ULTOP 40 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ultop, 10 mg, gastro-resistant hard capsules
3. Ultop, 20 mg, gastro-resistant hard capsules
4. Ultop, 40 mg, gastro-resistant hard capsules
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Ultop and what is it used for
6. Important information before taking Ultop
   1. When not to take Ultop
   2. Warnings and precautions
   3. Children
   4. Ultop and other medicines
   5. Ultop with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Ultop contains sucrose and sodium
7. How to take Ultop
   1. Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and reflux:
   2. Treatment of duodenal ulcers:
   3. Treatment of gastric ulcers:
   4. Prevention of relapse of gastric and duodenal ulcers:
   5. Treatment of gastric and duodenal ulcers caused by NSAIDs:
   6. Prevention of gastric and duodenal ulcers during NSAID therapy:
   7. Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):
   8. Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and reflux:
   9. How to take the medicine
   10. If you have difficulty swallowing the capsules
   11. What to do if you take more Ultop than you should
   12. What to do if you miss a dose of Ultop
8. Possible side effects
   1. If you experience 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 side effects, you should stop taking Ultop and contact your doctor immediately:
   2. Common side effects (may affect up to 1 in 10 people):
   3. Uncommon side effects (may affect up to 1 in 100 people):
   4. Rare side effects (may affect up to 1 in 1,000 people):
   5. Very rare side effects (may affect up to 1 in 10,000 people):
   6. Side effects with unknown frequency (frequency cannot be estimated from available data):
   7. Reporting side effects
9. How to store Ultop
10. Contents of the packaging and other information
    1. What Ultop contains
    2. What Ultop looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicine is authorized in the Member States of the European Economic Area under the following names:
    6. Netherlands
    7. Poland
    8. Portugal

Leaflet accompanying the packaging: patient information

Ultop, 10 mg, gastro-resistant hard capsules

Ultop, 20 mg, gastro-resistant hard capsules

Ultop, 40 mg, gastro-resistant hard capsules

Omeprazole

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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 those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ultop and what is it used for

Ultop contains the active substance omeprazole, which belongs to a group of medicines called proton pump inhibitors. The action of the medicine is to reduce the amount of acid produced by the stomach.
Ultop is used to treat the following diseases:
In adults:

• Gastroesophageal reflux disease (GERD), in which stomach acid flows back into the esophagus (the section connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers caused by infection with a bacterium called Helicobacter pylori. In such cases, the doctor may also prescribe antibiotics to cure the infection and heal the ulcer.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Ultop may also be used to prevent 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 weighing ≥ 10kg

• Gastroesophageal reflux disease, in which stomach acid flows back into the esophagus (the section connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, the disease may manifest as reflux of stomach contents into the mouth (regurgitation), nausea (vomiting), and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers caused by infection with a bacterium called Helicobacter pylori. In such cases, the doctor may also prescribe antibiotics to cure the infection and heal the ulcer.

2. Important information before taking Ultop

When not to take Ultop

• 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 hypersensitivity to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if you are taking nelfinavir (a medicine used to treat HIV infections).

You should not take Ultop if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking Ultop.

Warnings and precautions

Before starting treatment with Ultop, you should discuss it with your doctor or pharmacist.
During treatment with Ultop, severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If you notice any symptoms related to these severe skin reactions described in section 4, you should stop taking Ultop and seek medical attention immediately.
Ultop may mask the symptoms of other diseases, so if you experience any of the following symptoms before or during treatment with Ultop, you should contact your doctor immediately:

• unintentional weight loss and difficulty swallowing,
• abdominal pain or indigestion,
• vomiting or vomiting with blood,
• tarry stools (with blood),
• severe or persistent diarrhea, as omeprazole may increase the risk of infectious diarrhea,
• severe liver problems,
• if you have ever had a skin reaction after taking a medicine that reduces stomach acid,
• if a specific blood test (chromogranin A measurement) is planned.

