Omeprazole apteo med

Package leaflet: Information for the patient

Omeprazole APTEO MED, 20 mg, enteric-coated hard capsules
Omeprazolum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine is available without a prescription. This medicine should always be used exactly as described in this
patient leaflet or as recommended by a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days, or if you feel worse, you should consult your doctor.

Table of contents of the leaflet:

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

Omeprazole APTEO MED contains the active substance omeprazole. It belongs to a group of medicines
called "proton pump inhibitors". These medicines work by reducing the amount of acid
produced in the stomach.
Omeprazole APTEO MED is used to treat symptoms of reflux (e.g. heartburn or regurgitation) in adults.
Reflux refers to the backflow of acidic stomach contents into the oesophagus, which may cause pain and inflammation of the oesophagus. The condition is characterized by a burning sensation in the chest (heartburn) and a sour taste in the mouth (regurgitation of acidic stomach contents).
Symptom relief may not occur until after 2–3 days of taking the medicine.

2. Important information before using Omeprazole APTEO MED

When not to use Omeprazole APTEO MED

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an allergic reaction 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).

Do not take Omeprazole APTEO MED if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with Omeprazole APTEO MED.

Warnings and precautions

Do not take Omeprazole APTEO MED for longer than 14 days without consulting a doctor. If symptoms do not improve or worsen after 14 days, contact a doctor.

Omeprazole APTEO MED may mask symptoms of other diseases. Therefore, if any of the following symptoms occur before or during treatment with Omeprazole APTEO MED, contact a doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting food or blood;
• passing black stools (blood-stained faeces);
• severe or persistent diarrhoea, as omeprazole use is associated with a slightly increased risk of infectious diarrhoea;
• if the patient has had a stomach ulcer or gastrointestinal surgery;
• if the patient has been using medicines for indigestion and heartburn for more than 4 weeks;
• if indigestion or heartburn persists for more than 4 weeks;
• if the patient has jaundice or another serious liver disease;
• if the patient is over 55 years old and has recently developed new symptoms.

Before starting Omeprazole APTEO MED, consult a doctor:

• if the patient has ever had a skin reaction to a medicine similar to Omeprazole APTEO MED that reduces gastric acid secretion;
• if the patient is scheduled for a specific blood test (chromogranin A level).

If a skin rash develops, especially in areas exposed to sunlight, inform the doctor as soon as possible, as treatment with Omeprazole APTEO MED may need to be discontinued. Also report any other adverse effects, such as joint pain.

Omeprazole APTEO MED is not recommended for preventive use.

If Omeprazole APTEO MED has been used for longer than the maximum recommended period of 14 days, the patient should read the following information.

If Omeprazole APTEO MED has been taken for more than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

During treatment with omeprazole, 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 the doctor.

Children and adolescents

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

Omeprazole APTEO MED and other medicines

Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use, including those available without a prescription. This is important because Omeprazole APTEO MED may affect the action of certain medicines, and some other medicines may affect the action of Omeprazole APTEO MED.

Do not take Omeprazole APTEO MED if taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform the doctor or pharmacist if the patient is taking clopidogrel (used to prevent blood clots).

Inform the doctor or pharmacist if 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, muscle tension, or epilepsy);
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will monitor the patient’s condition when starting or stopping Omeprazole APTEO MED;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient when starting or stopping Omeprazole APTEO MED;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used after organ transplantation);
• St John’s wort (Latin: 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 for cancer treatment) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue 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 the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but its effect on the infant is unlikely when used at therapeutic doses. The decision on whether a breastfeeding woman can take Omeprazole APTEO MED will be made by the doctor.

Driving and operating machinery

Omeprazole APTEO MED does not affect the ability to drive or operate tools and machinery. However, adverse effects such as dizziness or visual disturbances may occur (see section 4). If these occur, do not drive or operate mechanical equipment.

Omeprazole APTEO MED contains lactose, sucrose, and sodium

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

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

3. How to take Omeprazole APTEO MED

This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 20 mg once daily for 14 days. If symptoms persist after this period,
you should contact your doctor.
Symptom relief may not occur until after 2–3 days of taking the medicine.

Instructions for taking the medicine

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

What to do if you have difficulty swallowing the capsules
If a patient has difficulty swallowing the capsule:

• Open the capsule and swallow the contents directly with a glass of water, or mix the contents with a glass of still water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or with apple puree.
• Always mix the preparation immediately before use (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure the full dose is taken, rinse the glass thoroughly with half a glass of water and drink this liquid as well. Do not use milk or carbonated water. The solid particles contain the medicine – do not chew or crush them.

If you take more Omeprazole APTEO MED than you should
If you take more than the recommended dose, contact your doctor or pharmacist immediately.

If you forget to take Omeprazole APTEO MED
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.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If you notice any of the following rare but serious adverse effects, stop taking Omeprazole APTEO MED
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).
• Redness of the skin with formation of blisters 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.
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver dysfunction.

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 disturbances (insomnia);
• feeling of dizziness, tingling and pricking sensation, drowsiness;
• sensation of spinning (vertigo);
• 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 1,000 people):

• blood-related problems, such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising or increased likelihood of developing infections;
• 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 sense of taste;
• vision disturbances, such as blurred vision;
• sudden sensation of wheezing or shortness of breath (bronchospasm);
• dryness of the mouth;
• inflammation of the mucous membrane of the mouth;
• a fungal infection known as "thrush", which may affect the intestines;
• liver dysfunction, including jaundice, which may cause yellowing of the skin, dark urine and fatigue;
• hair loss (alopecia);
• skin rash occurring during 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 morphology including agranulocytosis (absence 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 or formation of blisters on 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 males.

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

• inflammation of the intestines (causing diarrhoea);
• if Omeprazole APTEO MED has been taken for longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels;
• rash accompanied by joint pain.

In very rare cases, Omeprazole APTEO MED 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 well-being, 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 in such a situation the patient informs the doctor or pharmacist about the medicine being taken.

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

5. How to store Omeprazole APTEO MED

Store 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 pack after EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

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

What Omeprazole APTEO MED looks like and contents of the pack
Omeprazole APTEO MED is a capsule. The capsules are green in colour. Each capsule contains 20 mg of omeprazole in the form of pellets.
The pack contains 7 or 14 capsules in blisters, packed in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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