Naproxen sodium TAD 550 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Naproxen sodium TAD 550mg film-coated tablets EFG

Read all of 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Naproxen Sodium TAD is and what it is used for

Naproxen Sodium TAD contains the active substance naproxen sodium, a compound belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Naproxen Sodium TAD is indicated for:

• 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 condition causing damage to the cartilage), acute gout attacks, and ankylosing spondylitis (inflammation affecting the joints of the spine),
• relief of menstrual pain,
• relief of pain associated with acute migraine attacks,
• treatment of pain secondary to bleeding associated with intrauterine devices (IUDs).

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 to any of the other ingredients of this medicine (listed in section 6)
• if you have experienced difficulty breathing (bronchial asthma), hives, or inflammation of the mucous membrane of the nose (rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs, non-steroidal anti-rheumatic drugs)
• if you currently have or have had more than once: a stomach or duodenal ulcer or gastrointestinal bleeding
• if you have previously had gastrointestinal bleeding or a gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug
• if you have severe heart failure
• if you are in the third trimester of pregnancy
• if you have ulcerative colitis (an intestinal disease)
• if you have severe hepatic (liver) or renal (kidney) impairment
• if you are taking other medicines of this type (non-steroidal anti-inflammatory drugs)

Warnings and precautions

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

• It is important to use the lowest effective dose for the shortest duration 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 had stomach or duodenal bleeding or gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug,
• This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine,
• 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 appropriate dose,
• If you have Crohn's disease or ulcerative colitis, as medicines like Naproxen Sodium TAD 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 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 Naproxen Sodium TAD may mask the usual signs and symptoms of infectious processes,
• If you experience stomach pain and/or notice black stools while taking Naproxen Sodium TAD, you must stop treatment immediately,
• If you experience visual disturbances during treatment,
• This medicine should be used with caution in patients on a low-salt diet or with a history of gastrointestinal problems.

Naproxen Sodium TAD may affect fertility. Inform your doctor if you are planning to become pregnant or if you have difficulty becoming pregnant.

Medicines such as Naproxen Sodium TAD 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 or prolonged treatment are used. Do not exceed the recommended dose or duration of treatment.

Serious skin reactions have been reported with naproxen, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking naproxen and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

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

Also, this type of medicine may cause fluid retention, especially in patients with heart problems and/or high blood pressure (hypertension).

Other medicines and Naproxen Sodium TAD

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Due to interactions with certain other medicines, the effect of Naproxen Sodium TAD or of these medicines may be increased or decreased. This may occur with:

• medicines used to neutralize stomach acidity (antacids or cholestyramine)
• medicines used to prevent blood clotting (warfarin)
• medicines used to prevent blood clots (aspirin/acetylsalicylic acid)
• medicines used to treat diabetes (sulfonylureas)
• medicines used to treat epilepsy (hydantoin derivatives)
• medicines used to treat high blood pressure (angiotensin receptor antagonists or blockers and diuretics)
• medicines that increase urine production (furosemide)
• medicines used to treat mental disorders (lithium)
• medicines used to treat malignant diseases (methotrexate)
• medicines used to treat joint pain and inflammation (steroids and corticosteroids)

Taking Naproxen Sodium TAD with food and drink

Take the tablets with sufficient liquid and preferably with food.

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.

Naproxen Sodium TAD must not be administered during pregnancy, childbirth, or while breastfeeding.

Because the use of medicines like Naproxen Sodium TAD has been associated with an increased risk of congenital abnormalities, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary and as directed by your doctor. In such cases, the dose and duration should be limited to the minimum possible. From week 20 of pregnancy, Naproxen Sodium TAD may cause kidney problems in the 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.

In the third trimester, administration of Naproxen Sodium TAD is contraindicated. It may cause kidney and heart problems in the fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond expected duration.

For women of childbearing age, it should be noted that medicines like Naproxen Sodium TAD have been associated with reduced fertility.

