Goprazol 20 mg

Package leaflet: Information for the patient

Goprazol 20 mg, 20 mg, hard enteric-coated capsules
Omeprazolum
Read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• 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 identical.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Goprazol is and what it is used for

Goprazol contains the active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.

Goprazol is used to treat the following conditions:

In adults:

• Gastro-esophageal reflux disease (GERD). This occurs when stomach acid 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). Goprazol may also be used to prevent ulcers from developing during NSAID treatment.
• Excessive stomach acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).

In children:

Children above 1 year of age and ≥ 10 kg body weight

• Gastro-esophageal reflux disease (GERD). This 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 above 4 years of age

• 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 Goprazol

When not to use Goprazol

• if the patient has a known allergy (hypersensitivity) to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an allergy 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).

If there are any doubts before starting to take Goprazol, the patient should
speak to a doctor or pharmacist.
Warnings and precautions
Talk to a doctor or pharmacist before taking Goprazol.
Severe skin reactions have been reported during treatment with omeprazole, including
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia
and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
If any symptoms related to these severe skin reactions described in section 4 occur, treatment with omeprazole should be stopped immediately and medical help should be sought without delay.
Goprazol may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Goprazol, contact a doctor immediately:

• unexplained weight loss and difficulty swallowing,
• stomach pain or indigestion,
• vomiting of food or blood,
• passing black stools (blood-stained faeces),
• severe or persistent diarrhoea, as there is a slight increase in the risk of infectious diarrhoea associated with the use of omeprazole,
• severe liver problems,
• taking proton pump inhibitors such as Goprazol, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• if the patient has currently or previously experienced a skin reaction after taking a medicine similar to Goprazol used to reduce stomach acid secretion,
• inform your doctor about a planned specific blood test (chromogranin A levels).

Inflammation of the kidneys may occur during treatment with omeprazole. Symptoms may include
reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as
fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.
If Goprazol is used long-term (longer than 1 year), the patient will likely require careful and regular medical monitoring. During visits to the doctor, report any new or unusual symptoms or circumstances.
If a skin rash appears, especially in areas exposed to sunlight, inform the doctor as soon as possible, as it may be necessary to discontinue treatment with Goprazol. Remember to also inform the doctor about any other adverse effects, such as joint pain.
Children
Some children with chronic diseases may require long-term treatment, although this is not recommended. This medicine should not be given to children under 1 year of age or weighing less than 10 kg.
Goprazol with other medicines
Tell your doctor about all medicines currently taken or recently used, including those available without a prescription. This is important because Goprazol may affect how some other medicines work, and some other medicines may affect how Goprazol works.
Do not take Goprazol 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 to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting or stopping Goprazol.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient’s condition when starting or stopping Goprazol.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used in organ transplantation).
• 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 (used to treat rheumatoid arthritis and certain types of cancer) – if the patient is receiving high doses of methotrexate, the doctor may decide to temporarily discontinue treatment with Goprazol.

If the doctor has prescribed the patient antibiotics amoxicillin and clarithromycin along with Goprazol
to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.
Goprazol with food and drink
See section 3.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the infant when therapeutic doses are used. The doctor will decide whether a breastfeeding patient can take Goprazol during this period.
Driving and using machines
Goprazol 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 contains sucrose
If the patient has been diagnosed with an intolerance to certain sugars, the patient should contact a doctor before starting this medicine.
Goprazol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Goprazol

Goprazol should always be taken exactly as directed by your doctor or pharmacist. In case of
doubt, contact your doctor or pharmacist again.
Your doctor will inform you how many capsules to take and for how long. This will
depend on your medical condition and age.

Recommended dose of Goprazol:
Adults:
Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If your doctor has diagnosed mild damage to your oesophagus, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend taking 40 mg once daily for an additional 8 weeks if the oesophagus has not healed.
• The usual dose after healing of the oesophagus is typically 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

Treatment of ulcers in the upper part of the small intestine (duodenal ulcers):

• The usual dose is 20 mg once daily for 2 weeks. Your doctor may recommend continuing the same dose for another 2 weeks if 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 stomach ulcers (gastric ulcers):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for another 4 weeks if 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 usual 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 usual dose is 20 mg once daily for 4–8 weeks.

