Omeprazole Aurobindo Pharma Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Omeprazolo Aurobindo Pharma Italia 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

Generic medicine
Please read 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Omeprazolo Aurobindo Pharma Italia is and what it is used for
What you need to know before taking Omeprazolo Aurobindo Pharma Italia
How to take Omeprazolo Aurobindo Pharma Italia
Possible side effects
How to store Omeprazolo Aurobindo Pharma Italia
Contents of the pack and other information

1. What Omeprazolo Aurobindo Pharma Italia is and what it is used for

Omeprazolo Aurobindo Pharma Italia contains the active substance 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 Aurobindo Pharma Italia is used to treat the following conditions:
In adults:

'Gastro-oesophageal reflux disease' (GERD). This condition occurs when acid leaks 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 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). Omeprazolo Aurobindo Pharma Italia can 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 from 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, 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 Omeprazolo Aurobindo Pharma Italia

Do not take Omeprazolo Aurobindo Pharma Italia if:

You are allergic to omeprazole or to any of the other ingredients of this medicine (listed in section 6).
You are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
You are taking a medicine containing nelfinavir (used to treat HIV infections).

If you have any doubts, consult your doctor or pharmacist before taking Omeprazolo Aurobindo Pharma Italia.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Omeprazolo Aurobindo Pharma Italia.

Omeprazolo Aurobindo Pharma Italia may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Omeprazolo Aurobindo Pharma Italia, contact your doctor immediately:

Unintentional weight loss and difficulty swallowing.
Stomach pain or indigestion.
Vomiting food or blood.
Dark-coloured stools (presence of blood in stools).
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 Omeprazolo Aurobindo Pharma Italia that reduces gastric acidity.
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 treatment with Omeprazolo Aurobindo Pharma Italia may need to be stopped. Remember to also report any other side effects such as joint pain.

If you take a proton pump inhibitor such as Omeprazolo Aurobindo Pharma Italia, especially for more 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.

If you take Omeprazolo Aurobindo Pharma Italia 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.

Children

Some children with chronic conditions may require long-term treatment, although this is not generally recommended.

Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Omeprazolo Aurobindo Pharma Italia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Omeprazolo Aurobindo Pharma Italia may affect how some medicines work, and some medicines may affect the action of Omeprazolo Aurobindo Pharma Italia.

Do not take Omeprazolo Aurobindo Pharma Italia if you are taking a medicine containing nelfinavir (used to treat HIV infections).

Inform 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 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 at the beginning and end of treatment with Omeprazolo Aurobindo Pharma Italia.
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 Aurobindo Pharma Italia.
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))
Erlotinib (used to treat cancer)
Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with Omeprazolo Aurobindo Pharma Italia.

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

Omeprazolo Aurobindo Pharma Italia with food and drink

See section 3.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will decide whether you can take Omeprazolo Aurobindo Pharma Italia 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 Omeprazolo Aurobindo Pharma Italia while breastfeeding.

Driving and using machines

It is unlikely that Omeprazolo Aurobindo Pharma Italia will affect your ability to drive or use tools or machines. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.

Omeprazolo Aurobindo Pharma Italia contains sucrose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Omeprazolo Aurobindo Pharma Italia

Always take this medicine exactly as instructed 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
your age.
The recommended doses are listed below.

Adults:

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

If your doctor has informed 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 an additional 8 weeks if the esophagus has not yet fully healed.
Once the esophagus has healed, the recommended dose 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 taking NSAIDs (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 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 Omeprazolo Aurobindo Pharma Italia twice daily for one week.
Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, tinidazole, and metronidazole.

For the treatment of excessive stomach acid caused by pancreatic tissue overgrowth (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:

Omeprazolo Aurobindo Pharma Italia 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:

Omeprazolo Aurobindo Pharma Italia 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 should be taken before a meal (e.g., breakfast) 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 coated granules designed 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 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 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 Aurobindo Pharma Italia than you should
If you take more Omeprazolo Aurobindo Pharma Italia than prescribed, contact your doctor or pharmacist immediately.

If you forget to take Omeprazolo Aurobindo Pharma Italia
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 have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you notice any of the following very rare but serious side effects, stop taking Omeprazole Aurobindo Pharma Italia 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 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 problems: diarrhoea, stomach pain, 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, skin rash with skin swelling (urticaria) and itching of the skin.
General feeling of being unwell and lack of energy.
If you take a proton pump inhibitor such as Omeprazole Aurobindo Pharma Italia, 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 may make infections more likely.
Allergic reactions, sometimes 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.
Feelings of restlessness, confusion or depression.
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” affecting the intestine, 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 which may lead to kidney failure).
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 unreal events (hallucinations).
Severe liver problems up to liver failure and brain inflammation.
Sudden onset of severe rash or blisters and skin peeling. These effects may be associated with high fever and joint pains (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Breast enlargement in men.

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

Inflammation of the intestine (resulting in diarrhoea).
If you take Omeprazole Aurobindo Pharma Italia 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.
Reduced calcium levels in the blood (hypocalcaemia). Reduced calcium levels in the blood may result from very low magnesium levels.
Reduced potassium levels in the blood (hypokalaemia).
Erythema, possible muscle pain.

In very rare cases, Omeprazole Aurobindo Pharma Italia 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 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omeprazolo Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton or the blister,
after “EXP”. The expiry date refers to the last day of that month.
Capsule containers: Do not store above 30°C. Keep the container tightly closed
to protect the medicine from moisture.
Blister packs: do not store above 25°C. Store in the original packaging to
protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Omeprazolo Aurobindo Pharma Italia contains

The active substance is omeprazole. Each capsule contains 10 mg or 20 mg of omeprazole.
The other components are sugar spheres (sucrose, maize starch, water), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, hypromellose, talc, mannitol, macrogol 6000, titanium dioxide (E171), polysorbate 80, disodium phosphate anhydrous, sodium lauryl sulfate. Capsule shell ( 10 mg and 20 mg ): gelatin, water, titanium dioxide (E171), quinoline yellow (E104).

Description of the appearance of Omeprazolo Aurobindo Pharma Italia and the contents of the pack
10 mg: yellow, opaque capsule.
20 mg: yellow, opaque capsule.
The capsules contain white-cream (ivory) spherical microgranules.
Packs:
Blister packs: 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280 and 500 capsules.
Bottle packs: 7, 14, 28, 30, 56, 60, 90, 100 and 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, Nº 7. Polígono Industrial Miralcampo,
19200 Azuqueca de Henares, Guadalajara
Spain

MPF B.V. (Manufacturing Packaging Farmaca)
Neptunus 12
8448 CN Heerenveen
The Netherlands

MPF B.V. (Manufacturing Packaging Farmaca)
Appelhof 13
8465 RX Oudehaske
The Netherlands