Esomeprazole Pensapharma: detailed information

Package leaflet: Information for the user

Esomeprazole Pensa Pharma 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:

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

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

Esomeprazolo Pensa Pharma contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by your stomach.
Esomeprazolo Pensa Pharma is used to treat the following conditions:
Adults:

“Gastroesophageal reflux disease” (GERD). This occurs when acid from the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers associated with infection by bacteria called “Helicobacter pylori”. In such cases, 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). Esomeprazolo Pensa Pharma may also be used to prevent the formation of stomach ulcers during treatment with NSAIDs.
Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment to prevent re-bleeding of ulcers, following initial prevention with intravenous esomeprazole.

Adolescents aged 12 years and older:

“Gastroesophageal reflux disease” (GERD). This occurs when acid from the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers associated with infection by bacteria called “Helicobacter pylori”. In such cases, your doctor may

prescribe antibiotics to treat the infection and allow the ulcer to heal.

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

Do not take Esomeprazolo Pensa 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 (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
if you are taking a medicine containing nelfinavir (used for the treatment of HIV).
if you have ever had a severe skin rash or skin peeling, or a rash with blisters and/or mouth ulcers after taking Esomeprazolo Pensa Pharma or other related medicines.

Do not take Esomeprazolo Pensa Pharma if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Esomeprazolo Pensa Pharma.

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazolo Pensa Pharma:

if you have severe liver problems;
if you have severe kidney problems;
if you are due to undergo a specific blood test (chromogranin A).

Esomeprazolo Pensa Pharma may mask symptoms of other diseases. Therefore, if any of the
following occur before starting or while taking Esomeprazolo Pensa Pharma, inform your
doctor immediately:

you lose weight significantly without reason or have difficulty swallowing;
you experience stomach pain or indigestion;
you start vomiting food or blood;
your stools become dark in colour (indicating blood in the stools).

If you have been prescribed Esomeprazolo Pensa Pharma “as needed”, contact your doctor if symptoms persist or change in nature.

If you are taking a proton pump inhibitor such as Esomeprazolo Pensa Pharma, 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 have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Skin rash and skin reactions

Severe skin reactions have been reported in association with treatment with Esomeprazolo Pensa Pharma, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using Esomeprazolo Pensa Pharma and seek immediate medical advice if you notice any of the symptoms related to these severe skin reactions described in section 4.

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 discontinue treatment with Esomeprazolo Pensa Pharma.

Remember to also report any other adverse 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 and swollen eyes). These severe skin reactions often begin with flu-like symptoms such as fever, headache, and muscle pain. The rash may spread over large areas of the body, with blistering and skin peeling. 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 Esomeprazolo Pensa Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Esomeprazolo Pensa Pharma may affect how some medicines work, and some medicines may affect Esomeprazolo Pensa Pharma.

Do not take Esomeprazolo Pensa Pharma if you are taking a medicine containing nelfinavir (used for the treatment of HIV).

Inform your doctor or pharmacist if you are taking any 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 the treatment of cancer)
Citalopram, imipramine or clomipramine (used for the treatment of depression)
Diazepam (used for anxiety, muscle relaxation or epilepsy)
Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Esomeprazolo Pensa Pharma
Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with Esomeprazolo Pensa Pharma
Cilostazol (used for the treatment of intermittent claudication – leg pain when walking caused by insufficient blood supply)
Cisapride (used for indigestion and heartburn)
Digoxin (used for heart problems)
Tacrolimus (used in organ transplants)
Methotrexate (a medicine used in high-dose chemotherapy for cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazolo Pensa Pharma
Rifampicin (used for the treatment of tuberculosis)
St. John’s Wort (Hypericum perforatum) (used for the treatment of depression)

If your doctor has prescribed antibiotics such as amoxicillin and clarithromycin together with Esomeprazolo Pensa Pharma for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Esomeprazolo Pensa Pharma with food and drink

The capsules can be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazolo Pensa Pharma during this time. It is not known whether Esomeprazolo Pensa Pharma passes into breast milk, therefore you should not take Esomeprazolo Pensa Pharma if you are breastfeeding.

Driving and using machines

It is unlikely that Esomeprazolo Pensa Pharma will affect your ability to drive or use machines. However, uncommon or rare adverse reactions such as dizziness and visual disturbances may occur (see section “Undesirable effects”). If you experience these, do not drive or operate machinery.

Esomeprazolo Pensa Pharma contains sucrose and sodium

Esomeprazolo Pensa Pharma contains sugar spheres which contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him or her before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Esomeprazole Pensa Pharma

Always take Esomeprazole Pensa Pharma exactly as directed 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 monitor you (especially if you have been taking the medicine for more than one year).
If your doctor has instructed you to take the medicine as needed, inform your doctor if your symptoms change.

How much medicine to take

Your doctor will inform you of the number of capsules to take and for how long. This depends on your condition, age and liver function.
The usual doses are listed below.

Use in adults aged 18 years and older:
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma 40 mg once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if your oesophagus has not healed.
After healing of the oesophagus, the recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma 20 mg once daily.
If your oesophagus is not damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma 20 mg daily. When symptoms are under control, your doctor may advise you to take the medicine as needed, up to a maximum of one gastro-resistant capsule of Esomeprazole Pensa Pharma 20 mg per day.
In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

Treatment of gastric ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma 20 mg once daily for 4 to 8 weeks.

Prevention of gastric ulcers in patients taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma once daily.

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

The recommended dose is Esomeprazole Pensa Pharma 40 mg twice daily.
Your doctor will adjust the dose according to your needs and will also decide how long treatment should continue. The maximum dose is 80 mg twice daily.

Long-term treatment to prevent re-bleeding of ulcers, following intravenous esomeprazole administration:
The recommended dose is one capsule of Esomeprazole Pensa Pharma 40 mg once daily for 4 weeks.
Use in adolescents aged 12 years and older:
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma 40 mg once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if your oesophagus has not healed.
After healing of the oesophagus, the recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma 20 mg once daily.
If your oesophagus is not damaged, the recommended dose is one gastro-resistant capsule of Esomeprazole Pensa Pharma 20 mg daily.
In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

How to take the medicine

You may take the capsules at any time of day.
You may take the capsules with or without food.
Swallow the capsules whole with a glass of water. Do not chew or crush the capsules, as they contain coated granules that protect the medicine from stomach acid. It is therefore important not to damage the granules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:
Carefully open the capsule into a glass of non-carbonated water and empty the contents (the granules). No other liquids should be used.
Stir the mixture. Drink immediately or within 30 minutes. Always stir 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 and must not be chewed or crushed.
If you are completely unable to swallow, the capsule contents may be mixed with a small amount of water, drawn into a syringe, and administered through a tube directly into the stomach (gastric tube).

Use in children under 12 years of age
Esomeprazole Pensa Pharma is not recommended in children under 12 years of age.
Elderly
Dose adjustment is not required in elderly patients.
If you take more Esomeprazole Pensa Pharma than you should
If you have taken more Esomeprazole Pensa Pharma than prescribed by your doctor, inform your doctor or pharmacist immediately.
If you forget to take Esomeprazole Pensa Pharma

If you forget to take a dose, take it as soon as you remember. 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, ask your doctor or pharmacist.

4. Possible side effects

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

Yellowing of the skin, dark urine, and fatigue may be symptoms of liver problems. These effects are rare, affecting fewer than 1 in 1,000 people.
Sudden shortness of breath, swelling of the lips, tongue, throat or body, rash, feeling faint or difficulty swallowing (severe allergic reaction). These effects are rare, affecting fewer than 1 in 1,000 people.
Sudden onset of a severe skin rash or reddening 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 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 effects are very rare, affecting fewer than 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.

