NIFLAM 250 мг Капсулы

Содержание инструкции

1. NIFLAM 250 mg hard capsules
   1. What Niflam is and what it is used for
   2. What you need to know before using Niflam
   3. How to use Niflam
   4. Possible side effects
   5. How to store Niflam
   6. Contents of the pack and other information
2. NIFLAM 285 mg suppositories children
   1. What is Niflam and what is it used for?
   2. What you need to know before giving Niflam to your child
   3. How to give Niflam to your child
   4. Possible side effects
   5. How to store Niflam
   6. Contents of the pack and other information
3. NIFLAM 500 mg suppositories adults
   1. What Niflam is and what it is used for
   2. What you need to know before using Niflam
   3. How to use Niflam
   4. Possible side effects
   5. How to store Niflam
   6. Contents of the pack and other information

NIFLAM 250 mg hard capsules

Niflumic acid

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

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

Contents of this leaflet:

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

1. What Niflam is and what it is used for

Niflam contains the active ingredient niflumic acid and belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs).
Niflam is indicated in adultsand in children over 12 yearsto reduce inflammation, pain and
fluid accumulation in the tissues (edema) accompanying various diseases and in particular:

• diseases affecting the joints of the bones: chronic inflammation of the joints manifesting with pain and swelling (rheumatoid arthritis and acute gouty arthritis), degeneration of the cartilage of the joints (hip arthrosis and osteoarthritis), inflammation of the spine (rheumatoid spondylitis and ankylosing spondylitis), chronic joint inflammation associated with chronic skin inflammation (arthritis associated with psoriasis)
• diseases not affecting the joints of the bones: inflammation of the fluid-filled sacs, called "bursae", which protect the joints (bursitis), inflammation of the tendons (tenosynovitis), inflammation of the membrane lining the inner surface of the joints (synovitis), inflammation of the tendons of the elbow (epicondylitis)
• trauma: partial or complete fractures of a bone (fractures), injuries to a joint (sprains), contusions
• in sports medicine: joint pain, inflammation affecting the membrane surrounding the tibia (tibial periostitis), soft tissue injuries, etc.
• post-operative inflammatory states: tooth extractions and other dental or oral interventions, obstetric-gynecological interventions, surgical interventions on the nose and throat
• acute and subacute diseases affecting the ear, nose and throat (ENT)
• diseases affecting the bronchi and lungs: chronic inflammation of lung tissue (bronchopneumopathies), inflammation of the pulmonary pleura (pleuritis)
• other diseases: acute inflammation of superficial veins (acute superficial thrombophlebitis).

In children Niflam is indicated in the treatment of pain associated with inflammation of the ear,
nose and throat (ENT) or mouth and its appendages (stomatological apparatus).

2. What you need to know before using Niflam

Do not use Niflam

• If you are allergic to niflumic acid or any of the other ingredients of this medicine (listed in section 6)

• If you have previously experienced allergy or asthma caused by the administration of niflumic acid/morniflumate or substances with similar activity, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you suffer from lesions to the inner walls of the stomach and duodenum (gastroduodenal ulcer).
• If you have a history of bleeding (hemorrhage) or perforation of the gastrointestinal tract.
• If you have a history of frequent gastroduodenal bleeding/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding).
• If you suffer from severe problems with the liver, kidneys and heart.
• If you are pregnant for more than 6 months (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 increased undesirable effects on the heart and/or blood circulation. The doctor will check your blood pressure during the initial phase of treatment and throughout the duration of therapy.
• if you suffer from digestive disorders (for example peptic ulcer, hiatal hernia, gastrointestinal bleeding) and gastrointestinal diseases (for example ulcerative colitis, Crohn's disease (chronic inflammatory bowel disease)), especially the elderly.
• if you are to undergo or have undergone surgery to restore normal blood flow to the heart in case of blocked coronary arteries (aorto-coronary bypass).
• if you have heart problems or a history of sudden blockage or rupture of a cerebral vessel (stroke) or may be at risk (for example if you have high blood pressure, diabetes or high cholesterol or smoke), as Niflam may lead to an increased risk of heart attack (myocardial infarction) or stroke.
• if you have an ongoing infection or are at risk of infection because Niflam may mask the usual signs and symptoms of an infection.
• if you have contracted chickenpox. The volume of urine and kidney function must be closely monitored at the beginning of treatment with niflumic acid/morniflumate in patients with chronic heart problems, with kidney or liver problems, who are taking diuretics, who have undergone major surgery with a consequent decrease in circulating blood volume, and especially in elderly subjects.

