Mesopral

Package leaflet: Information for the patient

Mesopral, 20 mg, hard enteric-coated capsules
Mesopral, 40 mg, hard enteric-coated capsules
Esomeprazolum
Please read 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Mesopral is and what it is used for

Mesopral contains an active substance called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.

Mesopral is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach ulcers or infection of the upper part of the intestine caused by the bacterium Helicobacter pylori. If you have one of these conditions, your doctor may also prescribe antibiotics to eliminate the infection and allow healing of the ulcer.
• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Mesopral may also be used to prevent the development of stomach ulcers during treatment with NSAIDs.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).
• Long-term treatment following prevention of rebleeding with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach ulcers or infection of the upper part of the intestine caused by the bacterium Helicobacter pylori. If you have one of these conditions, your doctor may also prescribe antibiotics to eliminate the infection and allow healing of the ulcer.

2. Important information before using Mesopral

When not to use Mesopral:

• if the patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other medicines in the proton pump inhibitor group (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole);
• if the patient has ever experienced severe skin rash, skin peeling, formation of blisters and/or mouth ulcers after taking Mesopral or other similar medicines;
• if the patient is currently taking a medicine containing nelfinavir (used in the treatment of HIV infection).
  If any of the above situations apply, Mesopral must not be used. If in doubt, consult a doctor or pharmacist before using Mesopral.

Warnings and precautions
Before starting Mesopral, inform your doctor or pharmacist:

• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• if the patient has ever had a skin reaction to a medicine similar to Mesopral that reduces stomach acid secretion;
• if the patient develops a skin rash, especially in areas exposed to sunlight, the patient should inform the doctor immediately, as treatment with Mesopral may need to be discontinued. The patient should also report any other adverse reactions such as joint pain;
• about any planned specific blood test (chromogranin A levels).

Treatment with Mesopral may mask symptoms of other diseases. Therefore, it is essential to inform the doctor immediately
if any of the following symptoms occur before or during treatment:

• significant, unintentional weight loss and difficulty swallowing;
• abdominal pain or indigestion symptoms;
• vomiting or vomiting blood;
• black, tarry stools (containing blood).
  If Mesopral is used on an as-needed basis, contact the doctor if symptoms persist or change in nature.

Taking proton pump inhibitors such as Mesopral, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform the doctor if osteoporosis has been diagnosed or if the patient is taking corticosteroid medicines (which may increase the risk of osteoporosis).

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Mesopral treatment. The patient should stop taking Mesopral and seek immediate medical advice if any symptoms related to these severe skin reactions described in section 4 occur.

Mesopral with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take, including those purchased without a prescription. This is important because Mesopral may affect the action of other medicines, or the effect of Mesopral may be altered when taken together with other medicines.

Do not take Mesopral if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used in the treatment of HIV infection);
• Clopidogrel (used to prevent blood clots);
• Ketoconazole, itraconazole or voriconazole (medicines used to treat fungal infections);
• Erlotinib (used in the treatment of cancer);
• Citalopram, imipramine or clomipramine (medicines used to treat depression);
• Diazepam (a medicine used to treat anxiety, epilepsy or to relax muscles);
• Phenytoin (a medicine used to treat epilepsy). If the patient is taking phenytoin, the doctor may recommend additional blood tests at the beginning and after completion of Mesopral treatment;
• Blood-thinning medicines such as warfarin. The doctor may recommend additional blood tests at the beginning and after completion of Mesopral treatment;
• Cilostazol (used to treat intermittent claudication – leg pain during walking due to poor blood flow);
• Cisapride (a medicine used to treat indigestion or heartburn);
• Digoxin (a medicine used to treat heart conditions);
• Methotrexate (a chemotherapy medicine, used in high doses for cancer treatment);
  if the patient is taking high doses of methotrexate, the doctor may recommend temporarily stopping Mesopral;
• Tacrolimus (used after organ transplantation);
• Rifampicin (a medicine used to treat tuberculosis);
• St. John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression).

If the doctor has prescribed antibiotics (amoxicillin and clarithromycin) to be taken together with Mesopral for the treatment of ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about any other medicines being taken.

Mesopral with food and drink
It is recommended to take Mesopral (preferably in the morning) 30–60 minutes before the first meal of the day.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether Mesopral can be used during this period. There are no data on whether esomeprazole passes into human breast milk. Therefore, Mesopral should not be given to breastfeeding women.

Driving and using machines
Mesopral is unlikely to affect the ability to drive or operate machinery. However, dizziness or blurred vision may occur occasionally or rarely (see section 4). If such adverse effects occur, the patient should not drive or operate machinery.

