FLUMARIN*ORAL GRAT 20SACH 350MG

FLUMARIN 350 mg granules for oral suspension
Morniflumate

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

FLUMARIN is used:
in ADULTS and ADOLESCENTS aged 15 years and over to treat pain of various origins and nature, also 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 feel better or if you feel worse after 5 days of treatment.

What you need to know before taking the medicine
Do not take FLUMARIN:
• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in paragraph 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 bowel movements or black and tarry stools);
• if you have had even one episode of stomach or intestinal ulcer, perforation or bleeding caused by taking medicines;
• if you have severe liver, kidney or heart problems;
• after the sixth month of pregnancy;
• if you are breastfeeding.

FLUMARIN 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 FLUMARIN granules for oral suspension if you suffer from phenylketonuria.

Warnings and precautions
Consult your doctor or pharmacist before taking FLUMARIN if:
• you are taking other NSAIDs;
• you have had stomach or intestinal diseases, for example ulcers or bleeding, hiatus hernia, Crohn's disease, ulcerative colitis; you are taking medicines that may increase the risk of ulcers and bleeding (see paragraph Other medicines and Flumarin);
• you are elderly or feel very weak (debilitated) or have a low body weight, as you are more likely to develop adverse events to this medicine;
• you have asthma associated with chronic inflammation of the nose or nasal cavities as a whole (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 as a precaution if:
• you have reduced kidney function;
• you have recently undergone surgery that caused significant blood loss;
• you have liver problems;
• you have heart or blood vessel problems, such as stroke, heart attack or heart failure or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke), as medicines like FLUMARIN can be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL ASSESS THE NEED FOR FOLLOW-UP TESTS.

PAY ATTENTION, as during treatment with all NSAIDs:
• at any time, with or without warning symptoms, even in patients without previous severe stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal;
• although very rarely, severe skin reactions have been reported, some of which are fatal, which manifest as redness, blistering and exfoliation (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 in most cases within the first month of treatment;
• signs of infection may be masked.

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

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 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.
FLUMARIN should be administered only when strictly necessary and under direct medical supervision, as adolescents are more likely to develop adverse events to this medicine.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Stop taking FLUMARIN immediately and consult 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 stomach or duodenal (peptic) or abdominal ulcer;
• 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 unusual fatigue with reduced urine elimination (due to invisible bleeding);
• severe skin rashes with redness, blistering and exfoliation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects
• 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), reduced heart function (insufficiency), low blood pressure (hypotension), inflammation of the blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), difficulty defecating (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), e.g. patchy or diffuse color changes (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• altered kidney function (renal insufficiency) which can cause swelling (edema), protein loss with urine, decreased blood proteins (nephrotic syndrome), kidney inflammation (interstitial nephritis), blood in urine (hematuria);
• altered liver function tests;
• altered tests (false positive) that detect the presence of drugs such as marijuana and hashish (THC screening tests);
• fluoride poisoning (fluorosis), especially if FLUMARIN is taken at high doses and for several years.

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