There have been alterations in the test (false positives) that detect the presence of drugs in the urine even in the absence of these substances, therefore inform your doctor or laboratory personnel that you are taking/have taken Niflam.

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

Other medicines and Niflam
Tell 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 capable of slowing down or stopping the blood clotting process), such as warfarin
• with heparin (a medicine capable of slowing down or stopping the blood clotting process) and related products
• with lithium (a medicine used to treat psychiatric illnesses)
• with methotrexate (a medicine used in the treatment of some tumors and autoimmune diseases) at doses greater than 15 mg per week

Combinations that require precautions for use

• with diuretics and drugs used to treat high blood pressure in the arteries (angiotensin-converting enzyme inhibitors and angiotensin II antagonists)
• with methotrexate, used at doses less than 15 mg per week Combinations that the doctor will carefully evaluate
• with antiplatelet agents (medicines capable of blocking platelet aggregation in the blood, preventing the formation of thrombi and emboli), for example ticlopidine, clopidogrel, tirofiban, eptifibatide and abciximab, iloprost and with heparins used for preventive purposes
• with potassium salts, diuretic drugs that reduce the amount of potassium in the urine (potassium-sparing diuretics), drugs used to reduce the body's immune response (cyclosporine, tacrolimus) and trimethoprim (an antibiotic capable of inhibiting bacterial replication)
• with beta-blockers, medicines used to treat high blood pressure and heart problems
• with medicines to treat inflammation given orally (corticosteroids)
• with medicines to treat depression (selective serotonin re-uptake inhibitors, SSRIs)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Niflam in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Niflam during the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor.
If treatment is necessary during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, 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 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.
Breastfeeding
If you are breastfeeding, ask your doctor who will assess whether to discontinue breastfeeding or treatment with Niflam.
Fertility
Niflam may cause problems with female fertility and is not recommended for women trying to become pregnant.
In women who have difficulty becoming pregnant or who are undergoing tests for infertility, discontinuation of Niflam should be considered.

Driving and using machines
During the use of Niflam, you may experience dizziness and drowsiness that can affect your ability to drive vehicles or use machines.

Niflam contains azorubine (E122)
Azorubine may cause allergic reactions. If you have a known allergy to azorubine, contact your doctor before taking the 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is generally 1 Niflam capsule three times a day, to be taken during or
immediately after meals. In case of severe inflammation, especially that of long duration or tending
to worsen, a maximum daily dose of 4 Niflam capsules may be administered (corresponding to
1000 mg of niflumic acid).
As symptoms improve, the dosage should be reduced to a maintenance dose that
proves effective. Doses higher than four capsules daily (1000 mg of niflumic acid) do not
significantly increase the therapeutic effects, but may cause the appearance of undesirable effects
that rarely occur at the recommended dose. In acute gouty arthritis, an initial dose of 2 capsules (500 mg of niflumic acid) should be administered followed by one capsule (250 mg of niflumic acid)
2 or 4 hours after the start of therapy. From the following day onwards, proceed with the normal dose of one
capsule 3 or 4 times a day.
The combination of capsules and suppositories allows the treatment to be adapted to individual cases; obviously the dose is
established based on the symptoms manifested by the patient.
The suppository formulation is suitable for the treatment of patients who cannot eat orally and
who nevertheless have difficulty swallowing and therefore taking the preparation in capsules.

Elderly
In the treatment of elderly patients, the dosage must be carefully established by the doctor who must
assess a possible reduction of the above dose due to possible side effects which may also be
serious.

Duration of treatment
The duration of treatment with Niflam should be as short as possible.
In disorders affecting the ear, nose and throat (ENT) or the mouth and its appendages
(dental apparatus) the therapy should not exceed 4-5 days.

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

If you use more Niflam than you should
The manifestations of overdose with Niflam depend on the dose taken and in most cases
are mild and have no symptoms.
Symptoms
The symptoms of mild toxicity from overdose are:

• irritation at the level of the stomach or intestine (nausea, vomiting, diarrhea, abdominal pain)
• drowsiness and headache The symptoms of more advanced toxicity from overdose are:
• increased concentration of nitrogen in the blood (azotemia)
• increased creatinine in the blood, an index of extensive kidney damage
• increased liver function test
• increased prothrombin time (plasma protein involved in blood coagulation)
• reduction in the number of platelets circulating in the blood (thrombocytopenia)
• slowed heartbeat (bradycardia)
• low blood pressure (hypotension)
• excessive drowsiness usually associated with an increase in the amount of acids in the blood (metabolic acidosis) The symptoms of severe toxicity from overdose are:
• kidney problems
• increased amount of acids in the blood (metabolic acidosis)
• convulsions
• drowsiness progressing to coma
• visual and auditory disturbances More rarely, the following have been observed:
• bleeding of the walls of the stomach or intestine (gastrointestinal bleeding)
• inflammation of the kidneys (glomerulonephritis)

Treatment
If you have taken high doses of Niflam, immediately inform your doctor or go to the nearest
hospital, as appropriate measures may be necessary.

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

If you stop the treatment with Niflam
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.
If you experience the following side effects during treatment with Niflam, contact your doctor immediately, who will STOPtreatment with Niflam:

• bleeding and lesions of the stomach or intestinal walls (gastrointestinal ulceration), especially in the elderly, debilitated individuals, people with low body weight and patients undergoing therapy with anticoagulants or antiplatelet agents (see paragraph “Other medicines and Niflam”)
• increased liver enzymes (evaluated with a blood test). Increased liver enzyme levels are symptoms of impaired liver function
• skin rashes (cutaneous rash), destruction and detachment of the skin and mucous membranes resulting from an allergic reaction (Stevens-Johnson syndrome and Lyell's syndrome)
• severe allergic reaction (anaphylactic shock)

In addition, the following side effects have been observed and reported during treatment with Niflam:

Effects involving the mouth, stomach and intestines

• Lesions of the inner walls of the stomach and duodenum (gastroduodenal ulcer), especially in the elderly, debilitated individuals, people with low body weight and patients undergoing therapy with anticoagulants or antiplatelet agents (see paragraph “Other medicines and Niflam”)
• Nausea, vomiting, diarrhea, excessive gas formation in the stomach or intestines (flatulence), constipation, persistent or recurrent pain and/or discomfort in the upper abdomen (dyspepsia), abdominal pain, passage of dark stools due to the presence of blood (melena), emission of blood from the mouth originating from the digestive tract (hematemesis), inflammation of the oral mucosa with the 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 involving the immune system
• Appearance of red or white wheals of various sizes (urticaria), inflammation of blood vessels (vasculitis), appearance of purplish skin patches of different sizes (purpura), itching, appearance of ring-shaped, bright red lesions (erythema multiforme) and blistering skin manifestations (bullous eruptions), increased sensitivity of the skin to the harmful action of sunlight (photosensitization)
• Asthma attacks, in patients who present 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 in the presence of growths in the nasal cavity or paranasal sinuses (nasal polyposis), particularly those allergic to acetylsalicylic acid or other NSAIDs
• Feeling unwell with low blood pressure. Effects involving the nervous system
• Headache and dizziness Effects involving the kidneys and bladder
• Impaired kidney function (acute renal dysfunction), inflammation involving the renal interstitium (interstitial nephritis), alteration of the renal glomeruli resulting in protein loss with urine (nephrotic syndrome) Effects involving the bones
• Accumulation of fluoride in the bones (fluorosis), after treatment at high doses for several years Effects involving the skin and underlying tissue
• Accumulation of fluid in the tissues (edema)
• Severe complications of skin infections in case of varicella Effects involving the heart and blood vesselsincreased blood pressure and heart problems (heart failure)
• Diseases related to the formation of blood clots inside the arteries (for example myocardial infarction or stroke)

Changes in blood test results

• Alteration of the test that measures liver function
• Decrease in the number of platelets in the blood
• Decrease in the number of white blood cells in the blood
• Alteration of the test (false positive) that detects the presence of drugs in the urine Side effects can be reduced by using the lowest effective dose for the shortest duration possible to control symptoms.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Niflam

This medicine does not require any special storage conditions.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Niflam contains

• The active ingredient is niflumic acid 250 mg
• The other ingredients are: talc, corn 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 capsules for oral use 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

NIFLAM 285 mg suppositories children

Morniflumate

Read this leaflet carefully before giving this medicine to your child as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What is Niflam and what is it used for?

Niflam contains the active ingredient morniflumate and belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs).
Niflam is indicated in childrenover 6 months of agein the treatment of pain associated with inflammation of the
ear, nose and throat (ENT) or mouth and its appendages (dental apparatus).

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

Do not give Niflam to your child

• If they are allergic to morniflumate or any of the other ingredients of this medicine (listed in section 6)
• If they have previously experienced allergy or asthma caused by the administration of niflumic acid/morniflumate or substances with similar activity, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).
• If they suffer from lesions to the inner walls of the stomach and duodenum (gastroduodenal ulcer).
• If they have a history of bleeding (hemorrhage) or perforation of the gastrointestinal tract.
• If they have a history of frequent gastroduodenal bleeding/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding).
• If they suffer from severe problems with the liver, kidneys and heart.
• If they are pregnant for more than 6 months (see section “Fertility, pregnancy and breastfeeding”).
• If they suffer from inflammation or bleeding in the rectum (proctitis or rectorrhagia).
• If your child is less than 6 months of age (see section “Children and adolescents”).

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

• If they have a history of high blood pressure (hypertension) and/or heart problems, as Niflam may lead to the development of hypertension or a worsening of pre-existing hypertension and an increase in undesirable effects on the heart and/or blood circulation. The doctor will

check their blood pressure during the initial phase of treatment and throughout the duration of
therapy.

• If they suffer from digestive disorders (for example peptic ulcer, hiatal hernia) and gastrointestinal diseases (for example ulcerative colitis, Crohn's disease, chronic inflammatory bowel disease).
• If they are to undergo or have undergone surgery to restore normal blood flow to the heart in case of blocked coronary arteries (coronary artery bypass graft).
• If they have heart problems or a history of sudden blockage or rupture of a cerebral vessel (stroke) or think they may be at risk (for example if they have high blood pressure, diabetes or high cholesterol or smoke), as Niflam may lead to an increased risk of heart attack (myocardial infarction) or stroke.
• If they have an ongoing infection or are at risk of infection because Niflam may mask the usual signs and symptoms of an infection.
• If they suffer from chickenpox.

The volume of urine and kidney function must be closely monitored at the beginning of
treatment with niflumic acid/morniflumate in patients with chronic heart problems, with kidney
or liver problems, who are taking diuretics, who have undergone major surgery with
consequent decrease in circulating blood volume.
There have been alterations in the test (false positives) that detect the presence of drugs in the urine even in
the absence of these substances, therefore inform the doctor or laboratory personnel that they are taking/have
taken Niflam.

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

Other medicines and Niflam
Tell your doctor or pharmacist if your child is taking, has 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 capable of slowing down or stopping the blood clotting process), such as warfarin for example
• with heparin (a medicine capable of slowing down or stopping the blood clotting process)
• with lithium (a medicine used to treat psychiatric illnesses)
• with methotrexate (a medicine used in the treatment of some cancers and autoimmune diseases) at doses higher than 15 mg per week

Combinations that require precautions for use

• with diuretics and drugs used to treat high blood pressure in the arteries (angiotensin-converting enzyme inhibitors and angiotensin II antagonists)
• with methotrexate, used at doses lower than 15 mg per week

Combinations that the doctor will carefully evaluate

• with antiplatelet agents (medicines capable of blocking platelet aggregation in the blood preventing the formation of thrombi and emboli), for example ticlopidine, clopidogrel, tirofiban, eptifibatide and abciximab, iloprost and with heparins used for preventive purposes
• with potassium salts, diuretic medicines that reduce the amount of potassium in the urine (potassium-sparing diuretics), drugs used to reduce the body's immune response (cyclosporine, tacrolimus) and trimethoprim (an antibiotic capable of inhibiting bacterial replication)
• with beta-blockers, medicines used to treat high blood pressure and heart problems
• with medicines to treat inflammation given orally (corticosteroids)
• with medicines to treat depression (selective serotonin re-uptake inhibitors, SSRIs)

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before giving this medicine to your child.
Pregnancy
Do not take Niflam in the last 3 months of pregnancy, as it may harm the fetus or cause problems
during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect your and the
child's tendency to bleed and delay or prolong labor more than expected. You should not take
Niflam during the first 6 months of pregnancy, unless absolutely necessary and under the advice of a doctor.
If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, Niflam can
cause kidney problems in the fetus, if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the narrowing of a blood vessel (ductus
arteriosus) in the baby's heart. If treatment is needed for more than a few days, the
doctor may recommend additional monitoring.
Breastfeeding
If you are breastfeeding, ask your doctor who will assess whether to discontinue
breastfeeding or treatment with Niflam.
Fertility
Niflam can cause problems with female fertility and is not recommended for women trying to become
pregnant.
In women who have difficulty getting pregnant or who are undergoing tests for
infertility, discontinuation of Niflam should be considered.

