Niflactol 250 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Niflactol 250 mg Capsules

Niflumic acid

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

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

Leaflet contents

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

1. What Niflactol is and what it is used for

Niflactol belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (to reduce inflammation) and non-steroidal antirheumatic drugs (for the treatment of rheumatism).

Niflactol is indicated in adults and children over 12 years of age:

• for long-term treatment of:

  . certain types of chronic inflammatory rheumatism,

  . certain types of osteoarthritis.

• for short-term treatment of pain in acute osteoarthritis and certain types of inflammation of joint structures, such as tendinitis and bursitis.

• for the treatment of pain caused by inflammation of the throat, ears, or mouth.

This medicine should be taken under medical supervision.

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

It is important that you use the smallest dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms.

Do not take Niflactol

• If you are in the third trimester of pregnancy.
• If you have a history of allergy or asthma triggered by this medicine or similar medicines, particularly other non-steroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid (aspirin).
• If you are allergic (hypersensitive) to niflumic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have severe heart failure.
• In children under 12 years of age.

Take special care with Niflactol if:

• You have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider adding a stomach-protective medicine.
• You experience symptoms of allergy to this medicine, especially asthma attacks or swelling of the face or neck (see section 4. Possible side effects). STOP 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 medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular check-ups. Your doctor will advise you on how often these checks should occur.
• You have an infection. Close monitoring is required.
• You have chickenpox. Taking this medicine is not recommended, as serious skin infections may exceptionally occur.

Tell your doctor:

• If you are taking medicines that affect blood clotting, such as corticosteroids, oral anticoagulants, or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn’s disease or ulcerative colitis, as medicines like Niflactol may worsen these conditions.
• If you have a history of gastrointestinal disorders (hiatal hernia, gastrointestinal bleeding, previous gastric or duodenal ulcer).
• If you have heart, liver, or kidney disease.
• If you have asthma, as in some patients asthma attacks may be related to allergy to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs. This medicine is contraindicated in such 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 had or are about to have heart surgery.

Cardiovascular precautions

Medicines like Niflactol may be associated with a moderate increase in the risk of heart attacks ("myocardial infarction") or stroke. This risk is more likely when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss this treatment with your doctor or pharmacist.

These medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension). Your doctor will closely monitor your blood pressure at the start of treatment with Niflactol and throughout the treatment.

Children

Do not give to children under 12 years of age.

Other medicines and Niflactol

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, if you are taking any of the following medicines:

• Painkillers and other non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin) and other salicylates (which reduce pain and inflammation), without consulting your doctor.

• Oral anticoagulants of the dicoumarol type (acenocoumarol, warfarin).

• Antiplatelet agents such as ticlopidine, clopidogrel, tirofiban, eptifibatide, and abciximab, iloprost, including those containing acetylsalicylic acid (to prevent blood clot formation).

• Unfractionated heparins, low molecular weight heparins, and related medicines, as their use with Niflactol may increase the risk of bleeding.

• Thrombolytics (medicines that dissolve or break down blood clots).

• Oral corticosteroids.

• Antidepressants, especially serotonin reuptake inhibitors, and lithium.

• Methotrexate (used in the treatment of cancer and rheumatoid arthritis).

• Medicines that increase blood potassium: potassium salts, potassium-sparing diuretics, angiotensin II inhibitors, angiotensin-converting enzyme inhibitors, low molecular weight heparins, cyclosporine, tacrolimus, trimethoprim.

• Diuretics: furosemide and other thiazide diuretics (for urine elimination).

• Medicines to lower blood pressure: such as angiotensin-converting enzyme inhibitors, angiotensin II enzyme inhibitors, and beta-blockers.

• Cyclosporine, tacrolimus (used to prevent organ transplant rejection).

• Medicines for diabetes.

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Precautions during pregnancy and in women of childbearing age

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

For women of childbearing age, it should be noted that medicines like Niflactol have been associated with a reduced ability to conceive.

Breastfeeding

This medicine is excreted in breast milk. As a precaution, its use should be avoided during breastfeeding.

Consult your doctor or pharmacist before taking this medicine.

Driving and use of machines

Dizziness and drowsiness have occasionally been reported in patients taking Niflactol.

Do not drive or operate machinery if you experience dizziness and/or drowsiness while using Niflactol.

Niflactol contains azorubine and sodium

This medicine may cause allergic reactions as it contains azorubine (E122).

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take Niflactol

Follow exactly the administration instructions for Niflactol provided by your doctor. If in 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 symptoms. In general, the recommended daily dose is 1 capsule every 4 or 6 hours, taken throughout the day. The maximum recommended daily dose is 1000 mg. The dose may be increased to 1500 mg of niflumic acid (6 capsules) distributed throughout the day in cases of severe inflammation.

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

Children:

For children aged 12 years and older, the recommended dose is 2 to 3 capsules per day, taken every 12 or 8 hours, i.e., 500–750 mg of niflumic acid in 24 hours. The maximum daily dose should not exceed 750 mg per day.

Elderly:

As with other NSAIDs, caution should be exercised when treating elderly patients, as they are generally more susceptible to adverse effects and are more likely to have impaired renal, cardiovascular, or hepatic function and to be receiving concomitant medication. Specifically, it is recommended to use the lowest effective dose in these patients. Only after confirming good tolerance may the dose be increased to that established for the general population.

Patients with kidney and/or liver disease:

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

If you take more Niflactol than you should

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

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

If a severe poisoning 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 forget to take Niflactol

Do not take a double dose to make up for missed doses.

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Gastrointestinal:

The most frequent adverse effects associated with medicines such as Niflactol are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been reported.

Cardiovascular:

Medicines such as Niflactol may be associated, especially, with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Dermatological:

Medicines such as Niflactol may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Hepatic:

Medicines such as Niflactol may be associated with liver disorders causing yellowing of the skin and eyes, sometimes accompanied by high fever or swelling and tenderness in the upper abdomen.

If any of the following reactions occur: yellowing of the skin or eyes, stop treatment and inform your doctor IMMEDIATELY.

Some effects are rare but serious.

You must stop treatment immediately and contact your doctor if you experience:

• Allergic reactions:

• affecting the skin, such as rash, itching, severe skin reactions upon exposure to sunlight or ultraviolet rays; rarely, vesicular lesions (blisters) on mucous membranes or skin,

• affecting the lungs, such as asthma attacks,

• generalized reactions, such as anaphylactic shock.

• Gastrointestinal bleeding (bleeding from the mouth or in stool, dark-colored stools). These effects are more frequent with high doses.

• Very rarely, severe skin infections have been observed in cases of chickenpox.

In addition, cases of duodenal ulcer and perforation have been observed.

Other effects require that you inform your doctor. Only your doctor can advise you on what to do if you experience:

• Gastrointestinal disturbances such as abdominal pain, vomiting, nausea, changes in bowel habits.
• Cases of bone abnormalities have been observed after treatment with high doses over several years.
• Certain changes in laboratory test results might require monitoring of blood counts or liver or kidney function.
• Purple spots on the skin.
• General malaise with decreased blood pressure.
• Headache.
• Tinnitus (ringing in the ears).
• Somnolence.
• Dizziness.
• Swelling of the limbs.
• Anorexia.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Niflactol

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use Niflactol after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Niflactol

• The active substance is niflumic acid.
• The other components are corn starch, talc, and magnesium stearate.
• Capsule composition: gelatin, azorubine (E122).

Appearance of the medicine and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Local representative

NEWLINE PHARMA, S.L.U.

Calle Tarragona 151-157, 11th Floor, Door 1, Block A

08014 Barcelona (Spain)

Tel.: 931851380

Manufacturer:

UPSA

304, Av. Dr. Jean Bru

F- 47000 – Agen

FRANCE

or

UPSA

979, Avenue des Pyrénées

47520 - Le Passage

France

Date of the most recent revision of this leaflet: February 2023.

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/