Esomeprazole Aurobindo Pharma: detailed information

Package leaflet: Information for the user

Esomeprazole Aristo 20 mg gastro-resistant hard capsules

Esomeprazole Aristo 40 mg gastro-resistant hard capsules
Esomeprazole
Generic medicine

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. Never give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Contents of this leaflet

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

1. What Esomeprazolo Aristo is and what it is used for

Esomeprazolo Aristo contains a medicine called esomeprazole, which belongs to a group of
medicines called "proton pump inhibitors". These medicines work by reducing the amount
of acid produced by the stomach.
Esomeprazolo Aristo is used to treat the following conditions:
Adults and adolescents aged 12 years and older

"Gastro-oesophageal reflux disease" (GERD). In this condition, acid moves from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper digestive tract (intestinal) ulcers infected with bacteria called "Helicobacter pylori". If you have this condition, your doctor may 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). Esomeprazolo Aristo 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 ulcer bleeding with intravenous esomeprazole.

2. What you need to know before taking Esomeprazole Aristo

Do not take Esomeprazole Aristo

if you are allergic to esomeprazole or to any of the excipients of Esomeprazole Aristo (listed in section 6)
if you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole)
if you are taking a medicine containing nelfinavir (used for the treatment of HIV).

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

if you have severe liver problems
if you have severe kidney problems.

Esomeprazole Aristo may mask symptoms of other diseases. Therefore, if you experience any of the
following while before or during treatment with Esomeprazole Aristo, 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 in colour (blood in stools).

Taking a proton pump inhibitor such as Esomeprazole Aristo, especially for treatment periods longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
If your doctor has prescribed Esomeprazole Aristo “as needed”, you must contact your doctor if symptoms persist or if you notice any changes.
Taking Esomeprazole Aristo with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. Indeed, Esomeprazole Aristo may affect how certain medicines work, and some medicines may affect Esomeprazole Aristo.
Do not take Esomeprazole Aristo if you are taking a medicine containing nelfinavir (used for the treatment of HIV).
Inform your doctor if you are taking any of the following medicines:

Atazanavir (used for the treatment of HIV)
Ketoconazole, itraconazole or voriconazole (used for the treatment of fungal infections)
Citalopram, imipramine or clomipramine (used for the treatment of depression)
Diazepam (used for the treatment of anxiety, for muscle relaxation, 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 Aristo.
Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with Esomeprazole Aristo.
Cisapride (used for indigestion and heartburn)
Clopidogrel (used to prevent blood clots)
Digoxin (used for heart problems)
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
Aristo to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.
Taking Esomeprazole Aristo with food, drinks and alcohol
See section 3 for instructions on how to take Esomeprazole Aristo.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Esomeprazole Aristo passes into breast milk. Therefore, you must not take Esomeprazole Aristo if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazole Aristo will affect your ability to drive or operate tools or machinery.

3. How to take Esomeprazole Aristo

Always take Esomeprazole Aristo exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Esomeprazole Aristo capsules 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 and when needed, inform your doctor if your symptoms change.

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. The capsules contain 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:
o Open the capsule and empty the contents into a glass of plain (non-carbonated) water. Do not use any other liquids.
o Stir and drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking.
o To ensure you have taken all the medicine, rinse the glass with half a glass of water, stir, and drink.
The solid particles contain the medicine – do not chew or crush them.

How much Esomeprazole Aristo 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 your liver function.
The usual doses are listed below.

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

If your doctor has found that your oesophagus has been mildly damaged, the usual dose is one 40 mg Esomeprazole Aristo capsule 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 gastro-resistant 20 mg Esomeprazole Aristo capsule per day.
If your oesophagus has not been damaged, the usual dose is one gastro-resistant 20 mg Esomeprazole Aristo capsule per day. Once your condition is under control, your doctor may instruct you to take the medicine as and when needed, up to a maximum dose of one 20 mg Esomeprazole Aristo capsule 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 to prevent them from recurring

Adults aged 12 years and older: the usual dose is one gastro-resistant Esomeprazole Aristo 20 mg capsule 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 gastro-resistant Esomeprazole Aristo 20 mg capsule once daily for 4–8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

Adults aged 18 years and older: the usual dose is one gastro-resistant Esomeprazole Aristo 20 mg capsule 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 gastro-resistant Esomeprazole Aristo 40 mg capsule 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

Adults aged 18 years and older: the usual dose is one gastro-resistant Esomeprazole Aristo 40 mg capsule once daily for 4 weeks.

