ANTALGIN 550 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for thepatient

Antalgin 550mg film-coated tablets

Sodium naproxen

Read the entire package leaflet carefully beforestarting totakethis medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Antalgin and what is it used for

Antalgin contains the active substance sodium naproxen, which belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Antalgin is indicated for the treatment of:

• Mild or moderate pain, treatment of symptoms of rheumatoid arthritis (inflammation of the joints, including usually those of the 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 Antalgin

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

Do not take Antalgin

• If you are allergic (hypersensitive) to naproxen or sodium 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 other non-steroidal anti-inflammatory drugs 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 bleeding,
• If you have had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract 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) 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 Antalgin.

Severe skin reactions have been reported with the use of non-steroidal anti-inflammatory drugs, appearing as red 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 medicine (see section 4). If you have developed any of these severe skin reactions with the use of Antalgin, you should 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 that you use the smallest dose that relieves-controls the pain and do not take this medicine 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 stomach or duodenal bleeding or have suffered a perforation of the digestive tract 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 the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medicine.

• If you have or have had stomach problems, as Antalgin can cause stomach irritation, bleeding, or ulcers. Your doctor will recommend the most suitable dose,
• If you have Crohn's disease or ulcerative colitis, as medicines of the Antalgin type can worsen these conditions,
• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), as Antalgin can cause breathing difficulties (bronchospasm),
• If you have severe kidney, liver, or heart problems,
• If you take medicines that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medicines 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 Antalgin 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 Antalgin, you should interrupt treatment with Antalgin,
• If you experience vision disorders during treatment,
• This medicine should be used with caution in patients who have a low-salt diet and a history of digestive problems,
• If you wish to become pregnant, as Antalgin can affect fertility.

Cardiovascular precautions

Medicines like Antalgin 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 high doses and prolonged treatments are used. 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.

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

Other medicines and Antalgin

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

This is very important, as Antalgin can alter the way other medicines work. It is essential that you inform your doctor if you take any of the following medicines:

• Antacids or cholestyramine, as they can delay the action of Antalgin, but do not affect the total effect,
• Acetylsalicylic acid to prevent blood clots,

• Hydantoins (medicines used preferably for epilepsy),
• Sulfonylureas (medicines for diabetes),
• Sulfonamides (a type of diuretic medicine),

• Methotrexate (an immunosuppressive medicine),
• Beta-blockers (antihypertensive medicine),
• Furosemide (a medicine with a natriuretic effect),
• Lithium. It can cause an increase in lithium plasma concentration,
• Corticosteroids, Antalgin can interfere with adrenal function tests,
• ACE inhibitors (angiotensin-converting enzyme inhibitors, antihypertensive medicine).
• Angiotensin receptor antagonists or blockers (antihypertensive medicines)

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

Taking Antalgin 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 medicine.

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 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.

Because the administration of medicines of the Antalgin type has been associated with an increased risk of congenital anomalies/abortions, you should not take Antalgin during the first and second trimester of pregnancy unless it is strictly necessary and indicated 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, Antalgin 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). If you need treatment for more than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be noted that medicines of the Antalgin type have been associated with a decrease in fertility.

Driving and using machines

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

Antalgin contains sodium

This medicine contains 50 mg of sodium (the main component of table salt) per tablet. This is equivalent to 2.5% of the maximum recommended daily sodium intake for an adult.

3. How to take Antalgin

Follow the administration instructions of this medicine indicated by your doctor or pharmacist exactly. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets (550 mg or 1100 mg of sodium naproxen). The initial dose is usually 1 tablet (550 mg of sodium naproxen) followed by half a tablet (275 mg of sodium 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 (550 mg of sodium naproxen) taken twice a day (in the morning and at night) or 2 tablets (1100 mg of sodium naproxen) taken once a day.

For the treatment of acute gout episodes: the initial dose is usually 1 and a half tablets (825 mg of sodium naproxen) followed by half a tablet (275 mg of sodium naproxen) every 8 hours until the pain is relieved. Consult your doctor about the duration of treatment.

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

For the treatment of migraine attacks: the initial dose is 1 and a half tablets (825 mg of sodium naproxen) when the first symptoms appear, followed by half a tablet (275 mg of sodium naproxen) after half an hour of the initial intake.

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 (825 mg and 1375 mg of sodium naproxen) divided into two daily doses. Continue with a dose of 1 or 2 tablets per day (550 mg or 1100 mg of sodium naproxen) divided into two daily doses for the next 4 days at most.

Use in patients over 65 years old or with kidney and/or liver disease

In patients over 65 years old or with kidney or liver disease, 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 medicine is not recommended in children under 16 years old.

Method of administration:

This medicine 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 smallest 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 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 medicine.

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

If you forget to take Antalgin

Do not take a double dose to make up for forgotten doses, take the dose at the moment you remember and continue with the next dose.

4. Possible Adverse Effects

Like all medicines, this medicine 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 Antalgin 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 (blackish-colored stools) have been reported.

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 leukocytes in the blood), thrombocytopenia (decrease of platelets), lymph node enlargement, and affectation of other body 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 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 disturbances, 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 Antalgin may be associated with a moderate increased 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 (yellowish skin color), and elevated liver enzyme levels. Medicines like Antalgin may be associated with rare cases of liver damage.

Skin and Subcutaneous Tissue Disorders:cutaneous hemorrhage, itching, capillary hemorrhage, generalized cutaneous eruptions, sweating, alopecia, skin desquamation, lichen planus (skin disease with small, flat nodules), pus vesicle reaction, skin redness, systemic lupus erythematosus (autoimmune disease with characteristic skin signs, eruption, and skin redness), severe bullous reactions such as Stevens-Johnson syndrome (cutaneous eruption 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 (defect of liver enzymes), or epidermolysis bullosa. If cutaneous fragility, blister formation, or other symptoms indicative of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Musculoskeletal, Connective Tissue, and Bone Disorders:muscle pain, muscular asthenia.

Renal and Urinary Disorders:blood in the urine, interstitial nephritis (renal inflammation with yellowish-brown discoloration), nephrotic syndrome, kidney disease, renal failure, renal papillary necrosis (death of the cells that form the renal papillae due to altered metabolism).

Reproductive System and Breast Disorders:infertility.

General Disorders and Administration Site Conditions:general malaise, pyrexia (chills and fever), thirst, sore throat, a characteristic allergic skin reaction known as fixed drug eruption, which usually reappears in the same location upon re-exposure to the medicine and may appear as reddish, round, or oval patches and skin swelling, hives (urticaria), and itching.

Investigations:abnormal values of liver function tests, elevated serum creatinine, hyperpotassemia.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Antalgin

Keep this medicine out of the sight and reach of 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 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 of Antalgin

• The active ingredient is sodium naproxen. Each tablet contains 550 mg of sodium naproxen (equivalent to 500 mg of naproxen)
• The other components (excipients) are: microcrystalline cellulose, povidone, talc, magnesium stearate, hypromellose (E464), macrogol, titanium dioxide (E-171), indigo lake (E-132), and purified water.

Appearance of the Product and Package Contents

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

It is available in packages of 10 and 40 film-coated 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

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

Date of the Last Revision of this Prospectus:February 2025

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