CLETUS 20 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

CLETUS

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 personally. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• 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 CLETUS is and what it is used for
• 2. What you need to know before you take CLETUS
• 3. How to take CLETUS
• 4. Possible side effects
• 5. How to store CLETUS
• 6. Contents of the pack and other information

1. What CLETUS is and what it is used for

CLETUS 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.
CLETUS 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 the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘Helicobacter 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). CLETUS can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid production in the stomach caused by an overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing 10 kg or more

• 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 adolescentsUlcers infected by a bacterium called ‘Helicobacter 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 CLETUS

Do not take CLETUS

• If you are allergic to the active ingredient (omeprazole) 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).

If you have any doubts, ask your doctor or pharmacist before taking CLETUS.

Warnings and precautions
Talk to your doctor or pharmacist before taking CLETUS.
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 CLETUS. Stop using
CLETUS and consult your doctor immediately if you notice any of the symptoms related to these severe
skin reactions described in section 4.
CLETUS may mask the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking CLETUS or while taking it, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stools (presence of blood in the stools).
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to CLETUS that reduces stomach acid.
• If you are going to undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your
doctor as soon as possible, as you may need to stop therapy with CLETUS. Remember to also report any other undesirable effects such as joint pain.
If you take CLETUS 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 particular symptoms.
If you are taking a proton pump inhibitor such as CLETUS, 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.
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.
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 the urine and/or hypersensitivity reactions such as fever, skin rashes and joint stiffness. Report these signs to your doctor.

Other medicines and CLETUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. This is important because
CLETUS can influence the way some medicines work and, in turn, some medicines can
affect the action of CLETUS.
Do not take CLETUS if you are taking a medicine containing nelfinavir (used for the treatment
of HIV infections).

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections).
• Digoxin (used for the treatment of heart problems).
• Diazepam (used for the treatment of 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 CLETUS.
• 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 CLETUS.
• Rifampicin (used for the treatment of tuberculosis).
• Atazanavir (used for the treatment of HIV infection).
• Tacrolimus (used in organ transplantation).
• St. John's Wort (Hypericum perforatum) (used for the treatment of mild depression).
• Cilostazol (used for the treatment of intermittent claudication).
• Saquinavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi).
• Erlotinib (used for the treatment of cancer).
• Methotrexate (a chemotherapeutic medicine used in high doses for the treatment of cancer) - if you are taking methotrexate in high doses, your doctor may temporarily interrupt treatment with CLETUS.

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

CLETUS with food, drinks and alcohol
The capsules can be taken with food or on an empty stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor
will decide whether you can take CLETUS 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 CLETUS during breastfeeding.

Driving and operating machinery
It is unlikely that CLETUS will affect your ability to drive or operate tools or machinery.
Adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you
suffer from these, do not drive vehicles or use machinery.

CLETUS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially
‘sodium-free’.

3. How to take CLETUS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, 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 usual doses are listed below.
Use in adults
For the treatment of GERD symptoms, such as heartburn and acid reflux:

• 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. Your 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 usual 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. Your doctor may extend the intake of 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 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. Your doctor may extend the intake of 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 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. Your 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 caused by infection with Helicobacter pyloriand prevention of their
recurrence :

• The recommended dose is 20 mg of CLETUS twice a day for one week.
• Your doctor will also tell you to take two antibiotics such as 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.
• Your 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 reflux:

• CLETUS 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 with Helicobacter
pylori:

• CLETUS 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.
• Your 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 should 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 have difficulty swallowing the capsules

• If you or the child have 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), acidic 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 thoroughly with half a glass of water and drink the contents. The solid particles contain the medicine - do not chew or crush them.

If you take more CLETUS than you should
If you take an amount of CLETUS greater than that prescribed by your doctor, contact your
doctor or pharmacist immediately.

If you forget to take CLETUS
Do not take a double dose to make up for a missed dose.
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.

If you stop taking CLETUS
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, CLETUS 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 CLETUS
and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin 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 occur.

This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
(very rare)

• Widespread skin rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread red and scaly skin 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).
• Benign polyps in the stomach.
• Feeling unwell (nausea) or feeling sick (vomiting).

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

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling giddy (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 being unwell and lack of energy.
• If you are taking a proton pump inhibitor like CLETUS, 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 1000 people)

• Changes in blood composition, such as a reduction 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.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Problems with vision, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” which can affect the intestines and is caused by a fungus.
• 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 the number of blood cells, including agranulocytosis (lack of white blood

cells).

• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Side effects with unknown frequency: (frequency cannot be estimated on the basis of the available data)

• Inflammation of the intestine (resulting in diarrhea).
• If you take CLETUS for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, 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 blood levels of potassium or calcium. The doctor should decide whether to check magnesium levels in the blood periodically.
• Reduction of calcium levels in the blood (hypocalcemia). The reduction of calcium levels in the blood may result from very low levels of magnesium.
• Reduction of potassium levels in the blood (hypokalaemia).
• Erythema, possible joint pain;

In very rare cases CLETUS can affect white blood cells leading to immunodeficiency. If you should
develop an infection with symptoms such as fever with a severedeterioration of general health
or fever with symptoms of local infection such as sore throat, sore throat or mouth 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
inform the doctor about the medicine you are taking.
Do not worry about the list of possible side effects. You may not experience any of them.

Reporting of side effects
If you get any side effects, talk to 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
this medicine .

5. How to store CLETUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated 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.
Keep this medicine in the original package (blister) to protect the medicine
from humidity.
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 CLETUS contains
The active ingredient is omeprazole. CLETUS hard gastro-resistant 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:gelatin, indigo carmine (E-132), titanium dioxide, water.

Description of the appearance of CLETUS and contents of the pack
CLETUS 20 mg hard gastro-resistant capsules.
CLETUS is available in packs of 14 or 28 hard gastro-resistant capsules containing 20 mg.

Marketing authorisation holder and manufacturer
So.Se.PHARM S.r.l.- Via dei Castelli Romani, 22 – 00071 Pomezia (RM) - Italy

Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR) – Italy