Leaflet: information for the user

Niflactol 250 mg Capsules

Niflumic acid

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Niflactol is and for what it is used

2. What you need to know before starting to take Niflactol

3. How to take Niflactol

4. Possible side effects

5. Storage of Niflactol

6. Contents of the pack and additional information

Niflactol belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) and antirheumatic agents.

Niflactol is indicated in adults and children over 12 years:

- in prolonged treatments of:

. certain types of chronic inflammatory rheumatism,

. certain types of osteoarthritis.

- in short-term treatments of pain in acute osteoarthritis and certain types of joint inflammation, such as tendinitis and bursitis.

- in the treatment of pain caused by inflammation of the throat, ears, or mouth.

This medication should be taken under medical supervision.

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to manage your symptoms.

Do not take Niflactol

• During the third trimester of pregnancy.
• If you have a history of allergy or asthma caused by this medication or similar, particularly with other nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin.
• If you are allergic (hypersensitive) to niflumic acid or any of the other components of this medication (listed in section 6).
• If you have had a stomach or duodenal ulcer or have experienced gastrointestinal bleeding.
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have severe heart failure.
• In children under 12 years old.

Be cautious with Niflactol if:

• You have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider associating a stomach protector medication.
• You experience symptoms of allergy to this medication, especially asthma attacks, facial or neck swelling (see section 4. Possible adverse effects). INTERRUPT TREATMENT AND CONTACT YOUR DOCTOR OR EMERGENCY MEDICAL SERVICES IMMEDIATELY.
• You have heart, kidney, or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• You have an infection. You need close monitoring.
• You have chickenpox. It is not recommended to take this medication due to the risk of severe skin infections.

Inform your doctor:

• If you are taking medications that alter blood clotting, such as corticosteroids, oral anticoagulants, or antiplatelet agents like aspirin. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as medications like Niflactol may worsen these conditions.
• If you have a history of gastrointestinal disorders (hiatal hernia, gastrointestinal bleeding, previous gastric or duodenal ulcers).
• If you have heart, liver, or kidney disease.
• If you have asthma, as, in some patients, asthma attacks are associated with allergy to aspirin or other nonsteroidal anti-inflammatory drugs. This medication is contraindicated in these cases.
• If you experience any of the following symptoms: chest pain, difficulty breathing, weakness, or speech disturbances.
• If you have undergone coronary bypass surgery or have recently undergone or will undergo cardiac surgery.

Cardiovascular Precautions

Medications like Niflactol may be associated with a moderate increase in the risk of myocardial infarction (heart attack) or cerebrovascular accidents. This risk is more likely to occur when using high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), consult this treatment with your doctor or pharmacist.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure. Your doctor will closely monitor your blood pressure at the start of treatment with Niflactol and throughout the treatment.

Children

Do not administer to children under 12 years old.

Other Medications and Niflactol

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medications.

Particularly if you are using any of the following medications:

• Analgesics and other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and other salicylates (which reduce pain and inflammation), without consulting your doctor.

• Oral anticoagulants of the dicumarin type (acenocoumarol, warfarin).
• Antiplatelet agents like ticlopidine, clopidogrel, tirofiban, eptifibatide, and abciximab, iloprost, including those containing aspirin (to prevent blood clot formation).
• Unfractionated heparin, low molecular weight heparin, and other related medications, as the use of these with Niflactol may increase the risk of bleeding.
• Thrombolytics (medications that dissolve or break down blood clots).
• Oral corticosteroids.
• Antidepressants, especially selective serotonin reuptake inhibitors and lithium.
• Methotrexate (used in cancer and rheumatoid arthritis treatment).
• Medications that increase potassium levels in the blood: potassium salts, potassium-sparing diuretics, angiotensin II inhibitors, ACE inhibitors, heparins of low molecular weight, ciclosporin, tacrolimus, trimetoprim.
• Diuretics: furosemide and other thiazide diuretics (for urine elimination).
• Medications to lower blood pressure: ACE inhibitors, angiotensin II inhibitors, and beta blockers.
• Ciclosporin, tacrolimus (used to prevent organ transplant rejection).
• Diabetes medications.

Taking Niflactol with Food and Drinks

It is recommended to take the capsules with meals and with sufficient water.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy and Fertility Precautions

Do not take Niflactol if you are in 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 your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Niflactol during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, Niflactol may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

For women of childbearing age, it is essential to note that medications like Niflactol have been associated with a decrease in the ability to conceive.

Breastfeeding

This medication is excreted in breast milk. As a precaution, it is recommended to avoid its use during breastfeeding.

Consult your doctor or pharmacist before taking this medication.

Driving and Operating Machines

In some cases, dizziness and somnolence have been reported in patients taking Niflactol.

Do not drive or operate machinery if you experience dizziness and/or somnolence while taking Niflactol.

Niflactol contains azorubine and sodium

This medication may cause allergic reactions due to the presence of azorubine (E122).

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free."

Follow exactly the administration instructions for Niflactol indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

The recommended dose is:

Adults:

The dosage should be adjusted according to the severity of the disorder and the patient's discomfort. In general, the recommended daily dose is 1 capsule every 4 or 6 hours, divided throughout the day. The maximum recommended dose is1000 mgper day. The dose can be increased to 1500 mg of niflumic acid (6 capsules) divided throughout the day in cases of severe inflammation.

If you estimate that the action of Niflactol is not as expected, inform your doctor or pharmacist.

Children:

In children 12 years of age or older, the recommended dose is2 to3 capsules per day divided every 12 or 8 hours, that is, 500-750 mg of niflumic acid in 24 hours. The maximum daily dose should not exceed750 mgper day.

Seniors:

As with other NSAIDs, precautions should be taken when treating elderly patients since they are generally more prone to adverse effects and have a higher probability of presenting renal, cardiovascular, or hepatic function alterations and receiving concomitant medication. Specifically, it is recommended to use the lowest effective dose in these patients. Only after verifying good tolerance, the dose can be increased to reach the established dose in the general population.

Patients with kidney and/or liver diseases:

The use of niflumic acid is contraindicated in patients with severe renal and/or hepatic insufficiency. In patients with mild or moderate renal and/or hepatic insufficiency, it is recommended to use the lowest effective dose.

If you take moreNiflactol than you should

If you have taken Niflactol more than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If a severe intoxication has occurred, the doctor will take the necessary measures.

The most frequent symptoms in case of overdose are: gastrointestinal irritation, nausea, vomiting, diarrhea, and abdominal pain.

Other manifestations include: drowsiness and headache.

If you forgot to take Niflactol

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at its usual time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medication may cause side effects, although not everyone will experience them.

Gastrointestinal::

The most common side effects that occur with medications likeNiflactolare gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, the appearance of gastritis has been observed.

Cardiovascular:

Medications likeNiflactol,especially may be associated with a moderate increase in the risk of suffering a heart attack (“myocardial infarction”) or cerebral.

Dermatological::

Medications likeNiflactolmay be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Hepatic:

Medications like Niflactolmay be associated with liver disorders that cause yellowing of the skin and eyes, sometimes with high fever or swelling and sensitivity of the upper abdomen.

If any of the following reactions occur: yellowing of the skin or eyes, discontinue treatment and IMMEDIATELY report to the doctor.

Some effects are rare but serious.

You must discontinue treatment immediately and inform your doctor in the following cases:

• Allergic reactions:

• that affect the skin, such as rash, itching, severe skin reactions to sunlight or ultraviolet rays; rarely, vesicular lesions (blisters) on mucous membranes or skin,
• that affect the lungs, such as asthma attacks,
• generalized, such as anaphylactic shock.

• Gastrointestinal bleeding (loss of blood through the mouth or in stool, darkening of stool). These effects are more frequent with high doses.

• Exceptionally, severe skin infections have been observed in cases of varicella.

Additionally, some cases of duodenal ulcer and perforation have been observed.

There are other effects that require you to inform your doctor. Only he can tell you what to do in case of:

• Digestive alterations such as abdominal pain, vomiting, nausea, changes in bowel movements.
• Cases of bone alterations have been observed after treatment with high doses for several years.
• Certain changes in laboratory test results may require monitoring of blood counts or liver or kidney function.
• Violet spots on the skin.
• General discomfort with decreased blood pressure.
• Headache.
• Tinnitus.
• Drowsiness.
• Dizziness.
• Swelling of the extremities.
• Anorexia.

If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use Niflactol after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Niflactol

- The active ingredient is niflumic acid.

- The other components are cornstarch, talc, magnesium stearate.

- Composition of the capsule: gelatin, azorubine (E122).

Appearance of the product and contents of the packaging

Niflactol is presented in a package containing 30 capsules. Each capsule of Niflactol contains 250 mg of niflumic acid.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Local representative

NEWLINE PHARMA, S.L.U.

Calle Tarragona 151-157, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Responsible for manufacturing:

UPSA

304, Av. Dr. Jean Bru

F- 47000 – Agen

FRANCE

or

UPSA

979, Avenue des Pyrénées

47520 - Le Passage

France

Last review date of this leaflet:February 2023.

Other sources of information

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/