Asamax

Package leaflet: Information for the patient

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

Mesalazine
Please read all of this leaflet carefully before you start taking/giving your child 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/your child 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 ASAMAX is and what it is used for
2. What you need to know before taking/giving your child ASAMAX
3. How to take/give your child ASAMAX
4. Possible side effects
5. How to store ASAMAX
6. Contents of the pack and other information

1. What ASAMAX is and what it is used for

ASAMAX is a medicinal product containing mesalazina, 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 age for the treatment of
intestinal inflammations (ulcerative colitis and Crohn's disease) and for the prevention of relapses.

2. What you should know before taking/giving ASAMAX to the child

Do not take/give ASAMAX to the child

• if allergic to mesalazine, or to any of the other components of this medicine (listed in section 6)
• if allergic to any medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), particularly salicylates
• if suffering from severe liver disease
• if suffering from severe kidney disease (severe nephropathies and renal failure)
• if currently experiencing stomach or intestinal lesions (gastric or duodenal ulcers)
• if suffering from a blood disorder that predisposes to bleeding
• if the child is under six years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving ASAMAX to the child.
Before starting treatment, your doctor will carry out appropriate tests (blood and urine) and examinations, and will decide how often these tests should be repeated during treatment with ASAMAX.
Contact 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 sulfasalazine-based medicines (see section 4. Possible side effects). Please note that prolonged use of the product may lead to allergic reactions
• suffer from stomach disorders causing abnormally slow or difficult digestion (pyloric stenosis). The tablet may release mesalazine already in the stomach, possibly causing gastric irritation and loss of drug efficacy
• have ever developed a severe skin rash or skin exfoliation, blisters and/or mouth ulcers after taking mesalazine.

If, during treatment with ASAMAX, you or the child develop bruising, bleeding, anaemia, fever or sore throat, your doctor will perform blood tests and, if necessary, will advise stopping the treatment.
The use of mesalazine may cause kidney stone formation. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink an adequate amount of fluids during treatment with 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.
After stopping treatment with ASAMAX and during maintenance therapy, symptoms of the disease may reappear.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with mesalazine treatment. Discontinue use of mesalazine and immediately consult a doctor if you notice any of the symptoms related to these serious skin reactions described in section 4.
Children and adolescents
Do not give ASAMAX tablets to children under 6 years of age.
Other medicines and ASAMAX
Inform your doctor or pharmacist if you and/or the child are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you/the child are taking:

• Lactulose, a medicine used to treat constipation, or other medicines known to affect intestinal acidity, as they may interfere with the release of mesalazine in the intestine.
• Medicines to lower blood sugar levels (oral hypoglycaemics such as sulfonylureas).
• Medicines to make the blood thinner (coumarins, such as warfarin).
• Medicines to treat inflammation (corticosteroids). However, in cases of severe intestinal inflammation, your doctor may prescribe corticosteroid treatment as well.
• Other medicines for treating inflammation belonging to the class of NSAIDs (non-steroidal anti-inflammatory drugs).
• Methotrexate, a medicine used to treat cancer.
• Probenecid, a medicine used to treat gout.
• Sulfinpyrazone, a medicine used to treat serious blood disorders.
• Spironolactone and furosemide, medicines used to treat heart diseases.
• Rifampicin, a medicine used to treat infections.
• Azathioprine, a medicine used to treat disorders of the immune system.
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukaemia).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ASAMAX during the last weeks of pregnancy.
During the first trimester of pregnancy, take this medicine only if clearly needed and under direct medical supervision.
Breastfeeding
Mesalazine passes into breast milk; therefore, take this medicine only if clearly needed and under direct medical supervision. If the child develops diarrhoea, discontinue 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 the child this medicine exactly as directed by the
doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
Adults
The recommended dose is: 1-2 tablets of ASAMAX 400 mg or 1 tablet of
ASAMAX 800 mg, three times daily.
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
For children from the age of 6 years, the doctor will prescribe the appropriate doses.
If you take/give the child more ASAMAX than you should
In case of accidental ingestion/overdose of ASAMAX,
contact the doctor immediately or go to the nearest hospital.
The doctor will determine which supportive treatments are necessary.
If you forget to take/give ASAMAX to your child
Do not take/give the child a double dose to make up for a missed dose.
If you stop treatment with ASAMAX
After stopping treatment with ASAMAX, or during treatment, symptoms of the disease may
reappear.
If you have any doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you or the child experience any of the following while taking ASAMAX:

• abdominal cramps
• severe abdominal pain
• bloody diarrhoea
• fever
• severe headache
• skin rashes
• reddish, non-elevated patches on the trunk, often target-shaped or circular, sometimes with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These serious skin reactions may be preceded by fever and flu-like symptoms, which could indicate an allergic reaction. Stop treatment with ASAMAX immediately and contact your doctor.

