OMEPRAZOLE 20 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Omeprazole APTEO MED, 20 mg, Gastro-Resistant Capsules, Hard
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
3. What is Omeprazole APTEO MED and what is it used for
4. Important information before taking Omeprazole APTEO MED
   1. When not to take Omeprazole APTEO MED
   2. Warnings and precautions
   3. Children and adolescents
   4. Omeprazole APTEO MED and other medicines
   5. Omeprazole APTEO MED with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Omeprazole APTEO MED contains lactose, sucrose, and sodium
5. How to take Omeprazole APTEO MED
   1. How to take the medicine
   2. What to do if you have difficulty swallowing the capsules
   3. Taking a higher dose of Omeprazole APTEO MED than recommended
   4. Missing a dose of Omeprazole APTEO MED
6. Possible side effects
   1. If you experience any of the following rare but serious side effects, stop taking Omeprazole APTEO MED and immediately consult your doctor:
   2. Common side effects (may affect up to 1 in 10 people):
   3. Uncommon side effects (may affect up to 1 in 100 people):
   4. Very rare side effects (may affect up to 1 in 10,000 people):
   5. Frequency not known (cannot be estimated from the available data):
   6. Reporting side effects
7. How to store Omeprazole APTEO MED
8. Contents of the pack and other information
   1. What Omeprazole APTEO MED contains
   2. What Omeprazole APTEO MED looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

Omeprazole APTEO MED, 20 mg, Gastro-Resistant Capsules, Hard

Omeprazole

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

This medicine is available without a prescription. This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, you should consult your doctor.

Table of Contents of the Package Leaflet:

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

1. What is Omeprazole APTEO MED and what is it used for

Omeprazole APTEO MED contains the active substance omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. Their action is to reduce the amount of acid produced in the stomach.
Omeprazole APTEO MED is used to treat symptoms of reflux (e.g., heartburn or regurgitation of stomach contents) in adults.
Reflux occurs when acidic stomach contents flow back into the esophagus, causing pain and inflammation of the esophagus. The disease is characterized by a burning sensation in the chest (heartburn) and a sour taste in the mouth (regurgitation of acidic stomach contents).
Relief of symptoms may occur only after 2-3 days of taking the medicine.

2. Important information before taking Omeprazole APTEO MED

When not to take Omeprazole APTEO MED

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with an allergy 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 APTEO MED if any of the above points apply to you.
In case of any doubts before starting to take Omeprazole APTEO MED, consult your doctor or pharmacist.

Warnings and precautions

Do not take Omeprazole APTEO MED for longer than 14 days without consulting your doctor. If after 14 days there is no improvement or you feel worse, you should consult your doctor.
Omeprazole APTEO MED may mask the symptoms of other diseases. For this reason, if any of the following symptoms occur before starting or during treatment with Omeprazole APTEO MED, you should immediately consult your doctor:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting blood or black tarry stools;
• severe or persistent diarrhea, as the use of omeprazole is associated with a slight increase in the frequency of infectious diarrhea;
• if you have had stomach ulcers or surgery in the digestive tract;
• if you are taking antacids or heartburn medicines for a period longer than 4 weeks;
• if you have indigestion or heartburn that persists for more than 4 weeks;
• if you have jaundice or other severe liver disease;
• if you are over 55 years old and have recently experienced new symptoms.

Before starting to take Omeprazole APTEO MED, consult your doctor:

• if you have ever had a skin reaction after taking a medicine that reduces stomach acid production, similar to Omeprazole APTEO MED;
• if you are going to have a specific blood test (chromogranin A levels).

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Omeprazole APTEO MED. You should also tell your doctor about any other side effects, such as joint pain.
Omeprazole APTEO MED is not recommended for use as a preventive measure.
If you have taken Omeprazole APTEO MED for a period longer than the maximum recommended duration of 14 days, you should read the following information.
If you have taken Omeprazole APTEO MED 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 heart rate. If you experience any of these symptoms, you should immediately inform your doctor. Low magnesium levels can lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
During treatment with omeprazole, 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. You should report such symptoms to your doctor.

Children and adolescents

Omeprazole APTEO MED is not intended for use in children and adolescents.

