Package leaflet: Information for the patient

FLOMAX 700 mg tablets

morniflumate
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 others, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FLOMAX is and what it is used for
What you need to know before taking FLOMAX
How to take FLOMAX
Possible side effects
How to store FLOMAX
Contents of the pack and other information

1. What FLOMAX is and what it is used for

This medicine contains the active substance morniflumate and belongs to a class of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.
FLOMAX is used in ADULTS and adolescents from the age of 15 to treat pain of various origins and types, even when accompanied by fever, particularly in cases of ear inflammation (otitis), paranasal sinuses (sinusitis), tonsils (tonsillitis), throat (pharyngitis, laryngitis).

Consult your doctor if you do not get better or if you feel worse after 5 days of treatment.

2. What you need to know before taking FLOMAX

Do not take FLOMAX:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have had an allergic reaction or asthma after taking other NSAIDs, such as acetylsalicylic acid (known as aspirin);
if you have a stomach and/or duodenal ulcer (gastroduodenal);
if you have had two or more separate episodes of stomach or intestinal ulcer, bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
if you have ever had a single episode of ulcer, perforation, or bleeding in the stomach or intestine caused by taking medications;
if you have severe problems with your liver, kidneys, or heart;
after the sixth month of pregnancy.

Flomax is contraindicated in adolescents under 15 years of age and in adolescents with a history of
rectal inflammation (rectitis), rectal bleeding, or ulceration.
Warnings and precautions
Talk to your doctor or pharmacist before taking Flomax if:

you are taking other NSAIDs;
you have had stomach or intestinal disorders, such as ulcers or bleeding, hiatal hernia, Crohn's disease, or ulcerative colitis;
you are taking medicines that may increase the risk of ulcers and bleeding (see section “Other medicines and Flomax”);
you are elderly, feel very weak (debilitated), or have low body weight, as you are more likely to develop side effects;
you have asthma associated with chronic inflammation of the nose or nasal cavities (sinusitis) and/or nasal polyps;
you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it;
you need to undergo urine tests detecting drugs such as marijuana and hashish, as this medicine may give positive results even in the absence of these substances.

In particular, consult your doctor cautiously if:

you have reduced kidney function;
you have recently undergone surgery resulting in significant blood loss;
you have liver problems;
you have or have had heart or circulatory problems, such as stroke, heart attack, or heart failure, or are at risk for these conditions (for example, if you have high blood pressure, diabetes, elevated triglycerides, or smoke), since medicines like FLOMAX may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE WHETHER MONITORING TESTS ARE NECESSARY.
BE CAREFUL, because during treatment with all NSAIDs:

at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal (see section 4.8);
very rarely, severe skin reactions have been reported, some of which have been fatal, manifesting as redness, blistering, and peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial stages of therapy, patients appear to be at higher risk: such reactions occur mostly within the first month of treatment (see section 4.8);
signs of infection may be masked.

The risk of experiencing side effects increases with higher doses and prolonged treatment. Do not exceed the recommended dose
of FLOMAX and do not take it for long periods; always follow your doctor's instructions carefully.
STOP treatment and contact your doctor if:

you notice any symptoms affecting the stomach or intestine (gastrointestinal), especially if bleeding occurs;
a skin rash, mucosal lesions, or any other sign of an allergic reaction appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children and adolescents
Do not give this medicine to children or adolescents under 15 years of age.
FLOMAX should be administered only when strictly necessary and under direct medical supervision, as
adolescents are more likely to develop adverse effects from this medicine.
Other medicines and FLOMAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine, as some drugs may interact with FLOMAX or increase the risk of adverse
events, even serious ones.
In particular, inform your doctor if you are taking:

corticosteroids (steroidal anti-inflammatory drugs);
blood-thinning medicines (anticoagulants and antiplatelets), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin) and other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, and heparin;
diuretics and medicines for high blood pressure (hypertension) such as: ACE inhibitors, beta-blockers, angiotensin II antagonists;
medicines called selective serotonin reuptake inhibitors (SSRIs), used as antidepressants;
lithium, used in depression;
methotrexate, used in cancer treatment and for certain immune system disorders, e.g., rheumatoid arthritis;
cyclosporine and tacrolimus, medicines that suppress the immune system;
trimethoprim, an antibiotic;
potassium salts.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take FLOMAX during the last three months of pregnancy, as it may harm the fetus or cause problems
during childbirth. It may cause heart, lung, or kidney problems in the fetus. It could affect your and your baby's tendency
to bleed and delay or prolong labor more than expected.
You should not take FLOMAX during the first six months of pregnancy unless absolutely necessary and under
medical advice.
If treatment is required during this period or while trying to conceive, the lowest possible dose for the shortest possible duration should be used.
From the 20th week of pregnancy, FLOMAX may cause kidney problems in the fetus if taken for more than a
few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing
narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days,
your doctor may recommend additional monitoring.
If you are breastfeeding, discontinue breastfeeding as a precautionary measure during Flomax treatment.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.
Driving and using machines
Like other NSAIDs, this medicine may cause dizziness, fatigue, and reduced reflexes. Be
careful before driving vehicles or operating machinery.
FLOMAX tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain sugars,
contact him/her before taking this medicine.

3. How to take FLOMAX

Take this medicine exactly as directed by your doctor, who will determine the correct dose for your condition and the duration of treatment. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 15 years
1 tablet of FLOMAX 700 mg, twice daily
Elderly (over 65 years)
Half a tablet of 700 mg, 2-3 times daily, unless otherwise indicated by the doctor.
Your doctor will decide whether a dose reduction is necessary.
Method of administration
Take FLOMAX by mouth (oral administration) with food.
FLOMAX tablets have a score line to facilitate splitting into two equal halves.
If you take more FLOMAX than you should
You may experience abdominal pain (gastrointestinal irritation), drowsiness, headache.
In case of overdose, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required (e.g. activated charcoal, gastric lavage).
If you forget to take FLOMAX
Do not take a double dose to make up for the missed dose.
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 everybody will experience them.
Stop taking FLOMAX immediately and contact your doctor if you experience any of the following:

severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat, with breathing difficulties, sudden drop in blood pressure (anaphylactic shock);
severe breathing difficulties (asthmatic attacks);
severe stomach problems, burning sensation or abdominal pain due to stomach or duodenal (peptic) ulcer or abdominal ulcer;
sudden and severe pain in the upper abdomen (perforation of the ulcer);
vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestine (gastrointestinal), or unusual fatigue with reduced urine output (due to non-visible bleeding);
severe skin rashes with redness, blistering and peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be estimated from the available data)

worsening of chickenpox-related skin infections;
decrease in platelets (thrombocytopenia), decrease in white blood cells (leucopenia);
headache and dizziness;
heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), inability of the heart to pump sufficient blood to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of colon inflammation (colitis) and Crohn's disease, gastritis;
more or less sudden appearance of skin lesions, even after exposure to sunlight (photosensitivity dermatitis), for example discoloured spots or widespread changes (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
changes in kidney function (renal failure) which may cause swelling (oedema), loss of protein in urine, decreased protein levels in blood (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in urine (haematuria);
changes in liver function tests;
interference with drug screening tests (false positive results) for substances such as marijuana and hashish; additional testing is required to confirm a positive result.
fluoride poisoning (fluorosis), especially if FLOMAX is taken at high doses and for several years.

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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store FLOMAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the word EXP. The expiry date refers to the last day of that month. This date applies to the product when packed intact and stored correctly.
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 FLOMAX contains
The active substance is morniflumate.
Each FLOMAX 700 mg tablet contains: 700 mg of morniflumate.
The other components are:

FLOMAX tablets: lactose, crospovidone, methylhydroxypropylcellulose, magnesium stearate, sodium lauryl sulfate, hydrated colloidal silica.

Description of the appearance of FLOMAX and contents of the pack
FLOMAX 700 mg tablets are available in packs of 20 or 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHIESI FARMACEUTICI S.p.A., Via Palermo 26/A, Parma.
Manufacturer
CHIESI FARMACEUTICI S.p.A., Officine di Parma, Via S. Leonardo 96
FINE FOODS & Pharmaceuticals N.T.M. S.p.A., Via Grignano, n.43 - Brembate - Bergamo.