The possible side effects are listed below by frequency:
Common (may affect up to 1 in 10 people)

• nausea
• diarrhoea
• abdominal distension
• headache (cephalalgia)
• high blood pressure (hypertension)
• skin rash
• weakness (asthenia)
• fever (pyrexia)

Uncommon (may affect up to 1 in 100 people)

• abdominal pain
• somnolence
• tremor
• increased heart rate (tachycardia)
• low blood pressure (hypotension)
• itching (pruritus)
• fatigue
• facial swelling

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

• dizziness
• excessive intestinal gas (flatulence)
• vomiting
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

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

• reduction in all types of blood cells
• nerve disorders in arms and legs
• inflammation of the heart (myocarditis)
• inflammation of the membrane surrounding the heart (pericarditis)
• lung diseases (allergic and fibrotic pulmonary reactions)
• inflammation, even acute, of the pancreas (the gland involved in food digestion)
• kidney problems
• hair loss
• muscle and joint pain
• allergic reactions such as skin rashes, fever due to medicine administration
• systemic lupus erythematosus syndrome
• inflammation of the entire colon (part of the intestine)
• abnormal liver function test results
• liver inflammation (hepatitis, cholestatic hepatitis)
• gallstone formation in the gallbladder
• decreased (reversible) sperm count in semen

Not known (frequency cannot be estimated from the available data)

• swelling of the face, lips and throat due to an allergic reaction (angioedema)
• kidney stones and associated kidney pain (see also section 2)

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, contact 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 ASAMAX

Keep this medicine out of the sight and reach of
children. Store below 25°C.
Do not use this medicine after the expiry date stated on the pack
after the word “EXP”.
The expiry date refers to the last day of that month. This date applies to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine 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 ASAMAX contains
One 400 mg gastro-resistant tablet contains:

• Active substance: mesalazine 400 mg
• Other components: Core: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid-methyl methacrylate copolymer 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:

• Active substance: mesalazine 800 mg
• Other components: Core: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid-methyl methacrylate copolymer 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 contents of the pack
ASAMAX 400 mg is available in packs containing 50 gastro-resistant tablets of 400 mg.
ASAMAX 800 mg is available in packs containing 24 or 60 gastro-resistant tablets of 800 mg.

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

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

Package leaflet: information for the patient

ASAMAX 500 mg suppositories suppositories

Mesalazine
Please read this leaflet carefully before using/giving 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you/your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact 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. Package contents and other information

1. What ASAMAX is and what it is used for

ASAMAX is a medicinal product 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 2 years of age for the treatment of intestinal inflammation (ulcerative colitis affecting the rectal area) and for the prevention of relapses.

2. What you should know before using/giving the child ASAMAX

DO NOT use/give the child ASAMAX

• 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), particularly salicylates
• if you have severe liver disease
• if you have severe kidney disease (severe nephropathies or renal failure)
• if you currently have stomach or intestinal lesions (gastric or duodenal ulcers)
• if you have a blood disorder that makes you prone to bleeding
• if the child is under two years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using/giving the child ASAMAX.
Before starting treatment, your doctor will carry out appropriate tests (blood and urine) and examinations, and will decide how often these tests should be repeated during treatment with ASAMAX.
Contact your doctor if you and/or the child:

• have liver problems
• have kidney problems
• are taking other medicines (see section 2. Other medicines and ASAMAX)
• have a lung disease (particularly asthma)
• have had an allergic reaction to sulfasalazine-based medicines (see section 4. "Possible side effects"). Please note that prolonged use of this product may lead to allergic reactions
• have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking mesalazine.

If, during treatment with ASAMAX, you develop bruising, bleeding, anaemia, fever or sore throat, your doctor will perform blood tests and, if necessary, will discontinue treatment.
The use of mesalazine may cause kidney stone formation. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink sufficient fluids during treatment with 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.
After stopping treatment with ASAMAX and during maintenance therapy, symptoms of the disease may recur.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with mesalazine treatment. Stop using mesalazine and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Children and adolescents
Do not give ASAMAX suppositories to children under 2 years of age.
Other medicines and ASAMAX
Inform your doctor or pharmacist if you and/or the child are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you/the child are taking:

• Medicines to lower blood sugar levels (oral hypoglycaemics such as sulfonylureas)
• Medicines to make the blood less likely to clot (anticoagulants such as coumarins, e.g. warfarin)
• Medicines to treat inflammation (corticosteroids). However, in cases of severe intestinal inflammation, your doctor may prescribe corticosteroid treatment as well.
• Other medicines for treating inflammation belonging to the NSAID class (non-steroidal anti-inflammatory drugs)
• Methotrexate, a medicine used to treat cancer
• Probenecid, a medicine used to treat gout
• Sulfinpyrazone, a medicine used to treat serious blood disorders
• Spironolactone and furosemide, medicines used to treat heart conditions
• Rifampicin, a medicine used to treat infections
• Azathioprine, a medicine used to treat disorders of the immune system
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukaemia)

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use ASAMAX during the last weeks of pregnancy.
During the first part of pregnancy, use this medicine only if clearly needed and under direct medical supervision.
Breastfeeding
Mesalazine passes into breast milk; therefore, use this medicine only if clearly needed and under direct medical supervision. If the child develops diarrhoea, stop breastfeeding.
Driving and using machines
ASAMAX does not affect the ability to drive vehicles or operate machinery.

