Package Insert: Information for the User

Naproxen Sodium Cinfa 550 mg Coated Tablets

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• Ifyou experienceadverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

Naproxeno belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxeno is indicated for the treatment of:

• Mild to moderate pain, treatment of symptoms of rheumatoid arthritis (inflammation of the joints, including those in the hands and feet, resulting in swelling and pain), osteoarthritis (a chronic disorder that causes cartilage damage), acute gout episodes, and ankylosing spondylitis (inflammation affecting the spine's joints).
• Menstrual pain.
• Relief of pain from acute migraine attacks.
• Pain secondary to bleeding associated with intrauterine devices (IUDs).

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

Do not take Naproxeno sódico cinfa

• If you are allergic to naproxen or naproxen sodium or to any of the other components of this medication (listed in section 6).
• If you know that you are allergic to acetylsalicylic acid or to other nonsteroidal anti-inflammatory drugs and/or cause severe allergic reactions such as: asthma, rhinitis, or nasal polyps.
• If you are taking other medications of this type (nonsteroidal anti-inflammatory drugs).
• If you currently have or have had more than once: a stomach ulcer or bleeding in the stomach or duodenum.
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you have ulcerative colitis (a bowel disease).
• If you have severe liver (liver dysfunction) or kidney (kidney dysfunction) disease.
• 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 Naproxeno sódico cinfa.

Be especially careful withNaproxenosódicocinfa:

• It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.
• If you have had or develop a stomach ulcer, bleeding, or perforation in the stomach or duodenum, which may manifest as 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 nonsteroidal anti-inflammatory drug.
• This risk is higher when using high doses and prolonged treatments, 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 protector medication.
• If you have or have had stomach problems, as naproxeno sódico can cause irritation, bleeding, or stomach ulcers. Your doctor will recommend the most suitable dose.
• If you have Crohn's disease or ulcerative colitis, as naproxeno sódico can worsen these conditions.
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxeno sódico can cause breathing difficulties (bronchospasm).

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

• If you are taking medications that alter blood clotting or increase the risk of ulcers, such as oral anticoagulants, or antiplatelet agents of the type of acetylsalicylic acid, to prevent blood clots. You should also inform your doctor about the use of other medications that may increase the risk of these bleeding events, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have or suspect that you have an infection, as naproxeno sódico can mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe black stools while taking naproxeno sódico, you should discontinue treatment with naproxeno sódico.
• If you experience visual disturbances during treatment.
• This medication should be used with caution in patients with low-sodium diets and a history of digestive problems.
• If you want to become pregnant, as naproxeno sódico can affect fertility.

Cardiovascular precautions

Medications likenaproxenosódicocan 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 using high doses and prolonged treatments. 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 this treatment with your doctor or pharmacist.

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

Severe skin reactions

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

Other medications andNaproxeno sódico cinfa

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

This is very important as naproxeno sódico can 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 can delay the action of naproxeno sódico, but do not affect the overall effect.
• Acetylsalicylic acid to prevent blood clots.
• Hydantoins (medications used primarily for epilepsy).
• Sulfonilureas (medications for diabetes).
• Sulfonamides (a type of diuretic medication).
• Methotrexate (an immunosuppressive medication).
• Beta-blockers (anti-hypertensive medication).
• Furosemide (a medication with natriuretic effect).
• Lithium. It can cause an increase in lithium plasma concentration.
• Glucocorticoids, naproxeno sódico can interfere with adrenal function tests.
• ACE inhibitors (anti-hypertensive medication).
• Angiotensin receptor blockers (anti-hypertensive medication).

You may need your doctor to adjust the dose of one of the two medications. Consult your doctor if you have any doubts about these points.

TakingNaproxenosódicocinfa with food and drinks:

Swallow the tablets with a sufficient amount of liquid (a glass of water), preferably during meals or immediately after eating, to reduce the likelihood of stomach discomfort.

Pregnancy, breastfeeding, and fertility

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

Naproxeno sódico should not be administered during pregnancy, childbirth, or breastfeeding.

Do not take this medication 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 tendency and that of your baby to bleed and delay or prolong delivery more than expected. Due to the association of naproxeno sódico administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimesters of pregnancy, except in cases where 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 week 20 of pregnancy, naproxeno 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 more than a few days, your doctor may recommend additional monitoring.

For fertile women, it should be noted that naproxeno sódico has been associated with a decrease in the ability to conceive.

Driving and operating machinery

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

Naproxeno sódico cinfa contains sodium

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

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

Your doctor will indicate the duration of your treatment with naproxeno sódico.

The recommended dose is:

Adults

The daily dose is 1 or 2 tablets of naproxeno sódico (550 mg or 1100 mg of naproxeno sódico). As an initial dose, it is recommended to administer 1 tablet (550 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 6 or 8 hours, depending on the intensity of the process.These doses may be modified at the indication of your doctor.

In the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitisThe initial dose is usually 1 tablet (550 mg of naproxeno sódico) taken twice a day (in the morning and at night) or 2 tablets (1100 mg of naproxeno sódico) taken once a day.

In the treatment of acute gout episodesThe initial dose is usually 1 and a half tablets (825 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 8 hours until you no longer feel pain. Consult your doctor about the duration of treatment.

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

In the treatment of migraine crisesThe initial dose is 1 and a half tablets (825 mg of naproxeno sódico) when you first experience symptoms, followed by half a tablet (275 mg of naproxeno sódico) when 30 minutes have passed since the initial dose.

In the treatment of menorrhagia (pain associated with excessive menstrual bleeding)The recommended dose for the first day of menstruation is between 1 and a half tablets and 2 and a half tablets (825 mg and 1375 mg of naproxeno sódico) divided into two doses per day. Continue with a dose of 1 or 2 tablets per day (550 mg or 1100 mg of naproxeno sódico) divided into two doses per day for a maximum of 4 days.

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

In patients over 65 years or with 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

This medication is not recommended for use in children under 16 years.

Administration form:

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 another liquid, preferably during or after meals.

Always take the lowest effective dose.

If you take more Naproxeno sódico cinfa than you should

If you have taken more naproxeno sódico 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, proceed with gastric lavage and initiate symptomatic treatment. The rapid administration of 50-100 g of activated charcoal in the form of a water suspension reduces the absorption of the medication.

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

If you forgot to take Naproxeno sódico cinfa

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Gastrointestinal disorders:

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

It may cause inflammation, bleeding (in some cases fatal, especially in older adults), peptic ulcers, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive system). Cases of esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach lining), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease have been observed. Also, cases of stomach acid, indigestion, abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools) have been observed.

Blood and lymphatic system disorders:

Granulocytosis (increase/decrease of certain white blood cells), aplastic and hemolytic anemia (reduction of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase of certain white blood cells in the blood), leucopenia (decrease of white blood cells in the blood), and thrombocytopenia (decrease of platelets).

Immune system disorders::

Anaphylactoid reactions (acute allergic reaction) and angioneuritic edema (inflammation of the skin, mucosa, and viscera).

Metabolism and nutrition disorders:

Hypercalcemia (increase of calcium concentration in the blood).

Psychiatric disorders:

Difficulty concentrating, depression, and sleep disturbances.

Nervous system disorders:

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

Eye disorders::

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

Ear and labyrinth disorders:

Auditory disturbances, tinnitus (ringing in the ears), and hearing loss.

Cardiac disorders::

Palpitations, congestive heart failure (heart's inability to pump blood), hypertension (high blood pressure). The medications like naproxen sodium 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 (yellow discoloration of the skin). The medications like naproxen sodium may be associated, in rare cases, to liver damage.

Skin and subcutaneous tissue disorders:

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

Musculoskeletal and connective tissue disorders:

Muscle pain and asthenia.

Renal and urinary disorders:

Blood in the urine, interstitial nephritis (renal inflammation with yellow-brown discoloration), nephrotic syndrome, renal disease, renal insufficiency, and papillary necrosis (death of cells forming the renal papillae due to metabolic alteration).

Reproductive and breast disorders:

Infertility.

General disorders and administration site conditions:

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

Complementary examinations:

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

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

Skin and subcutaneous tissue disorders:

Generalized skin eruption, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and affection of other body organs (drug reaction with eosinophilia and systemic symptoms known as DRESS). See also section 2.

A characteristic cutaneous allergic reaction known as fixed drug eruption, which generally reappears at the same site upon re-exposure to the drug and may appear as red, round, or oval patches and skin swelling, blisters (urticaria), and pruritus.

Reporting of adverse reactions

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

Keepthis medicationout of the sight andreach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofNaproxenosodiumcinfa

• The active ingredient is naproxeno sodium. Eachcoated tablet contains 550 mg of naproxeno sodium (equivalent to 500 mg of naproxeno).
• The other components are:

Core:microcrystalline cellulose, sodium lauryl sulfate, povidone, talc, magnesium stearate, sodium carboxymethyl cellulose (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 content of the container

Naproxeno sodium cinfa is presented in the form of an oblong, biconvex, coated, scored on one of its faces, tablet with the logo “N550C” and blue color.

PVC-PVDC /Aluminum blister.

Naproxeno sodium cinfa is presented in containers of 10, 40 or 500 coated tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:July 2024

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

You can access detailed and updated information about this medication 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