AGASTIN 20 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Agastin 20 mg, 20 mg gastro-resistant hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Agastin 20 mg and what is it used for
4. Important information before taking Agastin 20 mg
   1. When not to take Agastin 20 mg
   2. Warnings and precautions
   3. Children
   4. Agastin 20 mg and other medicines
   5. Agastin 20 mg with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Agastin 20 mg contains sucrose
   9. Agastin 20 mg contains sodium
5. How to take Agastin 20 mg
   1. How to take this medicine
   2. What to do if you have difficulty swallowing the capsules (in adults or children)
   3. 30 minutes.
   4. Taking a higher dose of Agastin 20 mg than recommended
   5. Forgetting to take a dose of Agastin 20 mg
   6. Stopping treatment with Agastin 20 mg
6. Possible side effects
   1. If you notice any of the following serious side effects, stop taking Agastin 20 mg and contact a doctor immediately:
   2. Reporting side effects
7. How to store Agastin 20 mg
8. Contents of the pack and other information
   1. What Agastin 20 mg contains
   2. What Agastin 20 mg looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Agastin 20 mg, 20 mg gastro-resistant hard capsules

Omeprazole

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

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

Table of contents of the leaflet:

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

Agastin 20 mg contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of acid produced in the stomach.

Agastin 20 mg is used to treat the following diseases and disorders:

In adults:

• Gastro-esophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). Agastin 20 mg can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

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

• Gastro-esophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include reflux of stomach contents into the mouth (regurgitation), vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers infected with bacteria called "Helicobacter pylori". If a child has this disease, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Agastin 20 mg

When not to take Agastin 20 mg

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you have been diagnosed with an allergy to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Agastin 20 mg if any of the above points apply to you. If you are in doubt, consult your doctor or pharmacist before taking Agastin 20 mg.

Warnings and precautions

Before taking Agastin 20 mg, discuss it with your doctor or pharmacist.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with Agastin 20 mg. If you notice any symptoms related to these serious skin reactions described in section 4, stop taking Agastin 20 mg and seek medical help immediately.

Agastin 20 mg may mask the symptoms of other diseases. Therefore, if you experience any of the following conditions before or during treatment with Agastin 20 mg, inform your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole is associated with a slight increase in the incidence of infectious diarrhea.
• Severe liver problems.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid.
• About a planned specific blood test (chromogranin A level).

During long-term treatment with Agastin 20 mg (longer than 1 year), you will likely remain under close and regular medical supervision. During the visit to the doctor, report any new and unusual symptoms and circumstances.

When taking proton pump inhibitors like Agastin 20 mg, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. 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 you experience any of the following symptoms, which may indicate low vitamin B12 levels:

• Extreme fatigue or lack of energy;
• Numbness or tingling;
• Pain or redness of the tongue, mouth ulcers;
• Muscle weakness;
• Vision problems;
• Memory problems, disorientation, depression.

Kidney inflammation may occur during omeprazole treatment. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. Report such symptoms to your doctor.

If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Agastin 20 mg. Also, report any other side effects, such as joint pain.

Children

Some children with chronic diseases may require long-term treatment, but such treatment is not recommended. Do not give this medicine to children under 1 year of age or with a body weight of less than 10 kg.

Agastin 20 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription. It is important because Agastin 20 mg may affect the way some other medicines work, and some other medicines may affect the way Agastin 20 mg works.

Do not take Agastin 20 mg if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell 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 rhythm disorders)
• Diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy)
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Agastin 20 mg
• 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 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 chemotherapy medicine used to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Agastin 20 mg

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin and Agastin 20 mg to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Agastin 20 mg with food and drink

See section 3.

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.

Omeprazole passes into breast milk, but its effect on the baby is unlikely if the medicine is used at therapeutic doses. Whether a breastfeeding woman can take Agastin 20 mg will be decided by the doctor.

Driving and using machines

Agastin 20 mg does not affect the ability to drive or use machines.

However, side effects such as dizziness and blurred vision (see section 4) may occur. If they do, do not drive or operate machinery.

