Naprosyn 500 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Naprosyn 500 mg tablets

Naproxen

Read the entire 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, and you should not give it to others, 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.

Contents of the leaflet

1. What Naprosyn is and what it is used for
2. What you need to know before taking Naprosyn
3. How to take Naprosyn
4. Possible side effects
5. How to store Naprosyn
6. Contents of the pack and other information

1. What Naprosyn is and what it is used for

Naprosyn contains naproxen as the active substance, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Naprosyn is indicated for the treatment of:

• Mild to moderate pain, and the symptomatic treatment of rheumatoid arthritis (inflammation of the joints, usually affecting those of the hands and feet, resulting in swelling and pain), osteoarthritis (a chronic condition causing damage to cartilage), acute gout attacks, and ankylosing spondylitis (inflammation affecting the spinal joints).

• Menstrual pain.

• Relief of pain during acute migraine attacks.

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

2. What you need to know before taking Naprosyn

It is important that you use the lowest dose that relieves/controls your pain and that you do not take Naprosyn for longer than necessary to control your symptoms.

Do not take Naprosyn

• If you are allergic (hypersensitive) to naproxen or to any of the other ingredients 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 on more than one occasion: a stomach or duodenal ulcer or bleeding,

• If you have previously experienced stomach or duodenal bleeding or a gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug,

• If you have ulcerative colitis (a bowel disease),

• If you have severe liver (liver disorders) or kidney (kidney disorders) 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 Naprosyn.

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 greatest risk of these severe skin reactions occurs during the first weeks of treatment, but they may begin to develop several months after starting the medicine (see section 4). If you have experienced any of these severe skin reactions with Naprosyn, you must never restart treatment with Naprosyn. If you develop a skin rash or these skin symptoms, stop taking Naprosyn and contact your doctor or seek immediate medical attention.

Exercise caution in the following situations:

• It is important that you use the lowest dose that relieves/controls your pain and do 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, or even without prior warning symptoms.

• If you have previously experienced stomach or duodenal bleeding or 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 prescribing a stomach-protective medicine.

• If you have or have had stomach problems, as Naprosyn may cause irritation, bleeding or ulcers in the stomach. Your doctor will recommend the most appropriate dose.

• If you have Crohn's disease or ulcerative colitis, as medicines like Naprosyn may worsen these conditions.

• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as Naprosyn may cause breathing difficulties (bronchospasm).

• If you have severe kidney, liver or heart problems.

• If you are taking medicines 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 medicines 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 Naprosyn may mask the usual signs and symptoms of infectious processes.

• If you experience stomach pain and/or notice black-coloured stools while taking Naprosyn, you should stop treatment with Naprosyn.

• If you experience vision disturbances during treatment.

• If you are planning to become pregnant, as Naprosyn may affect fertility.

Cardiovascular precautions

Medicines such as Naprosyn 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 of 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.

In addition, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Other medicines and Naprosyn

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

This is very important because Naprosyn may alter how other medicines work. It is important that you inform your doctor if you are taking any of the following drugs:

• Antacids or cholestyramine, as they may delay the action of Naprosyn, but do not affect the overall effect,

• Acetylsalicylic acid for prevention of blood clots,

• Hydantoins (drugs used primarily for epilepsy),

• Sulfonylureas (medicines for diabetes),

• Sulfonamides (a type of diuretic medicine),

• Methotrexate (an immunosuppressive medicine),

• Beta-blockers (anti-hypertensive medicine),

• Furosemide (a medicine with natriuretic effect),

• Lithium. Naprosyn may increase plasma lithium concentration,

• Steroids, Naprosyn may interfere with adrenal function tests,

• ACE inhibitors (Angiotensin-Converting Enzyme Inhibitors, anti-hypertensive medicine),

• Angiotensin receptor antagonists or blockers (anti-hypertensive medicines).

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 Naprosyn 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Naprosyn must not be administered during pregnancy, childbirth, or during breastfeeding.

Do not take Naprosyn if you are in the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour beyond the expected duration.

