Antalgin 550 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Antalgin 550 mg film-coated tablets

Naproxen sodium

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 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 effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Antalgin is and what it is used for

Antalgin contains sodium naproxen as the active ingredient, a substance belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Antalgin is indicated for the treatment of:

• Mild to moderate pain, treatment of symptoms of rheumatoid arthritis (inflammation of the joints, usually affecting those of the hands and feet, leading to swelling and pain), osteoarthritis (a chronic disorder causing damage to 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 taking Antalgin

It is important that you use the smallest dose that relieves/controls your pain and that you 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 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), or if they cause you serious allergic reactions such as: asthma, rhinitis, or nasal polyps

• If you are currently taking other medicines of this type (non-steroidal anti-inflammatory drugs)

• If you currently have or have previously had on more than one occasion: a stomach or duodenal ulcer or gastrointestinal bleeding

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

• If you suffer from ulcerative colitis (an intestinal disease)

• If you have severe liver (liver disorders) or severe 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 Antalgin.

Serious skin reactions have been reported with the use of non-steroidal anti-inflammatory drugs, appearing as red 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 serious skin reactions occurs during the first weeks of treatment, but they may begin developing several months after starting the medication (see section 4). If you have experienced any serious skin reactions while using Antalgin, you must never restart treatment with Antalgin. If you develop a skin rash or these skin symptoms, stop taking Antalgin and contact your doctor or seek immediate medical attention.

Use caution in the following situations:

• It is important that you use the smallest dose that relieves/controls your pain and that you do not take this medicine for 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 greater 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 will consider prescribing a stomach-protective medication.

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

• If you suffer from Crohn's disease or ulcerative colitis, as medicines like Antalgin 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 affect 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 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 Antalgin may mask the usual signs and symptoms of infectious processes.

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

• 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 digestive problems.

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

Cardiovascular precautions

Medicines such as Antalgin 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 are used or treatment is prolonged. 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, 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, especially in patients with heart failure and/or high blood pressure (hypertension).

Other medicines and Antalgin

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 Antalgin 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 Antalgin, but do not affect its overall effect

• Acetylsalicylic acid used to prevent blood clots

• Hydantoins (drugs primarily used for epilepsy)

• Sulfonylureas (diabetes medications)

• Sulfonamides (a type of diuretic medication)

• Methotrexate (an immunosuppressive medication)

• Beta-blockers (anti-hypertensive medication)

• Furosemide (a medication with natriuretic effect)

• Lithium. May cause an increase in plasma lithium concentration

• Steroids; Antalgin may interfere with adrenal function tests

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

• Angiotensin receptor antagonists or blockers (anti-hypertensive medications)

Your doctor may need to adjust the dose of one or both medications. Consult your doctor if you have any questions about these points.

Taking Antalgin 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, 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 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 that of your baby to bleed and may delay or prolong labor beyond the expected duration.

Because the use of medicines like Antalgin has been associated with an increased risk of congenital abnormalities or miscarriage, you should not take Antalgin 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, Antalgin may cause kidney problems in your fetus if taken for more than a few days, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

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

Driving and using machines

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

Antalgin contains sodium

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

3. How to take Antalgin

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

Your doctor will determine 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 sodium naproxen). As initial dose, it is recommended to take 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 severity of the condition. These doses may be adjusted at your doctor's discretion.

For the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: the usual initial dose is 1 tablet (550 mg of sodium naproxen) taken twice daily (in the morning and at night), or 2 tablets (1100 mg of sodium naproxen) taken once daily.

For the treatment of acute gout attacks: the usual initial dose is one and a half tablets (825 mg of sodium naproxen), followed by half a tablet (275 mg of sodium 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 (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 one and a half tablets (825 mg of sodium naproxen) at the onset of symptoms, followed by half a tablet (275 mg of sodium 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 (825 mg and 1375 mg of sodium naproxen), divided into two daily doses. Continue with a daily dose of 1 or 2 tablets (550 mg or 1100 mg of sodium naproxen), divided into two daily doses, for up to the next 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 time. 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.

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 dose that is effective.

If you take more Antalgin than you should

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

Symptoms of overdose include 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 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 a missed dose. Take the missed dose as soon as you remember, then continue with your next scheduled dose.

4. Possible adverse effects

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

Adverse effects that may occur during treatment with this medicine, which have been observed very rarely (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 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 stomach 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 the number of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase in certain white blood cells in the blood), leucopenia (decrease in the number of white blood cells), thrombocytopenia (decrease in the number of platelets), lymph node enlargement, and involvement of other organs in the body (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 (swelling 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, 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 (swelling of the optic disc).

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 pump effectively), hypertension (high blood pressure). Medicines such as Antalgin may be associated with a moderate increase in the 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 Antalgin 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 (a skin disease characterized by small, flat nodules), pustular reactions, skin redness, systemic lupus erythematosus (an autoimmune disease with typical skin signs, rash, and skin redness), severe blistering reactions such as Stevens-Johnson syndrome (a map-like skin rash) and toxic epidermal necrolysis, allergy, photosensitivity reactions including rare cases where the skin resembles that seen in 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 yellowish-brown 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: general malaise, pyrexia (chills and fever), thirst, sore throat, a characteristic drug-related skin allergy known as fixed drug eruption, which typically reappears in the same location upon re-exposure to the drug 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.

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 through 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 Antalgin

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

Do not use Antalgin after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Package contents and other information

Composition of Antalgin

• The active substance 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 carmine lake (E-132), and purified water.

Appearance of the medicine and contents of the pack

Antalgin are film-coated oval-shaped blue tablets, with the inscription "NPS 550" on one side. The tablet is divisible (can be split into two equal doses).

It is available in packs 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, Spain

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 most recent revision of this leaflet: February 2025

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