FLUMARIN 350 mg Tabletka

Treść ulotki

1. FLUMARIN 700 mg tablets, 350 mg tablets, 3.5g/100ml oral suspension
   1. What is FLUMARIN and what is it used for
   2. What you need to know before taking FLUMARIN
   3. How to take FLUMARIN
   4. Possible side effects
   5. How to store FLUMARIN
   6. Contents of the pack and other information
2. FLUMARIN 350 mg granules for oral suspension
   1. What is FLUMARIN and what is it used for
   2. What you need to know before taking FLUMARIN
   3. How to take FLUMARIN
   4. Possible side effects
   5. How to store FLUMARIN
   6. Contents of the pack and other information
3. FLUMARIN ADULTI 700 mg suppositories
   1. What is FLUMARIN and what is it used for
   2. What you need to know before taking FLUMARIN
   3. How to take FLUMARIN
   4. Possible side effects
   5. How to store FLUMARIN
   6. Contents of the pack and other information
4. FLUMARIN BAMBINI 400 mg suppositories
   1. What is FLUMARIN and what is it used for
   2. What you need to know before giving FLUMARIN to your child
   3. How to take FLUMARIN
   4. Possible side effects
   5. How to store FLUMARIN
   6. Contents of the pack and other information

FLUMARIN 700 mg tablets, 350 mg tablets, 3.5g/100ml oral suspension

Morniflumate

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FLUMARIN is and what it is used for
• 2. What you need to know before you take FLUMARIN
• 3. How to take FLUMARIN
• 4. Possible side effects
• 5. How to store FLUMARIN
• 6. Contents of the pack and other information

1. What is FLUMARIN and what is it used for

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

• in ADULTSto reduce inflammation, with or without pain and/or fever, in cases of inflammation:
• of the ear (otitis), of the nasal cavities as a whole (sinusitis), of the tonsils (tonsillitis), of the mouth and throat (pharyngitis, laryngitis);
• of the trachea (tracheitis), of the bronchi (bronchitis);
• of the bladder (cystitis), of the urethra (urethritis), of the vagina (vaginitis), of the prostate (prostatitis), of the ovaries and fallopian tubes (salpingitis);
• of the bones and joints (osteo-articular system);
• in CHILDRENto reduce pain associated with inflammation of the ear (otitis), of the nasal cavities as a whole (sinusitis), of the tonsils (tonsillitis), of the mouth and throat.

2. What you need to know before taking FLUMARIN

Do not take FLUMARIN:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergy or asthma after taking other NSAIDs such as acetylsalicylic acid known as aspirin;
• if you have an ulcer in the stomach and/or duodenum (gastroduodenal);
• if you have had two or more distinct episodes of ulcer or bleeding in the stomach or intestine (including blood in 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 medications;
• if you have serious problems with the liver, kidneys or heart;
• after the sixth month of pregnancy;
• if you are breastfeeding.

Warnings and precautions
Tell your doctor before taking FLUMARIN if:

• you are taking other NSAIDs;
• you have had stomach or intestinal problems, such as ulcers or bleeding, a stomach hernia (hiatal), Crohn's disease, ulcerative colitis;
• you are taking medicines that can increase the risk of ulcers and bleeding (see section “Other medicines and Flumarin”);
• you are elderly or feel very weak (debilitated) or have a reduced body weight, as you are more likely to develop adverse events with this medicine;
• you have asthma associated with chronic inflammation of the nose or sinuses and/or nasal polyps;
• you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it.
• you are going to 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 as a precaution if:

• you have reduced kidney function;
• you have recently undergone surgery that caused you 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 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 THE NEED TO SUBJECT YOU TO CHECK-UP EXAMS.

