Emoxen

Leaflet accompanying the packaging: Patient information

Emoxen, 500 mg + 20 mg, tablets with modified release

Naproxen + Esomeprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Emoxen and what is it used for
• 2. Important information before taking Emoxen
• 3. How to take Emoxen
• 4. Possible side effects
• 5. How to store Emoxen
• 6. Contents of the packaging and other information

1. What is Emoxen and what is it used for

What is Emoxen

Emoxen contains two different medicines called naproxen and esomeprazole. Each of these medicines works in a different way.

• Naproxen belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). It reduces pain and inflammation.
• Esomeprazole belongs to a group of medicines called "proton pump inhibitors". It reduces the production of stomach acid. Esomeprazole helps reduce the risk of stomach ulcers and other stomach problems that can occur in patients who need to take NSAIDs.

What is Emoxen used for

Emoxen is used in adults to relieve symptoms of the following conditions:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.

Emoxen helps reduce pain, swelling, redness, and increased temperature (inflammation). The patient will receive the medicine if low doses of NSAIDs are ineffective in relieving pain and are at risk of stomach ulcers or ulcers in the first part of the small intestine (duodenum) when taking NSAIDs.

2. Important information before taking Emoxen

When not to take Emoxen:

• If the patient has been diagnosed with an allergy (hypersensitivity) to naproxen.
• If the patient has been diagnosed with an allergy to esomeprazole or other proton pump inhibitors.
• If the patient has been diagnosed with an allergy to any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking atazanavir or nelfinavir (used to treat HIV infection).
• If the patient has experienced asthma (wheezing) or an allergic reaction such as itching of the skin or hives (urticaria) after taking acetylsalicylic acid (e.g., aspirin), naproxen, or other NSAIDs such as ibuprofen, diclofenac, or COX-2 inhibitors (e.g., celecoxib, etoricoxib).
• If the patient is in the last three months of pregnancy.
• If the patient has severe liver, kidney, or heart problems.
• If the patient has stomach or intestinal ulcers.
• If the patient has bleeding disorders or serious and unexpected bleeding.
• If the patient has ever experienced a severe skin rash or skin peeling after taking Emoxen or other similar medicines.

If any of these situations apply to the patient, they should not take Emoxen. If they are unsure, they should consult their doctor or pharmacist before taking Emoxen.

Warnings and precautions

Before starting to take Emoxen, the patient should discuss it with their doctor or pharmacist. The patient should not take Emoxen and should contact their doctor immediately if any of the following situations have occurred before or during treatment with Emoxen, as the medicine may mask the symptoms of another disease:

• Significant, unintended weight loss and swallowing disorders.
• Vomiting or vomiting with blood.
• Black stools (stool discolored with blood). If any of these situations apply to the patient (or the patient has doubts), they should inform their doctor or pharmacist before taking this medicine.

Before taking this medicine, the patient should consult their doctor or pharmacist if:

• The patient has intestinal inflammation (Crohn's disease or ulcerative colitis).
• The patient has other liver or kidney problems or is elderly.
• The patient is taking medicines such as oral corticosteroids, warfarin, clopidogrel, selective serotonin reuptake inhibitors (SSRIs), acetylsalicylic acid (aspirin), or NSAIDs, including COX-2 inhibitors (see section "Emoxen and other medicines").
• The patient has ever experienced a skin reaction after taking a medicine similar to esomeprazole (a component of Emoxen) that reduces stomach acid production.
• The patient needs to undergo a specific blood test (chromogranin A determination).

If any of these situations apply to the patient (or the patient has doubts), they should inform their doctor or pharmacist before taking this medicine. If the patient has had stomach ulcers or bleeding before, they should inform their doctor. The patient will be asked to report any unusual stomach symptoms (e.g., pain) to their doctor. Taking medicines like Emoxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and longer treatment. The patient should not exceed the recommended dose and duration of treatment. Emoxen contains naproxen, an NSAID. Like all NSAIDs, naproxen should be used at the lowest effective dose for the shortest possible time to minimize the risk of adverse reactions. The doctor will therefore assess whether Emoxen is still suitable for the patient at regular intervals. Emoxen is not suitable for rapid relief of acute pain, as it takes several hours for the pain-relieving substance naproxen to be absorbed into the blood. Before taking the medicine, the patient should also inform their doctor if they have heart problems, have had a stroke, or think they are at risk of these diseases. The patient may be at risk of these diseases if:

• The patient has high blood pressure.
• The patient has circulation or blood clotting problems.
• The patient has diabetes.
• The patient has high cholesterol levels in the blood.
• The patient smokes.