Omeprazole APTEO MED and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription. This is important because Omeprazole APTEO MED may affect the action of some medicines, and some other medicines may affect the action of Omeprazole APTEO MED.
Do not take Omeprazole APTEO MED if you are taking a medicine containing nelfinavir (used to treat HIV infection).
You should tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
You should inform your doctor or pharmacist if you are taking any of the following medicines:

• ketokonazole, 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 monitor your condition when starting or stopping Omeprazole APTEO MED;
• 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 APTEO MED;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used after organ transplants);
• 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 in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Omeprazole APTEO MED.

Omeprazole APTEO MED with food and drink

Omeprazole APTEO MED can be taken with food or on an empty stomach.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole passes into breast milk, but its effect on the baby is unlikely when the medicine is used at therapeutic doses. Whether a breastfeeding woman can take Omeprazole APTEO MED will be decided by her doctor.

Driving and using machines

Omeprazole APTEO MED does not affect the ability to drive or use machines. However, it is possible to experience side effects such as dizziness and visual disturbances (see section 4). If these occur, do not drive or operate machinery.

Omeprazole APTEO MED contains lactose, sucrose, and sodium

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially sodium-free.

3. How to take Omeprazole APTEO MED

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
The recommended dose is 20 mg once a day for 14 days. If symptoms persist after this period, you should consult your doctor.
Relief of symptoms may occur only after 2-3 days of taking the medicine.

How to take the medicine

• It is recommended to take the capsules in the morning.
• Omeprazole APTEO MED 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, 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

If you have problems swallowing a capsule, you should:

• Open the capsule and swallow the contents directly, with a glass of water, or pour the contents into a glass of still water, any acidic fruit juice (e.g., apple, orange, or pineapple), 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 the medicine, rinse the glass with half a glass of water and drink the liquid. Do not usemilk or carbonated water. The solid particles contain the medicine - do not chew or crush them.

Taking a higher dose of Omeprazole APTEO MED than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.

Missing a dose of Omeprazole APTEO MED

If you miss a dose due to forgetting, you should take the dose as soon as you remember.
If it is time for your next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following rare but serious side effects, stop taking Omeprazole APTEO MED and immediately consult your doctor:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. It is also possible to develop large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver disorders.

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 (bloating);
• nausea or vomiting;
• mild stomach polyps.

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

• swelling of the feet and ankles;
• sleep disturbances (insomnia);
• feeling of dizziness, tingling, and numbness;
• feeling of spinning (vertigo);
• changes in liver function tests;
• skin rash, hives, and itching;
• general feeling of being unwell and lack of energy.

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

• blood disorders, such as reduced white blood cell count or platelet count. This can lead to weakness, easier 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;
• visual disturbances, such as blurred vision;
• sudden wheezing or shortness of breath (bronchospasm);
• dry mouth;
• inflammation of the mouth;
• infection known as "thrush", which can affect the intestines and is caused by fungi;
• liver disorders, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue;
• hair loss (alopecia);
• skin rash during sun exposure;
• 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;
• seeing, feeling, or hearing things that do not exist (hallucinations);
• severe liver disorders leading to liver failure and brain inflammation;
• sudden onset of severe skin rash or blistering, or peeling of the skin. 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 (cannot be estimated from the available data):

• inflammation of the intestines (causing diarrhea);
• if you have taken Omeprazole APTEO MED 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 heart rate. If you experience any of these symptoms, you should immediately inform your doctor. Low magnesium levels can lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels;
• skin rash that may be accompanied by joint pain.

In very rare cases, Omeprazole APTEO MED may affect the white blood cell count, leading to a lack of immunity. If you experience an infection with symptoms such as fever with a serious deterioration in general condition or fever with symptoms of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential to inform your doctor or pharmacist about the medicine you are taking.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of 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
Side effects can also be reported 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 APTEO MED

Store in a temperature below 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine 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 pack and other information

What Omeprazole APTEO MED contains

The active substance of the medicine is omeprazole. Omeprazole APTEO MED capsules contain 20 mg of omeprazole.
The other ingredients are: sucrose, pellets, lactose anhydrous, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, hypromellose phthalate, diethyl phthalate.
The capsule shell contains: gelatin, indigo carmine (E 132), quinoline yellow (E 104).

What Omeprazole APTEO MED looks like and contents of the pack

Omeprazole APTEO MED is available in the form of capsules. The capsules are green in color. Each capsule contains 20 mg of omeprazole in the form of pellets.
The pack contains 7 or 14 capsules in blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel.: 22 32 16 240

Manufacturer

Industria Química y Farmacéutica Vir, S.A
C/Laguna, 66-68-70 Poligono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain

Date of last revision of the package leaflet: