Package leaflet: Information for the patient

NIFLAM 250 mg hard capsules

Niflumic Acid
Please read this leaflet carefully before using this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Niflam is and what it is used for
What you need to know before taking Niflam
How to take Niflam
Possible side effects
How to store Niflam
Contents of the pack and other information

1. What Niflam is and what it is used for

Niflam contains the active substance niflumic acid and belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Niflam is indicated in adults and in children over 12 years of age to reduce inflammation, pain and fluid accumulation in tissues (oedema) associated with various diseases, in particular:

diseases affecting bone joints: chronic joint inflammations manifesting with pain and swelling (rheumatoid arthritis and acute gouty arthritis), degeneration of joint cartilage (hip osteoarthritis and osteoarthritides), spinal inflammations (rheumatoid spondylitis and ankylosing spondylitis), chronic joint inflammation associated with chronic skin inflammation (arthritis associated with psoriasis)
diseases not affecting bone joints: inflammation of fluid-filled sacs called "bursae" that protect the joints (bursitis), tendon inflammations (tenosynovitis), inflammation of the membrane lining the inner surface of joints (synovitis), inflammation of tendons in the elbow (epicondylitis)
trauma: partial or complete bone fractures (fractures), joint injuries (sprains), contusions
in sports medicine: joint pain, inflammation affecting the membrane surrounding the

tibia

p (tibial periostitis)

tibia (tibial periostitis), soft tissue injuries, etc.

post-operative inflammatory conditions: dental extractions and other dental or oral surgeries, obstetric and gynecological procedures, surgical interventions on nose and throat
acute and subacute ear, nose, and throat disorders (ENT system)
diseases affecting bronchi and lungs: chronic inflammation of lung tissue (bronchopneumopathies), inflammation of the lung pleura (pleuritis)
other diseases: acute inflammation of superficial veins (acute superficial thrombophlebitis).

In children, Niflam is indicated for the treatment of pain associated with inflammatory conditions of the ear,
nose and throat (ENT system) or of the mouth and its adjacent structures (stomatognathic system).

2. What you should know before using Niflam

Do not use Niflam

If you are allergic to niflumic acid or to any of the other ingredients of this medicine (listed in section 6)
If you have previously experienced allergy or asthma triggered by administration of niflumic acid/morniflumate or substances with similar activity, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)
If you have lesions in the inner lining of the stomach and duodenum (gastroduodenal ulcer)
If you have a history of bleeding (haemorrhage) or perforation of the gastrointestinal tract
If you have a history of frequent gastroduodenal bleeding/ulceration (two or more distinct episodes of proven ulceration or bleeding)
If you have severe liver, kidney, or heart problems
If you are more than 6 months pregnant (see section “Fertility, pregnancy and breastfeeding”)
If you are under 12 years of age (see section “Children and adolescents”)

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

If you have a history of high blood pressure (hypertension) and/or heart problems, as Niflam may lead to the development of hypertension or worsening of pre-existing hypertension, and increase the risk of unwanted effects on the heart and/or blood circulation. Your doctor will monitor your blood pressure during the initial phase of treatment and throughout the duration of therapy.
If you suffer from digestive disorders (e.g. peptic ulcer, hiatal hernia, gastrointestinal bleeding) or gastrointestinal diseases (e.g. ulcerative colitis, Crohn’s disease (chronic inflammatory bowel disease)), especially in elderly patients.
If you are undergoing or have recently undergone surgery to restore normal blood flow to the heart in case of blocked coronary arteries (coronary artery bypass grafting).
If you have heart problems or a history of sudden blockage or rupture of a cerebral blood vessel (stroke), or if you are at risk of such events (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke), as Niflam may increase the risk of heart attack (myocardial infarction) or stroke.
If you currently have an infection or are at risk of infection, as Niflam may mask the usual signs and symptoms of infection.
If you have contracted chickenpox. Urine output and kidney function should be closely monitored at the start of treatment with niflumic acid/morniflumate in patients with chronic heart problems, kidney or liver disease, those taking diuretics, those who have undergone major surgery resulting in reduced circulating blood volume, and particularly in elderly individuals.

False positive results have been reported in drug screening tests for urine, even in the absence of such substances; therefore, inform your doctor or laboratory personnel that you are taking/have taken Niflam.

Children and adolescents
Niflam capsules are contraindicated in children under 12 years of age.

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

Combinations not recommended

With other medicines belonging to the same group, NSAIDs (including acetylsalicylic acid and other salicylates)
With anticoagulants (medicines that slow down or stop the blood clotting process), such as warfarin
With heparin (a medicine that slows down or stops the blood clotting process) and related products
With lithium (a medicine used to treat psychiatric disorders)
With methotrexate (a medicine used in the treatment of certain cancers and autoimmune diseases) at doses exceeding 15 mg per week

Combinations requiring precautions

With diuretics and medicines used to treat high blood pressure in arteries (angiotensin-converting enzyme inhibitors and angiotensin II antagonists)
With methotrexate used at doses below 15 mg per week

Combinations that your doctor will carefully evaluate

With antiplatelet agents (medicines that inhibit platelet aggregation in the blood, preventing thrombus and embolus formation), e.g. ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost, and with heparins used for prophylactic purposes
With potassium salts, potassium-sparing diuretics (diuretics that reduce potassium loss in urine), medicines used to suppress the body's immune response (cyclosporine, tacrolimus), and trimethoprim (an antibiotic that inhibits bacterial replication)
With beta-blockers, medicines used to treat high blood pressure and heart problems
With oral anti-inflammatory medicines (corticosteroids)
With medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs)

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Niflam during the last 3 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 your and your baby's tendency to bleed and may delay or prolong labour beyond normal duration. You should not take Niflam during the first 6 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, Niflam 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 narrowing 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.

Breastfeeding
If you are breastfeeding, consult your doctor, who will decide whether to discontinue breastfeeding or the treatment with Niflam.

Fertility
Niflam may cause problems with female fertility and is not recommended for women trying to become pregnant. In women experiencing difficulty conceiving or undergoing fertility investigations, discontinuation of Niflam should be considered.

Driving and using machines
While using Niflam, you may experience dizziness and drowsiness, which may affect your ability to drive or operate machinery.

Niflam contains azorubine (E122)
Azorubine may cause allergic reactions. If you are known to be allergic to azorubine, contact your doctor before taking this medicine.

Niflam contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium (contained in the azorubine component) per capsule, i.e. it is essentially "sodium-free".

3. How to use Niflam

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is generally 1 Niflam capsule three times daily, taken during or immediately after meals. In cases of severe inflammation, especially long-lasting or frequently recurring conditions, a maximum daily dose of 4 Niflam capsules (equivalent to 1000 mg of niflumic acid) may be administered. As symptoms improve, the dosage should be reduced to a maintenance dose proven effective. Doses exceeding four capsules per day (1000 mg of niflumic acid) do not significantly enhance therapeutic effects but may increase the risk of adverse reactions, which are rarely observed at the recommended dose.

In acute gouty arthritis, an initial dose of 2 capsules (500 mg of niflumic acid) should be given, followed by 1 capsule (250 mg of niflumic acid) 2 or 4 hours after the start of treatment. From the following day onward, proceed with the standard dose of 1 capsule 3 or 4 times daily.

The combination of capsules and suppositories allows treatment to be tailored to individual cases. The dosage is adjusted according to the patient's symptoms.

The suppository formulation is suitable for patients who cannot take oral nutrition and who have difficulty swallowing, making capsule administration problematic.

Elderly patients
In treating elderly patients, dosage must be carefully determined by the physician, who should consider reducing the above dose due to possible adverse effects, which may sometimes be serious.

Duration of treatment
Treatment with Niflam should be as short as possible.
For disorders affecting the ear, nose, and throat (ENT) or the mouth and associated structures (stomatological system), treatment must not exceed 4–5 days.

Use in children and adolescents
Niflam capsules are contraindicated in children under 12 years of age.

If you take more Niflam than you should
Symptoms of overdose with Niflam depend on the amount ingested and are usually mild and often asymptomatic.

Symptoms
Symptoms of mild toxicity due to overdose include:

irritation of the stomach or intestine (nausea, vomiting, diarrhoea, abdominal pain)
drowsiness and headache

Symptoms of more advanced toxicity due to overdose include:

increased blood nitrogen levels (azotemia)
increased blood creatinine levels, indicating extensive kidney damage
elevated liver function tests
prolonged prothrombin time (a plasma protein involved in blood coagulation)
reduced number of circulating platelets in the blood (thrombocytopenia)
slowed heart rate (bradycardia)
low blood pressure (hypotension)
excessive drowsiness, usually associated with increased blood acid levels (metabolic acidosis)

Symptoms of severe toxicity due to overdose include:

kidney problems
increased blood acid levels (metabolic acidosis)
convulsive seizures
drowsiness progressing to coma
visual and hearing disturbances

Less frequently observed are:

bleeding from the walls of the stomach or intestine (gastrointestinal haemorrhage)
kidney inflammation (glomerulonephritis)

Treatment
If a large dose of Niflam has been taken, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.

If you forget to take/give your child Niflam
Do not take/give your child a double dose to make up for a missed dose.