Driving and operating machinery
During the use of Niflam your child may experience dizziness and drowsiness which may affect
the ability to drive vehicles or use machinery.

3. How to give Niflam to your child

Give this medicine to your child following the instructions of the doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

• for children between 6 and 12 months of age: 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 every 10 kg of body weight, or 285 mg of niflumic acid, corresponding to 400 mg of normiflumate, every 10 kg of weight.

Duration of treatment
The duration of treatment with Niflam must be as short as possible. In disorders affecting the ear,
nose and throat (ENT) or the mouth and its appendages (dental apparatus) the therapy should 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 too much Niflam
The manifestations of overdose with Niflam depend on the dose taken and in most cases
are mild and do not present symptoms.
Symptoms
The symptoms of mild toxicity from overdose are:

• irritation of the stomach or intestines (nausea, vomiting, diarrhea, abdominal pain)
• drowsiness and headache. The symptoms of more advanced toxicity from overdose are:
• increased nitrogen concentration in the blood (azotemia)
• increased creatinine in the blood, an index of extensive kidney damage
• increased liver function test
• increased prothrombin time (plasma protein involved in blood coagulation)
• reduction in the number of platelets circulating in the blood (thrombocytopenia)
• slowed heartbeat (bradycardia)
• low blood pressure (hypotension)
• excessive drowsiness usually associated with an increase in acids in the blood (metabolic acidosis) The symptoms of severe toxicity from overdose are:
• kidney problems
• increased amount of acids in the blood (metabolic acidosis)
• convulsions
• drowsiness progressing to coma
• visual and auditory disturbances More rarely, the following have been observed:
• bleeding of the walls of the stomach or intestines (gastrointestinal hemorrhage)
• inflammation of the kidneys (glomerulonephritis) Niflam suppositories can also cause local effects, such as skin irritation (erythema), itching and skin rashes (rash).

Treatment
If you have taken high doses of Niflam, immediately inform your doctor or go to the nearest
hospital, as appropriate measures may be necessary.

If you forget to give your child Niflam
Do not give your child a double dose to make up for a missed dose.
If you should forget to take the dose at the prescribed times, take it as soon as possible, then
continue treatment as usual.

If you stop treatment with Niflam
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.
If your child experiences the following side effects during treatment with Niflam, contact your doctor immediately, who will STOPthe treatment with Niflam:

• bleeding and lesions of the stomach or intestinal walls (gastrointestinal ulceration), in debilitated subjects, in people with low body weight and in patients undergoing therapy with anticoagulants or antiplatelet agents (see paragraph “Other medicines and Niflam”)
• increased liver enzymes (evaluated with a blood test). Increased liver enzyme values are symptoms 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

• Toxicity at the local level Effects concerning the mouth, stomach and intestines
• Lesions of the internal walls of the stomach and duodenum (gastroduodenal ulcer), in debilitated subjects, in people with low body weight and patients who are undergoing therapy with anticoagulants or antiplatelet agents (see paragraph “Other medicines and Niflam”)
• Nausea, vomiting, diarrhea, excessive gas formation in the stomach or intestines (flatulence), constipation, pain and/or persistent or recurrent discomfort in the upper abdomen (dyspepsia), abdominal pain, passage of dark stools due to the presence of blood (melena), emission of blood from the mouth originating from the digestive tract (hematemesis), inflammation of the oral mucosa with the formation of small lesions (ulcerative stomatitis), exacerbation of inflammation of the colon and chronic inflammatory bowel disease (Crohn's disease)
• Inflammation of the gastric mucosa (gastritis) Effects concerning the immune system
• Appearance of red or white blisters of various sizes (urticaria), inflammation of blood vessels (vasculitis), appearance of purplish patches of different sizes (purpura), itching, appearance of target-shaped, bright red lesions (erythema multiforme) and blistering manifestations on the skin (bullous eruptions), increased sensitivity of the skin to the harmful action of sunlight (photosensitization)
• Asthma attacks, in patients who present asthma associated with chronic inflammation of the nasal mucosa (chronic rhinitis), with chronic inflammation of the mucous membranes and paranasal sinuses (chronic sinusitis) and/or in the presence of growths in the nasal cavity or paranasal sinuses (nasal polyposis), particularly in subjects allergic to acetylsalicylic acid or other NSAIDs
• Discomfort with low blood pressure. Effects concerning the nervous system
• Headache and dizziness Effects concerning kidneys and bladder
• Impaired kidney function (acute renal dysfunction), inflammation involving the renal interstitium (interstitial nephritis), alteration of the renal glomeruli leading to protein loss in the urine (nephrotic syndrome) Effects concerning the bones
• Accumulation of fluorine in the bones (fluorosis), after treatment at high doses for several years Effects concerning the skin and underlying tissue
• Accumulation of fluids in the tissues (edema)
• Severe complications of skin infections in case of chickenpox Effects concerning the heart and blood vesselsincreased blood pressure and heart problems (heart failure)
• Diseases related to the formation of blood clots inside the arteries (for example myocardial infarction or stroke)
• Changes in blood test results
• Alteration of the test that measures liver function
• Decrease in the number of platelets in the blood
• Decrease in the number of white blood cells in the blood
• Alteration of the test (false positive) that detects the presence of drugs in the urine. Side effects can be reduced by using the lowest effective dose for the shortest possible duration of treatment needed to control the symptoms.

