KOMEZOL 20 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Komezol 20 mg gastro-resistant capsules
   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

Komezol 20 mg 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 Komezol is and what it is used for
• 2. What you need to know before you take 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 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.
Komezol is used for the treatment of the following conditions:
In adults:

• Gastro-oesophageal reflux disease (GERD). This disease occurs when acid rises 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 “ 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). Komezol can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an increase in 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 rises 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 “ 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 Komezol

Do not take Komezol

• if you are allergic to omeprazole or 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 you fall into any of the above categories. If you have any doubts, ask your doctor or pharmacist before taking Komezol.

Warnings and precautions
Talk to your doctor or pharmacist before taking Komezol.
Komezol may mask the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking Komezol or while you are 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 diarrhoea, because omeprazole has been associated with a slight increase in infectious diarrhoea.
• Serious liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Komezol 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 treatment with Komezol. Remember to also report any other undesirable effects such as joint pain.
If you take Komezol 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 Komezol, 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.
During treatment with omeprazole, inflammation of your kidneys may occur. Signs and symptoms may include 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

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 Komezol
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 Komezol can affect how some medicines work and, in turn, some medicines can affect the action of Komezol.
Do not take Komezol if you are taking a medicine containing nelfinavir(used for the treatment of HIV infections).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• 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 Komezol.
• 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 Komezol.
• Rifampicin (antibiotic also used for the treatment of tuberculosis).
• Atazanavir (used for the treatment of HIV infection).
• Tacrolimus (immunosuppressant drug 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 your treatment with Komezol. If your doctor has prescribed you amoxicillin and clarithromycin antibiotics together with Komezol for the treatment of ulcers caused by Helicobacter pyloriinfections, it is very important that you tell them if you are taking any other medicines.

Komezol with food and drink
See section 3.

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 Komezol 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 Komezol during breastfeeding.

Driving and using machines
It is unlikely that Komezol will affect your ability to drive vehicles or use tools or machinery. Side effects such as dizziness and visual disturbances may occur (see section 4). If you suffer from these, do not drive vehicles or use machinery.

Komezol contains mannitol
It may have a mild laxative effect.
This medicine contains less than 1 mmol (23 mg) of sodium per hard gastro-resistant capsule, i.e. essentially ‘sodium-free’.

3. How to take Komezol

Take this medicine following exactly the instructions of your doctor. If you have any 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 condition and
age.
The recommended dose is:

Adults:
For the treatment of symptoms of GERD, such as heartburnand 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 caused by Helicobacter Pylori infectionand prevention of their
recurrence:

• The recommended dose is 20 mg of Komezol 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 overgrowth of 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

Children over 1 year of age and weighing more than 10 kg
For the treatment of GERD and symptoms of GERD, such as heartburn and acid regurgitation:

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

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

• 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.

How to use
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
decomposed by the acid present 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), 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 very well 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 Komezol than you should
If you take a quantity of Komezol greater than that 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 to
take the 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 doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness 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”.
• Yellowing of the skin, dark urine and fatigue may be symptoms of liver problems.

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.
• Disturbed sleep (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 unwellness and lack of energy.
• If you are taking a proton pump inhibitor such as Komezol, 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 the composition of the blood, 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.
• Problems with vision, 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 the blood cell count, 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.

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

• Lowering of magnesium levels in the blood (hypomagnesemia). If you take Komezol for more than three months, blood magnesium levels may decrease. Low magnesium levels can

manifest as fatigue, involuntary muscle contractions, disorientation, convulsions,
dizziness, increased heart rate. If you experience any of these symptoms, consult your
doctor immediately. Low magnesium levels can also lead to a decrease in blood levels of
potassium or calcium. Your doctor may decide to check your blood magnesium levels periodically.

• Lowering of calcium levels in the blood (hypocalcemia). Lowering of calcium levels in the blood may result from very low levels of magnesium.
• Lowering of potassium levels in the blood (hypokalemia).
• Inflammation of the intestine (resulting in diarrhea).
• Erythema, possible joint pain.

In very rare cases Komezol 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 in this case to inform the doctor about the
medicine you are taking.

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
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 which is reported on the packaging after Expiry. The expiry
date refers to the last day of the month.
Do not store at a temperature above 30 °C.
Keep the blister in the original packaging or keep the bottle tightly closed 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 Komezol contains

• The active ingredient is omeprazole. Komezol gastro-resistant hard capsules contains 20 mg of omeprazole.
• The other ingredients 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 Komezol 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 and manufacturer

Marketing authorisation holder
Konpharma srl – Via Pietro della Valle 1 - 00193 Rome

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