Esomeprazole Eurogenerici: detailed information

Package leaflet: Information for the user

Esomeprazolo EG STADA 20 mg gastro-resistant tablets

Esomeprazolo EG STADA 40 mg gastro-resistant tablets
Esomeprazole
Equivalent medicine
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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esomeprazole EG STADA is and what it is used for

Esomeprazole EG STADA contains a medicine called esomeprazole. This belongs to a group of medicines known as 'proton pump inhibitors', which work by reducing the amount of acid produced by your stomach.
Esomeprazole EG STADA is used to treat the following conditions:
Adults and adolescents from the age of 12 years

Gastro-oesophageal reflux disease (GORD). This condition occurs when acid leaks out of the stomach and 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 infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and help heal the ulcer.

Adults

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

2. What you need to know before taking Esomeprazole EG STADA

Do not take Esomeprazole EG STADA

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 for the treatment of HIV).

Do not take Esomeprazole EG STADA if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Esomeprazole EG STADA.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole EG STADA:

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 EG STADA that reduces stomach acid;
if you need to undergo a specific blood test (chromogranin A).

If you develop 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 EG STADA.
Remember to also report any other side effects such as joint pain.
Esomeprazole EG STADA may mask symptoms of other diseases. Therefore, if you experience any of the
following events before or while taking Esomeprazole EG STADA, contact your doctor immediately:

you lose weight significantly without reason and have difficulty swallowing;
you have stomach pain or indigestion;
you start vomiting food or blood;
you pass black stools (stools containing blood). If Esomeprazole EG STADA has been prescribed "on demand", you should contact your doctor if symptoms persist or change in nature.

Taking a proton pump inhibitor such as Esomeprazole EG STADA, especially for more than one year, may slightly increase the risk of wrist, hip, or spine fractures. Inform your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
Other medicines and Esomeprazole EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Esomeprazole EG STADA can affect how some medicines work, and conversely, some medicines may affect the action of Esomeprazole EG STADA.
Do not take Esomeprazole EG STADA if you are taking a medicine containing nelfinavir (used for the treatment of HIV).
Inform your doctor or pharmacist if you are taking one or more of the following medicines:

Atazanavir (used for the treatment of HIV).
Clopidogrel (used to prevent blood clots).
Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
Erlotinib (used for cancer treatment).
Citalopram, imipramine, or clomipramine (used for the treatment of depression).
Diazepam (used for anxiety, muscle relaxation, or in epilepsy).
Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you closely at the beginning and end of treatment with Esomeprazole EG STADA.
Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you closely at the beginning and end of treatment with Esomeprazole EG STADA.
Cilostazol (used for the treatment of intermittent claudication – leg pain when walking due to inadequate blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a chemotherapy medicine used at high doses for cancer treatment) – if you are taking a high dose of methotrexate, your doctor may decide to temporarily stop your treatment with Esomeprazole EG STADA.
Tacrolimus (used in organ transplantation).
Rifampicin (used for the treatment of tuberculosis).
St. John’s wort (Hypericum perforatum) (used for the treatment of depression). If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Esomeprazole EG STADA for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.

Esomeprazole EG STADA with food and drinks
You may take the tablets with food or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Esomeprazole EG STADA during this time.
It is not known whether Esomeprazole EG STADA is excreted in breast milk. Therefore, you should not take Esomeprazole EG STADA during breastfeeding.
Driving and using machines
It is unlikely that Esomeprazole EG STADA will affect your ability to drive or operate machinery.
Esomeprazole EG STADA contains sucrose and sodium
This medicine contains sucrose, which is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Esomeprazole EG STADA

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

Esomeprazole EG STADA gastro-resistant tablets are not recommended for children under 12 years of age.
If you are taking the 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 instructed you to take the medicine as and when needed, inform your doctor if your symptoms change.

Taking this medicine

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

What to do if you have difficulty swallowing the tablets

If you have trouble swallowing the tablets:
Place them in a glass of plain water (not carbonated). Do not use any other liquid.
Stir until the tablets dissolve (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking.
To make sure you have taken all the medicine, rinse the glass thoroughly 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, the tablet can be mixed with water and the mixture administered via a syringe. It can then be given through a tube directly into the stomach ('gastric tube').

How much 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 your liver function.
The usual doses are indicated below.

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

Adults and children from 12 years of age:
If your doctor has found that your digestive tract (oesophagus) has been slightly damaged, the usual dose is one tablet of Esomeprazole EG STADA 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.
Once your oesophagus has healed, the usual dose is one tablet of Esomeprazole EG STADA 20 mg once daily.
If your oesophagus has not been damaged, the usual dose is one tablet of Esomeprazole EG STADA 20 mg daily. Once the condition is under control, your doctor may instruct you to take the medicine as and when needed, up to a maximum of one tablet of Esomeprazole EG STADA 20 mg daily.
If you have severe liver problems, your doctor may prescribe a lower dose.

