Naproxene and esomeprazole Abdi: detailed information

Package leaflet: Information for the user

Naproxen and esomeprazole ABDI 500 mg/20 mg modified-release tablets

Naproxen/Esomeprazole
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Naproxen and esomeprazole ABDI is and what it is used for
What you need to know before taking Naproxen and esomeprazole ABDI
How to take Naproxen and esomeprazole ABDI
Possible side effects
How to store Naproxen and esomeprazole ABDI
Contents of the pack and other information

1. What is Naproxen and Esomeprazole ABDI and what is it used for

What is Naproxen and Esomeprazole ABDI
Naproxen and Esomeprazole ABDI 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" and reduces the amount of acid in your stomach. Esomeprazole helps reduce the risk of developing stomach ulcers and stomach problems in patients who need to take NSAIDs.

What is Naproxen and Esomeprazole ABDI used for
Naproxen and Esomeprazole ABDI is used in adults to relieve symptoms of:

Osteoarthritis.
Rheumatoid arthritis.
Ankylosing spondylitis.

Naproxen and Esomeprazole ABDI helps relieve pain, swelling, redness, and warmth (inflammation).
This medicine will be prescribed to you if it is considered likely that a lower dose of NSAID would not be sufficient to relieve your pain, and if you are at risk of developing a stomach or duodenal ulcer when taking NSAIDs.

2. What you need to know before taking Naproxen and esomeprazole ABDI

Do not take Naproxen and esomeprazole ABDI if

You are allergic (hypersensitive) to naproxen.
You are allergic to esomeprazole or to other proton pump inhibitor medicines.
You are allergic to any of the other ingredients of this medicine (listed in section 6).
You are taking a medicine called "atazanavir" or "nelfinavir" (used to treat HIV).
Acetylsalicylic acid (e.g. aspirin), naproxen, or other NSAIDs such as ibuprofen, diclofenac, or COX-2 inhibitors (e.g. celecoxib, etoricoxib) have previously caused you asthma (wheezing) or an allergic reaction such as itching or skin rash (urticaria).
You are in the last 3 months of pregnancy.
You have severe liver, kidney, or heart problems.
You have a stomach or intestinal ulcer.
You have a bleeding disorder or sudden severe bleeding.

Do not take Naproxen and esomeprazole ABDI if any of the conditions listed above apply to you. If you have any doubts,
speak to your doctor or pharmacist before taking Naproxen and esomeprazole ABDI.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naproxen and esomeprazole ABDI.
Do not take Naproxen and esomeprazole ABDI and consult your doctor immediately if any of the following events occur
before or during treatment with Naproxen and esomeprazole ABDI, as this
medicine may mask symptoms of other diseases:

You lose weight significantly without reason and have difficulty swallowing.
You start vomiting food or blood.
Your stools are dark-coloured (blood in stools). If any of the conditions listed above apply to you (or you are unsure), speak to your doctor or pharmacist before taking this medicine.

Check with your doctor or pharmacist before taking this medicine if:

You have intestinal inflammation (Crohn’s disease or ulcerative colitis).
You have any 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 "Other medicines and Naproxen and esomeprazole ABDI").
You have ever had a skin reaction after treatment with a medicine similar to esomeprazole (a component of Naproxen and esomeprazole ABDI) that reduces stomach acidity.
You need to undergo a specific blood test (chromogranin A).

If any of the conditions listed above apply to you (or you are unsure), speak to your doctor or
pharmacist before taking this medicine.
If you have previously had a stomach ulcer or gastrointestinal bleeding, inform your doctor. You will be asked to
report any unusual stomach symptoms (e.g. pain) to your doctor.
Medicines such as Naproxen and esomeprazole ABDI may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Naproxen and esomeprazole ABDI contains the NSAID naproxen. As with all NSAIDs, naproxen should be used at the lowest effective dose for the shortest possible duration to reduce the risk of adverse effects. Your doctor will regularly assess whether Naproxen and esomeprazole ABDI remains appropriate for you.
Naproxen and esomeprazole ABDI is not suitable for rapid relief of acute pain,
as it takes several hours for the pain-relieving substance naproxen to reach the bloodstream.
Additionally, consult your doctor before taking this medicine if you have heart problems, have had a
stroke, or believe you may be at risk of either of these conditions. You may be at risk if:

You have high blood pressure.
You have circulation or blood clotting problems.
You have diabetes.
You have high cholesterol.
You are a smoker.

