Esomeprazole Teva Italia: detailed information

Package leaflet: Information for the user

Esomeprazole Teva Italia 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Equivalent medicine
Please read 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esomeprazole Teva Italia is and what it is used for

Esomeprazole Teva Italia contains a medicine called esomeprazole magnesium dihydrate. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by your stomach.
Esomeprazole Teva Italia is used to treat the following conditions:

Adults

Gastroesophageal reflux disease (GERD). This is a condition in which acid produced by the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers caused by infection with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and help heal the ulcer.
Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole Teva Italia may also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
Excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment following prevention of bleeding from ulcers with intravenous esomeprazole.

Adolescents aged 12 years and older

Gastroesophageal reflux disease (GERD). This is a condition in which acid produced by the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers caused by infection with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and help heal the ulcer.

2. What you need to know before taking Esomeprazole Teva Italia

Do not take Esomeprazole Teva 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). Do not take Esomeprazole Teva Italia if you are in any of the above conditions. If you have any doubts, consult your doctor or pharmacist before taking Esomeprazole Teva Italia.

Warnings and precautions
Tell your doctor before taking this medicine if:

you have severe liver problems.
you have severe kidney problems.
you have vitamin B12 deficiency.
you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Teva Italia that reduces stomach acid.
you need to undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazole Teva Italia. Remember to also report any other side effects such as joint pain.
Esomeprazole Teva Italia may mask symptoms of other diseases. Therefore, inform your doctor immediately if, before starting or while taking Esomeprazole Teva Italia, you experience any of the following conditions:

unexplained weight loss and difficulty swallowing.
stomach pain or indigestion.
start vomiting food or blood.
your stools are black (blood in stools). If you have been prescribed Esomeprazole Teva Italia to take “as needed”, contact your doctor if symptoms persist or if the nature of the symptoms changes.

If you take a proton pump inhibitor such as Esomeprazole Teva, 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.
Other medicines and Esomeprazole Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because Esomeprazole Teva Italia may affect the action of certain medicines and vice versa.
Do not take Esomeprazole Teva Italia if you are taking a medicine containing nelfinavir (used to treat HIV).
Inform your doctor or pharmacist if you are taking any of the following medicines:

atazanavir (used to treat HIV infection).
ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
digoxin (used to treat heart problems).
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 Teva Italia.
medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping Esomeprazole Teva Italia.
cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood supply).
cisapride (used for indigestion and heartburn).
methotrexate (a chemotherapy drug used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop treatment with Esomeprazole Teva Italia.
clopidogrel (used to prevent blood clots (thrombi)).
tacrolimus (in case of organ transplant).
rifampicin (to treat tuberculosis).
St. John’s Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin in addition to Esomeprazole Teva Italia to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking other medicines.
Esomeprazole Teva Italia with food and drink
You may take the capsules with food or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazole Teva Italia during this time.
It is not known whether Esomeprazole Teva Italia passes into breast milk. Therefore, do not take Esomeprazole Teva Italia if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazole Teva Italia affects the ability to drive or use tools or machinery. However, side effects such as dizziness and visual disturbances may occur uncommonly or rarely (see section 4). If these occur, you must not drive or use machinery.
Esomeprazole Teva Italia contains sucrose
Esomeprazole Teva Italia contains sugar spheres which contain sucrose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, speak with your doctor before taking this medicine.

3. How to take Esomeprazole Teva Italia

Always take this medicine exactly as instructed 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 Teva Italia to take

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

Adults aged 18 years and older
For treating heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has diagnosed that your digestive tract (oesophagus) has been slightly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 40 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the oesophagus has not yet healed.
The recommended dose once the oesophagus has healed is one gastro-resistant capsule of Esomeprazole Teva Italia 20 mg once daily.
If the oesophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 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 gastro-resistant capsule of Esomeprazole Teva Italia 20 mg daily.
If you have severe liver problems, your doctor may give you a lower dose. For treating ulcers caused by a Helicobacter pylori infection and to prevent them from recurring:
The recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 20 mg twice daily for one week.
Your doctor may also prescribe antibiotics, for example amoxicillin and clarithromycin.

For treating stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

The recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 20 mg once daily for 4–8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory
drugs):

The recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 20 mg once daily.

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

The recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 40 mg 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.

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

The recommended dose is one capsule of Esomeprazole Teva Italia 40 mg once daily for 4 weeks.

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

If your doctor has diagnosed that your digestive tract (oesophagus) has been slightly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 40 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the oesophagus has not yet healed.
The recommended dose once the oesophagus has healed is one gastro-resistant capsule of Esomeprazole Teva Italia 20 mg once daily.
If the oesophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 20 mg daily.
If you have severe liver problems, your doctor may give you a lower dose. For treating ulcers caused by a Helicobacter pylori infection and to prevent them from recurring:
The recommended dose is one gastro-resistant capsule of Esomeprazole Teva Italia 20 mg twice daily for one week.
Your doctor may also prescribe antibiotics, for example amoxicillin and clarithromycin.

