Cletus

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

CLETUS

20 mg gastro-resistant hard capsules
omeprazole
Generic Medicine
Please read all of this leaflet carefully before taking 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 personally. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 substance omeprazole. It belongs to a group of medicines known as 'proton pump inhibitors', which work by reducing the amount of acid produced in the stomach.
CLETUS is used for the treatment of the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach 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 infected 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). CLETUS may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excessive acid production in the stomach caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age 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 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 over 4 years of age and adolescents
Ulcers infected 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 should know before taking CLETUS

Do not take CLETUS

• If you are allergic to the active substance (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, consult your doctor or pharmacist before taking CLETUS.
Warnings and precautions
Talk to your doctor or pharmacist before taking CLETUS.
Severe skin reactions have been reported in association with treatment with CLETUS, including
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and
systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using
CLETUS and contact a doctor immediately if you notice any of the symptoms related to these severe
skin reactions described in section 4.
CLETUS may mask symptoms of other diseases. Therefore, if you experience any of the following
symptoms before or while taking CLETUS, 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 CLETUS that reduces gastric acidity.
• If you are scheduled for a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with CLETUS may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
If you have been taking CLETUS for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice any new or unusual symptoms.
If you take a proton pump inhibitor such as CLETUS, especially for over a 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 may increase the risk of osteoporosis), consult your doctor.
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.
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 rashes, and joint stiffness. Report such 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 without a prescription. This is important because CLETUS can affect how some medicines work, and conversely, some medicines may affect the action of CLETUS.
Do not take CLETUS if you are taking a medicine containing nelfinavir (used to treat HIV infections).

• 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 CLETUS.
• 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 CLETUS.
• 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 agent used in high doses to treat cancer) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with CLETUS.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with CLETUS 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.
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, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can
take CLETUS during this time. Omeprazole is excreted in breast milk, but it is unlikely to affect the
baby when used at therapeutic doses.
Your doctor will decide whether you can take CLETUS while breastfeeding.
Driving and using machines
It is unlikely that CLETUS will affect your ability to drive or use tools or machines.
Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
CLETUS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take CLETUS

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, 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 listed below.

Use in adults
For the treatment of symptoms of GERD, 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 daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for another 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 usual 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 NSAID use (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 when taking 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 CLETUS twice daily for one week.
• Your doctor will also instruct you to take two antibiotics, selected from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by a growth of 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 will also decide how long you should take the medicine.

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

• CLETUS 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:

• CLETUS 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 juice), 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 the full dose of medicine is taken, rinse the glass thoroughly with half a glass of water and drink the rinse water. The solid particles contain the medicine—do not chew or crush them.

If you take more CLETUS than you should
If you take more CLETUS than 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 the missed dose.
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.

If you stop taking CLETUS
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CLETUS can cause side effects, although not everyone 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, stop taking CLETUS and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, 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 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 fatigue 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)
• Benign stomach polyps
• Feeling unwell (nausea) or being unwell (vomiting)

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

• Swelling of the feet and ankles
• Disturbed sleep (insomnia)
• Dizziness, tingling, drowsiness
• Sensation of spinning (vertigo)
• Changes in blood tests related to liver function
• Rash, skin rash with skin swelling (urticaria) and itching
• General feeling of being unwell and lack of energy
• If you take a proton pump inhibitor such as CLETUS, especially for longer 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 may 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 reduced numbers of white blood cells or platelets. This may cause weakness and easy bruising, or make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
• Restlessness, confusion or depression
• Taste disturbances
• Vision problems, such as blurred vision
• Sudden wheezing or breathlessness (bronchospasm)
• Dry mouth
• Inflammation inside the mouth
• A fungal infection called “candidiasis” which may affect the intestine
• Hair loss (alopecia)
• Rash occurring 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)
• Aggression
• Seeing, feeling or hearing things that are not real (hallucinations)
• Severe liver problems up to liver failure and brain inflammation
• Erythema multiforme
• Muscle weakness
• Breast enlargement in men

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

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

In very rare cases, CLETUS may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by 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 must contact your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) through a blood test. It is important that you inform your doctor about the medicine you are taking.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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-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 stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Store this medicine in the original packaging (blister) 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What CLETUS contains
The active substance is omeprazole. CLETUS 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 CLETUS and contents of the pack
CLETUS 20 mg gastro-resistant hard capsules.
CLETUS is available in packs containing 14 or 28 gastro-resistant hard capsules of 20 mg.

Marketing Authorization 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