3. How to use/give ASAMAX to the child

Use/give this medicine to the child exactly as directed by the
doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
Adults
The recommended dose is:

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

Children and adolescents
For children above two years of age, the doctor will prescribe the appropriate dosage.
Method of administration:
Retain the suppository in the rectum for at least 30 minutes or as long as possible, preferably overnight.
During hot seasons, it may be necessary to immerse the suppository container in cold water to re-solidify suppositories that may have softened.
If you use/give the child more ASAMAX than you should
In case of accidental ingestion/overdose of ASAMAX, contact the doctor immediately or go to the nearest hospital.
If you forget to use/give ASAMAX to your child
Do not use/give a double dose to make up for the missed dose.
If you stop treatment with ASAMAX
After stopping treatment with ASAMAX, or during treatment, symptoms of the disease may recur.
If you have any doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you or the child experience any of the following during treatment with ASAMAX:

• abdominal cramps
• severe abdominal pain
• bloody diarrhoea
• fever
• severe headache
• skin rashes
• red, flat, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These serious skin reactions may be preceded by fever and flu-like symptoms

which could be signs of an allergic reaction, stop treatment with ASAMAX immediately and contact your doctor.

The possible side effects are listed below by frequency:

Common (may affect up to 1 in 10 people)

• nausea
• diarrhoea
• bloated abdomen
• headache (cephalalgia)
• 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 (pruritus)
• fatigue
• facial swelling

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

• dizziness
• excessive intestinal gas (flatulence)
• vomiting
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

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

• reduction in all types of blood cells
• nerve disorders in arms and legs
• inflammation of the heart (myocarditis)
• inflammation of the membrane covering the heart (pericarditis)
• lung diseases (allergic and fibrotic pulmonary reactions)
• inflammation of the pancreas (digestive gland), including acute cases
• kidney problems
• hair loss
• muscle and joint pain
• muscle cramps, pain in arms and legs
• allergic reactions such as skin rashes, drug-induced fever
• lupus erythematosus syndrome
• inflammation of the entire colon (part of the intestine)
• abnormal liver function test results
• liver inflammation (hepatitis, cholestatic hepatitis)
• gallstone formation in the gallbladder
• reversible decrease in sperm count in seminal fluid

Not known (frequency cannot be estimated from available data)

• swelling of the face, lips and throat due to an allergic reaction (angioedema)
• kidney stones and associated kidney pain (see also section 2)

Reporting of side effects
If you or the child 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 ASAMAX

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging after the word “EXP”. The expiry date refers to the last day of that month. This date applies to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other

information What ASAMAX contains
Each suppository contains:

• The active substance is: mesalazine 500 mg
• The other components are: semisynthetic glycerides.

Description of the appearance of ASAMAX and contents of the pack
ASAMAX is available in packs containing 20 suppositories of 500 mg.
Marketing Authorization 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)
Package leaflet: information for the patient

ASAMAX 2 g/50 ml rectal suspension, 4 g/100 ml rectal suspension

Mesalazine
Please read this leaflet carefully before using/giving 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you/your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, consult 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 ASAMAX is and what it is used for

ASAMAX is a medicinal product 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 2 years of age for the treatment
of intestinal inflammation (ulcerative colitis affecting the rectosigmoid region) and for the prevention of relapses.

2. What you should know before using/giving 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)
• you are allergic to any medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), particularly salicylates
• you have severe liver disease
• you have severe kidney disease (severe nephropathies or renal failure)
• you currently have stomach or intestinal lesions (gastric or duodenal ulcers)
• you have a blood disorder that makes you prone to bleeding
• the child is under two years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using/giving ASAMAX to the child.
Before starting treatment, your doctor will carry out tests (blood and urine) and examinations as appropriate, and will decide how often these tests should be repeated during treatment with ASAMAX.
Contact your doctor if you and/or the child:

• have liver disorders
• have kidney disorders
• are taking other medicines (see section 2. Other medicines and ASAMAX)
• have a lung disease (particularly asthma)
• have previously had an allergic reaction to sulfasalazine-based medicines (see section 4. "Possible side effects"). Please note that prolonged use of the product may lead to allergic reactions
• have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after using mesalazine.

