Label: Information for the Patient

Actromadol 660 mg Modified Release Tablets

Naproxen Sodium

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days for pain or 3 days for fever.

Actromadol contains naproxen sodium as its active ingredient, a substance that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs, and acts by reducing pain and fever.

Actromadolis indicated for adults aged 18 to 65 years, for symptomatic relief of occasional mild to moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (spasms) or back pain (lumbago), as well as in febrile states.

Consult a doctor if symptoms worsen or do not improve after 3 days for fever or 5 days for pain.

Do not take Actromadol:

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

• if you currently have or have had more than one episode of stomach or intestinal ulcers or bleeding,
• • if you have had a previous stomach or duodenal hemorrhage or have experienced a perforation of the digestive system while taking a nonsteroidal anti-inflammatory drug,

• if you have had allergic reactions of an asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases coughing or ringing in the ears) or urticaria when taking anti-inflammatory medications, aspirin, or other analgesics,
• if you have asthma,
• if you have nasal polyps,
• if you have severe kidney, liver, and/or heart diseases (renal, hepatic, and/or cardiac insufficiency),
• if you are in your third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actromadol.

It is essential to use the smallest dose that relieves pain and not to take this medication for longer than necessary to control your symptoms.

Be especially careful if:

• You have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatments, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider associating a stomach protector medication.

Inform your doctor:

• If you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like aspirin. You should also mention the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as Actromadol-type medications may worsen these conditions.
• If you have high blood pressure, reduced kidney, heart, or liver function, or coagulation disorders.
• If you have or have had rhinitis or urticaria.
• If you are in the first or second trimester of pregnancy.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Actromadol. Stop taking Actromadol and consult your doctor immediately if you observe any symptoms related to severe skin reactions described in section 4.

Cardiovascular precautions

Medications like Actromadol may be associated with a moderate increase in the risk of heart attacks or strokes. This risk is more likely to occur when using high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration (1 660 mg naproxen sodium tablet per day for a maximum of 5 days).

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

These types of medications may also cause fluid retention, especially in patients with heart problems (heart failure) and/or high blood pressure.

Avoid concurrent use with alcohol.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years old.

Actromadol with other medications

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

This is especially important in the case of:

• other analgesics or nonsteroidal anti-inflammatory drugs (medications used to treat pain, fever, and/or inflammation),
• some antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding,
• anticoagulants (medications used to "thin" the blood and prevent the formation of clots) like warfarin,
• medications used to prevent transplant rejection (ciclosporin and tacrolimus),
• corticosteroids, as it may potentiate the risk of gastrointestinal bleeding,
• diuretics, ACE inhibitors, and angiotensin II receptor antagonists (for the treatment of high blood pressure or hypertension),
• lithium (used in some psychiatric disorders),
• methotrexate (medication used to treat cancer, rheumatoid arthritis).
• low-dose aspirin (used to prevent blood clots).

Actromadol with food, drinks, and alcohol

Take this medication with meals or with milk.

Do not administer this medication with alcohol to avoid damaging the stomach.

If you regularly consume alcohol (three or more alcoholic beverages – beer, wine, liquor, etc. – per day), taking Actromadol may cause stomach bleeding.

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 medication.

Pregnancy

Breastfeeding

Women in the lactation period should consult their doctor before using this medication, as naproxen passes into breast milk.

Fertility

For fertile patients, it is essential to consider that medications containing naproxen have been associated with a decrease in the ability to conceive.

Driving and operating machinery

Use with caution in patients whose activity requires attention and who have observed fatigue, dizziness, vertigo, insomnia, or visual disturbances during treatment with this medication.

Actromadol contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

This medication contains 60 mg of sodium (main component of table salt/for cooking) in each tablet. This corresponds to 3% of the recommended maximum daily sodium intake for an adult.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults between 18 and 65 years:Take 1 tablet (660 mg of naproxen sodium) every 24 hours. The maximum daily dose is 1 tablet per day.

Do not take more than 1 tablet every 24 hours.

Patients over 65 years:do not administer to patients over 65 years.Older people are more prone to adverse effects, so it is recommended to use lower doses in these patients.

Patients with liver, kidney, or heart disease:do not administer this medication as it is recommended to reduce the dose, using the minimum dose the patient needs. Consult your doctor.

Use in children and adolescents

Do not administer this medication to children and adolescents under 18 years, as there are not enough available data on its safety and efficacy.

Administration form:

This medication is administered orally.

Take thetablet whole, with a glass of water and without chewing, with meals or with milk, especially if digestive discomfort is noted.

The administration of this medication is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, discontinue this medication.

If pain persists for more than 5 days, or fever for more than 3 days, or if symptoms worsen or new ones appear, discontinue treatment and consult your doctor.

Ifyou take more Actromadolthan you should

If you have taken moreActromadolthan you should, consult your doctor or pharmacist immediately.

The symptoms of overdose are: headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, rapid breathing, mental confusion, nausea, vomiting, and occasionally diarrhea. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Frequent side effects (may affect up to 1 in 10 patients):

• Gastrointestinal disorders, such as dyspepsia (stomach pain or heaviness), nausea, heartburn, stomach pain,
• Headache, dizziness, feeling of fainting.

Less frequent side effects (may affect up to 1 in 100 people):

• Dizziness, insomnia, drowsiness,
• Vomiting, constipation or diarrhea,
• Dizziness,
• Hypersensitivity reactions with exanthema (skin rash), pruritus, urticaria.

Rare side effects (may affect up to 1 in 1,000 patients):

• Gastrointestinal bleeding, peptic ulcers with or without bleeding, hematemesis and/or melena (vomiting with blood and/or bloody stools),
• Renal damage,
• Liver damage,
• Angioedema (severe allergic reaction),
• Peripheral edema (especially in patients with hypertension or renal insufficiency), fever, chills.

Very rare side effects (may affect up to 1 in 10,000 patients):

• Colitis, stomatitis (inflammation of the mucous membrane of the mouth), esophagitis, pancreatitis, aphthae, intestinal ulcers,
• Jaundice (yellow discoloration of the skin), hepatitis (inflammation of the liver), altered liver function,
• Renal alterations such as interstitial nephritis (inflammation at the level of the kidney), capillary necrosis, nephrotic syndrome (manifests with cloudy urine and facial swelling), acute renal failure, hematuria, proteinuria,
• Aplastic or hemolytic anemia (reduction in the number of red blood cells, white blood cells, and platelets in the blood), increased blood pressure, blood disorders (leukopenia (decrease in the number of white blood cells), thrombocytopenia (decrease in the number of platelets), eosinophilia (increase in certain white blood cells) and agranulocytosis (increase/decrease in certain white blood cells)), vasculitis (inflammation of the blood vessels),
• Dyspnea (sensation of lack of air), asthma, eosinophilic pneumonitis, sweating, photosensitivity (sensitivity to light), hair loss, cold sores, erythema multiforme exudative (blisters on the skin), fixed drug eruption (rash), vesicular skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), lichen planus (inflammation of the skin with red papules mainly on the neck, forearm, and abdomen), erythema nodosum (presence of nodules on the skin), systemic lupus erythematosus, purpura (blood clots in the skin), porphyria, and epidermolysis bullosa,
• Anaphylaxis/allergic reactions (occurring with swelling due to accumulation of fluid in the face, tongue, or larynx (facial, lingual, and laryngeal edema), dyspnea (sensation of lack of air), tachycardia, and fall in blood pressure),
• Visual disturbances, corneal opacity (alteration of the cornea ranging from a faint spot to a grayish-white spot visible to the naked eye), papillitis (inflammation of the papilla), papilledema (inflammation of the optic papilla) and optic neuritis (inflammation of the optic nerve),
• Disability of hearing (decrease in hearing), ringing in the ears (tinnitus) and auditory disorders,
• Heart failure, pulmonary edema (swelling due to accumulation of fluid in the lung),
• Psychiatric disorders, depression, sleep disorders, lack of concentration,
• Edema (swelling due to accumulation of fluid), thirst, discomfort,
• Increased levels of serum creatinine and liver enzymes, hyperkalemia,
• Symptoms similar to aseptic meningitis (general discomfort, headache, vomiting, and stiffness of the neck) in patients with autoimmune disorders, cognitive dysfunction (alteration in knowledge) or seizures.

If you notice the appearance of the following side effects, stop taking Actromadol and consult your doctor immediately:

Unknown frequency: cannot be estimated from available data

• Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood disorders (eosinophilia), lymph node enlargement, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms known as DRESS). See also section 2.
• A characteristic skin allergic reaction known as fixed drug eruption, which generally reappears at the same site upon re-exposure to the medication and may be seen as red, rounded, or oval spots and swelling of the skin, blisters (urticaria), and itching.

If you consider that any of the side effects you are experiencing are severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

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

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Actromadol

• The active ingredient is naproxen sodium. Each modified-release tablet contains 660 mg of naproxen sodium (equivalent to 600 mg of naproxen and 60 mg of sodium).
• The other components (excipients) are: microcrystalline cellulose, povidone, talc, magnesium stearate, hypromellose 2208, lactose monohydrate, anhydrous colloidal silica, hypromellose 2910, titanium dioxide, aluminum lake (E132), and carnauba wax.

Appearance of the product and content of the packaging

Actromadol 660 mg are modified-release tablets. The tablets are oval-shaped and blue in color.

They are presented in packaging containing 4 and 8 modified-release tablets.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer Bitterfeld GmbH,

Salegaster Chaussee 1

06803 Bitterfeld-Wolfen (Germany)

Last review date of this leaflet: August 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/