Omeprazol Medreg

Leaflet accompanying the packaging: patient information

Omeprazole Medreg, 10 mg, gastro-resistant hard capsules

Omeprazole Medreg, 20 mg, gastro-resistant hard capsules

Omeprazole Medreg, 40 mg, gastro-resistant hard capsules

Omeprazole

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Omeprazole Medreg contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of acid produced in the stomach.

Omeprazole Medreg is used to treat the following diseases:

In adults:

• Gastroesophageal reflux disease. This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by medications known as non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Medreg can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid production due to a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight of ≥ 10 kg:

• Gastroesophageal reflux disease. This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

In children, symptoms of this disorder may include: regurgitation of stomach contents into the mouth (regurgitation, vomiting), vomiting, and insufficient weight gain.

Children and adolescents over 4 years of age:

• Ulcers infected with bacteria called "Helicobacter pylori". If the child has this disease, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Omeprazole Medreg

When not to take Omeprazole Medreg:

• If the patient has been diagnosed with an allergy (hypersensitivity) to omeprazole or any of the other ingredients of Omeprazole Medreg (listed in section 6).
• If the patient has been diagnosed with an allergy to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If the patient is taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Omeprazole Medreg if any of the above situations apply to the patient. Before starting to take Omeprazole Medreg, discuss this with a doctor or pharmacist.

Warnings and precautions

Before starting to take Omeprazole Medreg, discuss this with a doctor or pharmacist.

In connection with the treatment with Omeprazole Medreg, severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). In case of noticing any symptoms related to these severe skin reactions described in section 4, stop taking Omeprazole Medreg and seek medical help immediately.

Omeprazole Medreg may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Omeprazole Medreg, contact a doctor immediately:

• Unexplained weight loss and 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.
• Severe liver disease.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid production.
• Planned specific blood test (chromogranin A levels).

In case of long-term use of Omeprazole Medreg (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During the visit to the doctor, all new and unusual symptoms and circumstances should be reported.

Taking a proton pump inhibitor, such as Omeprazole Medreg, especially for a period longer than a year, may slightly increase the risk of hip, wrist, or spine fractures. Inform the doctor if osteoporosis is present or if corticosteroids are being taken (which may increase the risk of osteoporosis).

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as it may be necessary to discontinue Omeprazole Medreg. Also, inform the doctor about any other side effects, such as joint pain.

While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.

This medicine may affect the way the body absorbs vitamin B12, especially if it needs to be taken for a long time. Inform the doctor if any of the following symptoms are noticed, which may indicate a low level of vitamin B12:

• Extreme fatigue or lack of energy
• Numbness and tingling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or with a body weight below 10 kg.

Omeprazole Medreg and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those that can be obtained without a prescription. This is important because Omeprazole Medreg may affect the way some other medicines work, and some other medicines may affect the way Omeprazole Medreg works.

Do not take Omeprazole Medreg if taking a medicine containing nelfinavir (used to treat HIV infection).

Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart rhythm disorders)
• 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 need to monitor the patient's condition when starting or stopping Omeprazole Medreg.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient's condition when starting or stopping Omeprazole Medreg.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplantation)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used to treat cancer) - if high doses of methotrexate are taken, the doctor may temporarily stop Omeprazole Medreg treatment.

If the doctor has prescribed antibiotics amoxicillin and clarithromycin and Omeprazole Medreg to treat ulcers caused by Helicobacter pylori infection, it is very important for the patient to inform the doctor about any other medicines being taken.

Omeprazole Medreg with food and drink

See section 3 of the leaflet.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Omeprazole passes into breast milk, but there is no risk of harmful effects on the baby when used at therapeutic doses. Whether a breastfeeding patient can take Omeprazole Medreg will be decided by the doctor.

Driving and using machines

Omeprazole Medreg should not affect the ability to drive or use machines. However, dizziness and vision disturbances (see section 4) may occur. If they do, do not drive or operate machinery.

Omeprazole Medreg contains sucrose

If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.

Omeprazole Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Omeprazole Medreg

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist.

The doctor will tell the patient how many capsules to take and for how long. This will depend on the patient's health and age.

Recommended doses are given below:

Adults

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and acid regurgitation:

• If the doctor has found that the patient's esophagus is slightly damaged, the usual dose is 20 mg once a day for 4 to 8 weeks. The doctor may recommend that the patient take a dose of 40 mg for a further 8 weeks if the esophagus has not yet healed.
• The usual dose after healing of the esophagus is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The usual dose is 20 mg once a day for 2 weeks. The doctor may recommend that the patient take the same dose for a further 2 weeks if the ulcers have not healed by then.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The usual dose is 20 mg once a day for 4 weeks. The doctor may recommend that the patient take the same dose for a further 4 weeks if the ulcers have not healed by then.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once a day for 8 weeks.

Prevention of duodenal and gastric ulcers:

• The usual dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

Treatment of ulcers caused by NSAIDs:

• The usual dose is 20 mg once a day for 4 to 8 weeks.

Prevention of duodenal and gastric ulcerswhen taking NSAIDs:

• The usual dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The usual dose of Omeprazole Medreg is 20 mg twice a day for one week or 40 mg of Omeprazole Medreg once a day for one week.
• The doctor will also recommend that the patient take two antibiotics, amoxicillin and clarithromycin.

Treatment of excessive stomach acid production due to a tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long the treatment should last.

Use in children and adolescents

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and acid regurgitation:

• Children over 1 year of age and with a body weight greater than 10 kg can take Omeprazole Medreg. The dose for children depends on the child's body weight. The doctor will recommend the appropriate dose.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• Children over 4 years of age can take Omeprazole Medreg. The dose for children depends on the child's body weight. The doctor will recommend the appropriate dose.
• The doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for the child.

