Esomeprazole Mylan Generics Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole Mylan Generics Italia 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

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

Contents of this leaflet:

What Esomeprazole Mylan Generics Italia is and what it is used for
What you need to know before taking Esomeprazole Mylan Generics Italia
How to take Esomeprazole Mylan Generics Italia
Possible side effects
How to store Esomeprazole Mylan Generics Italia
Contents of the pack and other information

1. What Esomeprazole Mylan Generics Italia is and what it is used for

Esomeprazole Mylan Generics Italia contains an active substance called esomeprazole, which
belongs to a group of medicines known as "proton pump inhibitors". These medicines
work by reducing the amount of acid produced by your stomach.
Esomeprazole Mylan Generics Italia is used to treat the following conditions:
In adults and adolescents aged 12 years and older

Gastroesophageal reflux disease (GERD). In this condition, stomach acid flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
Stomach ulcers or ulcers in the upper part of the digestive tract (intestine) caused by 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.

In adults only:

Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole Mylan Generics Italia may also be used to help prevent stomach ulcers if you are taking NSAIDs.
Excess stomach acid caused by a tumour growth in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment following prevention of ulcer bleeding with intravenous esomeprazole.

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

Do not take Esomeprazole Mylan Generics Italia

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 (e.g. 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, skin rash with blisters and/or mouth ulcers after taking Esomeprazole Mylan Generics Italia or other related medicines. Do not take Esomeprazole Mylan Generics Italia if any of these apply to you. If you are in doubt, consult your doctor or pharmacist before taking Esomeprazole Mylan Generics Italia.

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

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 acid.
if you are due to undergo a specific blood test (chromogranin A).

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

if you lose weight significantly without reason and have difficulty swallowing
if you have stomach pain or indigestion
if you start vomiting food or blood
if your stools are black and tar-like (blood in stools) or if you have diarrhoea.

If you have been prescribed Esomeprazole Mylan Generics Italia “as needed”, contact your doctor if
symptoms persist or change in nature.
Taking a proton pump inhibitor such as Esomeprazole Mylan Generics Italia, particularly for more than
one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you
have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
Skin rash and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor
as soon as possible, as it may be necessary to discontinue treatment with esomeprazole.
Remember to also report any other side effects such as joint pain.
Serious skin reactions have been reported in association with treatment with Esomeprazole Mylan
Generics Italia, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with
eosinophilia and systemic symptoms (DRESS). The skin rash may include mouth, throat, nose, genital
ulcers and conjunctivitis (red and swollen eyes). These serious skin reactions often occur after flu-like
symptoms such as fever, headache and muscle pain. Stop using Esomeprazole Mylan Generics Italia and
seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions
described in section 4.
Children under 12 years of age
Esomeprazole Mylan Generics Italia must not be used in children under 12 years of age as there are no
available data.
Other medicines and Esomeprazole Mylan Generics Italia
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those without a prescription. Esomeprazole Mylan Generics Italia may affect how
some medicines work, and some medicines may affect Esomeprazole Mylan Generics Italia.
You must not take Esomeprazole Mylan Generics Italia 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 or saquinavir (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 treatment with Esomeprazole Mylan Generics Italia
medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with Esomeprazole Mylan Generics Italia
cilostazol (used to treat circulation problems – leg pain when walking, caused by inadequate blood supply)
cisapride (used for indigestion and heartburn)
digoxin (used for heart problems)
methotrexate (used in the treatment of cancer and rheumatic disorders – if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazole Mylan Generics Italia)
tacrolimus (used to prevent organ transplant rejection)
rifampicin (used to treat tuberculosis)
St. John’s wort (a herbal medicine used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Esomeprazole
Mylan Generics Italia to treat ulcers caused by Helicobacter pylori infection, it is very important that
you inform your doctor if you are taking other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, consult your doctor before taking this medicine.
Your doctor will decide whether you can take Esomeprazole Mylan Generics Italia during this time.
It is not known whether Esomeprazole Mylan Generics Italia passes into breast milk. Therefore, you must
not take Esomeprazole Mylan Generics Italia if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazole Mylan Generics Italia will affect your ability to drive or use tools or
machinery. Esomeprazole Mylan Generics Italia may cause side effects such as dizziness and blurred
vision (see section 4). If affected, do not drive or use machinery.
Esomeprazole Mylan Generics Italia contains sucrose, benzoic acid (E210) and sodium

