Esomeprazole Pharmacare: detailed information

Package leaflet: Information for the user

Esomeprazole Pharmacare 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

Esomeprazole
Generic medicine
Please 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, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What is in this leaflet:

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

1. What Esomeprazole Pharmacare is and what it is used for

Esomeprazole Pharmacare 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 the stomach.
Esomeprazole Pharmacare is used to treat the following conditions:
Adults and adolescents from the age of 12
"Gastroesophageal reflux disease" (GERD). In this condition, acid from the stomach 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) associated with infection 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.
Adults

Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole Pharmacare may also be used to prevent the development of stomach ulcers if you are taking NSAIDs.
Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment to prevent re-bleeding of ulcers after initial prevention with intravenous esomeprazole.

2. What you need to know before taking Esomeprazole Pharmacare

Do not take Esomeprazole Pharmacare

if you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6); 1/8
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).

Do not take Esomeprazole Pharmacare if any of the above conditions apply to you. If you have any doubts,
consult your doctor, pharmacist, or nurse before taking Esomeprazole Pharmacare.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole Pharmacare:

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 Pharmacare that reduces stomach acid
if you are due to undergo a specific blood test (Chromogranin A).

Esomeprazole Pharmacare may mask symptoms of other diseases. Therefore, if you experience any of the
following conditions before or during treatment with Esomeprazole Pharmacare, contact your doctor
immediately:

if you have significant and unintentional weight loss and difficulty swallowing
if you have stomach pain or indigestion
if you start vomiting food or blood
if your stools are dark in colour (blood-stained stools).

If Esomeprazole Pharmacare has been prescribed for you “as needed”, you should contact your doctor if symptoms
persist or if you notice any changes.
Taking a proton pump inhibitor such as Esomeprazole Pharmacare, especially if treatment lasts longer 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 develop 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 Pharmacare. Also remember to report any other
side effects, such as joint pain.
Serious skin rashes have occurred in patients taking esomeprazole (see also 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
and may be associated with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin symptoms,
stop taking this medicine and contact your doctor immediately.
Other medicines and Esomeprazole Pharmacare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This
is because Esomeprazole Pharmacare may affect how some medicines work, and conversely, some medicines may
affect Esomeprazole Pharmacare.
Do not take Esomeprazole Pharmacare 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). 2/8
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 Pharmacare.
medicines used to thin the blood, such as warfarin. Your doctor may decide to monitor you when starting or stopping treatment with Esomeprazole Pharmacare.
cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply).
cisapride (used for indigestion and heartburn).
digoxin (used for heart problems).
methotrexate (a medicine used in high-dose chemotherapy for cancer treatment) – if you are taking a high dose of methotrexate, your doctor may temporarily stop treatment with Esomeprazole Pharmacare.
tacrolimus (used in organ transplantation).
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 together with Esomeprazole
Pharmacare to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform
your doctor about any other medicines you are taking.
Esomeprazole Pharmacare with food and drink
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,
ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take Esomeprazole Pharmacare during this time.
It is not known whether Esomeprazole Pharmacare passes into breast milk. Therefore, you should not take
Esomeprazole Pharmacare if you are breastfeeding.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines. However, uncommon or
rare adverse reactions such as dizziness and blurred vision may occur (see section 4). If these occur, do not
drive or operate machinery.
Esomeprazole Pharmacare contains sucrose
Esomeprazole Pharmacare gastro-resistant tablets contain sucrose, a type of sugar. If your doctor has diagnosed
you with an intolerance to certain sugars, contact him or her before taking this medicine.
Esomeprazole Pharmacare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Esomeprazole Pharmacare

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

Esomeprazole Pharmacare gastro-resistant tablets are 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 to take 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 protect 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 difficulty swallowing the tablets:
Place them in a glass of plain (non-carbonated) water. Do not use any other liquid.
Stir until the tablet dissolves (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking.
To ensure you have taken all the medicine, rinse the glass thoroughly by filling it halfway with water and drink it. The solid particles contain the medicine – do not chew or crush them.
If you are unable to swallow the tablet at all, it may be mixed with water and administered via a syringe. It can then be delivered through a tube directly into the stomach (“gastric tube”).

How much Esomeprazole Pharmacare 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 listed 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 observed that your oesophagus has been mildly damaged, the usual dose is one 40 mg Esomeprazole Pharmacare tablet once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your oesophagus has not yet healed.
The usual dose once your oesophagus has healed is one 20 mg Esomeprazole Pharmacare tablet per day.
If your oesophagus has not been damaged, the usual dose is one 20 mg Esomeprazole Pharmacare tablet per day. Once your condition is under control, your doctor may instruct you to take the medicine as needed, up to a maximum of one 20 mg Esomeprazole Pharmacare tablet per day.
If you have severe liver problems, your doctor may prescribe a lower dose.

