NAPROXEN SODIUM TAD 550 MG FILM-COATED TABLETS

2. What you need to know before taking Naproxen Sodium TAD

Do not take Naproxen Sodium TAD

• if you are allergic to naproxen sodium or any of the other components of this medication (listed in section 6)
• if you have experienced difficulty breathing (bronchial asthma), hives, or inflammation of the nasal mucosa (rhinitis) when taking acetylsalicylic acid and other non-steroidal anti-inflammatory medications (NSAIDs, non-steroidal anti-rheumatics)
• if you currently have or have had more than one occasion: a stomach or duodenal ulcer or bleeding
• if you have had a previous gastrointestinal bleeding or have suffered a perforation while taking a non-steroidal anti-inflammatory medication
• if you have severe heart failure
• if you are in the third trimester of pregnancy
• if you have ulcerative colitis (a bowel disease)
• if you have severe liver (hepatic) or kidney (renal) impairment
• if you are taking other medications of this type (non-steroidal anti-inflammatory medications)

Warnings and Precautions

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

• It is essential to use the lowest effective dose for the shortest possible time to control your symptoms,
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black-colored stools, or even without prior warning symptoms,
• If you have had a previous stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication,
• This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in the elderly. 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 TAD may cause irritation, bleeding, or stomach ulcers. Your doctor will recommend the most suitable dose,
• If you have Crohn's disease or ulcerative colitis, as medications of the Naproxen Sodium TAD type may worsen these conditions,
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as Naproxen Sodium TAD may cause breathing difficulties (bronchospasm),
• If you have severe kidney, liver, or heart problems,
• If you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type. 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 TAD may mask the usual signs and symptoms of infectious processes,
• If you experience stomach pain and/or observe black-colored stools while taking Naproxen Sodium TAD, you should interrupt treatment with Naproxen Sodium TAD,
• If you experience vision disorders during treatment,
• This medication should be used with caution in patients who have a low-sodium diet and a history of digestive problems.

Naproxen Sodium TAD may affect fertility. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Medications like Naproxen Sodium TAD 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 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) and toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), in association with naproxen. Stop taking naproxen and consult your doctor immediately if you observe 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 (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 problems and/or high blood pressure (hypertension).

Other Medications and Naproxen Sodium TAD

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

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

• medications used to neutralize stomach acid (antacids or cholestyramine)
• medications used to prevent blood coagulation (warfarin),
• medications to prevent blood clots (Aspirin/acetylsalicylic acid)
• medications used to treat diabetes (sulfonylurea)
• medications used to treat epilepsy (hydantoin derivatives)
• medications used to treat high blood pressure (angiotensin receptor antagonists or blockers and diuretics)
• medications that increase urination (furosemide)
• medications used to treat mental disorders (lithium)
• medications used to treat malignant diseases (methotrexate)
• medications used to treat pain and inflammation of the joints (steroids and corticosteroids)

Taking Naproxen Sodium TAD with Food and Drinks

Take the tablets with a sufficient amount of liquid and preferably with food.

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

Because the administration of medications of the Naproxen Sodium TAD type has been associated with an increased risk of congenital anomalies, 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 Sodium TAD may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

In the third trimester, the administration of Naproxen Sodium TAD is contraindicated. 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 labor more than expected.

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

Driving and Using Machines

Naproxen Sodium TAD should be used with caution in patients whose activities require attention and who have observed dizziness or visual disturbances during treatment with this medication.

Naproxen Sodium TAD Contains Sodium

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

3. How to Take Naproxen Sodium TAD

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

Adults and Children Over 16 Years

The daily dose is usually 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 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 (morning and night) 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 subsides.

Dysmenorrhea (Menstrual Pain)

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

The use of Naproxen Sodium TAD is not recommended in children and adolescents under 16 years.

Elderly

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

Method of Administration:

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 effective dose.

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.

Symptoms of overdose are characterized by drowsiness, stomach burning, indigestion, nausea, vomiting, and in some cases, convulsions. In the event of accidental or intentional overdose, gastric lavage should be performed, and symptomatic treatment should be initiated. The rapid administration of 50-100 grams 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. 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 make up for forgotten 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 are taking naproxen sodium to relieve short-term pain, you can stop taking it as soon as you no longer need it. When a long-term treatment is prescribed, you should consult your doctor before stopping treatment.

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

4. Possible Adverse Effects

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

If you observe the appearance of the following adverse effects, stop taking naproxen and consult your doctor immediately (frequency not known: cannot be estimated from the available data):

• Widespread skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), enlargement of lymph nodes, 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 generally reappears in the same location when re-exposed to the medicine and may appear as reddish, round, or oval patches, skin swelling, blisters (urticaria), and itching.

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

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

Inflammation, bleeding (in some cases fatal, especially in the elderly), 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 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 (blackish-colored stools) have 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 leukocytes in the blood), thrombocytopenia (decrease in the number of platelets).

Immune system disorders:anaphylactoid reactions (acute allergic reaction), angioneurotic edema (inflammation in the skin, mucosa, and viscera).

Metabolic and nutritional disorders:hypercalcemia (increased calcium concentration in the blood).

Psychiatric disorders:difficulty concentrating, depression, sleep disturbances.

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

Eye disorders:vision disorders, 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), hypoacusis (decreased hearing).

Cardiac disorders:palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines like naproxen sodium may be associated with a moderate increased 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 (yellowish skin coloration).

Skin and subcutaneous tissue disorders:skin 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, eruption, and skin redness), severe blistering reactions such as Stevens-Johnson syndrome (skin eruption 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 (defect of liver enzymes), or epidermolysis bullosa. If skin fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

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

Renal and urinary disorders:blood in the urine, interstitial nephritis (renal inflammation with yellowish-brown discoloration), nephrotic syndrome, kidney disease, renal failure, renal papillary necrosis (death of the cells that form the renal papillae due to metabolic alteration).

Reproductive system and breast disorders:infertility.

General disorders and administration site conditions:general malaise, pyrexia (chills and fever), thirst, sore throat.

Investigations:abnormal liver function test values, elevated serum creatinine, hyperpotasemia.

Medicines 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 TAD

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

Do not use this medicine after the expiration date stated 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 medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Naproxen Sodium TAD

• The active ingredient is naproxen sodium. Each film-coated tablet contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen.
• The other ingredients (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 carmine indigo (E132). See section 2 "Naproxen Sodium TAD contains sodium".

Appearance of the Product and Package Contents

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 Manufacturer

Marketing Authorization Holder

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

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 under the following names:

Date of the last revision of this prospectus: September 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/).