How to take the medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain enteric-coated pellets that prevent the medicine from being broken down by the acid in the stomach. It is essential not to damage the pellets.

What to do in case of difficulty swallowing the capsules (in adults or children)

If the patient has difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly, washing it down with a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or grapefruit), or applesauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose, rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them.

Taking a higher dose of Omeprazole Medreg than recommended

In case of taking a higher dose of Omeprazole Medreg than prescribed by the doctor, contact a doctor or pharmacist immediately.

Missing a dose of Omeprazole Medreg

In case of missing a dose due to forgetfulness, take the dose as soon as remembered. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Omeprazole Medreg

Do not stop taking Omeprazole Medreg without consulting a doctor or pharmacist.

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Omeprazole Medreg can cause side effects, although not everybody gets them.

In case of noticing any of the following rare or very rare but serious side effects, stop taking Omeprazole Medreg and contact a doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. It can also cause large blisters and bleeding in the eyes, mouth, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• Red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems (rare).

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• Feeling unwell (nausea) or vomiting.
• Mild stomach polyps.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Feeling of dizziness, tingling, or numbness.
• Feeling of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, hives, or itching.
• General feeling of being unwell and lack of energy.
• Fracture of the hip, wrist, or spine.

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

• Blood problems, such as a decreased number of white blood cells or platelets. This can lead to weakness, easy bruising, or increased risk of infection.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, or throat, fever, wheezing.
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden feeling of wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• A fungal infection called "thrush", which 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 during exposure to sunlight.
• Acute generalized exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS syndrome).
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• 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 disease.
• Sudden onset of severe rash or blistering of the skin, which can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in men.

Frequency not known (cannot be estimated from the available data)

• Intestinal inflammation (leading to diarrhea).
• If Omeprazole Medreg is used for more than three months, it is possible to decrease the level of magnesium in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If any of these symptoms occur, contact a doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Skin rash that can occur with joint pain.

In very rare cases, Omeprazole Medreg may affect the number of white blood cells in the blood, leading to a lack of immunity. If the patient experiences an infection with symptoms such as fever with a significant worsening of general well-being or fever with signs of a local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should consult a doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) detected in a blood test. It is essential for the patient to receive complete information about the medicine.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. 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 this medicine.

5. How to store Omeprazole Medreg

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, which is the last day of the month shown.

Blister: Store in a temperature below 25°C.

Store in the original packaging to protect from moisture.

Bottle: There are no special storage instructions.

Store the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Omeprazole Medreg contains

• The active substance is omeprazole. Omeprazole Medreg is a gastro-resistant hard capsule containing 10 mg, 20 mg, or 40 mg of omeprazole.

Other ingredients are:

• Sucrose spheres (consisting of cornstarch and sucrose), magnesium hydroxide (containing cornstarch), disodium phosphate, hypromellose type 2910, sodium lauryl sulfate, mannitol, sodium carboxymethylcellulose (Type A), talc, titanium dioxide (E 171), macrogol 6000, polysorbate 80, methacrylic acid, and ethyl acrylate copolymer (1:1) dispersion 30% (dry matter), gelatin, brilliant blue FCF (E 133, only for 10 mg), yellow iron oxide (E 172, only for 10 mg), FD&C blue 2 (indigo carmine E 132, only for 20 mg), black iron oxide (E 172, only for 40 mg).

What Omeprazole Medreg looks like and contents of the pack

Omeprazole Medreg, 10 mg, gastro-resistant hard capsules:Hard gelatin capsule, size "4" (approximately 14.3 mm ± 0.3 mm) with a green cap and white body, containing white to off-white or cream-colored, spherical pellets.

Omeprazole Medreg, 20 mg, gastro-resistant hard capsules:Hard gelatin capsule, size "4" (approximately 14.3 mm ± 0.3 mm) with a blue cap and white body, containing white to off-white or cream-colored, spherical pellets.

Omeprazole Medreg, 40 mg, gastro-resistant hard capsules:Hard gelatin capsule, size "3" (approximately 15.9 mm ± 0.3 mm) with a white cap and gray body, containing white to off-white or cream-colored, spherical pellets.

Pack sizes:

10 mg:

Gastro-resistant hard capsules are available in PVC/PE/PVDC/Aluminum blisters containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, 98, 100, and 112 capsules, in a cardboard box, and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120, and 250 capsules, in a cardboard box.

20 mg:

Gastro-resistant hard capsules are available in PVC/PE/PVDC/Aluminum blisters containing 7, 14, 15, 20, 28, 30, 35, 42, 50, 56, 60, 90, 98, 100, and 112 capsules, in a cardboard box, and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120, and 250 capsules, in a cardboard box.

40 mg:

Gastro-resistant hard capsules are available in PVC/PE/PVDC/Aluminum blisters containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, 98, 100, and 112 capsules, in a cardboard box, and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, and 120 capsules, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

tel.: (+420) 516 770 199

Manufacturer:

Medis International a.s.

Výrobní závod Bolatice

Průmyslová 961/16

747 23 Bolatice

Czech Republic

Pharmazet Group s.r.o.

Třtinová 260/1

Čakovice

196 00 Prague 9

Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Omeprazol Medreg

Poland:

Omeprazol Medreg

Romania:

Omeprazol Gemax Pharma 10 mg gastro-resistant capsules

Omeprazol Gemax Pharma 20 mg gastro-resistant capsules

Omeprazol Gemax Pharma 40 mg gastro-resistant capsules

Slovakia:

Omeprazol Medreg 10 mg

Omeprazol Medreg 20 mg

Omeprazol Medreg 40 mg

Date of last revision of the leaflet: 02/2025