GOPRAZOL 20 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. 20 mg, enteric-coated hard capsules
   2. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
2. What is Goprazol Max and what is it used for
3. Important information before taking Goprazol Max
   1. When not to take Goprazol Max
   2. Warnings and precautions
   3. Use in children and adolescents
   4. Goprazol Max and other medicines
   5. Goprazol Max with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Goprazol Max contains sucrose
   9. Goprazol Max contains sodium
4. How to take Goprazol Max
   1. How to take this medicine
   2. What to do if you have trouble swallowing the capsules
   3. Missing a dose of Goprazol Max
   4. Taking more Goprazol Max than prescribed
   5. Stopping treatment with Goprazol Max
5. Possible side effects
   1. If you notice any of the following rare but serious side effects, stop taking Goprazol Max and contact a doctor immediately:
   2. Frequency not known (frequency cannot be estimated from the available data):
   3. Reporting side effects
6. How to store Goprazol Max
7. Contents of the pack and other information
   1. What Goprazol Max contains
   2. What Goprazol Max looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:
   5. Additional information

Leaflet attached to the packaging: patient information

Goprazol Max,

20 mg, enteric-coated hard capsules

Omeprazole

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

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. This medicine is available without a prescription. However, to achieve the best treatment result, Goprazol Max should be taken with caution.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Goprazol Max and what is it used for

Goprazol Max in the form of enteric-coated hard capsules contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of hydrochloric acid produced in the stomach.
Goprazol Max is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn and acid reflux).
Reflux occurs when acid flows back from the stomach into the esophagus (which connects the throat to the stomach), which can lead to the development of inflammation and accompanying pain. This can cause symptoms such as a burning sensation in the chest rising to the throat (heartburn) and a sour taste in the mouth (due to acid reflux).
In order to relieve symptoms, it may be necessary to take capsules for 2-3 consecutive days.

2. Important information before taking Goprazol Max

When not to take Goprazol Max

In case of any doubts before starting to take Goprazol Max, consult a doctor or pharmacist.

Warnings and precautions

Goprazol Max should not be taken for more than 14 days without consulting a doctor.
In case of no improvement and in case of worsening of symptoms, consult a doctor.
Goprazol Max may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Goprazol Max, consult a doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting blood or food;
• passing black stools (stool discolored with blood);
• severe or persistent diarrhea, as the use of omeprazole is associated with a slight increase in the frequency of infectious diarrhea;
• previous stomach ulcer or gastrointestinal surgery;
• continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks;
• persistent indigestion or heartburn for 4 or more weeks;
• jaundice or severe liver disease;
• age over 55 and new or changing symptoms recently;
• during treatment lasting more than a year;
• before a specific blood test (chromogranin A level);
• similar to Goprazol Max, which reduces stomach acid production.

Patients should not take omeprazole as a preventive measure.
Omeprazole may affect some tests (chromogranin A). To avoid this effect, omeprazole should be discontinued 5 days before the test.
With Goprazol Max treatment, serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If any symptoms of these serious skin reactions occur, stop taking Goprazol Max and seek medical help immediately.
While taking 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. The patient should report such symptoms to their doctor.
If a skin rash appears, especially in areas exposed to sunlight, the patient should tell their doctor as soon as possible, as it may be necessary to stop taking Goprazol Max. The patient should also report any other side effects, such as joint pain.

Use in children and adolescents

Goprazol Max is not intended for use in children and adolescents.

Goprazol Max and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription. This is important because Goprazol Max may affect the way some other medicines work, and some other medicines may affect the way Goprazol Max works.
Do not take Goprazol Max if you are taking a medicine containing nelfinavir(used to treat HIV infection).
Tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• ketokonazole, itraconazole, or voriconazole (medicines used to treat fungal infections);
• digoxin (used to treat heart failure and atrial fibrillation with rapid ventricular rate);
• diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy);
• phenytoin (an antiepileptic medicine). If you are taking phenytoin, your doctor will monitor your condition when starting or stopping Goprazol Max;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will monitor your condition when starting or stopping Goprazol Max;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used after organ transplantation and to treat atopic dermatitis);
• erlotinib (used to treat cancer);
• methotrexate (used to treat rheumatoid arthritis and some types of cancer) - if you are receiving high doses of methotrexate, your doctor may decide to temporarily stop omeprazole treatment;
• St. John's Wort (Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat symptoms of intermittent claudication);
• saquinavir (used to treat HIV infection);
• clopidogrel (used to prevent blood clots).

Goprazol Max with food and drink

Goprazol Max capsules can be taken before meals (on an empty stomach) or with a meal.

Pregnancy, breastfeeding, and fertility

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.
Before taking Goprazol Max, the patient should inform the doctor if she is pregnant or trying to become pregnant. The doctor will decide if the patient can take Goprazol Max at that time.
The medicine passes into breast milk. The doctor will decide if the breastfeeding patient can take Goprazol Max.