Because the use of medicines like Naprosyn has been associated with an increased risk of congenital malformations or miscarriage, you should not take Naprosyn during the first and second trimesters of pregnancy unless strictly necessary and specifically prescribed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Naprosyn 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). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines like Naprosyn have been associated with a reduced ability to conceive.

Driving and using machines:

Naprosyn should be used with caution in patients whose activities require alertness and who have experienced dizziness or visual disturbances during treatment with this medicine.

Naprosyn contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free".

3. How to take Naprosyn

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (500 mg or 1000 mg of naproxen). As initial dose, administration of 1 tablet (500 mg of naproxen) followed by half a tablet (250 mg of naproxen) every 6 or 8 hours is recommended, 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) 30 minutes 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 suffer from kidney disease or liver disease, it is recommended to reduce the dose and use the lowest effective dose for the shortest possible duration. Consult your doctor.

Use in children and adolescents

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

Method of administration:

This medicine is taken orally.

The tablet may be divided into equal doses. Naprosyn 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 other drink, preferably during or after meals.

Always take the lowest effective dose.

If you take more Naprosyn than you should

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

Symptoms of overdose include drowsiness, heartburn, 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 as an aqueous suspension reduces drug absorption.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, Telephone (91) 562.04.20.

If you forget to take Naprosyn

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

The adverse effects that may occur during treatment with this medicine, 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 Naprosyn are of gastrointestinal nature (affecting the stomach and intestine).

Inflammation, bleeding (in some cases fatal, especially in elderly patients), 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 been observed. Cases of gastric acidity, dyspepsia (digestive disturbances), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black, tarry stools) have also been reported.

Blood and lymphatic system disorders: agranulocytosis (increase/decrease in certain white blood cells), aplastic and hemolytic anemia (reduction in red blood cells, white blood cells, and platelets), eosinophilia (increase in certain white blood cells in blood), leucopenia (decrease in the number of white blood cells in blood), thrombocytopenia (decrease in the number of platelets), enlargement of lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.

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

Metabolism and nutrition disorders: hypercalcemia (increased concentration of calcium 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 Naprosyn 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), and elevated liver enzyme levels. Medicines such as Naprosyn may rarely be associated with liver damage.

Skin and subcutaneous tissue disorders: skin hemorrhage, itching, capillary bleeding, generalized skin rashes, sweating, alopecia, skin peeling, lichen planus (skin disease characterized by small, flat nodules), pustular reactions, skin redness, systemic lupus erythematosus (autoimmune disease with typical skin signs, rash and skin redness), very severe blistering reactions such as Stevens-Johnson syndrome (map-like skin rash) and toxic epidermal necrolysis, allergic reactions, photosensitivity reactions including rare cases where the skin resembles 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 brownish-yellow discoloration), nephrotic syndrome, nephropathy (kidney disease), renal failure, renal papillary necrosis (death of cells forming the kidney papillae due to metabolic disturbances).

Reproductive system and breast disorders: infertility.

General disorders and administration site conditions: general malaise, pyrexia (chills and fever), thirst, sore throat, a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the medicine and may appear as round or oval red patches and skin swelling, blisters (urticaria), and itching.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Naprosyn

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

Do not use Naprosyn after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Naprosyn 500 mg tablets

• The active substance is naproxen. Each tablet contains 500 mg of naproxen.
• The other components are: povidone K-90, sodium croscarmellose, iron oxide (E-172) and magnesium stearate.

Appearance of the medicine and contents of the pack

The tablets are oval-shaped and yellow in colour. On one side they are engraved with "NPR LE 500", while on the other side there is a score line allowing the tablet to be divided into two equal doses.

Packaged in containers of 40 tablets.

Marketing Authorization Holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer

Recipharm Leganés S.L.U.

C/ Severo Ochoa, 13. Pol. Ind. Leganés

28914 Madrid

Atnahs Pharma Denmark ApS

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Misom Labs Ltd

Malta Life Sciences Park

LS2.01.06

Industrial Estate

San Gwann, SGN 3000

Malta

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the most recent review of this leaflet: February 2025

"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/"