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

5. How to store Niflam

Do not store at a temperature above 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Niflam contains

• The active ingredient is the beta-morpholinoethyl ester of niflumic acid 400 mg (equivalent to 285 mg of niflumic acid)
• The other ingredients are solid semi-synthetic glycerides

Description of the appearance of Niflam and contents of the pack
Children's suppositories for rectal use 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 9/11Rome - Italy

Manufacturer:
UPSA S.A.S.
Avenue du Docteur Jean Bru 304
Agen - France

NIFLAM 500 mg suppositories adults

Morniflumate

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

3. What Niflam is and what it is used for

Niflam contains the active ingredient morniflumate and belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs).
Niflam adult suppositories are indicated in adultsand in children over 12 yearsto reduce inflammation, pain and fluid accumulation in the tissues (edema) that accompany various diseases and in particular:

• diseases affecting the joints of the bones: chronic inflammation of the joints that manifests with pain and swelling (rheumatoid arthritis and acute gouty arthritis), degeneration of the cartilage of the joints (hip osteoarthritis and osteoarthrosis), inflammation of the spine (rheumatoid spondylitis and ankylosing spondylitis), chronic joint inflammation associated with chronic skin inflammation (arthritis associated with psoriasis)
• diseases not affecting the joints of the bones: inflammation of fluid-filled sacs, called "bursae", which protect the joints (bursitis), inflammation of the tendons (tenosynovitis), inflammation of the membrane lining the inner surface of the joints (synovitis), inflammation of the tendons of the elbow (epicondylitis)
• trauma: partial or complete fractures of a bone (fractures), injuries to a joint (sprains), contusions
• in sports medicine: joint pain, inflammation affecting the membrane surrounding the tibia (tibial periostitis), soft tissue injuries, etc.
• post-operative inflammatory states: tooth extractions and other dental or oral interventions, obstetric-gynecological interventions, surgical interventions on the nose and throat
• acute and subacute diseases affecting the ear, nose and throat (ENT)
• diseases affecting the bronchi and lungs: chronic inflammation of lung tissue (bronchopneumopathies), inflammation of the pulmonary pleura (pleurisy)
• other diseases: acute inflammation of superficial veins (acute superficial thrombophlebitis).

In children, Niflam is indicated in the treatment of pain associated with inflammation affecting the ear,
nose and throat (ENT) or the mouth and its appendages (stomatological apparatus).

2. What you need to know before using Niflam

Do not use Niflam

• If you are allergic to morniflumate or any of the other ingredients of this medicine (listed in section 6)
• If you have previously experienced allergy or asthma caused by the administration of niflumic acid/morniflumate or substances with similar activity, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you suffer from lesions to the internal walls of the stomach and duodenum (gastroduodenal ulcer).
• If you have a history of bleeding (hemorrhage) or perforation of the gastrointestinal tract.
• If you have a history of frequent bleeding/gastroduodenal ulcer (two or more distinct episodes of demonstrated ulceration or bleeding).
• If you suffer from severe problems with the liver, kidneys and heart.
• If you suffer from inflammation or bleeding of the rectum (rectitis or rectorrhagia).
• If you are pregnant for more than 6 months (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 increased undesirable effects on the heart and/or bloodstream. The doctor will check your blood pressure during the initial phase of treatment and throughout the duration of therapy.
• if you suffer from digestive disorders (for example peptic ulcer, hiatal hernia, gastrointestinal bleeding) and gastrointestinal diseases (for example ulcerative colitis, Crohn's disease (chronic inflammatory bowel disease)), especially the elderly.
• if you are to undergo or have undergone surgery to restore normal blood flow to the heart in case of blocked coronary arteries (aorto-coronary bypass).
• if you have heart problems or a history of sudden blockage or rupture of a cerebral vessel (stroke) or may be at risk (for example if you have high blood pressure, diabetes or high cholesterol or smoke), as Niflam may lead to an increased risk of heart attack (myocardial infarction) or stroke.
• if you have an ongoing infection or are at risk of infection because Niflam may mask the usual signs and symptoms of an infection.
• If you have contracted chickenpox. The volume of urine and kidney function must be strictly monitored at the beginning of treatment with niflumic acid/morniflumate in patients with chronic heart problems, with kidney or liver problems, who are taking diuretics, who have undergone major surgery with a consequent decrease in circulating blood volume, and especially in elderly subjects.

