Flumarin

Patient Information Leaflet

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

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 other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 FLUMARIN is and what it is used for

This medicinal product 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.
FLUMARIN is used:

• in ADULTS to reduce inflammation, with or without pain and/or fever, in inflammatory conditions of:
  • 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 (adnexitis);
  • bones and joints (osteo-articular system);
• in CHILDREN to reduce pain associated with inflammation of the ear (otitis), nasal cavities as a whole (sinusitis), tonsils (tonsillitis), mouth and throat.

2. What you should know before taking FLUMARIN

Do not take FLUMARIN:

• 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 (gastroduodenal) ulcer;
• 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 experienced a single episode of ulcer, perforation, or gastrointestinal bleeding caused by taking medications;
• if you have severe problems with your liver, kidneys, or heart;
• after the sixth month of pregnancy;
• if you are breastfeeding.

Warnings and precautions
Inform your doctor before taking FLUMARIN 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 FLUMARIN”);
• you are elderly, feel very weak (debilitated), or have low body weight, as you may be more likely to experience adverse effects from this medicine;
• 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 that detect drugs such as marijuana and hashish, as this medicine may give false-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 resulting in 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, high cholesterol, or smoke), since medicines like FLUMARIN may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL ASSESS WHETHER YOU NEED REGULAR MONITORING TESTS.
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 may occur, which can be fatal;
• very rarely, severe skin reactions, some of which are fatal, have been reported, characterized by redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial phase of therapy, patients appear to be at higher risk: these reactions mostly occur within the first month of treatment;
• signs of infection may be masked.

The risk of experiencing adverse effects increases with higher doses and prolonged use. Do not exceed the dose of FLUMARIN prescribed by your doctor 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 intestines (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
FLUMARIN should only be administered when strictly necessary and under direct medical supervision, as children and adolescents are more likely to experience adverse effects from this medicine. In particular, children between 6 and 12 months of age are at high risk of serious skin-related side effects.

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

• medicines containing cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelet agents), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (aspirin), tirofiban, eptifibatide, 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 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 FLUMARIN during the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It may affect the bleeding tendency in both mother and child and delay or prolong labor more than expected. You should not take FLUMARIN during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed 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, FLUMARIN may cause kidney problems in the fetus if taken for more than a few days, leading to reduced 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 for more than a few days is required, your doctor may recommend additional monitoring.
Be cautious with FLUMARIN:

• if you are planning a pregnancy or have fertility problems, 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 only be used when strictly necessary and under direct medical supervision;
• do not take FLUMARIN while breastfeeding.

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

FLUMARIN tablets contain:

• lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 (a main component of table salt) per maximum dose (20 ml). This corresponds to 2.39% of the maximum daily recommended dietary intake for an adult.
• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. It contains 6 g of sucrose (sugar) per maximum dose. This should be considered in patients with diabetes mellitus.
• methyl hydroxybenzoate and propyl hydroxybenzoate: may cause allergic reactions (including delayed ones).

3. How to take FLUMARIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the correct dose according to your condition and the duration of treatment.
Adults
1 tablet of FLUMARIN 700 mg twice daily, or 2 tablets (or two sachets) of 350 mg
twice daily.
Elderly patients over 65 years of age
1 tablet or 1 sachet of FLUMARIN 350 mg, 2–3 times daily, unless otherwise directed 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 once daily.
5 ml of oral suspension 3.5 g/100 ml once daily.
Children from 4 to 8 years of age (15–25 kg)
½ sachet of FLUMARIN 350 mg twice daily.
5 ml of oral suspension 3.5 g/100 ml twice daily.
Children from 8 to 14 years of age (25–45 kg)
1 tablet or 1 sachet of FLUMARIN 350 mg twice daily.
10 ml of oral suspension 3.5 g/100 ml twice daily.
Since the dose of FLUMARIN in children depends on body weight, your doctor may prescribe doses
different from those indicated above.
In children, the duration of treatment with FLUMARIN is 4–5 days.
Method of administration
Take FLUMARIN by mouth (orally) with food.
If you take more FLUMARIN 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, 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 using this
medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking FLUMARIN 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);
• serious 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 accompanied by 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

• 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 (edema), high blood pressure (hypertension), reduced heart function (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the mouth lining 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 exposure to sunlight (photosensitivity dermatitis), such as discoloured patches or widespread changes (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• changes in kidney function (renal impairment) which may cause swelling (oedema), loss of protein in the urine, decreased protein levels in the blood (nephrotic syndrome), kidney inflammation (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 (tests for THC);
• fluoride poisoning (fluorosis), especially if FLUMARIN 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 may 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 FLUMARIN

