Komezol

Package leaflet: Information for the user

Komezol 20 mg gastro-resistant capsules

Omeprazole
Generic medicine
Please read all of this leaflet carefully before you start 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 only. Do not give it to other people, even if their symptoms are the same as yours, as 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 Komezol is and what it is used for
2. What you need to know before taking Komezol
3. How to take Komezol
4. Possible side effects
5. How to store Komezol
6. Contents of the pack and other information

1. What Komezol is and what it is used for

Komezol 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 by the stomach.
Komezol is used to treat the following conditions:
In adults:

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid moves up from 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 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 non-steroidal anti-inflammatory drugs (NSAIDs). Komezol may also be used to prevent ulcers in patients taking NSAIDs.
• Excess stomach acid caused by overgrowth 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 moves up from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn. In children, symptoms of this disease may also include regurgitation of stomach contents 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 the 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 Komezol

Do not take Komezol

• if you are allergic to 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).

Do not take Komezol if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Komezol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Komezol.
Komezol may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Komezol, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-colored stools (indicating 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 Komezol that reduces gastric acidity.
• If you need to undergo 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 Komezol may need to be discontinued. Remember to report any other adverse effects such as joint pain.
If you have been taking Komezol 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 Komezol, 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.
During treatment with omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rashes, and joint stiffness. Report such signs to 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.
Other medicines and Komezol
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 Komezol may affect how some medicines work, and some medicines may affect the action of Komezol.
Do not take Komezol 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 Komezol.
• 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 Komezol.
• Rifampicin (an antibiotic also used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (an immunosuppressant 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 Komezol. If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Komezol 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.

Komezol with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Komezol during this period.
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 Komezol while breastfeeding.
Driving and using machines
It is unlikely that Komezol will affect your ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
Komezol contains mannitol
It may have a mild laxative effect.
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant hard capsule, i.e. essentially 'sodium-free'.

3. How to take Komezol

Take this medicine exactly as your doctor has told you. 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 recommended dose is:
Adults:
For the treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If your doctor has told you that your oesophagus 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 a further 8 weeks if the oesophagus has not yet fully healed.
• Once the oesophagus has healed, the recommended dose is 10 mg once daily.
• If the oesophagus 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 taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is 20 mg once daily for 4–8 weeks.
  To prevent the formation of duodenal and gastric ulcers if you are 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 Komezol twice daily for one week.
• Your doctor will also instruct you to take two antibiotics, chosen 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 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
Children older than 1 year of age and weighing more than 10 kg
For the treatment of GERD and GERD symptoms, such as heartburn and acid regurgitation:

• The dose for children is based on the child's body weight, and the exact dose will be determined by the doctor.

Children older than 4 years of age
For the treatment and prevention of recurrence of ulcers caused by Helicobacter pylori infection:

• The dose for children is based on the child's 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.

Instructions for use
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 specially 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 have difficulty swallowing the capsules
If you or the child have 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 a glass of 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. The solid particles contain the medicine; do not chew or crush them.

If you take more Komezol than you should
If you take more Komezol than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Komezol
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Komezol
Do not stop taking Komezol without first talking to your doctor or pharmacist.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you notice any of the following rare but serious side effects, stop taking Komezol and
contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• 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”.
• Yellowing of the skin, dark urine and tiredness could be symptoms of liver problems.

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

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

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, rash with skin swelling (urticaria) and itching of the skin.
• General feeling of malaise and lack of energy.
• If you take a proton pump inhibitor such as Komezol, 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 number of white blood cells or platelets. This may cause weakness, easy bruising, or 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, confusion or depression.
• Taste disturbances.
• 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 occurring during sun exposure.
• 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 count, 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 inflammation of the brain.
• 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.

Not known (frequency cannot be estimated from the available data)

• Decrease in magnesium levels in the blood (hypomagnesaemia). If you take Komezol for more than three months, magnesium levels in your blood 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, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to monitor your blood magnesium levels periodically.

• Decrease in calcium levels in the blood (hypocalcaemia). Reduced calcium levels in the blood may result from very low magnesium levels.

• Decrease in potassium levels in the blood (hypokalaemia).

• Inflammation of the intestine (resulting in diarrhoea).

• Erythema, possible joint pain.

In very rare cases, Komezol may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in general health or fever with symptoms of local infection such as neck, throat or mouth pain or difficulty urinating, you should contact 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.

Reporting of side effects
If you experience any side effects, 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 Komezol

Keep Komezol 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 the month.
Do not store above 30 °C.
Keep the blister 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 you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Komezol Contains

• The active substance is omeprazole. Komezol gastro-resistant hard capsules contain 20 mg of omeprazole.
• The other components 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 Komezol and Package Contents
Gastro-resistant hard capsules.
14 gastro-resistant hard capsules of 20 mg.
28 gastro-resistant hard capsules of 20 mg.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Konpharma srl – Via Pietro della Valle 1 - 00193 Rome, Italy
Manufacturer
Special Product’s Line S.p.a. – Via Fratta Rotonda Vado Largo 1, 03012 Anagni (FR), Italy