Naproxen Teva-Ratiopharm 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Naproxeno Teva-ratiopharm 500 mg film-coated tablets EFG

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

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may 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.

Leaflet contents

1. What Naproxeno Teva-ratiopharm is 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

5. How to store Naproxeno Teva-ratiopharm

6. Contents of the pack and other information

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

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

• Mild to moderate pain, and symptoms of rheumatoid arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), osteoarthritis (a chronic condition causing damage to the 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 Teva-ratiopharm

It is important that you use the smallest dose that relieves/controls your pain, and you should not take naproxen for longer than necessary to control your symptoms.

Do not take Naproxen Teva-ratiopharm

• If you are allergic (hypersensitive) to naproxen or to any of the other components of this medicine (listed in section 6).
• If you know you are allergic (hypersensitive) to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs) and/or they cause you severe 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 had more than once: a stomach or duodenal ulcer or gastrointestinal bleeding.
• If you have previously experienced stomach or duodenal bleeding or suffered a gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug.
• If you have ulcerative colitis (an intestinal 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 Naproxen Teva-ratiopharm.

Severe skin reactions have been reported with the use of non-steroidal anti-inflammatory drugs, appearing as reddish spots, generalized skin redness, ulcers or widespread rash, accompanied by flu-like symptoms including fever (see section 4). The rash may progress to widespread blisters or skin peeling. The highest risk of these severe skin reactions occurs during the first weeks of treatment, but they may begin to develop several months after starting the medication (see section 4). If you have experienced any severe skin reactions while using naproxen, you must not restart treatment with naproxen at any time. If you develop a skin rash or these skin symptoms, stop taking naproxen and contact your doctor or seek immediate medical attention.

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 symptoms related to the serious skin reactions described in section 4.

Exercise caution in the following situations:

• It is important to use the lowest dose that relieves/controls pain, and you should 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, even without prior warning symptoms.
• If you have previously experienced stomach or duodenal bleeding or a gastrointestinal perforation 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 medication.
• If you have or have had stomach problems, as 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 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 affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medications 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 naproxen may mask the usual signs and symptoms of infectious processes.
• If you experience stomach pain and/or notice black-colored stools while taking naproxen, you should stop treatment with naproxen.
• If you experience vision disturbances during treatment.
• If you are planning to become pregnant, as naproxen may affect fertility.

Cardiovascular precautions

Medications such as 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 for 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 medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Other medicines and Naproxen Teva-ratiopharm

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

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

• Antacids or cholestyramine, which may delay the action of naproxen but do not affect its overall effect,
• Acetylsalicylic acid for preventing blood clots,
• Hydantoins (drugs primarily used for epilepsy),
• Sulfonylureas (diabetes medications),
• Sulfonamides (a type of diuretic medication),
• Methotrexate (an immunosuppressive medication),
• Beta-blockers (antihypertensive medication),
• Furosemide (a medication with natriuretic effect),
• Lithium. Naproxen may increase plasma lithium concentration,
• Steroids, as naproxen may interfere with adrenal function tests,
• ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors, antihypertensive medication),
• Angiotensin receptor antagonists or blockers (antihypertensive medications).

Your doctor may need to adjust the dose of one of the two medicines. 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 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.

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

Do not take naproxen during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor beyond expected. Naproxen should not be taken during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest effective dose for the shortest possible time. 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 blood vessels (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, your doctor may recommend additional monitoring.

Administration of naproxen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that naproxen-type medications have been associated with reduced fertility.

Driving and use of machines:

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 Teva-ratiopharm contains sodium

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

3. How to take Naproxen Teva-ratiopharm

Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

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 take 1 tablet (500 mg of naproxen), followed by half a tablet (250 mg of naproxen) every 6 or 8 hours, depending on the severity of the condition. These doses may be adjusted as directed by your doctor.

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

For the treatment of acute gout attacks: the usual initial dose is one and a half tablets (750 mg of naproxen), followed by half a tablet (250 mg of naproxen) every 8 hours until pain subsides. Consult your doctor regarding the duration of treatment.

For the treatment of dysmenorrhea (menstrual pain): the usual initial dose is 1 tablet (500 mg of naproxen), followed by half a tablet (250 mg of naproxen) every 6 or 8 hours.

For the treatment of migraine attacks: the initial dose is one and a half tablets (750 mg of naproxen) at the onset of symptoms, followed by half a tablet (250 mg of naproxen) half an hour after 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 one and a half and two and a half tablets (750 mg and 1250 mg of naproxen), divided into two daily doses. Continue with a daily dose of 1 or 2 tablets (500 mg or 1000 mg of naproxen), 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 disease 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. Naproxen 500 mg tablets are scored; the transverse groove on one side of the tablet allows the tablet to be split into two halves, for cases where doses of 250 mg or 750 mg are required.

Swallow the tablets with a sufficient amount of liquid, such as a glass of water or another drink, preferably during or after meals.

Always take the lowest effective dose.

If you take more Naproxen Teva-ratiopharm than you should

If you have taken more naproxen than you should, contact your doctor or pharmacist immediately.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the container and the package leaflet to the healthcare professional.

If you forget to take Naproxen Teva-ratiopharm

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

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

4. Possible adverse effects

Like all medicines, Naproxeno Teva-ratiopharm can cause adverse effects, although not everyone will experience them.

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

Gastrointestinal disorders: the most frequent adverse effects observed with naproxen are of 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 lining), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease have also been observed. Other reported cases include stomach acidity, dyspepsia (digestive disturbances), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting of blood), and melena (black, tarry stools).

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 blood), eosinophilia (increase in certain white blood cells in blood), leucopenia (decrease in the number of white blood cells), thrombocytopenia (decrease in the number of platelets).

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

Metabolism and nutrition disorders: hypercalcemia (increased calcium concentration in blood).

Psychiatric disorders: difficulty concentrating, depression, sleep disturbances.

Nervous system disorders: dizziness, somnolence, headache, sensation of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), convulsions, 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), hypoacusis (reduced hearing).

Cardiac disorders: palpitations, congestive heart failure (inability of the heart to perform its pumping function), hypertension (high blood pressure). Medicines such as naproxen may be associated with a moderately increased risk of 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 such as naproxen may rarely be associated with liver damage.

Skin and subcutaneous tissue disorders: generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other 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), pustular reactions, skin redness, systemic lupus erythematosus (autoimmune disease with typical skin signs, rash, and skin redness), severe blistering reactions such as Stevens-Johnson syndrome (map-like skin rash) and toxic epidermal necrolysis, allergy, photosensitivity reactions including rare cases in which the skin resembles that seen in porphyria cutanea tarda, pseudoporphyria (liver enzyme defect), or epidermolysis bullosa. If skin fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment must be discontinued and the patient monitored.

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

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

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 test results, elevated serum creatinine, hyperkalemia.

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 Teva-ratiopharm

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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Naproxen Teva-ratiopharm

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

Appearance of the product and contents of the pack

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

It is available in packs of 40 and 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

Date of the most recent review of this leaflet: July 2024

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

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