OMEPRAZOLE 20 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Omeprazole Mercapharm, 20 mg, gastro-resistant hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Omeprazole Mercapharm and what is it used for
   1. Omeprazole Mercapharm is used in adults:
4. Important information before taking Omeprazole Mercapharm
   1. When not to take Omeprazole Mercapharm:
   2. Warnings and precautions
   3. Children and adolescents
   4. Omeprazole Mercapharm and other medicines
   5. Omeprazole Mercapharm with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Omeprazole Mercapharm contains sucrose
5. How to take Omeprazole Mercapharm
   1. Recommended dose
   2. Method of administration
   3. What to do in case of difficulty swallowing capsules (by an adult patient)
   4. Use in children and adolescents
   5. Use of a higher than recommended dose of Omeprazole Mercapharm
   6. Missing a dose of Omeprazole Mercapharm
6. Possible side effects
   1. Reporting side effects
7. How to store Omeprazole Mercapharm
8. Contents of the pack and other information
   1. What Omeprazole Mercapharm contains
   2. What Omeprazole Mercapharm looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Omeprazole Mercapharm, 20 mg, gastro-resistant hard capsules

Omeprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist or doctor.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Omeprazole Mercapharm and what is it used for

Omeprazole Mercapharm is a medicine in the form of gastro-resistant hard capsules. The active substance is omeprazole, which belongs to a group of medicines called proton pump inhibitors. Their action is to reduce the amount of acid produced in the stomach.

Omeprazole Mercapharm is used in adults:

for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn and acid regurgitation).
Reflux occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), which can lead to inflammation and pain. This can cause symptoms such as a burning sensation in the chest rising to the throat (heartburn) and a sour taste in the mouth (due to acid regurgitation).
In order to alleviate symptoms, it may be necessary to take capsules for 2 or 3 consecutive days.

2. Important information before taking Omeprazole Mercapharm

When not to take Omeprazole Mercapharm:

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing nelfinavir (for HIV infection treatment).

In case of any doubts before starting to take Omeprazole Mercapharm, the patient should talk to their doctor or pharmacist.

Warnings and precautions

Omeprazole Mercapharm should not be taken for more than 14 days without consulting a doctor.
In case of no improvement and in case of worsening symptoms, the patient should consult a doctor.
Omeprazole Mercapharm may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Omeprazole Mercapharm, the patient should immediately contact their doctor:

• unexplained weight loss (not related to diet or exercise);
• difficulty swallowing;
• stomach pain or indigestion;
• vomiting blood or food;
• passing black stools (stool discolored with blood);
• severe or persistent diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea;
• previous stomach ulcer or gastrointestinal surgery;
• long-term use of medicines for indigestion or heartburn for 4 or more weeks;
• persistent indigestion or heartburn for 4 or more weeks;
• jaundice (yellowing of the skin and eyes) or severe liver disease;
• age over 55 and recent onset of new worrying symptoms or change in existing symptoms.

Before starting to take Omeprazole Mercapharm, the patient should contact their doctor:

• if the patient has ever had a skin reaction after taking a medicine similar to Omeprazole Mercapharm that reduces stomach acid;
• if the patient is scheduled for a specific blood test (chromogranin A levels).

When taking proton pump inhibitors like Omeprazole Mercapharm, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue Omeprazole Mercapharm.
The patient should also inform their doctor about any other side effects, such as joint pain.
Omeprazole should not be taken as a preventive measure.

Children and adolescents

Omeprazole Mercapharm should not be used in children and adolescents under 18 years of age.

Omeprazole Mercapharm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
This is important because Omeprazole Mercapharm may affect the way some other medicines work, and some other medicines may affect the way Omeprazole Mercapharm works.
The patient should not take Omeprazole Mercapharm if they are taking a medicine containing nelfinavir (for HIV infection treatment).
The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• antifungal medicines(e.g. ketoconazole, itraconazole, voriconazole);
• digoxin(used to treat heart failure and atrial fibrillation with rapid ventricular rate);
• diazepam(used to treat anxiety, to reduce muscle tension, or to treat epilepsy);
• phenytoin(used to treat epilepsy). If the patient is taking phenytoin, the doctor will monitor their condition when starting or stopping Omeprazole Mercapharm;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will monitor the patient's condition when starting or stopping Omeprazole Mercapharm;
• clopidogrel(used to prevent blood clots);
• rifampicin(used to treat tuberculosis);
• atazanavir(used to treat HIV infection);
• tacrolimus(used after organ transplantation and to treat atopic dermatitis);
• St. John's Wort(Hypericum perforatum) (used to treat mild depression);
• cilostazol(used to treat symptoms of intermittent claudication);
• saquinavir(used to treat HIV infection);
• erlotinib(used to treat cancer);
• methotrexate(a chemotherapy medicine used in high doses to treat cancer) - if the patient is taking high doses of methotrexate, the doctor may temporarily discontinue Omeprazole Mercapharm.

Omeprazole Mercapharm with food and drink

The capsules should be taken before a meal (on an empty stomach). They should NOT be chewed or crushed. They should be swallowed whole, with a glass of water (see section 3).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.
The doctor will decide whether the patient can take Omeprazole Mercapharm during pregnancy.
The doctor will decide whether Omeprazole Mercapharm can be used during breastfeeding.

