NAPROXEN TEVA-RATIOPHARM 500 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Naproxeno Teva-ratiopharm 500 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Naproxeno Teva-ratiopharm and what is it used for
2. What you need to know before taking Naproxeno Teva-ratiopharm
3. How to take Naproxeno Teva-ratiopharm
4. Possible side effects

5 Storage of Naproxeno Teva-ratiopharm

1. Package contents and additional information

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

Naproxeno Teva-ratiopharm contains the active substance naproxen, which belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). It is indicated for the treatment of:

• Mild or moderate pain, treatment of symptoms of rheumatoid arthritis, (inflammation of the joints, including hands and feet, leading to swelling and pain), osteoarthritis (a chronic disorder that causes cartilage damage), acute episodes of gout, and ankylosing spondylitis (inflammation that affects the joints of the spine).

• Menstrual pain.

• Relief of pain from acute migraine attacks.

• Pain secondary to bleeding associated with intrauterine devices (IUDs).

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

It is essential to use the smallest dose that relieves/control pain and not take naproxen for longer than necessary to control your 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 non-steroidal anti-inflammatory drugs and/or they cause severe allergic reactions such as: asthma, rhinitis, or nasal polyps,
• If you are taking other medications of this type (non-steroidal 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 suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication,
• If you have ulcerative colitis (a bowel disease),
• If you have severe liver (liver) or kidney (kidney) failure,
• 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 non-steroidal anti-inflammatory drugs, which appear as reddish spots, generalized redness of the skin, ulcers, or widespread rash accompanied by symptoms similar to those of the flu, including fever (see section 4). The rash can progress to generalized blisters or skin peeling. The greatest risk of these severe skin reactions is during the first weeks of treatment, but they could start to develop up to several months after taking the medication (see section 4). If you have developed any of these severe skin reactions with the use of naproxen, you should 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) and 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 observe any of the symptoms related to severe skin reactions described in section 4.

Be cautious in the following situations:

• It is essential to use the smallest dose that relieves/control pain and not take this medication for longer than necessary 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 stools, or even without previous 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 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 medications like naproxen can worsen these conditions.
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as naproxen can 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 discuss the use of other medications that could 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 can mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or observe that your stools appear black when taking naproxen, you should interrupt treatment with naproxen.
• If you experience vision disorders during treatment.
• If you wish to become pregnant, as naproxen can affect fertility.

Cardiovascular precautions

Medications like naproxen can 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 your doctor or pharmacist about this treatment.

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

Other medications and Naproxeno Teva-ratiopharm

Tell your doctor or pharmacist if you are using, have recently used, 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 can alter the way other medications work. It is essential to inform your doctor if you are taking any of the following medications:

• Antacids or cholestyramine, as they can delay the action of naproxen, but do not affect the overall effect,
• Acetylsalicylic acid to prevent blood clots,
• Hydantoins (medications used primarily for epilepsy),
• Sulfonylureas (medications for diabetes),
• Sulfonamides (a type of diuretic medication),
• Methotrexate (an immunosuppressive medication),
• Beta-blockers (antihypertensive medication),
• Furosemide (a medication with a natriuretic effect),
• Lithium. It can cause an increase in lithium plasma concentration,
• Corticosteroids, naproxen can interfere with adrenal function tests,
• ACE inhibitors (angiotensin-converting enzyme inhibitors, antihypertensive medication),
• Angiotensin receptor blockers or antagonists (antihypertensive medications)

It may be necessary for your doctor to adjust the dose of one of the medications. Consult your doctor if you have any doubts about these points.

Taking naproxen with food and drinks

It is recommended to take the tablets during meals or immediately after eating 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 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 can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take naproxen during the first 6 months of pregnancy unless it is clearly necessary and as directed 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 possible time. From the 20th week of pregnancy, naproxen can 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) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

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

For patients of childbearing age, it should be noted that medications like naproxen have been associated with a decrease in fertility.

Driving and using machines

Naproxen 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 Teva-ratiopharm contains sodium

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

3. How to take Naproxeno Teva-ratiopharm

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

Your doctor will indicate the duration of your treatment with naproxen.

The recommended dose is:

Adults

The daily dose is usually 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 by your doctor.

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

For the treatment of acute episodes of gout: 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 of dysmenorrhea(menstrual pain): 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 of migraineattacks: 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) after half an hour of the initial dose.

For the treatment of menorrhagia(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) divided into two daily doses. Continue with a dose of 1 or 2 tablets per day (500 mg or 1000 mg of naproxen) divided into two daily doses 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 if you have kidneyor liverdisease, it is recommended to reduce the dose and use the smallest effective dose for the shortest possible time. Consult your doctor.

Use in children and adolescents

The use of this medication is not recommended in children under 16 years.

Method of administration:

This medication is taken orally.

The tablet can be divided into equal doses. The Naproxeno 500 mg tablets are scored, and the transverse score on one of the tablet's faces allows it to be divided into two equal halves for cases where a 250 mg or 750 mg dose is required.

Swallow the tablets with a sufficient amount of liquid, a glass of water, or another 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.

Symptoms of overdose are characterized by drowsiness, stomach burning, indigestion, nausea, vomiting, and in some cases, convulsions.

In case 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, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and leaflet to the healthcare professional.

If you forget to take Naproxeno Teva-ratiopharm

Do not take a double dose to make up for forgotten doses; take the dose as soon as you remember and continue with the next dose.

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

4. Possible Adverse Effects

Like all medicines, Naproxeno Teva-ratiopharm can cause adverse effects, although not all people suffer from them.

The adverse effects that may occur during treatment with this medicine, and that 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 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 part of the 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 (black-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), leukopenia (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 (increase in 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 papilla edema.

Ear and labyrinth disorders:hearing alterations, 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 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 (yellowing of the skin). Medicines 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 anomalies (eosinophilia), lymph node enlargement, and affectation of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2. Cutaneous hemorrhage, itching, capillary hemorrhage, skin rashes, sweating, alopecia, skin peeling, lichen planus (skin disease with small flat nodules), pus vesicle reaction, skin redness, systemic lupus erythematosus (autoimmune disease with typical skin signs, rash, and skin redness), severe blistering reactions such as Stevens-Johnson syndrome (skin rash 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 (liver enzyme defect), or epidermolysis bullosa. If cutaneous fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

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

Renal and urinary disorders:blood in the urine, interstitial nephritis (renal inflammation with yellow-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 values of liver function tests, elevated serum creatinine, hyperpotasemia.

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 that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Naproxeno Teva-ratiopharm

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, 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 ofNaproxenoTeva-ratiopharm

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

Appearance of the product and package contents

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

They are available in packages of 40 and 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

Date of the last revision of this leaflet: July 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/)

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/61370/P_61370.html