There have been alterations in the test (false positives) that detect the presence of drugs in the urine even in the absence of these substances, therefore inform your doctor or laboratory personnel that you are taking/have taken Niflam.

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

Other medicines and Niflam
Tell 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 capable of slowing down or stopping the blood clotting process), such as warfarin
• with heparin (a medicine capable of slowing down or stopping the blood clotting process) and related products
• with lithium (a medicine used to treat psychiatric diseases)
• with methotrexate (a medicine used in the treatment of some tumors and autoimmune diseases) at doses higher than 15 mg per week

Combinations that require precautions for use

• with diuretics and drugs used to treat high blood pressure in the arteries (angiotensin converting enzyme inhibitors and angiotensin II antagonists)
• with methotrexate, used at doses less than 15 mg per week Combinations that the doctor will carefully evaluate
• with antiplatelet agents (medicines capable of blocking the aggregation of platelets in the blood preventing the formation of thrombi and emboli), for example ticlopidine, clopidogrel, tirofiban, eptifibatide and abciximab, iloprost and with heparins used for preventive purposes
• with potassium salts, diuretic medicines that reduce the amount of potassium in the urine (potassium-sparing diuretics), drugs used to reduce the body's immune response (cyclosporine, tacrolimus) and trimethoprim (an antibiotic capable of inhibiting bacterial replication)
• with beta-blockers, medicines used to treat high blood pressure and heart problems
• with medicines to treat inflammation administered orally (corticosteroids)
• with medicines to treat depression (selective serotonin re-uptake inhibitors, SSRIs)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Niflam in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Niflam during the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor. If treatment is needed during this period or during attempts to conceive, the lowest dose should be used for the shortest possible time. From the 20th week 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 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.Breastfeeding
If you are breastfeeding, ask your doctor who will assess whether to discontinue breastfeeding or treatment with Niflam.
Fertility
Niflam may cause problems with female fertility and is not recommended for women trying to become pregnant.
In women who have difficulty becoming pregnant or who are undergoing tests for infertility, discontinuation of Niflam should be considered.

Driving and operating machinery
During the use of Niflam you may experience dizziness and drowsiness which may affect your ability to drive vehicles or use machinery.

3. How to use Niflam

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is two suppositories per day, one in the morning and one in the evening.
The capsule-suppository combination allows the treatment to be adapted to individual cases; obviously the dose is
established based on the symptoms manifested by the patient.
The suppository formulation is suitable for the treatment of patients who cannot eat orally and
who also have difficulty swallowing and therefore taking the capsule preparation.

Elderly
In the treatment of elderly patients, the dosage must be carefully established by the doctor who must
assess a possible reduction of the above dose due to possible undesirable effects, sometimes even
serious.

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

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

If you use more Niflam than you should
The manifestations of overdose with Niflam depend on the dose taken and in most cases
are mild and do not present symptoms.
Symptoms
The symptoms of mild toxicity from overdose are:

• irritation at the level of the stomach or intestine (nausea, vomiting, diarrhea, abdominal pain)
• drowsiness and headache The symptoms of more advanced toxicity from overdose are:
• increased nitrogen concentration in the blood (azotemia)
• increased creatinine in the blood, an index of extensive kidney damage
• increased liver function test
• increased prothrombin time (plasma protein involved in blood coagulation)
• reduction in the number of platelets circulating in the blood (thrombocytopenia)
• slowed heartbeat (bradycardia)
• low blood pressure (hypotension)
• excessive drowsiness usually associated with an increase in the amount of acids in the blood (metabolic acidosis) The symptoms of severe toxicity from overdose are:
• kidney problems
• increased amount of acids in the blood (metabolic acidosis)
• convulsions
• drowsiness progressing to coma
• visual and auditory disturbances More rarely, the following have been observed:
• bleeding of the walls of the stomach or intestine (gastrointestinal hemorrhage)
• inflammation of the kidneys (glomerulonephritis) Niflam suppositories can also cause local effects, such as skin irritation (erythema), itching and skin rashes (rash). Treatment In case of taking high doses of Niflam, immediately inform your doctor or go to the nearest hospital, as adequate measures may be necessary.

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

If you stop using Niflam
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.
If you experience the following side effects during treatment with Niflam, contact your doctor immediately, who WILL STOPtreatment with Niflam:

• bleeding and lesions of the walls of the stomach or intestine (gastrointestinal ulceration), especially in the elderly, debilitated individuals, people with low body weight and patients undergoing therapy with anticoagulants or antiplatelet agents (see paragraph “Other medicines and Niflam”)
• increased liver enzymes (evaluated with a blood test). Increased liver enzyme levels are symptoms of impaired liver function
• skin rashes (cutaneous rash), destruction and detachment of the skin and mucous membranes resulting from an allergic reaction (Stevens-Johnson syndrome and Lyell's syndrome)
• severe allergic reaction (anaphylactic shock)

In addition, the following side effects have been observed and reported during treatment with Niflam:

Effects related to the route of administration

• Toxicity at the local level Effects affecting the mouth, stomach and intestines
• Lesions of the internal walls of the stomach and duodenum (gastroduodenal ulcer), especially in the elderly, debilitated individuals, people with low body weight and patients undergoing therapy with anticoagulants or antiplatelet agents (see paragraph “Other medicines and Niflam”)
• Nausea, vomiting, diarrhea, excessive gas formation in the stomach or intestine (flatulence), constipation, pain and/or persistent or recurrent discomfort in the upper abdomen (dyspepsia), abdominal pain, passage of dark stools due to the presence of blood (melena), emission of blood from the mouth originating from the digestive tract (hematemesis), inflammation of the oral mucosa with the formation of small lesions (ulcerative stomatitis), exacerbation of inflammation of the colon and chronic inflammatory bowel disease (Crohn's disease)
• Inflammation of the gastric mucosa (gastritis) Effects affecting the immune system
• Appearance of red or white blisters of various sizes (urticaria), inflammation of blood vessels (vasculitis), appearance of purplish skin patches of various sizes (purpura), itching, appearance of ring-shaped, bright red lesions (erythema multiforme) and blistering manifestations on the skin (bullous eruptions), increased sensitivity of the skin to the harmful action of sunlight (photosensitization)
• Asthma attacks, in patients who present 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 in the presence of growths in the nasal cavity or paranasal sinuses (nasal polyposis), particularly those allergic to acetylsalicylic acid or other NSAIDs
• Discomfort with low blood pressure. Effects affecting the nervous system
• Headache and dizziness Effects affecting the kidneys and bladder
• Impaired kidney function (acute renal dysfunction), inflammation involving the renal interstitium (interstitial nephritis), alteration of the renal glomeruli resulting in protein loss with urine (nephrotic syndrome) Effects affecting the bones
• Fluoride accumulation in the bones (osseous fluorosis), after treatment at high doses for several years Effects affecting the skin and underlying tissue
• Fluid accumulation in the tissues (edema) Effects affecting the heart and blood vesselsincreased blood pressure and heart problems (heart failure)
• Diseases related to the formation of blood clots inside the arteries (e.g. myocardial infarction or stroke)

Changes in blood test results

• Alteration of the test that measures liver function
• Decrease in the number of platelets in the blood
• Decrease in the number of white blood cells in the blood
• Alteration of the test (false positive) that detects the presence of drugs in urine. Side effects can be reduced by using the lowest effective dose for the shortest duration possible to control symptoms.

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

5. How to store Niflam

Do not store at a temperature above 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Niflam contains

• The active ingredient is the beta-morpholinoethyl ester of niflumic acid 700 mg (equivalent to 500 mg of niflumic acid)
• The other components are solid semi-synthetic glycerides

Description of the appearance of Niflam and contents of the pack
Adult suppositories for rectal use containing 500 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 9/11Rome - Italy

Manufacturer:
UPSA S.A.S.
Avenue du Docteur Jean Bru 304
Agen - France