Ultop

Package leaflet: Information for the patient

Ultop, 10 mg, enteric-coated capsules, hard
Ultop, 20 mg, enteric-coated capsules, hard
Ultop, 40 mg, enteric-coated capsules, hard
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. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Ultop is and what it is 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 pack and other information

1. What Ultop is and what it is used for

Ultop contains the active substance omeprazole, which belongs to a group of medicines called proton pump inhibitors. The medicine works by reducing the production of hydrochloric acid in the stomach.
Ultop is used to treat the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GERD), in which stomach acid flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Peptic ulcer of the upper intestine (duodenal ulcer) or stomach (gastric ulcer).
• Peptic ulcer associated with infection by the bacterium Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to eradicate the infection and heal the ulcer.
• Peptic ulcer caused by non-steroidal anti-inflammatory drugs (NSAIDs). Ultop may also be used to prevent the formation of ulcers during NSAID treatment.
• Excessive stomach acid production caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:
Children above 1 year of age and weighing ≥ 10 kg

• Gastro-oesophageal reflux disease, in which stomach acid flows back into the oesophagus, causing pain, inflammation, and heartburn. In children, the disease may manifest as regurgitation of stomach contents into the mouth, nausea (vomiting), and poor weight gain.

Children and adolescents above 4 years of age

• Peptic ulcer associated with infection by the bacterium Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to eradicate the infection and heal the ulcer.

2. Important information before using Ultop

When not to use Ultop

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient has hypersensitivity to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if nelfinavir (a medicine used to treat HIV infections) is being taken at the same time.

Do not take Ultop if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before taking Ultop.

Warnings and precautions

Before starting treatment with Ultop, discuss it with your doctor or pharmacist.

Severe skin reactions have been reported with omeprazole treatment, 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 related to these severe skin reactions described in section 4 occur, stop taking Ultop immediately and seek urgent medical help.

Ultop may mask symptoms of other diseases. Therefore, if any of the following symptoms occur before starting or during treatment with Ultop, contact your doctor immediately:

• unintentional weight loss and difficulty swallowing,
• abdominal pain or indigestion,
• vomiting or vomiting blood,
• black stools (containing blood),
• severe or persistent diarrhoea, as omeprazole may slightly increase the risk of infectious diarrhoea,
• serious liver problems,
• if the patient has ever had a skin reaction due to taking a medicine similar to Ultop that reduces stomach acid secretion,
• if a specific blood test (chromogranin A level measurement) is planned.

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Ultop may be necessary. Also report any other adverse effects such as joint pain.

If Ultop is taken for a prolonged period (over 1 year), the doctor will monitor the patient's health condition. Report any new or unusual symptoms to the doctor.

Taking proton pump inhibitors such as Ultop, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if osteoporosis has been diagnosed or if corticosteroids (which may increase the risk of osteoporosis) are being taken.

While taking omeprazole, interstitial nephritis (inflammation of the kidneys) may occur. Symptoms may include reduced urine volume or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.

This medicine may affect how the body absorbs vitamin B₁₂, especially if it needs to be taken for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B₁₂ levels:

• Extreme fatigue 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, even though this is not generally recommended.

Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Ultop and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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.

Do not take Ultop if you are also taking a medicine containing nelfinavir (used to treat HIV infections).

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, muscle spasms, or epilepsy),
• phenytoin (used in epilepsy); if the patient is taking phenytoin, the doctor will monitor the patient's condition when starting or stopping Ultop treatment,
• anticoagulants, including warfarin or other vitamin K antagonists; monitoring of the patient's health status may be necessary when starting or stopping Ultop treatment,
• rifampicin (used to treat tuberculosis),
• atazanavir (used to treat HIV infections),
• tacrolimus (used after 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 chemotherapeutic agent used in high doses for cancer treatment); if the patient is taking high-dose methotrexate, the doctor may recommend temporarily stopping Ultop.

If, in addition to Ultop, your doctor has prescribed antibiotics called amoxicillin and clarithromycin for treating ulcers caused by Helicobacter pylori infection, it is very important to inform them about any other medicines being taken.

Ultop with food and drink

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Omeprazole is excreted in human breast milk, but it is unlikely that omeprazole administered at therapeutic doses would affect the infant. The doctor will decide whether Ultop can be used during breastfeeding.

Driving and using machines

The effect of Ultop on the ability to drive or operate machinery is unlikely. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). Patients experiencing such adverse effects should not drive or operate machinery.

Ultop contains sucrose and sodium

If the patient has been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

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

3. How to use Ultop

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.
Depending on the patient's health condition and age, the doctor will prescribe the appropriate number of capsules and
inform you about the duration of treatment.
The usual doses of Ultop are given below.

Use in adults:

Treatment of symptoms of gastroesophageal reflux disease, e.g., heartburn and regurgitation of stomach contents:

• For patients with mild esophageal damage, the recommended dose is 20 mg once daily for 4 to 8 weeks. If healing has not occurred, your doctor may recommend continuing treatment with 40 mg once daily for another 8 weeks.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If the esophagus was not damaged, the usual dose is 10 mg once daily.

Treatment of peptic ulcer disease in the upper intestine (duodenal ulcer):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may recommend continuing this dose for another 2 weeks if healing has not occurred.
• If complete healing of the ulcer has not occurred, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcer (stomach ulcer):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing this dose for another 4 weeks if healing has not occurred.
• If complete healing of the ulcer has not occurred, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of gastric and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of gastric and duodenal ulcers caused by use of NSAIDs
(non-steroidal anti-inflammatory drugs):

• 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 pylori infection:

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

Treatment of excess stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

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

Use in children and adolescents:

Treatment of symptoms of gastroesophageal reflux disease, e.g., heartburn and regurgitation of stomach contents:

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

Treatment and prevention of ulcers caused by Helicobacter pylori infection:

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

How to take the medicine

• It is recommended to take the medicine in the morning.
• The medicine may be taken with food or on an empty stomach.
• Capsules should be swallowed whole with half a glass of water. Do not chew or crush the capsules, as they contain pellets coated with an acid-protective layer. It is very important not to damage the pellets.

If you have difficulty swallowing capsules

• If a patient (adult or child) has difficulty swallowing the capsule:
  • Open the capsule and swallow the contents with half a glass of water; alternatively, mix the capsule contents with a small amount of yogurt, acidic fruit juice (e.g., apple, orange, or pineapple juice), or applesauce.
  • The suspension should always be mixed immediately before consumption (the mixture will not be clear); it should be consumed immediately or no later than 30 minutes after preparation.
  • To ensure the entire dose is taken, refill the glass with half a glass of water and drink it. The undissolved solid residue contains the medicine – do not chew or crush it.

Taking more Ultop than recommended
If you take more Ultop than recommended, contact your doctor or pharmacist immediately.
If you miss a dose of Ultop
If you miss a dose, take it as soon as possible. However, 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 dose.
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 they do not occur in everyone.
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 reactions occur,
stop taking Ultop and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blisters or skin peeling. Blisters and bleeding from the lips, eyes, mouth, nose or genitals may also occur. These may be symptoms of 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 disease. (rare)

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

• Headache.
• Gastrointestinal disorders: diarrhoea, abdominal pain, constipation, flatulence (wind).
• Nausea or vomiting.
• Mild gastric polyps.

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

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Changes in blood test results indicating liver function abnormalities.
• Skin rash, nodular rash (urticaria), itching.
• Fracture of the hip, wrist or spine.
• General malaise and lack of energy.

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

• Blood disorders, e.g. reduced number of white blood cells or platelets. This may cause weakness, bruising or frequent infections.
• Low blood sodium levels. This may cause weakness, nausea (vomiting) and cramps.
• Restlessness, confusion or depression.
• Taste disturbances.
• Visual disturbances, e.g. blurred vision.
• Sudden breathlessness or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the mouth.
• Fungal infection called candidiasis, which may affect the intestines.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint pain or muscle pain.
• Severe kidney disease (interstitial nephritis).
• Excessive sweating.

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

• Blood cell disorders including deficiency of white blood cells (agranulocytosis).
• Aggression.
• Hallucinations (seeing, hearing or sensing things that are not there).
• Severe liver disease leading to liver failure and encephalopathy.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in males.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• If Ultop 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 contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms are observed, 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.
• Inflammation of the intestine (causing diarrhoea).
• Rash which may be accompanied by joint pain.

Ultop may, in very rare cases, adversely affect white blood cells, leading to
immune deficiency. If an infection occurs, with symptoms such as fever with very poor
general condition, or fever with signs of local infection such as neck, throat or
mouth pain, or difficulty urinating, contact your doctor immediately
for blood tests to rule out agranulocytosis (deficiency of white blood cells).
It is very important to inform your doctor about taking this medicine.
Reporting of adverse reactions
If any adverse symptoms 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 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 to provide more information on the
safety of this medicine.

5. How to store the medicine Ultop

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Store below 25 °C.
Keep in the original packaging 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 help protect the
environment.

6. Contents of the packaging and other information

What Ultop contains

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

What Ultop looks like and contents of the pack
Ultop 10 mg: opaque, yellow capsule containing spherical micropelettes ranging in colour from white to creamy-white.
Ultop 20 mg: opaque, yellow capsule containing spherical micropelettes ranging in colour from white to creamy-white.
Ultop 40 mg: capsule composed of two opaque parts: blue and white, containing spherical micropelettes ranging in colour from white to creamy-white.
Packaging: 7, 14, 15, 28, 30, 56, or 60 enteric hard capsules in blister packs, packed in a cardboard box.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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)