Taking a proton pump inhibitor (a component of Emoxen), especially for a period longer than a year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have osteoporosis or are taking corticosteroids (medicines that can increase the risk of osteoporosis). Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with Emoxen. These serious skin reactions often occur after flu-like symptoms such as fever, headache, body aches, and may include a severe rash. The rash can occur on a large area of the body, with blisters and peeling of the skin. The patient should stop taking the medicine and contact their doctor immediately if they experience any of the symptoms associated with these serious skin reactions, described in section 4. If a rash appears on the skin, especially in areas exposed to sunlight, the patient should inform their doctor as soon as possible, as it may be necessary to stop treatment with Emoxen. The patient should also mention any other symptoms, such as joint pain. During treatment with Emoxen, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. The patient should inform their doctor about such symptoms.

Children and adolescents

Emoxen is not recommended for use in children and adolescents under 18 years of age.

Emoxen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription, including herbal medicines. This is important because Emoxen may affect the action of other medicines. The action of Emoxen may also be affected if other medicines are taken. The patient should not take this medicine and should inform their doctor or pharmacist if they are taking:

• A medicine called "atazanavir" or "nelfinavir" (used to treat HIV infection).

The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• Acetylsalicylic acid (aspirin) (used as a pain reliever or to prevent blood clots). If the patient is taking low doses of acetylsalicylic acid (aspirin), they may continue to take Emoxen.
• Other NSAIDs (including COX-2 inhibitors).
• Certain medicines such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Erlotinib (or another anticancer medicine from the same class).
• Cholestyramine (a medicine used to lower cholesterol levels in the blood).
• Clarithromycin (an antibiotic).
• "Quinolone antibiotics" (used to treat infections), such as ciprofloxacin or moxifloxacin.
• Diazepam (a medicine used to treat anxiety, to relax muscles, or to treat epilepsy).
• Hydantoin derivatives such as phenytoin (a medicine used to treat epilepsy).
• Lithium salts (a medicine used to treat certain types of depression).
• Methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer).
• Probenecid (a medicine used to treat gout).
• Selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat anxiety and depression).
• Cyclosporine or tacrolimus (medicines used to reduce the body's immune response).
• Digoxin (used to treat heart rhythm disorders).
• Sulfonylurea derivatives such as glimepiride (oral medicines used to control blood sugar levels in diabetes).
• Medicines used to treat high blood pressure, called diuretics (such as furosemide or hydrochlorothiazide), ACE inhibitors (such as enalapril), angiotensin II receptor antagonists (such as losartan), and beta-adrenergic blockers (such as propranolol).
• Corticosteroids such as hydrocortisone or prednisolone (used as anti-inflammatory medicines).
• Anticoagulant medicines, such as warfarin, dicoumarol, heparin, or clopidogrel.
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (a medicine used to treat leg pain caused by poor blood flow).

If any of the above situations apply to the patient (or the patient has doubts), they should inform their doctor or pharmacist before taking Emoxen.

Emoxen with food

Emoxen should not be taken with food, as it may reduce and/or delay the action of Emoxen. The tablets should be taken at least 30 minutes before a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Emoxen should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect the patient's and their unborn child's tendency to bleed and may cause delayed or prolonged delivery. Emoxen should not be taken during the first six months of pregnancy, unless it is absolutely necessary and has been prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest dose should be used for the shortest possible time.
If the medicine is taken for more than a few days starting from the 20th week of pregnancy, it may cause kidney problems in the unborn child, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Emoxen should not be taken during breastfeeding. This is because small amounts of the medicine may pass into the breast milk of nursing mothers. If the patient plans to breastfeed, they should not take Emoxen.
Fertility
Emoxen may make it difficult to conceive. The patient should inform their doctor if they plan to conceive or have difficulty conceiving.

Driving and using machines

During treatment with Emoxen, dizziness or vision disturbances may occur. If they occur, the patient should not drive vehicles, use tools, or operate machines.

Emoxen contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Emoxen contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Emoxen

Emoxen should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

How to take the medicine

• The tablets should be swallowed whole, with water. They should not be chewed, divided, or crushed. It is essential to take the tablets whole for the medicine to work properly.
• The tablets should be taken at least 30 minutes before a meal. Food may reduce the protective effect of Emoxen on the stomach and intestines. Food may also cause significant delays in relieving pain and inflammation.
• If the patient is taking this medicine for a long time, their doctor may decide to monitor them (especially if they are taking the medicine for more than a year).

How many tablets to take

• The patient should take one tablet twice a day for a period consistent with their doctor's recommendations.
• Emoxen is available only in a dose of 500 mg + 20 mg. If the doctor decides that the dosage is not suitable for the patient, they may recommend alternative treatment.

What to do if the patient takes more Emoxen than they should

If the patient takes more Emoxen than they should, they should contact their doctor or pharmacist immediately. Possible symptoms of overdose include: lethargy, dizziness, drowsiness, pain and/or discomfort in the upper abdomen, heartburn, nausea, vomiting, liver function disorders (shown in blood tests), kidney function disorders, which can be severe, elevated blood acid levels, confusion, vomiting, gastrointestinal bleeding, high blood pressure, breathing difficulties, coma, uncontrolled body movements.

What to do if the patient misses a dose of Emoxen

• The patient should take the missed dose as soon as possible. However, if it is almost time for the next dose, they should not take the missed dose.
• The patient should not take a double dose (two doses at the same time) to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Emoxen can cause side effects, although not everybody gets them. The following side effects may occur after taking this medicine.

The patient should stop taking Emoxen and contact their doctor immediately if they experience any of the following serious side effects - they may need urgent medical attention:

• Sudden onset of wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• A characteristic skin allergic reaction called fixed drug eruption, which usually recurs in the same place (places) after re-administration of the medicine and may take the form of round or oval red patches and swelling of the skin, blisters (hives), itching.
• Sudden onset of a severe skin reaction, which may include widespread rash, blisters, or peeling, occurring even after several weeks of treatment, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs. Blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may transform into serious, widespread skin damage (exfoliation and superficial mucosal erosion) with life-threatening consequences. This may be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or DRESS/drug hypersensitivity syndrome, which occurs very rarely. See also section 2.
• Yellowing of the skin or whites of the eyes, dark urine, and fatigue, which may be symptoms of liver function disorders.
• Emoxen may be associated with a small increased risk of

heart attack (myocardial infarction) or stroke. Symptoms include chest pain radiating to the neck and arms and down the left arm, confusion or weakness of muscle strength or stiffness affecting only one side of the body.

• Passing black, tarry stools or bloody diarrhea.
• Vomiting blood or coffee-ground-like vomit.

The patient should contact their doctor immediately if they experience any of the following symptoms:

In rare cases, Emoxen may affect the white blood cell count, leading to weakened immunity.
If the patient experiences an infection with symptoms such as fever with a very bad general condition or fever with local infection symptoms such as neck, throat, or mouth pain, or difficulty urinating, they should consult their doctor as soon as possible to have a blood test to rule out a lack of white blood cells (agranulocytosis). It is essential to inform the doctor about the medicine being taken.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Fatigue.
• Thirst.
• •Depression.
• Shortness of breath.
• Excessive sweating.
• Itching skin and rashes.
• Feeling of spinning (vertigo).
• Red or purple spots, bruises, or discoloration on the skin.
• Nausea (vomiting) or vomiting.
• Palpitations (heart pounding).
• Sleep disturbances or difficulty sleeping (insomnia).
• Hearing disturbances or ringing in the ears.
• Dizziness, drowsiness, or loss of balance.
• Swelling of the hands, feet, and ankles (edema).
• Mouth inflammation.
• Vision disturbances.
• Diarrhea, abdominal pain, heartburn, nausea, constipation, bloating, or gas.
• Stomach ulcers or duodenal ulcers.
• Gastritis (inflammation of the stomach lining).
• Mild stomach polyps.

Uncommon, rare, or very rare (may affect up to 1 in 100 people or less)

• Mouth pain or mouth ulcers.
• Vision disturbances, such as blurred vision, conjunctivitis, or eye pain.
• Strange dreams.
• Drowsiness.
• Elevated blood sugar levels. Symptoms may include thirst and increased urine output.
• Low blood sugar levels. Symptoms may include hunger or weakness, sweating, and rapid heartbeat.

Coma.