If you stop treatment with Niflam
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you experience any of the following adverse reactions while taking Niflam, contact your doctor immediately,
who will STOP treatment with Niflam:

bleeding and damage to the walls of the stomach or intestine (gastrointestinal ulceration), particularly in elderly patients, debilitated individuals, those with low body weight, and patients receiving anticoagulant or antiplatelet therapy (see section “Other medicines and Niflam”)
increased liver enzymes (detected via blood test). Elevated liver enzymes indicate impaired liver function
skin rashes (cutaneous rash), skin and mucous membrane damage and detachment due to an allergic reaction (Stevens-Johnson syndrome and Lyell syndrome)
severe allergic reaction (anaphylactic shock)

Additionally, the following adverse reactions have been observed and reported during treatment with Niflam:
Effects involving mouth, stomach, and intestine

Damage to the inner walls of the stomach and duodenum (gastroduodenal ulcer), particularly in elderly patients, debilitated individuals, those with low body weight, and patients receiving anticoagulant or antiplatelet therapy (see section “Other medicines and Niflam”)
Nausea, vomiting, diarrhoea, excessive gas formation in the stomach or intestine (flatulence), constipation, persistent or recurring upper abdominal pain or discomfort (dyspepsia), abdominal pain, passage of dark stools due to blood (melena), vomiting blood from the gastrointestinal tract (haematemesis), inflammation of the oral mucosa with formation of small lesions (ulcerative stomatitis), worsening of colitis and chronic inflammatory bowel disease (Crohn's disease)
Inflammation of the gastric mucosa (gastritis)
Effects on the immune system
Appearance of red or white wheals of various sizes (urticaria), inflammation of blood vessels (vasculitis), appearance of purplish skin patches of varying sizes (purpura), itching, appearance of bright red target-like skin lesions (erythema multiforme), and blister-like skin eruptions (bullous eruptions), increased skin sensitivity to harmful effects of sunlight (photosensitisation)
Asthma attacks in patients with asthma associated with chronic inflammation of the nasal mucosa (chronic rhinitis), chronic inflammation of mucous membranes and paranasal sinuses (chronic sinusitis), and/or presence of nasal or paranasal polyps, particularly in individuals allergic to acetylsalicylic acid or other NSAIDs
Malaise with low blood pressure
Effects on the nervous system
Headache (cephalalgia) and dizziness (vertigo)
Effects on kidneys and bladder
Impaired kidney function (acute renal dysfunction), inflammation affecting the renal interstitium (interstitial nephritis), glomerular kidney damage leading to protein loss in urine (nephrotic syndrome)
Effects on bones
Accumulation of fluorine in bones (skeletal fluorosis), after high-dose treatment for several years
Effects on skin and underlying tissues
Fluid accumulation in tissues (oedema)
Severe complications of skin infections in case of chickenpox
Effects on heart and blood vessels
Increased blood pressure and heart problems (heart failure)
Diseases related to blood clot formation in arteries (e.g. myocardial infarction or stroke)

Changes in blood test results

Abnormal liver function test
Decreased platelet count in blood
Decreased white blood cell count in blood
False positive test result for detection of drugs in urine

Adverse reactions may be reduced by using the lowest effective dose for the shortest duration necessary to control symptoms.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may 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 Niflam

This medicine does not require any special storage conditions.
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 "Exp". The expiry date refers to the last day of that month.
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 Niflam contains

The active substance is niflumic acid 250 mg.
The other components are: talc, maize starch and magnesium stearate.
The components of the empty capsule are: gelatin and azorubine (E122) (see section "Niflam contains azorubine (E122)").

Description of the appearance of Niflam and contents of the pack
Hard oral capsules containing 250 mg of niflumic acid, packaged in boxes of 30 capsules.

Marketing Authorisation Holder
UPSA S.A.S.
3 Rue Joseph Monier 92500
Rueil Malmaison
France
represented in Italy by:
UPSA ITALY S.R.L. Viale Luca Gaurico 9/11
Rome - Italy

Manufacturer:
UPSA S.A.S.
Avenue du Docteur Jean Bru 304
Agen - France
UPSA S.A.S.
Avenue des Pyrénées 979
Le Passage - France

Patient information leaflet: information for the patient

NIFLAM 285 mg pediatric suppositories

Morniflumate
Please 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, 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 adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Niflam is and what it is used for
What you need to know before giving Niflam to your child
How to give Niflam to your child
Possible side effects
How to store Niflam
Package contents and other information

2. What Niflam is and what it is used for

Niflam contains the active substance morniflumate and belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Niflam is indicated in children over 6 months of age for the treatment of pain associated with inflammation of the ear, nose and throat (ENT system) or of the mouth and its adjacent structures (odontostomatological system).

