ACTROMADOL 660 mg MODIFIED-RELEASE TABLETS

2. What you need to know before starting to take Actromadol

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 once: a stomach or intestinal 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 medication,

• if you have presented allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) or urticaria when taking anti-inflammatory medications, acetylsalicylic acid, or other analgesics,
• if you have asthma,
• if you have nasal polyps,
• if you have severe kidney, liver, and/or heart disease (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 that you use the smallest dose that relieves the pain and do not take this medication for longer than necessary to control your symptoms.

Be particularly careful 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.
• This risk is higher when high doses and prolonged treatments are used, 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-protecting 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 of the acetylsalicylic acid type. You should also discuss the use of other medications that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications of the Actromadol type can worsen these conditions.
• If you have hypertension, or have reduced kidney, heart, or liver function, or have blood coagulation disorders,
• If you have rhinitis or urticaria,
• If you are in the first or second trimester of pregnancy.

There have been reports of serious skin reactions, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), associated with Actromadol. Stop taking Actromadol and consult your doctor immediately if you observe any symptoms related to serious skin reactions described in section 4.

Cardiovascular precautions

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

If you have heart problems, a history of strokes, or think you may be at risk of suffering from these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment.

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

The concomitant use of this medication with alcohol should be avoided.

There have also been reports of symptoms of an allergic reaction to this medication, including respiratory problems, swelling of the face and neck (angioedema), and chest pain, with naproxen. Stop taking Actromadol immediately and contact your doctor or medical emergencies if you observe any of these symptoms.

Children and adolescents

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

Taking Actromadol with other medications

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

This is especially important in the case of:

• other analgesics or non-steroidal anti-inflammatory medications (medications used to treat pain, fever, and/or inflammation),
• certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding,
• anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as warfarin,
• medications used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids, as they can increase 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 certain psychiatric illnesses),
• methotrexate (a medication used to treat cancer, rheumatoid arthritis),
• low-dose acetylsalicylic acid (used to prevent blood clots).

Taking 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 habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor, ... - per day), taking Actromadol may cause a stomach hemorrhage.

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.

Pregnancy

Breastfeeding

Women who are breastfeeding should consult their doctor before using this medication, as naproxen passes into breast milk.

Fertility

For patients of childbearing age, it should be noted that medications containing naproxen have been associated with a decrease in fertility.

Driving and using machines

This medication should be used with caution in patients whose activity requires attention and who have observed fatigue, dizziness, vertigo, insomnia, or vision disturbances during treatment with this medication.

Actromadol contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 60 mg of sodium (the main component of table salt) per tablet. This is equivalent to 3% of the maximum recommended daily sodium intake for an adult.

3. How to take Actromadol

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

The recommended dose is:

Adults between 18 and 65 years old: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.

Over 65 years old:Do not administer to patients over 65 years old. Elderly people are more prone to suffering from side effects, so it is recommended to use lower doses in these patients.

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

Use in children and adolescents

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

Method of administration:

This medication is administered orally.

Take the tablet whole, with a glass of water, and without chewing, with meals or with milk, especially if you notice digestive discomfort.

The administration of this medication is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, you should stop taking this medication.

If the pain persists for more than 5 days, or the fever for more than 3 days, or the symptoms worsen or other symptoms appear, you should interrupt the treatment and consult your doctor.

If you take more Actromadol than you should

If you have taken more Actromadol than you should, consult your doctor or pharmacist immediately.

The symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, rapid breathing, mental confusion, nausea, vomiting, and occasionally diarrhea. It is recommended to take 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can 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.

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

• dizziness, insomnia, drowsiness,
• vomiting, constipation, or diarrhea,
• vertigo,
• 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 blood and/or bleeding in stools),
• kidney 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 mouth mucosa), esophagitis, pancreatitis, aphthae, intestinal ulcers,
• jaundice (yellowing of the skin), hepatitis (inflammation of the liver), altered liver function,
• kidney disorders such as interstitial nephritis (inflammation of the kidney), capillary necrosis, nephrotic syndrome (manifested by cloudy urine and swelling in the face), 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, thrombocytopenia, eosinophilia, and agranulocytosis), vasculitis (inflammation of blood vessels),
• dyspnea (shortness of breath), asthma, eosinophilic pneumonitis, sweating, photosensitivity (sensitivity to light), hair loss, chilblains, erythema multiforme exudative (blisters on the skin), fixed drug eruption (skin rash), blistering skin reactions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (Lyell's syndrome), lichen planus (skin inflammation with red papules mainly on the neck, forearm, and abdomen), erythema nodosum (presence of nodules on the skin), systemic lupus erythematosus, purpura (blood spots on the skin), porphyria, and epidermolysis bullosa,
• anaphylaxis/anaphylactoid reactions (characterized by swelling due to fluid accumulation in the face, tongue, or larynx, shortness of breath, tachycardia, and a drop in blood pressure),
• vision disturbances, corneal opacity (alteration of the cornea that ranges 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),
• hearing impairment (reduced hearing), tinnitus (ringing in the ears), and hearing disorders,
• congestive heart failure, pulmonary edema (swelling due to fluid accumulation in the lungs),
• psychiatric disorders, depression, sleep disturbances, lack of concentration,
• edema (swelling due to fluid accumulation), thirst, discomfort,
• increased serum creatinine levels and liver values, hyperkalemia,
• symptoms similar to aseptic meningitis (general discomfort, headache, vomiting, and neck stiffness) in patients with autoimmune disorders, cognitive dysfunction (alteration in knowledge), or convulsions.

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

Frequency not known: cannot be estimated from the available data

• widespread skin rash, elevated body temperature, high liver enzyme levels, blood disorders (eosinophilia), lymph node enlargement, and affectation of other body organs (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 in the same location when re-exposed to the medication and may appear as red, round, or oval patches and swelling of the skin, blisters (urticaria), and itching.
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

If you consider that any of the side effects you are experiencing is serious, 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Actromadol

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the Sigre Point in your pharmacy. If in 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 Actromadol

• The active ingredient is sodium naproxen. Each modified-release tablet contains 660 mg of sodium naproxen (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 lacquer (E132), and carnauba wax.

Appearance of the Product and Package Contents

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

They are available in packages 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

Manufacturer

Bayer Bitterfeld GmbH,

Salegaster Chaussee 1

06803 Bitterfeld-Wolfen (Germany)

Date of the Last Revision of this Leaflet: April 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/