Prevention of recurrence of duodenal and gastric ulcers during NSAID (non-steroidal anti-inflammatory drug) therapy:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by bacterial infection Helicobacter pylori and prevention of their recurrence:

• The usual dose of Goprazol 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 pancreatic tumour (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg daily.

Your doctor will adjust the dose according to your individual needs and decide how long you should continue taking the medicine.

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

• Children above 1 year of age and weighing more than 10 kg may take Goprazol. The dose for children depends on body weight. Your doctor will prescribe a dose appropriate for the child.

Treatment of ulcers caused by bacterial infection Helicobacter pylori and prevention of their recurrence:

• Children above 4 years of age may take Goprazol. The dose for children depends on body weight. Your doctor will prescribe a dose appropriate for the child.
• Your doctor will also prescribe two antibiotics for the child: amoxicillin and clarithromycin.

How to take this medicine

• It is recommended to take the capsules in the morning.
• Capsules may be taken with or without food.
• 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 intact.

What to do if you have difficulty swallowing capsules (in adults or children)

• If an adult or child has difficulty swallowing capsules:
  • Open the capsule and swallow the contents directly with a glass of water, or mix the contents into a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, or pineapple juice), or apple puree.
  • Always mix the mixture immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes of preparation.
• To ensure the patient receives the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

Taking more Goprazol than recommended
If you take more Goprazol than recommended, contact your doctor or pharmacist immediately.

If you miss a dose of Goprazol
If you miss a dose, take it as soon as possible. However, do not take the missed dose if it is almost time for your next dose; instead, continue taking the medicine as prescribed.
Do not take a double dose to make up for a missed dose.

Stopping Goprazol
Do not stop taking Goprazol 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following rare (may occur in less than 1 in 1,000 people) or very rare (may occur in less than 1 in 10,000 people), but serious adverse reactions, stop taking Goprazol and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering 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. (very rare)
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue, which may be signs of liver problems. (rare)

Adverse reactions may occur with a certain frequency, defined as follows:
Other adverse reactions include:
Common adverse reactions (may occur in 1 in 10 people)

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

Uncommon adverse reactions (may occur in 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or prickling sensation, 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 reactions (may occur in 1 in 1,000 people)

• Blood problems such as reduced numbers of white blood cells or platelets. This may lead to weakness, easy bruising or increased risk of infection.
• 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 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 and is caused by fungi.
• 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 reactions (may occur in 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 problems leading to liver failure and encephalopathy.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

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

• Inflammation of the intestine (leading to diarrhoea).
• If you have taken Goprazol 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 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, sometimes accompanied by joint pain.

In very rare cases, Goprazol may affect the number of white blood cells in the blood, leading to immunodeficiency. If the patient develops an infection with symptoms such as fever accompanied by a serious deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, consult a doctor 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.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Goprazol 20 mg

Keep out of the sight and reach of children.
Do not use Goprazol 20 mg after the expiry date stated on the carton, bottle, label or blister after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25 °C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Goprazol contains

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• Other ingredients are:
  • Capsule contents: sucrose, pellets (containing maize starch and sucrose), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, polyethylene glycol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion.
  • Capsule shell: gelatin. The 20 mg capsules also contain the colouring agents quinoline yellow (E 104) and titanium dioxide (E 171).

What Goprazol looks like and contents of the pack
Enteric-release hard capsule.
Goprazol 20 mg is an opaque yellow capsule containing spherical microgranules ranging in colour from almost white to creamy white.
The capsules are available in blister packs containing 7, 14, 15, 28, 30, 35, 50, 56, 60, 90, 98, 100, 140, 280 and 500 capsules, and in HDPE bottles containing 5, 7, 14, 15, 28, 30, 50, 56, 60, 62, 90, 100, 110 and 500 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
Manufacturer:
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain

For information on the product names in the countries of the European Economic Area, please contact the Marketing Authorisation Holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
tel.: 71 330 50 80