Driving and using machines

Omeprazole Mercapharm does not affect the ability to drive or use machines.
If the patient experiences dizziness or visual disturbances, they should not drive or use machines.

Omeprazole Mercapharm contains sucrose

The medicine contains sucrose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Omeprazole Mercapharm

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose

1 capsule once a day. The medicine can be taken for 14 days.
The medicine should be taken for at least 2 to 3 consecutive days.
If symptoms do not improve within 14 days of uninterrupted treatment, the patient should consult their doctor.

Method of administration

• The medicine is recommended to be taken in the morning.
• The capsules should be taken before a meal (on an empty stomach).
• The capsules should be swallowed whole, with half a glass of water. They should NOT be chewed or crushed, as they contain enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is important that the pellets are not damaged. The pellets contain the active substance omeprazole and are protected from breakdown in the stomach to allow absorption from the intestine. The pellets release the active substance in the intestine, where it is absorbed and the medicine works.

What to do in case of difficulty swallowing capsules (by an adult patient)

• Open the capsule and mix its contents with still water or mix with any acidic fruit juice (e.g. apple, orange, or pineapple) or apple sauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• In order to ensure that the patient has taken the entire dose, the glass (in which the medicine was dissolved) should be rinsed with half a glass of water and this liquid should be drunk.
• Milk or carbonated water should not be used.
• The solid particles contain the medicine - they should NOT be chewed or crushed.

Use in children and adolescents

Omeprazole Mercapharm should not be used in children and adolescents under 18 years of age.

Use of a higher than recommended dose of Omeprazole Mercapharm

The patient should immediately consult their doctor or pharmacist. If possible, they should take the medicine and the leaflet with them.

Missing a dose of Omeprazole Mercapharm

The patient should NOT take a double dose to make up for a missed dose. They should take the next scheduled dose the next day at the usual time.
In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Omeprazole Mercapharm can cause side effects, although not everybody gets them.
The patient should immediately inform their doctor or contact the nearest hospitalif they experience any of the following serious side effects.They should also stop taking this medicine and take the leaflet and/or capsules with them.

• Severe allergic reactions:wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty breathing or swallowing.
• Severe skin reactions:redness of the skin with blistering or peeling. It is also possible to develop large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Other serious reactions(frequency not known): yellowing of the skin and whites of the eyes, dark urine, and fatigue, which can be symptoms of liver problems (jaundice).

Other side effects include:
Common(occurring in 1 to 10 people in 100):
headache; diarrhea, constipation, stomach pain, bloating (gas); nausea or vomiting; mild stomach polyps.
Uncommon(occurring in 1 to 10 people in 1,000):
swelling of the feet and ankles; sleep disturbances (insomnia), feeling of tingling and prickling, feeling of drowsiness;
feeling of spinning (dizziness); changes in liver function test results; general malaise and weakness.
Rare(occurring in 1 to 10 people in 10,000):
reduced white blood cell or platelet count (which can lead to weakness, easier bruising, or increased risk of infection); allergic reactions (see the beginning of section 4); low sodium levels in the blood (which can lead to weakness, vomiting, and muscle cramps); feeling of agitation, confusion, or depression; change in taste; vision problems, such as blurred vision; sudden shortness of breath or wheezing (bronchospasm); dry mouth; inflammation of the mouth; fungal infection, which can affect the intestines; liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue; hair loss (alopecia); skin rash during sun exposure; joint pain (arthralgia) or muscle pain (myalgia); severe kidney problems (interstitial nephritis); increased sweating.
Very rare(occurring in less than 1 person in 10,000):
changes in blood cell counts, including agranulocytosis (lack of white blood cells); aggression; seeing, feeling, or hearing things that do not exist (hallucinations); severe liver problems leading to liver failure and brain damage; sudden onset of severe skin rash or blistering or peeling of the skin (which may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)); muscle weakness; breast enlargement in men; hypomagnesemia (low magnesium levels in the blood). Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heart rate.
In case of any of the above symptoms, the patient should immediately inform their doctor.
Frequency not known(frequency cannot be estimated from the available data):
inflammation of the intestines (leading to diarrhea); rash that may be accompanied by joint pain.
In very rare cases, Omeprazole Mercapharm may affect the white blood cell count, which can lead to reduced immunity. If the patient experiences an infection with symptoms such as fever with serious deterioration of general condition or fever with symptoms of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, they should consult their doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is important for the patient to inform their doctor about the medicine they are taking.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Omeprazole Mercapharm

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton (after the expiry date). The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Omeprazole Mercapharm contains

• The active substance of the medicine is omeprazole. One gastro-resistant hard capsule contains 20 mg of omeprazole.
• The other ingredients are: sucrose spheres (sucrose and corn starch), hypromellose, talc, titanium dioxide (E 171), disodium phosphate dihydrate, methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30%, triethyl citrate. Capsule shell:body:titanium dioxide, purified water, gelatin; cap: titanium dioxide, purified water, gelatin. Ink:iron oxide black (E 172), potassium hydroxide, shellac.

What Omeprazole Mercapharm looks like and contents of the pack

Omeprazole Mercapharm 20 mg capsules are opaque, made of white hard gelatin, with the imprint "OM 20", and contain spherical granules.
14 gastro-resistant hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Mercapharm Sp. z o.o.
ul. Świętopełka 39
81-524 Gdynia, Poland

Manufacturer

TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona, Spain

Date of last revision of the leaflet: