Esomeprazole Almus Pharma

Package leaflet: Information for the user

Esomeprazolo Almus Pharma 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Equivalent medicine
Please read all of this leaflet carefully before you take 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 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.

Contents of this leaflet:

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

1. What Esomeprazolo Almus Pharma is and what it is used for

Esomeprazolo Almus Pharma 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.
Esomeprazolo Almus Pharma is used to treat the following conditions:
Adults and adolescents aged 12 years and above

• 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 or upper digestive tract (intestinal) ulcers infected with 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). Esomeprazolo Almus Pharma may also be used to prevent stomach ulcers if you are taking NSAIDs.
• Excess acid production due to a growth in the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment following prevention of re-bleeding from ulcers with intravenous esomeprazole.

2. What you need to know before taking Esomeprazolo Almus Pharma

Do not take Esomeprazolo Almus Pharma

• 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 (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV). Do not take Esomeprazolo Almus Pharma if any of these apply to you. If you are unsure, consult your doctor or pharmacist before taking Esomeprazolo Almus Pharma.

Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazolo Almus Pharma:

• 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 Esomeprazolo Almus Pharma that reduces stomach acid.
• If you need to undergo a specific blood test (chromogranin A).

Skin rashes and skin reactions
If you notice 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 Esomeprazolo Almus Pharma. Remember to also report any other side effects such as joint pain.
Severe 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, swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, and muscle pain. The rash may cover large areas of the body, 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.
Esomeprazolo Almus Pharma may mask symptoms of other diseases. Therefore, if you experience any of the
following events before or while taking Esomeprazolo Almus Pharma, 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 in colour (blood in stools).

If Esomeprazolo Almus Pharma has been prescribed for you to take “as needed”, contact your doctor if symptoms persist or if the nature of your symptoms changes.
If you take a proton pump inhibitor such as Esomeprazolo Almus Pharma, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Other medicines and Esomeprazolo Almus Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Esomeprazolo Almus Pharma may affect how other medicines work, and other medicines may affect Esomeprazolo Almus Pharma.
Do not take Esomeprazolo Almus Pharma capsules if you are taking a medicine containing nelfinavir (used to treat HIV).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• atazanavir (used to treat HIV)
• clopidogrel (used to prevent blood clots)
• ketoconazole, itraconazolo, 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 Esomeprazolo Almus Pharma
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping Esomeprazolo Almus Pharma
• cilostazol (used to treat intermittent claudication—a leg pain when walking caused by insufficient blood supply)
• cisapride (used for indigestion and heartburn)
• digoxin (used for heart problems)
• tacrolimus (used after organ transplantation)
• methotrexate (a chemotherapy medicine used at high doses to treat cancer)—if you are taking a high dose of methotrexate, your doctor may temporarily stop treatment with Esomeprazolo Almus Pharma
• rifampicin (an antibiotic used to treat tuberculosis)
• St John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression). If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Esomeprazolo Almus Pharma to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking other medicines.

Esomeprazolo Almus Pharma with food and drinks
You may take the capsules with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might 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 Esomeprazolo Almus Pharma during this time.
It is not known whether Esomeprazolo Almus Pharma passes into breast milk. Therefore, you should not take Esomeprazolo Almus Pharma while breastfeeding.
Driving and using machines
It is unlikely that Esomeprazolo Almus Pharma will affect your ability to drive or use tools or machines. However, adverse reactions such as dizziness and blurred vision may occur with uncommon or rare frequency (see section 4). If you experience such symptoms, do not drive or operate machinery.
Esomeprazolo Almus Pharma contains sucrose, which is a type of sugar.
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Esomeprazolo Almus Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Esomeprazole Almus Pharma

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

• Esomeprazole Almus Pharma gastro-resistant 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 (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 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. This is because the capsules contain 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: 1) open the capsule and empty the granules into half a glass of still (non-fizzy) water. Do not use any other liquid. 2) Stir and then drink the mixture immediately or within 30 minutes. Always stir the mixture just before drinking. 3) To ensure 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 anything, the granules can be mixed with a small amount of water and administered via a syringe. They can then be delivered directly into the stomach through a tube (‘gastric feeding tube’).

How much Esomeprazole Almus Pharma 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 listed below.

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

• If your doctor has diagnosed that your oesophagus has been mildly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Almus Pharma 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.
• The recommended dose once the oesophagus has healed is one gastro-resistant capsule of Esomeprazole Almus Pharma 20 mg once daily.
• If your oesophagus has not been damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Almus Pharma 20 mg per day. 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 Almus Pharma 20 mg 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 aged 12 years and older: the recommended dose is one gastro-resistant capsule of Esomeprazole Almus Pharma 20 mg 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 aged 18 years and older: the recommended dose is one gastro-resistant capsule of Esomeprazole Almus Pharma 20 mg 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 recommended dose is one gastro-resistant capsule of Esomeprazole Almus Pharma 20 mg 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 recommended dose is one gastro-resistant capsule of Esomeprazole Almus Pharma 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.

For long-term treatment following prevention of re-bleeding of ulcers with intravenous esomeprazole.

• Adults aged 18 years and older: the recommended dose is one capsule of Esomeprazole Almus Pharma 40 mg once daily for 4 weeks.

Elderly
No dose adjustment is necessary in elderly patients.
If you take more Esomeprazole Almus Pharma than you should
If you take more Esomeprazole Almus Pharma than prescribed by your doctor, speak to your
doctor or pharmacist immediately.
If you forget to take Esomeprazole Almus Pharma

• 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 further doubts 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 will experience them.
If you notice any of the following serious side effects, stop treatment with Esomeprazolo Almus Pharma and contact your doctor immediately:

• 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 breathlessness, swelling of the lips, tongue or throat, or body rash, fainting or difficulty swallowing (severe allergic reaction). These side effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of a severe skin rash or redness of the skin with blistering or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding may also appear in the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to serious widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. These side effects are rare and may affect up to 1 in 10,000 people.

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

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

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 dizziness.
• Dry mouth.
• Changes in blood test results used to monitor liver function.
• Skin rash, hives, and itching.
• Fractures of the hip, wrist, or spine (if Esomeprazolo Almus Pharma is used at high doses and for a long time).

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

• Blood problems, such as a decrease 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 restless, confusion, or depression.
• Taste disturbances.
• Vision problems such as blurred vision.
• Sudden feeling of breathlessness or shortness of breath (bronchospasm).
• Inflammation inside the mouth.
• An infection called “candidiasis” affecting the intestine, caused by a fungus.
• 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).
• General feeling of being unwell and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of a severe skin rash, blisters, or skin peeling. 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.

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

• If you take Esomeprazolo Almus Pharma 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 levels of potassium or calcium in the blood. Your doctor may decide to monitor your blood magnesium levels periodically.
• Inflammation of the intestine, which may cause diarrhoea.
• Erythema, possible joint pain.

In very rare cases, Esomeprazolo Almus Pharma may affect white blood cells, causing immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severely compromised general condition, or fever with signs of a local infection such as neck, throat or mouth pain, or difficulty urinating, contact your doctor as soon as possible to rule out a deficiency in white blood cells (agranulocytosis) through blood tests. At this stage, it is important that you inform your doctor about your treatment.

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 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 Almus Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Usable period after first opening of the bottle: 200 days.
Do not dispose of medicines 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 Almus Pharma contains

• The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg or 40 mg of esomeprazole (as sodium salt).

The excipients are:
Contents of the capsule:
Sugar spheres (sucrose and maize starch), methylcellulose, talc, titanium dioxide (E171), glycerol monostearate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing sodium lauryl sulfate, polysorbate 80 and methacrylic acid-ethyl acrylate copolymer), triethyl citrate, emulsion of glycerol monostearate, triethyl citrate and 20% polysorbate 80.
Capsule shell:
Carrageenan, potassium chloride, titanium dioxide (E171), red iron oxide (E172), hypromellose, ink (containing: lacquer, potassium hydroxide and black iron oxide (E172)).

Description of the appearance of Esomeprazolo Almus Pharma and contents of the pack
Esomeprazolo Almus Pharma 20 mg: the body and cap of the 20 mg capsules are pale pink opaque, with "ES" printed on the cap and "20" on the body. The 20 mg capsules are size 4 and contain spherical granules.
Esomeprazolo Almus Pharma 40 mg: the body and cap of the 40 mg capsules are opaque pink, with "ES" printed on the cap and "40" on the body. The 40 mg capsules are size 2 and contain spherical granules.
Esomeprazolo Almus Pharma 20 mg is available in boxes of 14 and 28 capsules in aluminium blisters or in bottles of 14 capsules in plastic (HDPE).
Esomeprazolo Almus Pharma 40 mg is available in boxes of 14 and 28 capsules in aluminium blisters or in bottles of 14 capsules in plastic (HDPE).

Marketing Authorization Holder
Almus S.r.l. - Via Cesarea 11/10 - 16121 Genova, Italy

Responsible manufacturer for batch release
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain

The following information is intended exclusively for healthcare professionals:

Administration through gastric tube:

1. Open the capsule and place the granules into an appropriate syringe, then fill with approximately 25 ml of water and approximately 5 ml of air. In some tubes, to prevent blockage by the granules, dispersion in 50 ml of water may be required.
2. Immediately shake the syringe for about 2 minutes to ensure uniform distribution of the granules in the suspension.
3. Hold the syringe upright and check that the tip is not obstructed.
4. Attach the gastric tube to the syringe, maintaining the upright position described above.
5. Shake the syringe and, with the tip pointing downward, immediately inject 5–10 ml into the tube. After injection, invert the syringe position and shake it (the syringe must be held with the tip pointing upward to prevent blockage).
6. Turn the syringe with the tip downward 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 residual sediment from the syringe. For some tubes, 50 ml of water may be required.