Esomeprazole Sandoz

Package leaflet: Information for the patient

Esomeprazole Sandoz 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Equivalent medicine
Please read all of 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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Esomeprazole Sandoz is and what it is used for
2. What you need to know before taking Esomeprazole Sandoz
3. How to take Esomeprazole Sandoz
4. Possible side effects
5. How to store Esomeprazole Sandoz
6. Contents of the pack and other information

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

Esomeprazole Sandoz 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 your stomach.
Esomeprazole Sandoz is used to treat the following conditions:
Adults

• Gastro-oesophageal reflux disease (GORD). 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 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.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). This medicine can also be used to prevent stomach ulcers from developing 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.

Adolescents aged over 12 years

• Gastro-oesophageal reflux disease (GORD). 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 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.

2. What you need to know before taking Esomeprazole Sandoz

Do not take Esomeprazole Sandoz

• if you are allergic to esomeprazole or to any of the excipients of this medicine (listed in section 6).
• if you are allergic to other proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).
• if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Esomeprazole Sandoz or other related medicines.

Do not take Esomeprazole Sandoz if any of these apply to you. If you are in doubt, consult your doctor or pharmacist before taking Esomeprazole Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole Sandoz:

• if you have severe liver problems
• if you have severe kidney problems
• if you have been diagnosed with, or are at risk of developing, vitamin B12 deficiency
• if you are scheduled for a specific blood test (chromogranin A)
• if you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Sandoz that reduces gastric acidity.

Skin rash and skin symptoms
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 stop treatment with Esomeprazole Sandoz. Remember to also report any other adverse effects such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Esomeprazole Sandoz. Stop using Esomeprazole Sandoz and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Esomeprazole Sandoz may mask symptoms of other diseases. Therefore, if you experience any of the following events before or while taking Esomeprazole Sandoz, speak to 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 dark-coloured (blood in stools).

If Esomeprazole Sandoz has been prescribed “on demand”, contact your doctor if symptoms persist or change in nature.
If you take a proton pump inhibitor such as Esomeprazole Sandoz, 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 can increase the risk of osteoporosis), consult your doctor.
Children under 12 years of age
Esomeprazole Sandoz is not recommended in children under 12 years of age due to insufficient data.
Other medicines and Esomeprazole Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Esomeprazole Sandoz may affect how other medicines work, and other medicines may affect Esomeprazole Sandoz.
Do not take Esomeprazole Sandoz 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)
• clopidogrel (used to prevent blood clots)
• digoxin (used to treat various heart conditions)
• rifampicin (used to treat tuberculosis)
• St John’s wort (Hypericum perforatum) (used to treat depression)
• ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• erlotinib (used to treat certain types of 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 this medicine
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping treatment with this medicine
• cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply)
• cisapride (used for indigestion and heartburn)
• tacrolimus (used to prevent organ transplant rejection)
• methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily ask you to stop taking this medicine.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Esomeprazole Sandoz to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking other medicines.
Esomeprazole Sandoz with food and drink
You may take the capsules with or without food (see section 3).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Esomeprazole Sandoz during this time.
It is not known whether Esomeprazole Sandoz passes into breast milk. Therefore, you must not take Esomeprazole Sandoz if you are breastfeeding.
Driving and using machines
It is unlikely that this medicine affects your ability to drive or use tools or machines. However, adverse effects such as dizziness and blurred vision may uncommonly or rarely occur (see section 4). If affected, do not drive or operate machinery.
Esomeprazole Sandoz contains sodium and sucrose
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant hard capsule, i.e. essentially “sodium-free”.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Esomeprazole Sandoz

Take this medicine exactly as prescribed by your doctor. 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 your doctor if your symptoms change.

How much Esomeprazole Sandoz 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 recommended doses are given below.

Adults over 18 years of age
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed that your esophagus has been mildly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 40 mg once daily for 4 weeks. Your doctor may instruct you to take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once your esophagus has healed is one gastro-resistant capsule of Esomeprazole Sandoz 20 mg once daily.
• If your esophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 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 gastro-resistant capsule of Esomeprazole Sandoz 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:

• The recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 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):

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

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

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

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

• The recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 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 recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 40 mg once daily for 4 weeks.

Adolescents over 12 years of age
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed that your esophagus has been mildly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 40 mg once daily for 4 weeks. Your doctor may instruct you to take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once your esophagus has healed is one gastro-resistant capsule of Esomeprazole Sandoz 20 mg once daily.
• If your esophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 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:

• The recommended dose is one gastro-resistant capsule of Esomeprazole Sandoz 20 mg twice daily for one week.
• Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

How to take this medicine

• You may take your capsules at any time of day.
• You may take your capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated granules that prevent your 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 (non-carbonated) water. Do not use any other liquids.
  • 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 unable to swallow anything, the granules may be mixed with a small amount of water and administered via a syringe. They can then be delivered through a tube directly into the stomach (‘gastric tube’).

