Emoxen

Package leaflet: Information for the patient

Emoxen, 500 mg + 20 mg, modified-release tablets
Naproxenum + Esomeprazolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Emoxen is and what it is 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 pack and other information

1. What Emoxen is and what it is used for

What Emoxen is
Emoxen contains two different medicines: 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 may occur in patients requiring long-term treatment with NSAIDs.

What Emoxen is 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).
You will be prescribed this medicine if low doses of NSAIDs alone are insufficient to control your pain and you are at risk of developing a stomach ulcer or duodenal ulcer while taking NSAIDs.

2. Important information before using Emoxen

When not to use Emoxen:

• If the patient has a known allergy (hypersensitivity) to naproxen.
• If the patient has a known allergy to esomeprazole or other proton pump inhibitors.
• If the patient has a known allergy to any of the other ingredients of this medicine (listed in section 6).
• If the patient is currently taking atazanavir or nelfinavir (used in the treatment of HIV infection).
• If the patient has previously experienced asthma (wheezing) or an allergic reaction such as skin itching or rash (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 problems with the liver, kidneys, or heart.
• If the patient has gastric or intestinal ulcers.
• If the patient has bleeding disorders or serious and unexpected bleeding.
• If the patient has ever developed severe skin rash, skin peeling, blistering, and/or oral mucosal ulcers after taking Emoxen or other similar medicines.

Do not take Emoxen if any of the above situations apply. If you are unsure, inform your doctor or pharmacist before using Emoxen.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Emoxen.

Do not take Emoxen and contact your doctor immediately if any of the following conditions have occurred previously or during treatment with Emoxen, as this medicine may mask symptoms of another illness:

• Significant, unintentional weight loss and difficulty swallowing.
• Vomiting or vomiting blood.
• Black stools (blood in the stool). If any of these conditions apply (or if you have any doubts), inform your doctor or pharmacist before taking this medicine.

Consult your doctor or pharmacist before taking this medicine if:

• The patient has inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
• The patient has any 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 with other medicines").
• The patient has ever had a skin reaction after taking a medicine similar to esomeprazole (a component of Emoxen) that reduces gastric acid secretion.
• If the patient needs to undergo a specific blood test (chromogranin A measurement).

If any of these conditions apply (or if you have any doubts), inform your doctor or pharmacist before taking this medicine.

If the patient has previously had gastric ulcers or gastrointestinal bleeding, inform the doctor. The patient will be asked to report any unusual stomach symptoms (e.g. pain) to the doctor.

Medicines such as Emoxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and prolonged use. Do not exceed the recommended dose or duration of treatment.

Emoxen contains naproxen, an NSAID. As with all NSAIDs, naproxen should be used at the lowest effective dose for the shortest possible duration to minimize the risk of adverse effects. Your doctor will therefore regularly assess whether Emoxen remains appropriate for you.

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 bloodstream.

Inform your doctor if the patient has heart problems, has previously had a stroke, or believes they are at risk of these conditions.

The patient may be at increased risk if:

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

Long-term use (particularly longer than one year) of a proton pump inhibitor (a component of Emoxen) may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has osteoporosis or is taking corticosteroids (medicines that may increase the risk of developing osteoporosis).

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with the use of this medicine. These serious reactions often begin with flu-like symptoms such as fever, headache, and body aches, and may include severe rash. The rash may cover large areas of the body, with blisters and skin peeling. Discontinue the medicine and contact your doctor immediately if any of the symptoms associated with these serious skin reactions (described in section 4) occur.

If a skin rash develops, especially in sun-exposed areas, inform your doctor as soon as possible, as treatment with Emoxen may need to be discontinued. Also mention any other symptoms such as joint pain.

Inflammation of the kidneys may occur during treatment with Emoxen. Symptoms may include reduced urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Inform your treating doctor if such symptoms occur.

Children and adolescents

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

Emoxen with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, such as herbal remedies. This is important because Emoxen may affect the action of other medicines, and the action of Emoxen may also be altered by other medicines.

Do not take this medicine and inform your doctor or pharmacist if the patient is taking:

• A medicine called "atazanavir" or "nelfinavir" (used in the treatment of HIV infection).

Inform your doctor or pharmacist if the patient is taking any of the following medicines:

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

If any of the above situations apply (or if you have any doubts), inform your doctor or pharmacist before taking Emoxen.

Emoxen with food

Do not take Emoxen with food, as this may reduce and/or delay its effect. Tablets should be taken at least 30 minutes before a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Emoxen during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendencies in both the mother and the unborn child and may delay or prolong labour. Do not use this medicine during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, use the lowest dose for the shortest possible time. If the medicine is taken for more than a few days starting from week 20 of pregnancy, it may cause kidney problems in the unborn child, leading to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If prolonged treatment is required, your doctor may recommend additional monitoring.

Breastfeeding

Do not breastfeed while taking Emoxen. This is because small amounts of the medicine may pass into breast milk. If the patient plans to breastfeed, she should not take Emoxen.

Fertility

Emoxen may make it more difficult to become pregnant. Inform your doctor if the patient is planning a pregnancy or has difficulty becoming pregnant.

Driving and using machines

Dizziness or visual disturbances may occur while taking Emoxen. If these occur, do not drive, operate tools, or use machinery.

Emoxen contains sodium

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

Emoxen contains lactose

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

3. How to use Emoxen

Emoxen must always be taken exactly as directed by the physician. If in doubt, consult a doctor or pharmacist.

Administration of the medicine

• Tablets should be swallowed whole with water. Do not chew, divide or crush the tablets. It is important to take the tablets whole so that the medicine works properly.
• 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 a significant delay in pain relief and reduction of inflammation.
• If a patient uses this medicine for a prolonged period, the physician may decide to monitor the patient (especially if the patient has been taking the medicine for longer than one year).

Dosage

• Take one tablet twice daily for the duration specified by the physician.
• Emoxen is available only in the 500 mg + 20 mg dosage. If the physician considers the dosage inappropriate for the patient, alternative treatment may be recommended.

Overdose of Emoxen
If more Emoxen than recommended has been taken, seek immediate advice from a doctor or pharmacist. Possible symptoms of overdose include: lethargy, dizziness, drowsiness, pain and/or discomfort in the upper abdomen, heartburn, indigestion, nausea, liver function disorders (detected in blood tests), kidney function disorders which may be serious, increased blood acid levels, confusion, vomiting, gastrointestinal bleeding, high blood pressure, breathing difficulties, coma, sudden allergic reactions (which may include shortness of breath, skin rash, facial and/or throat swelling, and/or collapse), and uncontrolled body movements.

Missed dose of Emoxen

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur after using this medicine.
You must stop taking Emoxen and contact your doctor immediately if
any of the following serious side effects occur – prompt treatment may be required:

• Sudden onset of wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).

• A characteristic skin allergic reaction called fixed drug eruption, which usually recurs in the same location(s) upon re-exposure to the medicine and may present as round or oval red patches and swelling of the skin, blisters (urticaria), or itching.

• Sudden onset of a severe skin reaction, which may include widespread rash, blisters or peeling occurring even several weeks after starting treatment, high fever, elevated liver enzymes, blood disorders (eosinophilia), swollen lymph nodes, and involvement of other organs. Blisters and bleeding from the lips, eyes, mouth, nose or genital organs may also occur. Skin rashes may progress to serious, extensive skin damage (exfoliation of the epidermis and superficial mucous membranes) with life-threatening consequences. This may be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis" or DRESS syndrome / drug hypersensitivity syndrome, which are very rare. See also section 2.

• Yellowing of the skin or whites of the eyes, dark urine and fatigue, which may indicate liver dysfunction.

• Use of medicines such as 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, particularly along the left arm, confusion or weakness or stiffness affecting only one side of the body.

• Passing black, tarry stools or bloody diarrhoea.

• Vomiting blood or black clumps resembling coffee grounds.

Contact your doctor immediately if any of the following symptoms occur:
In rare cases, Emoxen may affect white blood cell function, leading to weakened immunity.
If the patient develops an infection with symptoms such as fever with very poor general condition or fever with local signs of infection such as neck, throat or oral pain or difficulty urinating, medical advice should be sought as soon as possible to perform a blood count with blood smear to rule out absence of white blood cells (agranulocytosis). It is important to inform the doctor about the medicine being taken.
Other side effects include:
Common (may affect up to 1 in 10 people)

• Headache.
• Feeling of fatigue.
• Feeling thirsty.
• Feeling depressed.
• Shortness of breath.
• Excessive sweating.
• Itchy skin and skin rashes.
• Sensation of spinning (vertigo of labyrinthine origin).
• Red or purple spots, bruises or marks on the skin.
• Nausea or vomiting.
• Palpitations (awareness of heart beating).
• Sleep disturbances or difficulty falling asleep (insomnia).
• Hearing disturbances or ringing in the ears (tinnitus).
• Dizziness, drowsiness or feeling unbalanced.
• Swelling of hands, feet and ankles (oedema).
• Inflammation of the mouth.
• Visual disturbances.
• Diarrhoea, abdominal pain, heartburn, indigestion, constipation, belching or bloating with gas.
• Stomach ulcer or duodenal ulcer (in the first part of the small intestine).
• Inflammation of the stomach lining (gastritis).
• Benign gastric polyps.