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

Adults and adolescents from 12 years of age: the usual dose is one tablet of Esomeprazole EG STADA 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, for example, amoxicillin and clarithromycin.

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

Adults from 18 years of age: the usual dose is one tablet of Esomeprazole EG STADA 20 mg once daily for 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
Adults from 18 years of age: the usual dose is one tablet of Esomeprazole EG STADA 20 mg once daily.

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

Adults from 18 years of age: the usual dose is one tablet of Esomeprazole EG STADA 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.

For long-term treatment following prevention of recurrent bleeding from ulcers with intravenous esomeprazole:

Adults from 18 years of age: the usual dose is one tablet of Esomeprazole EG STADA 40 mg once daily for 4 weeks.

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

If you forget to take Esomeprazole EG STADA

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 everybody gets them.
If you experience any of the following serious side effects, stop taking Esomeprazole EG STADA and contact a doctor immediately:

Sudden breathlessness, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
Skin redness with blistering or peeling. There may be blisters and bleeding also on the lips, eyes, mouth, nose and genitals. This could be 'Stevens-Johnson syndrome' or 'toxic epidermal necrolysis'.
Yellowing of the skin, dark-coloured urine and tiredness, which may be symptoms of liver problems. These effects are rare (may 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, gas (flatulence).
Benign polyps in the stomach.
Feeling unwell (nausea) or being unwell (vomiting).

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Sleep disorders (insomnia).
Dizziness, tingling sensations like “pins and needles”, drowsiness.
Feeling of spinning (vertigo).
Dry mouth.
Changes in blood test values used to assess liver function.
Skin rash, hives (urticaria) and itching.
Fracture of the hip, wrist or spine (if Esomeprazole EG STADA is used at high doses and for a long duration).
Rare (may affect up to 1 in 1,000 people)
Blood disorders, such as a reduction in the number of white blood cells or platelets. This may cause weakness, bruising or make infections more likely.
Low sodium levels in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
Feeling agitated, confused or depressed.
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” which may affect the oesophagus.
Liver problems, including jaundice which may cause yellowing of the skin, dark-coloured urine and tiredness.
Hair loss (alopecia).
Skin redness following exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
Feeling generally unwell and lacking energy.
Increased sweating.

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

Changes in the number of blood cells including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not real (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.

Esomeprazole EG STADA may, in very rare cases, affect white blood cells causing immunodeficiency.
If you have an infection with symptoms such as fever with a severely reduced general condition or fever with signs of a local infection such as neck, throat or mouth pain or difficulty urinating, you must consult a doctor as soon as possible so that a blood test can rule out a lack of white blood cells (agranulocytosis). It is important that you provide information about this medicine at this time.
Not known (frequency cannot be estimated from the available data)

Inflammation of the intestine (leading to diarrhoea).
Erythema, possible joint pain.

If you have been treated with Esomeprazole EG STADA for more than three months, a decrease in blood magnesium levels may occur. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate. If you have 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 monitor your blood magnesium levels through regular blood tests.
The list of side effects should not worry you. 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, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website: 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 EG STADA

Keep this medicine out of the sight and reach of children. Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the carton or blister after Exp. The expiry date refers to the last day of that month.
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 EG STADA contains

The active substance is esomeprazole magnesium dihydrate. One tablet of Esomeprazolo EG STADA 20 mg contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate). One tablet of Esomeprazolo EG STADA 40 mg contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate).
The other components are:

Tablet core
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, talc, triethyl citrate, hypromellose,
sugar spheres, magnesium stearate, hydroxypropyl cellulose, glycerol monostearate 40-55, polysorbate
80, microcrystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearyl fumarate.
Tablet coating
Hypromellose, titanium dioxide (E171), macrogol/PEG 400, iron oxide red (E172), iron oxide yellow (E172).

Description of the appearance of Esomeprazolo EG STADA and pack sizes

The Esomeprazolo EG STADA 20 mg tablets are light pink, elliptical, biconvex, film-coated tablets, 6.55 x 13.6 mm.
The Esomeprazolo EG STADA 40 mg tablets are pink, elliptical, biconvex, film-coated tablets, 8.2 x 17 mm.
Tablets are available in the following pack sizes: Pack sizes: Blister packs: 14, 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy

Manufacturers
Actavis ehf.
Reykjavíkurvegur 76-78
IS -220 Hafnarfjörður
Iceland
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitza 2600
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Esomeprazolo EG STADA