PAY ATTENTION, 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;
• although very rarely, severe skin reactions, some of which are fatal, have been reported, manifesting with redness, blistering and exfoliation (for example, 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 an infection can be masked. The risk of adverse effects increases with high doses and prolonged treatments. Do not exceed the dose of FLUMARIN prescribed by your doctor 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 intestines (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
FLUMARIN should be administered only when necessary and under the direct supervision of a
doctor, as children and adolescents are more likely to develop adverse events with
this medicine. In particular, children between 6 and 12 months have a high risk of serious skin
adverse effects.

Other medicines and FLUMARIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Some medicines can interact with FLUMARIN or increase the risk of adverse events, even serious.
In particular, contact your doctor if you are taking:

• medicines that contain cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelet agents), for example warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin), tirofiban, eptifibatide and abciximab, iloprost, heparin;
• medicines for high blood pressure (hypertension) such as: diuretics, ACE inhibitors, beta-blockers, angiotensin II receptor antagonists;
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• other medicines that reduce pain and inflammation (NSAIDs and salicylates);
• lithium, used in depression;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, medicines that reduce the immune defenses;
• trimethoprim, an antibiotic medicine;
• potassium salts.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take FLUMARIN in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may affect the mother's and baby's tendency to bleed and delay or prolong labor more than expected. You should not take FLUMARIN in the first 6 months of pregnancy unless absolutely necessary and under
the advice of your doctor. If treatment is needed during this period or during attempts to conceive,
the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, FLUMARIN can cause kidney problems in the fetus, if taken for more than
a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or
causing the 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.
Be careful with FLUMARIN:

• if you want to become pregnant or have difficulty conceiving, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug;
• during the first months of pregnancy (up to the sixth month), as this medicine should be used only when necessary and under the direct supervision of your doctor;
• do not take FLUMARIN while breastfeeding.

Driving and operating machinery
Like other NSAIDs, this medicine may cause dizziness, fatigue and decreased reflexes.
Be careful before driving vehicles or using machinery.

FLUMARIN tablets contains:

• lactose: if your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
• sodium: less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

FLUMARIN oral suspension contains

• sodium:This medicine contains 47.8 mg of sodium (the main component of table salt) per maximum dose (20 ml). This is equivalent to 2.39% of the maximum recommended daily intake of sodium with the diet of an adult.
• sucrose:if your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine. It contains 6 g of sucrose (sugar) per maximum dose. This should be taken into consideration in people with diabetes mellitus.
• Methyl-parahydroxy benzoate and propyl parahydroxybenzoate:may cause allergic reactions (even delayed).

3. How to take FLUMARIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The doctor will indicate the correct dose, based on your condition, and the duration of treatment.

Adults
1 tablet of FLUMARIN 700 mg, 2 times a day or 2 tablets (or two sachets) of 350 mg two
times a day.

Elderly over 65 years
1 tablet or 1 sachet of FLUMARIN 350 mg, 2-3 times a day, unless otherwise indicated by
the doctor.

Children over 6 months of age

Children up to 4 years of age (10-15 Kg)
½ sachet of FLUMARIN 350 mg, 1 time a day.
5 ml of oral suspension 3.5g/100ml, 1 time a day.

Children from 4 to 8 years of age (15-25 Kg)
½ sachet of FLUMARIN 350 mg, 2 times a day.
5 ml of oral suspension 3.5g/100ml, 2 times a day.

Children from 8 to 14 years of age (25-45 kg)
1 tablet or 1 sachet of FLUMARIN 350 mg, 2 times a day.
10 ml of oral suspension 3.5g/100ml, 2 times a day.
Since in children the dose of FLUMARIN depends on body weight, the doctor may prescribe
dosages different from those indicated.
In children, the duration of treatment with FLUMARIN is 4-5 days.

Method of administration
Take FLUMARIN by mouth (orally) and on a full stomach.

If you take more FLUMARIN than you should
You may experience abdominal pain (gastrointestinal irritation), drowsiness, headache.
In case of taking high doses of FLUMARIN, immediately inform your doctor or go to the nearest
hospital, where appropriate measures will be taken (e.g. activated charcoal, gastric lavage).