Driving and using machines

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

Goprazol Max contains sucrose

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

Goprazol Max contains sodium

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

3. How to take Goprazol Max

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The usual dose is: one 20 mg capsule once a dayfor 14 days.
If symptoms do not improve after this time, consult a doctor.
In order to relieve symptoms, it may be necessary to take capsules for 2-3 consecutive days.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules should be taken before meals (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 the acid in the stomach. It is important that the pellets are not damaged. These pellets contain the active substance omeprazole and are protected from breakdown in the stomach to allow it to be absorbed from the intestine. The pellets release the active substance in the intestine, where it is absorbed and then acts.

What to do if you have trouble swallowing the capsules

If you have trouble swallowing the capsules:

• Open the capsule and mix its contents with still water or mix with any acidic fruit juice (e.g., apple, orange, or pineapple) or apple sauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• In order to ensure that the patient has taken the entire dose, 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.

Missing a dose of Goprazol Max

Continue taking the medicine as prescribed, following the dosing schedule of Goprazol Max.
Do not take a double dose to make up for a missed dose.

Taking more Goprazol Max than prescribed

If you have taken more than the prescribed dose, consult a doctor or pharmacist immediately.

Stopping treatment with Goprazol Max

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following rare but serious side effects, stop taking Goprazol Max and contact a doctor immediately:

• Appearance of wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty breathing or swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. It may also be accompanied by a severe blistering reaction and bleeding from the lips, eyes, mouth, nose, and genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver problems.

Other side effects include:
Common side effects(occurring in less than 1 in 10 people):

• headache,
• effects on the stomach and intestines: diarrhea, constipation, stomach pain, gas (bloating),
• nausea or vomiting,
• mild stomach polyps.

Uncommon side effects(occurring in less than 1 in 100 people):

• swelling of the feet and ankles,
• sleep disturbance (insomnia),
• dizziness, tingling, and numbness, drowsiness,
• feeling of spinning (dizziness),
• changes in liver function test results,
• skin rash, hives, and itching,
• general feeling of being unwell and weakness.

Rare side effects(occurring in less than 1 in 1,000 people):

• blood problems, such as a decreased number of white blood cells or platelets. This may lead to weakness, easy bruising, or an 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, which may lead to weakness, vomiting, and muscle cramps,
• feeling agitated, confused, or depressed,
• change in taste,
• vision problems, such as blurred vision,
• sudden onset of wheezing or shortness of breath (bronchospasm),
• dry mouth,
• inflammation of the mouth,
• fungal infection, which may include the intestines,
• liver problems, including jaundice, which may 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,
• microscopic colitis.

Very rare side effects(occurring in less than 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 problems leading to liver failure and brain disease,
• sudden onset of a severe rash or blistering of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• muscle weakness,
• breast enlargement in men,
• hypomagnesemia (low magnesium levels in the blood).

In very rare cases, Goprazol Max 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 of your general condition or fever with local infection symptoms 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 result. It is important that you inform your doctor that you are taking this medicine.

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

Rash that may be accompanied by joint pain.
If you have taken Goprazol Max for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat.
If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels may lead to low potassium or calcium levels in the blood.
Your doctor may recommend regular blood tests to monitor magnesium levels.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Goprazol Max

Keep out of the sight and reach of children.
Do not take Goprazol Max after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Store in a temperature below 30°C. Store in the original package to protect from moisture.
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 Goprazol Max contains

The active substance of the medicine is omeprazole.
One enteric-coated hard capsule contains 20 mg of omeprazole.
The other ingredients of the medicine are:
Contents of the capsule:sucrose, pellets (containing, among others, cornstarch and sucrose), sodium lauryl sulfate (2.5% solution), anhydrous disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion.
Capsule ingredients:
Cap: gelatin, quinoline yellow (E 104), titanium dioxide (E 171), purified water.
Body: gelatin, quinoline yellow (E 104), titanium dioxide (E 171), purified water.

What Goprazol Max looks like and contents of the pack

Enteric-coated hard capsules, non-transparent, yellow capsules, containing spherical pellets of almost white to cream-white color.
The enteric-coated hard capsules are packaged in OPA/Aluminum/PVC/Aluminum blisters, placed in a cardboard box.
The pack contains 7 or 14 enteric-coated hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
[email protected]
Manufacturer
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain

Date of last revision of the leaflet:

Additional information

How can you avoid acid reflux and heartburn?
Changing your lifestyle can reduce or even eliminate symptoms such as acid reflux and heartburn.
Changes to consider include:

• stopping smoking,
• avoiding stress, if possible,
• eating small portions of low-fat foods,
• avoiding excessive alcohol consumption,
• avoiding eating meals shortly before bedtime,
• using several pillows to sleep, which will keep your head higher than your stomach, preventing acid from flowing back into the esophagus.