Package Insert: Information for the Patient

Naproxen Sodium TAD 550mg Coated Tablets EFG

Read this 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.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Naproxeno sódico TAD contains naproxeno sódico as its active ingredient, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Naproxeno sódico TAD is indicated for:

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

Do not take Naproxeno sódico TAD

• if you are allergic to naproxeno sódico or any of the other components of this medication (listed in section 6)
• if you have experienced difficulty breathing (asthma), urticaria, or inflammation of the nasal mucous membrane (rhinitis) when taking acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs)
• if you currently have or have had more than one occasion: a stomach ulcer or gastrointestinal bleeding
• if you have had previous gastrointestinal bleeding or have suffered a perforation while taking a nonsteroidal anti-inflammatory drug
• if you have severe heart failure
• if you are in the third trimester of pregnancy
• if you have ulcerative colitis (a gastrointestinal disease)
• if you have severe liver (hepatic) or kidney (renal) disease
• if you are taking other medications of this type (nonsteroidal anti-inflammatory drugs)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Naproxeno sódico TAD.

• It is essential to use the lowest effective dose for the shortest duration necessary to control your symptoms.
• If you have had or develop a stomach ulcer, bleeding, or perforation, you may experience intense or persistent abdominal pain and/or black stools, or even no previous warning symptoms.
• If you have had previous gastrointestinal bleeding or have suffered a perforation of the digestive system while taking a nonsteroidal anti-inflammatory drug.
• This risk is higher when using high doses and prolonged treatments, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider associating a stomach protector medication.
• If you have or have had stomach problems, as Naproxeno sódico TAD 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 like Naproxeno sódico TAD may worsen these conditions.
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as Naproxeno sódico TAD may 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 like acetylsalicylic acid. 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 or suspect you have an infection, as Naproxeno sódico TAD may mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe black stools while taking Naproxeno sódico TAD, you should discontinue treatment.
• If you experience vision disturbances during treatment.
• This medication should be used with caution in patients with a low-sodium diet and a history of gastrointestinal problems.

Naproxeno sódico TAD may affect fertility. Inform your doctor if you are planning to become pregnant or have difficulty becoming pregnant.

Medications like Naproxeno sódico TAD may be associated with a moderate increase in the risk of heart attacks 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.

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

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

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

Other medications and Naproxeno sódico TAD

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those obtained without a prescription.

As a result of interactions with some other medications, the effect of Naproxeno sódico TAD or these medications may increase or decrease. This occurs with:

Taking Naproxeno sódico TAD with food and beverages

Take the tablets with sufficient liquid and preferably with food.

Pregnancy, lactation, and fertility

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

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

Due to the association of administering medications like Naproxeno sódico TAD with an increased risk of congenital anomalies, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except when 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 sódico TAD may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

In the third trimester, administering Naproxeno sódico TAD is contraindicated. 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.

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

Driving and operating machines

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

Naproxeno sódico TAD contains sodium

This medication contains 50 mg of sodium (the main component of table salt/for cooking) in each dose unit. This corresponds to 2.5% of the maximum daily sodium intake recommended for an adult.

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

Adults and children over 16 years old

The usual daily dose is 1 or 2 tablets (550 mg or 1100 mg of naproxen sodium). The recommended 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, depending on the intensity of the process. These doses may be modified as indicated by your doctor.

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:

The recommended initial dose is 550 mg of naproxen sodium (1 tablet) taken twice a day (in the morning and in the evening) or 1100 mg of naproxen sodium (2 tablets) taken once a day.

Acute gout attack

The recommended initial dose is 825 mg of naproxen sodium (1 and a half tablets), followed by 275 mg of naproxen sodium (half a tablet) every 8 hours until the attack decreases.

Menstrual cramps (dysmenorrhea)

The recommended initial dose is 550 mg of naproxen sodium (1 tablet), followed by 275 mg of naproxen sodium (half a tablet) every 6-8 hours if necessary.

Migraines

The recommended initial dose is 825 mg of naproxen sodium (1 and a half tablets) when the first symptoms appear, followed by 275 mg of naproxen sodium (half a tablet), half an hour later.

Menorrhagia (pain associated with excessive menstrual bleeding)

The recommended daily dose for the first day is between 825 mg (1 and a half tablets) and 1375 mg of naproxen sodium (2 and a half tablets) divided into two doses, followed by a daily dose of between 550 mg (1 tablet) and 1100 mg of naproxen sodium (2 tablets) divided into two doses, for a maximum period of four days.