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

Do not give Niflam to your child if

He or she is allergic to niflumic acid/morniflumate or to any of the other ingredients of this medicine (listed in section 6)
He or she has previously experienced allergy or asthma triggered by administration of niflumic acid/morniflumate or substances with similar activity, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)
He or she has lesions of the inner walls of the stomach and duodenum (gastroduodenal ulcer)
He or she has a history of bleeding (haemorrhage) or perforation of the gastrointestinal tract
He or she has a history of frequent gastroduodenal bleeding/ulceration (two or more distinct episodes of proven ulceration or bleeding)
He or she suffers from severe liver, kidney or heart problems
She is more than 6 months pregnant (see section “Fertility, pregnancy and breastfeeding”)
He or she suffers from inflammation or bleeding of the rectum (proctitis or rectal haemorrhage)
Your child is under 6 months of age (see section “Children and adolescents”)

Warnings and precautions
Talk to your doctor or pharmacist before giving Niflam to your child:

If he or she has a history of high blood pressure (hypertension) and/or heart problems, as Niflam may lead to development of hypertension or worsening of pre-existing hypertension, and to an increase in unwanted effects on the heart and/or blood circulation. Your doctor will

monitor your child’s blood pressure during the initial phase of treatment and throughout the duration of therapy.

If he or she suffers from digestive disorders (e.g. peptic ulcer, hiatal hernia) or gastrointestinal diseases (e.g. ulcerative colitis, Crohn’s disease, chronic inflammatory bowel disease)
If he or she is undergoing or has recently undergone surgery to restore normal blood flow to the heart due to blocked coronary arteries (coronary artery bypass grafting)
If he or she has heart problems or a history of sudden blockage or rupture of a blood vessel in the brain (stroke), or if you think he or she may be at risk (e.g. if he or she has high blood pressure, diabetes, high cholesterol or smokes), as Niflam may increase the risk of heart attack (myocardial infarction) or stroke
If he or she has an ongoing infection or is at risk of infection, as Niflam may mask the usual signs and symptoms of infection
If he or she has chickenpox

Urine output and kidney function should be closely monitored at the start of treatment with niflumic acid/morniflumate in patients with chronic heart problems, kidney or liver disease, those taking diuretics, or who have undergone major surgery resulting in reduced circulating blood volume.
False positive results in drug screening tests for substances in urine have been reported even in the absence of such substances; therefore, inform the doctor or laboratory staff that your child is taking/has taken Niflam.

Children and adolescents
Niflam pediatric suppositories are contraindicated in children under 6 months of age.
Niflumic acid in children may increase the risk of severe skin and mucosal reactions.
Since children aged between 6 and 12 months appear to be more likely to develop such reactions, administration of Niflam in this age group should only occur after careful assessment by the doctor of the risks and benefits of therapy for each individual patient.

Other medicines and Niflam
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

Combinations not recommended:

With other medicines of the same group, NSAIDs (including acetylsalicylic acid and other salicylates)
With anticoagulants (medicines that slow down or stop blood clotting), such as warfarin
With heparin (a medicine that slows down or stops blood clotting)
With lithium (a medicine used to treat psychiatric disorders)
With methotrexate (a medicine used in the treatment of certain cancers and autoimmune diseases) at doses exceeding 15 mg per week

Combinations requiring precautions in use:

With diuretics and medicines used to treat high blood pressure in the arteries (angiotensin-converting enzyme inhibitors and angiotensin II antagonists)
With methotrexate used at doses below 15 mg per week

Combinations that the doctor will carefully evaluate:

With antiplatelet agents (medicines that prevent platelet aggregation in the blood, thereby preventing thrombus and embolus formation), such as ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost, and with heparins used for prophylactic purposes
With potassium salts, potassium-sparing diuretics (diuretics that reduce potassium loss in urine), medicines used to suppress the body's immune response (cyclosporine, tacrolimus), and trimethoprim (an antibiotic that inhibits bacterial replication)
With beta-blockers, medicines used to treat high blood pressure and heart problems
With oral anti-inflammatory medicines (corticosteroids)
With medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs)

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before giving this medicine to your child.

Pregnancy
Do not take Niflam during the last 3 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 may affect your or your baby’s tendency to bleed and may delay or prolong labour more than expected. You should not take Niflam during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, Niflam 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 constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding
If you are breastfeeding, consult your doctor, who will decide whether to discontinue breastfeeding or treatment with Niflam.

Fertility
Niflam may cause fertility problems in women and is not recommended for women trying to become pregnant.
In women experiencing difficulty conceiving or undergoing fertility investigations, discontinuation of Niflam should be considered.

Driving and using machines
While using Niflam, your child may experience dizziness and drowsiness, which could affect the ability to drive or operate machinery.

