Esomeprazole Mylan Generics

Patient Information Leaflet

Esomeprazole Mylan Generics 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

Generic medicine
esomeprazole
Please read all of this leaflet carefully before you start taking this medicine, as 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esomeprazolo Mylan Generics is and what it is used for

Esomeprazolo Mylan Generics contains a medicine called esomeprazole. It belongs to a group of
medicines called "proton pump inhibitors". These work by reducing the amount of acid produced by
the stomach.
Esomeprazolo Mylan Generics is used to treat the following conditions:
Adults

• "Gastro-oesophageal reflux disease" (GORD). This is a condition in which acid produced by the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers infected with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazolo Mylan Generics may also be used to prevent the formation of stomach or upper intestinal ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment following prevention of re-bleeding from ulcers with intravenous esomeprazole.

Adolescents over 12 years of age

• "Gastro-oesophageal reflux disease" (GORD). This is a condition in which acid produced by the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

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• Stomach or upper intestinal ulcers infected with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazole Mylan Generics

Do not take Esomeprazole Mylan Generics:

• If you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitors (for example, pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).
  If you have ever had a severe skin rash or skin peeling, or a skin rash with blisters and/or mouth ulcers after taking Esomeprazole Mylan Generics or other related medicines, do not take Esomeprazole Mylan Generics if you are in any of the above conditions. If you have any doubts, consult your doctor or pharmacist before taking Esomeprazole Mylan Generics.

Warnings and precautions
Talk to your doctor before taking Esomeprazole Mylan Generics:

• If you have severe liver problems.
• If you have severe kidney problems.
• If you have ever had a skin reaction after treatment with a medicine similar to esomeprazole that reduces stomach acidity.
• If you are about to undergo a specific blood test (chromogranin A).
• If you have a vitamin B deficiency.

Esomeprazole Mylan Generics may mask symptoms of other diseases. Therefore, inform your doctor immediately
if, before starting or while taking Esomeprazole Mylan Generics, you experience any of the following
conditions:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-coloured stools (blood in stools).

If you have been prescribed Esomeprazole Mylan Generics to take as needed, contact your doctor if symptoms
persist or if the nature of symptoms changes.
If you take a proton pump inhibitor such as Esomeprazole Mylan Generics, especially for more than one year,
there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you suffer from osteoporosis or
are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
If you take a proton pump inhibitor such as Esomeprazole Mylan Generics, there may be a slight increase in the
risk of gastrointestinal infections (such as Salmonella and Campylobacter). Inform your doctor if you experience
symptoms such as nausea, vomiting, diarrhoea, fever, and abdominal cramps.
Skin rash and skin reactions
If you notice a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it
may be necessary to stop treatment with Esomeprazole Mylan Generics. Remember to also report any other
undesired effects such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with
eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with
Esomeprazole Mylan Generics.
Stop using Esomeprazole Mylan Generics and seek immediate medical advice if you notice any of the
symptoms related to these serious skin reactions described in section 4.
The skin rash may involve ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes).
These serious skin rashes often occur after flu-like symptoms such as fever, headache, and muscle pain. The
rash may cover large areas of the body, with blistering and skin peeling.
Other medicines and Esomeprazole Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is because Esomeprazole Mylan Generics may alter the effect of some medicines, and some medicines may
affect Esomeprazole Mylan Generics.
Do not take Esomeprazole Mylan Generics if you are taking a medicine containing nelfinavir (used to treat HIV
infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Saquinavir and Ritonavir together (medicines used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, to relax muscles, or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Esomeprazole Mylan Generics.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping Esomeprazole Mylan Generics.
• Cilostazol (used to treat intermittent claudication, a leg pain occurring when walking due to insufficient blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapeutic medicine used at high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor may temporarily discontinue treatment with Esomeprazole Mylan Generics.
• Tacrolimus (a medicine used for organ transplants).
• Rifampicin (used to treat tuberculosis).
• St John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazole Mylan
Generics to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor
if you are taking other medicines.
Taking Esomeprazole Mylan Generics with food and drinks
You may take the tablets with food or on an empty stomach.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take
Esomeprazole Mylan Generics during this period.
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It is not known whether Esomeprazole Mylan Generics passes into breast milk. Therefore, do not take
Esomeprazole Mylan Generics if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazole Mylan Generics affects your ability to drive or use tools or machines. However,
side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If this happens,
do not drive or use machinery.
Esomeprazole Mylan Generics contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.
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3. How to take Esomeprazole Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• If you have been 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).
• If your doctor has told you to take this medicine as needed, inform them if your symptoms change.