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

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

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

Adults from 18 years of age: the usual dose is one 20 mg Esomeprazole Pharmacare tablet once daily for 4–8 weeks.

For the prevention of gastric ulcers during NSAID (Non-Steroidal Anti-Inflammatory Drug) treatment:

Adults from 18 years of age: the usual dose is one 20 mg Esomeprazole Pharmacare tablet once daily.

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

Adults from 18 years of age: the usual dose is one 40 mg Esomeprazole Pharmacare tablet twice daily.
Your doctor will adjust the dose according to your needs and will also decide how long you should continue treatment. The maximum dose is 80 mg twice daily.

For long-term treatment of recurrent bleeding ulcers after initial intravenous esomeprazole therapy:

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

If you take more Esomeprazole Pharmacare than you should
If you take more Esomeprazole Pharmacare than prescribed by your doctor, inform your doctor or pharmacist immediately.
If you forget to take Esomeprazole Pharmacare

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, this medicine can cause side effects, although not everybody will get them.
If you notice any of the following serious side effects, stop taking Esomeprazole Pharmacare and contact your doctor immediately:

Yellowing of the skin, dark-coloured urine, and tiredness, which may be symptoms of liver problems. Sudden breathlessness, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction);
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling. These may occur even after several weeks of treatment. You may also notice blisters and severe bleeding on the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and surface mucous membranes), which may be life-threatening. This could be “Erythema multiforme”, “Stevens-Johnson Syndrome” or “toxic epidermal necrolysis” or “drug reaction with eosinophilia and systemic symptoms (DRESS)”.
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).
Nausea or vomiting.
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Sleep disturbance (insomnia).
Dizziness, tingling sensations with “pins and needles”, drowsiness.
Dizziness. 5/8
Dry mouth.
Changes in blood test results used to monitor liver function.
Skin rash, nodular skin rash (urticaria), and itchy skin.
Fracture of the hip, wrist, or spine (if Esomeprazole Pharmacare is used at high doses and for long periods).

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

Changes in blood composition, such as reduced numbers 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.
Feeling restless, confused, or depressed.
Altered taste.
Vision problems, such as blurred vision.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
An infection called “candidiasis”, which may affect the intestine and is caused by a fungus.
Liver problems, including jaundice, which may cause yellowing of the skin, dark-coloured urine, and tiredness.
Hair loss (alopecia).
Skin rash after 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, hearing, or feeling things that do not exist (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of a severe skin rash with blisters or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

Inflammation of the intestine (which leads to diarrhoea).
If you take Esomeprazole Pharmacare for more than three months, your blood magnesium levels may fall. Low magnesium levels may cause symptoms such as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, and 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.
Skin rash, possible joint pain.

Esomeprazole Pharmacare may, in very rare cases, affect white blood cells, causing immunodeficiency.
If you develop an infection with symptoms such as fever, severely compromised general condition, or
fever with signs of a local infection such as neck, throat or mouth pain, or difficulty urinating, you must
consult your doctor as soon as possible to rule out a deficiency of white blood cells
(agranulocytosis) by performing a blood test. It is important that you inform your doctor about all
medicines you are taking.
Do not be alarmed by the list of possible side effects listed above. You may not experience any of them.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your
doctor or pharmacist.
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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 Pharmacare

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 stated on the carton or blister pack after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of this 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 Pharmacare contains

The active substance is esomeprazole magnesium dihydrate. One tablet of Esomeprazolo Pharmacare 20 mg contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate). One tablet of Esomeprazolo Pharmacare 40 mg contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate).
The other components are: Microgranules: 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. Tablet core: microcrystalline cellulose, povidone, macrogol, crospovidone, sodium stearyl fumarate. Tablet coating: hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172), iron oxide yellow (E172).

Description of the appearance of Esomeprazolo Pharmacare and package contents

Esomeprazolo Pharmacare 20 mg tablets are light pink, elliptical, biconvex, film-coated tablets, 6.55 x 13.6 mm.
Esomeprazolo Pharmacare 40 mg tablets are pink, elliptical, biconvex, film-coated tablets, 8.2 x 17 mm.
The tablets are available in packages of:

Packaging:
Tablets are available in blister packs containing 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
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Pharmacare Srl
Via Marghera 29
20149 Milano
Italy

Manufacturer
BALKANPHARMA DUPNITSA AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Esomeprazolo Pharmacare
Denmark: Esomeprazole Pharmacare
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