УЛКЕТСОЛ 20 MG Enteric-coated hard capsule

Содержание инструкции

1. ULCEZOL 20 mg hard gastro-resistant capsules
   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. 1,000) or very rare (may affect up to 1 in 10,000) but serious, stop
   6. How to store ULCEZOL
   7. Contents of the pack and other information

ULCEZOL 20 mg hard gastro-resistant capsules

Omeprazole
Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even 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 you take 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 ingredient 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 for the treatment of the following conditions:
In adults:

• "Gastro-oesophageal reflux disease" (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or of the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘ Helycobacter pylori’. If you suffer from this disease, 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 can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an increase of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight greater than or equal to 10 kg

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

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

Children over 4 years of age and adolescents
Ulcers infected by a bacterium called ‘ Helycobacter pylori’. If the child suffers from this
disease, 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 ingredient 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 you fall into any of the above cases. If you have any doubts, ask 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 consult your doctor immediately if you notice any of the symptoms related to
these severe skin reactions described in section 4.
During treatment with omeprazole, inflammation of your kidneys may occur. Signs and
symptoms may include a reduced urine volume or the presence of blood in your urine and/or
hypersensitivity reactions such as fever, skin rashes and joint stiffness. Report these signs to
your doctor.
ULCEZOL can mask the symptoms of other diseases. Therefore, if you should experience the symptoms
described below before taking ULCEZOL or while taking it, contact your doctor
immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Dark-colored stools (presence of blood in the stool).
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Serious liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to ULCEZOL that reduces stomach acid.
• If you take ULCEZOL for a long time (more than 1 year) your doctor will prescribe regular check-ups. Tell your doctor if you notice the appearance of new and unusual symptoms.
• If you are taking a proton pump inhibitor such as ULCEZOL especially 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 can increase the risk of osteoporosis) consult your doctor.
• If you are to undergo a specific blood test (Chromogranin A)
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with ULCEZOL. Remember to report any other unwanted effects such as joint pain.

Children
Some children with chronic illnesses 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Including over-the-counter medicines. This is important
because ULCEZOL can affect the way some medicines work and, in turn, some
medicines can affect the action of ULCEZOL.
Do not take ULCEZOL if you are taking a medicine containing nelfinavir(used for
the treatment of HIV infections).
Tell 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 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 at the beginning and end of treatment with ULCEZOL.
• 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 (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapeutic medicine used in high doses to treat cancer); if you are taking methotrexate in high doses, your doctor may temporarily stop your treatment with ULCEZOL

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with ULCEZOL for the
treatment of ulcers caused by Helycobacter pyloriinfections, it is very important that
you report 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, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. The
doctor will decide whether you can take ULCEZOL during this period.
Omeprazole is excreted in breast milk but it is unlikely to have an effect on the baby when used at therapeutic doses
The doctor will decide whether you can take ULCEZOL during breastfeeding.

Driving and using machines
It is unlikely that ULCEZOL can affect your ability to drive vehicles or use tools
or machinery.
Adverse reactions to the medicine such as dizziness and visual disturbances (see section
4) may occur. If you suffer from these, you should not drive vehicles or use machinery.

ULCEZOL contains mannitol
ULCEZOL capsules contain mannitol, therefore it may 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 following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The doctor will tell you how many capsules to take and for how long. This will depend on your
conditions and age.
The usual doses are listed below.

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

• If your doctor has told you that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the recommended dose is 10 mg once a day.

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

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

For the treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. The doctor may extend

the intake of this dose for another 4 weeks, if the ulcer has not yet healed.

• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 8 weeks.

To preventthe recurrence of duodenal and gastric ulcers:

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

For the treatment of duodenal and gastric ulcers caused by taking NSAIDs(Non-Steroidal Anti-inflammatory Drugs):

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

To prevent the formation of duodenal and gastric ulcersif you are using NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers causedby infection byHelycobacter pyloriand prevention of their
recurrence :

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

For the treatment of excessive acid in the stomach caused by an increase in
tissue in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• The doctor will adjust the dose according to your needs and 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 can be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.

For the treatment and prevention of the recurrence of ulcers causedby infection by
Helycobacter pylori:

• ULCEZOL can be taken by children over 4 years of age. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.
• The doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed or crushed, as they contain granules coated in such a way as to prevent the medicine from being broken down by the acid in the stomach. 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 capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass very well with half a glass of water and drink the contents. Solid particles contain the medicine; do not chew or crush them.

If you take more ULCEZOL than you should
If you take an amount of ULCEZOL greater than that prescribed by your doctor, 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
to take the next dose, skip the missed dose. Do not take a double dose to
make up for the missed dose.

If you stop taking ULCEZOL
Do not stop taking the medicine unless after consulting your doctor, even if
you feel better. It is very important to continue therapy as prescribed by your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ULCEZOL can cause side effects, although not everybody gets them.
manifest.

If you notice any of the following rare side effects (may affect up to 1 in

1,000) or very rare (may affect up to 1 in 10,000) but serious, stop

taking ULCEZOL 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)
• Reddening of the skin with the appearance of blisters or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also appear. 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 and scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue may be symptoms 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, passing gas (flatulence).
• Feeling unwell (nausea) or feeling sick (vomiting).
• Benign polyps in the stomach

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of discomfort and lack of energy.
• If you are taking a proton pump inhibitor such as Ulcezol, especially 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 can increase the risk of osteoporosis) consult your doctor.

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

• Changes in blood composition, such as a decrease in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may make you more likely to get infections.
• Allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash during exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious 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)
• Aggression.
• Seeing, feeling or hearing events that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Sudden appearance of a severe rash or blisters and peeling of the skin. These

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

• Muscle weakness.
• Enlargement of the breasts in men.

In very rare cases ULCEZOL can affect white blood cells leading to immunodeficiency. If
you should experience an infection with symptoms such as fever with a severedeterioration in
general health or fever with symptoms of local infection such as sore throat, sore throat or
difficulty urinating, you should consult a doctor as soon as possible, in order to rule out
a lack of white blood cells (agranulocytosis) by performing a blood test. It is important that
in this case you inform the doctor about the medicine you are taking.

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

• Inflammation of the intestine (resulting in diarrhea).
• If you take ULCEZOL for more than three months, your magnesium levels in the blood may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. The doctor should decide whether to check magnesium levels in the blood periodically.
• Reduced levels of calcium in the blood (hypocalcemia). Reduced levels of calcium in the blood may result from very low levels of magnesium.
• Reduced levels of potassium in the blood (hypokalemia).
• Erythema, possible joint pains.

Do not worry about the list of possible side effects. You may not experience any of them.
If any of the side effects gets worse, or if you notice any side effect

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni avverse .
By reporting side effects you can help provide more information on the safety
of the 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 that is reported on the pack after Exp. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Store the blister in the original package or keep the container tightly closed to protect the medicine from moisture.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ULCEZOL contains

• The active substance is omeprazole. ULCEZOL gastro-resistant hard capsules contains 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, ethyl acrylate-methacrylic acid copolymer, triethyl citrate, sodium hydroxide, titanium dioxide, talc. Capsule: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 containing 20 mg.
28 gastro-resistant hard capsules containing 20 mg.

Marketing Authorisation 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)