These effects are rare, affecting fewer than 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, 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, drowsiness
Vertigo
Dry mouth
Changes in blood tests that monitor liver function
Skin rash, hives, and itching
Fractures of the hip, wrist, or spine (if Esomeprazolo Pensa Pharma is used at high doses and for prolonged periods)

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

Blood problems, such as a reduced number of white blood cells and platelets
This may cause weakness, bruising, or increased susceptibility to infections
Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps
Feeling restless, confused, or depressed
Taste disturbances
Vision problems, such as blurred vision
Sudden wheezing or shortness of breath (bronchospasm)
Inflammation inside the mouth
A fungal infection called "candidiasis" that may affect the intestine
Liver problems, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
Hair loss (alopecia)
Skin rash after exposure to sunlight
Joint pain (arthralgia) or muscle pain (myalgia)
General feeling of malaise and lack of strength
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 in the blood)
Aggression
Seeing, sensing, or hearing things that are not real (hallucinations)
Severe liver problems leading to liver failure and brain inflammation
Sudden onset of 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 available data):

If you take Esomeprazolo Pensa 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 should decide whether to periodically monitor your blood magnesium levels.
Inflammation of the intestine (which may lead to diarrhoea)
Rash, possibly with joint pain

Esomeprazolo Pensa Pharma, in very rare cases, may affect white blood cells,
leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe decline in general health, or fever with local infection signs such as neck, throat or mouth pain, or difficulty urinating, you must consult your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that you inform your doctor about all medicines you are taking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at
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 Pensa Pharma

Keep out of the sight and reach of children.
Do not use the tablets after the expiry date (EXP.) stated on the carton, bottle or blister pack. The expiry date refers to the last day of the month.
Blister: Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Bottle: Do not store above 30°C. Keep the container tightly closed to protect the medicine from moisture.
Bottle: Shelf life after first opening: 200 days
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Esomeprazolo Pensa Pharma contains

The active substance is esomeprazole. Esomeprazolo Pensa Pharma gastro-resistant hard capsules are available in 2 strengths containing 20 mg or 40 mg of esomeprazole (as sodium salt).
The excipients are: Capsule contents: Sugar spheres (containing maize starch and sucrose), methylcellulose, talc, titanium dioxide (E-171), glycerol monostearate, polysorbate-80, sodium lauryl sulfate, methacrylic acid-ethyl acrylate copolymer, and triethyl citrate.

Capsule shell:
Carrageenan, potassium chloride, iron oxide red (E-172), titanium dioxide (E-171),
hypromellose, ink (containing shellac, potassium hydroxide and iron oxide black (E-172)).

Description of the appearance of Esomeprazolo Pensa Pharma and contents of the pack
Esomeprazolo Pensa Pharma 20 mg hard capsules have a light pink opaque cap and body, are size 4 (approximately 14 mm) with "ES" printed on the cap and "20" on the body, and contain spherical granules.
Esomeprazolo Pensa Pharma 40 mg hard capsules have a pink opaque cap and body, are size 2 (approximately 18 mm) with "ES" printed on the cap and "40" on the body, and contain spherical granules.

Esomeprazolo Pensa Pharma is available in:
Aluminum/aluminum blisters:
14, 28, 30 and 56 capsules
White opaque polyethylene bottles containing desiccant packets (silica gel), with a polyethylene (PE) or polypropylene (PP) cap and a security seal.
14, 28, 90, 100 and 500 capsules (hospital pack)
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER

MARKETING AUTHORISATION HOLDER
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

MANUFACTURER
Towa Pharmaceutical Europe, S.L.
C/ de Sant Martì, 75-97,
08107 Martorelles – Barcelona
Spain

This medicinal product is authorised in the Member States of the European
Economic Area under the following names:
Germany Esomeprazol-Denk 20 mg magensaftresistente Hartkapseln
Esomeprazol-Denk 40 mg magensaftresistente Hartkapseln
Italy Esomeprazolo Pensa Pharma 20 mg gastro-resistant hard capsules
Esomeprazolo Pensa Pharma 40 mg gastro-resistant hard capsules

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The following information is intended for healthcare professionals only
Administration via gastric tube

Open the capsule and mix the intact pellets with 50 ml of water in a suitable syringe.
Disperse the granules by immediately shaking the syringe.
Hold the syringe upright and check that the tip is not blocked.
Attach the gastric tube to the syringe, maintaining the upright position described above.
Shake the syringe and position it with the tip 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 upward to prevent blockage).
Turn the syringe with the tip downward again and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
Fill the syringe with water and repeat step 5 if necessary to wash out any remaining residue from the syringe.