Omeprazole Genoptim

Leaflet attached to the packaging: patient information

Omeprazole Genoptim, 20 mg, capsules

Omeprazole

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Omeprazole Genoptim and what is it used for
• 2. Important information before taking Omeprazole Genoptim
• 3. How to take Omeprazole Genoptim
• 4. Possible side effects
• 5. How to store Omeprazole Genoptim
• 6. Package contents and other information

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

Omeprazole Genoptim contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors," which work by reducing the amount of acid produced in the stomach.
Omeprazole Genoptim is used to treat the following diseases and disorders:

In adults:

• Gastroesophageal reflux disease (GERD). This condition occurs when stomach acid flows back into the esophagus, causing pain, inflammation, and heartburn.
• Treatment of reflux esophagitis and long-term maintenance treatment after healing of reflux esophagitis.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Prevention of duodenal or gastric ulcer recurrences.
• Ulcers infected with bacteria called "Helicobacter pylori." In such cases, the doctor may also prescribe antibiotics to treat the infection and allow the ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Genoptim may also be used to prevent the development of ulcers during NSAID treatment.
• Excessive stomach acid production due to a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing ≥ 10 kg

• Treatment of reflux esophagitis.
• Symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease (GERD). This condition occurs when stomach acid flows back into the esophagus, causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include regurgitation of food into the mouth, vomiting, and poor weight gain.

Children and adolescents over 4 years of age

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

2. Important information before taking Omeprazole Genoptim

When not to take Omeprazole Genoptim

• If the patient has been diagnosed with an allergy (hypersensitivity) to omeprazole or any other component of Omeprazole Genoptim;
• 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).

In case of any doubts before taking Omeprazole Genoptim, consult your doctor or pharmacist.

Warnings and precautions

Before starting to take Omeprazole Genoptim, discuss it with your doctor, pharmacist, or nurse.
Omeprazole Genoptim may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Omeprazole Genoptim, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing;
• Stomach pain or indigestion;
• Vomiting blood or food;
• Passing black stools (stool discolored by blood);
• Severe or persistent diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea;
• Severe liver problems. Before starting Omeprazole Genoptim, consult your doctor:
• if the patient has ever had a skin reaction after taking a medicine similar to Omeprazole Genoptim, which reduces stomach acid production
• if the patient is scheduled for a specific blood test (chromogranin A level). If a skin rash occurs, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Omeprazole Genoptim. Also, report any other side effects, such as joint pain

In the case of long-term use of Omeprazole Genoptim (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During the visit to the doctor, report any new or unusual symptoms and circumstances.
When taking proton pump inhibitors like Omeprazole Genoptim, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
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.

Omeprazole Genoptim and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is important because Omeprazole Genoptim may affect the way some other medicines work, and some other medicines may affect the way Omeprazole Genoptim works.
Do not take Omeprazole Genoptim if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, 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 Genoptim;
• 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 Genoptim;
• 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 chemotherapeutic agent, used in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may interrupt omeprazole treatment for a period of time. If your doctor has prescribed you antibiotics amoxicillin and clarithromycin and Omeprazole Genoptim 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 Genoptim with food and drink or alcohol

Omeprazole Genoptim capsules can be taken with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

Before taking Omeprazole Genoptim, the patient should inform the doctor if she is pregnant or trying to become pregnant. The doctor will decide whether the patient can take Omeprazole Genoptim at that time.
The doctor will decide whether a breastfeeding patient can take Omeprazole Genoptim.

Driving and using machines

Omeprazole Genoptim does not affect the ability to drive or use tools and machines. However, side effects such as dizziness and vision disturbances (see section 4 of this leaflet) may occur. If they do, do not drive or operate machinery.

Omeprazole Genoptim contains lactose and sucrose

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

Omeprazole Genoptim contains sodium

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

3. How to take Omeprazole Genoptim

Always take this medicine exactly as your doctor or pharmacist 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 health and age.
The usual doses of Omeprazole Genoptim are given below.

Use in adults

Treatment of reflux esophagitis:

• The recommended dose of omeprazole is 20 mg once daily for 4 to 8 weeks.
• In patients with severe reflux esophagitis, omeprazole is used at a dose of 40 mg once daily for 8 weeks.

Long-term maintenance treatment in patients with healed reflux esophagitis:

• In long-term maintenance treatment, patients with healed reflux esophagitis are recommended to take omeprazole at a dose of 10 mg once daily. If necessary, the dose can be increased to 20-40 mg once daily.

Treatment of symptomatic gastroesophageal reflux disease (GERD):

• The recommended dose of omeprazole is 20 mg once daily. Since a response to 10 mg once daily may be adequate, it is recommended to consider individual dose adjustment. If symptom control has not been achieved after 4 weeks of treatment with omeprazole 20 mg once daily, further diagnostic evaluation is recommended.

