Prospect: information for thepatient

Antalgin 550mg coated tablets

Naproxenosodium

Read this prospect carefully beforestarting totakethis medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you and should not be given to other people, even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist, even if they are not listed in this prospect.See section 4.

1. What isAntalginand for what it is used

2. What you needto know before starting to takeAntalgin

3. Howto takeAntalgin

4. Possible adverse effects

5. Storage ofAntalgin

6. Contents of the package and additional information

Antalgin contains as itsactive ingredientnaproxeno sódico, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs(NSAIDs).

Antalgin is indicated for the treatment of:

• Mild to moderate pain, treatment of the 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 gout episodes,and ankylosing spondylitis(inflammation affecting the spine's joints),

• Menstrual pain.

• Relief of pain from acute migraine attacks.

• Pain secondary todegrees associated with intrauterine devices(IUDs).

It is essential to use the smallest effective dose to alleviate or control pain and not to take Antalgin for longer than necessary to manage your symptoms.

Do not take Antalgin

• If you are allergic (hypersensitive) to naproxen or naproxen sodium, or to any of the other components of this medication (listed in section 6)

• If you know that you are allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and/or 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 once: a stomach ulcer or bleeding, or a 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 Antalgin.

Severe skin reactions have been reported with the use of nonsteroidal anti-inflammatory drugs, appearing as red patches, generalized skin redness, ulcers, or widespread rashes 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 the use of Antalgin, do not restart treatment with Antalgin at any time. If you develop a skin rash or these symptoms, stop taking Antalgin and contact your doctor or seek immediate medical attention.

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 your symptoms.
• If you have had or develop a stomach 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 treatment, 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 medication.

• If you have or have had gastrointestinal problems, as Antalgin 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 Antalgin-type medications may worsen these conditions,
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as Antalgin may cause breathing difficulties (bronchospasm),
• If you have severe kidney, liver, or heart problems,
• If you are taking medications that alter blood clotting 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 (SSRIs),
• If you have or suspect you have an infection, as Antalgin may mask the usual signs and symptoms of infectious processes,
• If you experience stomach pain and/or observe black stools while taking Antalgin, you should discontinue treatment with Antalgin,
• If you experience visual disturbances during treatment,
• This medication should be used with caution in patients with a low-sodium diet and a history of gastrointestinal problems,
• If you wish to become pregnant, as Antalgin may affect fertility.

Cardiovascular precautions

Medications like Antalgin 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 treatment. 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 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 Antalgin

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

This is very important because Antalgin 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 Antalgin, 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, Antalgin 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 two medications. Consult your doctor if you have any doubts about these points..

Antalgin with food and beverages

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.

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

Do not take Antalgin if you are in 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 tendency and that of your baby to bleed and delay or prolong delivery more than expected.

Due to the association of administering medications like Antalgin with an increased risk of congenital anomalies/abortions, do not take Antalgin during the first and second trimesters of pregnancy unless it is strictly necessary and your doctor advises it. 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, Antalgin may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels surrounding the baby (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

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

Driving and operating machinery

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

Antalgin contains sodium

This medication contains 50 mg of sodium (the main component of table salt/for cooking) in each tablet. This is equivalent to 2.5% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again..

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

The recommended dose is:

Adults

The usual daily dose is 1 or 2 tablets (550 mg or 1100 mg of naproxeno sódico). As an initial dose, it is recommended to administer 1 tablet (550 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 6 or 8 hours, depending on the intensity of the process.These doses may be modified by your doctor's indication.

For the treatment ofrheumatoid arthritis,osteoarthritisandankylosing spondylitis: the initial dose is usually 1 tablet (550 mg of naproxeno sódico) taken twice a day (in the morning and at night) or 2 tablets (1100 mg of naproxeno sódico) taken once a day.

For the treatment of acute episodes of gout:the initial dose is usually 1 and a half tablets (825 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 8 hours until you no longer feel pain. Consult your doctor about the duration of treatment.

Por the treatment of dysmenorrhea (menstrual pain): the initial dose is usually 1 tablet (550 mg of naproxeno sódico) followed by half a tablet (275 mg of naproxeno sódico) every 6 or 8 hours.

Por the treatment of migraine crises:the initial dose is 1 and a half tablets (825 mg of naproxeno sódico) when the first symptoms appear, followed by half a tablet (275 mg of naproxeno sódico) when 30 minutes have passed since the initial dose.

Por 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 (825 mg and 1375 mg of naproxeno sódico)taken in two doses a day. Continue with a dose of 1 or 2 tablets a day (550 mg or 1100 mg of naproxeno sódico) 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 with kidney 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 medication is not recommended for use in children under 16 years old.

Administration form:

This medication is taken orally.

The tablet can be divided into equal doses.

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

Always take the lowest effective dose.

If you take more Antalgin than you should

If you have taken more Antalgin 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 voluntary 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 the Toxicological Information Service, Telephone (91) 562.04.20.

If you forgot to takeAntalgin

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side 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 side effects observed with Antalgin 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 pain, nausea, vomiting, diarrhea, constipation, flatulence (gas), hematemesis (vomiting blood), and melena (black 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), leucopenia (decrease of white blood cells in the blood), thrombocytopenia (decrease of platelets), lymph node enlargement, and affection of other organs of the body (drug reaction with eosinophilia and systemic symptoms known as DRESS). See section 2.

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

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). Medicines like Antalgin 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 (yellow discoloration of the skin), and elevated liver enzymes. Medicines like Antalgin may be associated with rare cases of liver damage.

Skin and subcutaneous tissue disorders:cutaneous hemorrhage, pruritus, capillary hemorrhage, generalized skin eruptions, sweating, alopecia, skin peeling, lichen planus (cutaneous disease of small flat nodules), vesicular rash, skin redness, systemic lupus erythematosus (autoimmune disease with typical skin symptoms, rash, and skin redness), severe bullous 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 (defect of liver enzymes) 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.

Renal and urinary disorders:hematuria, 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, a characteristic cutaneous allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the drug and may appear as red, rounded, or oval patches and skin swelling, urticaria (hives), and pruritus.

Complementary examinations:abnormal values of liver function tests, elevated serum creatinine, hyperkalemia.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reachof children.

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

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and unusedmedicines at the SIGREPoint of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Antalgin

-The active ingredient is naproxen sodium. Each tablet contains 550 mg of naproxen sodium (equivalent to 500 mg of naproxen)

-The other components (excipients) are: microcrystalline cellulose, povidone, talc, magnesium stearate, hypromellose (E464), macrogol, titanium dioxide (E-171), indigotin lake (E-132) and purified water.

Appearance of the product and content of the container

Antalgin are film-coated tablets, oval in shape, blue in color, and with the inscription NPS 550 on one of the faces of the tablet. The tablet is breakable (can be divided into two equal doses).

It is presented in containers of 10 and 40 film-coated tablets.

Holder of the marketing authorization:

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Responsible for manufacturing:

RECIPHARM LEGANÉS S.L.U.

C/ Severo Ochoa, 13.Pol. Ind. Leganés

28914 Madrid

RECIPHARM FONTAINE SAS

Rue des Près Potets

21121 Fontaine-Lès-Dijon – France

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

Last review date of this leaflet:February 2025

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”