Children under 12 years of age
Esomeprazole Sandoz gastro-resistant capsules are not recommended for children under 12 years of age.
Elderly
No dose adjustment is necessary in the elderly.
If you take more Esomeprazole Sandoz than you should
If you take more Esomeprazole Sandoz than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take Esomeprazole Sandoz

• 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 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 notice any of the following serious side effects, stop taking this medicine and contact your doctor immediately:

• Sudden breathlessness, swelling of lips, tongue or throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Yellowing of the skin, dark-coloured urine and tiredness, which may be symptoms of liver problems.

These side effects are rare and may affect up to 1 in 1,000 people.

• Sudden onset of a severe skin rash or reddening of the skin with blistering or peeling may occur even after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. 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" or "toxic epidermal necrolysis". (These side effects are very rare and may affect up to 1 in 10,000 people).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.

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

• headache
• stomach or bowel problems: diarrhoea, stomach ache, constipation, bloating (flatulence)
• feeling unwell (nausea) or sickness (vomiting)
• benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• swelling of feet and ankles
• disturbed sleep (insomnia)
• dizziness, tingling sensations like “pins and needles”, drowsiness
• sensation of spinning (vertigo)
• dry mouth
• changes in blood test results used to monitor liver function
• skin rash, hives and itching
• fracture of the hip, wrist or spine (if this medicine is taken at high doses and 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
• Feeling of restlessness, confusion or depression
• Altered taste
• Vision problems such as blurred vision
• Sudden sensation 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 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 blood cell counts including agranulocytosis (lack of white blood cells)
• Aggressiveness
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver problems leading to liver failure and brain inflammation
• Muscle weakness
• Severe kidney problems
• Breast enlargement in men

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

• If you take this medicine for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, consult 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 periodically.
• Inflammation of the bowel (causing diarrhoea).
• Skin rash, possible joint pain.

This medicine may very rarely affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as fever with a severely compromised general condition, or fever with symptoms of a local infection such as neck, throat or mouth pain, or difficulty urinating, you must contact your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that you provide your doctor with all information regarding the medicines you are taking.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, bottle, and packaging after "Exp.". The expiry date refers to the last day of that month.
OPA/Alu/PE blister + desiccant film and Alu foil:
Store in the original packaging to protect the medicine from moisture.
OPA/Alu/PVC/Alu blister:
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
HDPE bottle:
Store in the original packaging to protect the medicine from moisture.
Storage conditions after first opening of the bottle:
Keep the bottle tightly closed to protect the medicine from moisture.
After first opening of the bottle, the medicine must be used within 6 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 Sandoz contains

• The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg of esomeprazole (as magnesium dihydrate). Each gastro-resistant hard capsule contains 40 mg of esomeprazole (as magnesium dihydrate).
• The excipients are sugar spheres (containing sucrose and maize starch), povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 6000 (E 1521), macrogol 3000 (E 1521), talc (E 553b), heavy magnesium carbonate, polysorbate 80 (E 433), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% in the granules of the capsules; gelatin, titanium dioxide (E 171), red iron oxide (E 172) in the capsule shell.

Description of the appearance of Esomeprazolo Sandoz and package contents
20 mg:
Gastro-resistant hard capsules, light pink in colour (body and cap), size no. 3, containing white to off-white coated granules.
40 mg:
Gastro-resistant hard capsules, pink in colour (body and cap), size no. 1, containing white to off-white coated granules.
The gastro-resistant hard capsules are packaged in blisters made of OPA/Alu/PE + desiccant film and Alu foil, or in OPA/Alu/PVC/Alu blisters, or packaged in HDPE bottles with PP closure containing desiccant, and placed in a cardboard carton. Do not ingest the desiccant capsule provided in the container.
Pack sizes:
Blister packs: 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 gastro-resistant hard capsules
Bottle: 98 gastro-resistant hard capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers
KRKA d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 – 39179 Barleben, Germany
Lek Pharmaceuticals d.d. – Verovskova 57 – 1526 Ljubljana, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for physicians or healthcare professionals

Administration via gastric tube

1. Open the capsule and empty the pellets into a suitable syringe, then fill the syringe with approximately 25 ml of water and about 5 ml of air. For some tubes, dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe to evenly distribute the pellets in the suspension.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the above position.
5. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be held with the tip pointing upwards to prevent blockage of the tip).
6. 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.
7. 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.