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 water. Do not chew or crush the capsules. This is because the capsules 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 capsules
If you have difficulty swallowing the capsules:
Open the capsule and empty the granules into half a glass of still water (not sparkling).
Do not use any other liquids.
Then 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 granules can be mixed with a little water and placed in a syringe. They may be administered through a tube directly into the stomach (‘gastric tube’).
Children under 12 years of age
Esomeprazole Teva Italia is not recommended in children under 12 years of age.
Elderly
Dose adjustment is not required in the elderly.
If you take more Esomeprazole Teva Italia than you should
If you take more Esomeprazole Teva Italia than prescribed by your doctor, contact your
doctor or pharmacist immediately.
If you forget to take Esomeprazole Teva 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Esomeprazolo Teva Italia can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking
Esomeprazolo Teva Italia and contact a doctor immediately:

Sudden breathlessness, swelling of lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction);
Skin redness with blistering or peeling. Large blisters and severe bleeding of lips, eyes, mouth, nose and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis";
Yellowing of the skin, dark urine and tiredness, which may be symptoms of liver problems. These effects are rare and affect up to 1 in 1,000 people.

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

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

Uncommon (may affect up to 1 in 100 people)

Swelling of feet and ankles.
Sleep disturbances (insomnia).
Dizziness, tingling sensations like “pins and needles”, drowsiness.
Feeling of dizziness.
Dry mouth.
Changes in blood test results related to liver function.
Skin rash, hives and itching.
Fracture of the wrist, hip or spine (if Esomeprazolo Teva Italia is used at high doses for a long time).

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

Blood problems such as reduced number of white blood cells or platelets. This may cause weakness, bruising or make infections more likely.
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.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
A fungal infection called “thrush” that may affect the intestine.
Liver problems, including jaundice which may cause yellowing of the skin, dark urine and tiredness.
Hair loss (alopecia).
Skin rash when exposed 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)

Changes in blood cell counts (pancytopenia), including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, sensing or hearing things that are not there (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of a severe skin rash or blisters 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 enlargement in men.

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

If you take Esomeprazolo Teva Italia for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause 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 regular monitoring of blood magnesium levels is necessary.
Inflammation of the intestine (leading to diarrhoea)
Erythema, possible joint pain

In very rare cases, Esomeprazolo Teva Italia may affect white blood cells, causing immune deficiency. If you suffer from an infection with symptoms such as fever with a severely compromised general condition or fever with signs of a local infection such as pain in the neck, throat or mouth or difficulty urinating, contact your doctor as soon as possible so that a deficiency in white blood cells (agranulocytosis) can be ruled out by blood tests. At this stage, it is important that you provide information about your treatment.
Reporting of side effects
If you experience any side effects, 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 the following website: http://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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

OPA/Alu/PE+DES film and aluminium foil blister pack
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.

OPA/Alu/PVC and aluminium foil blister pack
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.

HDPE container
This medicine does not require any special storage temperature.
Keep the container tightly closed to protect the medicine from moisture.
After first opening the container, the medicine should be used within 6 months.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Esomeprazolo Teva Italia contains
The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg or 40 mg of
esomeprazole (as esomeprazole magnesium dihydrate).
The other ingredients are sugar spheres (sucrose and maize starch), povidone K30, sodium
lauryl sulfate, polyvinyl alcohol, titanium dioxide (E171), macrogol 6000, macrogol 3000, talc (E553b),
heavy magnesium carbonate, polysorbate 80 (E433), and methacrylic acid-ethyl acrylate copolymer (1:1)
30% dispersion in the granules within the capsule; and gelatin (E441), titanium dioxide (E171), and red iron oxide (E172) in the capsule shell. See section 2 “Esomeprazolo Teva Italia contains sucrose”.
Description of the appearance of Esomeprazolo Teva Italia and the contents of the pack
The body and cap of the 20 mg gastro-resistant hard capsules are slightly pink in colour. The capsules contain granules that are white to off-white in colour. Capsule size: No. 3.
The body and cap of the 40 mg gastro-resistant hard capsules are light pink in colour. The capsules contain granules that are white to off-white in colour. Capsule size: No. 1.
Capsules are available in packs of 7, 10, 14, 15, 28, 30, 50, 50x1 (hospital pack), 56, 60, 90, 98 and 100 capsules in blisters, and in packs of 98 and 100 capsules with a desiccant capsule in HDPE containers. Do not swallow the desiccant capsule provided in the container.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturers
KRKA d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands
This leaflet was last updated on:
The following information is intended for healthcare professionals only:
Administration via gastric tube

Open the capsule and empty the granules into a suitable syringe; fill the syringe with approximately 25 ml of water and about 5 ml of air. For some tubes, a dispersion in 50 ml of water may be required to prevent granules from blocking the tube.
Shake the syringe immediately to evenly distribute the granules in the suspension.
Hold the syringe with the tip pointing upwards and check that it has not become blocked.
Connect the syringe to the tube while maintaining the above position.
Shake the syringe and position it with the tip pointing downwards. Immediately inject 5 to 10 ml into the tube. After injection, turn the syringe upside down and shake it (the syringe must be held with the tip pointing upwards to prevent blockage of the tip).
Turn the syringe with the tip pointing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to remove any remaining residue in the syringe. For some tubes, 50 ml of water may be required.