Goprazol max

Package leaflet: Information for the user

Goprazol Max,
20 mg, hard enteric-coated capsules
Omeprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as directed by your
doctor or pharmacist. This medicine is available without a prescription. However, to achieve the best
treatment outcome, Goprazol Max should be used carefully.

• 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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

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

Goprazol Max in the form of hard enteric-coated capsules contains an active substance called
omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines
work by reducing the amount of hydrochloric acid produced in the stomach.
Goprazol Max is used in adults for short-term treatment of symptoms of gastro-oesophageal reflux disease (GORD) (e.g. heartburn and regurgitation of acidic stomach contents – acid regurgitation).
Reflux refers to the backflow of acid from the stomach into the oesophagus (the tube connecting the throat to the stomach), which may lead to inflammation and associated pain. This may cause symptoms such as a burning pain in the chest rising up to the throat (heartburn) and a sour taste in the mouth (due to acid regurgitation).
To relieve symptoms, it may be necessary to take the capsules for 2–3 consecutive days.

2. Important information before using Goprazol Max

When not to use Goprazol Max

• 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 atazanavir or nelfinavir (used in the treatment of HIV infection).

If in any doubt, consult a doctor or pharmacist before starting to take Goprazol Max.

Warnings and precautions

Do not take Goprazol Max for longer than 14 days without consulting a doctor.
If there is no improvement in symptoms, or if symptoms worsen, seek medical advice.

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

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• passing black stools (stools discolored by blood);
• severe or persistent diarrhoea, as use of omeprazole is associated with a small increased risk of infectious diarrhoea;
• previous history of stomach ulcer or gastrointestinal surgery;
• continuous use of symptomatic treatment for indigestion or heartburn for 4 or more weeks;
• ongoing indigestion or heartburn lasting 4 or more weeks;
• occurrence of jaundice or severe liver disease;
• age over 55 years and new onset of symptoms or recent change in existing symptoms;
• during treatment lasting longer than one year;
• prior to a planned specific blood test (chromogranin A level);
• if the patient has ever experienced a skin reaction to a medicine;
• similar to Goprazol Max, which reduces gastric acid secretion.

Patients should not take omeprazole preventively.

Omeprazole may affect certain tests (chromogranin A). To avoid this effect, omeprazole should be discontinued five days before the test.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with Goprazol Max. If any symptoms related to these serious skin reactions described in section 4 occur, stop taking Goprazol Max and seek immediate medical help.

Kidney inflammation may occur during omeprazole treatment. Symptoms may include reduced urine volume or presence of blood in urine and/or allergic reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as discontinuation of Goprazol Max may be necessary. Also report any other adverse 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 currently taken or recently taken, as well as any medicines planned for use, including those obtained without a prescription. This is important because Goprazol Max may affect the action of certain other medicines, and some other medicines may affect the action of Goprazol Max.

Do not take Goprazol Max if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

The patient should inform the doctor or pharmacist if they are taking clopidogrel (used to prevent blood clots).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections);
• digoxin (used in the treatment of heart failure and atrial fibrillation with rapid ventricular response);
• diazepam (used to treat anxiety, reduce muscle tension, or in epilepsy treatment);
• phenytoin (an antiepileptic medicine). If the patient is taking phenytoin, the doctor will monitor the patient's condition when starting or stopping Goprazol Max;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will monitor the patient's condition when starting or stopping Goprazol Max;
• rifampicin (used in the treatment of tuberculosis);
• atazanavir (used in the treatment of HIV infection);
• tacrolimus (used during organ transplantation and in the treatment of atopic dermatitis);
• erlotinib (used in the treatment of cancer);
• methotrexate (used in the treatment of rheumatoid arthritis and certain types of cancer) – if the patient receives high doses of methotrexate, the doctor may decide to temporarily discontinue omeprazole treatment;
• St. John's wort (Hypericum perforatum) (used in the treatment of mild depression);
• cilostazol (used to treat symptoms of intermittent claudication, i.e. cramping pain in the lower limbs during walking);
• saquinavir (used in the treatment of HIV infection);
• clopidogrel (used to prevent blood clot formation).

Goprazol Max with food and drink

Goprazol Max capsules may be taken before meals (on an empty stomach) or with food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Before starting Goprazol Max, the patient should inform the doctor whether she is pregnant or trying to become pregnant. The doctor will decide whether she can take Goprazol Max during this time.

The medicine passes into breast milk. The doctor will decide whether a breastfeeding woman can take Goprazol Max.

Driving and using machines

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

Goprazol Max contains sucrose

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

Goprazol Max 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 take Goprazol Max

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose is: one 20 mg capsule once daily for 14 days.
If symptoms do not improve after this time, consult your doctor.
It may take 2-3 days of treatment before symptoms improve.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules should be taken before food (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 coated pellets that protect the medicine from being broken down by stomach acid. It is essential that the pellets remain undamaged. These pellets contain the active substance omeprazole and are protected from degradation in the stomach so that the substance can be absorbed in the intestine. The pellets release the active substance in the intestine, where it is absorbed and then acts.

What to do if you have difficulty swallowing the capsules
If you have difficulty swallowing the capsules:

• Open the capsule and mix its contents with still (non-carbonated) water or mix with 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 that the full dose of medicine is taken, rinse the glass thoroughly with half a glass of water and drink this liquid. Do not use milk or carbonated water. The solid particles contain the medicine – do not chew or crush them.

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

If you take more Goprazol Max than you should
If you take more than the recommended dose, seek advice from your doctor or pharmacist immediately.

Stopping treatment with Goprazol Max
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following rare but serious adverse reactions occur, stop taking Goprazol Max immediately and contact your doctor without delay:

• Wheezing, swelling of the lips, tongue or throat, rash, fainting, or difficulty breathing or swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. There may also be a severe blistering reaction and bleeding from the lips, eyes, mouth, nose, or genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with subcutaneous nodules 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 adverse reactions include:
Common adverse reactions (occur in up to 1 in 10 people):

• headache,
• stomach and intestinal problems: diarrhoea, constipation, abdominal pain, gas (bloating),
• nausea or vomiting,
• mild gastric polyps.

Uncommon adverse reactions (occur in up to 1 in 100 people):

• swelling of feet and ankles,
• sleep disturbances (insomnia),
• dizziness, tingling or prickling sensations, drowsiness,
• sensation of spinning (dizziness),
• changes in liver function test results,
• skin rash, urticaria (hives), and itching,
• general malaise and weakness.

Rare adverse reactions (occur in up to 1 in 1000 people):

• blood-related problems such as reduced numbers of white blood cells or platelets. This may lead to fatigue, easier bruising, or increased risk of infection,
• allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing,
• low blood sodium levels, which may lead to weakness, vomiting, and muscle cramps,
• feeling agitated, confused, or depressed,
• altered sense of taste,
• vision problems such as blurred vision,
• sudden onset of wheezing or shortness of breath (bronchospasm),
• dryness of the mouth,
• inflammation of the mucous membrane of the mouth,
• fungal infection which may affect the intestines,
• liver problems, 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,
• microscopic colitis.

Very rare adverse reactions (occur in fewer than 1 in 10,000 people):

• changes in blood counts including agranulocytosis (absence of white blood cells),
• aggression,
• seeing, feeling, or hearing things that are not real (hallucinations),
• severe liver problems leading to liver failure and encephalopathy,
• sudden onset of severe rash, blistering 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,
• hypomagnesemia (low magnesium levels in blood).

In very rare cases, Goprazol Max may affect the number of white blood cells in the blood,
which may lead to immunodeficiency. If the patient develops an infection with symptoms such as fever accompanied by severe worsening of 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, in such a situation, the patient informs the doctor about the medicine being taken.
Frequency unknown (frequency cannot be estimated from available data):
Rash which may be accompanied by joint pain.
If Goprazol Max 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, or rapid heartbeat. If any of these symptoms are observed, 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.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions 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.: (22) 49 21 301, fax: (22) 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 use Goprazol Max after the expiry date stated on the cardboard package following "EXP". The expiry date refers to the last day of the specified month.
Store below 30 °C. Keep in the original packaging to protect from moisture.
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 package and other information

What Goprazol Max contains
The active substance is omeprazole.
One enteric hard capsule contains 20 mg of omeprazole.
Other ingredients are:
Contents of the capsule: sucrose, granules (containing, among others, maize starch and sucrose), sodium lauryl sulfate (2.5% solution), disodium phosphate, mannitol, hypromellose 6 cP, polyethylene glycol 6000, talc, polysorbate 80, titanium dioxide (E 171), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion.
Capsule components:
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 hard capsules, opaque, yellow capsules containing spherical pellets ranging in colour from almost white to cream-white.
Enteric hard capsules are packed in blisters made of OPA/Aluminium/PVC/Aluminium, placed in a cardboard box.
The pack contains 7 or 14 enteric hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

Additional information
How can you avoid gastroesophageal reflux and heartburn?
Lifestyle changes may reduce or even eliminate symptoms such as gastroesophageal reflux and heartburn.
The following changes should be considered:

• Stopping smoking,
• Avoiding stress, if possible,
• Eating small meals low in fat,
• Avoiding excessive alcohol consumption,
• Avoiding eating meals shortly before bedtime,
• Using several pillows when sleeping so that the head is elevated higher than the stomach, which helps prevent acid reflux into the oesophagus.