If you are taking a proton pump inhibitor (a component of Naproxen and esomeprazole ABDI),
especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
If you develop a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Naproxen and esomeprazole ABDI. Remember to also report any other adverse effects such as joint pain.
Life-threatening skin reactions have occurred in patients taking esomeprazole (see also section 4). The skin rash may involve ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These life-threatening skin reactions often begin with flu-like symptoms such as fever, headache, and muscle pain. The rash may cover large areas of the body with blisters and skin peeling.
If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.
Life-threatening skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Naproxen and esomeprazole ABDI. Discontinue treatment with Naproxen and esomeprazole ABDI and consult your doctor immediately if you notice any symptoms related to these life-threatening skin reactions, as described in section 4.
During treatment with Naproxen and esomeprazole ABDI, kidney inflammation may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You must report such signs to your doctor.
Children and adolescents
Naproxen and esomeprazole ABDI is not recommended for children and adolescents under 18 years of age.
Other medicines and Naproxen and esomeprazole ABDI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (including herbal medicines).
This is because Naproxen and esomeprazole ABDI may affect how other medicines work. Also, other medicines may affect how Naproxen and esomeprazole ABDI 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).

Inform your doctor or pharmacist if you are taking any of the following medicines:

Acetylsalicylic acid (aspirin) (used as a painkiller or to prevent blood clots). If you are taking low-dose acetylsalicylic acid (aspirin), you may continue to take Naproxen and esomeprazole ABDI.
Other NSAIDs (including COX-2 inhibitors).
Certain medicines such as ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
Erlotinib (or other anticancer drugs of the same class).
Cholestyramine (used to lower cholesterol).
Clarithromycin (used to treat infections).
"Quinolone antibiotics" (for infections) such as ciprofloxacin or moxifloxacin.
Diazepam (used to treat anxiety, to relax muscles, or in epilepsy).
Hydantoins such as phenytoin (used to treat epilepsy).
Lithium (used to treat certain types of depression).
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and some cancers).
Probenecid (for gout).
"Selective serotonin reuptake inhibitors" (SSRIs) (used to treat severe depression and anxiety disorders).
Cyclosporine or tacrolimus (medicines used to reduce the body's immune reactions).
Digoxin (used to treat heart conditions).
Sulfonylureas such as glimepiride (oral medicines used to treat diabetes to control blood sugar levels).
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).
Corticosteroid medicines such as hydrocortisone or prednisolone (used as anti-inflammatory medicines).
Medicines used to prevent blood clotting, 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 due to poor blood flow).

If any of the conditions listed above apply to you (or you are unsure), speak to your doctor or
pharmacist before taking Naproxen and esomeprazole ABDI.
Naproxen and esomeprazole ABDI with food
Do not take Naproxen and esomeprazole ABDI with food, as this may reduce and/or delay the effect
of Naproxen and esomeprazole ABDI. Take the tablets at least 30 minutes before meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Naproxen and esomeprazole ABDI during 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 and your baby's tendency to bleed and delay or prolong labour beyond the expected time. You should not take Naproxen and esomeprazole ABDI during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Naproxen and esomeprazole ABDI may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of blood vessels (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
You must not breastfeed while taking Naproxen and esomeprazole ABDI. This is because small amounts may pass into breast milk. If you intend to breastfeed, you should not take Naproxen and esomeprazole ABDI.
Fertility
Naproxen and esomeprazole ABDI may make it more difficult to conceive. Inform your doctor if you plan to start a pregnancy or if you have difficulty conceiving.
Driving and using machines
You may experience dizziness or blurred vision while taking Naproxen and esomeprazole ABDI. If this occurs, do not drive and do not operate tools or machinery.
Naproxen and esomeprazole ABDI contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
Naproxen and esomeprazole ABDI contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Naproxen and esomeprazole ABDI

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
How to take this medicine

Swallow the tablets whole with water. Do not chew, divide, or crush the tablets. It is important to take the tablets whole for the medicine to work properly.
Take the tablets at least 30 minutes before meals. Food may reduce the protective effect of Naproxen and esomeprazole ABDI on your stomach and intestines. Food may also cause a significant delay in pain and inflammation relief.
If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you have been taking it for more than one year).