Keep this medicine out of the sight and reach of children.
Store below 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 unopened packaging, properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Flumarin contains
The active substance is morniflumate.
Each tablet of FLUMARIN 700 and 350 mg contains: 700 and 350 mg of morniflumate.
100 ml of oral suspension of FLUMARIN 3.5g/100ml oral suspension contains: 3.5 g of morniflumate.
The other components are:
Flumarin tablets: lactose, crospovidone, methylhydroxypropylcellulose, magnesium stearate, sodium lauryl sulfate, colloidal hydrated silica.
FLUMARIN 3.5 g/100ml oral suspension: sucrose, microcrystalline cellulose, sodium carboxymethylcellulose, sodium citrate, sodium chloride, polysorbate 20, citric acid, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, fruit flavor, purified water.

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

Marketing Authorization 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)

Patient Information Leaflet

FLUMARIN 350 mg granules for oral suspension

Morniflumate
Please read this 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 told 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, consult 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:

1. What FLUMARIN is and what it is 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

1. What FLUMARIN is and what it is used for

This medicinal product 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.
FLUMARIN is used:
in ADULTS and ADOLESCENTS from the age of 15 to treat pains of various origin and nature,
even when accompanied by fever, particularly in case 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.

2. What you need to know before taking FLUMARIN

Do not take FLUMARIN:

• 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 (gastroduodenal) ulcer;
• if you have had two or more separate episodes of stomach or intestinal bleeding or ulcers (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 medicines;
• if you have severe problems with your 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 (proctitis), rectal bleeding, or ulcers.
Do not take FLUMARIN granules for oral suspension if you have 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 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 FLUMARIN”);
• you are elderly, feel very weak (debilitated), or have low body weight, as you are more likely to experience adverse effects from this medicine;
• 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 are undergoing urine tests for drugs such as marijuana and hashish, as this medicine may give false 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 involving 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, high cholesterol, or smoke), since medicines like FLUMARIN may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE WHETHER YOU NEED REGULAR MONITORING.
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;
• 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 usually occur within the first month of treatment;
• 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 FLUMARIN 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.
FLUMARIN should be administered only when strictly necessary and under direct medical supervision, as adolescents are more likely to experience adverse effects from 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 may interact with FLUMARIN or increase the risk of adverse effects, even serious ones.
In particular, contact your doctor if you are taking:

• medicines containing cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelets), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (aspirin), tirofiban, eptifibatide, 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 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take FLUMARIN during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It could affect the bleeding tendency in both mother and baby and delay or prolong labor more than expected.
You should not take FLUMARIN during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is needed during this period or while trying to conceive, the lowest effective dose for the shortest possible duration should be used.
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 cautious with FLUMARIN:

• if you are planning a pregnancy or have fertility problems, 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 only be used when strictly necessary and under direct medical supervision;
• do not take FLUMARIN while breastfeeding.

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

FLUMARIN granules for oral suspension contain

• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, consult them 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 (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, speak with your doctor before taking 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 have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it;
• orange yellow 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 exactly as described in this leaflet or as directed 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.
Elderly (over 65 years of age)
1 sachet of FLOMAX 350 mg, 2–3 times daily, unless otherwise directed by the 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 by mouth (oral route) and with food.
The FLUMARIN oral suspension granulate sachet is divided into two parts:
if you need to take the full dose, open the sachet along the line marked “full dose”;
to take ½ dose, open the sachet along the line marked “half dose”.
If you take more FLUMARIN 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, 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking FLUMARIN 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 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 accompanied by 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

• worsening of chickenpox-related skin infections;
• 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 (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (constipation), indigestion (dyspepsia), abdominal pain, inflammation of the mouth lining 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 impairment) which may cause swelling (oedema), loss of protein in the urine, decreased blood protein levels (nephrotic syndrome), kidney inflammation (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 (THC testing);
• fluoride poisoning (fluorosis), especially if FLUMARIN 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. 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.
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, unopened packaging, 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 Flumarin contains
The active substance is morniflumate.
Each sachet of FLUMARIN granules for oral suspension contains 350 mg of morniflumate.
The other components are:
FLUMARIN granules for oral suspension: sucrose, sorbitol, banana flavour on maltodextrin, fruit flavour, insoluble polyvinylpyrrolidone, methylhydroxypropylcellulose, aspartame, ammonium glycyrrhizinate, xanthan gum, polysorbate 20, sodium lauryl sulfate, sunset yellow FCF (E 110).
Description of the appearance of FLUMARIN and pack contents
FLUMARIN 350 mg granules for oral suspension is available in packs of 20 double-compartment 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 e 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)

Package leaflet: information for the patient

FLUMARIN ADULTS 700 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, 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 reaction, including those not listed in this leaflet, contact 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 taking 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 FLUMARIN is and what it is used for

This medicinal product 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.

