Nexium (Esomeprazole) 28 sachets

Excipients: Glycerol monostearate, hyprolose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, artificial paraffin, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and corn starch), talc, triethyl citrate, colorants: iron oxide (E172) (red-brown, yellow), titanium dioxide (E 171)

Please read this INSTRUCTIONS carefully before using this medicine. important information.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is NEXIUM® and what is it used for? 2. Cautions before using NEXIUM® 3. How to use NEXIUM®? 4. What are the possible side effects? 5. Storage of NEXIUM®

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1. What is NEXIUM® and what is it used for?

NEXIUM® is known as a ilaç proton pump inhibitor N. Reduces acid formation in your stomach.

NEXIUM® 20 mg tablet is light pink colored, rectangular with rounded corners,both sides

convex on, film coated, 20 mg on one side andother side

A EH on the.

Nexium is used to treat the following conditions:

• Gastro-esophageal reflux disease (GERD)

- gastric juice dish inflammation of the esophagus connected to escape into the pipe and pain (erosive

reflux in the treatment of oesophagitis)

- subject to escape into the gastric fluid esophagus, heartburn and vomiting asdisease

symptoms of(In symptomatic treatment of gastro-esophageal reflux disease)

• In patients requiring continuous NSAID (non-steroidal anti-inflammatory drug) treatment

- Symptoms such as pain or discomfort in the upper part of the stomach or abdominal cavity caused by a drug used for pain or inflammation (non-steroidal In the treatment of upper gastrointestinal symptoms associated with the use of anti-inflammatory drugs (NSAIDs)in the treatment

- Ulcers:and prevention of ulcers caused by drugs used for pain and inflammation (gastric and du prevention of odenal ulcers)

• A bacterial infection called Helicobacter pylori that causes ulcers.

• NEXIUM infusion solution to maintain the bleeding (= hemostasis) after the treatment and to prevent bleeding in the stomach or duodenum ulcers.

• In cases of excessive acid secretion in the stomach, including hormone producing tumors that cause excessive acid formation in the stomach (Zollinger-Ellison syndrome),

follow your doctor's advice and consult your doctor or pharmacist if you need more information.

2. Cautions before using

NEXIUM® DO NOT use NEXIUM® in the following cases

• If you are hypersensitive to esomeprazole, benzimidazole derivatives or any other ingredient in NEXIUM content

• If you are allergic to other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, omeprazole )

• esomeprazole with other proton pump inhibitors such as atazanavir or nelfinavir (HIV (AIDS) treatment drug) to be used together.

USE NEXIUM® CAREFULLY in the following cases

• - If you notice one of the following: - Significant weight loss for no apparent reason - If pain or indigestion occurs during treatment with NEXIUM - If you start vomiting blood or food - If the stool is black and there are bleeding points contact your doctor.

If you have serious liver problems, you should discuss this with your doctor, as your doctor may try to reduce the dose.

If you have serious kidney problems, you should talk to your doctor.

If you have been prescribed triple treatment for the destruction of H. pylori, or if NEXIUM is given to you if you need it, inform your doctor if there is any other medication you are taking.

If NEXIUM is prescribed to be used as la in need Eğer, you should contact your doctor if symptoms persist or change characteristics.

If you use a proton pump inhibitor, such as NEXIUM, especially for more than a year, the risk of hip, wrist or spine fracture may increase slightly. Tell your doctor if you have osteoporosis or if you use corticosteroids (which may increase the risk of osteoporosis).

A decrease in magnesium level in the blood (hypomagnesemia) has been reported. If you are taking the proton pump inhibitor together with drugs such as digoxin or drugs (such as diuretics) that cause a low level of magnesium in the blood (eg, diuretics), your doctor may monitor blood magnesium levels before and after treatment.

Interactions with investigations for neuroendocrine tumors: Due to drug-induced reductions in gastric acid levels, false positive results can be obtained in diagnostic tests for tumors related to the nervous system and the inner gland.

Gastric acid decreases for any reason, including proton pump suppressors, cause an increase in the number of bacteria normally present in the gastrointestinal tract. Treatment with proton pump suppressors can slightly increase the risk of certain gastrointestinal tract infections.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using NEXIUM® with food and drink You can take your tablets with food or on an empty stomach.

Pregnancy Consult your doctor or pharmacist before using the medication. Before using NEXIUM, inform your doctor that you are pregnant or are planning to become pregnant. If you are pregnant, use NEXIUM only if recommended by your doctor.

If you notice that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine.

Before using NEXIUM, tell your doctor that you are breastfeeding. In case of breastfeeding, use NEXIUM only if recommended by your doctor.

The use of tools and machinery does not affect your ability to use NEXIUM vehicles and machinery.

Important information on some excipients contained in NEXIUM® contains NEXIUM® sucrose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

When used in combination with other drugs NEXIUM may change the way some drugs are used when used with the following drugs and some drugs may have an effect on NEXIUM.

Do not use NEXIUM tablets if you are taking nelfinavir or atazanavir (used in the treatment of AIDS).

Tell your doctor or pharmacist if you are using any of the following drugs:

• Ketoconazole, itraconazole or voriconazole (medicines to prevent fungal inflammation)

• Erlotinib or another drug of the same class (used in the treatment of cancer)

• Citalopram, imipramine or clomipramine (used in the treatment of depression)

• Diazepam (used in the treatment of epilepsy) for the treatment of anxiety, for relaxation of the muscles or for the treatment

• Phenytoin (of epilepsy. If you use phenytoin, your doctor will need to follow you when you start using NEXIUM or when you stop using it.

• Warfarin or clopidogrel (anticoagulants used for the dilution of blood). Your doctor may need to follow you when you start using NEXIUM or when you stop using it.

• Cilostazol (used in the treatment of cut limping - the pain in your legs when you walk due to insufficient blood circulation)

• Sisaprid (used for indigestion and heartburn)

• Digoxin (heart problems drug)

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• Methotrexate (a chemotherapy drug used in high doses to treat cancer) . If you use high doses of methotrexate, treatment with NEXIUM may need to be temporarily interrupted.

• Rifampicin (tuberculosis treatment)

. John's Wort (Hypericum perforatum) If

your doctor prescribes NEXIUM as well as amoxicillin and clarithromycin antibiotics to treat the ulcer caused by Helicobacter pylori, it is extremely important that you inform your doctor about any other medicines you are taking.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medicine or have recently used it.

3. How to use NEXIUM®?

• Instructions for proper use and dose / frequency of administration:

Gastro-esophageal reflux disease (GERD)

Adults The

recommended dose (erosive reflux esophagitis) in the esophagus is 40 mg once a day for the treatment of inflammation and pain. The total treatment period is 4 to 8 weeks depending on the severity of the disease and your response to the treatment.

The recommended dose is NEXIUM 20 mg once daily to prevent recurrence.

In the treatment of symptoms such as gastric pain and vomiting (in symptomatic treatment of gastro-esophageal reflux disease), the recommended treatment dose is NEXIUM 20 mg once daily. If symptoms persist after 4 weeks, consult your doctor.

When symptoms disappear, your doctor may only recommend you to take NEXIUM 20 mg once a day if you need to.

Use in children aged 12-18 years: The

recommended dose in the esophagus and the treatment of pain (erosive reflux esophagitis) is NEXIUM 40 mg once a day. The total treatment period is 4 to 8 weeks depending on the severity of the disease and your response to the treatment.

The recommended dose is NEXIUM 20 mg once daily to prevent recurrence.

In the treatment of symptoms such as gastric pain and vomiting (in symptomatic treatment of gastro-esophageal reflux disease), the recommended treatment dose is NEXIUM 20 mg once daily. If symptoms persist after 4 weeks, consult your doctor.

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symptoms disappear, your doctor may recommend that you take NEXIUM 20 mg once a day, only if you need it.

In patients requiring continuous NSAID (non-steroidal anti-inflammatory drugs) treatment A recommended dose for the treatment of conditions such as pain or inflammation in the upper abdominal cavity caused by a drug used in adults for pain and inflammation (treatment of upper gastrointestinal symptoms associated with NSAIDs) NEXIUM is 20 mg. If symptoms persist within 4 weeks, consult your doctor.

The recommended dose for the treatment of ulcers caused by pain and inflammation is NEXIUM 20 or 40 mg once daily for 4 to 8 weeks.

The recommended dose for the prevention of ulcers caused by a drug used for pain and inflammation is NEXIUM 20 or 40 mg once daily.

Forcaused by a bacterium named Helicobacter pylori

adults: The recommended dose for adults is 20 mg twice a day. Your doctor will also recommend that you take the following antibiotics: amoxicillin and clarithromycin. The recommended duration of treatment is one week. Follow the instructions on using your medicine and consult with your doctor about any issues you are not sure about. This treatment will not only improve your existing ulcer, but will also prevent the recurrence of ulcers.

Use in children between 12-18 years of age: NEXIUM 20 mg twice a day in combination therapy with two antibiotics prescribed by your doctor. The overall duration of treatment is 1 week.

NEXIUM is the maintenance of mechanisms to stop the bleeding after the treatment with the infusion solution (= hemostasis) andthe prevention of re-bleeding in the stomach or duodenal ulcers

40 mg once daily for 4 weeks in. For the treatment of acid suppression, NEXIUM 80 mg infusion should be administered as a bolus infusion for 30 minutes prior to the oral treatment period, followed by a continuous intravenous infusion of 8 mg / h for 3 days (72 hours).

