NAPROXEN SODIUM CINFA 550 mg TABLETS

2. What you need to know before starting to take Naproxen Sodium Cinfa

It is essential to use the smallest dose that relieves-controls the pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Naproxen Sodium Cinfa

• If you are allergic to naproxen or naproxen sodium or any of the other components of this medication (listed in section 6).
• If you know you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs and/or they cause severe allergic reactions such as asthma, rhinitis, or nasal polyps.
• If you are taking other medications of this type (non-steroidal anti-inflammatory drugs).
• If you currently have or have had more than one occasion: a stomach or duodenal ulcer or bleeding.
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you have ulcerative colitis (an intestinal disease).
• If you have severe liver (liver disorders) or kidney (kidney disorders) failure.
• If you are in the third trimester of pregnancy.
• If you have severe heart failure.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Naproxen Sodium Cinfa.

Be particularly careful with Naproxen Sodium Cinfa:

• It is essential to use the smallest dose that relieves-controls the pain and not to take this medication for longer than necessary to control your symptoms.
• If you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• If you have or have had stomach problems, as naproxen sodium may cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most suitable dose.
• If you have Crohn's disease or ulcerative colitis, as medications of the naproxen sodium type may worsen these conditions.
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen sodium may cause breathing difficulties (bronchospasm).

• If you have severe kidney, liver, or heart problems.

• If you take medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type, to prevent blood clots. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have or suspect you have an infection, as naproxen sodium may mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe that your stools appear black when taking naproxen sodium, you should interrupt treatment with naproxen sodium.
• If you experience vision disorders during treatment.
• This medication should be used with caution in patients who have a low-salt diet and a history of digestive problems.
• If you wish to become pregnant, as naproxen sodium may affect fertility.

Cardiovascular precautions

Medications like naproxen sodium may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. 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 (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Severe skin reactions

There have been reports of severe skin reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), associated with naproxen. Stop taking naproxen and consult your doctor immediately if you observe any of the symptoms related to severe skin reactions described in section 4.

Other medications and Naproxen Sodium Cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

This is very important, as naproxen sodium may alter the way other medications work. It is essential to inform your doctor if you take any of the following medications:

• Antacids or cholestyramine, as they may delay the action of naproxen sodium, but do not affect the total effect.
• Acetylsalicylic acid to prevent blood clots.
• Hydantoins (medications used primarily for epilepsy).
• Sulfonylureas (medications for diabetes).
• Sulfonamides (a type of diuretic medication).
• Methotrexate (an immunosuppressive medication).
• Betablockers (antihypertensive medication).
• Furosemide (medication with a natriuretic effect).
• Lithium. It may cause an increase in lithium plasma concentration.
• Corticosteroids, as naproxen sodium may interfere with adrenal function tests.
• ACE inhibitors (angiotensin-converting enzyme inhibitors, antihypertensive medication).
• Angiotensin receptor blockers or antagonists (antihypertensive medications).

It may be necessary for your doctor to modify the dose of one of the two medications. Consult your doctor if you have any questions about these points.

Taking Naproxen Sodium Cinfa with food and beverages:

Take the tablets with a sufficient amount of liquid (a glass of water), preferably during or after meals, to reduce the possibility of stomach discomfort.

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.

Naproxen sodium should not be administered during pregnancy, childbirth, or breastfeeding.

Do not take this medication 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 your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. Since the administration of medications of the naproxen sodium type has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary and as indicated by your doctor. In these cases, the dose and duration will be limited to the minimum possible. From the 20th week of pregnancy, naproxen 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 you need treatment for more than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medications of the naproxen sodium type have been associated with a decrease in fertility.

Driving and using machines

Naproxen sodium should be used with caution in patients whose activity requires attention and who have observed dizziness or visual disturbances during treatment with this medication.

Naproxen Sodium Cinfa contains sodium

This medication contains 51 mg of sodium (the main component of table salt/cooking salt) per tablet. This is equivalent to 2.54% of the maximum recommended daily sodium intake for an adult.

3. How to take Naproxen Sodium Cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with naproxen sodium.

The recommended dose is:

Adults

The daily dose is 1 or 2 tablets of naproxen sodium (550 mg or 1100 mg of naproxen sodium). The initial dose is usually 1 tablet (550 mg of naproxen sodium) followed by half a tablet (275 mg of naproxen sodium) every 6 or 8 hours, depending on the intensity of the process. These doses may be modified by your doctor.

In the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: the initial dose is usually 1 tablet (550 mg of naproxen sodium) taken twice a day (morning and night) or 2 tablets (1100 mg of naproxen sodium) taken once a day.

In the treatment of acute episodes of gout: the initial dose is usually 1 and a half tablets (825 mg of naproxen sodium) followed by half a tablet (275 mg of naproxen sodium) every 8 hours until the pain is relieved. Consult your doctor about the duration of treatment.

In the treatment of dysmenorrhea (menstrual pain): the initial dose is 1 tablet (550 mg of naproxen sodium) followed by half a tablet (275 mg of naproxen sodium) every 6 or 8 hours.

In the treatment of migraine attacks: the initial dose is 1 and a half tablets (825 mg of naproxen sodium) when the first symptoms appear, followed by half a tablet (275 mg of naproxen sodium) after half an hour of the initial intake.

In the treatment of menorrhagia (pain associated with excessive menstrual bleeding): the recommended dose on the first day of menstruation is between 1 and a half and 2 and a half tablets (825 mg and 1375 mg of naproxen sodium) divided into two daily doses. Continue with a dose of 1 or 2 tablets per day (550 mg or 1100 mg of naproxen sodium) divided into two daily doses for the next 4 days at most.

Use in patients over 65 years or with kidney and/or liver disease

In patients over 65 years or if you suffer from kidney or liver disease, it is recommended to reduce the dose and use the lowest effective dose for the shortest possible time. Consult your doctor.

Use in children and adolescents

The use of this medication is not recommended in children under 16 years.

Method of administration:

This medication is taken orally.

The tablet can be divided into equal doses.

Swallow the tablets with a sufficient amount of liquid, a glass of water or other liquid, preferably during or after meals.

Always take the lowest effective dose.

If you take more Naproxen Sodium Cinfa than you should

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

The symptoms of overdose are characterized by drowsiness, stomach burning, indigestion, nausea, vomiting, and in some cases, convulsions.

In case of accidental or intentional overdose, gastric lavage should be performed, and symptomatic treatment should be initiated. The rapid administration of 50-100 g of activated charcoal in the form of an aqueous suspension reduces the absorption of the medication.

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

If you forget to take Naproxen Sodium Cinfa

Do not take a double dose to make up for forgotten doses. Take the dose as soon as you remember and continue with the next dose.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The adverse effects that may occur during treatment with this medicine, and which have been observed with a very rare frequency (may affect up to 1 in 10,000 patients), are:

Gastrointestinal disorders:

The most frequent adverse effects observed with sodium naproxen are of a gastrointestinal nature (affecting the stomach and intestine).

Inflammation, bleeding (in some cases fatal, especially in elderly people), peptic ulcers, perforation, and obstruction of the upper or lower part of the gastrointestinal tract (digestive system) may occur. Cases of esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach mucosa), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease have been observed. Additionally, cases of stomach acidity, dyspepsia (digestive disorders), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black-colored stools) have been reported.

Disorders of the blood and lymphatic system:

Agranulocytosis (increase/decrease in certain white blood cells), aplastic and hemolytic anemia (reduction in the number of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase in certain white blood cells in the blood), leukopenia (decrease in the number of leukocytes in the blood), and thrombocytopenia (decrease in the number of platelets).

Disorders of the immune system:

Anaphylactoid reactions (acute allergic reaction) and angioedema (inflammation of the skin, mucous membranes, and viscera).

Disorders of metabolism and nutrition:

Hypercalcemia (increased calcium concentration in the blood).

Psychiatric disorders:

Difficulty concentrating, depression, and sleep disturbances.

Disorders of the nervous system:

Dizziness, somnolence, headaches, feeling of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), convulsions, and insomnia.

Ocular disorders:

Visual disturbances, corneal opacity, papillitis (inflammation of the papilla), retrobulbar optic neuritis (inflammation of the optic nerve), and papillary edema.

Disorders of the ear and labyrinth:

Hearing disturbances, tinnitus (ringing in the ears), and hypoacusis (decreased hearing).

Cardiac disorders:

Palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines like sodium naproxen may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Vascular disorders:

Vasculitis (inflammation of blood vessels) and edema.

Respiratory, thoracic, and mediastinal disorders:

Asthma, eosinophilic pneumonitis, dyspnea (shortness of breath), and pulmonary edema.

Infections and infestations:

Aseptic meningitis.

Hepatobiliary disorders:

Hepatitis (inflammation of the liver), jaundice (yellowing of the skin). Medicines like sodium naproxen may be associated, in rare cases, with liver damage.

Disorders of the skin and subcutaneous tissue:

Cutaneous hemorrhage, itching, capillary hemorrhage, skin eruptions, sweating, alopecia, skin desquamation, lichen planus (skin disease with small, flat nodules), pus vesicle reaction, skin redness, systemic lupus erythematosus (autoimmune disease with characteristic skin signs, rash, and skin redness), severe blistering reactions such as Stevens-Johnson syndrome (skin rash with a map-like appearance) and toxic epidermal necrolysis, allergy, photosensitivity reactions including rare cases where the skin takes on a appearance of porphyria cutanea tarda, pseudoporphyria (liver enzyme defect), or epidermolysis bullosa. If cutaneous fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Musculoskeletal and connective tissue disorders:

Muscle pain and muscle asthenia.

Renal and urinary disorders:

Blood in the urine, interstitial nephritis (renal inflammation with yellow-brown discoloration), nephrotic syndrome, kidney disease, renal failure, renal papillary necrosis (death of the cells that form the renal papillae due to altered metabolism).

Disorders of the reproductive system and breast:

Infertility.

General disorders and administration site conditions:

General malaise, pyrexia (chills and fever), thirst, sore throat.

Investigations:

Abnormal values of liver function tests, elevated serum creatinine, hyperpotassemia.

The adverse effects that may occur during treatment with this medicine, and which have been observed with an unknown frequency (cannot be estimated from the available data), are:

Disorders of the skin and subcutaneous tissue:

Generalized skin eruption, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and affectation of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.

A characteristic allergic skin reaction known as fixed drug eruption, which usually reappears in the same location upon re-exposure to the medicine and may appear as red, round, or oval patches and skin swelling, blisters (urticaria), and itching.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Naproxen Sodium Cinfa

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that are no longer needed at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofNaproxenSodiumCinfa

• The active ingredient is sodium naproxen. Each film-coated tablet contains 550 mg of sodium naproxen (equivalent to 500 mg of naproxen).
• The other ingredients are:

Core:microcrystalline cellulose, sodium lauryl sulfate, povidone, talc, magnesium stearate, sodium carboxymethyl starch (type A) (from potato), and purified water.

Coating:macrogol 400/titanium dioxide (E-171)/hypromellose (Opadry Y-1-7000), indigo carmine lake (E-132), and macrogol 6000.

Appearance of the Product and Package Contents

Naproxen Sodium Cinfa is presented in the form of an oblong, biconvex, film-coated tablet, scored on one side, with the logo "N550C" and blue in color.

PVC-PVDC/Aluminum blister pack.

Naproxen Sodium Cinfa is available in packages of 10, 40, or 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet:July 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65730/P_65730.html

QR code to: https://cima.aemps.es/cima/dochtml/p/65730/P_65730.html