EMOXEN 500 mg/20 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Emoxen 500 mg/20 mg Modified Release Tablets EFG

naproxen/esomeprazol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Emoxen and what is it used for

What is Emoxen

Emoxen contains two different medicines called naproxen and esomeprazol. 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.
• Esomeprazol belongs to a group of medicines called “proton pump inhibitors”. It reduces the amount of acid in your stomach.

Esomeprazol helps to reduce the risk of ulcers and stomach problems that occur in patients who need to take NSAIDs.

What Emoxen is used for

Emoxen is used in adults to relieve symptoms of:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis.

Emoxen helps to reduce pain, swelling, redness, and heat (inflammation).

You will receive this medicine if it is considered unlikely that a lower dose of NSAID will relieve your pain and you are at risk of developing a stomach ulcer or an ulcer in the first part of the small intestine (duodenum) while taking an NSAID.

2. What you need to know before you take Emoxen

Do not take Emoxen:

• If you are allergic (hypersensitive) to naproxen.
• If you are allergic to esomeprazol or other proton pump inhibitors.
• If you are allergic to any of the other ingredients of this medicine (listed in section 6).
• If you are taking a medicine called “atazanavir” or “nelfinavir” (used to treat HIV infection).
• If acetylsalicylic acid (e.g. aspirin), naproxen, or other NSAIDs such as ibuprofen, diclofenac, or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have ever caused you asthma (wheezing), an allergic reaction such as itching or skin rash (urticaria).
• If you are in the last 3 months of pregnancy.
• If you have severe liver, kidney, or heart problems.
• If you have a stomach or intestinal ulcer.
• If you have any bleeding disorder or severe or unexpected bleeding.
• If you have ever developed a severe skin rash or blistering of the skin, mouth, or eyes after taking esomeprazol or other medicines related to it.

Do not take Emoxen if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Emoxen.

Do not take Emoxen and consult your doctor immediately if you experience any of the following episodes before or during treatment with Emoxen, as this medicine may hide the symptoms of another illness:

• if you lose a lot of weight without apparent reason and have difficulty swallowing.
• if you vomit food or blood.
• if your stools are black (blood-stained).

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking this medicine.

Consult your doctor or pharmacist before taking this medicine if:

• You have inflammation in your intestines (Crohn's disease or ulcerative colitis).
• You have other liver or kidney problems or if you are elderly.
• You are taking medicines such as oral corticosteroids, warfarin, clopidogrel, Selective Serotonin Reuptake Inhibitors (SSRIs), acetylsalicylic acid (aspirin), or NSAIDs including COX-2 inhibitors (see section Taking Emoxen with other medicines).
• If you have ever had a skin reaction after treatment with a medicine similar to esomeprazol (a component of Emoxen) to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking this medicine.

If you have had a stomach or intestinal ulcer in the past, inform your doctor. You will be asked to inform your doctor of any unusual stomach symptoms (e.g. pain).

Some medicines like Emoxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is always greater with high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Emoxen contains the NSAID naproxen. Like all NSAIDs, naproxen should be used at the lowest effective dose with the shortest possible duration to reduce the risk of unwanted effects. Your doctor will therefore assess at regular intervals whether Emoxen is still suitable for you.

Emoxen is not suitable for rapid relief of acute pain, as it takes several hours for the analgesic naproxen to reach the bloodstream.

Consult your doctor before taking this medicine if you have any heart problems, a history of stroke, or think you are at risk of suffering from these problems. You may be at risk of suffering from these problems if:

• you have high blood pressure;
• you have circulation or coagulation problems;
• you are diabetic;
• you have high cholesterol levels;
• you are a smoker.

Taking a proton pump inhibitor (which is one of the components of Emoxen), especially for a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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), in association with Emoxen. These serious skin reactions usually appear after symptoms similar to those of the flu, such as fever, headache, and body aches. The rash can cover large areas of the body with blisters and skin peeling.

Stop taking Emoxen and consult your doctor immediately if you notice any of the symptoms related to serious skin reactions described in section 4.

If you experience a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Emoxen. Remember to mention any other symptoms you may notice, such as joint pain.

During treatment with Emoxen, kidney inflammation may occur. The signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should inform your doctor of these signs.

Children and adolescents

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

Other medicines and Emoxen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, including herbal medicines. This is because Emoxen may affect the way other medicines work. Also, some medicines may affect the way Emoxen works.

Do not take this medicine and inform your doctor or pharmacist if you are taking:

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

Tell your doctor or pharmacist if you are taking any of these medicines:

• Acetylsalicylic acid (aspirin) (used as a pain reliever or to prevent blood clots). If you are taking low doses of acetylsalicylic acid (aspirin), you may still be able 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 of the same class).
• Colestyramine (used to reduce cholesterol).
• Clarithromycin (used to treat infections).
• “Quinolone antibiotics” (for infections), such as ciprofloxacin or moxifloxacine.
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Lithium (used to treat some types of depression).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer).
• Probenecid (used for gout).
• “Selective Serotonin Reuptake Inhibitors” (SSRIs) (used to treat severe depression and anxiety disorders).
• Ciclosporin or tacrolimus (medicines used to reduce the body's immune reactions).
• Digoxin (used to treat heart problems).
• Sulfonylureas such as glimepiride (oral medicines used to control blood sugar levels in diabetes).
• Medicines used to treat high blood pressure that are called diuretics (such as furosemide or hydrochlorothiazide), ACE inhibitors (such as enalapril), angiotensin II receptor antagonists (such as losartan), and beta-blockers (such as propranolol).
• Corticosteroid medicines such as hydrocortisone or prednisolone (used as anti-inflammatory medicines).
• Medicines to prevent blood clotting, such as warfarin, dicumarol, heparin, or clopidogrel.
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used for leg pain due to poor blood flow).

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking Emoxen.

Taking Emoxen with food

Do not take Emoxen with food, as it may reduce and/or delay the effect of this medicine. Take the tablets at least 30 minutes before meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Emoxen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency to bleed, and that of your baby, and that delivery may be delayed or prolonged more than expected. You should not use Emoxen during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, Emoxen may cause kidney problems in the fetus that can lead to low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need to prolong treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Do not breastfeed if you are taking Emoxen, as small amounts may pass into breast milk. If you are planning to breastfeed your child, do not take Emoxen.

Fertility

Emoxen may make it difficult for you to become pregnant. You should inform your doctor if you are planning a pregnancy or are having difficulty becoming pregnant.

Driving and using machines

You may feel dizzy or experience blurred vision during treatment with Emoxen. If this happens, do not drive or use tools or machines.

Emoxen contains sodium

This medicine contains less than 1 mmol of sodium (23mg) per tablet, i.e., it is essentially “sodium-free”.

Emoxen contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Emoxen

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

How to take this medicine

• Swallow the tablets whole with water. Do not break, chew, or crush the tablets. It is important that you swallow the tablets whole for the medicine to work correctly.
• Take the tablets at least 30 minutes before meals. Food may reduce the protective effect of Emoxen on your stomach and intestines. Food may also cause a significant delay in the relief of pain and inflammation.
• If you have been taking this medicine for a long time, your doctor will want to perform checks (especially if you have been taking it for more than a year).

How much to take

• Take one tablet twice a day for the time indicated by your doctor.
• Emoxen is only available as 500 mg/20 mg.
• If your doctor thinks this dose is not suitable for you, they may prescribe another treatment.

If you take more Emoxen than you should

If you take more Emoxen than you should, consult your doctor or pharmacist immediately. The symptoms of an overdose may include lethargy, dizziness, drowsiness, pain and/or discomfort in the upper abdomen, heartburn, indigestion, nausea, liver problems (which can be seen in a blood test), kidney problems that can be severe, high levels of acid in your blood, disorientation, vomiting, stomach or intestinal bleeding, high blood pressure, breathing difficulties, coma, sudden allergic reactions (which can include shortness of breath, skin rashes, swelling of the face and/or throat and/or collapse), and uncontrolled body movements.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Emoxen

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for missed doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Emoxen and seek medical attention immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Allergic skin reaction characterized by a fixed drug eruption, which usually reappears in the same place when exposed to the medicine again and may appear as reddish round or oval patches and swelling of the skin, blisters (urticaria), and itching.
• Sudden appearance of a severe skin reaction that can include widespread rash, blisters, or peeling, even after several weeks of treatment, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It could be a “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “DRESS / drug reaction with eosinophilia and systemic symptoms”, which is very rare. See also section 2
• Yellowing of the skin or the whites of the eyes, dark urine, and fatigue, which can be symptoms of liver problems.
• Medicines like Emoxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The signs are chest pain that radiates to the neck and shoulders and down the left arm, confusion, or numbness or muscle weakness that can affect only one side of the body.
• Dark, sticky stools or bloody diarrhea.
• Vomiting blood or dark particles that look like coffee grounds.

Inform your doctor as soon as possible if you experience any of the following symptoms:

In rare cases, Emoxen can affect the white blood cells in the blood, which can lead to an immune deficiency.

If you have an infection with symptoms such as fever with a severe worsening of your general health or fever with symptoms of local infection such as neck, throat, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out through a blood test. It is essential that you report your medication at that time.

Other adverse effects are:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Feeling of fatigue.
• Feeling of thirst.

• Feeling of depression.
• • Shortness of breath.
  • Increased sweating.
  • Itching of the skin and skin rash.
  • Feeling that everything is spinning (vertigo).
  • Red or purple spots, bruises, or patches on the skin.
  • Nausea or vomiting.
  • Feeling of heart palpitations.
  • Sleep disturbance or difficulty sleeping (insomnia).
  • Hearing problems or ringing in the ears.
  • Dizziness, feeling of drowsiness, or feeling of fainting.
  • Swelling of the hands, feet, and ankles (edema).
  • Inflammation inside the mouth.
  • Vision problems.
  • Diarrhea, stomach pain, acidity, indigestion, constipation, belching, or gas (flatulence).
  • Stomach ulcers or ulcers in the first part (duodenum) of the small intestine.
  • Inflammation of the stomach lining (gastritis).
  • Benign polyps in the stomach.

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

• Sores or ulcers in the mouth.
• Vision problems such as blurred vision, conjunctivitis, or eye pain.
• Unusual dreams.
• Feeling of sleepiness.
• Increased blood sugar (glucose) levels. Symptoms may include feeling thirsty and urinating more frequently.
• Low blood sugar (glucose) levels. Symptoms may include feeling hungry or weak, sweating, and an increased heart rate.
• Coma.
• Inflammation of the 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.
• Enlargement of the lymph nodes.
• Fracture of the hip, wrist, or spine (if Emoxen is used in high doses and for extended periods).
• Fever.
• Fainting.
• Dry mouth.
• Aggression.
• Hearing loss.
• Asthma attack.
• Tremors or convulsions.
• Menstrual problems.
• Weight changes.

• Hair loss (alopecia).
• • Skin rash with blisters.
  • Joint pain (arthralgia).
  • Enlargement of the breasts in males.
  • Pain or swelling of the tongue.
  • Muscle spasms or tremors.
  • Appetite problems or altered taste.
  • Muscle weakness or pain (myalgia).
  • Blood may take longer to clot.
  • Difficulty becoming pregnant if you are a woman.
  • Fever, redness, or other signs of infection.
  • Irregular, slow, or very rapid heartbeats.
  • Feeling of tingling.
  • Difficulty with memory or concentration.
  • Feeling of agitation, confusion, anxiety, or nervousness.
  • Feeling of general discomfort, weakness, and lack of energy.
  • Edema or pain in some parts of the body due to fluid retention.
  • High or low blood pressure. You may experience dizziness or fainting.
  • Skin rash or blistering, or increased sensitivity of the skin to the sun.
  • Seeing, feeling, or hearing things that do not exist (hallucinations).
  • Changes in blood test results, such as those used to check liver function. Your doctor can explain this better.
  • Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
  • Presence of blood in the urine (water) or other kidney problems. You may experience back pain.
  • Difficulty breathing, which can worsen slowly. It may indicate the development of pneumonia or inflammation in the lungs.
  • Low sodium levels in the blood, which can cause weakness, vomiting, and cramps.
  • Symptoms of meningitis such as fever, feeling unwell, stiff neck, headache, sensitivity to bright light, and confusion.
  • Pancreas problems. The signs include severe stomach pain that radiates to the back.
  • Light-colored stools that are a sign of severe liver problems (hepatitis). Severe liver problems that cause liver failure and brain damage.
  • Colitis or worsening of an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis. The signs include stomach pain, diarrhea, vomiting, and weight loss.
  • Blood problems, such as a decrease in red blood cells (anemia), white blood cells, or platelets, which can cause weakness, bruising, fever, chills, sore throat, or more frequent infections.
  • Increased number of a certain type of white blood cell (eosinophilia).
  • Lack of all types of blood cells (pancytopenia).
  • Problems with the way the heart pumps blood to the body or damage to the blood vessels. The symptoms are fatigue, difficulty breathing, weakness, chest pain, or generalized pain.

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

• If you are treated with Emoxen for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or an increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

Do not worry about this list of possible adverse effects.You may not experience any of them.

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 is not listed in this prospectus. You can also report it directly through the Spanish Medicines Agency: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Emoxen

Keep this medication out of sight and reach of children.

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

This medication does not require special temperature storage conditions.

Store in the original packaging and keep the bottle tightly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If you are in doubt, ask your pharmacist how to dispose of medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Emoxen

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

Appearance of the product and package contents

They are yellow, oval, 19.4 mm long, biconvex, smooth on both sides tablets.

Package sizes: 30 or 60 modified-release tablets.

Not all package sizes may be marketed.

The bottles contain silica gel desiccant (to keep the tablets dry). Do not remove the desiccant container from the bottle. Do not ingest the desiccant container in the bottle.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer:

Bausch Health Poland Sp. z o. o.

ul. Przemyslowa 2

35-959 Rzeszów

Poland

or

Bausch Health Poland Sp. z o. o.

ul. Kosztowska 21

41-409 Myslowice

Poland

This medication 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

Hungary: Apranax PLUS 500 mg/20 mg modified-release tablet

Poland: Emoxen

Spain: Emoxen 500 mg/20 mg modified-release tablets EFG

Date of the last revision of the prospectus: 04/2025.

Other sources of information

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