Patient information leaflet

FLOMAX 350 mg granules for oral suspension, 700 mg tablets

Morniflumate
Please read this entire leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

What FLOMAX is and what it is used for
What you need to know before taking FLOMAX
How to take FLOMAX
Possible side effects
How to store FLOMAX
Contents of the pack and other information

1. What FLOMAX is and what it is used for

This medicine contains the active substance morniflumate and belongs to a class of drugs known as NSAIDs (non-steroidal anti-inflammatory drugs), which act against pain, fever and inflammation.
FLOMAX is used:
in ADULTS and adolescents from the age of 15, to treat pain of various origin and nature, even when accompanied by fever, particularly in cases of inflammation of the ear (otitis), paranasal sinuses (sinusitis), tonsils (tonsillitis), throat (pharyngitis, laryngitis).
Consult your doctor if you do not feel better or feel worse after 5 days of treatment.

2. What you should know before taking FLOMAX

Do not take FLOMAX:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have had an allergic reaction or asthma after taking other NSAIDs such as acetylsalicylic acid (known as aspirin);
if you have a stomach and/or duodenal ulcer (gastroduodenal);
if you have had two or more separate episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
if you have ever had a single episode of stomach or intestinal ulcer, perforation, or bleeding caused by taking medications;
if you have severe problems with your liver, kidneys, or heart;
after the sixth month of pregnancy.

FLOMAX is contraindicated in children and adolescents under 15 years of age and in adolescents with
a history of rectal inflammation (proctitis), rectal bleeding, or ulceration.
Do not take FLOMAX oral suspension granules if you have phenylketonuria.

Warnings and precautions
Talk to your doctor or pharmacist before taking FLOMAX if:

you are taking other NSAIDs;
you have had stomach or intestinal disorders, such as ulcers or bleeding, hiatal hernia, Crohn’s disease, or ulcerative colitis;
you are taking medicines that may increase the risk of ulcers and bleeding (see section “Other medicines and FLOMAX”);
you are elderly, feel very weak (debilitated), or have low body weight, as you may be more likely to experience adverse effects;
you have asthma associated with chronic inflammation of the nose or nasal sinuses (sinusitis) and/or nasal polyps;
you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it;
you need to undergo urine tests detecting drugs such as marijuana and hashish, as this medicine may give positive results even in the absence of these substances.

In particular, consult your doctor cautiously if:

you have reduced kidney function;
you have recently undergone surgery involving significant blood loss;
you have liver problems;
you have or have had heart or circulatory problems, such as stroke, heart attack, or heart failure, or are at risk for these conditions (for example, if you have high blood pressure, diabetes, elevated triglycerides, or smoke), since medicines like FLOMAX may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL ASSESS WHETHER MONITORING TESTS ARE NECESSARY.
BE CAREFUL, because during treatment with all NSAIDs:

at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal (see section 4.8);
very rarely, severe skin reactions have been reported, some of which have been fatal, presenting as redness, blistering, and peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial stages of therapy, patients appear to be at higher risk: such reactions occur mostly within the first month of treatment (see section 4.8);
signs of infection may be masked.

The risk of experiencing adverse effects increases with higher doses and prolonged treatment. Do not exceed the dose
of FLOMAX and do not take it for long periods; always follow your doctor’s instructions carefully.
STOP treatment and contact your doctor if:

you notice any symptoms affecting the stomach or intestine (gastrointestinal), especially if bleeding occurs;
a skin rash, mucosal lesions, or any other sign of allergic reaction appear (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children and adolescents
Do not give this medicine to children and adolescents under 15 years of age.
FLOMAX should be administered only when strictly necessary and under direct medical supervision, as
adolescents may be more likely to develop adverse reactions to this medicine.

