Naproxen sodium Cinfa 550 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Naproxen sodium cinfa 550 mg film-coated tablets EFG

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

• Keep this leaflet, as 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 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.

Contents of the leaflet

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

1. What Naproxeno Sódico Cinfa is and what it is used for

Naproxen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Naproxen is indicated for the treatment of:

• Mild to moderate pain, and relief of symptoms of rheumatoid arthritis (inflammation of the joints, usually affecting those of the hands and feet, causing swelling and pain), osteoarthritis (a chronic disorder causing damage to cartilage), acute gout attacks, and ankylosing spondylitis (inflammation affecting the joints of the spine).
• Menstrual pain.
• Relief of pain during acute migraine attacks.
• Pain secondary to bleeding associated with intrauterine devices (IUDs).

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

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

Do not take Naproxen Sodium cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Naproxen Sodium cinfa.

Take special care with Naproxen Sodium cinfa:

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

• 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.

• If you have previously had stomach or duodenal bleeding or have experienced 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 ulcer, and in elderly patients. In these cases, your doctor may consider adding a stomach-protective medicine.

• If you have or have previously had stomach problems, as sodium naproxen may cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most appropriate dose.

• If you have Crohn's disease or ulcerative colitis, as medicines like sodium naproxen may worsen these conditions.

• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as sodium naproxen may cause breathing difficulties (bronchospasm).

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

• If you are taking medicines that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid, to prevent blood clots. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

• If you have or suspect you have an infection, as sodium naproxen may mask the usual signs and symptoms of infectious processes.

• If you experience stomach pain and/or notice black stools while taking sodium naproxen, you should stop treatment with sodium naproxen.

• If you experience vision disturbances during treatment.

• This medicine should be used with caution in patients on a low-salt diet and with a history of digestive problems.

• If you are planning to become pregnant, as sodium naproxen may affect fertility.

Cardiovascular precautions

Medicines such as sodium naproxen may be associated with a moderate increase in the risk of heart attacks ("myocardial infarction") or strokes. 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 of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

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

Serious skin reactions

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

Other medicines and Naproxen Sodium cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

This is very important because sodium naproxen may alter how other medicines work. It is important that you inform your doctor if you are taking any of the following medicines:

• Antacids or cholestyramine, as they may delay the action of sodium naproxen, but do not affect the overall effect.
• Acetylsalicylic acid used to prevent blood clots.
• Hydantoins (medicines mainly used for epilepsy).
• Sulfonylureas (medicines for diabetes).
• Sulfonamides (a type of diuretic medicine).
• Methotrexate (an immunosuppressive medicine).
• Beta-blockers (antihypertensive medicine).
• Furosemide (a medicine with natriuretic effect).
• Lithium. May cause an increase in plasma lithium concentration.
• Steroids, sodium naproxen may interfere with adrenal function tests.
• ACE inhibitors (Angiotensin-Converting Enzyme inhibitors, antihypertensive medicine).
• Angiotensin receptor antagonists or blockers (antihypertensive medicines).

Your doctor may need to adjust the dose of one or both medicines. Consult your doctor if you have any doubts about these points.

Taking Naproxen Sodium cinfa with food and drink:

Take the tablets with sufficient liquid (a glass of water), preferably during or immediately 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 medicine.

Sodium naproxen should not be administered during pregnancy, childbirth, or breastfeeding.

Do not take this medicine during the last 3 months of pregnancy, as it could 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 may delay or prolong labor more than expected. Because the use of medicines like sodium naproxen has been associated with an increased risk of congenital abnormalities or miscarriage, administration is not recommended during the first and second trimesters of pregnancy unless strictly necessary and as directed by your doctor. In such cases, the dose and duration will be limited to the minimum possible. From week 20 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

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

Driving and using machines

Sodium naproxen should be used with caution in patients whose activities require alertness and who have experienced dizziness or visual disturbances during treatment with this medicine.

Naproxen Sodium cinfa contains sodium

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

3. How to take Naproxen Sodium cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine 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). As initial dose, it is recommended to take 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 severity of the condition. These doses may be adjusted at your doctor's discretion.

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

In the treatment of acute gout attacks: the usual initial dose is one and a half tablets (825 mg of naproxen sodium), followed by half a tablet (275 mg of naproxen sodium) every 8 hours until pain subsides. Consult your doctor regarding 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 one and a half tablets (825 mg of naproxen sodium) at the onset of symptoms, followed by half a tablet (275 mg of naproxen sodium) half an hour after the first dose.

In the treatment of menorrhagia (pain associated with excessive menstrual bleeding): the recommended dose on the first day of menstruation is between one and a half and two 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 daily (550 mg or 1100 mg of naproxen sodium), divided into two daily doses, for up to the following 4 days.

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

In patients aged 65 years or older, or if you have 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 medicine is not recommended for use in children under 16 years of age.

Method of administration:

This medicine is taken orally.

The tablet may be divided into equal doses.

Swallow the tablets with a sufficient amount of liquid, such as a glass of water or another 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, contact your doctor or pharmacist immediately.

Symptoms of overdose include drowsiness, stomach burning, indigestion, nausea, vomiting, and in some cases, seizures.

In case of accidental or intentional overdose, gastric lavage should be performed and symptomatic treatment initiated. Rapid administration of 50–100 g of activated charcoal as an aqueous suspension reduces drug absorption.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Naproxen Sodium cinfa

Do not take a double dose to make up for a missed dose. Take the dose as soon as you remember, and then continue with your next scheduled dose.

4. Possible adverse effects

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

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

Gastrointestinal disorders:

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

Inflammation, bleeding (in some cases fatal, especially in elderly patients), peptic ulcers, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive system) may occur. 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. Cases of stomach acidity, dyspepsia (digestive disturbances), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools) have also been reported.

Blood and lymphatic system disorders:

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), leucopenia (decrease in the number of white blood cells in the blood), and thrombocytopenia (decrease in the number of platelets).

Immune system disorders:

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

Metabolism and nutrition disorders:

Hypercalcemia (increased concentration of calcium in the blood).

Psychiatric disorders:

Difficulty concentrating, depression, and sleep disturbances.

Nervous system disorders:

Dizziness, somnolence, headache, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), seizures, and insomnia.

Eye disorders:

Visual disturbances, corneal opacity, papillitis (inflammation of the optic disc), retrobulbar optic neuritis (inflammation of the optic nerve), and papilledema.

Ear and labyrinth disorders:

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

Cardiac disorders:

Palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines such as naproxen sodium may be associated with a moderate increase in the risk of 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 such as naproxen sodium may rarely be associated with liver damage.

Skin and subcutaneous tissue disorders:

Cutaneous hemorrhage, pruritus (itching), capillary hemorrhage, skin rashes, sweating, alopecia (hair loss), skin desquamation, lichen planus (a skin disease characterized by small, flat nodules), pustular reactions, skin redness, systemic lupus erythematosus (an autoimmune disease with typical skin signs such as rash and redness), and very severe blistering reactions such as Stevens-Johnson syndrome (a map-like skin rash) and toxic epidermal necrolysis. Allergic reactions, photosensitivity reactions including rare cases where the skin resembles porphyria cutanea tarda, pseudoporphyria (defect in liver enzymes), or epidermolysis bullosa may also occur. If skin fragility, blister formation, or other symptoms suggestive of pseudoporphyria occur, treatment must be discontinued and the patient closely monitored.

Musculoskeletal and connective tissue disorders:

Muscle pain and muscular asthenia.

Renal and urinary disorders:

Blood in urine, interstitial nephritis (kidney inflammation with brownish-yellow discoloration), nephrotic syndrome, nephropathy (kidney disease), renal failure, and renal papillary necrosis (death of cells forming the renal papillae due to metabolic disturbances).

Reproductive system and breast disorders:

Infertility.

General disorders and administration site conditions:

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

Additional investigations:

Abnormal liver function tests, elevated serum creatinine, hyperkalemia.

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

Skin and subcutaneous tissue disorders:

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

A characteristic skin allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the drug and may present as round or oval red patches, 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Naproxen Sódico cinfa

• The active substance is naproxen sodium. Each film-coated tablet contains 550 mg of naproxen sodium (equivalent to 500 mg of naproxen).
• The other components 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 medicinal product and contents of the pack

Naproxen Sódico cinfa is presented as an oblong, biconvex, film-coated tablet, scored on one side, bearing the logo “N550C” and blue in colour.

PVC-PVDC/Aluminum blister.

Naproxen Sódico cinfa is available in packs containing 10, 40, or 500 film-coated tablets.

Only certain pack 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 most recent revision of this leaflet: July 2024

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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