Package Leaflet: Information for the Patient

Naproxeno Teva-ratiopharm 500 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What is Naproxeno Teva-ratiopharm and what it is used for

2.What you need to know before taking Naproxeno Teva-ratiopharm

3.How to take Naproxeno Teva-ratiopharm

4.Possible side effects

5Storage of Naproxeno Teva-ratiopharm

6.Contents of the pack and additional information

Naproxeno Teva-ratiopharm contains naproxeno as its active ingredient, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It 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 episodes of gout, and ankylosing spondylitis (inflammation affecting the joints of the spine).

• 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 effective dose to alleviate or control pain and not to take naproxen for longer than necessary to manage symptoms.

Do not take Naproxeno Teva-ratiopharm

• If you are allergic (hypersensitive) to naproxen or any of the other components of this medication (listed in section 6).
• If you know you are allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and experience 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 one occasion: a stomach or duodenal ulcer, or bleeding,
• If you have had a previous stomach or duodenal bleeding or have experienced a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug,
• If you have ulcerative colitis (a gastrointestinal disease),
• If you have severe liver (hepatic) or kidney (renal) impairment,
• 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 Teva-ratiopharm.

Severe skin reactions have been reported with the use of nonsteroidal anti-inflammatory drugs, appearing as red patches, generalized skin redness, ulcers, or widespread rash accompanied by symptoms similar to the flu, including fever (see section 4). The rash may progress to generalized blisters or skin peeling. The highest risk of these severe skin reactions is during the first weeks of treatment, but they may start to develop several months after medication administration (see section 4). If you have developed any of these severe skin reactions with naproxen, do not restart treatment with naproxen at any time. If you develop a skin rash or these symptoms, stop taking naproxen and contact your doctor or seek immediate medical attention.

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 naproxen. Stop taking naproxen and consult your doctor immediately if you observe any symptoms related to severe skin reactions described in section 4.

Be cautious in the following situations:

• It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to manage symptoms.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• If you have had a previous stomach or duodenal bleeding or have experienced 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 the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector.
• If you have or have had gastrointestinal problems, as naproxen 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 naproxen-type medications may worsen these conditions.
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen 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 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 naproxen may mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe black stools while taking naproxen, you should discontinue treatment.
• If you experience vision disturbances during treatment.
• If you wish to become pregnant, as naproxen may affect fertility.

Cardiovascular Precautions

Medications like naproxen 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.

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

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

Other Medications and Naproxeno Teva-ratiopharm

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes any medication purchased without a prescription or herbal remedies.

This is very important, as naproxen 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, but do not affect the overall effect,
• Acetylsalicylic acid to prevent blood clots,
• Hydantoins (medications used primarily for epilepsy),
• Sulfonilureas (diabetes medications),
• Sulfonamides (a type of diuretic medication),
• Metotrexate (an immunosuppressant medication),
• Beta-blockers (anti-hypertensive medication),
• Furosemide (a medication with natriuretic effect),
• Lithium. It may cause an increase in lithium plasma concentration,
• Glucocorticoids, as naproxen may 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 medications. Consult your doctor if you have any doubts about these points.

Taking Naproxeno with Food and Beverages

It is recommended to take the tablets 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.

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

Do not take naproxen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take naproxeno during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, naproxen may cause renal 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 the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

In the third trimester, the administration of naproxen is contraindicated.

For fertile women, it is essential to consider that medications like naproxen have been associated with a decrease in the ability to conceive.

Driving and Operating Machines:

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

Naproxeno Teva-ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet, which is essentially sodium-free.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Your doctor will inform you of the duration of your naproxen treatment.

The recommended dose is:

Adults

The usual daily dose is 1 or 2 tablets (500 mg or 1000 mg of naproxen).

As an initial dose, it is recommended to administer 1 tablet (500 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 6 or 8 hours, depending on the intensity of the process. These doses may be modified at the discretion of your doctor.

For the treatment ofrheumatoid arthritis,osteoarthritisandankylosing spondylitis:the initial dose is usually 1 tablet (500 mg of naproxen) taken twice a day (in the morning and at night) or 2 tablets (1000 mg of naproxen) taken once a day.

For the treatment ofacute gout attacks:the initial dose is usually 1 and a half tablets (750 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 8 hours until the pain subsides. Consult your doctor about the duration of treatment.

For the treatment ofmenstrual cramps:the initial dose is usually 1 tablet (500 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 6 or 8 hours.

For the treatment ofmigraine attacks:the initial dose is 1 and a half tablets (750 mg of naproxen) when the first symptoms appear, followed by half a tablet (250 mg of naproxen) when 30 minutes have passed since the initial dose.

For the treatment ofmenorrhagia(pain associated with excessive menstrual bleeding): the initial dose on the first day of menstruation is between 1 and a half and 2 and a half tablets (750 mg and 1250 mg of naproxen) taken in two doses a day. Continue with a dose of 1 or 2 tablets a day (500 mg or 1000 mg of naproxen) taken in two doses a 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 withkidney diseaseorliver 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. Naproxen 500 mg tablets are scored, the transverse score on one of the faces of the tablet allows the tablet to be divided into two halves for cases where a dose of 250 mg or 750 mg is required.

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

Always take the smallest effective dose.

If you take more Naproxeno Teva-ratiopharm than you should

If you have taken more naproxen 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you forget to take Naproxeno Teva-ratiopharm

Do not take a double dose to compensate for the missed doses, take the dose at the time you remember and continue with the next dose.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, Naproxeno Teva-ratiopharm may cause side effects, although not everyone will experience them.

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

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

It may cause inflammation, bleeding (in some cases fatal, especially in the elderly), 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, dyspepsia (digestive disorders), abdominal discomfort, 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), leukopenia (decrease of white blood cells in the blood), thrombocytopenia (decrease of platelets).

Immune system disorders:Anaphylactoid reactions (acute allergic reaction), 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, 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:Auditory 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 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:Heptatitis (inflammation of the liver), jaundice (yellowing of the skin). Medications like naproxen may be associated with rare cases of liver damage.

Skin and subcutaneous tissue disorders:Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and effects on other organs of the body (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2. Cutaneous hemorrhage, pruritus, capillary hemorrhage, skin rash, 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 (muscle weakness).

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:Anomalous values of liver function tests, elevated serum creatinine, hyperpotasemia.

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 prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es.By reporting adverse reactions, 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.

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

Composition ofNaproxenoTeva-ratiopharm

• The active ingredient is naproxeno.
• 1. The other components are microcrystalline cellulose, cornstarch, gelatin, sodium carboxymethyl starch (from potato), magnesium stearate, anhydrous colloidal silica, hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E-171), macrogol 6000, glycerol, and yellow iron oxide (E 172).

Appearance of the product and contents of the packaging

Naproxeno Teva-ratiopharm 500 are coated tablets, yellow in color, oblong, and scored on both faces of the tablet.

They are presented in packaging of 40 and 500 coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

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 carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/61370/P_61370.html