If your doctor has told you that you have an intolerance to certain sugars, such as sucrose, consult your doctor before taking this medicine.
Esomeprazole Mylan Generics Italia 20 mg contains 0.0018 mg of benzoic acid in each capsule.
Esomeprazole Mylan Generics Italia 40 mg contains 0.0035 mg of benzoic acid in each capsule.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Esomeprazole Mylan Generics Italia

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

Esomeprazole Mylan Generics Italia is not recommended for children under 12 years of age.
If you have been taking this medicine for a long time, your doctor will want to monitor you (particularly if you have been taking it for more than one year).
If your doctor has instructed you to take this medicine as needed, inform your doctor if your symptoms change.

How much Esomeprazole Mylan Generics Italia to take

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and how well your liver is functioning.
The usual doses are listed below.
If you have severe liver or kidney problems, your doctor may prescribe a lower dose.

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):
Adults and children aged 12 years and older:

If your doctor has found that your oesophagus has been slightly damaged, the usual dose is one capsule of Esomeprazole Mylan Generics Italia 40 mg once daily for 4 weeks. Your doctor may instruct you to continue taking the same dose for another 4 weeks if your oesophagus has not yet healed.
The usual dose once your oesophagus has healed is one capsule of Esomeprazole Mylan Generics Italia 20 mg once daily.
If your oesophagus has not been damaged, the usual dose is one capsule of Esomeprazole Mylan Generics Italia 20 mg daily. When your condition is under control, your doctor may instruct you to take the medicine as needed, up to a maximum dose of one capsule of Esomeprazole Mylan Generics Italia 20 mg daily.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

Adults and adolescents aged 12 years and older: the usual dose is one capsule of Esomeprazole Mylan Generics Italia 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

For the treatment of ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

Adults aged 18 years and older: the usual dose is one capsule of Esomeprazole Mylan Generics Italia 20 mg once daily for 4–8 weeks.

For the prevention of stomach ulcers in patients taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

Adults aged 18 years and older: the usual dose is one capsule of Esomeprazole Mylan Generics Italia 20 mg once daily.

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

Adults aged 18 years and older: the usual dose is one capsule of Esomeprazole Mylan Generics Italia 40 mg twice daily.
Your doctor will adjust your dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Long-term treatment following prevention of ulcer bleeding with intravenous esomeprazole:

The usual dose is one capsule of Esomeprazole Mylan Generics Italia 40 mg once daily for 4 weeks.

How to take this medicine

You may take the capsules at any time of day.
You may take the capsules with food or on an empty stomach.
Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain enteric-coated granules that prevent your medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules: 1) Open the capsule and empty the contents (the granules) into a glass of plain water (not carbonated). Do not use any other liquids. 2) Stir the mixture and drink it immediately or within 30 minutes. Always stir the mixture just before drinking. 3) 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 unable to swallow anything, the granules can be mixed with a small amount of water and drawn into a syringe. They can then be administered through a tube directly into the stomach (a 'gastric tube').

Elderly
Dose adjustment is not required in elderly patients.
If you take more Esomeprazole Mylan Generics Italia than you should
Contact your doctor or pharmacist immediately. Signs of overdose may include stomach pain, diarrhoea, nausea or vomiting, and weakness.
If you forget to take Esomeprazole Mylan Generics Italia

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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you experience any of the following serious side effects, stop treatment with Esomeprazole Mylan Generics Italia and contact your doctor immediately:

Uncommon (may affect up to 1 in 100 people)

Fracture of the hip, wrist, or spine (if Esomeprazole Mylan Generics Italia is used at high doses and for prolonged periods).

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

Sudden breathlessness, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).
Yellowing of the skin or eyes, dark urine, feeling unwell, loss of appetite, and fatigue, which may be signs of liver problems.
Signs of infection such as fever, with a severely reduced general condition or fever with symptoms of 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)

After several weeks of treatment, sudden onset of a severe skin rash or redness of the skin with blisters or peeling may occur. There may be blistering and severe bleeding also on the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, “drug reaction with eosinophilia and systemic symptoms” (widespread rash, high body temperature, and

swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)) or
“toxic epidermal necrolysis”.