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

If you forget to take Esomeprazole Aristo

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.

For further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

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

Sudden breathlessness, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction)
Skin redness with blistering or peeling. There may be blisters and severe 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 and affect fewer than 1 in 1,000 patients.

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

Headache
Stomach or bowel effects: diarrhoea, stomach pain, constipation, gas (flatulence)
Nausea or vomiting

Uncommon (may affect up to 1 in 100 people)

Swelling of feet and ankles
Sleep disturbances (insomnia)
Dizziness, tingling sensations with “pins and needles”, drowsiness
Vertigo
Dry mouth
Changes in blood test results used to check liver function
Skin rash, urticaria and itching
Fracture of the hip, wrist or spine

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

Blood problems, such as a reduction in the 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
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 yellow skin, dark-coloured urine and tiredness
Hair loss (alopecia)
Skin redness 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, feeling or hearing things that are not real (hallucinations)
Severe liver problems leading to liver failure and brain inflammation
Sudden onset of severe redness, 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

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

If you take Esomeprazolo Aristo for more than three months, it is possible that your blood magnesium levels may decrease. This reduction in magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, 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 carry out regular blood tests to monitor your magnesium levels.

Esomeprazolo Aristo may, in very rare cases, affect white blood cells causing
immunodeficiency. If you develop an infection with symptoms such as fever, with severe worsening
of your general health, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that you inform your doctor about any medicines you are taking.
If you notice any side effect, even if not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole Aristo

Keep out of the reach and sight of children.
Do not store above 25 °C.
Store the bottle tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the packaging after the word “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 Aristo contains
The active substance is esomeprazole. Esomeprazolo Aristo gastro-resistant capsules are available in two strengths containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate).
The excipients are:
Contents of the capsules
Microgranules: carrageenan; microcrystalline cellulose; mannitol; sodium hydroxide; sodium hydrogen carbonate
Isolating coating: polyvinyl alcohol-PEG copolymer; sodium hydroxide; talc; titanium dioxide (E171); hydrated colloidal silica
Gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer (1:1); triethyl citrate; talc; titanium dioxide (E171)
Capsule
Esomeprazolo Aristo 20 mg gastro-resistant capsules:
Cap: gelatin; titanium dioxide (E171); yellow iron oxide (E172)
Body: gelatin; titanium dioxide (E171)
Esomeprazolo Aristo 40 mg gastro-resistant capsules:
Cap: gelatin; red iron oxide (E172); titanium dioxide (E171); yellow iron oxide (E172)
Body: gelatin; titanium dioxide (E171)

Appearance of Esomeprazolo Aristo and contents of the pack
Esomeprazolo Aristo 20 mg gastro-resistant capsules:
Gastro-resistant hard capsules with an opaque white printed body and an opaque yellow printed cap, containing white to almost white gastro-resistant granules.
Esomeprazolo Aristo 40 mg gastro-resistant capsules:
Gastro-resistant hard capsules with an opaque white printed body and an opaque light orange printed cap, containing white to almost white gastro-resistant granules.
The capsules are available in HDPE plastic bottles with a desiccant cap contained in PP or in aluminum/aluminum blisters. Do not swallow the desiccant capsule.
Pack sizes:
14, 15, 28, 30, 50, 60, 90 and 100 capsules
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer
Medinsa (Laboratorios Medicamentos Internacionales S.A.)
c/ Solana, 26
28850 Torrejón de Ardoz (Madrid)
Spain

This medicinal product is authorized in the EEA (European Economic Area) Member States under the following names:
Germany Ulcerex
Austria Esomeprazol Aristo
Belgium Ulcerex
Denmark Ulcerex
Spain Esomeprazol Medinsa
Finland Ulcerex
Ireland Esomeprazole Aristo
Italy Esomeprazolo Aristo
Netherlands Esomeprazol Aristo
Sweden Ulcerex
United Kingdom Esomeprazole

Date of the latest approval of this package leaflet