Ulcezol

Italy
Brand name Ulcezol
Form capsules, hard gelatin, gastro-resistant
Active substance / Dosage
OMEPRAZOLE
Prescription type Prescription only
ATC code
A02BC01
Registration number 038239
Manufacturer S.F. GROUP S.R.L.

Table of Contents

PACKAGE LEAFLET: Information for the user

ULCEZOL 20 mg gastro-resistant hard capsules

Omeprazole
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What ULCEZOL is and what it is used for
  2. What you need to know before taking ULCEZOL
  3. How to take ULCEZOL
  4. Possible side effects
  5. How to store ULCEZOL
  6. Contents of the pack and other information

1. What ULCEZOL is and what it is used for

ULCEZOL contains the active substance omeprazole. It belongs to a group of medicines called
"proton pump inhibitors", which work by reducing the amount of acid produced by the
stomach.
ULCEZOL is used to treat the following conditions:

In adults:

  • "Gastro-oesophageal reflux disease" (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
  • Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
  • Ulcers associated with a bacterium called 'Helicobacter pylori'. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  • Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). ULCEZOL may also be used to prevent ulcers from developing if you are taking NSAIDs.
  • Excess acid production in the stomach caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year and with body weight greater than or equal to 10 kg

  • "Gastro-oesophageal reflux disease" (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.

In children, symptoms of this condition may also include regurgitation of stomach contents back into the mouth, discomfort (vomiting), and poor weight gain.

Children aged over 4 years and adolescents
Ulcers associated with a bacterium called 'Helicobacter pylori'. If your child has this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking ULCEZOL

Do not take ULCEZOL

  • If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
  • If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
  • If you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take ULCEZOL if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking ULCEZOL.

Warnings and precautions

Talk to your doctor or pharmacist before taking ULCEZOL.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ULCEZOL. Stop using ULCEZOL and contact a doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.

During treatment with omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Report such signs to your doctor.

ULCEZOL may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking ULCEZOL, contact your doctor immediately:

  • Unintentional weight loss and difficulty swallowing.
  • Stomach pain or indigestion.
  • Vomiting of food or blood.
  • Dark-colored stools (indicating presence of blood in the stool).
  • Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
  • Severe liver problems.
  • If you have ever had a skin reaction after treatment with a medicine similar to ULCEZOL that reduces gastric acidity.
  • If you have been taking ULCEZOL for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice the appearance of new or unusual symptoms.
  • If you are taking a proton pump inhibitor such as ULCEZOL, particularly for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine.
  • If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
  • If you are scheduled for a specific blood test (chromogranin A).
  • If you develop a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with ULCEZOL may need to be discontinued. Remember to also report any other adverse effects such as joint pain.

Children

Some children with chronic conditions 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.

Other medicines and ULCEZOL

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is important because ULCEZOL may affect how some medicines work, and conversely, some medicines may affect the action of ULCEZOL.

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

Inform your doctor or pharmacist if you are taking one or more of the following medicines:

  • Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
  • Digoxin (used to treat heart problems)
  • Diazepam (used to treat anxiety, to relax muscles, or for epilepsy)
  • Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you closely at the beginning and end of treatment with ULCEZOL.
  • Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you closely at the beginning and end of treatment with ULCEZOL.
  • Rifampicin (used to treat tuberculosis)
  • Atazanavir (used to treat HIV infection)
  • Tacrolimus (used in organ transplants)
  • 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 (thrombi))
  • Erlotinib (used to treat cancer)
  • Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment); if you are taking high-dose methotrexate, your doctor may temporarily discontinue treatment with ULCEZOL.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with ULCEZOL for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform them if you are taking any other medicines.

ULCEZOL with food and drink

The capsules can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take ULCEZOL during this time.

Omeprazole is excreted in breast milk, but it is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide whether you can take ULCEZOL while breastfeeding.

Driving and using machines

It is unlikely that ULCEZOL will affect your ability to drive or use tools or machines.

However, adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.

ULCEZOL contains mannitol

ULCEZOL capsules contain mannitol and may therefore have a mild laxative effect.

ULCEZOL contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".

3. How to take ULCEZOL

Take this medicine exactly as your doctor has told you. If you are unsure, consult 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 usual doses are given below.

Use in adults

For the treatment of GERD symptoms, such as heartburn and acid regurgitation:

  • If your doctor has informed you that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for an additional 8 weeks if the esophagus has not yet fully healed.
  • The recommended dose once the esophagus has healed is 10 mg once daily.
  • If the esophagus is not damaged, the recommended dose is 10 mg once daily.

For the treatment of ulcers in the upper part of the intestine (duodenal ulcer):

  • The recommended dose is 20 mg once daily for 2 weeks. Your doctor may extend treatment with this dose for another 2 weeks if the ulcer has not yet healed.
  • If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 4 weeks.

For the treatment of stomach ulcers (gastric ulcer):

  • The recommended dose is 20 mg once daily for 4 weeks. Your doctor may extend treatment with this dose for another 4 weeks if the ulcer has not yet healed.
  • If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 8 weeks.

For preventing the 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 once daily.

For the 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.

For preventing the formation of duodenal and gastric ulcers if you are using NSAIDs:

  • The recommended dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

  • The recommended dose is 20 mg of ULCEZOL twice daily for one week.
  • Your doctor will also instruct you to take two antibiotics among amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome):

  • The recommended dose is 60 mg daily.
  • Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine.

Use in children and adolescents

For the treatment of GERD symptoms, such as heartburn and acid regurgitation:

  • ULCEZOL may be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on body weight, and the exact dose will be determined by the doctor.

For the treatment and prevention of recurrence of ulcers caused by Helicobacter pylori infection:

  • ULCEZOL may be taken by children over 4 years of age. The dose for children is based on body weight, and the exact dose will be determined by the doctor.
  • Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

How to take this medicine

  • 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. The capsules must not be chewed or crushed, as they contain granules coated to prevent the medicine from being broken down by stomach acid. It is important not to damage the granules.

What to do if you or the child has difficulty swallowing the capsules

  • If you or the child has difficulty swallowing the capsules:
    • Open the capsule and take the contents directly with half a glass of water, or pour the contents into a glass of water (non-carbonated), into an acidic fruit juice (e.g., apple, orange, or pineapple), or into apple puree.
    • Always shake the mixture before drinking (the mixture will not be clear), and drink it immediately or within 30 minutes.
    • To ensure that all the medicine is taken, rinse the glass thoroughly with half a glass of water and drink the rinse. The solid particles contain the medicine; do not chew or crush them.

If you take more ULCEZOL than you should
If you take more ULCEZOL than prescribed, contact your doctor or pharmacist immediately.
If you forget to take ULCEZOL
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the forgotten one.
If you stop taking ULCEZOL
Do not stop taking this medicine unless advised by your doctor, even if you feel better. It is very important to continue the treatment as prescribed.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ULCEZOL can cause side effects, although not everybody gets 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) but serious side effects, stop taking ULCEZOL and contact your doctor immediately:

  • Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
  • Skin redness with blistering or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (very rare)
  • Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
  • A widespread red, scaly rash with bumps under the skin 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 tiredness could be symptoms of liver problems. (rare)

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

  • Headache
  • Stomach or intestinal problems: diarrhoea, stomach ache, constipation, passing wind (flatulence)
  • Feeling unwell (nausea) or sickness (vomiting)
  • Benign polyps in the stomach

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

  • Swelling of the feet and ankles
  • Sleep disorders (insomnia)
  • Dizziness, tingling, drowsiness
  • Feeling dizzy (vertigo)
  • Changes in blood tests related to liver function
  • Rash, skin rash with skin swelling (urticaria) and itching of the skin
  • General feeling of being unwell and lack of energy
  • If you take a proton pump inhibitor such as Ulcezol, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), please consult your doctor.

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

  • Changes in blood composition, such as reduced number of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
  • Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
  • Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
  • Feeling restless, confused or depressed.
  • Changes in taste.
  • Vision problems, such as blurred vision.
  • Sudden wheezing or breathlessness (bronchospasm).
  • Dry mouth.
  • Inflammation inside the mouth.
  • An infection called “candidiasis” which may affect the intestine and is caused by a fungus.
  • Liver problems, including jaundice, which may cause yellowing of the skin, dark urine and tiredness.
  • Hair loss (alopecia).
  • Rash during exposure to sunlight.
  • Joint pain (arthralgia) or muscle pain (myalgia).
  • Severe kidney problems (interstitial nephritis).
  • Increased sweating.

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

  • Changes in blood cell counts, including agranulocytosis (lack of white blood cells)
  • Aggressiveness
  • Seeing, feeling or hearing things that are not real (hallucinations)
  • Severe liver problems up to liver failure and brain inflammation
  • Sudden onset of severe rash or blisters and skin peeling. These

effects may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

  • Muscle weakness
  • Breast enlargement in men

In very rare cases ULCEZOL may affect white blood cells leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in your general health, or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that in this case you inform your doctor about the medicine you are taking.
Frequency not known (frequency cannot be estimated from the available data)

  • Inflammation of the intestine (resulting in diarrhoea)
  • If you take ULCEZOL for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to monitor your blood magnesium levels periodically.
  • Reduced levels of calcium in the blood (hypocalcaemia). Reduced calcium levels may result from very low magnesium levels.
  • Reduced levels of potassium in the blood (hypokalaemia).
  • Erythema, possible joint pain.

Don’t be alarmed by this list of possible side effects. You may not experience any of them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni%20avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ULCEZOL

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
  • Do not store above 30°C.
  • Keep the blister pack in the original packaging or keep the bottle tightly closed to protect the medicine from moisture.
  • Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ULCEZOL contains

  • The active substance is omeprazole. ULCEZOL gastro-resistant hard capsules contain 20 mg of omeprazole.
  • The excipients are core: microcrystalline cellulose, low-substituted hydroxypropylcellulose, mannitol, sodium croscarmellose, polysorbate 80, povidone K-30, arginine, sodium lauryl sulfate, glycine, light magnesium carbonate. Coating: hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, sodium hydroxide, titanium dioxide, talc. Capsule shell: gelatin, indigo carmine (E-132), titanium dioxide, water.

Description of the appearance of ULCEZOL and contents of the pack
Gastro-resistant hard capsules.
14 gastro-resistant hard capsules of 20 mg.
28 gastro-resistant hard capsules of 20 mg.
Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, n° 1143 - 00156 Roma
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, n° 1
03012 Anagni (FR)
May 2023