Mesopral contains sucrose, benzoic acid and sodium
Mesopral contains sucrose (a type of sugar), benzoic acid (E210) and sodium.

• If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using this medicine;
• The medicine contains 1.80 micrograms of benzoic acid in each 20 mg hard enteric-coated capsule or 3.50 micrograms of benzoic acid in each 40 mg hard enteric-coated capsule;
• The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Mesopral

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.

• If this medicine is taken long-term, especially for more than one year, your doctor may recommend additional monitoring and/or tests.
• If your doctor has advised you to take the medicine on an as-needed basis, i.e. when symptoms occur, you should inform your doctor if symptoms change.

How to take Mesopral

• Your doctor will inform you how many capsules to take and for how long. This depends on your condition, age, and liver function.
• The recommended doses are given below.

Adults aged 18 years and above
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed mild damage to the oesophagus, the recommended dose of Mesopral is 40 mg. One capsule should be taken once daily for 4 weeks. In patients who have not healed within this time or whose symptoms persist, your doctor may recommend continuing the same dose for another 4 weeks.
• After healing of the oesophagus, your doctor may recommend taking one capsule of Mesopral 20 mg once daily.
• In patients in whom damage to the oesophageal wall has been ruled out, the recommended dose is 20 mg once daily. Once symptoms are controlled, your doctor may recommend taking Mesopral on an as-needed basis, i.e. when symptoms occur, at a dose of one 20 mg capsule once daily.
• In patients with severe liver disease, your doctor may recommend a reduced dose.

Treatment of peptic ulcer disease caused by Helicobacter pylori infection and prevention of recurrence:

• The recommended dose of Mesopral is one 20 mg capsule twice daily for 1 week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose of Mesopral is one 20 mg capsule once daily for 4 to 8 weeks.

Prevention of gastric ulcers during treatment with non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose of Mesopral is one 20 mg capsule once daily.

Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome):

• The recommended dose of Mesopral is one 40 mg capsule twice daily.
• Your doctor may adjust the dose and duration of treatment according to your individual needs. The maximum dose is 80 mg twice daily.

Long-term treatment following prevention of rebleeding using intravenous esomeprazole:
The recommended dose is one 40 mg capsule of Mesopral once daily for 4 weeks.

Adolescents aged 12 years and above
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed mild damage to the oesophagus, the recommended dose of Mesopral is 40 mg. One capsule should be taken once daily for 4 weeks. In patients who have not healed within this time or whose symptoms persist, your doctor may recommend continuing the same dose for another 4 weeks.
• After healing of the oesophagus, your doctor may recommend taking one capsule of Mesopral 20 mg once daily.
• In patients in whom damage to the oesophageal wall has been ruled out, the recommended dose is 20 mg once daily.
• In patients with severe liver disease, your doctor may recommend a reduced dose.

Treatment of peptic ulcer disease caused by Helicobacter pylori infection and prevention of recurrence:

• The recommended dose of Mesopral is one 20 mg capsule twice daily for 1 week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

How to take Mesopral

• It is recommended to take the capsules (preferably in the morning) 30–60 minutes before the first meal of the day.
• Capsules should be swallowed whole with a glass of water. Do not chew or crush the capsules or their contents, as the coating protecting the drug pellets from the action of gastric acid may be damaged. This is important to ensure the pellets remain intact.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the capsule: 1) Carefully open the capsule over a glass of still water and pour the contents (pellets) into the glass. Do not use any other liquid. 2) Stir the mixture. The solution should be taken immediately or within 30 minutes of preparation. Always stir the solution again immediately before drinking. 3) To ensure the entire dose is taken, refill the glass halfway with water, stir, and drink. Undissolved particles contain the active substance; do not chew or crush them.
• If a patient cannot swallow independently, the contents of the capsule may be dispersed in water and administered via a gastric tube using a syringe.

Children under 12 years of age
Mesopral is not recommended for use in children under 12 years of age.

Elderly patients
Dose adjustment is not necessary in elderly patients.

Taking more Mesopral than recommended
If you take more Mesopral than recommended, seek immediate advice from your doctor or pharmacist.

