ESOMEPRAZOLO 20 mg Enteric-Coated Hard Capsules

Зміст інструкції

1. Esomeprazolo Almus Pharma 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules
   1. What is Esomeprazolo Almus Pharma 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. Package contents and other information

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

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Esomeprazolo Almus Pharma 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 for the treatment of the following conditions:
Adults and adolescents aged 12 years and over

• Gastro-oesophageal reflux disease (GERD). In this disease, acid from the stomach leaks back into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers of the stomach or the upper part of the digestive tract (intestine) that are infected by bacteria called " Helicobacter pylori". If you have this disease, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Ulcers of the stomach caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazolo Almus Pharma can also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment following prevention of re-bleeding of ulcers with esomeprazole intravenously.

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

Do not take Esomeprazolo Almus Pharma

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines that are proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used for the treatment of HIV). Do not take Esomeprazolo Almus Pharma if any of these apply to you. If you are unsure, ask 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 are going to have a specific blood test (Chromogranin A).

Skin rashes and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Esomeprazolo Almus Pharma. Remember to also report any other unwanted effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, muscle pain. The rash can cover large areas of the body with blister formation and skin peeling.
If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.
Esomeprazolo Almus Pharma may mask the symptoms of other diseases. Therefore, if any of the following events occur to you before taking Esomeprazolo Almus Pharma or while you are taking it, tell your doctor immediately:

• If you lose a lot of weight 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 color (blood in the stools).

If you have been prescribed Esomeprazolo Almus Pharma to be taken “as needed” contact your doctor if the symptoms persist or if the nature of the symptoms changes.
If you take a proton pump inhibitor such as Esomeprazolo Almus Pharma, especially for a period longer 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.

Other medicines and Esomeprazolo Almus Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In fact, Esomeprazolo Almus Pharma can influence how other medicines work and other medicines can have effects on Esomeprazolo Almus Pharma.
Do not take Esomeprazolo Almus Pharma capsules if you are taking a medicine that contains nelfinavir (used for the treatment of HIV).
Tell 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 for the treatment of fungal infections)
• erlotinib (used in the treatment of some types of cancer)
• citalopram, imipramine or clomipramine (used for the treatment of depression)
• diazepam (used for the treatment of anxiety, to relax muscles or in epilepsy)
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Esomeprazolo Almus Pharma
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazolo Almus Pharma
• cilostazol (used for the treatment of intermittent claudication - a leg pain when walking that is caused by insufficient blood supply)
• cisapride (used for indigestion and heartburn)
• digoxin (used for heart problems)
• tacrolimus (organ transplant)
• methotrexate (a chemotherapeutic medicine used at high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt treatment with Esomeprazolo Almus Pharma
• rifampicin (antibiotic used for the treatment of tuberculosis)
• St John's Wort (Hypericum perforatum)(a herbal medicine used to treat depression). If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Esomeprazolo Almus Pharma for the treatment of ulcers caused by an infection with Helicobacter pylori, it is very important that you tell your doctor if you are taking other medicines.

Esomeprazolo Almus Pharma with food and drink
You can take the capsules with or without food

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide whether you can take Esomeprazolo Almus Pharma during this period.
It is not known whether Esomeprazolo Almus Pharma passes into breast milk. Therefore, you should not take Esomeprazolo Almus Pharma if you are breastfeeding.

Driving and using machines
It is unlikely that Esomeprazolo Almus Pharma will affect your ability to drive or operate tools or machinery. However, adverse reactions such as dizziness and blurred vision can 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 told you that you have an intolerance to certain sugars, contact them 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 Esomeprazolo Almus Pharma

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

• Esomeprazolo Almus Pharma gastro-resistant capsules are not recommended for children under 12 years of age.
• If you are taking this medicine for a long time, your doctor will want to keep you under control (especially if you are taking it for more than one year).
• If your doctor has told you to take this medicine only when needed, tell your doctor if your symptoms change.

How to take this medicine

• You can take the capsules at any time of the day.
• You can 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 acids. It is important not to damage the granules.

What to do if you have problems swallowing the capsules

• If you have problems swallowing the capsules:
• 1) open the capsule and empty the granules into half a glass of plain water (non-carbonated). Do not use other liquids.
• 2) Mix and then drink the mixture immediately or within 30 minutes. Always mix the mixture just before drinking it.
• 3) To be sure you have drunk all the medicine, rinse the glass well with half a glass of water and drink its contents. The solid particles contain the medicine: do not chew or crush them.
• If you cannot swallow anything, the granules can be mixed with a little water and placed in a syringe. They can then be administered to you through a tube directly into the stomach (‘gastric tube’).

How much Esomeprazolo 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 the function of your liver.
• The recommended doses are indicated below.

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

• If your doctor has diagnosed that your esophagus has been slightly damaged, the recommended dose is one Esomeprazolo Almus Pharma 40 mg gastro-resistant capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose to be taken once the esophagus has healed is one Esomeprazolo Almus Pharma 20 mg gastro-resistant capsule once a day.
• If your esophagus has not been damaged, the recommended dose is one Esomeprazolo Almus Pharma 20 mg gastro-resistant capsule per day. Once the condition is controlled, your doctor may prescribe you to take the medicine only when needed, up to a maximum of one Esomeprazolo Almus Pharma 20 mg gastro-resistant capsule per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused byHelicobacter pyloriinfection and prevention of their
recurrence:

• Adults and adolescents 12 years of age and older: the recommended dose is one Esomeprazolo Almus Pharma 20 mg gastro-resistant capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.

