Omeprazole Git

Package leaflet: Information for the user

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

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 others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 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

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

Omeprazole GIT 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.
Omeprazole GIT is used to treat the following conditions:

In adults:

• 'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks out of the stomach and passes 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). Omeprazole GIT 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 and passes 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 need to know before taking Omeprazole GIT

Do not take Omeprazole GIT

• if you are allergic to the active substance 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 Omeprazole GIT.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole GIT.
Omeprazole GIT may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Omeprazole GIT, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-colored stools (indicating presence of blood in stools).
• Severe or persistent diarrhea, as 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 Omeprazole GIT that reduces stomach acidity.

Inform your doctor before taking this medicine if you are due to have 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 it may be necessary to discontinue treatment with Omeprazole GIT. Remember to also report any other side effects such as joint pain.
If you have been taking Omeprazole GIT for a long time (more than 1 year), your doctor will prescribe regular check-ups.
Inform your doctor if you notice the onset of new or unusual symptoms.
If you take a proton pump inhibitor such as Omeprazole GIT, 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 suffer from 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 presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Report such signs to your doctor.
Other medicines and Omeprazole GIT
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. This is important because Omeprazole GIT may affect how some medicines work, and conversely, some medicines may affect the action of Omeprazole GIT.
Do not take Omeprazole GIT 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, 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 Omeprazole GIT.
• 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 Omeprazole GIT.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used in organ transplants).
• 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)).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole GIT 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.
Omeprazole GIT with food and drink
The capsules can be taken with food or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Omeprazole GIT during this period.
Driving and using machines
It is unlikely that Omeprazole GIT will affect your ability to drive or use tools or machinery. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
Omeprazole GIT contains sucrose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Omeprazolo GIT

Take this medicine exactly as directed by your doctor. 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 doses are:

Adults

For treatment of symptoms of GERD, such as heartburn and acid regurgitation:

• If your doctor has told you that your esophagus is slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for an additional 8 weeks if the esophagus has not yet fully healed.
• Once the esophagus has healed, the usual dose is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

For treatment of ulcers in the upper part of the intestine (duodenal ulcer):

• The usual 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 treatment of stomach ulcers (gastric ulcer):

• The usual 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 recurrence of duodenal and gastric ulcers:

• The usual dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

For treatment of duodenal and gastric ulcers caused by taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The usual dose is 20 mg once daily for 4–8 weeks.

For preventing the formation of duodenal and gastric ulcers if you are using NSAIDs:

• The usual dose is 20 mg once daily.

For treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The usual dose is 20 mg of Omeprazolo GIT twice daily for one week.
• Your doctor will also instruct you to take two antibiotics among amoxicillin, clarithromycin, and metronidazole.

For treatment of excessive stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome):

• The usual 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

For treatment of symptoms of GERD, such as heartburn and acid regurgitation:

• 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 body weight, and the exact dose will be determined by the doctor.

For treatment and prevention of recurrence of ulcers caused by Helicobacter pylori infection:

• Omeprazolo GIT can 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. Do not chew or crush the capsules, 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 (such as 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 you have taken the full dose, 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 Omeprazolo GIT than you should
If you take more Omeprazolo GIT than 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 for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten 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 Omeprazole
GIT 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. There may also be severe blister formation with bleeding of the lips, eyes, mouth, nose and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark coloured urine and tiredness could be symptoms of liver problems.

Side effects may occur with a certain frequency as defined below:

Other adverse reactions include:
Common adverse reactions

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

Uncommon adverse reactions

• Swelling of the feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, drowsiness.
• Feeling 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 being unwell and lack of energy.
• Fracture of the hip, wrist or spine (see section “Warnings and precautions”).

Rare adverse reactions

• Changes in blood composition, such as reduced numbers of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue and throat, fever, breathlessness.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting), and cramps.
• Feeling restless, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden breathlessness or shortness of breath (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 exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse reactions

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing events that are not real (hallucinations).
• Severe liver problems up to liver failure and inflammation of the brain.
• Sudden onset of severe rash, 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.
• Breast enlargement in men.

Frequency not known

• Hypomagnesaemia. If you take Omeprazolo GIT for more than three months, magnesium levels in the 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. Your doctor should decide whether to periodically monitor your blood magnesium levels.
• Erythema, possible joint pain.

In very rare cases, Omeprazolo GIT may affect white blood cells leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in your general health, or fever with symptoms of a local infection such as neck, throat or mouth pain, or difficulty urinating, you must consult 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.
Do not be alarmed by this list of possible adverse reactions. You may not experience any of them.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Omeprazole GIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging 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 Omeprazolo GIT Contains

• The active substance is omeprazole. Each capsule contains 10 mg, 20 mg or 40 mg of omeprazole in the form of gastro-resistant granules.
• The other components are:

Capsule core: sugar spheres (sucrose and maize starch), sodium carboxymethyl starch (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) (10 mg only), erythrosine (E127), indigo carmine (E132) (20 mg and 40 mg only), titanium dioxide (E171), water, gelatin.
Capsule body: quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171), 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” is printed in white ink on the cap and the number “10” on the body. The capsules are filled with coated microgranules ranging in colour from white to beige.
Blister packs 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” is printed in white ink on the cap and the number “20” on the body. The capsules are filled with coated microgranules ranging in colour from white to beige.
Blister packs 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” is printed in white ink on the cap and the number “40” on the body. The capsules are filled with coated microgranules ranging in colour from white to beige.
Blister packs containing 14 or 28 capsules.

Marketing Authorization Holder
SF GROUP S.r.L. – Via Tiburtina 1143, 00156 Rome (Italy)

Manufacturer
TEVA Pharma S.L.U.
Polígono Industrial Malpica, Calle C, No. 4, 50016 Zaragoza
Spain