3. How to give Niflam to your child

Always give this medicine to your child exactly as directed by the doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

for children aged between 6 and 12 months: 1 suppository per day
for children over 12 months of age: from 1 to a maximum of 3 suppositories per day, depending on age and weight. On average, in these cases, the daily dose is 1 suppository per 10 kg of body weight, corresponding to 285 mg of niflumic acid, equivalent to 400 mg of normiflumate, per 10 kg of body weight.

Duration of treatment
The duration of treatment with Niflam should be as short as possible. In disorders affecting the ear,
nose and throat (ENT system) or the mouth and its associated structures (stomatological system), treatment must not
exceed 4–5 days.
Use in children and adolescents
Niflam children's suppositories are contraindicated in children under 6 months of age.
If you give your child more Niflam than you should
Symptoms of overdose with Niflam depend on the amount taken and are in most cases
mild and asymptomatic.
Symptoms
Symptoms of mild toxicity due to overdose include:

irritation of the stomach or intestine (nausea, vomiting, diarrhoea, abdominal pain)
drowsiness and headache. Symptoms of more advanced toxicity due to overdose include:
increased blood nitrogen levels (azotemia)
increased creatinine levels in the blood, indicating extensive kidney damage
elevated liver function tests
prolonged prothrombin time (a plasma protein involved in blood coagulation)
reduced number of circulating platelets in the blood (thrombocytopenia)
slowed heart rate (bradycardia)
low blood pressure (hypotension)
excessive drowsiness, usually associated with increased levels of acid in the blood (metabolic acidosis). Symptoms of severe toxicity due to overdose include:
kidney problems
increased levels of acid in the blood (metabolic acidosis)
convulsive seizures
drowsiness progressing to coma
visual and hearing disturbances. Less frequently observed are:
bleeding from the walls of the stomach or intestine (gastrointestinal haemorrhage)
kidney inflammation (glomerulonephritis). Niflam suppositories may also cause local effects such as skin irritation (erythema), itching, and skin rashes.

Treatment
In case of ingestion of high doses of Niflam, contact your doctor immediately or go to the nearest
hospital, as appropriate measures may be necessary.
If you forget to give Niflam to your child
Do not give your child a double dose to make up for the missed dose.
If you forget to administer the dose at the prescribed time, give it as soon as possible, then
continue treatment as usual.
If you stop treatment with Niflam
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 everybody gets them.
If your child experiences any of the following side effects during treatment with Niflam, consult your doctor immediately, who will DISCONTINUE treatment with Niflam:

bleeding and damage to the walls of the stomach or intestine (gastrointestinal ulceration) in debilitated patients, individuals with low body weight, and patients undergoing treatment with anticoagulants or antiplatelet agents (see section “Other medicines and Niflam”)
increased liver enzymes (detected by a blood test). Elevated liver enzymes are signs of impaired liver function
skin rashes (cutaneous rash)

In addition, the following side effects have been observed and reported during treatment with Niflam:
Effects related to the route of administration

Local toxicity
Effects involving mouth, stomach, and intestine
Injury to the inner walls of the stomach and duodenum (gastroduodenal ulcer) in debilitated patients, individuals with low body weight, and patients undergoing treatment with anticoagulants or antiplatelet agents (see section “Other medicines and Niflam”)
Nausea, vomiting, diarrhoea, excessive gas formation in the stomach or intestine (flatulence), constipation, persistent or recurrent pain or discomfort in the upper abdomen (dyspepsia), abdominal pain, passage of dark stools due to the presence of blood (melena), vomiting of blood from the gastrointestinal tract (haematemesis), inflammation of the oral mucosa with formation of small lesions (ulcerative stomatitis), worsening of inflammation of the colon and chronic inflammatory bowel disease (Crohn's disease)
Inflammation of the gastric mucosa (gastritis)
Effects on the immune system
Appearance of red or white wheals of various sizes (urticaria), inflammation of blood vessels (vasculitis), appearance of purplish skin spots of varying sizes (purpura), itching, appearance of bright red target-like skin lesions (erythema multiforme), and blister-like skin eruptions (bullous eruptions), increased sensitivity of the skin to the harmful effects of sunlight (photosensitisation)
Asthma attacks in patients with asthma associated with chronic inflammation of the nasal mucosa (chronic rhinitis), chronic inflammation of the mucous membranes and paranasal sinuses (chronic sinusitis), and/or presence of nasal polyps, particularly in individuals allergic to acetylsalicylic acid or other NSAIDs
Malaise with low blood pressure.
Effects on the nervous system
Headache (cephalalgia) and dizziness (vertigo)
Effects on kidneys and bladder
Impaired kidney function (acute renal dysfunction), inflammation involving the renal interstitium (interstitial nephritis), glomerular damage leading to protein loss in urine (nephrotic syndrome)
Effects on bones
Accumulation of fluorides in bones (skeletal fluorosis), after high-dose treatment for several years
Effects on the skin and underlying tissues
Fluid accumulation in tissues (oedema)
Severe complications of skin infections in case of chickenpox
Effects on the heart and blood vessels
Increased blood pressure and heart problems (heart failure)
Diseases related to blood clot formation in arteries (e.g. myocardial infarction or stroke)
Blood test abnormalities
Abnormal liver function test
Decreased number of platelets in the blood
Decreased number of white blood cells in the blood
Abnormal test result (false positive) for detection of drugs in urine

Side effects may be reduced by using the lowest effective dose for the shortest duration necessary to control symptoms.

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, consult 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 Niflam

Do not store above 25°C.
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 packaging after EXP. The expiry date refers to the last day of that month.
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 Niflam contains

The active substance is the beta-morpholinoethyl ester of niflumic acid mg 400 (equivalent to mg 285 of niflumic acid)
The other components are solid semisynthetic glycerides

Description of the appearance of Niflam and contents of the pack
Paediatric rectal suppositories containing 285 mg of niflumic acid, packaged in boxes of 10 suppositories.
Marketing Authorisation Holder
UPSA S.A.S.
3 Rue Joseph Monier 92500
Rueil Malmaison
France
represented in Italy by:
UPSA ITALY S.R.L. Viale Luca Gaurico 9/11 Rome - Italy
Manufacturer:
UPSA S.A.S.
Avenue du Docteur Jean Bru 304
Agen - France

Package leaflet: information for the patient

NIFLAM 500 mg suppositories for adults

Morniflumate
Please read this leaflet carefully before using this medicine because 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, because it could 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:

What Niflam is and what it is used for
What you need to know before using Niflam
How to use Niflam
Possible side effects
How to store Niflam
Contents of the pack and other information

3. What Niflam is and what it is used for

Niflam contains the active substance morniflumate and belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Niflam suppositories for adults is indicated in adults and in children over 12 years of age to reduce inflammation, pain, and fluid accumulation in tissues (edema) associated with various conditions, particularly:

diseases affecting bone joints: chronic joint inflammations presenting with pain and swelling (rheumatoid arthritis and acute gouty arthritis), degeneration of joint cartilage (coxarthrosis and osteoarthritides), spinal inflammations (rheumatic spondylitis and ankylosing spondylitis), chronic joint inflammation associated with chronic skin inflammation (psoriatic arthritis)
diseases not affecting bone joints: inflammation of fluid-filled sacs, called "bursae", that protect the joints (bursitis), tendon inflammations (tenosynovitis), inflammation of the membrane lining the inner surface of joints (synovitis), inflammation of tendons at the elbow (epicondylitis)
trauma: partial or complete bone fractures (fractures), joint injuries (sprains), contusions
in sports medicine: joint pain, inflammation affecting the membrane surrounding the

tibia

p (tibial periostitis)

tibia (shin splints), soft tissue injuries, etc.

postoperative inflammatory conditions: dental extractions and other dental or oral surgeries, obstetric and gynecological procedures, nasal and throat surgeries
acute and subacute diseases of the ear, nose, and throat (ENT system)
diseases affecting the bronchi and lungs: chronic inflammation of lung tissue (bronchopneumopathies), inflammation of the lung pleura (pleuritis)
other conditions: acute inflammation of superficial veins (acute superficial thrombophlebitis).

In children, Niflam is indicated for the treatment of pain associated with inflammatory conditions of the ear,
nose, and throat (ENT system) or of the mouth and its associated structures (stomatognathic system).

2. What you should know before using Niflam

Do not use Niflam

If you are allergic to morniflumate or to any of the other ingredients of this medicine (listed in section 6)
If you have previously experienced allergy or asthma triggered by administration of niflumic acid/morniflumate or substances with similar activity, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)
If you have lesions in the inner walls of the stomach and duodenum (gastroduodenal ulcer)
If you have a history of bleeding (haemorrhage) or perforation in the gastrointestinal tract
If you have a history of frequent gastroduodenal bleeding/ulceration (two or more distinct episodes of proven ulceration or bleeding)
If you have severe problems with the liver, kidneys, or heart
If you have inflammation or bleeding of the rectum (proctitis or rectal haemorrhage)
If you are more than 6 months pregnant (see section "Fertility, pregnancy and breastfeeding")
If you are under 12 years of age (see section "Children and adolescents")

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

If you have a history of high blood pressure (hypertension) and/or heart problems, as Niflam may cause development of hypertension or worsening of pre-existing hypertension, and increase the risk of unwanted effects on the heart and/or blood circulation. Your doctor will monitor your blood pressure during the initial phase of treatment and throughout the duration of therapy.
If you suffer from digestive disorders (e.g. peptic ulcer, hiatal hernia, gastrointestinal bleeding) or gastrointestinal diseases (e.g. ulcerative colitis, Crohn's disease (chronic inflammatory bowel disease)), especially in elderly patients.
If you are undergoing or have recently undergone coronary artery bypass surgery to restore normal blood flow to the heart in case of blocked coronary arteries.
If you have heart problems or a history of sudden blockage or rupture of a blood vessel in the brain (stroke), or are at risk of such events (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke), as Niflam may increase the risk of heart attack (myocardial infarction) or stroke.
If you have an active infection or are at risk of infection, as Niflam may mask the usual signs and symptoms of infection.
If you have contracted chickenpox. Urine output and kidney function must be closely monitored at the start of treatment with niflumic acid/morniflumate in patients with chronic heart conditions, kidney or liver problems, those taking diuretics, those who have undergone major surgery resulting in reduced circulating blood volume, and particularly in elderly patients.

False positive results have been reported in urine drug screening tests even in the absence of drugs; therefore, inform your doctor or laboratory personnel that you are taking/have taken Niflam.

Children and adolescents
Niflam adult suppositories are contraindicated in children under 12 years of age.

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

Combinations not recommended:

With other medicines belonging to the same group, NSAIDs (including acetylsalicylic acid and other salicylates)
With anticoagulants (medicines that slow down or stop the blood clotting process), such as warfarin
With heparin (a medicine that slows down or stops the blood clotting process) and related products
With lithium (a medicine used to treat psychiatric disorders)
With methotrexate (a medicine used in the treatment of certain cancers and autoimmune diseases) at doses exceeding 15 mg per week

Combinations requiring precautions in use:

With diuretics and medicines used to treat high blood pressure in the arteries (angiotensin-converting enzyme inhibitors and angiotensin II antagonists)
With methotrexate used at doses below 15 mg per week

Combinations that your doctor will carefully evaluate:

With antiplatelet agents (medicines that block platelet aggregation in the blood, preventing thrombus and embolus formation), such as ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost, and with heparins used for prophylactic purposes
With potassium salts, potassium-sparing diuretics (diuretics that reduce potassium loss in urine), medicines used to reduce the body's immune response (cyclosporine, tacrolimus), and trimethoprim (an antibiotic that inhibits bacterial replication)
With beta-blockers, medicines used to treat high blood pressure and heart problems
With oral medicines used to treat inflammation (corticosteroids)
With medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs)

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Niflam 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 may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected. You should not take Niflam during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, Niflam may cause kidney problems in the fetus if taken for more than a few days, thereby reducing 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 required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
If you are breastfeeding, consult your doctor, who will decide whether to discontinue breastfeeding or Niflam treatment.

Fertility
Niflam may cause problems with female fertility and is not recommended for women attempting to become pregnant. In women experiencing difficulty conceiving or undergoing fertility investigations, discontinuation of Niflam should be considered.

Driving and using machines
While taking Niflam, you may experience dizziness and drowsiness, which may affect your ability to drive or operate machinery.

3. How to use Niflam

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is two suppositories per day, taken one in the morning and one in the evening.
The combination of capsules and suppositories allows treatment to be tailored to individual cases; the dose is obviously determined according to the symptoms presented by the patient.
The suppository formulation is suitable for treating patients who cannot take oral nutrition and who, in any case, have difficulty swallowing and therefore taking the capsule formulation.

Elderly patients
In treating elderly patients, dosage must be carefully established by the doctor, who should consider reducing the above dose due to possible adverse effects, which may sometimes be serious.

Duration of treatment
The duration of treatment with Niflam adult suppositories should be as short as possible.
In disorders affecting the ear, nose, and throat (ENT system) or the mouth and its associated structures (stomatological system), treatment must not exceed 4-5 days.

Use in children and adolescents
Niflam adult suppositories are contraindicated in children under 12 years of age.

If you use more Niflam than you should
Symptoms of overdose with Niflam depend on the amount taken and, in most cases, are mild and asymptomatic.

Symptoms
Symptoms of mild toxicity due to overdose include:

irritation of the stomach or intestine (nausea, vomiting, diarrhoea, abdominal pain)
drowsiness and headache

Symptoms of more advanced toxicity due to overdose include:

increased blood nitrogen levels (azotemia)
increased blood creatinine levels, indicating extensive kidney damage
increased liver function test values
prolonged prothrombin time (a plasma protein involved in blood coagulation)
reduced number of circulating platelets in the blood (thrombocytopenia)
slowed heart rate (bradycardia)
low blood pressure (hypotension)
excessive drowsiness, usually associated with increased levels of acid in the blood (metabolic acidosis)

Symptoms of severe toxicity due to overdose include:

kidney problems
increased levels of acid in the blood (metabolic acidosis)
convulsive seizures
drowsiness progressing to coma
visual and hearing disturbances

Less frequently, the following have been observed:

bleeding from the walls of the stomach or intestine (gastrointestinal haemorrhage)
kidney inflammation (glomerulonephritis)

Niflam suppositories may also cause local effects such as skin irritation (erythema), itching, and skin rashes.

Treatment
If a large dose of Niflam has been taken, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.

If you forget to use Niflam
Do not use a double dose to make up for a forgotten dose.

If you stop using Niflam
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 will experience them.
If you experience any of the following side effects while taking Niflam, contact your doctor immediately,
who will STOP treatment with Niflam:

Bleeding and damage to the walls of the stomach or intestine (gastrointestinal ulceration), particularly in elderly patients, debilitated individuals, people with low body weight, and patients receiving treatment with anticoagulants or antiplatelet agents (see section “Other medicines and Niflam”)
Increased liver enzymes (detected by a blood test). Elevated liver enzymes indicate impaired liver function
Skin rashes (cutaneous rash), destruction and detachment of the skin and mucous membranes due to an allergic reaction (Stevens-Johnson syndrome and Lyell syndrome)
Severe allergic reaction (anaphylactic shock)

Additionally, the following side effects have been observed and reported during treatment with Niflam:
Effects related to the route of administration

Local toxicity
Effects affecting mouth, stomach, and intestine
Damage to the inner walls of the stomach and duodenum (gastroduodenal ulcer), particularly in elderly patients, debilitated individuals, people with low body weight, and patients undergoing treatment with anticoagulants or antiplatelet agents (see section “Other medicines and Niflam”)
Nausea, vomiting, diarrhoea, excessive gas formation in the stomach or intestine (flatulence), constipation, persistent or recurrent upper abdominal pain and/or discomfort (dyspepsia), abdominal pain, passage of dark stools due to blood (melena), vomiting blood originating from the gastrointestinal tract (haematemesis), inflammation of the oral mucosa with formation of small lesions (ulcerative stomatitis), worsening of colonic inflammation and chronic inflammatory bowel disease (Crohn's disease)
Inflammation of the gastric mucosa (gastritis)
Effects on the immune system
Appearance of red or white wheals of varying sizes (urticaria), inflammation of blood vessels (vasculitis), appearance of purplish skin patches of varying sizes (purpura), itching, appearance of bright red target-like skin lesions (erythema multiforme), blistering skin eruptions (bullous eruptions), increased sensitivity of the skin to harmful effects of sunlight (photosensitisation)
Asthma attacks in patients with asthma associated with chronic inflammation of the nasal mucosa (chronic rhinitis), chronic inflammation of the mucous membranes and paranasal sinuses (chronic sinusitis), and/or presence of nasal polyps, particularly in individuals allergic to acetylsalicylic acid or other NSAIDs
Malaise with low blood pressure.
Effects on the nervous system
Headache (cephalalgia) and dizziness (vertigo)
Effects on kidneys and bladder
Impaired kidney function (acute renal dysfunction), inflammation involving the renal interstitium (interstitial nephritis), glomerular damage leading to protein loss in urine (nephrotic syndrome)
Effects on bones
Accumulation of fluorine in bones (skeletal fluorosis), after high-dose treatment for several years
Effects on skin and underlying tissue
Fluid accumulation in tissues (oedema)
Effects on heart and blood vessels
Increased blood pressure and heart problems (heart failure)
Diseases related to blood clot formation in arteries (e.g. myocardial infarction or stroke)

Changes in blood test results

Abnormal liver function test
Decreased platelet count in blood
Decreased white blood cell count in blood
Abnormal test result (false positive) for detection of drugs in urine

Side effects may be reduced by using the lowest effective dose for the shortest duration necessary to control symptoms.

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 Niflam

Do not store above 25°C.
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 "Exp". The expiry date refers to the last day of that month.
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 Niflam contains

The active substance is the beta-morpholinoethyl ester of niflumic acid 700 mg (equivalent to 500 mg of niflumic acid)
The other components are solid semisynthetic glycerides

Description of the appearance of Niflam and contents of the pack
Adult rectal suppositories containing 500 mg of niflumic acid, packaged in boxes of 10 suppositories.
Marketing Authorization Holder
UPSA S.A.S.
3 Rue Joseph Monier 92500
Rueil Malmaison
France
represented in Italy by:
UPSA ITALY S.R.L. Viale Luca Gaurico 9/11 Rome - Italy
Manufacturer:
UPSA S.A.S.
Avenue du Docteur Jean Bru 304
Agen - France