Omeprazole genoptim

Package leaflet: Information for the patient

Omeprazole Genoptim, 40 mg, hard enteric-coated capsules
Omeprazolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• 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 similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Omeprazole Genoptim is and what it is 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 pack and other information

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

Omeprazole Genoptim contains the active substance called omeprazole. It belongs to a group of medicines known as proton pump inhibitors, which work by reducing the amount of acid produced in the stomach.

Omeprazole Genoptim is used to treat the following conditions:

In adults:

• Gastro-esophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus (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 in the 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). Omeprazole Genoptim may also be used to prevent ulcers during NSAID treatment.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).

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

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

Children and adolescents aged above 4 years

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

2. Important information before using Omeprazole Genoptim

When not to use Omeprazole Genoptim

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazol, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Omeprazole Genoptim if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with Omeprazole Genoptim.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole Genoptim.
Omeprazole Genoptim may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Omeprazole Genoptim, inform your doctor immediately:

• Unexplained weight loss and difficulty swallowing;
• Stomach pain or indigestion;
• Vomiting food or blood;
• Passing black stools (stools discolored by blood);
• Severe or persistent diarrhoea, as use of omeprazole is associated with a slight increase in the risk of infectious diarrhoea;
• Severe liver problems;
• If the patient has ever had a skin reaction to a medicine similar to Omeprazole Genoptim that reduces gastric acid secretion;
• If planning a specific blood test (chromogranin A levels).

If Omeprazole Genoptim is used long-term (longer than 1 year), the patient will likely require regular medical monitoring. During visits to the doctor, report any new or unusual symptoms or circumstances.
Taking proton pump inhibitors such as Omeprazole Genoptim, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if osteoporosis has been diagnosed or if you are taking corticosteroid medicines (which may increase the risk of osteoporosis).
If a skin rash develops, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue Omeprazole Genoptim. Also inform your doctor about any other side effects, such as joint pain.
Children
Some children with chronic illnesses 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.
Omeprazole Genoptim and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without a prescription. This is important because Omeprazole Genoptim may affect the action of certain other medicines, and some other medicines may affect the action of Omeprazole Genoptim.
Do not take Omeprazole Genoptim if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform 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 disorders);
• Diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment);
• Phenytoin (used in epilepsy treatment). If the patient is taking phenytoin, the doctor will need to monitor the patient when starting and stopping Omeprazole Genoptim;
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient when starting and stopping Omeprazole Genoptim;
• Rifampicin (used to treat tuberculosis);
• Atazanavir (used in the treatment of HIV infection);
• Tacrolimus (used after organ transplantation);
• St John's wort (Hypericum perforatum) (used to treat mild depression);
• Cilostazol (used to treat intermittent claudication);
• Saquinavir (used in the treatment of HIV infection);
• Clopidogrel (used to prevent blood clots);
• Erlotinib (used in cancer treatment);
• Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient is taking high doses of methotrexate, the doctor may temporarily discontinue Omeprazole Genoptim.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole Genoptim to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.
Omeprazole Genoptim with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before starting this medicine.
Omeprazole passes into breast milk, but its effect on the infant is unlikely when used at therapeutic doses. The decision whether a breastfeeding woman can take Omeprazole Genoptim will be made by the doctor.
Driving and using machines
Omeprazole Genoptim does not affect the ability to drive or operate tools and machines. However, side effects such as dizziness and visual disturbances may occur (see section 4 of this leaflet). If these occur, do not drive or operate mechanical equipment.
Omeprazole Genoptim contains lactose and sucrose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Omeprazole Genoptim contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Omeprazole Genoptim

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will depend on your
medical condition and age.
Dosage recommendations are given below.

Use in adults
Treatment of GERD symptoms such as heartburn and acid regurgitation:

• If your doctor has determined that your oesophagus has been slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend taking 40 mg for an additional 8 weeks if the oesophagus has not healed;
• The recommended dose after healing of the oesophagus is 10 mg once daily;
• If the oesophagus is not damaged, the usual dose is 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 (stomach ulcers):

• The recommended 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 recommended 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 (non-steroidal anti-inflammatory drugs):

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

Prevention of recurrence of duodenal and gastric ulcers during treatment with NSAIDs (non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by bacterial infection Helicobacter pylori:

• The usual dose of Omeprazole Genoptim is 20 mg twice 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 pancreatic tumour (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and decide how long treatment with Omeprazole Genoptim should continue.

Use in children and adolescents
Treatment of GERD symptoms such as heartburn and acid regurgitation:

• Omeprazole Genoptim may be used in children over 1 year of age and weighing more than 10 kg. The dose is based on body weight and will be individually determined by the treating doctor.

Treatment of ulcers caused by bacterial infection Helicobacter pylori:

• Children over 4 years of age may take Omeprazole Genoptim. The dose for children depends on body weight and will be individually determined by the treating doctor;
• 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.
• 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 designed to protect the medicine from breakdown by stomach acid. It is important that the pellets remain intact.

What to do if you have difficulty swallowing the capsules (in adults or children)
If an adult or child has difficulty swallowing the 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 mixture immediately before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure the patient receives the full dose of Omeprazole Genoptim, rinse the glass thoroughly with half a glass of water and drink this liquid as well. The solid particles contain the medicine – do not chew or crush them.

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

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 missed dose.

Stopping Omeprazole Genoptim
Do not stop taking Omeprazole Genoptim without first 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 effects

Like all medicines, Omeprazole Genoptim may cause adverse effects, although not everyone experiences them.
If you notice any of the following rare but serious adverse effects, stop taking Omeprazole Genoptim immediately and contact your doctor without delay:

• Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction);
• Reddening of the skin with blistering or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver function disorders.

Other adverse effects include:
Common adverse effects (may affect up to 1 in 10 people):

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

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

• Swelling of feet and ankles;
• Sleep disturbance (insomnia);
• Dizziness, tingling and pricking sensations, drowsiness;
• Sensation of spinning (dizziness);
• Changes in liver function test results;
• Skin rash, nodular rash (urticaria), and skin itching;
• General malaise and lack of energy.

Rare adverse effects (may affect up to 1 in 1000 people):

• Blood-related problems, such as reduced numbers of white blood cells or platelets. This may lead to weakness, easier bruising, or increased likelihood of infection;
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing;
• Low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps;
• Feeling of restlessness, confusion or depression;
• Altered taste sensation;
• Vision problems, such as blurred vision;
• Sudden sensation of wheezing or breathlessness (bronchospasm);
• Dryness of the mouth;
• Inflammation of the mucous membrane of the mouth;
• Fungal infection known as "thrush", which may affect the intestines;
• Liver function disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue;
• Hair loss (alopecia);
• Skin rash upon exposure to sunlight;
• Joint pain (arthralgia) or muscle pain (myalgia);
• Severe kidney problems (interstitial nephritis);
• Increased sweating.

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

• Changes in blood count, including agranulocytosis (lack of white blood cells);
• Aggression;
• Seeing, feeling or hearing things that are not real (hallucinations);
• Severe liver function disorders leading to liver failure and encephalopathy;
• Sudden onset of severe rash or blistering of the skin 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 (causing diarrhoea).
• If Omeprazole Genoptim has been taken for longer than three months, there may be a decrease in magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash, possibly accompanied by joint pain.

In very rare cases, Omeprazole Genoptim 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 severe 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 deficiency of white blood cells (agranulocytosis), based on blood test results. It is important that the patient informs the doctor about the medicine being taken in such a situation.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Omeprazole Genoptim

Store below 30°C.
Keep 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 stated 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. Omeprazole Genoptim capsules contain 40 mg of omeprazole.
• Other ingredients are: sucrose, beads, anhydrous lactose, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, hypromellose phthalate, diethyl phthalate.
• Capsule shell composition: gelatin, indigotine (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 colour. Each
capsule contains 40 mg of omeprazole in the form of sugar spheres.
The pack contains 28 capsules in blisters, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland
Manufacturer
Industria Química y Farmacéutica Vir, S.A
C/Laguna 66-70
Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain