Esonalgen

Package Leaflet: Information for the Patient

Naproxen + Esomeprazole, 500 mg + 20 mg, modified-release tablets
Naproxen + Esomeprazole

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

• Keep this leaflet, you may need to read it again.
• 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

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

1. What Esonalgen is and what it is used for

What Esonalgen is

Esonalgen 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 amount of acid produced by the stomach.

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

What Esonalgen is used for

Esonalgen is used in adults to relieve symptoms of the following diseases:

• osteoarthritis.
• rheumatoid arthritis.
• ankylosing spondylitis.

Esonalgen 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 developing stomach ulcers or ulcers in the first part of the small intestine (duodenum) while taking NSAIDs.

2. Important information before taking Esonalgen

When not to take Esonalgen:

• 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 a medicine called "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 3 months of pregnancy.
• If the patient has severeliver, kidney, or heart problems.
• If the patient has stomach or intestinal ulcers.
• If the patient has bleeding disorders or severe and unexpected bleeding.

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

Warnings and precautions

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

• significant, unintended weight loss and swallowing disorders.
• vomiting or vomiting with blood.
• black, tarry 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:

• they have intestinal inflammation (Crohn's disease or ulcerative colitis).
• they have any other liver or kidney disease or are elderly.
• they are taking medicines such as oral corticosteroids, warfarin, clopidogrel, selective serotonin reuptake inhibitors (SSRIs), acetylsalicylic acid, or NSAIDs, including COX-2 inhibitors (see section "Esonalgen and other medicines").
• they have ever had a skin reaction after taking a medicine similar to esomeprazole (which reduces stomach acid production), which is a component of Esonalgen.
• they need to have 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 symptoms from the stomach (e.g., pain).
Taking medicines like Esonalgen 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.
Esonalgen 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 Esonalgen is still suitable for the patient at regular intervals.
Esonalgen 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:

• they have high blood pressure.
• they have circulation or blood clotting problems.
• they have diabetes.
• they have high cholesterol levels in the blood.
• they smoke.

Taking a proton pump inhibitor (a component of Esonalgen), 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 may increase the risk of developing osteoporosis).
In case of a skin rash, 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 Esonalgen. The patient should also mention any other symptoms, such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (also see section 4). The rash can include ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms, such as fever, headache, body aches. The rash can occur over a large area of the body, with blisters and peeling of the skin. If a rash or any of these skin symptoms occur at any time during treatment (even after a few weeks), the patient should stop taking the medicine and contact their doctor immediately.

• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Esonalgen. The patient should stop taking Esonalgen and seek medical attention immediately if they experience any of the symptoms associated with these severe skin reactions described in section 4.

While taking Esonalgen, the patient may develop inflammation of the kidneys. Symptoms may include: decreased urine output or blood in the urine and/or allergic reactions, such as fever, rash, and stiffness of the joints. The patient should tell their doctor about these symptoms.

Children and adolescents

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

Esonalgen 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 Esonalgen may affect the way other medicines work. The effect of Esonalgen 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 (used as a pain reliever or to prevent blood clots). If the patient is taking low doses of acetylsalicylic acid, they may continue to take Esonalgen.
• 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 depression and anxiety).
• Cyclosporine or tacrolimus (medicines used to reduce the immune system's 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-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 Esonalgen.

Esonalgen with food and drink

The patient should not take Esonalgen with food, as it may reduce and/or delay the effect of Esonalgen. 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 baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should not take Esonalgen during the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney or heart problems in the unborn baby. It may affect the patient's and their baby's tendency to bleed and may cause the delivery to be delayed or longer than expected. The patient should not take the medicine during the first 6 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 patient should use the lowest dose 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 baby, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
The patient should not breastfeed while taking Esonalgen. This is because small amounts of the medicine may pass into the breast milk of nursing women. If the patient plans to breastfeed, they should not take Esonalgen.
Fertility
Esonalgen may make it harder to get pregnant. The patient should inform their doctor if they plan to get pregnant or are having trouble getting pregnant.