Other medicines and FLOMAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine, as some drugs may interact with FLOMAX or increase the risk of adverse
events, even serious ones.
In particular, inform your doctor if you are taking:

corticosteroids (steroidal anti-inflammatory drugs);
blood-thinning medicines (anticoagulants and antiplatelets), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin), other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, and heparin;
diuretics and medicines for high blood pressure (hypertension) such as: ACE inhibitors, beta-blockers, angiotensin II antagonists;
medicines called selective serotonin reuptake inhibitors (SSRIs), used as antidepressants;
lithium, used in depression;
methotrexate, used in cancer treatment and certain immune system disorders, e.g., rheumatoid arthritis;
cyclosporine and tacrolimus, medicines that suppress the immune system;
trimethoprim, an antibiotic;
potassium salts.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take FLOMAX during the last three months of pregnancy, as it may harm the fetus or cause problems during
delivery. It may cause heart, lung, or kidney problems in the fetus. It may affect your or your baby’s tendency to bleed and delay or prolong labor more than expected.
You should not take FLOMAX during the first six months of pregnancy unless absolutely necessary and under
medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used.
From the 20th week of pregnancy, FLOMAX may cause kidney problems in the fetus if taken for more than a few
days, reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
If you are breastfeeding, discontinue breastfeeding as a precautionary measure during FLOMAX treatment.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and use of machinery
Like other NSAIDs, this medicine may cause dizziness, fatigue, and reduced reflexes. Be cautious before driving or operating machinery.

FLOMAX granules contain:

sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
sorbitol: this medicine contains 363 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, consult your doctor before taking this medicine;
aspartame: this medicine contains 15 mg of aspartame per sachet. 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;
orange yellow S (E 110): may cause allergic reactions.

FLOMAX tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain
sugars, contact him/her before taking this medicine.

3. How to take FLOMAX

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is as follows:
Adults and adolescents over 15 years of age
2 sachets of FLOMAX 350 mg, twice daily.
1 tablet of FLOMAX 700 mg, twice daily.
Elderly (over 65 years of age)
1 sachet of FLOMAX 350 mg, 2–3 times daily, unless otherwise directed by the doctor.
Half a 700 mg tablet, 2–3 times daily, unless otherwise directed by the doctor.
Contact your doctor if you do not feel better or feel worse after 5 days of treatment.
Method of administration
Take FLOMAX by mouth (oral administration) with food.
FLOMAX tablets have a score line to facilitate splitting into two equal parts.
If you take more FLOMAX than you should
You may experience abdominal pain (gastrointestinal irritation), drowsiness, headache.
In case of overdose, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required (e.g. activated charcoal, gastric lavage).
If you forget to take FLOMAX
Do not take a double dose to make up for the missed dose.
If you have any questions 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 everybody gets them.
Stop taking FLOMAX immediately and contact your doctor if you experience any of the following:

severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, or throat with breathing difficulties, sudden drop in blood pressure (anaphylactic shock);
severe breathing difficulties (asthma attacks);
severe stomach problems, burning sensation or abdominal pain due to stomach or duodenal (peptic) ulcer or abdominal inflammation;
sudden and severe pain in the upper abdomen (perforation of the ulcer);
vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestines (gastrointestinal), or unusual fatigue with reduced urine output (due to
non-visible bleeding);
severe skin rashes with redness, blistering, and skin peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be estimated from the available data)

worsening of skin infections caused by chickenpox;
decrease in platelets (thrombocytopenia), decrease in white blood cells (leucopenia);
headache and dizziness;
heart attack (myocardial infarction) or stroke, swelling (oedema), high blood pressure (hypertension), inability of the heart to supply adequate blood flow to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the mouth lining with ulcers (ulcerative stomatitis), worsening of colon inflammation (colitis) and Crohn's disease, gastritis;
more or less sudden appearance of skin lesions, even after sun exposure (photosensitivity dermatitis), for example colour changes in spots or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
changes in kidney function (renal failure) which may cause swelling (oedema), protein loss in urine, reduced protein levels in blood (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in urine (haematuria);
changes in liver tests;
changes in drug screening tests (false positive) detecting substances such as marijuana and hashish; additional testing is required to confirm a positive result.
fluoride poisoning (fluorosis), especially if FLOMAX is taken at high doses and for several years.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 FLOMAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the word EXP. The expiry date refers to the last day of that month. This date applies to the product when kept in its original packaging and stored correctly.
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 FLOMAX Contains
The active substance is morniflumate.
Each sachet of FLOMAX granules contains: 350 mg of morniflumate.
Each FLOMAX 700 mg tablet contains: 700 mg of morniflumate.
The other components are:

FLOMAX granules: sucrose, sorbitol, banana flavour, maltodextrin, fruit flavour, crospovidone, hypromellose, aspartame, ammonium glycyrrhizinate, xanthan gum, polysorbate 20, sodium lauryl sulfate,
orange yellow S (E 110).
FLOMAX tablets: lactose, crospovidone, methylhydroxypropylcellulose, magnesium stearate, sodium lauryl sulfate, colloidal hydrated silica.

Description of the Appearance of FLOMAX and Contents of the Pack
FLOMAX 350 granules are available in packs of 20 or 30 sachets.
FLOMAX 700 mg tablets are available in packs of 10 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CHIESI FARMACEUTICI S.p.A., Via Palermo 26/A, Parma.
Manufacturer
CHIESI FARMACEUTICI S.p.A., Manufacturing Facilities in Parma, Via S. Leonardo 96.
FINE FOODS & Pharmaceuticals N.T.M. S.p.A., Via Grignano, n.43 - Brembate - Bergamo.

Patient Information Leaflet

FLOMAX ADULT 700 mg suppositories

morniflumate
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 others, even if their symptoms are the same as yours, as it could 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:

What FLOMAX is and what it is used for
What you need to know before taking FLOMAX
How to take FLOMAX
Possible side effects
How to store FLOMAX
Package contents and other information

1. What FLOMAX is and what it is used for

This medicine contains the active substance morniflumate and belongs to a class of medicines called NSAIDs
(non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.
FLOMAX is used in adults to reduce inflammation, with or without pain and/or fever, in inflammatory conditions affecting:

the ear (otitis), nasal cavities as a whole (sinusitis), tonsils (tonsillitis), mouth and throat (pharyngitis, laryngitis);
the trachea (tracheitis), bronchi (bronchitis);
the bladder (cystitis), urethra (urethritis), vagina (vaginitis), prostate (prostatitis), ovaries and fallopian tubes (annexitis);
bones and joints (musculoskeletal system).

2. What you need to know before taking FLOMAX

Do not take FLOMAX:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have had an allergic reaction or asthma after taking other NSAIDs such as acetylsalicylic acid (aspirin);
if you have a stomach and/or duodenal ulcer (gastroduodenal ulcer);
if you have had two or more separate episodes of stomach or intestinal ulcer, bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
if you have ever had a single episode of stomach or intestinal ulcer, perforation, or bleeding caused by taking medications;
if you have severe problems with your liver, kidneys, or heart;
if you suffer from inflammation or bleeding of the rectum (proctitis or rectal bleeding);
after the sixth month of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flomax if:

you are taking other NSAIDs;
you are taking medicines that may increase the risk of ulcers and bleeding (see section “Other medicines and Flomax”);
you have had stomach or intestinal disorders, such as ulcers or bleeding, hiatal hernia, Crohn’s disease, or ulcerative colitis;
you are elderly, feel very weak (debilitated), or have low body weight, as you are more likely to develop side effects;
you have asthma associated with chronic inflammation of the nose or sinuses (sinusitis) and/or nasal polyps;
you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it;
you are undergoing urine tests for drugs such as marijuana and hashish, as this medicine may give positive results even in the absence of these substances.

In particular, consult your doctor cautiously if:

you have reduced kidney function;
you have recently undergone surgery involving significant blood loss;
you have liver problems;
you have or have had heart or blood vessel problems, such as stroke, heart attack, or heart failure, or are at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or triglycerides, or smoke), since medicines like Flomax may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE WHETHER REGULAR MONITORING TESTS ARE NEEDED.

BE CAREFUL, because during treatment with all NSAIDs:

at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal (see section 4.8);
very rarely, severe skin reactions, some of which have been fatal, have been reported, manifesting as redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). In the early stages of therapy, patients appear to be at higher risk: such reactions occur mostly within the first month of treatment (see section 4.8);
signs of infection may be masked.

The risk of experiencing side effects increases with higher doses and prolonged treatment. Do not exceed the dose of FLOMAX or take it for long periods; always follow your doctor’s instructions carefully.
STOP TREATMENT and contact your doctor if:

you notice any gastrointestinal symptoms, especially bleeding;
a skin rash, mucosal lesions, or any other sign of an allergic reaction appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children
FLOMAX ADULT 700 mg suppositories are not suitable for children. If necessary, consult your doctor or pharmacist, as lower dosage forms of FLOMAX are available specifically for these patients.

Other medicines and FLOMAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, as some medicines may interact with FLOMAX or increase the risk of adverse events, even serious ones.
In particular, inform your doctor if you are taking:

corticosteroids (steroidal anti-inflammatory drugs);
blood-thinning medicines (anticoagulants and antiplatelets), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (aspirin), other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, heparin;
diuretics and medicines for high blood pressure (hypertension), such as ACE inhibitors, beta-blockers, angiotensin II antagonists;
medicines called 'selective serotonin reuptake inhibitors' (SSRIs), used as antidepressants;
lithium, used in depression;
methotrexate, used in cancer treatment and for certain immune system disorders, such as rheumatoid arthritis;
cyclosporine and tacrolimus, medicines that suppress the immune system;
trimethoprim, an antibiotic;
potassium salts.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take FLOMAX during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause heart, lung, or kidney problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond normal duration.
You should not take FLOMAX during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or when trying to conceive, the lowest effective dose for the shortest possible time should be used.
From the 20th week of pregnancy, FLOMAX may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
If you are breastfeeding, discontinue breastfeeding as a precautionary measure during Flomax treatment.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and using machines
Like other NSAIDs, this medicine may cause dizziness, fatigue, and reduced reflexes. Be cautious before driving or operating machinery.

3. How to take FLOMAX

Take this medicine exactly as your doctor has instructed. Your doctor will tell you the correct dose according to your condition and how long you should take it for. If you have any doubts, consult your doctor or pharmacist.
Adults
2 FLOMAX ADULT suppositories per day, 1 in the morning and 1 in the evening.
Elderly (over 65 years)
Your doctor will decide whether a dose reduction is necessary.
If you take more FLOMAX than you should
You may experience rectal problems.
If you ingest/absorb a large amount of FLOMAX, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.
If you forget to take FLOMAX
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking FLOMAX immediately and contact your doctor if you experience any of the following:

severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with breathing difficulties, sudden drop in blood pressure (anaphylactic shock);
severe breathing difficulties (asthma attacks);
severe stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) ulcer or abdominal ulcer;
sudden, intense pain in the upper abdomen (perforation of the ulcer);
vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestines (gastrointestinal), or unusual fatigue with reduced urine output (due to non-visible bleeding);
severe skin rashes with redness, blistering and skin peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be estimated from the available data)

rectal reactions, especially if treatment is prolonged, frequent or at high doses;
worsening of skin infections caused by chickenpox;
decrease in platelets (thrombocytopenia), decrease in white blood cells (leucopenia);
headache and dizziness;
heart attack (myocardial infarction) or stroke, swelling (oedema), high blood pressure (hypertension), inability of the heart to adequately supply blood to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of colonic inflammation (colitis) and Crohn's disease, gastritis;
more or less sudden appearance of skin lesions, even after sun exposure (photosensitivity dermatitis), for example, discolouration in spots or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
changes in kidney function (renal failure) which may cause swelling (oedema), loss of protein in the urine, decreased protein levels in the blood (nephrotic syndrome), inflammation of the kidney (interstitial nephritis), presence of blood in the urine (haematuria);
changes in liver function tests;
interference with drug screening tests (false positive results) for substances such as marijuana and hashish;
fluoride poisoning (fluorosis), especially if FLOMAX is taken at high doses and for several years.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please 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 FLOMAX

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30 °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, undamaged packaging and stored correctly.
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 FLOMAX contains
The active substance is morniflumate.
Each FLOMAX ADULTS 700 mg suppository contains: 700 mg of morniflumate.
The other components are: solid semisynthetic glycerides.
Description of the appearance of FLOMAX and contents of the pack
FLOMAX ADULTS 700 mg suppositories are available in packs of 10 suppositories.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CHIESI FARMACEUTICI S.p.A., Via Palermo 26/A, Parma.
Manufacturer
LAMP SAN PROSPERO S.p.A., Via della Pace 25/A, S. Prospero (MO).

Package leaflet: information for the patient

FLOMAX CHILDREN 400 mg suppositories

morniflumate
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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could 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:

What FLOMAX is and what it is used for
What you need to know before taking FLOMAX
How to take FLOMAX
Possible side effects
How to store FLOMAX
Contents of the pack and other information

1. What FLOMAX is and what it is used for

This medicine contains the active substance morniflumate and belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.
FLOMAX is used in children to reduce pain associated with inflammation of the ear (otitis), nasal cavities as a whole (sinusitis), tonsils (tonsillitis), and of the mouth and throat.

2. What you should know before taking FLOMAX

Do not take FLOMAX:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have had an allergic reaction or asthma after taking other NSAIDs such as acetylsalicylic acid (aspirin);
if you have a stomach and/or duodenal ulcer (gastroduodenal);
if you have had two or more separate episodes of stomach or intestinal ulcer, bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
if you have ever experienced an episode of ulcer, perforation, or gastrointestinal bleeding caused by taking medications;
if you have severe liver, kidney, or heart problems;
if you suffer from rectal inflammation or bleeding (proctitis or rectorrhagia);
after the sixth month of pregnancy.

FLOMAX is contraindicated in children under six months of age.
Warnings and precautions

Consult your doctor or pharmacist before using Flomax if you are taking other NSAIDs;
you have had stomach or intestinal disorders, such as ulcers or bleeding, hiatal hernia, Crohn's disease, or ulcerative colitis;
you are taking medicines that may increase the risk of ulcers and bleeding (see section "Other medicines and Flomax");
you are elderly, feel very weak (debilitated), or have low body weight, as you are more likely to develop adverse effects;
you have asthma associated with chronic inflammation of the nose or nasal sinuses (sinusitis) and/or nasal polyps;
you have chickenpox, since NSAIDs may worsen the severity of skin lesions caused by it;
you need to undergo urine tests detecting drugs such as marijuana and hashish, since this medicine may give positive results even in the absence of these substances.

In particular, consult your doctor cautiously if:

you have reduced kidney function;
you have recently undergone surgery causing significant blood loss;
you have liver problems;
you have or have had heart or circulatory problems, such as stroke, heart attack, or heart failure, or are at risk for these conditions (for example, if you have high blood pressure, diabetes, elevated cholesterol or triglycerides, or smoke), since medicines like Flomax may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL ASSESS WHETHER MONITORING TESTS ARE NECESSARY.
BE CAREFUL, because during treatment with all NSAIDs:

at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, gastrointestinal bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal (see section 4.8);
very rarely, severe skin reactions have been reported, some of which have been fatal, manifesting as redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial stages of therapy, patients appear to be at higher risk: such reactions occur mostly within the first month of treatment (see section 4.8);
signs of infection may be masked.

The risk of adverse effects increases with higher doses and prolonged treatment. Do not exceed the recommended dose of FLOMAX or take it for long periods; always follow your doctor's instructions carefully.
DISCONTINUE treatment and contact your doctor if:

you notice any gastrointestinal symptoms, especially if they involve bleeding;
a skin rash, mucosal lesions, or any other sign of an allergic reaction appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children and adolescents
FLOMAX should be administered only when strictly necessary and under direct medical supervision, as children and adolescents are more likely to develop adverse effects from this medicine.
In particular, children between 6 and 12 months of age are at high risk of serious skin-related adverse effects.
Other medicines and FLOMAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, as some drugs may interact with FLOMAX or increase the risk of adverse events, even serious ones.
In particular, you must inform your doctor if you are taking:

corticosteroids (steroidal anti-inflammatory drugs);
blood-thinning medicines (anticoagulants and antiplatelet agents), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (aspirin), other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, and heparin;
diuretics and medicines for high blood pressure (hypertension), such as ACE inhibitors, beta-blockers, angiotensin II antagonists;
medicines known as selective serotonin reuptake inhibitors (SSRIs), used as antidepressants;
lithium, used in depression;
methotrexate, used in cancer treatment and certain immune system disorders, such as rheumatoid arthritis;
cyclosporine and tacrolimus, medicines that suppress the immune system;
trimethoprim, an antibiotic;
potassium salts.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take FLOMAX during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause problems to the fetus's heart, lungs, or kidneys. It may also affect your or your baby's tendency to bleed and delay or prolong labor beyond expectations.
You should not take FLOMAX during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or while trying to conceive, the lowest possible dose for the shortest possible duration should be used.
From the 20th week of pregnancy, FLOMAX may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
If you are breastfeeding, discontinue breastfeeding as a precautionary measure during Flomax treatment.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.
Driving and using machines
Like other NSAIDs, this medicine may cause dizziness, fatigue, and reduced reflexes. Exercise caution before driving vehicles or operating machinery.

3. How to take FLOMAX

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Children from 6 to 12 months of age: 1 suppository of FLOMAX CHILDREN per day.
Children over 1 year of age: 1 to 3 suppositories of FLOMAX CHILDREN per day, depending on weight and age.
Since in children the dose of FLOMAX depends on body weight and age, your doctor will indicate the dosage to be administered.
In children, the duration of treatment with FLOMAX is 4-5 days.
If you take more FLOMAX than you should
You may experience problems at rectal level.
In case of ingestion/absorption of high doses of FLOMAX, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be necessary.
If you forget to take FLOMAX
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking FLOMAX immediately and contact your doctor if you experience any of the following:

severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with breathing difficulties, sudden drop in blood pressure (anaphylactic shock);
severe breathing difficulties (asthma attacks);
severe stomach problems, burning sensation or abdominal pain due to stomach or duodenal (peptic) ulcer or abdominal ulcer;
sudden and severe pain in the upper abdomen (perforation of the ulcer);
vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestines (gastrointestinal), or unusual fatigue with reduced urine output (due to non-visible bleeding);
severe skin rashes with redness, blistering and skin peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be estimated from the available data)

rectal reactions, especially if treatment is prolonged, frequent, or at high doses;
worsening of chickenpox-related skin infections;
decrease in platelets (thrombocytopenia), decrease in white blood cells (leucopenia);
headache and dizziness;
heart attack (myocardial infarction) or stroke, swelling (oedema), high blood pressure (hypertension), inability of the heart to supply adequate blood to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the mucosa of the mouth with ulcers (ulcerative stomatitis), worsening of inflammation of the colon (colitis) and Crohn's disease, gastritis;
more or less sudden appearance of skin lesions, even after sun exposure (photosensitivity dermatitis), for example, discolouration in spots or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
changes in kidney function (renal failure) which may cause swelling (oedema), loss of protein in urine, decreased protein levels in blood (nephrotic syndrome), inflammation of the kidney (interstitial nephritis), presence of blood in urine (haematuria);
changes in liver function tests;
interference with drug screening tests (false positive results) for substances such as marijuana and hashish;
fluoride poisoning (fluorosis), especially if FLOMAX is taken at high doses and for several years.

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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store FLOMAX

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30 °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 when unopened and properly 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 FLOMAX contains
The active substance is morniflumate.
Each FLOMAX BAMBINI 400 mg suppository contains: 400 mg of morniflumate.
The other components are: solid semisynthetic glycerides.

Description of the appearance of FLOMAX and contents of the pack
FLOMAX BAMBINI 400 mg suppositories are available in packs of 10 suppositories.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CHIESI FARMACEUTICI S.p.A., Via Palermo 26/A, Parma.
Manufacturer
LAMP SAN PROSPERO S.p.A., Via della Pace 25/A, S. Prospero (MO).