If you forget to take FLUMARIN
Do not take a double dose to make up for the forgotten one. If you have any doubts about the use of this
medicine, ask your doctor or pharmacist

4. Possible side effects

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

• 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 crises);
• serious stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) or abdominal ulcers;
• sudden and severe pain in the epigastrium (ulcer perforation);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blister formation 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 blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation in the colon (colitis) and Crohn's disease, gastritis;
• more or less sudden appearance of skin lesions, even following exposure to the sun (photosensitization dermatitis), for example, color changes in patches or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• alterations in kidney function (renal insufficiency) that can cause swelling (edema), protein loss in the urine, decreased protein in the blood (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in the urine (hematuria);
• alterations in liver tests;
• alterations in tests (false positive) that detect the presence of drugs such as marijuana and hashish (THC testing);
• fluoride intoxication (fluorosis), especially if FLUMARIN is taken at high doses and for several years.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 FLUMARIN

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 which is stated on the pack after the wording EXP. The
expiry date refers to the last day of that month. This applies to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in 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 Flumarin contains
The active ingredient is morniflumate.
Each tablet of FLUMARIN 700 and 350 mg contains: 700 and 350 mg of morniflumate.
100 ml of FLUMARIN 3.5g/100ml oral suspension contains: 3.5 g of morniflumate
The other ingredients are:
Flumarin tablets: lactose, crospovidone, methylhydroxypropylcellulose, magnesium stearate, sodium
lauryl sulfate, hydrated colloidal silica.
FLUMARIN 3.5 g/100ml oral suspension: sucrose, microcrystalline cellulose, sodium carboxymethylcellulose,
sodium citrate, sodium chloride, polysorbate 20, citric acid, methyl parahydroxybenzoate,
propyl parahydroxybenzoate, fruit flavour, purified water.

Description of the appearance of FLUMARIN and contents of the pack
FLUMARIN 700 mg tablets is available in packs of 20 tablets.
FLUMARIN 350 mg tablets is available in packs of 30 tablets.
FLUMARIN 3.5g/100ml oral suspension is available in 200 ml bottles of suspension.

Marketing Authorisation Holder
I.B.N. SAVIO S.R.L. – Via del Mare, 36 – Pomezia – (Rm)

Manufacturer
CHIESI FARMACEUTICI S.p.A. - Officine di Parma, Via S. Leonardo N. 96 (tablets and sachets) and Via
Palermo N. 26/A (suspension).
FINE FOODS & PHARMACEUTICAL N.T.M. SPA – via dell’Artigianato, 8/10 – Brembate (BG) (sachets)
SPECIAL PRODUCT’S LINE S.p.A. Via Fratta Rotonda Vado Largo 1 Anagni (FR) (sachets)

FLUMARIN 350 mg granules for oral suspension

Morniflumate

Read this leaflet carefully before taking this medicine as it contains important
information for you.Always take this medicine exactly as described in this leaflet, or
as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.

• If you have any doubts, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

• 1. What FLUMARIN is and what it is used for
• 2. What you need to know before you take FLUMARIN
• 3. How to take FLUMARIN
• 4. Possible side effects
• 5. How to store FLUMARIN
• 6. Contents of the pack and other information

1. What is FLUMARIN and what is it used for

This medicine contains the active ingredient morniflumate and belongs to a class of drugs called
NSAIDs (non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.
FLUMARIN is used:
in ADULTS and ADOLESCENTS starting from 15 yearsto treat pain of various origins and nature,
even accompanied by fever, particularly in cases of ear inflammation (otitis), paranasal sinuses
(sinusitis), tonsils (tonsillitis), throat (pharyngitis, laryngitis).
See a doctor if you do not feel better or if you feel worse after a treatment of 5 days.