If, during treatment with ASAMAX, you develop bruising, bleeding, anaemia, fever or sore throat, your doctor will perform blood tests and, if necessary, will advise you to stop treatment.
The use of mesalazine may cause kidney stone formation. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink sufficient fluids during treatment with 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.
After stopping treatment with ASAMAX and during maintenance therapy, symptoms of the disease may reappear.
Serious skin reactions have been reported in association with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, and toxic epidermal necrolysis. 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.

Children and adolescents
DO NOT give rectal ASAMAX suspension to children under 2 years of age.

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

• Medicines to lower blood sugar levels (oral hypoglycaemics such as sulfonylureas)
• Medicines that make the blood thinner (coumarins, such as warfarin)
• Medicines to treat inflammation (corticosteroids). However, in cases of severe intestinal inflammation, your doctor may prescribe corticosteroid treatment as well
• Other medicines for treating inflammation belonging to the class of NSAIDs (non-steroidal anti-inflammatory drugs)
• Methotrexate, a medicine used to treat cancer
• Probenecid, a medicine used to treat gout
• Sulfinpyrazone, a medicine used to treat serious blood disorders
• Spironolactone and furosemide, medicines used to treat heart diseases
• Rifampicin, a medicine used to treat infections
• Azathioprine, a medicine used to treat disorders of the body's defence system (immune system)
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukaemia)

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
DO NOT use ASAMAX during the last weeks of pregnancy.
During the first part of pregnancy, use this medicine only if clearly needed and under direct medical supervision.
Breastfeeding
Mesalazine passes into breast milk; therefore, use this medicine only if clearly needed and under direct medical supervision. If the child develops diarrhoea, stop breastfeeding.

Driving and using machines
ASAMAX does not affect the ability to drive 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 the child

Use/give this medicine to the child exactly as directed by the
doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
Adults
The recommended dose is: 1 container of 2 g/50 ml 1–2 times daily, in the morning and/or
in the evening before going to sleep, or 1 container of 4 g/100 ml once daily,
in the evening before going to sleep.
Children and adolescents
For children over two years of age, the doctor will prescribe the
appropriate dosage. 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 for administration
• lie on the left side and bend the right leg
• insert the cannula into the rectum
• squeeze the bottle until it is completely empty
• remove the enema
• remain lying down for at least 30 minutes, turning the body from the right to the left side to promote distribution of the medicine over a larger intestinal surface
• retain the liquid in the intestine for as long as possible, preferably throughout the night;
• unscrew the cannula and dispose of it.

If you use/give the child more ASAMAX than you should
In case of accidental ingestion/overdose of ASAMAX,
contact the doctor immediately or go to the nearest hospital.
If you forget to use/give your child ASAMAX
Do not use/give a double dose to make up for the missed dose.
If you stop treatment with ASAMAX
After stopping treatment with ASAMAX, and during treatment, symptoms of the disease may reappear.
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 gets them.
If you or the child experience any of the following during treatment with ASAMAX:

• abdominal cramps
• severe abdominal pain
• bloody diarrhoea
• fever
• severe headache
• skin rashes
• flat, reddish, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These serious skin reactions may be preceded by fever and flu-like symptoms

which may be signs of an allergic reaction, stop treatment with ASAMAX immediately and contact your doctor.

The possible side effects are listed below by frequency:

Common (may affect up to 1 in 10 people)

• nausea
• diarrhoea
• abdominal distension
• headache (cephalalgia)
• 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 (pruritus)
• fatigue
• facial swelling

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

• dizziness
• excessive intestinal gas (flatulence)
• vomiting
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

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

• reduction in all types of blood cells
• nerve disorders in arms and legs
• inflammation of the heart (myocarditis)
• inflammation of the membrane covering the heart (pericarditis)
• lung diseases (allergic and fibrotic pulmonary reactions)
• inflammation, including acute, of the pancreas (the gland involved in food digestion)
• kidney problems
• hair loss
• muscle and joint pain
• allergic reactions affecting the joints
• allergic reactions, such as skin rashes
• fever caused by the medicine
• lupus erythematosus syndrome
• inflammation of the entire colon (part of the intestine)
• abnormal liver function test results
• liver inflammation (hepatitis, cholestatic hepatitis)
• gallstone formation
• reversible decrease in sperm count in semen

Not known (frequency cannot be estimated from available data)

• swelling of the face, lips and throat due to an allergic reaction (angioedema)
• kidney stones and associated kidney pain (see also section 2)

Reporting of side effects
If you or the child 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 ASAMAX

Keep this medicine out of the sight and reach of
children. Store below 25°C.
Do not use this medicine after the expiry date stated on the pack after the word “EXP”. The expiry date refers to the last day of that month. This date applies to the product in original, unopened packaging, correctly stored.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

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

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

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

• The active substance is: mesalazine 4 g
• The other components 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 containers of rectal suspension,
including the administration cannula.
Marketing Authorization 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)