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

• Adults 18 years of age and older: the recommended dose is one Esomeprazolo Almus Pharma 20 mg gastro-resistant capsule once a day for 4-8 weeks.

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

• Adults 18 years of age and older: the recommended dose is one Esomeprazolo Almus Pharma 20 mg gastro-resistant capsule once a day.

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

• Adults 18 years of age and older: the recommended dose is one Esomeprazolo Almus Pharma 40 mg gastro-resistant capsule twice a day.
• The doctor will adjust your dose according to your needs and also decide how long you should take this medicine. The maximum dose is 80 mg twice a day.

For prolonged treatment after prevention of bleeding ulcers with esomeprazole via intravenous route.

• Adults 18 years of age and older: the recommended dose is one Esomeprazolo Almus Pharma 40 mg capsule once a day for 4 weeks.

Elderly
No dosage adjustment is required in the elderly

If you take more Esomeprazolo Almus Pharma than you should
If you take more Esomeprazolo Almus Pharma than prescribed by your doctor, talk to
your doctor or pharmacist immediately.

If you forget to take Esomeprazolo Almus Pharma

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose.
• Do not take a double dose to make up for the missed dose.

If you have further questions on 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 gets them.

If you notice any of the following serious side effects, stop taking Esomeprazolo Almus
Pharma and contact your doctor immediately:

• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden shortness of breath, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction). These 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 blisters or peeling may occur even after several weeks of treatment. Severe blisters and bleeding may also appear on the lips, eyes, mouth, nose and genitals. The rashes may develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis” or drug reaction with eosinophilia and systemic symptoms”. These 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.
• Effects on the stomach or intestines: diarrhea, 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 disturbances (insomnia).
• Dizziness, sensations of tingling like “pins and needles”, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Changes in the values of blood tests that check liver function.
• Rash, hives and itching.
• Hip, wrist or spine fracture (if Esomeprazolo Almus Pharma is used at high doses and for a long period).

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

• Problems with the blood, such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising or make you more likely to get infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling of agitation, confusion or depression.
• Alteration of taste.
• Vision problems such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Inflammation inside the mouth.
• An infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash after exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

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

• Changes in the count of blood cells including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation
• Sudden onset of a severe skin rash or 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.

Not known (frequency cannot be estimated from available data)

• If you take Esomeprazolo Almus Pharma for more than three months, your blood magnesium levels may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. Your doctor may decide to check your blood magnesium levels periodically.
• Inflammation of the intestine, which can cause diarrhea.
• Erythema, possible joint pain.

In very rare cases Esomeprazolo Almus Pharma can affect white blood cells causing an impaired
immune system. If you suffer from an infection with symptoms such as fever with a severely
compromised general condition or fever with symptoms of a local infection such as sore throat, sore throat or
difficulty urinating, consult your doctor as soon as possible so that a deficiency of
white blood cells (agranulocytosis) can be ruled out with blood tests. At this stage, it is important that you provide
information about your treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Esomeprazolo Almus Pharma

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 packaging after “Scad.”. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original packaging to protect the medicine from moisture.
Period of validity after first opening of the bottle: 200 days.
Do not dispose of any medicine in 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 ingredient is esomeprazole. Each gastro-resistant hard capsule contains 20 mg or 40 mg of esomeprazole (as sodium salt).

The excipients are:
Capsule content
Sugar spheres (sucrose and corn starch), Methylcellulose, Talc, Titanium dioxide (E171), Glycerol
monostearate, Polysorbate 80, Acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
(containing sodium lauryl sulfate, polysorbate 80 and acrylic acid-ethyl acrylate copolymer), Triethyl citrate,
Glycerol monostearate, triethyl citrate and polysorbate 80 emulsion 20%.
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 package contents
Esomeprazolo Almus Pharma 20 mg: the body and head of the 20 mg capsules are pale pink
opaque, with ES printed on the head and 20 on the body. The 20 mg capsules are size 4 and contain
spherical granules.
Esomeprazolo Almus Pharma 40 mg: the body and head of the 40 mg capsules are opaque pink,
with ES printed on the head and 40 on the body. The 40 mg capsules are size 2 and contain granules
spherical.
Esomeprazolo Almus Pharma 20 mg is available in boxes of 14 and 28 capsules in aluminum blisters or in
14 capsules in plastic bottles (HDPE).
Esomeprazolo Almus Pharma 40 mg is available in boxes of 14 and 28 capsules in aluminum blisters or in
14 capsules in plastic bottles (HDPE).

Marketing authorization holder
Almus S.r.l. - Via Cesarea 11/10 - 16121 Genoa

Manufacturer responsible 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 via gastric tube:

• 1. Open the capsule and place the granules in an appropriate syringe and fill it with approximately 25 ml of water and approximately 5 ml of air. In some tubes, in order to prevent obstruction by the granules, a dispersion in 50 ml of water is necessary.
• 2. Immediately shake the syringe for about 2 minutes, so as to distribute the granules evenly in the suspension.
• 3. Hold the syringe upright and check that there are no obstructions in the tip.
• 4. Connect the tube to the syringe maintaining the position described above.
• 5. Shake the syringe and, keeping the tip pointing downwards, immediately inject 5-10 ml into the tube. Invert the position of the syringe after injection and shake (the syringe must be held with the tip upwards to prevent obstruction of the same).
• 6. Turn the syringe with the tip downwards and immediately inject another 5-10 ml into the tube. The procedure should be repeated until the syringe is emptied.
• 7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to eliminate any sediment remaining in the syringe. For some tubes it is necessary to use 50 ml of water.