2. What you need to know before taking FLUMARIN

Do not take FLUMARIN:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergy or asthma after taking other NSAIDs such as acetylsalicylic acid, commonly known as aspirin;
• if you have a stomach and/or duodenal ulcer (gastroduodenal);
• if you have had two or more distinct episodes of ulcer or bleeding in the stomach or intestine (including blood in 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 medications;
• if you have serious problems with the liver, kidneys or heart;
• 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 (rectitis), rectal bleeding or ulcer. Do not take FLUMARIN oral suspension granules if you suffer from phenylketonuria.

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

• you are taking other NSAIDs;
• you have had stomach or intestinal problems, such as ulcers or bleeding, hiatal hernia, Crohn's disease, ulcerative colitis; you are taking medications that can increase the risk of ulcers and bleeding (see section “Other medicines and Flumarin”);
• you are elderly or feel very weak (debilitated) or have a reduced body weight, as you are more likely to develop adverse events with this medicine;
• you have asthma associated with chronic inflammation of the nose or sinuses 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 to 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 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 problems with the heart or blood vessels, 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 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 THE NEED TO SUBJECT YOU TO
CHECKUP EXAMS.
BE CAREFUL, as during treatment with all NSAIDs:

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal problems (gastrointestinal), bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal;
• although very rarely, serious skin reactions have been reported, some of which have been fatal, which manifest with redness, blistering and exfoliation (for example, 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 an infection can be masked.

The risk of having undesirable 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 the
doctor's instructions.
STOP the treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (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 necessary and under the direct supervision of a
doctor, as adolescents are more likely to develop adverse events with this
medicine.

Other medicines and FLUMARIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Some medicines can interact with FLUMARIN or increase the risk of adverse events, even serious.
In particular, contact your doctor if you are taking:

• medicines that contain cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelet agents), for example warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (commonly known as aspirin), tirofiban, eptifibatide and abciximab, iloprost, heparin;
• medicines for high blood pressure (hypertension) such as: diuretics, ACE inhibitors, beta-blockers, angiotensin II antagonists;
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• other medicines that reduce pain and inflammation (NSAIDs and salicylates);
• lithium, used in depression;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, medicines that reduce the immune defenses;
• trimethoprim, an antibiotic medicine;
• potassium salts.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take FLUMARIN in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect the mother and baby's tendency to
bleeding and delay or prolong labor more than expected.
You should not take FLUMARIN in the first 6 months of pregnancy unless absolutely necessary and
under the advice of your doctor.
If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, FLUMARIN may cause kidney problems in the fetus if taken for more than
a few days, 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.
Be careful with FLUMARIN:

• if you want to become pregnant or have difficulty conceiving, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug;
• during the first months of pregnancy (up to the sixth month), as this medicine should be used only when necessary and under the direct supervision of a doctor;
• do not take FLUMARIN while breastfeeding.

Driving and operating machinery
Like other NSAIDs, this medicine may cause dizziness, fatigue and decreased reflexes.
Be careful before driving vehicles or using machinery.

FLUMARIN oral suspension granules contains

• sucrose:if you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine;
• sorbitol: This medicine contains 1092 mg of sorbitol per maximum dose. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before you (or your child) take this medicine..
• aspartame: this medicine contains 45 mg of aspartame per maximum dose. Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it properly.
• Yellow Orange S (E 110): may cause allergic reactions.
• sodium: less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to take FLUMARIN

Take this medicine following exactly the instructions in this leaflet or as indicated 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
2 sachets of FLOMAX 350 mg, 2 times a day.

Elderly (over 65 years)
1 sachet of FLOMAX 350 mg, 2-3 times a day, unless otherwise directed by your doctor.
Contact your doctor if you do not feel better or if you feel worse after 5 days of treatment.

Method of administration
Take FLUMARIN orally (by mouth) and on a full stomach.
The FLUMARIN granule sachet for oral suspension is divided into two parts:
if you need to take the entire dose, open the sachet along the line indicated “entire dose”;
to take ½ dose, open the sachet along the line indicated “half dose”.