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to discontinue Ultop. You should also report any other side effects, such as joint pain.
If you have been taking Ultop for a long time (more than 1 year), your doctor will monitor your health. You should report any new or unusual symptoms to your doctor.
Taking proton pump inhibitors, such as Ultop, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions, such as fever, rash, and joint stiffness. You should report such symptoms to your doctor.
This medicine may affect the way your body absorbs vitamin B, especially if you need to take it for a long time. You should contact your doctor if you notice any of the following symptoms, which may indicate a low level of vitamin B:

• Extreme fatigue or lack of energy
• Numbness and tingling
• Painful 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.
You should not give this medicine to children under 1 year of age or weighing less than 10 kg.

Ultop and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Ultop may affect the action of other medicines, and other medicines may affect the action of Ultop.
You should not take Ultop if you are taking a medicine containing nelfinavir(used to treat HIV infections).
You should inform your doctor or pharmacist about taking any of the following medicines:

• ketokonazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections),
• digoxin (used to treat heart diseases),
• diazepam (used to treat anxiety, muscle relaxation, or epilepsy),
• phenytoin (used to treat epilepsy); if you are taking phenytoin, your doctor will monitor your condition when starting or stopping treatment with Ultop,
• blood thinners, including warfarin or other vitamin K antagonists; your doctor may need to monitor your condition when starting or stopping treatment with Ultop,
• rifampicin (used to treat tuberculosis),
• atazanavir (used to treat HIV infections),
• 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 infections),
• 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 recommend temporarily stopping Ultop.

If, in addition to Ultop, your doctor has prescribed antibiotics called amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pyloriinfection, it is very important to inform your doctor about other medicines you are taking.

Ultop with food and drink

Ultop can be taken with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole is excreted into breast milk, but it is unlikely to affect the baby when taken in therapeutic doses. Your doctor will decide whether to use Ultop during breastfeeding.

Driving and using machines

Ultop is unlikely to affect your ability to drive or use machines.
However, side effects such as dizziness and blurred vision (see section 4) may occur. Patients who experience such side effects should not drive or use machines.

Ultop contains sucrose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Ultop

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
Depending on your health condition and age, your doctor will prescribe the appropriate number of capsules and tell you how long to take the medicine.
The usual doses of Ultop are given below.
Adults:

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and reflux:

• For patients with mild esophageal damage, the recommended dose is 20 mg once daily for 4 to 8 weeks. If the esophagus has not healed, the doctor may recommend taking 40 mg for another 8 weeks.
• The recommended dose after esophageal healing is 10 mg once daily.
• If the esophagus was 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 taking the same dose for another 2 weeks if the ulcer has not healed.
• If the ulcer has not fully 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 taking the same dose for another 4 weeks if the ulcer has not healed.
• If the ulcer has not fully healed, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of relapse of gastric and duodenal 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 gastric and duodenal ulcers caused by NSAIDs:

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

Prevention of gastric and duodenal ulcers during NSAID therapy:

• The recommended dose is 20 mg once daily.

Treatment and prevention of ulcers caused by Helicobacter pyloriinfection:

• The recommended dose is 20 mg of Ultop twice daily for 1 week.
• The doctor will also recommend two of the following antibiotics: amoxicillin, clarithromycin, or metronidazole.

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

• The recommended dose is 60 mg daily.
• The doctor will adjust the dose according to the patient's needs and determine the duration of treatment.

Children and adolescents:

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and reflux:

• Children over 1 year of age and weighing more than 10 kg can take Ultop. The dose for children depends on their weight. The doctor will determine the appropriate dose.

Treatment and prevention of ulcers caused by Helicobacter pyloriinfection:

• Children over 4 years of age can take Ultop. The dose for children depends on their weight. The doctor will determine the appropriate dose.
• The doctor will also recommend two antibiotics: amoxicillin and clarithromycin.

How to take the medicine

• It is recommended to take the medicine in the morning.
• The medicine can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. The capsules should not be chewed or crushed, as they contain pellets coated with a layer that protects them from stomach acid. It is very important not to damage the pellets.

If you have difficulty swallowing the capsules

• If you (adult or child) have difficulty swallowing a capsule, you should:
• open the capsule and swallow its contents with half a glass of water; you can also mix the contents of the capsule with a small amount of yogurt, acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce.
• the suspension should always be mixed just before drinking (the mixture will not be clear); the mixture should be drunk immediately or at the latest within 30 minutes of preparation.
• to ensure that the entire medicine is taken, you should refill the glass with water to the half and drink it. The undissolved, solid residue contains the medicine - do not chew or crush it.

What to do if you take more Ultop than you should

If you have taken more Ultop than you should, you should contact your doctor or pharmacist as soon as possible.

What to do if you miss a dose of Ultop

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience 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 side effects, you should stop taking Ultop and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blisters or peeling of the skin. Blisters and bleeding can also occur on the lips, eyes, mouth, nose, and genitals. This may be a sign of 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 bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellow skin, dark urine, and fatigue, which can be symptoms of liver disease. (rare)

Other side effects:

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

• Headache.
• Stomach or intestine problems: diarrhea, abdominal pain, constipation, gas (bloating).
• Nausea or vomiting.
• Mild stomach polyps.

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, drowsiness.
• Feeling of spinning (vertigo of labyrinthine origin).
• Changes in blood test results showing liver function.
• Skin rash, lumpy rash (hives), itching.
• Fracture of the hip, wrist, or spine.
• General feeling of being unwell and lack of energy.

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

• Blood disorders, such as decreased white blood cell or platelet count. This can lead to weakness, bruising, or frequent infections.
• Low sodium levels in the blood. This can cause weakness, nausea (vomiting), and muscle cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual disturbances, such as blurred vision.
• Sudden shortness of breath or difficulty breathing (bronchospasm).
• Dry mouth.
• Oral thrush.
• Fungal infection that can affect the intestines.
• Hair loss (alopecia).
• Skin rash that can occur after exposure to sunlight.
• Joint or muscle pain.
• Severe kidney disease (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people):

• Blood disorders, including agranulocytosis (low white blood cell count).
• Aggression.
• Hallucinations (seeing, hearing, or feeling things that are not there).
• Severe liver disease leading to liver failure and brain inflammation.
• Polymorphic erythema
• Muscle weakness.
• Enlarged breasts in men.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• If you have taken Ultop 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 heartbeat. If you experience any of these symptoms, you should inform your doctor immediately. Low magnesium levels can lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Intestinal inflammation (causing diarrhea).
• Rash that can occur with joint pain.

Ultop may very rarely affect the white blood cells, leading to a lack of immunity. If you experience an infection with symptoms such as fever with a very bad general condition, or fever with signs of a local infection, such as neck, throat, or mouth pain, or difficulty urinating, you should contact your doctor immediately for a blood test to rule out agranulocytosis (low white blood cell count).
It is very important to inform your doctor that you are taking Ultop.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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 181C, 02-222 Warsaw
Phone: +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 Ultop

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of the month.
The batch number is stated on the packaging after 'Lot'.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ultop contains

• The active substance of Ultop is omeprazole. Each gastro-resistant hard capsule contains 10 mg, 20 mg, or 40 mg of omeprazole.
• Other ingredients are:
• Contents of the capsule:sucrose, pellets (consisting of cornstarch and sucrose), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), and copolymer of methacrylic acid and ethyl acrylate (1:1). See section 2 "Ultop contains sucrose and sodium".
• Capsule shell:gelatin; the 10 mg and 20 mg capsules also contain the colorants: quinoline yellow (E 104) and titanium dioxide (E 171). The 40 mg capsules also contain indigo carmine (E 132) and titanium dioxide (E 171).

What Ultop looks like and contents of the pack

Ultop, 10 mg: yellow, opaque capsule containing white to off-white spherical micro-pellets.
Ultop, 20 mg: yellow, opaque capsule containing white to off-white spherical micro-pellets.
Ultop, 40 mg: capsule consisting of two opaque parts: blue and white, containing white to off-white spherical micro-pellets.
Packaging:7, 14, 15, 28, 30, 56, or 60 gastro-resistant hard capsules in blisters, in a cardboard box

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

LABORATORIOS LICONSA, S.A.
Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

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

Netherlands

Omeprazol Krka 10 mg, maagsapresistente capsules, hard
Omeprazol Krka 20 mg, maagsapresistente capsules, hard
Omeprazol Krka 40 mg, maagsapresistente capsules, hard

Poland

Ultop

Portugal

Omeprazol Krka (20 mg)
Date of last revision of the leaflet:24.10.2024