Driving and using machines

While taking Esonalgen, the patient may experience dizziness or vision disturbances. If these occur, the patient should not drive, use tools, or operate machinery.

Esonalgen contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Esonalgen

Esonalgen should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

How to take the medicine

• The tablets should be swallowed whole, with a glass of water. The patient should not chew, divide, or crush the tablets. It is important to take the tablets whole, so the medicine works properly.
• The tablets should be taken at least 30 minutes before a meal. Food may reduce the protective effect of Esonalgen on the stomach and intestines. Food may also cause a significant delay in relieving pain and inflammation.

If the patient has been taking this medicine for a long time, their doctor may decide to monitor them (especially if the patient has been taking the medicine for more than a year).

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

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

If the patient takes more Esonalgen 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, indigestion, nausea, liver function disorders (shown in blood tests), kidney function disorders, which can be severe, increased acid levels in the blood, confusion, vomiting, gastrointestinal bleeding, high blood pressure, breathing difficulties, coma, and uncontrolled body movements.

What to do if the patient misses a dose of Esonalgen

• 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, Esonalgen can cause side effects, although not everybody gets them.
The following side effects may occur after taking this medicine.

The patient should stop taking Esonalgen 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, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Sudden onset of severe rash or redness of the skin with blisters or peeling, which may occur even after a few weeks of treatment. Blisters or bleeding may also occur in the mouth, eyes, nose, and genitals. Skin rashes may develop into serious, widespread skin damage (exfoliative dermatitis and toxic epidermal necrolysis) with life-threatening consequences. This may be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms". These reactions are very rare and may affect up to 1 in 10,000 people.
• Yellowing of the skin or whites of the eyes, dark urine, and fatigue, which may be symptoms of liver function disorders.
• Taking medicines like Esonalgen 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, which affects only one side of the body.

• Passing black, tarry stools or bleeding 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, Esonalgen may affect the white blood cell count, leading to weakened immunity.
If the patient develops an infection with symptoms such as fever with a very bad general condition or fever with symptoms of a local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should consult their doctor as soon as possible so that a blood test can be done to rule out a lack of white blood cells (agranulocytosis). It is essential to inform the doctor about the medicine they are taking.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Feeling tired.
• Feeling thirsty.
• •Feeling depressed.
• Shortness of breath.
• Increased sweating.
• Itchy skin and rashes.
• Feeling dizzy (vertigo).
• Red or purple spots, bruises, or patches on the skin.
• Nausea (vomiting) or vomiting.
• Feeling of palpitations (heart pounding).
• Sleep disturbances or difficulty sleeping (insomnia).
• Hearing disturbances or ringing in the ears.
• Dizziness, drowsiness, or feeling unbalanced.
• Swelling of the hands, feet, and ankles (edema).
• Mouth inflammation.
• Vision disturbances.
• Diarrhea, abdominal pain, heartburn, indigestion, constipation, belching, or gas.
• Stomach ulcers or duodenal ulcers.
• Gastritis (stomach lining inflammation).
• Mild stomach polyps.

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

• Mouth pain or mouth ulcers.
• Vision disturbances, such as blurred vision, conjunctivitis, or eye pain.
• Strange dreams.
• Feeling drowsy.
• Increased blood sugar (glucose) levels. Possible symptoms include thirst and increased urine output.
• Low blood sugar (glucose) levels. Possible symptoms include hunger or weakness, sweating, and rapid heartbeat.
• Coma.
• Blood vessel inflammation.
• 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.
• Fractures of the hip, wrist, or spine (in cases of long-term use of Esonalgen in high doses).
• Fever.
• Fainting.
• Dry mouth.
• Aggression.
• Hearing loss.
• Asthma attack.
• Seizures.
• Menstrual disorders.
• Weight changes.
• Hair loss (alopecia).
• •Hives (urticaria).
• Joint pain (arthralgia).
• Breast enlargement in men.
• Pain or swelling of the tongue.
• Mild muscle spasms or tremors.
• Appetite disturbances or taste changes.
• Muscle weakness or pain (myalgia).
• Prolonged blood clotting time.
• Women may experience difficulty getting pregnant.
• Fever, redness, or other signs of infection.
• Irregular, slow, or very fast heartbeat.
• Numbness or tingling.
• Memory or concentration problems.
• Feeling agitated, confused, anxious, or irritable.
• General feeling of being unwell, 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 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 slowly. 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. Symptoms include severe abdominal pain radiating to the back.
• Light-colored stools, which may be a sign of severe liver disease (hepatitis). Severe liver disease can lead to liver failure and brain function disorders.
• Colitis or worsening of 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 levels of certain types of white blood cells (eosinophilia).

Pancytopenia (reduced levels of all blood cell types).

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

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

• If the patient takes Esonalgen for more than three months, they may experience a decrease in magnesium levels in the blood. Low magnesium levels in the blood may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should inform their doctor immediately. Low magnesium 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 magnesium levels.
• Rash, possibly with joint pain.
• Widespread rash, high body temperature, elevated liver enzyme levels, blood disorders (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• A characteristic skin allergic reaction called fixed drug eruption, which usually recurs in the same location (locations) after re-exposure to the medicine and may take the form of round or oval red patches and swelling of the skin, blisters (hives), itching.

The patient should not worry 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,
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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Esonalgen

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 stated.
The medicine should be stored at a temperature below 25°C.
The medicine should be stored in its original packaging to protect it from light. The bottle should be kept tightly closed to protect it from moisture.
Shelf life after first opening the bottle: 60 days.
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 need. This will help protect the environment.

6. Contents of the pack and other information

What Esonalgen contains

• •The active substances are naproxen and esomeprazole.
• •Each modified-release tablet contains 500 mg of naproxen and 20 mg of esomeprazole (as esomeprazole magnesium trihydrate).
• •The other ingredients are: in the tablet core: colloidal anhydrous silica, methacrylic acid - ethyl acrylate copolymer (1:1) (30% dispersion), polysorbate 80, glyceryl monostearate 40-55, triethyl citrate, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, microcrystalline cellulose (type 112), microcrystalline cellulose (type 302), magnesium oxide, povidone K30, calcium stearate; in the coating: hypromellose, macrogol 400, titanium dioxide, yellow iron oxide.

What Esonalgen looks like and contents of the pack

These are yellow, elongated, biconvex modified-release tablets, 8.9 mm x 19.4 mm in size, coated with a yellow color, smooth on both sides.
The coated tablets are packaged in HDPE bottles containing a desiccant (to keep the tablets dry), closed with an aluminum induction seal and a screw cap. The patient should not consume the desiccant containers.
Package sizes - 30 or 60 modified-release tablets.
Not all package sizes may be marketed.

Marketing authorization holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Poland
Phone: 22 209 70 00

Importer

Interpharma Services Ltd.
43A Cherni Vrach Blvd. Sofia 1407
Bulgaria
Flavine Pharma France
3 Voie d’Allemagne, Vitrolles, 13127
France
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben
Germany

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

Estonia
ESMAPREN
Lithuania
Esmapren 500 mg/20 mg modified-release tablets
Latvia
Esmapren 500 mg/20 mg modified-release tablets
Austria
Naproxen/Esomeprazol Sandoz 500 mg/20 mg tablets with modified release
Ireland
Naproxen / Esomeprazole Rowex 500 mg/20 mg modified-release tablets
Spain
Naproxeno/Esomeprazol Sandoz 500 mg/20 mg modified-release tablets EFG
Finland
Vamtexar 500 mg/20 mg modified-release tablets
Croatia
Vamtexar 500 mg/20 mg tablets with modified release
Norway
Vamtexar
Poland
Portugal
Naproxeno + Esomeprazol Sandoz
Slovenia
Combolly 500 mg/20 mg tablets with modified release
Date of last revision of the leaflet:02/2025
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