Treatment of duodenal ulcers(duodenal ulcers):

• The usual dose is 20 mg once daily for 2 weeks. The doctor may recommend taking the same dose for another 2 weeks if the ulcers do not heal within this time;
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers(gastric ulcers):

• The usual dose is 20 mg once daily for 4 weeks. The doctor may recommend taking the same dose for another 4 weeks if the ulcers do not heal within this time;
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcer recurrences:

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

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

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

Prevention of
duodenal and
gastric ulcer
recurrences
during
NSAID
treatment

NSAID treatment

(non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once daily.

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

• The usual dose of Omeprazole Genoptim is 20 mg twice daily for one week;
• The doctor will also prescribe 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 daily. The doctor will adjust the dose according to individual patient needs and decide how long Omeprazole Genoptim should be taken.

Use in children

Treatment of symptomatic GERD, such as heartburn and acid reflux:

• Children over 1 year of age and weighing ≥ 10 kg can take Omeprazole Genoptim. The dose for children depends on the child's weight, and the appropriate dose will be recommended by the doctor. The treatment period is 2-4 weeks. If symptom control has not been achieved after 2-4 weeks of treatment, the patient should undergo further diagnostic evaluation.

Treatment of reflux esophagitis:

• Children over 1 year of age and weighing ≥ 10 kg can take Omeprazole Genoptim. The dose for children depends on the child's weight, and the appropriate dose will be recommended by the doctor. The treatment period is 4-8 weeks.

Treatment of duodenal ulcers caused by Helicobacter pylori infection:

• Children over 4 years of age can take Omeprazole Genoptim. The dose for children depends on the child's weight, and the appropriate dose will be recommended by the doctor;
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take Omeprazole Genoptim

• It is recommended to take the capsules in the morning.
• The capsules can 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. This is important because the capsules 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 have 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 immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that you have taken the entire dose of Omeprazole Genoptim, rinse the glass with half a glass of water and drink the liquid. Do not use milk or carbonated water. The solid particles contain the medicine - do not chew or crush them.

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

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

What to do if you forget to take Omeprazole Genoptim

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 dose.

4. Possible side effects

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

If you notice any of the following rare but serious side effects, stop taking Omeprazole Genoptim and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction);
• Redness of the skin with blistering or peeling. Large blisters and bleeding in the mouth, eyes, lips, genitals, or skin may also occur. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• Yellowing of the skin, dark urine, and fatigue, which can be signs of liver problems.

Side effects can occur with the following frequency:

Very common: occurring in more than 1 in 10 patients
Common: occurring in 1 to 10 in 100 patients
Uncommon: occurring in 1 to 10 in 1,000 patients
Rare: occurring in 1 to 10 in 10,000 patients
Very rare: occurring in less than 1 in 10,000 patients
Frequency not known: frequency cannot be estimated from the available data
Other side effects include:

Common side effects:

• Headache;
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating), mild stomach polyps;
• Nausea or vomiting.

Uncommon side effects:

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

Rare side effects:

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, easy bruising, or increased risk of infection;
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing;
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps;
• Feeling agitated, confused, or depressed;
• Change in taste;
• Vision problems, such as blurred vision;
• Sudden shortness of breath or wheezing (bronchospasm);
• Dry mouth;
• Oral thrush;
• 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 when exposed to sunlight;
• Joint pain (arthralgia) or muscle pain (myalgia);
• Severe kidney problems (interstitial nephritis);
• Increased sweating.

Very rare side effects:

• Changes in blood cell count, 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 inflammation;
• Sudden onset of severe skin rash or blistering. This 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:

• Colitis (leading to diarrhea)
• If you have taken Omeprazole Genoptim for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can lead to low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels
• Rash, which may be associated with joint pain

In very rare cases, Omeprazole Genoptim 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 with a serious deterioration in general health or fever with local infection symptoms, such as neck, throat, or mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on blood test results. It is essential to inform your doctor that you are taking Omeprazole Genoptim.
Do not worry about the list of side effects mentioned above. It is possible that you will not experience any of them. If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 gather more information on the safety of this medicine.

5. How to store Omeprazole Genoptim

There are no special precautions for storing the medicine.
Store the medicine out of sight and reach of children.
Do not use Omeprazole Genoptim after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Omeprazole Genoptim contains

The active substance of the medicine is omeprazole.
The other ingredients are: sucrose, lactose anhydrous, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, disodium phosphate dihydrate, hypromellose phthalate, diethyl phthalate,
The capsule shell contains: gelatin, indigo carmine (0.4%) (E 132), quinoline yellow (0.1286%) (E 104).

What Omeprazole Genoptim looks like and contents of the pack

Omeprazole Genoptim is available as capsules. The capsules are green.
Each capsule contains 20 mg of omeprazole in the form of sugar pellets.
The pack contains 7, 14, or 28 capsules in blisters, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

Industria Química y Farmacéutica VIR, S.A
C/Laguna 66-70
Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain
Date of last revision of the leaflet:March 2023