In(Zollinger-Ellison syndrome), including hormone producing tumors that cause excessive acidity in the stomach,

adults with hypersecretionthe recommended initial dose for adults is NEXIUM 40 mg twice daily. Your doctor will adjust the dose according to your needs and also decide how long to use the medication.

• Method and method of administration: Always use NEXIUM as recommended by your doctor. Talk to your doctor or pharmacist if you are unsure. The dose of the tablet you use and how long you

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usedepends on the condition of your disease. The tablets should not be chewed or crushed. You can take your tablets with food or on an empty stomach. As a whole, half a glass should be swallowed with liquid.

The tablet may also be introduced into half a glass of water so that it will be easier to disperse. Do not use any other liquids. Be sure to swallow all tiny pellets from the tablet without chewing. Do not allow pellets to remain in water for longer than 30 minutes before drinking. After drinking, shake the glass with water and drink this part.

• Different age groups: Use in children: NEXIUM tablets should not be used in children under 12 years of age. Use in elderly: NEXIUM can be used in the elderly.

• Specific conditions of use: Hepatic impairment In patients with mild to moderate hepatic impairment, the destruction of esomeprazole may be impaired. In patients with severe hepatic impairment, the destruction of the drug decreases and blood levels may increase. Therefore, 20 mg dose should not be exceeded in patients with severe hepatic impairment. Esomeprazole and degradation products do not tend to accumulate in the body during single dose use.

Renal failure There is no study on patients with renal failure. In patients with renal insufficiency, esomeprazole destruction is not expected to change.

If you feel the effect of NEXIUM® is too strong or too weak, talk to your doctor or pharmacist.

If you have used more NEXIUM® than you should use:used more than NEXIUM®,

If you havetalk to a doctor or pharmacist.

If you forget to take the NEXIUM® dose:forget to takeit as soon as you

If youa dose, takeremember that you forgot to take the dose. However, if almost the next dose is due, do not take the missed dose, but only if the time is over.

Do not take double doses to compensate for forgotten doses.

4. What are the possible side effects?

As with all medicines, NEXIUM® may have side effects in people who are sensitive to the substances contained in its contents.

If you have any of the following, stop using NEXIUM® and IMMEDIATELY tell your doctor or contact the emergency department of your nearest hospital:

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• sudden wheezing, lips, tongue and throat or swelling in the body, skin rash, fainting or difficulty swallowing (severe allergic reaction)

• Redness of the skin with blisters or peeling. In addition, severe blistering and bleeding may occur in the lips, eyes, mouth, nose and genital areas. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".

• Also yellowing, dark urine and fatigue, which are symptoms of liver problems. These are all very serious side effects. All of these serious side effects are infrequent (less than 1 in 1000).

Other side effects are as follows:

Common (affects less than 1 in 10 people)

• Headache

• Effect on your abdomen or intestines: Diarrhea, abdominal pain, constipation, gas collection

• Sick feeling (nausea) or sickness (vomiting)

Uncommon (100 people affects less than 1)

• Foot and swelling in the ankles

• Sleep disturbances (insomnia)

• dizziness, "pinprick" such as tingling sensation, feeling sleepy

• Dizziness sensation (vertigo)

• dry mouth

• changes in blood tests that show how the liver works

• Skin rash, lumpy rash (hives) and skin itching

• Hip, wrist or spine fracture (if NEXUMUM is used at high doses and for too long)

Sparse (affects less than 1 in 1000 people)

• Blood problems such as decrease in the number of white blood cells or platelets . This may cause fatigue, bruising or make infection more likely.

• Low sodium values ​​in blood. This may lead to fatigue, feeling sick (vomiting) and cramping.

• agitated, confused or feeling depressed

• Taste disorder

• visual problems such as blurred vision

• Sudden wheezing or breathlessness stay (bronchospasm)

• inflammation in the mouth

• caused by a fungus and can affect the gut "thrush" inflammation of a named

• yellowing of the skin, jaundice that can cause dark urine and fatiguegoes

• Hair loss (alopecia)

• Rash on the skin when the sunout

• Joint pain (arthralgia) or muscle aches (myalgia)

• In general, feeling unwell and weakness

• Increasing perspiration

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Very sparse (10,000 people 1 from the affects less)

• the changes in blood values including agranulocytosis (lack of white blood cells)

• Aggression / angry state of being

• see Non stuff, feel or hear (hallucinations)

• inflammation of the intestines that causes diarrhea (microscopic colitis)

• bankruptcy and the liver inflammation severe serious liver problems

• Suddenly severe rash or blistering or skin peeling. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

• Muscle weakness

• Severe kidney problems

• Breast growth in men

• Reduction of magnesium in the blood (If you use NEXUM for more than three months, There are likely to fall levels. Low magnesium levels of fatigue, involuntary muscle contractions, disorientation, remittances, manifested in the form of acceleration of dizziness or heart rate. If any of these symptoms arise in you, tell your