Omeprazol Medreg

Package Leaflet: Information for the Patient

Omeprazole Medreg, 10 mg, Gastro-Resistant Capsules, Hard

Omeprazole Medreg, 20 mg, Gastro-Resistant Capsules, Hard

Omeprazole Medreg, 40 mg, Gastro-Resistant Capsules, Hard

Omeprazole

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

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package and other information

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

Omeprazole Medreg contains the active substance 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 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 caused by 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 medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Medreg can also be used to prevent ulcers when taking NSAIDs.
• Too much acid in the stomach due to a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing 10 kg or more:

• 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 vomiting or regurgitation of food, vomiting, and poor weight gain.

Children and adolescents over 4 years of age:

• Ulcers caused by bacteria called Helicobacter pylori. If a 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 you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Omeprazole Medreg (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Omeprazole Medreg if any of the above applies to you. Before taking Omeprazole Medreg, discuss this with your doctor or pharmacist.

Warnings and precautions

Before taking Omeprazole Medreg, discuss this with your doctor or pharmacist.

There have been reports of severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) during treatment with Omeprazole Medreg. If you notice any symptoms related to these severe skin reactions, stop taking Omeprazole Medreg and seek medical help immediately.

Omeprazole Medreg may mask the symptoms of other diseases. Therefore, if you experience any of the following before or during treatment with Omeprazole Medreg, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole use is associated with a small increase in the frequency of infectious diarrhea.
• Severe liver disease.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid.
• Planned specific blood test (chromogranin A levels).

During long-term treatment with Omeprazole Medreg (longer than 1 year), you will most likely remain under close and regular medical supervision. During the visit, report any new or unusual symptoms and circumstances.

Taking a proton pump inhibitor like Omeprazole Medreg, especially for a period longer than a year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Omeprazole Medreg. Also, report any other side effects, such as joint pain.

During omeprazole treatment, 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. Report such symptoms to your doctor.

This medicine may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, 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 weighing less than 10 kg.

Omeprazole Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have 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 you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are 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 you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Omeprazole Medreg.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your 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 in high doses) - if high doses of methotrexate are taken, your doctor may temporarily stop Omeprazole Medreg treatment.

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin and Omeprazole Medreg to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Omeprazole Medreg with food and drink

See section 3 of the package leaflet.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole passes into breast milk, but there is no risk of adverse effects on the baby during therapeutic doses. Whether a breastfeeding woman can take Omeprazole Medreg will be decided by the doctor.

Driving and using machines

Omeprazole Medreg is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If they do, do not drive or operate machinery.

Omeprazole Medreg contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your 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 your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

Recommended doses are as follows:

Adults

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

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

Treatment of duodenal ulcers:

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

Treatment of gastric ulcers:

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

Prevention of duodenal and gastric ulcers:

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

Treatment of duodenal and gastric ulcers caused by NSAIDs:

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

Prevention of duodenal and gastric ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

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

• The usual dose of Omeprazole Medreg is 20 mg twice daily for one week or 40 mg once daily for one week.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

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

• The usual dose is 60 mg daily.
• Your doctor will adjust the dose according to your individual needs and decide how long you need to take the medicine.

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 weighing more than 10 kg can take Omeprazole Medreg. The dose for children is based on their weight. Your doctor will recommend the appropriate dose.

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

• Children over 4 years of age can take Omeprazole Medreg. The dose for children is based on their weight. Your doctor will recommend the appropriate dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your 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 stomach acid. It is essential not to damage the pellets.

What to do if you have difficulty swallowing the capsules (in adults or children)

If you or your child have difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly, washing it down with a glass of water or mix the contents with 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). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure that you or your child have taken the entire dose, rinse the glass with half a glass of water and drink the liquid.

What to do if you take more Omeprazole Medreg than you should

If you take more Omeprazole Medreg than prescribed by your doctor, contact your doctor or pharmacist immediately.

What to do if you forget to take Omeprazole Medreg

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

What to do if you stop taking Omeprazole Medreg

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Omeprazole Medreg and contact a doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or difficulty swallowing (severe allergic reaction) (rare).
• Reddening of the skin with blistering, peeling, or bleeding. This may also include high fever and a failure of blood cells to work properly (very rare).
• Severe skin rash including blistering of the skin, mouth, eyes, and genitals. This may be associated with high fever (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
• Widespread skin rash with high fever and enlarged lymph nodes (DRESS or hypersensitivity syndrome) (rare).
• Red, blistering, peeling skin rash with high fever, which may occur after only a few doses (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin or whites of the eyes (jaundice), dark urine, and tiredness. These may be signs 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 sick (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 dizzy or sleepy, tingling, or numbness.
• Feeling of spinning (vertigo).
• Changes in liver function tests.
• 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 decrease in the number of white blood cells or platelets. This may cause weakness, bruising, or make you more prone to infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, or throat, fever, or difficulty breathing.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Eye problems, such as blurred vision.
• Sudden onset of wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Thrush (infection of the mouth or vagina).
• Fungal infections (thrush).
• Liver problems, including jaundice, which may cause yellowing of the skin or whites of the eyes.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Acute generalized exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS).
• 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 cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, hearing, or feeling things that are not there (hallucinations).
• Severe liver problems, which may lead to liver failure and brain disease.
• Sudden onset of a severe skin rash or blistering, or peeling of the skin. This may 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)

• Colitis (inflammation of the colon, which may cause diarrhea).
• If Omeprazole Medreg is used for more than three months, it is possible that the level of magnesium in the blood may decrease. Low magnesium levels can cause fatigue, muscle spasms, confusion, seizures, or an irregular heartbeat. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to low levels of potassium or calcium in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Skin rash that may be associated 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 you experience an infection with symptoms such as fever and a serious deterioration in general health or fever with local infection symptoms, such as sore throat, mouth, or urinary problems, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) with a blood test. It is essential that you receive complete information about the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omeprazole Medreg

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

Do not use this medicine after the expiry date stated on the carton, bottle, or blister after EXP. The expiry date refers to the last day of the month.

Blister: Store in a temperature below 25°C.

Store in the original package to protect from moisture.

Bottle: No special storage precautions.

Store the bottle tightly closed to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and other information

What Omeprazole Medreg contains

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

Other ingredients are:

• Sucrose spheres (consisting of maize starch and sucrose), magnesium hydroxide (containing maize starch), disodium phosphate, hypromellose type 2910, sodium lauryl sulfate, mannitol, sodium carboxymethylcellulose (Type A), talc, titanium dioxide (E 171), macrogol 6000, polysorbate 80, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (dry mass), 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 capsules, hard: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 capsules, hard: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 capsules, hard: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 capsules, hard, 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 capsules, hard, 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 capsules, hard, 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

Phone: (+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 package leaflet: 02/2025