Dosage

Take one tablet twice daily for the duration specified by your doctor.
Naproxen and esomeprazole ABDI is available only in the 500 mg/20 mg dosage strength. If your doctor considers this dose unsuitable for you, they may prescribe a different treatment.

If you take more Naproxen and esomeprazole ABDI than you should
If you take more Naproxen and esomeprazole ABDI than prescribed, inform your doctor or pharmacist immediately.
Symptoms of overdose may include lethargy, dizziness, drowsiness, upper abdominal pain and/or discomfort, heartburn, indigestion, nausea, liver problems (evident from blood tests), kidney problems which may be severe, increased levels of acid in the blood, confusion, vomiting, gastrointestinal bleeding, high blood pressure, difficulty breathing, coma, sudden allergic reactions (which may include shortness of breath, skin rashes, swelling of the face and/or throat, and/or collapse), and involuntary body movements.
If you forget to take Naproxen and esomeprazole ABDI

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine.
Stop taking Naproxen and esomeprazole ABDI and contact your doctor immediately
if you notice any of the following side effects – you may need urgent medical treatment:

Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. Skin rashes may progress to widespread skin damage that can be life-threatening (peeling of the superficial epidermis and mucous membranes), with potentially fatal consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms”. These effects 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 problems.
Medicines such as Naproxen and esomeprazole ABDI may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Signs include chest pain spreading to the neck and shoulders and down the left arm, confusion, or muscle weakness or numbness, which may affect only one side of the body.
Presence of black, tarry stools or diarrhoea with blood.
Vomiting blood or dark particles resembling coffee grounds.
Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2. [Not known (frequency cannot be estimated from the available data)]
A distinct skin allergic reaction known as drug-induced fixed eruption, which usually recurs in the same location or locations upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, blistering rash (urticaria), or itching sensation. [Not known (frequency cannot be estimated from the available data)]

Tell your doctor as soon as possible if you notice any of the following side effects:
Naproxen and esomeprazole ABDI may, in very rare cases, affect white blood cells and lead to immunodeficiency.
If you have an infection with symptoms such as fever with severely reduced general condition or fever with signs of a local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible so that a deficiency in white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that you provide your doctor with any information about the medicines you are taking.

Other side effects include:
Common (may affect up to 1 in 10 people)

Headache.
Feeling of fatigue.
Feeling thirsty.
Feeling depressed.
Feeling short of breath.
Increased sweating.
Itching of the skin and skin rashes.
Sensation of dizziness (vertigo).
Red or purple spots, bruising or spots on the skin.
Feeling unwell (nausea) or illness (vomiting).
Awareness of your heartbeat (palpitations).
Sleep disturbances or difficulty sleeping (insomnia).
Hearing problems or ringing in the ears.
Dizziness, drowsiness or lightheadedness.
Swelling of the hands, feet and ankles (oedema).
Inflammation inside the mouth.
Vision problems.
Diarrhoea, stomach pain, heartburn, indigestion, constipation, belching or bloating (flatulence).
Gastric ulcer or ulcer 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 fewer)

Mouth pain or mouth ulcers.
Vision problems such as blurred vision, conjunctivitis or eye pain.
Abnormal dreams.
Feeling drowsy.
Increased levels of sugar (glucose) in the blood. Symptoms may include feeling thirsty and increased urine output.
Low levels of sugar (glucose) in the blood. Symptoms may include feeling hungry or weak, sweating and rapid heartbeat.
Coma.
Inflammation of blood vessels.
Perforation (hole) of the stomach or intestine.
Systemic lupus erythematosus (SLE), a disease in which the immune system attacks the body, causing joint pain, rashes and fever.
Swollen lymph nodes.
Fracture of the hip, wrist or spine (if Naproxen and esomeprazole ABDI is used at high doses and for long durations).
Fever.
Fainting.
Dry mouth.
Aggressiveness.
Loss of hearing.
Asthma attack.
Seizures or epileptic fits.
Menstrual cycle problems.
Changes in weight.
Hair loss (alopecia).
Raised skin rash (urticaria).
Joint pain (arthralgia).
Breast enlargement in men.
Sore or swollen tongue.
Muscle contractions or tremors.
Appetite problems or changes in taste.
Weakness or muscle pain (myalgia).
Blood clotting may take longer than normal.
Fertility problems in women.
Fever, redness or other signs of infection.
Irregular, slow or very fast heartbeat.
Tingling sensations such as “pins and needles”.
Memory or concentration problems.
Feeling restless, confused, anxious or nervous.
General feeling of illness, weakness and lack of energy.
Swollen or painful body parts due to fluid retention.
High or low blood pressure. You may feel like fainting or experience dizziness.
Skin rashes or blister formation, or skin becoming more sensitive to sunlight.
Seeing, hearing or sensing things that are not there (hallucinations).
Changes in blood test results, such as those for liver function. Your doctor can explain these to you in detail.
An infection called “candidiasis” affecting the intestine, caused by a fungus.
Blood in the urine or other kidney problems. You may have back pain.
Breathing difficulties, which may slowly worsen. This may be a symptom of pneumonia or lung swelling.
Low levels of salt (sodium) in the blood. This may cause weakness, illness (vomiting) and cramps.
Symptoms of meningitis such as fever, feeling unwell or illness, stiff neck, headache, sensitivity to bright light and confusion.
Pancreatic problems. Symptoms include severe stomach pain radiating to the back.
Pale-coloured stools, a symptom of life-threatening liver problems (hepatitis). Life-threatening liver problems may lead to liver failure and brain disorders.
Colitis or worsening of inflammatory bowel diseases such as Crohn’s disease or ulcerative colitis. Symptoms include stomach pain, diarrhoea, vomiting and weight loss.
Blood problems, such as reduced numbers of red blood cells (anaemia), white blood cells or platelets. This may cause weakness, bruising, fever, severe chills, sore throat or make infections more likely.
Increased number of a certain type of white blood cells (eosinophilia).
Reduction in all types of blood cells (pancytopenia).
Problems with how the heart pumps blood through the body or damage to blood vessels. Symptoms may include fatigue, shortness of breath, feeling faint, chest pain or general pain.

Not known (frequency cannot be estimated from the available data)

If you take Naproxen and esomeprazole ABDI for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to periodically monitor your blood magnesium levels.
Skin rash, possibly accompanied by joint pain.

Do not be alarmed by this list of possible side effects. You may not experience any of them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Naproxen and Esomeprazole ABDI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date refers to the last day of that month.
Do not store above 25 °C.
Store in the original packaging and keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Naproxen and Esomeprazole ABDI contains

Each modified-release tablet contains 500 mg of naproxen and 20 mg of esomeprazole (as magnesium trihydrate).
The other components (excipients) in the tablet core are anhydrous colloidal silica, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, glycerol 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, hypromellose (E464), macrogol (E1521), titanium dioxide (E171), iron oxide yellow (E172).

Description of the appearance of Naproxen and Esomeprazole ABDI and package contents
Yellow, oblong, biconvex, film-coated tablets, smooth on both sides. Tablet dimensions:
approximately 19.4 mm x 8.9 mm.
Pack sizes: 30 or 60 modified-release tablets.
Not all pack sizes may be marketed.
Bottles contain silica gel desiccant (to keep the tablets dry). Do not ingest the desiccant sachet contained in the bottle.

Marketing Authorization Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany

Manufacturers
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Flavine Pharma France
3 Voie d’Allemagne
13127 Vitrolles
France