Omeprazole medreg

Package leaflet: Information for the patient

Omeprazol Medreg, 10 mg, hard enteric-coated capsules
Omeprazol Medreg, 20 mg, hard enteric-coated capsules
Omeprazol Medreg, 40 mg, hard enteric-coated capsules
Omeprazolum
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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

Omeprazol Medreg contains the active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced in the stomach.
Omeprazol Medreg is used to treat the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GORD). This is when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers of the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to eliminate the infection and allow ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazol Medreg may also be used to prevent ulcers developing during NSAID treatment.
• Excessive acid production due to a tumour in the pancreas (Zollinger-Ellison syndrome).

In children
Children above 1 year of age and weighing ≥ 10 kg:

• Gastro-oesophageal reflux disease (GORD). This is when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.

In children, symptoms of this condition may include regurgitation of stomach contents into the mouth (spitting up, vomiting), vomiting, and poor weight gain.
Children and adolescents above 4 years of age:

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

2. Information before taking Omeprazol Medreg

When not to use Omeprazol Medreg:

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

Omeprazol Medreg must not be used if any of the above situations apply to the patient.
Before starting treatment with Omeprazol Medreg, please discuss this with your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Omeprazol Medreg, please discuss this with your doctor or pharmacist.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with Omeprazol Medreg. If any symptoms related to these severe skin reactions described in section 4 occur, discontinue use of Omeprazol Medreg immediately and seek urgent medical advice.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Passing black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as omeprazole use has been associated with a slightly increased risk of infectious diarrhoea.
• Severe liver disease.
• If the patient has ever experienced a skin reaction to a medicine similar to Omeprazol Medreg that reduces gastric acid secretion.
• Planned specific blood test (chromogranin A levels).

If Omeprazol Medreg is used long-term (longer than 1 year), the patient will likely require close and regular medical monitoring. During visits to the doctor, report any new or unusual symptoms or circumstances.

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

If the patient develops a skin rash, particularly in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Omeprazol Medreg may be necessary. Also report any other adverse reactions, such as joint pain.

While taking omeprazole, interstitial nephritis (kidney inflammation) may occur. Symptoms may include reduced urine volume or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.

This medicine may affect how the body absorbs vitamin B₁₂, particularly if taken for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B₁₂ levels:

• Extreme tiredness or lack of energy
• Tingling and numbness
• 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. This medicine must not be given to children under 1 year of age or weighing less than 10 kg.

Omeprazol Medreg and other medicines

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

Do not take Omeprazol Medreg if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform your 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 disorders)
• Diazepam (used to treat anxiety, reduce muscle tension, or 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 Omeprazol 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 Omeprazol Medreg.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplant patients)
• 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 drug used in high doses to treat cancer) – if high-dose methotrexate is being taken, the doctor may temporarily discontinue treatment with Omeprazol Medreg.

If your doctor has prescribed amoxicillin and clarithromycin antibiotics along with Omeprazol Medreg to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

Omeprazol Medreg with food and drink

See section 3 of the leaflet.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but there is no risk of adverse effects on the infant when used at therapeutic doses. The decision on whether a breastfeeding patient may take Omeprazol Medreg will be made by the doctor.

Driving and using machines

Omeprazol Medreg is not expected to affect the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate mechanical equipment.

Omeprazol Medreg contains sucrose

If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Omeprazol Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Omeprazol Medreg

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will depend on your
health condition and age.
The recommended doses are presented below:

Adults

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of
acidic stomach contents:

• If your doctor has determined that your oesophagus has been mildly damaged, the usual dose is 20 mg once daily for 4 to 8 weeks. Your doctor may recommend taking 40 mg for an additional 8 weeks if the oesophagus has not yet healed.
• The usual dose after healing of the oesophagus is typically 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is typically 10 mg once daily.

Treatment of duodenal ulcers (ulcers in the upper part of the small intestine):

• The usual dose is 20 mg once daily for 2 weeks. Your doctor may recommend continuing the same dose for another 2 weeks if the ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers (ulcers in the stomach):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for another 4 weeks if the ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence 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 recurrence of duodenal and gastric ulcers during treatment with NSAIDs:

• The usual dose is 20 mg once daily.

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

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

Treatment of excessive gastric acid secretion caused by a hyperplastic lesion in the pancreas
(Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and decide for how long the medicine should be taken.

Use in children and adolescents

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of
acidic stomach contents:

• Children above 1 year of age and weighing more than 10 kg may take Omeprazol Medreg. The dose for children depends on body weight. Your doctor will recommend the appropriate dose.

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

• Children above 4 years of age may take Omeprazol Medreg. The dose for children depends on body weight. Your doctor will recommend the appropriate dose.
• Your doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take the medicine

• It is recommended to take the capsules in the morning.
• Capsules may be taken with food or on an empty stomach.
• Swallow the capsules whole, with half a glass of water. Do not chew or crush the capsules, as they contain coated pellets that protect the medicine from being broken down by stomach acid. It is important that the pellets remain intact.

What to do if you have difficulty swallowing capsules (in adults or children)
If an adult or a child has difficulty swallowing capsules:

• Open the capsule and swallow the contents directly 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 pineapple juice), or with apple puree.
• Always mix the preparation immediately 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 full dose, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

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

If you forget to take Omeprazol 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 missed one.

Stopping Omeprazol Medreg
Do not stop taking Omeprazol Medreg without consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following rare or very rare but serious adverse reactions, stop taking Omeprazol Medreg and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Reddening of the skin with blister formation or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• Red, scaly, widespread rash with subcutaneous nodules 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 may indicate liver function disorders (rare).

Other adverse reactions include:
Common (may affect up to 1 in 10 patients)

• Headache.
• Effects on stomach or intestines: diarrhoea, stomach pain, constipation, gas (bloating).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon (may affect up to 1 in 100 patients)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or pricking sensations, drowsiness.
• Sensation of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, nodular rash (urticaria), and itching.
• General malaise and lack of energy.
• Fracture of hip, wrist or spine.

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

• Blood-related problems such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising or increased risk of infection.
• Allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing.
• Low sodium levels in blood. This may lead to weakness, vomiting and muscle cramps.
• Feeling of restlessness, confusion or depression.
• Altered sense of taste.
• Vision problems such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the mucous membrane of the mouth.
• Fungal infection known as "thrush", which may affect the intestines.
• Liver disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash occurring during exposure to sunlight.
• Acute generalized exanthematous pustulosis (AGEP), drug reaction 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 patients)

• Blood count abnormalities including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver disorders leading to liver failure and encephalopathy.
• Sudden onset of severe rash, blistering or skin peeling. 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 (frequency cannot be estimated from available data)

• Inflammation of the intestine (leading to diarrhoea).
• If Omeprazol Medreg is used for longer than three months, blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If any of these symptoms occur, contact 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.
• Rash associated with joint pain.

In very rare cases, Omeprazol Medreg may affect the number of white blood cells in the blood, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by marked deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible white blood cell deficiency (agranulocytosis), detectable in blood tests. It is important that the patient receives full information about the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Omeprazol Medreg

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle,
and blister pack following EXP. The expiry date refers to the last day of the stated month.
Blister pack: Store below 25°C.
Keep in the original packaging to protect from moisture.
Bottle: No special storage temperature requirements.
Keep the bottle tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the Packaging and Other Information

What Omeprazol Medreg Contains

• The active substance is omeprazole. Omeprazol Medreg is an enteric hard capsule containing 10 mg, 20 mg, or 40 mg of omeprazole.

• Other ingredients are: sucrose granules (composed of corn starch and sucrose), magnesium hydroxide (containing corn starch), disodium phosphate, hypromellose type 2910, sodium lauryl sulfate, mannitol, sodium carboxymethyl starch (Type A), talc, titanium dioxide (E 171), macrogol 6000, polysorbate 80, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (dry weight), gelatin, brilliant blue FCF (E 133, for 10 mg only), yellow iron oxide (E 172, for 10 mg only), FD&C Blue No. 2 (indigotine E 132, for 20 mg only), black iron oxide (E 172, for 40 mg only).

What Omeprazol Medreg Looks Like and Contents of the Packaging
Omeprazol Medreg, 10 mg, enteric 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.
Omeprazol Medreg, 20 mg, enteric 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.
Omeprazol Medreg, 40 mg, enteric hard capsules: Hard gelatin capsule, size “3” (approximately 15.9 mm ± 0.3 mm) with a white cap and grey body, containing white to off-white or cream-colored, spherical pellets.

Pack sizes:
10 mg:
Enteric hard capsules are available in PVC/PE/PVDC/Aluminium 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:
Enteric hard capsules are available in PVC/PE/PVDC/Aluminium 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:
Enteric hard capsules are available in PVC/PE/PVDC/Aluminium 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised 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 capsule gastrorezistente
Omeprazol Gemax Pharma 20 mg capsule gastrorezistente
Omeprazol Gemax Pharma 40 mg capsule gastrorezistente
Slovakia: Omeprazol Medreg 10 mg
Omeprazol Medreg 20 mg
Omeprazol Medreg 40 mg