Agastin 20 mg

Package leaflet: Information for the patient

Agastin 20 mg, 20 mg enteric hard capsules
Omeprazolum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Agastin 20 mg is and what it is used for

Agastin 20 mg contains the active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced in the stomach.

Agastin 20 mg is used in the treatment of the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers of the upper part of the small intestine (duodenal ulcers) or 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). Agastin 20 mg can also be used to prevent the development of ulcers during NSAID treatment.
• Excessive acid production in the stomach due to a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

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

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid from the stomach 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), vomiting, and poor weight gain.

Children and adolescents aged above 4 years

• 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 Agastin 20 mg

When not to use Agastin 20 mg

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced 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 Agastin 20 mg if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with Agastin 20 mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Agastin 20 mg.
Severe skin reactions have been reported with treatment using Agastin 20 mg, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). If any symptoms of these serious skin reactions described in section 4 occur, stop taking Agastin 20 mg immediately and seek urgent medical advice.

Agastin 20 mg may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Agastin 20 mg, inform your 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 use of omeprazole is associated with a slightly increased risk of infectious diarrhoea.
• Severe liver problems.
• If the patient has ever had a skin reaction to a medicine similar to Agastin 20 mg that reduces stomach acid secretion.
• If planning a specific blood test (chromogranin A level).

If Agastin 20 mg is used long-term (longer than 1 year), the patient will likely require regular medical monitoring. During doctor visits, report any new or unusual symptoms or circumstances.

Taking proton pump inhibitors such as Agastin 20 mg, especially for more 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).

This medicine may affect the absorption of vitamin B₁₂, especially if taken for a long time. Contact your doctor if the patient experiences any of the following symptoms, which may indicate low vitamin B₁₂ levels:

• Severe fatigue or lack of energy;
• Tingling or numbness;
• Pain or redness of the tongue, mouth ulcers;
• Muscle weakness;
• Vision disturbances;
• Memory problems, disorientation, depression.

Kidney inflammation may occur during treatment with omeprazole. 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 their doctor.

If a skin rash develops, especially in areas exposed to sunlight, inform your doctor as soon as possible, as treatment with Agastin 20 mg may need to be discontinued. Also report any other adverse effects such as joint pain.

Children
Some children with chronic diseases may require long-term treatment, but such treatment is not recommended. Do not use this medicine in children under 1 year of age weighing less than 10 kg.

Agastin 20 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes medicines available without a prescription. This is important because Agastin 20 mg may affect how some other medicines work, and some other medicines may affect how Agastin 20 mg works.

Do not take Agastin 20 mg 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 disorders)
• Diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy)
• 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 treatment with Agastin 20 mg
• 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 treatment with Agastin 20 mg
• 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 (a chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high doses of methotrexate, the doctor may temporarily discontinue Agastin 20 mg

If your doctor has prescribed amoxicillin and clarithromycin antibiotics together with Agastin 20 mg to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

Agastin 20 mg with food and drink
See section 3.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Omeprazole passes into human milk, but its effect on the infant is unlikely when used at therapeutic doses. The decision on whether a breastfeeding woman can take Agastin 20 mg will be made by the doctor.

Driving and operating machinery
Agastin 20 mg does not affect the ability to drive or operate 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 mechanical equipment.

Agastin 20 mg contains sucrose
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Agastin 20 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning this medicine is considered "sodium-free".

3. How to take Agastin 20 mg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Your doctor will inform you how many capsules to take and for how long. This will depend on your medical condition and age.

Dosage recommendations are provided below.

Use in adults:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If your doctor has determined that your oesophagus has been slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend taking 40 mg (2 x 20 mg) once daily for an additional 8 weeks if healing has not occurred.
• The recommended dose after healing of the oesophagus is 10 mg once daily.
• If your oesophagus 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. Your doctor may recommend continuing the same dose for an additional 2 weeks if ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg (2 x 20 mg) once daily for 4 weeks.

**Treatment of **(gastric ulcers):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for an additional 4 weeks if ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg (2 x 20 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. Your doctor may increase the dose to 40 mg (2 x 20 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 4–8 weeks.

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

• The recommended dose is 20 mg once daily.

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

• The recommended dose of Agastin 20 mg 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 usual dose is 60 mg (3 x 20 mg) per day.
• Your doctor will adjust the dose according to individual needs and determine how long treatment should continue.

Use in children and adolescents:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• Agastin 20 mg may be given to children over 1 year of age and weighing more than 10 kg. The dose depends on the child's body weight and is individually determined by the treating physician.

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

• Children over 4 years of age may take Agastin 20 mg. The dose depends on the child's body weight and is individually determined by the treating physician.
• Your doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The 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, as they contain enteric-coated pellets designed to protect the active substance from degradation by stomach acid. It is important that the pellets remain intact.

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

• If an adult or child has difficulty swallowing the capsules:
• Open the capsule and swallow the contents immediately with half a glass of water (non-carbonated), or mix the contents with half a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, or pineapple juice), or apple puree.
• Always mix the preparation immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• 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 active substance—do not chew or crush them.

Taking more Agastin 20 mg than prescribed
If you take more Agastin 20 mg than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Agastin 20 mg
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 missed one.

Stopping Agastin 20 mg
Do not stop taking Agastin 20 mg 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 affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people), yet serious adverse reactions, stop taking Agastin 20 mg 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 blister formation 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)

Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people)

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

Uncommon adverse reactions (may affect up to 1 in 100 people)

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

Rare adverse reactions (may affect up to 1 in 1,000 people)

• Blood disorders, such as reduced numbers of white blood cells or platelets. This may lead to weakness, easier 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 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
• 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 reactions (may affect less than 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 the available data)

• Inflammation of the intestine (leading to diarrhoea)
• If Agastin 20 mg has been taken for longer than three months, there may be a decrease in blood magnesium levels. 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 occurring with joint pain

In very rare cases, Agastin 20 mg 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 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 the patient informs the doctor about the medicine being taken in such a situation.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 181 C, 02-222 Warsaw, Tel.: +48 22 4921 301, Fax: +48 22 4921 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 Agastin 20 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep blisters in the original packaging or keep the bottle tightly closed 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Agastin 20 mg contains

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• Other ingredients are:
  • Capsule contents: Sucrose, pellets (containing corn starch and sucrose), Sodium lauryl sulphate, Disodium phosphate, Mannitol, Hypromellose 6 cP, Macrogol 6000, Talc, Polysorbate 80, Titanium dioxide (E171), Methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%.
  • Capsule shell: Gelatin, Quinoline yellow (E104), Titanium dioxide (E171).

What Agastin 20 mg looks like and contents of the pack

• Agastin 20 mg: opaque yellow capsules containing almost white to cream-white spherical microgranules.

Capsules are available in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 280 and 500 capsules, and
in HDPE bottles with a silicone desiccant in the cap containing 5, 7, 14, 28, 30, 56, 60, 90 and 500
capsules.
In Poland, blister packs of 28 capsules are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: Exeltis Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Manufacturer: LABORATORIOS LICONSA, S.A.
Av. Miralcampo, No. 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain

This medicinal product is registered in the Member States of the European Economic Area under the following names:
Netherlands: Omolin 20 mg, capsules, gastro-resistant capsules
Hungary: Ludea 20 mg, gyomornedv ellenálló kemény kapszula
Italy: Omolin 20 mg capsule rigide gastroresistenti
Poland: Agastin 20 mg
Slovenia: Omolin 20 mg gastrorezistentna kapsula, trda