• FLUMARIN is used in adults to reduce inflammation, with or without associated pain and/or fever, in inflammatory conditions of:
  • 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 (adnexitis);
  • bones and joints (osteo-articular system).

2. What you should know before taking FLUMARIN

Do not take FLUMARIN:

• 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 (gastroduodenal) ulcer;
• if you have had two or more separate episodes of stomach or intestinal bleeding or ulcers (including blood in vomit or during bowel movements, or black, tarry stools);
• if you have ever had even a single episode of ulcer, perforation, or bleeding in the stomach or intestine caused by taking medicines;
• if you have severe problems with your 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 this product is intended specifically for adults.

Warnings and precautions
Inform your doctor before taking FLUMARIN 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 elderly, feel very weak (debilitated), or have low body weight, as you may be at higher risk of developing adverse effects from this medicine;
• 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.

In particular, consult your doctor as a precaution if:

• you have reduced kidney function;
• you have recently undergone surgery resulting in 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, high cholesterol, or smoke), since medicines like FLUMARIN may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE WHETHER YOU NEED
REGULAR CHECK-UPS.
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 may occur, which can be fatal;
• 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). In the early stages of therapy, patients appear to be at higher risk: such reactions mostly occur within the first month of treatment;
• 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 FLUMARIN prescribed by your doctor, and do not take it for extended 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 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
FLUMARIN ADULT 700 mg suppositories are not suitable for children. If needed, consult your doctor or pharmacist, as lower doses of FLUMARIN are available specifically for these patients.

Other medicines and FLUMARIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Some medicines may interact with FLUMARIN or increase the risk of adverse events, even serious ones.
In particular, contact your doctor if you are taking:

• medicines containing cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelet agents), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (aspirin), and 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 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, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take FLUMARIN during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It could affect the bleeding tendency in both mother and baby and delay or prolong labor more than expected. You should not take FLUMARIN 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 possible dose for the shortest possible time should be used. 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 cautious with FLUMARIN:

• if you are planning a pregnancy or have fertility problems, 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 only be used when strictly necessary and under direct medical supervision;
• do not take FLUMARIN while breastfeeding.

3. How to take FLUMARIN

Take this medicine exactly as directed by your doctor, who will determine the correct dose for you based on your condition and the required duration of treatment. If you have any doubts, consult your doctor or pharmacist.

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

Elderly patients over 65 years
1 FLUMARIN ADULT suppository per day, unless otherwise directed by the doctor.

If you take more FLUMARIN than you should
You may experience problems affecting the rectum.
In case of ingestion/absorption of high doses of FLUMARIN, inform your doctor immediately 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
Stop taking FLUMARIN 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 of 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 adverse reactions

• rectal reactions, especially if treatment is prolonged, frequent or with high doses;
• worsening of skin infections caused by chickenpox;
• reduced platelet count (thrombocytopenia), reduced white blood cell count (leucopenia);
• headache and dizziness;
• heart attack (myocardial infarction) or stroke, swelling (oedema), high blood pressure (hypertension), reduced heart function (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (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 sun exposure (photosensitivity dermatitis), for example discoloured spots or widespread changes (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• changes in kidney function (renal impairment) which may cause swelling (oedema), loss of protein in urine, reduced blood protein levels (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 (tests for THC);
• fluoride poisoning (fluorosis), especially if FLUMARIN is taken at high doses and for several years.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 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 in its original, unopened packaging 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. Pack contents and other information

What FLUMARIN contains
The active substance is morniflumate.
Each suppository of FLUMARIN ADULTS 700 mg contains: 700 mg of morniflumate.
The other components are: semisynthetic solid glycerides.
Description of the appearance of FLUMARIN and pack contents
FLUMARIN ADULTS 700 mg suppositories are available in packs of 10 suppositories.
Marketing Authorization Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00040 Pomezia - (Rm)
Manufacturer
MONTEFARMACO S.p.A., Pero (MI) facility - Via G. Galilei 7
Or
LAMP S.PROSPERO S.p.A., Via della Pace 25/A, S. Prospero (MO)

Package leaflet: information for the patient

FLUMARIN CHILDREN 400 mg suppositories

Morniflumate
Please read this leaflet carefully before administering 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, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms are the same, as it could be harmful.
• If any side effect occurs, including those not listed in this leaflet, consult 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 administering FLUMARIN to your child
3. How to administer FLUMARIN
4. Possible side effects
5. How to store FLUMARIN
6. Package contents and other information

1. What FLUMARIN is and what it is used for

This medicinal product 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.
FLUMARIN 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 administering FLUMARIN to your child

Do not administer FLUMARIN to your child:

• if he/she is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if he/she has had an allergic reaction or asthma after taking other NSAIDs, such as acetylsalicylic acid (known as aspirin);
• if he/she has a stomach and/or duodenal ulcer (gastroduodenal);
• if he/she has 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 he/she has ever had even a single episode of stomach or intestinal ulcer, perforation, or bleeding caused by taking medications;
• if he/she has severe problems with the liver, kidneys, or heart;
• if he/she suffers from inflammation or bleeding of the rectum (proctitis or rectal bleeding).

FLUMARIN must not be used in children under six months of age.
Warnings and precautions
Inform the doctor before administering FLUMARIN to your child if:

• he/she is taking other NSAIDs;
• he/she has had stomach or intestinal disorders, such as ulcers or bleeding, hiatal hernia, Crohn’s disease, or ulcerative colitis;
• he/she is elderly, feels very weak (debilitated), or has low body weight, as he/she may have a higher risk of developing adverse reactions to this medicine;
• he/she has asthma associated with chronic inflammation of the nose or nasal sinuses (sinusitis) and/or nasal polyps;
• he/she has chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it.

In particular, consult the doctor as a precaution if your child:

• has reduced kidney function;
• has recently undergone surgery resulting in significant blood loss;
• has liver problems;
• has heart or blood vessel problems, such as stroke, heart attack, or heart failure, or if you think he/she may be at risk for these conditions (for example, if he/she has high blood pressure, diabetes, high cholesterol, or smokes), since medicines like FLUMARIN 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 it is necessary to perform monitoring tests on the child.
BE CAREFUL, because during treatment with all NSAIDs:

• at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems (stomach or intestine), bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal;
• although very rare, severe skin reactions have been reported, some of which have been fatal, characterized by 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;
• signs of infection may be masked.

The risk of experiencing adverse effects increases with higher doses and prolonged treatment. Do not exceed the FLUMARIN dose prescribed by the doctor and do not take it for long periods; always follow the doctor’s instructions carefully.
STOP treatment and contact the 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 appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children and adolescents
Administer FLUMARIN only when strictly necessary and under direct medical supervision, as children and adolescents have a higher risk of developing adverse reactions to this medicine. In particular, children between 6 and 12 months of age have a high risk of severe skin-related adverse effects.
Other medicines and FLUMARIN
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicine.
Some medicines may interact with FLUMARIN or increase the risk of adverse reactions, even serious ones.
In particular, contact the doctor if your child is taking:

• medicines containing cortisone (corticosteroids);
• medicines that thin the blood (anticoagulants and antiplatelet agents), e.g., 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 cancer treatment and for certain types of 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 FLUMARIN during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It could affect the tendency of both mother and child to bleed and delay or prolong labor beyond expected duration. You should not take FLUMARIN 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 possible dose for the shortest possible time should be used. From week 20 of pregnancy, FLUMARIN 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 constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Be cautious with FLUMARIN:

• if you are planning a pregnancy or have fertility problems, 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 only be used when strictly necessary and under direct medical supervision;
• do not take FLUMARIN while breastfeeding.

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

3. How to take FLUMARIN

Administer this medicine to your child exactly as instructed by the doctor, who will indicate the correct dose according to your child's 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 doses different from those indicated.
In children, the duration of treatment with FLUMARIN is 4-5 days.
If you administer more FLUMARIN to your child than you should
Your child may experience problems at the rectal level.
In case of ingestion/overdose of FLUMARIN, immediately contact your doctor or go to the nearest hospital, where appropriate measures will be taken.
If you forget to administer FLUMARIN to your child
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 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 (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 intestines (gastrointestinal), or unusual fatigue accompanied by 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

• rectal reactions, especially if treatment is prolonged, frequent, or administered 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 (edema), high blood pressure (hypertension), reduced heart function (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (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 exposure to sunlight (photosensitivity dermatitis), such as 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 (tests for THC);
• fluoride poisoning (fluorosis), especially if FLUMARIN 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 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 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 in its original, undamaged packaging and properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What FLUMARIN contains
The active substance is morniflumate.
Each FLUMARIN CHILDREN 400 mg suppository contains: 400 mg of morniflumate.
The other components are: solid semisynthetic glycerides.

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

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

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