Omeprazole Genoptim

Leaflet accompanying the packaging: patient information

Omeprazole Genoptim, 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, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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. Contents of the packaging 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.

In adults:

• Gastro-esophageal reflux disease (GERD). This is where 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 this case, your 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 can also be used to prevent ulcers when taking NSAIDs.
• Too much acid in the stomach due to a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

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

• Gastro-esophageal reflux disease (GERD). This is where stomach acid flows back into the esophagus, causing pain, inflammation, and heartburn. In children, symptoms of this condition may include reflux of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers caused by bacteria called Helicobacter pylori. If your child has this condition, your 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 you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to 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 Genoptim if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Omeprazole Genoptim.

Warnings and precautions

Before taking Omeprazole Genoptim, tell your doctor or pharmacist:

• Unexplained weight loss and difficulty swallowing;
• Stomach pain or indigestion;
• Vomiting blood or black tarry stools;
• Severe diarrhea, as omeprazole may increase the risk of infectious diarrhea;
• Severe liver problems.
• If you have ever had a skin reaction with a medicine that reduces stomach acid,
• About any planned specific blood test (chromogranin A).

If you have been taking Omeprazole Genoptim for a long time (more than 1 year), your doctor will likely monitor you regularly. During these check-ups, tell your doctor about any new or unusual symptoms.

Children

Some children with chronic diseases may require long-term treatment, even though it is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Omeprazole Genoptim with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription. This is because Omeprazole Genoptim may affect the way other medicines work, and other medicines may affect the way Omeprazole Genoptim works.

• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections);
• Digoxin (used to treat heart rhythm disorders);
• Diazepam (used to treat anxiety, muscle tension, or epilepsy);
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Omeprazole Genoptim;
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you 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 chemotherapy medicine used to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Omeprazole Genoptim.

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

Omeprazole Genoptim with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Omeprazole Genoptim contains lactose and sucrose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Omeprazole Genoptim contains sodium

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

3. How to take Omeprazole Genoptim

Always take this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, consult your doctor or pharmacist.

Adults

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

• If your doctor has found that your esophagus is slightly damaged, the usual dose is 20 mg once daily for 4-8 weeks. Your doctor may prescribe a dose of 40 mg for a further 8 weeks if your esophagus has not healed;
• The recommended dose after healing of the esophagus is 10 mg once daily;
• If your esophagus has not been 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 prescribe the same dose for a further 2 weeks if the ulcer has not healed;
• If the ulcer has not healed, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may prescribe the same dose for a further 4 weeks if the ulcer has not healed;
• If the ulcer has not healed, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcers:

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

Treatment of ulcers caused by NSAIDs:

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

Prevention of ulcers caused by NSAIDs:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection:

• The usual dose of Omeprazole Genoptim is 20 mg twice daily for 1 week;
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

Treatment of excessive acid production in the stomach due to a growth 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 Omeprazole Genoptim.

Children and adolescents

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

• Omeprazole Genoptim can be taken by children over 1 year of age and weighing 10 kg or more. The dose will be determined by your doctor based on the child's weight.

Treatment of ulcers caused by Helicobacter pylori infection:

• Children over 4 years of age can take Omeprazole Genoptim. The dose for children will be determined by your doctor based on the child's weight;
• Your 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 or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated pellets that prevent the medicine from being broken down by stomach acid. It is essential to keep the pellets intact.

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, or mix the contents with a glass of water, non-carbonated fruit juice (e.g., apple, orange, or grapefruit), or applesauce.
• Always mix the contents just before drinking (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
• To ensure you take the full dose of Omeprazole Genoptim, rinse the glass with half a glass of water and drink it. 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. 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.

Stopping treatment with Omeprazole Genoptim

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

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 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);
• Reddening of the skin with blistering, peeling, or bleeding. This could be a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis;
• Jaundice (yellowing of the skin or eyes), dark urine, or fatigue, which can be signs of liver problems.

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

• Headache;
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas;
• Nausea or vomiting;
• Mild gastric polyps.

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles;
• Sleep disturbances (insomnia);
• Dizziness, tingling, or drowsiness;
• Vertigo (dizziness);
• Changes in liver function tests;
• Skin rash, hives, or itching;
• General feeling of being unwell and lack of energy.

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

• Blood problems, such as a reduced number of white blood cells or platelets, which may 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, which may lead to weakness, vomiting, and muscle cramps;
• Agitation, confusion, or depression;
• Changes in taste;
• Vision problems, such as blurred vision;
• Sudden wheezing or shortness of breath (bronchospasm);
• Dry mouth;
• Oral thrush (infection of the mouth);
• Fungal infections (thrush), which can affect the intestines;
• Liver problems, including jaundice, which can cause yellowing of the skin or eyes, dark urine, and fatigue;
• Hair loss (alopecia);
• Skin rash in areas exposed to sunlight;
• Joint pain (arthralgia) or muscle pain (myalgia);
• Severe kidney problems (interstitial nephritis);
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells);
• Aggression;
• Hallucinations (seeing, hearing, or feeling things that are not there);
• Severe liver problems leading to liver failure and encephalopathy;
• Sudden onset of a severe rash or blistering of the skin, which may be accompanied by high fever and joint pain (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• Muscle weakness;
• Breast enlargement in men (gynaecomastia).

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

• Colitis (inflammation of the colon, which can cause diarrhea).
• If you have taken Omeprazole Genoptim for more than 3 months, there is a risk of low magnesium levels in the blood. Low magnesium levels can cause fatigue, muscle cramps, seizures, and dizziness. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also 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 accompanied by joint pain.

In very rare cases, Omeprazole Genoptim may affect the number of white blood cells in the blood, leading to a lack of immune response. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local signs of infection 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) based on a blood test. It is essential to inform your doctor that you are taking Omeprazole Genoptim.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omeprazole Genoptim

Store in a temperature below 30°C.

Keep this medicine out of the 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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Omeprazole Genoptim contains

• The active substance is omeprazole. Each capsule of Omeprazole Genoptim contains 40 mg of omeprazole.
• The other ingredients are: sucrose, maize starch, lactose anhydrous, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, hypromellose phthalate, diethyl phthalate.
• The capsule shell contains: gelatin, indigo carmine (E 132), erythrosine (E 127).

What Omeprazole Genoptim looks like and contents of the pack

Omeprazole Genoptim is a capsule. The capsules are blue-violet in color. Each capsule contains 40 mg of omeprazole in the form of sugar pellets.

The pack contains 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

Poland

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