If you take more FLUMARIN than you should
You may experience abdominal pain (gastrointestinal irritation), drowsiness, headache.
In case of taking high doses of FLUMARIN, immediately inform your doctor or go to the nearest
hospital, where appropriate measures will be taken (e.g. activated charcoal, gastric lavage).

If you forget to take FLUMARIN
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

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

• 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 crises);
• severe stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) or abdominal ulcers;
• severe and sudden pain in the epigastrium (ulcer perforation);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blister formation 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 blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation in 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, color changes in patches or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• alterations in kidney function (renal insufficiency) which can cause swelling (edema), protein loss in the urine, decreased protein in the blood (nephrotic syndrome), inflammation of the kidney (interstitial nephritis), presence of blood in the urine (hematuria);
• alterations in liver tests;
• alterations in tests (false positive) that detect the presence of drugs such as marijuana and hashish (THC testing);
• fluoride intoxication (fluorosis), especially if FLUMARIN is taken at high doses and for several years.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can contribute
to providing more information on the safety of this medicine.

5. How to store FLUMARIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after the wording EXP. The
expiry date refers to the last day of that month. This date applies to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in 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 Flumarin contains
The active ingredient is morniflumate.
Each sachet of FLUMARIN granules for oral suspension contains 350 mg of morniflumate.
The other ingredients are:
FLUMARIN granules for oral suspension: sucrose, sorbitol, banana flavour on maltodextrin, fruit flavour, insoluble polyvinylpyrrolidone, methylhydroxypropylcellulose, aspartame, ammonium glycyrrhizate,
xanthan gum, polysorbate 20, sodium lauryl sulfate, Yellow Orange S (E 110).

Description of the appearance of FLUMARIN and contents of the pack
FLUMARIN 350 mg granules for oral suspension is available in packs of 20 bipartite sachets.

Marketing Authorisation Holder
I.B.N. SAVIO S.R.L. – Via del Mare, 36 – Pomezia – (Rm)

Manufacturer
CHIESI FARMACEUTICI S.p.A. - Officine di Parma, Via S. Leonardo N. 96 and Via Palermo N. 26/A
(suspension).
FINE FOODS & PHARMACEUTICAL N.T.M. SPA – via dell’Artigianato, 8/10 – Brembate (BG)
SPECIAL PRODUCT’S LINE S.p.A. Via Fratta Rotonda Vado Largo 1 Anagni (FR)

FLUMARIN ADULTI 700 mg suppositories

Morniflumate

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FLUMARIN is and what it is used for
• 2. What you need to know before you take FLUMARIN
• 3. How to take FLUMARIN
• 4. Possible side effects
• 5. How to store FLUMARIN
• 6. Contents of the pack and other information

1. What is FLUMARIN and what is it used for

This medicine contains the active ingredient morniflumate and belongs to a class of drugs called
NSAIDs (non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.

• FLUMARIN is used in adults to reduce inflammation, with or without pain and/or fever, in cases of inflammation of: the ear (otitis), the nasal cavities as a whole (sinusitis), the tonsils (tonsillitis), the mouth and throat (pharyngitis, laryngitis);
• the trachea (tracheitis), the bronchi (bronchitis);
• the bladder (cystitis), the urethra (urethritis), the vagina (vaginitis), the prostate (prostatitis), the ovaries and fallopian tubes (adnexitis);
• the bones and joints (osteo-articular system).

2. What you need to know before taking FLUMARIN

Do not take FLUMARIN:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had 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 ulcer or bleeding in the stomach or intestine (including blood in 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 medications;
• if you have serious problems with the liver, kidneys or heart;
• if you suffer from inflammation or bleeding of the rectum (proctitis or rectorrhagia);
• after the sixth month of pregnancy.
• if you are breastfeeding

Do not use Flumarin adult suppositories in children, as the product is specific for adults.

Warnings and precautions
Tell your doctor before taking FLUMARIN if:

• you are taking other NSAIDs;
• you have had stomach or intestinal problems, such as ulcers or bleeding, a stomach hernia (hiatal), Crohn's disease, ulcerative colitis;
• you are elderly or feel very weak (debilitated) or have a reduced body weight, as you are more likely to develop adverse events with this medicine;
• you have asthma associated with chronic inflammation of the nose or sinuses and/or nasal polyps;
• you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it.

In particular, consult your doctor as a precaution if:

• you have reduced kidney function;
• you have recently undergone surgery that caused you a large loss of blood;
• you have liver problems;
• you have problems with the heart or blood vessels, 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 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 THE NEED TO SUBJECT YOU
TO CHECK-UP EXAMS.
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 problems (gastrointestinal), bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal;
• although very rarely, serious skin reactions, some of which are fatal, have been reported, manifesting with redness, blistering and exfoliation (for example, 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;
• the signs of an infection can be masked.

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

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding;
• a skin rash, mucous membrane 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
FLUMARIN ADULT 700 mg suppositories are not suitable for children. If necessary, ask your
doctor or pharmacist for advice, as there are dosages (lower) of FLUMARIN specifically for such
patients.

Other medicines and FLUMARIN
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.ù
Some drugs may interact with FLUMARIN or increase the risk of adverse events, even serious.
In particular, contact your doctor if you are taking:

• drugs that contain corticosteroids;
• drugs that thin the blood (anticoagulants and antiplatelet agents), for example warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin), and heparin;
• drugs for high blood pressure (hypertension) such as: diuretics, ACE inhibitors, beta-blockers, angiotensin II antagonists;
• drugs called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• other drugs that reduce pain and inflammation (NSAIDs and salicylates);
• lithium, used in depression;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, drugs that reduce the immune defenses;
• trimethoprim, an antibiotic drug;
• potassium salts.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take FLUMARIN in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect the tendency
of the mother and child to bleed and delay or prolong labor more than expected. You should not take FLUMARIN in the first 6 months of pregnancy, unless absolutely necessary and under
doctor's advice. If treatment is needed during this period or during attempts to conceive,
the lowest dose should be used for the shortest possible time. From the 20th week of pregnancy,
FLUMARIN may cause kidney problems in the fetus, if taken for more than a few days, 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.
Be careful with FLUMARIN:

• if you want to become pregnant or have problems getting pregnant, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug;
• during the first months of pregnancy (up to the sixth month), as this medicine should be used only when actually necessary and under the direct control of the doctor;
• do not take FLUMARIN while breastfeeding.

3. How to take FLUMARIN

Take this medicine following the instructions of your doctor exactly, who will indicate the correct dose,
based on your condition, and the duration of treatment. If you have any doubts, consult your doctor or
pharmacist.

Adults
2 suppositories of FLUMARIN ADULTI per day, 1 in the morning and 1 in the evening.

Elderly over 65 years
1 suppository of FLUMARIN ADULTI per day, unless otherwise indicated by your doctor.

If you take more FLUMARIN than you should
You may notice problems at the level of the rectum.
In case of ingestion/taking of high doses of FLUMARIN, immediately inform your doctor or go to the
nearest hospital, where appropriate measures will be taken.

If you forget to take FLUMARIN
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 gets them.
Stop taking FLUMARIN immediately and contact your doctor if any of the following conditions occur:

• 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 crises);
• severe stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) or abdominal ulcers;
• sudden and severe pain in the epigastrium (ulcer perforation);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blister formation and exfoliation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects

• reactions at the rectum level, especially if the therapy is long or frequent or with high doses;
• 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 blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation in the colon (colitis) and Crohn's disease, gastritis;
• more or less sudden appearance of skin lesions, even following exposure to the sun (photosensitization dermatitis), for example, changes in color in patches or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• alterations in kidney function (renal insufficiency) that can cause swelling (edema), protein loss with urine, decreased proteins in the blood (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in the urine (hematuria);
• alterations in liver tests;
• alterations in tests (false positive) that detect the presence of drugs such as marijuana and hashish (THC testing);
• fluoride intoxication (fluorosis), especially if FLUMARIN is taken at high doses and for several years.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 FLUMARIN

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 which is stated on the pack after the wording EXP. The
expiry date refers to the last day of that month. This applies to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in 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 FLUMARIN contains
The active ingredient is morniflumate.
Each FLUMARIN ADULTI 700 mg suppository contains: 700 mg of morniflumate.
The other ingredients are: solid semi-synthetic glycerides.