Driving and using machines

Naproxen Sodium TAD 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 Sodium TAD contains sodium

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

3. How to take Naproxen Sodium TAD

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

Adults and children over 16 years of age

The usual daily dose is 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 severity of the condition. These doses may be adjusted at your doctor's discretion.

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:

The recommended initial dose is 550 mg of naproxen sodium (1 tablet) taken twice daily (in the morning and at night), or 1100 mg of naproxen sodium (2 tablets) taken once daily.

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.

Menstrual pain (dysmenorrhea):

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 as needed.

Migraine:

The recommended initial dose is 825 mg of naproxen sodium (1 and a half tablets) at the onset of symptoms, 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 of four days.

Use in children and adolescents under 16 years of age

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

Elderly

Dosage 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 used for the shortest possible time. Consult your doctor or pharmacist.

Method of administration:

This medicine is taken orally.

The tablet may be divided into equal doses.

Swallow the tablets with a glass of water, preferably with food.

Always take the lowest dose that is effective.

If you take more Naproxen Sodium TAD than you should

If you have taken more Naproxen Sodium TAD than you should, contact your doctor or pharmacist immediately.

Symptoms of overdose include drowsiness, heartburn, indigestion, nausea, vomiting, and in some cases, seizures. In case of accidental or intentional overdose, gastric lavage should be performed and symptomatic treatment initiated. Rapid administration of 50–100 grams of activated charcoal as an 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 medicine and the amount ingested.

If you forget to take Naproxen Sodium TAD

Do not take a double dose to make up for a missed dose.

Take the medicine at the same time each day. If you forget to take the medicine at the scheduled time, take it as soon as you remember.

If you stop taking Naproxen Sodium TAD

If you are taking naproxen sodium for short-term pain relief, you may stop taking it as soon as it is no longer needed. When long-term treatment is prescribed, consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs in the body (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.
• 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 present as round or oval reddish patches, skin swelling, blisters (urticaria), and itching.

The adverse effects that may occur during treatment with this medicine, observed very rarely (in less than 1 in 10,000 patients), are:

Gastrointestinal disorders: The most frequent adverse effects observed with sodium naproxen 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 also been observed. Other reported effects include gastric acidity, dyspepsia (digestive disturbances), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting 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 red blood cells, white blood cells, and platelets), eosinophilia (increase in certain white blood cells), leukopenia (decrease in white blood cell count), thrombocytopenia (decrease in platelet count).

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

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

Psychiatric disorders: difficulty concentrating, depression, sleep disturbances.

Nervous system disorders: dizziness, drowsiness, headache, sensation of dizziness, vertigo, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), seizures, 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 (hearing loss).

Cardiac disorders: palpitations, congestive heart failure (the heart's inability to pump blood effectively), hypertension (high blood pressure). Medicines such as sodium 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 (liver inflammation), jaundice (yellowing of the skin).

Skin and subcutaneous tissue disorders: skin hemorrhage, itching, capillary bleeding, skin rashes, sweating, alopecia, skin peeling, lichen planus (a skin disease characterized by small flat nodules), pustular reactions, skin redness, systemic lupus erythematosus (an autoimmune disease with typical skin signs such as rash and redness), severe blistering reactions such as Stevens-Johnson syndrome (a map-like skin rash) and toxic epidermal necrolysis, allergic reactions, photosensitivity reactions including rare cases presenting features similar to porphyria cutanea tarda, pseudoporphyria (liver enzyme defect), or epidermolysis bullosa. If skin fragility, blister formation, or other symptoms suggestive 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 renal papillae due to metabolic disturbances).

Reproductive system and breast disorders: infertility.

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

Investigations: abnormal liver function test results, elevated serum creatinine, hyperkalemia.

Medicines such as sodium naproxen may, rarely (affecting up to 1 in 1,000 people), be associated with liver injury.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Naproxen Sodium TAD

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.

Store the blister pack in the outer packaging to protect it from light.

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Naproxen Sodium TAD

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

Appearance of the product and contents of the pack

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.

Film-coated tablets are available in packs of 10x1, 16x1, 30x1, 40x1 and 60x1 tablets in blisters.

Only certain pack 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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this product information: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).