes you/the child prone to bleeding
• if the child is less than six years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving ASAMAX to a child.
Before starting treatment, your doctor will subject you to tests (blood and urine) and
relevant examinations and will decide how often to repeat these tests during treatment
with ASAMAX.
Talk to your doctor if you and/or the child:

• suffer from liver disorders
• suffer from kidney disorders
• are taking other medicines (see section 2. Other medicines and ASAMAX)
• suffer from a lung disease (particularly asthma)
• have had an allergic reaction following the use of medicines based on sulfasalazine (see section 4. “Possible side effects”). Keep in mind that prolonged use of the product may give rise to allergic reactions
• suffer from stomach disorders that make digestion exceptionally slow or difficult (pylorus stenosis). The tablet may release the mesalazine already in the stomach, with possible irritation of the stomach and loss of drug effect
• have ever developed a severe skin rash or exfoliation of the skin, blisters and/or ulcers in the mouth after using mesalazine.

If, following treatment with ASAMAX, you develop bruises, bleeding, anemia,
fever or sore throat, your doctor will subject you to blood tests and, if necessary, will
interrupt the treatment.
The use of mesalazine can cause the formation of kidney stones. Symptoms may
include pain on the sides of the abdomen and blood in the urine. It is recommended to drink a
sufficient amount of fluids during treatment with mesalazine.
Mesalazine can cause a red-brown discoloration of the urine after contact
with sodium hypochlorite contained in bleach present in the toilet water. This is
caused by a harmless chemical reaction that occurs between mesalazine and
bleach.
After stopping treatment with ASAMAX and during maintenance treatment, recurrence of disease symptoms may occur.
Severe skin reactions, including drug-induced hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with mesalazine. Stop using
mesalazine and consult a doctor immediately if you notice any of the symptoms related
to these severe skin reactions described in section 4.

Children and adolescents
Donot give ASAMAX tablets to children under 6 yearsof age.

Other medicines and ASAMAX
Tell your doctor or pharmacist if you and/or the child are taking, have
recently taken or might take any other medicines.
In particular, tell your doctor if you/the child are taking:

• Lactulose, a medicine for treating constipation or other medicines known to affect the acidity of the intestine, because they can hinder the release of mesalazine in the intestine.
• Medicines to lower blood sugar levels (oral hypoglycemic agents such as sulfonylureas).
• Medicines to make the blood more fluid (coumarins, such as warfarin)
• Medicines to treat inflammation (corticosteroids). However, in cases of severe intestinal inflammation, the doctor may also prescribe treatment with corticosteroids.
• Other medicines for the treatment of inflammation belonging to the class of NSAIDs (non-steroidal anti-inflammatory drugs).
• Methotrexate, a medicine for treating tumors.
• Probenecid, a medicine for treating gout.
• Sulfinpyrazone, a medicine for treating severe blood disorders.
• Spironolactone and furosemide, medicines for treating heart disease.
• Rifampicin, a medicine for treating infections.
• Azathioprine, a medicine for treating disorders of the disease defense system (immune system).
• 6-mercaptopurine and thioguanine, medicines for treating blood cancers (leukemia).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy

Donot take ASAMAX in the last weeks of pregnancy.
In the first part of pregnancy, take this medicine only if absolutely
necessary and under the direct control of your doctor.

Breastfeeding
Mesalazine passes into breast milk, so take this medicine only if absolutely
necessary and under the direct control of your doctor. If the child develops
diarrhea, stop breastfeeding.

Driving and using machines
ASAMAX does not impair the ability to drive vehicles or operate machinery.

3. How to take/give ASAMAX to the child

Take/give this medicine to the child following the instructions of the doctor or pharmacist exactly as given. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommendeddose is: 1-2 tablets of ASAMAX 400 mg or 1 tablet of
ASAMAX 800 mg, 3 times a day.
In severe cases, the dose may be increased up to 10 tablets of ASAMAX 400 mg or 5
tablets of ASAMAX 800 mg per day.

Children and adolescents
In children starting from 6 years of age, the doctor will prescribe the correct doses.

If you take/give the child too much ASAMAX
In case of accidental ingestion/intake of an excessive dose of ASAMAX
immediately notify the doctor or go to the nearest hospital.
The doctor will determine which supportive therapies will be necessary.

