Gasec-20 gastrocaps

Package leaflet: information for the patient

Gasec-20 Gastrocaps, 20 mg, capsules
Omeprazolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Gasec-20 Gastrocaps is and what it is used for
2. Important information before taking Gasec-20 Gastrocaps
3. How to take Gasec-20 Gastrocaps
4. Possible side effects
5. How to store Gasec-20 Gastrocaps
6. Contents of the pack and other information

1. What Gasec-20 Gastrocaps is and what it is used for
Gasec-20 Gastrocaps 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.
Gasec-20 Gastrocaps is used to treat the following conditions:
In adults:

• Gastro-esophageal reflux disease (GERD). This condition 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 eradicate the infection and allow ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Gasec-20 Gastrocaps may also be used to prevent the development of ulcers 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 condition 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 (spitting up), 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, your doctor may also prescribe antibiotics to eradicate the infection and allow ulcers to heal.

2. Important information before taking Gasec-20 Gastrocaps

When not to take Gasec-20 Gastrocaps

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if you have impaired liver function and are taking clarithromycin;
• if you are taking a medicine containing atazanavir, e.g. Reyataz (used in the treatment of HIV infection);
• if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Gasec-20 Gastrocaps if any of the above apply to you.
If you are unsure, speak to your doctor or pharmacist before starting treatment with Gasec-20 Gastrocaps.
Warnings and precautions
Talk to your doctor or pharmacist before taking Gasec-20 Gastrocaps.
Severe 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 Gasec-20 Gastrocaps. If you notice any symptoms related to these severe skin reactions described in section 4, stop taking Gasec-20 Gastrocaps immediately and seek medical help.
Gasec-20 Gastrocaps may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Gasec-20 Gastrocaps, inform your doctor:

• Unexplained weight loss and difficulty swallowing
• Stomach pain or indigestion
• Vomiting food or blood
• Passing black stools (blood in the stool)
• Severe or persistent diarrhoea, as omeprazole use has been associated with a slightly increased risk of infectious diarrhoea
• Severe liver problems
• If you have previously had a skin reaction to a medicine similar to Gasec-20 Gastrocaps that reduces stomach acid secretion
• Planned specific blood test (chromogranin A level)
• Kidney inflammation may occur during omeprazole treatment. Symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Report such symptoms to your doctor.
• If you have previously had a skin reaction to a medicine similar to Gasec-20 Gastrocaps that reduces stomach acid secretion
• Planned specific blood test (chromogranin A level)
• Kidney inflammation may occur during omeprazole treatment. Symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Report such symptoms to your doctor.

If you are taking Gasec-20 Gastrocaps long-term (longer than 1 year), you will likely require regular medical monitoring. Report any new or unusual symptoms or circumstances during your doctor visits.
When taking proton pump inhibitors such as Gasec-20 Gastrocaps, especially for longer than one year, there may be an increased risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor immediately, as treatment with Gasec-20 Gastrocaps may need to be discontinued. Also report any other adverse effects such as joint pain.
This medicine may affect how your body absorbs vitamin B({12}), especially if taken for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B({12}) levels:

• Extreme tiredness or lack of energy
• Tingling and numbness
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Vision disturbances
• Memory problems, confusion, depression

Children
Some children with chronic diseases may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.
Use of proton pump inhibitors may slightly increase the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter. Hospitalized patients may also be at risk of Clostridium difficile infection.
Omeprazole may affect the results of certain tests (chromogranin A measurement). To avoid omeprazole affecting test results, discontinue omeprazole 5 days before the test.
Gasec-20 Gastrocaps and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription. This is important because Gasec-20 Gastrocaps may affect how other medicines work, and some other medicines may affect the action of Gasec-20 Gastrocaps.
Do not take Gasec-20 Gastrocaps 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, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart conditions)
• Diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy)
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Gasec-20 Gastrocaps
• 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 Gasec-20 Gastrocaps
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplantation)
• Methotrexate (used in rheumatoid arthritis and certain cancers) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue Gasec-20 Gastrocaps
• 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 in certain cancers)

If your doctor has prescribed amoxicillin and clarithromycin together with Gasec-20 Gastrocaps to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about all other medicines you are taking.
Gasec-20 Gastrocaps with food and drink
Gasec-20 Gastrocaps capsules can be taken with food or on an empty stomach. See section 3.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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. Whether a breastfeeding woman can take Gasec-20 Gastrocaps will be decided by the doctor.
Driving and operating machinery
Gasec-20 Gastrocaps does not affect the ability to drive or operate tools and machinery. However, side effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate mechanical equipment.
Gasec-20 Gastrocaps contains sucrose and sodium.
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Gasec-20 Gastrocaps

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The doctor will inform the patient how many capsules to take and for how long. This will
depend on the patient's health condition and age.
Dosage recommendations are provided below.

Use in adults:
Treatment of GERD symptoms such as heartburn and acid regurgitation:

• If the doctor has determined that the patient's esophagus has been slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. The doctor may recommend taking a dose of 40 mg for an additional 8 weeks if the esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

**Treatment of **(duodenal ulcers):

• The recommended dose is 20 mg once daily for 2 weeks. The doctor may recommend continuing the same dose for another 2 weeks if ulcers have not healed by then.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 4 weeks.