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

• Pain in the mouth or mouth ulceration.

• Visual disturbances such as blurred vision, conjunctivitis or eye pain.

• Strange dreams.

• Drowsiness.

• Increased blood sugar (glucose) levels. Symptoms may include feeling thirsty and increased urination.

• Low blood sugar (glucose) levels. Symptoms may include feeling hungry or weak, sweating and rapid heartbeat.

• Coma.

• Vasculitis (inflammation of blood vessels).

• Perforation (punching through) of 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.

• Swollen lymph nodes.

• Fracture of the hip, wrist or spine (when Emoxen is used in high doses and for a long time).

• Fever.

• Fainting.

• Dryness of the mouth.

• Aggression.

• Hearing loss.

• Asthma attack.

• Seizures or convulsions.

• Menstrual disturbances.

• Changes in body weight.

• Hair loss (alopecia).

• Raised skin rash (urticaria).

• Joint pain (arthralgia).

• Breast enlargement in men.

• Tongue pain or swelling.

• Minor muscle cramps or tremors.

• Changes in appetite or taste.

• Muscle weakness or muscle pain (myalgia).

• Prolonged blood clotting time.

• In women, difficulty becoming pregnant.

• Fever, redness or other signs of infection.

• Irregular, slow or very fast heartbeat.

• Tingling and numbness.

• Memory or concentration difficulties.

• Feeling restless, confused, anxious or agitated.

• General malaise, weakness and lack of energy.

• Swelling or pain in body parts due to fluid retention.

• High or low blood pressure. Fainting or dizziness may occur.

• Skin rash or blistering, or increased sensitivity of the skin to sunlight.

• Seeing, feeling or hearing things that are not real (hallucinations).

• Changes in blood test results assessing liver function. Your doctor will explain this in detail.

• A fungal infection called "candidiasis", which may affect the intestines.

• Blood in the urine or other kidney function disorders. This may be accompanied by back pain.

• Breathing difficulties, which may gradually worsen. These may be symptoms of developing pneumonia or pulmonary oedema.

• Low levels of salt (sodium) in the blood. This may cause weakness, vomiting and cramps.

• Symptoms of meningitis such as fever, nausea, vomiting, neck stiffness, headache, light sensitivity and confusion.

• Pancreatic dysfunction. Symptoms include severe abdominal pain radiating to the back.

• Pale stools, which are a sign of severe liver disease (hepatitis). Severe liver disease may lead to liver failure and encephalopathy.

• Inflammation of the large intestine or worsening of inflammatory bowel disease such as Crohn's disease or ulcerative colitis. Symptoms include abdominal pain, diarrhoea, vomiting and weight loss.

• Blood disorders such as decreased number of red blood cells (anaemia), white blood cells or platelets. This may cause weakness, bruising, fever, severe chills, sore throat or increased susceptibility to infections.

• Increased number of certain types of white blood cells (eosinophilia).

• Deficiency of all types of blood cells (pancytopenia).

• Problems with the way the heart pumps blood around the body or damage to blood vessels. Symptoms may include fatigue, shortness of breath, weakness, chest pain or generalised pain.

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

• During treatment with Emoxen for at least three months, a decrease in blood magnesium levels may occur. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, disorientation, convulsions, dizziness or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may recommend periodic blood tests to monitor magnesium levels.
• Skin rash, possibly accompanied by joint pain.

Do not be alarmed by the possible side effects listed above. The patient may not experience any of them.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorisation holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Emoxen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after:
"EXP". The expiry date refers to the last day of the stated month.
No special temperature storage requirements apply.
Store in the original packaging and keep the bottle tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Emoxen contains

• The active substances are naproxen 500 mg and esomeprazole 20 mg (in the form of magnesium trihydrate).
• Other components (excipients) are: in the tablet core: colloidal anhydrous silica, copolymer of methacrylic acid and ethyl acrylate (1:1), sodium lauryl sulfate, polysorbate 80, glycerol monostearate 40-55, triethyl citrate, lactose monohydrate, sodium croscarmellose, 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
These 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.
Bottles contain a desiccant in the form of silica gel (to ensure tablet dryness). The containers containing the desiccant must not be removed from the bottles. The containers containing the desiccant must not be ingested.

Marketing Authorisation 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 medicinal product is authorised in 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