Description of the appearance of FLUMARIN and contents of the pack
FLUMARIN ADULTI 700 mg suppositories are available in packs of 10 suppositories.

Marketing Authorisation Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00040 Pomezia - (Rm)

Manufacturer
MONTEFARMACO S.p.A., Officina di Pero (MI) - Via G. Galilei 7
Or
LAMP S.PROSPERO S.p.A., Via della Pace 25/A, S. Prospero (MO)

FLUMARIN BAMBINI 400 mg suppositories

Morniflumato

Read this leaflet carefully before 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, ask your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if they have the same symptoms as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FLUMARIN is and what it is used for
• 2. What you need to know before giving FLUMARIN to your child
• 3. How to give FLUMARIN
• 4. Possible side effects
• 5. How to store FLUMARIN
• 6. Contents of the pack and other information

1. What is FLUMARIN and what is it used for

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

2. What you need to know before giving FLUMARIN to your child

Do not give FLUMARIN to your child:

• if they are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if they have had an allergy or asthma after taking other NSAIDs such as acetylsalicylic acid known as aspirin;
• if they have a stomach and/or duodenal ulcer (gastroduodenal);
• if they have had two or more distinct episodes of ulcer or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);
• if they have had even one episode of ulcer, perforation or bleeding in the stomach or intestine caused by taking medicines;
• if they have serious problems with the liver, kidneys or heart;
• if they suffer from inflammation or bleeding of the rectum (proctitis or rectorrhagia);

FLUMARIN should not be used in children under six months of age.

Warnings and precautions
Tell your doctor before giving FLUMARIN to your child if:

• they are taking other NSAIDs;
• they have had stomach or intestinal problems, such as ulcers or bleeding, a stomach hernia (hiatal hernia), Crohn's disease, ulcerative colitis;
• they are elderly or feel very weak (debilitated) or have a reduced body weight, as they are more likely to develop adverse events with this medicine;
• they have asthma associated with chronic inflammation of the nose or nasal cavities (sinusitis) and/or nasal polyps;
• they have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it. In particular, consult your doctor as a precaution if your child:
• has reduced kidney function;
• has recently undergone surgery that caused significant blood loss;
• has liver problems;
• has heart or blood vessel problems, such as stroke, heart attack or heart failure, or think they may be at risk for these conditions (for example, if they have high blood pressure, diabetes or high cholesterol or smoke), as medicines like FLUMARIN may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.

In all of these cases, your doctor will assess the need to subject the child to control tests.
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;
• although very rarely, serious skin reactions, some of which have been fatal, have been reported, which manifest with redness, blistering and exfoliation (for example, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). Patients appear to be at higher risk in the early stages of therapy: such reactions occur in most cases within the first month of treatment;
• the signs of an infection can be masked. The risk of adverse effects increases with high doses and prolonged treatments. Do not exceed the dose of FLUMARIN prescribed by your doctor 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 intestines (gastrointestinal), especially if it is bleeding;
• a skin rash, mucous membrane 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
Give FLUMARIN only if absolutely necessary and under the direct supervision of your doctor, as
children and adolescents are more likely to develop adverse events with this medicine. In
particular, children between 6 and 12 months have a high risk of serious skin side effects.