**Treatment of **(gastric ulcers):

• The recommended dose is 20 mg once daily for 4 weeks. The doctor may recommend continuing the same dose for another 4 weeks if ulcers have not healed by then.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once daily. The 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 recommended dose is 20 mg once daily for 4 to 8 weeks.

**Prevention of recurrence of duodenal and gastric ulcers during treatment with NSAIDs **(non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily.

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

• The recommended dose of Gasec-20 Gastrocaps is 20 mg twice daily for one week.
• The doctor will also prescribe two antibiotics from among amoxicillin, clarithromycin, and metronidazole.

**Treatment of excessive gastric acid secretion caused by pancreatic hyperplasia **(Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• The doctor will adjust the dose according to individual patient needs and will decide how long treatment with Gasec-20 Gastrocaps should continue.

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

• Children over 1 year of age and weighing more than 10 kg may take Gasec-20 Gastrocaps. The dose for children depends on body weight and will be individually prescribed by the doctor for each child.

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

• Children over 4 years of age may take Gasec-20 Gastrocaps. The dose for children depends on body weight and will be individually prescribed by the doctor for each child.
• The doctor will also prescribe two antibiotics for the child: amoxicillin and clarithromycin.

How to take Gasec-20 Gastrocaps

• It is recommended to take the capsules in the morning.
• The capsules 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 whose coating prevents the drug from being broken down by stomach acid. It is important that the pellets remain undamaged.

**What to do if swallowing capsules is difficult **(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.
• To ensure the patient has taken the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid. Do not mix the medicine with milk or carbonated water. The solid particles contain the active substance – do not chew or crush them.

If you take more Gasec-20 Gastrocaps than you should
If you take more Gasec-20 Gastrocaps than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Gasec-20 Gastrocaps
If you forget to take a dose, take it as soon as you remember.
If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

Stopping Gasec-20 Gastrocaps
Do not stop taking Gasec-20 Gastrocaps 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious adverse effects occur, stop taking Gasec-20 Gastrocaps immediately and contact your doctor without delay.

• 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 genitals 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 indicate liver problems. (rare)

Other adverse effects include:
Common adverse effects (may affect up to 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 effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling or pricking sensations, drowsiness
• Sensation of spinning (vertigo)
• Changes in liver function test results
• Skin rash, nodular rash (urticaria), and itchy skin
• General malaise and lack of energy
• Fracture of the hip, wrist or spine

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, tendency to bruise 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 may lead to weakness, vomiting and muscle cramps
• Feeling of restlessness, confusion or depression
• Change in taste perception
• Vision problems 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
• Fungal infection known as "thrush", which may affect the intestines
• Liver-related problems, 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 count including agranulocytosis (absence of white blood cells) and pancytopenia (reduced number of red blood cells, white blood cells and platelets)
• Aggression
• Seeing, feeling or hearing things that are not real (hallucinations)
• Severe liver function disorders leading to liver failure and encephalopathy
• Sudden onset of severe rash or blistering or peeling 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 males

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestines (causing diarrhoea)
• Decreased magnesium levels. If Gasec-20 Gastrocaps has been taken for longer than three months, there may be a decrease in magnesium levels in the blood. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, 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 (severe hypomagnesemia potentially causing hypocalcemia). Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash associated with joint pain
• Microscopic colitis

In very rare cases, Gasec-20 Gastrocaps may affect the number of white blood cells in the blood, leading to immunodeficiency. If an infection occurs with symptoms such as fever accompanied by severe 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 the patient informs the doctor about the medicine being taken in such a situation.
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
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gasec-20 Gastrocaps

Keep the medicine out of the sight and reach of children.
Do not use Gasec-20 Gastrocaps after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated on the packaging.
Store below 30°C. Protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Gasec-20 Gastrocaps contains

• The active substance is omeprazole. Each Gasec-20 Gastrocaps capsule contains 20 mg of omeprazole.
• Other ingredients are: sucrose, povidone (K30), sodium lauryl sulfate, sodium starch glycolate (type A), trisodium phosphate, hypromellose, triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, sodium hydroxide, titanium dioxide (E 171), and talc.
  Capsule shell composition: gelatin, erythrosine (E 127), indigotine (E 132), titanium dioxide (E 171), quinoline yellow (E 104).

What Gasec-20 Gastrocaps looks like and contents of the pack
Blue-orange capsules with white marking "O" on the cap and "20" on the body,
containing micropelettes ranging in colour from white to beige.
Gasec-20 Gastrocaps capsules are packed in HDPE polyethylene bottles (with a moisture absorber in the cap) or in Al/Al blisters. The bottles and blisters are placed in a cardboard box.
Pack sizes: 7, 14, 28 and 56 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków
Poland
TEVA Pharma S.L.U.
Poligono Industrial Malpica
Calle C, No 4
Zaragoza, 50016
Spain
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany

For further information, please contact the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00