If you forget to take/give ASAMAX to your child
Do not take/give your child a double dose to compensate for a missed dose.

If you stop the treatment with ASAMAX
After stopping the treatment with ASAMAX and during the treatment, a recurrence of the symptoms of the disease may occur.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If during treatment with ASAMAX you and/or the child experience

• abdominal cramps
• severe abdominal pain
• diarrhea with blood
• fever
• severe headache
• skin rashes
• reddish, non-raised, target- or circular-shaped patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms which may be symptoms of an allergic reaction, immediately discontinuetreatment with ASAMAX and consult your doctor.

Possible side effects are listed below according to frequency:

common (may affect up to 1 in 10 people)

• nausea
• diarrhea
• tense abdomen
• headache
• high blood pressure (hypertension)
• skin rash
• weakness (asthenia)
• fever (pyrexia). Uncommon(may affect up to 1 in 100 people)
• abdominal pain
• drowsiness
• tremor
• increased heart rate (tachycardia)
• low blood pressure (hypotension)
• itching
• fatigue
• facial swelling. Rare (may affect up to 1 in 1,000 people)
• dizziness
• excessive intestinal gas (flatulence)
• vomiting
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity) Very rare (may affect up to 1 in 10,000 people)
• reduction of all types of blood cells
• nerve disorders of arms and legs
• inflammation of the heart (myocarditis)
• inflammation of the membrane surrounding the heart (pericarditis)
• lung diseases (allergic and fibrotic lung reactions)
• inflammation, even acute, of the pancreas (gland involved in food digestion)
• kidney problems
• hair loss
• muscle and joint pain
• allergic reactions, such as skin rashes, fever caused by the administration of the medicine
• systemic lupus erythematosus
• inflammation of the entire colon (part of the intestine)
• abnormal results of liver function tests
• inflammation of the liver (hepatitis, hepatitis due to obstruction of the bile duct)
• formation of gallstones
• decrease (reversible) in the number of sperm in seminal fluid

Not known (frequency cannot be estimated from available data)

• swelling of the face, lips and throat caused by an allergic reaction (angioedema)
• kidney stones and associated kidney pain (see also paragraph 2)

Reporting of side effects
If you/the child experiences any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through 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 ASAMAX

Keep this medicine out of the sight and reach of children. Store at a temperature below 25°C.
Do not take this medicine after the expiry date which is stated on the pack
after the wording “EXP”.
The expiry date refers to the last day of that month. This date applies to the
product in intact packaging, correctly stored.
Do not dispose of any medicine in 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 ASAMAX contains

One 400 mg gastro-resistant tablet contains:

• The active ingredient is: mesalazine 400 mg
• The other ingredients are: Core: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid copolymer - methacrylate and methyl methacrylate (eudragit FS30D), sodium hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, macrogol 6000.

One 800 mg gastro-resistant tablet contains:

• The active ingredient is: mesalazine 800 mg
• The other ingredients are: Core: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid copolymer - methacrylate and methyl methacrylate (eudragit FS30D), sodium hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, macrogol 6000.

Description of the appearance of ASAMAX and package contents

ASAMAX 400 mg is presented in packaging containing 50 gastro-resistant 400 mg tablets

ASAMAX 800 mg is presented in packaging containing 24 and 60 gastro-resistant 800 mg tablets.

Marketing Authorisation Holder
Ca.Di. Group S.p.A. Via Salorno 58/60 00124 Rome

Manufacturer
FINE FOODS & PHARMACEUTICALS N.T.M. SpA
Via Grignano, 43
24041 Brembate (BG)

ASAMAX 500 mg suppositories suppositories

Mesalazine

Read this leaflet carefully before using/giving this medicine to your child
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 only for you/your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ASAMAX is and what it is used for
• 2. What you need to know before using/giving ASAMAX to your child
• 3. How to use/give ASAMAX to your child
• 4. Possible side effects
• 5. How to store ASAMAX
• 6. Contents of the pack and other information

1. What is ASAMAX and what is it used for

ASAMAX is a medicine based on mesalazine, which belongs to the class of
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), medicines used to treat
inflammation.
ASAMAX is indicated in adults and children over 2 years of agefor the treatment
of intestinal inflammation (ulcerative colitis in the rectum) and
in the prevention of relapses.

2. What you need to know before you use/give ASAMAX to the child

ASAMAX Do not use/give ASAMAX to the child

• if you are allergic to mesalazine, or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to any medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), in particular to salicylates
• if you suffer from a severe liver disease
• if you suffer from severe kidney diseases (severe nephropathies and renal failure)
• if you have ongoing lesions of the stomach or intestine (gastric or duodenal ulcers)
• if you have a blood disorder that makes you/the child prone to bleeding
• if the child is less than two years old.

Warnings and precautions
Consult your doctor or pharmacist before using/giving ASAMAX to the child.
Before starting treatment, your doctor will subject you to examinations (blood and urine) and
relevant check-ups and will decide how often to repeat these examinations during the
treatment with ASAMAX.
Consult your doctor if you and/or the child:

• suffer from liver disorders
• suffer from kidney disorders
• are taking other medicines (see section 2. Other medicines and ASAMAX)
• suffer from a lung disease (particularly asthma)
• have had an allergic reaction following the use of medicines based on sulfasalazine (see section 4. “Possible side effects”). Keep in mind that prolonged use of the product can give rise to allergic reactions
• have ever developed a severe skin rash or exfoliation of the skin, blisters and/or ulcers in the mouth after using mesalazine.

If, following treatment with ASAMAX, you develop bruises, bleeding, anemia,
fever or sore throat, your doctor will subject you to blood tests and, if necessary, will
interrupt the treatment.
The use of mesalazine can cause the formation of kidney stones. Symptoms may
include pain on the sides of the abdomen and blood in the urine. It is recommended to drink a
sufficient amount of fluids during treatment with mesalazine.
Mesalazine can cause a reddish-brown discoloration of the urine after contact
with sodium hypochlorite contained in bleach present in the toilet water. This is
caused by a harmless chemical reaction that occurs between mesalazine and the
bleach.
After stopping treatment with ASAMAX and during maintenance treatment, a recurrence of the symptoms of the disease may occur.
Severe skin reactions, including drug-induced reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with mesalazine. Stop using
mesalazine and consult your doctor immediately if you notice any of the symptoms related to
these severe skin reactions described in section 4.

Children and adolescents
Donot give ASAMAX suppositories to children under the age of 2 years.

Other medicines and ASAMAX
Inform your doctor or pharmacist if you and/or the child are using, have
recently used or may use any other medicine.
In particular, inform your doctor if you/the child are using:

• Medicines to lower blood sugar levels (oral hypoglycemic agents such as sulfonylureas)
• Medicines to make the blood more fluid (coumarins, such as warfarin)
• Medicines to treat inflammation (corticosteroids). However, in cases of severe intestinal inflammation, your doctor may also prescribe treatment with corticosteroids.
• Other medicines for the treatment of inflammation belonging to the class of NSAIDs (non-steroidal anti-inflammatory drugs).
• Methotrexate, a medicine to treat tumors
• Probenecid, a medicine to treat gout
• Sulfinpyrazone, a medicine to treat severe blood disorders
• Spironolactone and furosemide, medicines to treat heart disease
• Rifampicin, a medicine to treat infections
• Azathioprine, a medicine to treat disorders of the defense system against diseases (immune system)
• 6-mercaptopurine ethioguanine, medicines to treat blood cancers (leukemia)

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Pregnancy

Donot use ASAMAX in the last weeks of pregnancy.
In the first part of pregnancy, use this medicine only if absolutely necessary
and under the direct control of your doctor.

Breastfeeding
Mesalazine passes into breast milk, so use this medicine only if
absolutely necessary and under the direct control of your doctor. If the child develops
diarrhea, stop breastfeeding.

Driving and operating machinery
ASAMAX does not impair the ability to drive vehicles or operate machinery.

3. How to use/give ASAMAX to a child

Use/give this medicine to the child following the instructions of the doctor or pharmacist exactly at all times. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommendeddose is:

• 3 suppositories a day, divided into 2-3 administrations during the treatment of ongoing inflammation;
• 1-2 suppositories a day for the prevention of relapses.

Children and adolescents
In children over two years of age, the doctor will prescribe the correct doses.
Method of administration:
Retain the suppository inside the rectum for at least 30 minutes or for as long as possible, preferably for the entire night.
During the warm season, it may be necessary to immerse the container of the suppositories in cold water to re-solidify the suppositories that have become soft.

If you use/give the child more ASAMAX than you should
In case of accidental ingestion/intake of an excessive dose of ASAMAX
immediately notify the doctor or go to the nearest hospital.

If you forget to use/give ASAMAX to your child
Do not use/give your child a double dose to compensate for a missed dose.

If you stop the treatment with ASAMAX
After stopping the treatment with ASAMAX and during the treatment, a recurrence of the symptoms of the disease may occur.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If during treatment with ASAMAX you and/or the child experience

• abdominal cramps
• severe abdominal pain
• diarrhea with blood
• fever
• severe headache
• skin rashes
• reddish, non-raised, target-like or circular patches on the trunk, often with central blisters, skin exfoliation, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms

which may be symptoms of an allergic reaction, immediately stopthe
treatment with ASAMAX and consult your doctor.
Possible side effects are listed below according to frequency:

common (may affect up to 1 in 10 people)

• nausea
• diarrhea
• tense abdomen
• headache
• high blood pressure (hypertension)
• skin rash
• weakness (asthenia)
• fever (pyrexia). uncommon (may affect up to 1 in 100 people)
• abdominal pain
• drowsiness
• tremor
• increased heart rate (tachycardia)
• low blood pressure (hypotension)
• itching
• fatigue
• facial swelling. rare (may affect up to 1 in 1,000),
• dizziness,
• excessive intestinal gas (flatulence)
• vomiting,
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity). very rare (may affect up to 1 in 10,000)
• reduction of all types of blood cells,
• nerve disorders of arms and legs,
• inflammation of the heart (myocarditis),
• inflammation of the membrane surrounding the heart (pericarditis),
• lung diseases (allergic and fibrotic lung reactions),
• inflammation, even acute, of the pancreas (gland involved in food digestion),
• kidney problems,
• hair loss,
• muscle and joint pain
• muscle cramps, pain in arms and legs,
• allergic reactions, such as skin rashes, fever caused by the administration of the medicine,
• lupus erythematosus syndrome,
• inflammation of the entire colon (part of the intestine),
• abnormal results of liver function tests,
• inflammation of the liver (hepatitis, hepatitis due to obstruction of the bile duct),
• formation of gallstones
• decrease (reversible) in the number of spermatozoa in seminal fluid. not known (frequency cannot be estimated based on available data)
• swelling of the face, lips and throat caused by an allergic reaction (angioedema)
• kidney stones and associated kidney pain (see also paragraph 2).

Reporting of side effects
If you/the child experiences any side effects, including those not listed
in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly
through 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 ASAMAX

Keep this medicine out of the sight and reach of children. Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the pack after the
words “EXP”. The expiry date refers to the last day of that month. This date
applies to the product in intact packaging, correctly stored.
Do not dispose of any medicine in waste water 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 ASAMAX contains

Each suppository contains:

• The active ingredient is: mesalazine 500 mg
• The other ingredients are: semi-synthetic glycerides.

Description of the appearance of ASAMAX and package contents
ASAMAX is presented in a package containing 20 suppositories of 500 mg.

Marketing Authorisation Holder
Ca.Di. Group S.p.A. Via Salorno 58/60 00124 Rome

Manufacturer
Special Product’s Line S.r.l. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

ASAMAX 2 g/50 ml rectal suspension

ASAMAX 4 g/100 ml rectal suspension
Mesalazine

Read this leaflet carefully before using/giving this medicine to your child
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 only for you/your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ASAMAX is and what it is used for
• 2. What you need to know before using/giving ASAMAX to your child
• 3. How to use/give ASAMAX to your child
• 4. Possible side effects
• 5. How to store ASAMAX
• 6. Contents of the pack and other information

1. What is ASAMAX and what is it used for

ASAMAX is a medicine based on mesalazine, which belongs to the class of
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), medicines used to treat
inflammation.
ASAMAX is indicated in adults and children over 2 years of agefor the treatment
of intestinal inflammation (ulcerative colitis in the location at the recto-
sigmoid level) and in the prevention of relapses.

2. What you need to know before you use/give ASAMAX to the child

ASAMAX Do not use/give ASAMAX to the child

• if you are allergic to mesalazine, or to any of the other ingredients of this medicine

(listed in paragraph 6)

• if you are allergic to any medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), in particular to salicylates
• if you suffer from a severe liver disease
• if you suffer from severe kidney diseases (severe nephropathies and renal insufficiency)
• if you have ongoing lesions of the stomach or intestine (gastric or duodenal ulcers)
• if you have a blood disorder that makes you/the child prone to bleeding
• if the child is less than two years of age.

Warnings and precautions
Consult your doctor or pharmacist before using/giving ASAMAX to the child.
Before starting treatment, the doctor will subject you to examinations (blood and urine) and
visits as appropriate, and will decide how often to repeat these examinations during the
treatment with
ASAMAX.
Consult your doctor if you and/or the child:

• suffer from liver disorders
• suffer from kidney disorders
• are taking other medicines (see paragraph 2. Other medicines and ASAMAX)
• suffer from a lung disease (in particular asthma)
• have had an allergic reaction following the use of medicines based on sulfasalazine (see paragraph 4. “Possible undesirable effects”). Keep in mind that prolonged use of the product may give rise to allergic reactions
• have ever developed a severe skin rash or exfoliation of the skin, blisters and/or mouth ulcers after using mesalazine.

If, following treatment with ASAMAX, you develop bruises, bleeding, anemia,
fever or sore throat, the doctor will subject you to blood tests and, if necessary, will
interrupt the treatment.
The use of mesalazine can cause the formation of kidney stones. Symptoms may
include pain on the sides of the abdomen and blood in the urine. It is recommended to drink a
sufficient amount of fluids during treatment with mesalazine.
Mesalazine can cause a red-brown discoloration of the urine after contact
with sodium hypochlorite contained in bleach present in the toilet water. This is
caused by a harmless chemical reaction that occurs between mesalazine and
bleach.
After stopping treatment with ASAMAX and during maintenance treatment, recurrence of the symptoms of the disease may occur.
Severe skin reactions, including drug-induced hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with mesalazine. Stop using
mesalazine and consult a doctor immediately if you notice any of the symptoms related
to these severe skin reactions described in paragraph 4.

Children and adolescents
Donot give ASAMAX rectal suspension to children under the age of 2 years.

Other medicines and ASAMAX
Tell your doctor or pharmacist if you and/or the child are taking, have recently
taken or may take any other medicine.
In particular, tell your doctor if you/the child are using:

• Medicines to lower blood sugar levels (oral hypoglycemic agents such as sulfonylureas).
• Medicines to make the blood more fluid (coumarins, such as warfarin).
• Medicines to treat inflammation (corticosteroids). However, in cases of severe intestinal inflammation, the doctor may also prescribe treatment with corticosteroids.
• Other medicines for the treatment of inflammation belonging to the class of NSAIDs
• (non-steroidal anti-inflammatory drugs).
• Methotrexate, a medicine to treat tumors.
• Probenecid, a medicine to treat gout.
• Sulfinpyrazone, a medicine to treat severe blood disorders.
• Spironolactone and furosemide, medicines to treat heart disease.
• Rifampicin, a medicine to treat infections.
• Azathioprine, a medicine to treat immune system disorders.
• 6-mercaptopurine and thioguanine, medicines to treat blood cancers (leukemia).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.

Pregnancy

Donot use ASAMAX in the last weeks of pregnancy.
In the first part of pregnancy, use this medicine only if absolutely necessary
and under the direct control of the doctor.

Breastfeeding
Mesalazine passes into breast milk, so use this medicine only if
absolutely necessary and under the direct control of the doctor. If the child develops
diarrhea, discontinue breastfeeding.

Driving and operating machinery
ASAMAX does not impair the ability to drive vehicles or operate machinery.

ASAMAX contains sodium benzoate
Each single-dose container of ASAMAX 2 g/50 ml rectal suspension contains 0.05
grams of sodium benzoate.
Each single-dose container of ASAMAX 4 g/ 100 ml rectal suspension contains 0.10
grams of sodium benzoate.
Sodium benzoate may cause local irritation.

3. How to use/give ASAMAX to a child

Use/give this medicine to the child following the instructions of the
doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommendeddose is: 1 container of 2 g/50 ml 1-2 times a day, morning and/or
evening before going to bed, or 1 container of 4 g/100 ml 1 time a day, the
evening before going to bed.

Children and adolescents
In children over two years of age, the doctor will prescribe the
correct doses. Instructions for use and method of administration:

• shake the bottle for about one minute, to obtain a homogeneous suspension
• remove the cap from the rectal cannula
• the enema is now ready to be administered
• lie on your left side and bend your right leg
• insert the cannula into the rectum
• press the bottle until it is completely empty
• remove the enema
• remain lying down for at least 30 minutes, rotating your body onto your left and right sides to favor the distribution of the medicine over a wider surface of the intestine
• retain the liquid inside the intestine for as long as possible, preferably for the entire night;
• unscrew the cannula and discard it.

If you use/give your child too much ASAMAX
In case of accidental ingestion/intake of an excessive dose of ASAMAX
immediately notify your doctor or go to the nearest hospital.

If you forget to use/give ASAMAX to your child
Do not use/give your child a double dose to compensate for a missed dose.

If you stop the treatment with ASAMAX
After stopping the treatment with ASAMAX and during the treatment, a
recurrence of the symptoms of the disease may occur.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If during treatment with ASAMAX you and/or the child experience

• abdominal cramps
• severe abdominal pain
• diarrhea with blood
• fever
• severe headache
• skin rashes
• reddish, non-raised blotches in the shape of a target or circles on the trunk, often with central blisters, skin exfoliation, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms

which may be symptoms of an allergic reaction, immediately stop
treatment with ASAMAX and consult your doctor.
Possible side effects are listed below according to frequency:

common (may affect up to 1 in 10 people)

• nausea
• diarrhea
• tense abdomen
• headache
• high blood pressure (hypertension)
• skin rashes
• weakness (asthenia)
• fever (pyrexia).

uncommon (may affect up to 1 in 100 people)

• abdominal pain
• drowsiness
• tremor
• increased heart rate (tachycardia)
• low blood pressure (hypotension)
• itching
• fatigue
• facial swelling. rare (may affect up to 1 in 1,000)
• dizziness
• excessive intestinal gas (flatulence)
• vomiting
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity). very rare (may affect up to 1 in 10,000)
• reduction of all types of blood cells
• nerve disorders of arms and legs
• inflammation of the heart (myocarditis)
• inflammation of the membrane surrounding the heart (pericarditis)
• lung diseases (allergic and fibrotic lung reactions)
• inflammation, even acute, of the pancreas (gland involved in food digestion)
• kidney problems
• hair loss
• muscle and joint pain
• allergic reactions and joints
• allergic reactions, such as skin rashes
• fever caused by the administration of the medicine
• systemic lupus erythematosus
• inflammation of the entire colon (part of the intestine)
• abnormal results of liver function tests
• inflammation of the liver (hepatitis, hepatitis due to obstruction of the bile duct)
• formation of gallstones
• decrease (reversible) in the number of sperm in seminal fluid. not known (frequency cannot be estimated based on available data)
• swelling of the face, lips and throat caused by an allergic reaction (angioedema)
• kidney stones and associated kidney pain (see also section 2).

Reporting of side effects
If you/the child experiences any side effects, including those not listed
in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly
through 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 ASAMAX

Keep this medicine out of the sight and reach of children. Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the pack after the
words “EXP”. The expiry date refers to the last day of that month. This date applies to the
product in intact packaging, correctly stored.
Do not dispose of any medicine in 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 ASAMAX contains

Each ready-to-use single-dose container of 2 g in 50 ml contains:

• The active ingredient is: mesalazine 2 g
• The other ingredients are: tragacanth gum, xanthan gum, disodium edetate, sodium metabisulfite, sodium benzoate, sodium acetate, purified water.

Each ready-to-use single-dose container of 4 g in 100 ml contains:

• The active ingredient is: mesalazine 4 g
• The other ingredients are: tragacanth gum, xanthan gum, disodium edetate, sodium metabisulfite, sodium benzoate, sodium acetate, purified water.

Description of the appearance of ASAMAX and package contents
ASAMAX is available in packs of 7 single-dose rectal suspension containers,
containing the cannula for administration.

Marketing Authorisation Holder
Ca.Di. Group S.p.A. Via Salorno 58/60 00124 Rome

Manufacturer
Special Product’s Line S.r.l. – Via Fratta Rotonda Vado Largo 1- 03012 Anagni (FR)