Agastin 20 mg contains sucrose

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

Agastin 20 mg 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 Agastin 20 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

The recommended dose is given below.

Adults:

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

• If your doctor has found that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4-8 weeks. Your doctor may prescribe a dose of 40 mg (2 x 20 mg) for a further 8 weeks if the esophagus has not healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If the esophagus has not been 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 prescribe the same dose for a further 2 weeks if the ulcers have not healed within this time.
• If the ulcer has not healed 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 prescribe the same dose for a further 4 weeks if the ulcers have not healed within this time.
• If the ulcer has not healed completely, the dose may be increased to 40 mg (2 x 20 mg) once daily for 8 weeks.

Prevention 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 non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg once daily for 4-8 weeks.

Prevention of duodenal and gastric ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection 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: amoxicillin and clarithromycin.

Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg (3 x 20 mg) per day.
• Your doctor will adjust the dose according to your individual needs and decide how long you need to take the medicine.

Children and adolescents:

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

• Agastin 20 mg can be taken by children over 1 year of age and with a body weight of over 10 kg. The dose depends on the child's body weight and is determined individually by the doctor.

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

• Children over 4 years of age can take Agastin 20 mg. The dose for children depends on their body weight and is determined individually by the doctor.
• 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 can 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 that prevent the medicine from being broken down by the acid in the stomach. It is essential to keep the pellets intact.

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

• If you or your child have difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, washing it down with half a glass of non-carbonated water or mix the contents with non-carbonated water, any acidic fruit juice (e.g. apple, orange, or pineapple), or apple sauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.

30 minutes.

• To ensure that you have taken the entire dose, rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them.

Taking a higher dose of Agastin 20 mg than recommended

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

Forgetting to take a dose of Agastin 20 mg

If you forget to take a dose, take it as soon as you remember. If it is time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Agastin 20 mg

Do not stop taking Agastin 20 mg without first consulting your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, Agastin 20 mg can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Agastin 20 mg and contact a doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering, peeling, or bleeding. It can also cause large blisters and bleeding in the mouth, eyes, genitals, or around the anus. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
• Red, scaly, widespread rash with small bumps under the skin and blisters, accompanied by fever, which usually appears at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be signs of liver problems. (rare)

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling, or drowsiness.
• Feeling of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, urticaria, and itching.
• General malaise and lack of energy.

Rare side effects (may affect up to 1 in 1,000 people)

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, easy bruising, or an increased risk of infection.
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden breathing difficulties or shortness of breath (bronchospasm).
• Dry mouth.
• Oral thrush (infection of the mouth by a fungus).
• Fungal infection of the intestines.
• Hair loss (alopecia).
• Skin rash in response to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect 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 are not there (hallucinations).
• Severe liver problems leading to liver failure and encephalopathy.
• Stevens-Johnson syndrome.
• Muscle weakness.
• Breast enlargement in men.

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

• Intestinal inflammation (leading to diarrhea).
• If you have taken Agastin 20 mg for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can lead to low potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.
• Skin rash that may be associated with joint pain.

In very rare cases, Agastin 20 mg 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 severe deterioration of general well-being or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential to inform your doctor about the medicine you are taking.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 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 Agastin 20 mg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of that month.

Store in a temperature below 25°C.

Store the blisters in the original packaging or keep the bottle tightly closed 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. These 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.
• The other ingredients are:
• Contents of the capsule:Sucrose, pellets (containing maize starch and sucrose), sodium lauryl sulfate, 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: yellow, non-transparent capsules containing white to off-white spherical microgranules.

The capsules are available in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 280, and 500 capsules, as well as in HDPE bottles with a silicone desiccant in the cap, containing 5, 7, 14, 28, 30, 56, 60, 90, and 500 capsules.

In Poland, capsules are available in blisters of 28 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Exeltis Poland Sp. z o.o.

ul. Szamocka 8

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 authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Omolin 20 mg, capsules, maagsapresistente 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

Date of last revision of the leaflet: 20.05.2023