Signs of a reduced number of various blood cells, which may cause pale skin, feeling tired and short of breath, and dark urine (reduction in red blood cells), bleeding or bruising more frequently than normal or unexpectedly, even without injury (reduced number of platelets).
Difficulty or pain during urination, with back pain, fever or general malaise. These may be signs of kidney problems.
Severe liver problems may also lead to feeling disoriented or confused, which are signs of brain inflammation.

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

Persistent diarrhoea with stomach discomfort or pain and weight loss, which may be signs of problems in the large intestine (colon).
Skin rashes with possible joint pain.

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

Headache.
Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence.
Nausea or vomiting.
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Sleep disorders (insomnia).
Dizziness, tingling sensations such as “pins and needles”, drowsiness.
Vertigo.
Dry mouth.
Changes in blood test values used to monitor 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 susceptibility to infections.
Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
Feeling agitated, confused, or depressed.
Altered taste.
Vision problems such as blurred vision.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
A fungal infection called “thrush” that may affect the intestine.
Hair loss (alopecia).
Skin redness after exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
Feeling of general malaise and lack of energy.
Increased sweating.

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

Changes in the number of blood cells, including agranulocytosis (absence of white blood cells in the blood).
Aggression.
Seeing, feeling, or hearing things that are not there (hallucinations).
Muscle weakness.
Breast enlargement in men.

Frequency not known (frequency cannot be estimated from the available data)
If you are being treated with esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult 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 Esomeprazole Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store the medicine in the original packaging (blister) or keep the container tightly closed (bottle) to protect the medicine from moisture.
Do not use Esomeprazole Mylan Generics Italia after the expiry date stated on the carton, bottle, or blister. The expiry date refers to the last day of that month.
After opening the bottle, the capsules must be used within three months.
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 Italia contains

The active substance is esomeprazole. Esomeprazolo Mylan Generics Italia is available in two strengths containing 20 mg or 40 mg of esomeprazole (as dihydrate magnesium salt).
The other components are: Capsule contents: sugar spheres (containing sucrose and maize starch), hypromellose, simeticone emulsion 30% (containing simeticone, benzoic acid, sorbic acid, methylcellulose, polysorbate 65, polyglycolyzed stearate, glycerides, xanthan gum, purified water and sulfuric acid), polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing methacrylic acid copolymer and ethyl acrylate, sodium lauryl sulfate and polysorbate 80), triethyl citrate and stearoyl macrogol glycerides.

Capsule shell:
Yellow iron oxide (E172), titanium dioxide (E171) and gelatin
Black ink:
Shellac, black iron oxide (E172), ammonia, propylene glycol, potassium hydroxide
(See section 2 “Esomeprazolo Mylan Generics Italia contains sucrose, benzoic acid (E210) and sodium”.)

Description of the appearance of Esomeprazolo Mylan Generics Italia and package contents

Esomeprazolo Mylan Generics Italia 20 mg capsules have an opaque yellow cap and an opaque white body. “20 mg” is printed in black on both the cap and the body.
Esomeprazolo Mylan Generics Italia 40 mg capsules have an opaque yellow cap and an opaque yellow body. “40 mg” is printed in black on both the cap and the body.
Capsules are available in the following pack sizes: Bottles of 28, 30 or 90 capsules (20 mg): Blister packs of 7, 14, 15, 28, 30, 50, 60 or 90 capsules (40 mg): Blister packs of 14, 15, 28, 30, 50, 60 or 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder
MYLAN S.p.A.
Via Vittor Pisani 20 – 20124 - Milano
ITALY

Manufacturer
ETHYPHARM Z.I de Saint-Arnoult, 28170 Châteauneuf-en-Thymerais, France
or
ETHYPHARM Chemin de la Poudrière - 76120 Grand-Quevilly, France
or
Viatris Santé 1 Rue de Turin, 69007 Lyon, France
or
Mylan Hungary Kft. H-2900 Komárom, Mylan utca 1, Hungary
or
Européenne de Pharmacotechnie-Europhartech, rue Henri Matisse 63370 Lempdes, France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: Esomeprazole Viatris
Iceland: Prazolene
Italy: Esomeprazolo Mylan Generics Italia