Use in children and adolescents under 16 years old

Naproxen sodium TAD is not recommended for use in children and adolescents under 16 years old.

Seniors

The dose should be reduced in elderly patients and the lowest effective dose should be used for the shortest duration possible. Consult your doctor or pharmacist.

Patients with kidney and/or liver problems

If you have kidney and/or liver problems, the dose should be reduced and the lowest effective dose should be used for the shortest duration possible. Consult your doctor or pharmacist.

Administration form:

This medication is taken orally.

The tablet can be divided into equal doses.

Swallow the tablets with a glass of water, preferably with food.

Always take the lowest dose that is effective.

If you take more Naproxen sodium TAD than you should

If you have taken more Naproxen sodium TAD 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 to gastric lavage and initiate symptomatic treatment. The rapid administration of 50-100 grams 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 Toxicology Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Naproxen sodium TAD

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

Take the medication at the same time every day. If you forget to take the medication at the scheduled time, take it as soon as you remember.

If you interrupt treatment with Naproxen sodium TAD

If you take naproxen sodium for short-term pain relief, you can stop taking it as soon as you no longer need it. When a long-term treatment is prescribed, consult your doctor before stopping treatment.

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.

If you notice the appearance of the following side effects, stop taking naproxen and consult your doctor immediately (unknown frequency: cannot be estimated from available data):

• Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ damage (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See section 2.
• A characteristic skin allergic reaction known as fixed drug eruption, which usually reappears in the same location when exposed to the medication again and can be seen as red, round, or oval patches and skin swelling, blisters (urticaria), and itching.

The side effects that may occur during treatment with this medication, and which have been observed with a very rare frequency (in less than 1 in 10,000 patients) are:

Gastrointestinal disorders:The most common 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 the elderly), 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, dyspepsia (digestive disorders),abdominal pain, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools) have been observed.

Blood and lymphatic system disorders:agranulocytosis (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), thrombocytopenia (decrease of platelets).

Immune system disorders:anaphylactoid reactions (acute allergic reactions), angioneuritic edema (inflammation of the skin, mucosa, and viscera).

Metabolism and nutrition disorders:hypercalcemia (elevated calcium levels in the blood).

Mental disorders:difficulty concentrating, depression, sleep disturbances.

Nervous system disorders:dizziness, somnolence, headaches, sensation of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), convulsions, insomnia.

Eye disorders:vision disturbances, corneal opacity, papillitis (inflammation of the papilla), retrobulbar optic neuritis (inflammation of the optic nerve), and papillary edema.

Ear and labyrinth disorders:hearing disturbances, tinnitus (ringing in the ears), hearing loss.

Cardiac disorders:palpitations, congestive heart failure (heart's inability to pump blood), hypertension (high blood pressure). 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), edema.

Respiratory, thoracic, and mediastinal disorders:asthma, eosinophilic pneumonitis, dyspnea (shortness of breath), pulmonary edema.

Infections and infestations:aseptic meningitis.

Hepatobiliary disorders:hepatitis (inflammation of the liver), jaundice (yellow discoloration of the skin).

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

Musculoskeletal, connective tissue, and bone disorders:muscle pain, asthenia.

Renal and urinary disorders:blood in the urine, interstitial nephritis (renal inflammation with yellow-brown discoloration), nephrotic syndrome, renal disease, renal insufficiency, 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, hyperkalemia.

Medications like naproxen sodium with a rare frequency (may affect up to 1 in 1,000 people) may be associated with liver damage.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side 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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store the blister pack in the outer packaging to protect it from light.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Naproxeno sódico TAD

-The active ingredient is naproxeno sódico. Each coated tablet contains 550 mg of naproxeno sódico, equivalent to 500 mg of naproxeno.

-The other components (excipients) are: povidone K30, microcrystalline cellulose, talc, and magnesium stearate in the tablet core. The film coating contains hypromellose, titanium dioxide (E171), macrogol 8000, and indigo carmine (E132). See section 2 “Naproxeno sódico TAD contains sodium”.

Appearance of the product and contents of the package

The tablets are oval, slightly biconvex, scored on one side, blue, and film-coated. Dimensions 18 x 8 mm.

The tablet can be divided into equal doses.

The film-coated tablets are available in packages of 10x1, 16x1, 30x1, 40x1, and 60x1 tablets in blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Responsible manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet: September 2024

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