FLOMAX 350 MG GRANULES FOR ORAL SUSPENSION 20 PE/AI/PAPER SACHETS

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


What is it and what is it for?
This medicine contains the active substance morniflumate and belongs to a class of drugs called NSAIDs (nonsteroidal anti-inflammatory drugs) which act against pain, fever and inflammation.

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

Contact 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 substance or to 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 an ulcer in your stomach and/or duodenum (gastroduodenal);
• if you have had two or more distinct episodes of ulcers or bleeding in your stomach or intestines (including blood in your vomit or during bowel movements or black, tarry stools);
• if you have had even one episode of ulcer, perforation or bleeding in the stomach or intestine caused by taking medicines;
• if you have serious 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 (rectitis), rectal bleeding or ulcers.

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


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

• is taking other NSAIDs;
• have had stomach or intestinal problems, such as ulcers or bleeding, hernia of the stomach (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");
• are elderly or feel very weak (debilitated) or have a low body weight, as they are more likely to develop side effects;
• has asthma associated with chronic inflammation of the nose or nasal passages as a whole (sinusitis) and/or nasal polyps;
• have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it;
• you must undergo urine tests that detect the presence of 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 with caution if:
• has reduced kidney function;
• recently had surgery that caused significant blood loss;
• has liver problems;
• you have or have had heart or blood circulation problems, such as stroke, heart attack or heart failure, or are at risk of these conditions (for example if you have high blood pressure, diabetes or raised triglycerides or if you smoke), as medicines such as FLOMAX may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, THE DOCTOR WILL EVALUATE THE NEED TO CARRY OUT CHECK-UP TESTS.

PLEASE NOTE , as during treatment with all NSAIDs:
• bleeding, ulceration or perforation of the stomach or intestine, which can be fatal, has been reported at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems (see section 4.8);
• although very rare, serious skin reactions, some of them fatal, manifesting as redness, blistering and peeling (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), have been reported. Patients appear to be at highest risk early in the course of therapy: these reactions occur in the majority of cases within the first month of treatment (see section 4.8);
• signs of infection can be masked.

The risk of side effects increases with high doses and prolonged treatment. Do not exceed the dose of FLOMAX or take it for long periods; always carefully follow your doctor's instructions.

STOP treatment and contact your doctor if:
• note any symptoms affecting your stomach and intestines (gastrointestinal), 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
Do not give this medicine to children and adolescents under 15 years of age.

FLOMAX should be administered only when strictly necessary and under the direct supervision of a doctor, 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 (asthma attacks);
• severe stomach problems, heartburn or abdominal pain due to a stomach or duodenal (peptic) ulcer or abdominal ulcer;
• sudden, severe pain in the pit of the stomach (perforation of the ulcer);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or abnormal tiredness with reduced urine output (due to invisible 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 skin infections caused by chickenpox;
• decrease in platelets (thrombocytopenia), decrease in white blood cells (leukopenia);
• headache and dizziness;
• heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), inability of the heart to supply adequate blood to the body (heart failure), low blood pressure (hypotension), inflammation of the blood vessels (vasculitis);
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the mouth mucosa 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 following exposure to the sun (photosensitivity dermatitis), for example spotty or widespread changes in color (rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• changes in kidney function (renal failure) which can cause swelling (edema), loss of proteins in the urine, decreased proteins in the blood (nephrotic syndrome), inflammation of the kidney (interstitial nephritis), presence of blood in the urine (hematuria);
• changes in liver tests;
• test alterations (false positive) that detect the presence of drugs such as marijuana and hashish; further tests are necessary to confirm the positive result;
• fluoride poisoning (fluorosis), especially if FLOMAX is taken in high doses and for several years.

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