Missed dose of Mesopral

• Take the missed dose as soon as possible. However, if it is almost time for the next dose, do not take the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the serious adverse effects described below occur, stop taking Mesopral immediately and contact your doctor without delay:

• Sudden onset of wheezing, facial or body swelling, rash, fainting or difficulty swallowing (severe allergic reaction). These symptoms are rare and may occur in less than 1 in 1,000 treated patients.
• Reddening of the skin with blistering or skin peeling. Blisters and bleeding may also occur in the mouth, eyes, oral cavity, nose, and genital area. Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. These symptoms are very rare and may occur in less than 1 in 10,000 patients.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These symptoms are very rare.
• Yellowing of the skin, dark urine, and general fatigue may be symptoms of liver disease. These symptoms are rare.

Other adverse effects:
Common (occur in less than 1 in 10 patients)

• Headache.
• Gastrointestinal symptoms: abdominal pain, constipation, diarrhoea, bloating (with passing of wind), mild gastric polyps.
• Nausea, vomiting.

Uncommon (occur in less than 1 in 100 patients)

• Swelling of feet and around the ankles.
• Sleep disturbances (insomnia).
• Dizziness, prickling sensations, tingling and numbness (paraesthesiae), drowsiness.
• Vertigo.
• Dryness of the mouth.
• Changes in blood tests assessing liver function.
• Rash, urticaria (hives), and itchy skin.
• Fractures of the hip, wrist, or spine (if Mesopral is used in high doses and for prolonged periods).

Rare (occur in less than 1 in 1,000 patients)

• Blood disorders such as reduced numbers of white blood cells and platelets. These may cause weakness, bruising, or increased susceptibility to infections.
• Low levels of sodium ions in the blood. Symptoms may include weakness, nausea (vomiting), and cramps.
• Feeling of restlessness, disorientation, or depression.
• Changes in taste sensation.
• Visual disturbances such as blurred vision.
• Sudden onset of breathlessness, difficulty breathing (bronchospasm).
• Inflammation of the mucous membrane of the mouth.
• Fungal infection known as candidiasis, which may affect the intestines.
• Liver disorders, including jaundice, which may cause yellowing of the skin and whites of the eyes, dark urine, and feeling of fatigue.
• Hair loss.
• Rash after exposure to sunlight.
• Joint or muscle pain.
• General malaise, lack of energy.
• Increased sweating.

Very rare (occur in less than 1 in 10,000 patients)

• Changes in blood cell counts, including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and encephalopathy.
• Sudden onset of severe rash, skin ulceration or peeling. These may occur together with high fever and muscle pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome).
• Muscle weakness.
• Severe kidney disorders.
• Breast enlargement in men.

Frequency not known (cannot be estimated from available data)

• If Mesopral has been taken for longer than three months, there may be a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms are observed, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Inflammation of the intestine (leading to diarrhoea).
• Rash associated with joint pain.

Very rarely, Mesopral may affect white blood cells, leading to immune system disorders.
If a patient develops an infection with symptoms such as fever with a very poor general condition
or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating,
immediate medical consultation is required to rule out a possible reduction in white blood cell count (agranulocytosis) via blood testing. It is essential to inform the doctor about all currently used medications.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Mesopral

• Keep the medicine out of the sight and reach of children.
• Do not store above 25°C.
• Store the medicine in its original packaging to protect it from moisture (blister packs), or keep the container tightly closed (bottle) to protect from moisture.
• Do not use this medicine after the expiry date stated on the cardboard box, bottle, or foil blister. The expiry date refers to the last day of the stated month.
• After opening the bottle, the capsules should be used within 3 months.
• The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
• Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Mesopral contains

• The active substance in Mesopral is esomeprazole. Each capsule contains either 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• Other ingredients are:
  Capsule contents: sucrose, pellets (sucrose and corn starch), hypromellose 3 cP, simethicone emulsion 30% (containing simethicone, polyoxyethylene sorbitan tristearate (polysorbate 65) (E436), methylcellulose, polyethylene glycol stearate, glycerides, xanthan gum, benzoic acid (E210), sorbic acid (E200), sulfuric acid), polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30% (containing methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate and polysorbate 80), triethyl citrate and macrogol glyceryl stearates.
  Capsule shell: black iron oxide (E172), shellac, gelatin, yellow iron oxide (E172) and titanium dioxide (E171).

What Mesopral looks like and contents of the pack

• Mesopral 20 mg capsules have an opaque (yellow) cap and an opaque (white) body. The marking “20 mg” is printed on both the cap and the body. The capsule contains white or greyish spherical pellets.
• Mesopral 40 mg capsules have an opaque (yellow) cap and an opaque (yellow) body. The marking “40 mg” is printed on both the cap and the body. The capsule contains white or greyish spherical pellets.
• Capsules are available in the following pack sizes: Bottles containing 28, 30, 90 or 98 capsules. Blister packs of 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 140 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01