How much Esomeprazole Mylan Generics to take

• Your doctor will tell you how many tablets to take and for how long. This will depend on your condition, your age, and liver function.
• The recommended doses are given below.

Adults aged over 18 years
For treating heartburn caused by gastro-esophageal reflux disease (GERD)

• If your doctor has diagnosed that your digestive tract (oesophagus) has been slightly damaged, the recommended dose is one tablet of Esomeprazole Mylan Generics 40 mg once daily for 4 weeks. Your doctor may prescribe you to continue taking the same dose for another 4 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is one tablet of Esomeprazole Mylan Generics 20 mg once daily.
• If the oesophagus has not been damaged, the recommended dose is one tablet of Esomeprazole Mylan Generics 20 mg daily. Once the condition is under control, your doctor may prescribe you to take the medicine as needed, up to a maximum of one tablet of Esomeprazole Mylan Generics 20 mg per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For treating ulcers caused by Helicobacter pylori infection and to prevent their recurrence

• The recommended dose is one gastro-resistant tablet of Esomeprazole Mylan Generics 20 mg twice daily for one week.
• Your doctor may also prescribe antibiotics, such as amoxicillin and clarithromycin.

For treating stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

• The recommended dose is one gastro-resistant tablet of Esomeprazole Mylan Generics 20 mg once daily for 4–8 weeks.

To prevent stomach or upper intestinal ulcers if you are taking NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs)

• The recommended dose is one gastro-resistant tablet of Esomeprazole Mylan Generics 20 mg once daily.

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Long-term treatment of re-bleeding ulcers after initial prevention with intravenous esomeprazole

The recommended dose is one tablet of Esomeprazole Mylan Generics 40 mg once daily for 4 weeks.

For treating excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome)

• The recommended dose is 40 mg of Esomeprazole Mylan Generics twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine. The maximum dose is 80 mg twice daily.

Adolescents aged 12 years and older
For treating heartburn caused by gastro-esophageal reflux disease (GERD):

• If your doctor has found that your digestive tract (oesophagus) has been slightly damaged, the recommended dose is one gastro-resistant tablet of Esomeprazole Mylan Generics 40 mg once daily for 4 weeks.
• The recommended dose once the oesophagus has healed is one gastro-resistant tablet of Esomeprazole Mylan Generics 20 mg once daily.
• If the oesophagus has not yet healed, the recommended dose is one gastro-resistant tablet of Esomeprazole Mylan Generics 20 mg once daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For treating ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one gastro-resistant tablet of Esomeprazole Mylan Generics 20 mg twice daily for one week.
• Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

Method and route of administration

• You may take the tablets at any time of day.
• You may take the tablets with or without food.
• Swallow the tablets whole with water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being inactivated by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets:
• Place the tablets in a glass of plain water (not sparkling). Do not use any other liquid.
• Stir until the tablets disintegrate (the mixture will appear cloudy). Drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking.
• To ensure you have taken all the medicine, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine: do not chew or crush them.
• If you are completely unable to swallow, the tablets may be mixed with a small amount of water and administered via a syringe. They may then be given through a tube directly into the stomach ('gastric tube').

Use in children and adolescents
Children under 12 years of age
Esomeprazole Mylan Generics gastro-resistant tablets are not recommended for children under 12 years of age.

Elderly patients
Dose adjustment is not required in elderly patients.

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If you take more Esomeprazole Mylan Generics than you should
If you take more Esomeprazole Mylan Generics than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Esomeprazole Mylan Generics

• 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 to make up for a forgotten 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 gets them.
If you notice any of the following serious side effects, stop taking Esomeprazole Mylan Generics and contact a doctor immediately:

Uncommon (may affect up to 1 in 100 people):

• Fractures of the hip, wrist or spine (if Esomeprazole Mylan Generics is used at high doses or for a long period of time)

Rare (may affect up to 1 in 1,000 people):

• Sudden breathlessness, swelling of lips, tongue or throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Yellowing of the skin, dark-coloured urine, pale stools with fever, feeling unwell and tiredness, which may be symptoms of liver problems.
• Signs of infection such as fever, or fever with symptoms of a local infection such as neck, throat or mouth pain or difficulty urinating. These may be signs of a reduced number of white blood cells.

Very rare (may affect up to 1 in 10,000 people):

• 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. Large blisters and severe bleeding of the lips, eyes, mouth, nose and genitals may also occur, accompanied by joint pain and high fever. Skin rashes may progress to widespread severe skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”.
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Changes in the number of certain blood cells causing tiredness, weakness or pale skin (low red blood cells), bruising or bleeding more frequently or for longer than normal (low platelets).
• Changes in the number of white blood cells, including agranulocytosis (lack of white blood cells).
• Reduced urine output, or inability to urinate, blood or mucus in the urine, lower back pain possibly with skin rash, fever, feeling unwell. These may be signs of kidney problems.
• Severe liver problems leading to liver failure and inflammation of the brain.

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

• Intestinal inflammation causing pain and diarrhoea, possibly containing blood.
• Skin rash, possibly with joint pain.

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

• Headache.
• Stomach or intestinal effects: diarrhoea, stomach ache, constipation, flatulence (gas).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

• Swelling of feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensations like "pins and needles", drowsiness.
• Feeling of dizziness.
• Dry mouth.
• Changes in blood test values related to liver function.
• Skin rash, hives and itching.

Rare (may affect up to 1 in 1,000 people):

• Blood disorders, for example a reduced number of white blood cells and platelets. This may cause weakness, bruising or increased risk of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
• Restlessness, confusion or depression.
• Taste disturbances.
• Vision problems such as blurred vision.
• Difficulty breathing (bronchospasm).
• Inflammation of the inside of the mouth.
• A fungal infection called "thrush" which may affect the intestine.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of being unwell and lacking energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people):

• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Muscle weakness.
• Severe kidney problems.
• Breast enlargement in men.

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

• Inflammation of the intestine (which may lead to diarrhoea).
• If you take Esomeprazole Mylan Generics for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of magnesium levels in the blood is necessary.
• Skin rash, possibly with joint pain.

Esomeprazole Mylan Generics, in very rare cases, may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever with severe deterioration
in general health or fever with symptoms of a local infection, such as neck, throat or mouth pain or
difficulty urinating, you should consult a doctor as soon as possible so that a lack of white blood
cells (agranulocytosis) can be ruled out by a blood test. It is important that you inform your doctor
about all medicines you are taking.
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 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 Esomeprazole Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep the blister in the original packaging 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 Esomeprazolo Mylan Generics contains
The active substance is esomeprazole.
20 mg: each tablet contains 20 mg of esomeprazole (as amorphous esomeprazole magnesium).
40 mg: each tablet contains 40 mg of esomeprazole (as amorphous esomeprazole magnesium).
The other components are:
Tablet core: hydroxypropylcellulose (E463), crospovidone (Type A).
Coating: povidone K30, macrogol-400, macrogol-4000, macrogol 6000, hypromellose phthalate (HP-55S),
hypromellose phthalate (HP-50), diethyl phthalate, hydroxypropylcellulose (E463), microcrystalline cellulose (PH 101),
microcrystalline cellulose (PH 112), crospovidone (Type B), sodium stearyl fumarate, Opadry brown
03B86651, (HMPC 2910/Hypromellose 6cP , titanium dioxide (E171), macrogol/PEG 400, red iron oxide
(E 172) , sugar spheres (sucrose and maize starch), talc (E553b).
Description of the appearance of Esomeprazolo Mylan Generics and package contents
Esomeprazolo Mylan Generics 20 mg gastro-resistant tablets: film-coated, oval, biconvex tablets, light brick-red to brown in colour, with "E5" imprinted on one side and smooth on the other side.
Esomeprazolo Mylan Generics 40 mg gastro-resistant tablets: film-coated, oval, biconvex tablets, light brick-red to brown in colour, with "E6" imprinted on one side and smooth on the other side.
The tablets are available in the following pack sizes:
20 mg and 40 mg:

• OPA/AI/PE-desiccant-HDPE/Al blister packs containing 7, 14, 28 and 56 tablets.
• Cold-form laminated OPA-Al-PVC/Al blister packs containing 7, 14, 28 and 56 tablets.
  Not all pack sizes may be marketed.

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Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20 – 20124
Milan, Italy
Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp, The Netherlands
Terapia SA
124 Fabricii Str.
400 632 Cluj-Napoca, Romania
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