Other medicines and FLUMARIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Some medicines can interact with FLUMARIN or increase the risk of adverse events, even serious.
In particular, contact your doctor if you are taking:

• medicines that contain corticosteroids;
• medicines that thin the blood (anticoagulants and antiplatelet agents), for example warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin), and heparin;
• medicines for high blood pressure (hypertension) such as: diuretics, ACE inhibitors, beta-blockers, angiotensin II antagonists;
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• other medicines that reduce pain and inflammation (NSAIDs and salicylates);
• lithium, used in depression;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, drugs that reduce the immune defenses;
• trimethoprim, an antibiotic drug;
• potassium salts.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take FLUMARIN in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect the tendency
of the mother and child to bleed and delay or prolong labor more than expected. You should not take FLUMARIN in the first 6 months of pregnancy unless absolutely necessary and under
the advice of your doctor. If treatment is needed during this period or during attempts to conceive,
the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy,
FLUMARIN can cause kidney problems in the fetus if taken for more than a few days, reducing the levels
of amniotic fluid surrounding the baby (oligohydramnios) or causing a blood vessel to narrow
(ductus arteriosus) in the baby's heart. If treatment is needed for more than a few
days, your doctor may recommend additional monitoring.

Be careful with FLUMARIN:

• if you want to become pregnant or have problems conceiving, as this medicine may impair fertility. This effect is reversible upon discontinuation of the drug;
• during the first months of pregnancy (up to the sixth month), as this medicine should be used only when absolutely necessary and under the direct supervision of your doctor;
• do not take FLUMARIN while breastfeeding.

Driving and operating machinery
Like other NSAIDs, this medicine may cause dizziness, fatigue and decreased reflexes.
Be careful before driving vehicles or using machinery.

3. How to take FLUMARIN

Give this medicine to your child following the doctor's instructions exactly, who will indicate the correct dose, based on their condition, and the duration of treatment. If you have any doubts, consult your doctor or pharmacist.

Children from 6 to 12 months of age:1 suppository of FLUMARIN BAMBINI per day.

Children over 1 year of age:1 to 3 suppositories of FLUMARIN BAMBINI per day.
Since in children the dose of FLUMARIN depends on body weight and age, the doctor may
prescribe dosages different from those indicated.
In children, the duration of treatment with FLUMARIN is 4-5 days.

If you give your child more FLUMARIN than you should
The child may notice problems at the level of the rectum.
In case of ingestion/administration of high doses of FLUMARIN, immediately notify your doctor or
go to the nearest hospital where appropriate measures will be taken.

If you forget to give your child FLUMARIN
Do not give your child 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 gets them.
Stop taking FLUMARIN immediately and contact your doctor if any of the following occur:

• 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 crises);
• serious stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) or abdominal ulcers;
• sudden and severe pain in the epigastrium (ulcer perforation);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blistering and exfoliation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects

• reactions at the level of the rectum, especially if the therapy is long or frequent or with high doses;
• 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 blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation in the colon (colitis) and Crohn's disease, gastritis;
• more or less sudden appearance of skin lesions, even following exposure to the sun (photosensitization dermatitis), for example, changes in color in patches or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• alterations in kidney function (renal insufficiency) which can cause swelling (edema), protein loss with urine, decreased proteins in the blood (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in the urine (hematuria);
• alterations in liver tests;
• alterations in tests (false positive) that detect the presence of drugs such as marijuana and hashish (THC testing);
• fluoride intoxication (fluorosis), especially if FLUMARIN is taken at high doses and for several years.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 FLUMARIN

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 which is stated on the pack after the wording EXP. The
expiry date refers to the last day of that month. This applies to the product in its
intact packaging, correctly stored.
Do not dispose of any medicine in 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 FLUMARIN contains
The active ingredient is morniflumate.
Each FLUMARIN BAMBINI 400 mg suppository contains: 400 mg of morniflumate.
The other ingredients are: solid semi-synthetic glycerides.

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

Marketing Authorisation Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00040 Pomezia - (Rm)

Manufacturer
MONTEFARMACO S.p.A., Officina di Pero (MI) - Via G. Galilei 7
Or
LAMP S.PROSPERO S.p.A., Via della Pace 25/A, S. Prospero (MO)