FLOMAX*10TAB 700MG

FLOMAX 350 mg granules for oral suspension
FLOMAX 700 mg tablets
Morniflumate

What it is and what it is used for
This medicine contains the active ingredient morniflumate and belongs to a class of drugs called NSAIDs (non-steroidal anti-inflammatory drugs) that act against pain, fever and inflammation.

FLOMAX is used:
in ADULTS and adolescents aged 15 and over, to treat pain of various origins and nature, even accompanied by fever, particularly in cases of ear inflammation (otitis), paranasal sinuses (sinusitis), tonsils (tonsillitis), and throat (pharyngitis, laryngitis).

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

What you need to know before taking the medicine
Do not take FLOMAX:
• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergy 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 distinct episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or during evacuation or black and tarry stools);
• if you have had even a single episode of ulcer, perforation, or bleeding in the stomach or intestine caused by taking medication;
• if you have severe liver, kidney, or heart problems;
• 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 ulcer.

Do not take FLOMAX granules for oral suspension if you suffer from phenylketonuria.

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

• you are taking other NSAIDs;
• you have had stomach or intestinal conditions, such as ulcer or bleeding, hiatal hernia, Crohn's disease, ulcerative colitis;
• you are taking medicines that may increase the risk of ulcers and bleeding (see section Other medicines and FLOMAX);
• you are elderly or feel very weak (debilitated) or have a 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 could worsen the severity of skin lesions caused by it;
• you need to undergo urine tests that detect the presence of drugs such as marijuana and hashish, as this medicine can give positive results even in the absence of these substances.

In particular, consult your doctor carefully if:
• you have reduced kidney function;
• you have recently undergone surgery that caused significant blood loss;
• you have liver problems;
• you have or have had heart or blood circulation problems, such as a stroke, heart attack or heart failure, or are at risk for these conditions (for example, if you have high blood pressure, diabetes or increased triglycerides, or smoke), as medicines like FLOMAX may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, THE DOCTOR WILL EVALUATE THE NEED FOR CHECK-UP EXAMINATIONS.

BE CAREFUL, as 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 can be fatal (see section 4.8);
• although very rare, severe skin reactions have been reported, some of which were fatal, manifesting with redness, blistering and exfoliation (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). In the early stages of therapy, patients seem to be at higher risk: such reactions occur in most cases within the first month of treatment (see section 4.8);
• signs of an infection can be masked.

The risk of side effects increases with high doses and prolonged treatments. 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 and intestine (gastrointestinal), especially if it is bleeding;
• a skin rash, mucosal lesions or any other sign of an allergic reaction (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure) appears.

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 are more likely to develop side effects from this medicine.

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 conditions:
• severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, sudden drop in blood pressure (anaphylactic shock);
• severe breathing difficulties (asthmatic attacks);
• severe stomach problems, heartburn or abdominal pain due to a stomach or duodenal (peptic) ulcer or abdominal pain;
• violent and sudden pain in the pit of the stomach (ulcer perforation);
• vomiting containing blood (hematemesis) or black stools (melena), associated with stomach or intestinal (gastrointestinal) bleeding or abnormal fatigue with reduced urine output (due to invisible bleeding);
• severe skin rashes with redness, blistering and exfoliation (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;
• decreased platelets (thrombocytopenia), decreased white blood cells (leukopenia);
• headache and dizziness;
• heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), the heart's inability to adequately supply blood to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the oral 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 sun exposure (photosensitivity dermatitis), such as patchy or diffuse color changes (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• changes in kidney function (renal failure) which can cause swelling (edema), protein loss in the urine, decreased blood protein (nephrotic syndrome), kidney inflammation (interstitial nephritis), blood in the urine (hematuria);
• abnormal liver test results;
• altered test results (false positive) that detect the presence of drugs such as marijuana and hashish; further analyses are required to confirm the positive result;
• fluoride poisoning (fluorosis), especially if FLOMAX is taken at high doses and for several years.

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.