OMEPRAZOLO 10 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Omeprazolo GIT 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules
   1. What Omeprazolo GIT is and what it is used for
   2. What you need to know before taking Omeprazolo GIT
   3. How to take Omeprazolo GIT
   4. Possible side effects
   5. How to store Omeprazolo GIT
   6. Contents of the pack and other information

Omeprazolo GIT 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules

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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What Omeprazolo GIT is and what it is used for

Omeprazolo GIT 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.
Omeprazolo GIT 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 ‘ 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). Omeprazolo GIT can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight of 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 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 Omeprazolo GIT

Do not take Omeprazolo GIT

• 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).

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

Warnings and precautions
Consult your doctor or pharmacist before taking Omeprazolo GIT.
Omeprazolo GIT can mask the symptoms of other diseases. Therefore, if you experience the symptoms below
described before taking Omeprazolo GIT 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 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 Omeprazolo GIT that reduces stomach acid.

Inform your doctor before taking this medicine if you need 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 therapy with Omeprazolo GIT. Remember
to also report any other undesirable effects such as joint pain.
If you take Omeprazolo GIT for a long time (more than 1 year) your doctor will prescribe regular check-ups.
Inform your doctor if you notice the appearance of new and particular symptoms.
If you are taking a proton pump inhibitor such as Omeprazolo GIT, 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 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 Omeprazolo GIT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This is important because Omeprazolo GIT can affect the way some medicines work and in turn some medicines can affect the action of Omeprazolo GIT.
Do not take Omeprazolo GIT if you are taking a medicine containing nelfinavir(used for
the treatment of HIV infections).
Inform your doctor or pharmacist if you are taking one or more of the following medicines:

• Ketoconazole, itraconazole 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 Omeprazolo GIT.
• 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 Omeprazolo GIT.
• 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)).

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Omeprazolo GIT for
the treatment of ulcers caused by Helicobacter pylori infections, it is very important that you report if you are
taking any other medicines.

Omeprazolo GIT with food and drink
The capsules can be taken with food or on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide
if you can take Omeprazolo GITduring this period.

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

Omeprazolo GIT contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Omeprazolo GIT

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 doses are:

• If your doctor has told you that your esophagus is slightly damaged, the usual 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 usual 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 usual 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 usual 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 usual 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 usual 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 usual dose is 20 mg once a day.

For the treatment of ulcers caused by infection byHelicobacter pyloriand prevention of their
recurrence:

• The usual dose is 20 mg of Omeprazolo GIT twice a day for one week.
• The 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 usual 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
For the treatment of symptoms of GERD, such as heartburn and acid reflux:

• Omeprazolo GIT 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 byHelicobacter pylori:

• Omeprazolo GIT 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. The solid particles contain the medicine - do not chew or crush them.

If you take more Omeprazolo GIT than you should
If you take a quantity of Omeprazolo GIT greater than that prescribed by your doctor, contact
your doctor or pharmacist immediately.

If you forget to take Omeprazolo GIT
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.

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 Omeprazolo
GIT 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).
• Redness of the skin with blistering or flaking. A severe formation of blisters 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.

Side effects can occur with a certain frequency, as defined below:
Other side effects include:

Common side effects

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, emission of gas (flatulence), benign polyps in the stomach.
• Feeling unwell (nausea) or feeling sick (vomiting).

Uncommon side effects

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, feeling sleepy.
• Feeling dizzy (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.
• Fracture of the hip, wrist or spine (see section “Warnings and precautions”).

Rare side effects

• 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” which 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

• 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 inflammation of the brain.
• Sudden onset of a severe rash or blisters and flaking of the skin. 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.

Frequency not known

• hypomagnesemia. If you take Omeprazolo GIT for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. The doctor should decide whether to periodically check your blood magnesium levels.
• Erythema, possible joint pain.

In very rare cases Omeprazolo GIT can affect white blood cells leading to immunodeficiency. If
you should experience an infection with symptoms such as fever with a severedeterioration of the general
condition 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, so as to exclude 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.
Do not be worried by the list of possible side effects. You may not experience any of them.

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 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 Omeprazolo GIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in waste water 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 Omeprazolo GIT contains

• The active ingredient is omeprazole. Each capsule contains 10 mg, 20 mg or 40 mg of omeprazole as gastro-resistant granules.
• The other ingredients are:

Capsule core:sugar spheres (sucrose and corn starch), sodium carboxymethylcellulose (Type
A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid –ethyl
acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide.

Capsule cap:red iron oxide (E172) (only 10 mg), erythrosine (E127), indigotine
(E132) (only 20 mg and 40 mg) titanium dioxide (E171), water, gelatin.

Capsule body:Quinoline Yellow (E-104), erythrosine (E-127), titanium dioxide (E-171), water,
gelatin.

Printing ink -shellac, povidone, propylene glycol, sodium hydroxide, titanium dioxide
(E171).

Description of the appearance of Omeprazolo GIT and contents of the pack
Omeprazolo GIT 10 mg:
Hard gelatin capsules, size 3, with an opaque red cap and an opaque orange body. The letter “O” has been
printed on the cap and the number “10” on the body with white ink. The capsules are filled with pelleted
microgranules ranging in colour from white to beige.
Blister containing 14 or 28 capsules.
Omeprazolo GIT 20 mg:
Hard gelatin capsules, size 2, with an opaque blue cap and an opaque orange body. The letter “O” has been
printed on the cap and the number “20” on the body with white ink. The capsules are filled with pelleted
microgranules ranging in colour from white to beige.
Blister containing 14 or 28 capsules.
Omeprazolo GIT 40 mg:
Hard gelatin capsules, size 0, with an opaque blue cap and an opaque orange body. The letter “O” has been
printed on the cap and the number “40” on the body with white ink. The capsules are filled with pelleted
microgranules ranging in colour from white to beige.
Blister containing 14 or 28 capsules.

Marketing Authorisation Holder
SF GROUP SrL – via Tiburtina 1143, 00156 Roma (Italy)

Manufacturer
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C., number 4, 50016 Zaragoza
Spain