• Vasculitis (inflammation of blood vessels).
• Perforation (hole) in the stomach or intestine.
• Systemic lupus erythematosus (SLE), a disease in which the immune system attacks the body, causing joint pain, skin rashes, and fever.
• Enlarged lymph nodes.
• Fracture of the hip, wrist, or spine (in cases of long-term use of Emoxen in high doses).
• Fever.
• Fainting.
• Dry mouth.
• Aggression.
• Hearing loss.
• Asthma attack.
• Seizures or convulsions.
• Menstrual disorders.
• Weight changes.
• Hair loss (alopecia).
• •Hives (urticaria).
• Joint pain (arthralgia).
• Breast enlargement in men.
• Tongue pain or swelling.
• Mild muscle spasms or tremors.
• Appetite or taste disturbances.
• Muscle weakness or pain (myalgia).
• Prolonged blood clotting time.
• Women may experience difficulty conceiving.
• Fever, redness, or other signs of infection.
• Irregular, slow, or very fast heartbeat.
• Numbness or tingling.
• Memory or concentration problems.
• Feeling of excitement, confusion, anxiety, or agitation.
• General malaise, weakness, and lack of energy.
• Swelling or pain in parts of the body due to fluid retention.
• High or low blood pressure. Symptoms may include fainting or dizziness.
• Skin rash or blistering, or increased sensitivity to sunlight.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Changes in liver function test results. The doctor will explain this in detail.
• A fungal infection called "thrush", which can affect the intestines and is caused by fungi.
• Blood in the urine or other kidney function disorders. This may be accompanied by back pain.
• Breathing difficulties, which may worsen gradually. These may be symptoms of developing pneumonia or pulmonary edema.
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle spasms. Low sodium levels in the blood may also lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor sodium levels.
• Symptoms of meningitis, such as fever, nausea, vomiting, stiff neck, headache, sensitivity to light, and confusion.
• Pancreatitis (inflammation of the pancreas). Symptoms include severe abdominal pain radiating to the back.
• Jaundice (a severe liver disease). Symptoms include pale stools, which are a sign of severe liver disease. Severe liver diseases can lead to liver failure and brain disease.
• Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). Symptoms include abdominal pain, diarrhea, vomiting, and weight loss.

Blood disorders, such as reduced red blood cell count (anemia), white blood cell count, or platelet count. This may cause weakness, bruising, fever, severe chills, sore throat, or increased susceptibility to infections.

• Increased white blood cell count (eosinophilia).
• Lack of all types of blood cells (pancytopenia).
• Problems with the way the heart pumps blood or damage to blood vessels. Symptoms may include fatigue, shortness of breath, weakness, chest pain, or general pain.

Frequency not known (frequency cannot be estimated from available data)

• Taking Emoxen for at least three months may cause a decrease in blood magnesium levels. Low blood magnesium levels may cause fatigue, involuntary muscle spasms, disorientation, convulsions, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should inform their doctor immediately. Low blood magnesium levels may also lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Rash, possibly with joint pain.

The patient should not be concerned about the possible side effects listed.They may not experience any of them.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Emoxen

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the carton or bottle after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
The patient should store the medicine in its original packaging and keep the bottle tightly closed to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Emoxen contains

• •The active substances are naproxen 500 mg and esomeprazole 20 mg (as magnesium trihydrate).
• •The other ingredients (excipients) are: in the tablet core: silicon dioxide, methacrylic acid, and ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, glyceryl monostearate 40-55, triethyl citrate, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, microcrystalline cellulose, light magnesium oxide, povidone, calcium stearate; in the coating: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), yellow iron oxide (E172).

What Emoxen looks like and contents of the pack

Emoxen are yellow, elongated, biconvex tablets, 19.4 mm long, smooth on both sides.
Pack sizes: 30 or 60 modified-release tablets. Not all pack sizes may be marketed.
The bottles contain a desiccant in the form of silica gel (which keeps the tablets dry). The desiccant containers should not be removed from the bottles. The desiccant containers should not be swallowed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Importer

Bausch Health Poland Sp. z o. o.
ul. Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland Sp. z o. o.
ul. Kosztowska 21
41-409 Mysłowice

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Slovakia: Emoxen Plus
Denmark, Finland, Norway, Sweden: Emoxenduo
Spain: Emoxen 500 mg/20 mg comprimidos de liberación modificada EFG
Poland: Emoxen
Hungary: Apranax PLUS 500 mg/20 mg módosított hatóanyagleadású tabletta
Date of last revision of the leaflet:April 2025