Omeprazole Aurobindo

Package leaflet: Information for the user

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

omeprazole
Generic medicine
Please read all of 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 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 Omeprazolo Aurobindo is and what it is used for
2. What you need to know before taking Omeprazolo Aurobindo
3. How to take Omeprazolo Aurobindo
4. Possible side effects
5. How to store Omeprazolo Aurobindo
6. Contents of the pack and other information

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

Omeprazolo Aurobindo 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 in the stomach.
Omeprazolo Aurobindo is used to treat the following conditions:

In adults:

• Treatment of 'gastro-oesophageal reflux disease' (GERD). This condition occurs when stomach acid leaks 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 may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive production of stomach acid caused by abnormal growth 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

• Treatment of 'gastro-oesophageal reflux disease' (GERD). This condition occurs when stomach acid leaks into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

• In children, symptoms of this condition may include regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children aged over 4 years 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 Aurobindo

Do not take Omeprazole Aurobindo

• 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 to treat HIV infections).

Do not take Omeprazole Aurobindo if any of the above apply to you. If you are unsure,
consult your doctor or pharmacist before taking Omeprazole Aurobindo.
Warnings and precautions
Consult your doctor or pharmacist before taking Omeprazole Aurobindo.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment. Stop using omeprazole and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Omeprazole Aurobindo may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before starting or while taking Omeprazole Aurobindo, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-coloured stools (indicating presence of blood in the stool).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in the risk of infectious diarrhoea.
• Severe liver problems.
• A history of skin reactions after treatment with a medicine similar to Omeprazole Aurobindo that reduces stomach acid.
• An upcoming specific blood test (chromogranin A).

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, rash, and joint stiffness. Report such symptoms to your doctor.
If you take Omeprazole Aurobindo long-term (more than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms or circumstances at each medical visit.
Taking a proton pump inhibitor such as Omeprazole Aurobindo, particularly for more than one year, may slightly increase 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 a skin rash develops, especially in sun-exposed areas, inform your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazole Aurobindo. Remember to report any other adverse effects, such as joint pain.
Children
Some children with chronic conditions may require long-term treatment, despite it not being recommended. Do not give this medicine to children under 1 year of age or weighing <10 kg.
Other medicines and Omeprazole Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because Omeprazole Aurobindo may affect how some medicines work, and some medicines may affect the action of Omeprazole Aurobindo.
Do not take Omeprazole Aurobindo 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 when starting or stopping treatment with Omeprazole Aurobindo.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor may need to monitor you when starting or stopping treatment with Omeprazole Aurobindo.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (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 at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily discontinue your treatment with Omeprazole Aurobindo.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole Aurobindo to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them if you are taking any other medicines.
Omeprazole Aurobindo with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Omeprazole is excreted in breast milk but is unlikely to affect the breastfed infant when used at therapeutic doses. Your doctor will decide whether you can take Omeprazole Aurobindo while breastfeeding.
Driving and using machines
It is unlikely that Omeprazole Aurobindo will affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
Omeprazole Aurobindo contains sucrose
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
Omeprazole Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Omeprazole Aurobindo

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.
Use in adults:
To treat symptoms of GERD, such as heartburn and acid regurgitation:

• If your doctor has informed you that your food pipe (oesophagus) has been slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may instruct you to increase the dose to 40 mg for another 8 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

To treat ulcers in the upper part of the intestine (duodenal ulcer):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may instruct you to take the same dose for another 2 weeks if the ulcer has not yet healed.
• If ulcers have not completely healed, the dose may be increased to 40 mg once daily for 4 weeks.

To treat stomach ulcers (gastric ulcer):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may instruct you to take the same dose for another 4 weeks if the ulcer has not yet healed.
• If ulcers have 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.

To treat 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 duodenal and gastric ulcers if you are using NSAIDs:

• The recommended dose is 20 mg once daily.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

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

To treat excessive stomach acid caused by a pancreatic tumour
(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
To treat symptoms of GERD, such as heartburn and acid regurgitation:

• Children over 1 year of age and weighing more than 10 kg may take Omeprazole Aurobindo. The dose for children is based on body weight, and your doctor will determine the exact dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• Children over 4 years of age may take Omeprazole Aurobindo. The dose for children is based on body weight, and your doctor will determine the exact dose.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin.

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. 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 your 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 still (non-fizzy) water, acidic fruit juice (such as apple, orange or pineapple), or apple puree.
• Always shake the mixture well just before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To ensure you have taken all the medicine, 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 Omeprazole Aurobindo than you should
If you take more Omeprazole Aurobindo than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take Omeprazole Aurobindo
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.
If you stop taking Omeprazole Aurobindo
Do not stop taking Omeprazole Aurobindo without first talking to your doctor or pharmacist. If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
If you notice any of the following rare (may affect up to 1 in 1,000 people)
or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking
Omeprazole Aurobindo and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• A widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption). (rare)
• Yellowing of the skin, dark urine and tiredness, which may be signs of liver problems (rare).

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

• Headache
• Stomach or bowel problems: diarrhoea, stomach pain, constipation, passing wind (flatulence)
• Feeling unwell (nausea) or being sick (vomiting)
• Benign polyps in the stomach

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Difficulty sleeping (insomnia)
• Dizziness, tingling, drowsiness
• Feeling dizzy (vertigo)
• Changes in blood tests related to liver function
• Skin rash, skin rash with lumps (urticaria) and itchy skin
• General feeling of being unwell and lack of energy

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 and bruising, or make infections more likely.
• 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 wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” affecting the intestine, caused by a fungus.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• 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 blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, hearing or sensing things that are not real (hallucinations).
• Serious liver problems leading to liver failure and inflammation of the brain.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in men.

Not known (frequency cannot be estimated from available data)

• Inflammation of the intestine (resulting in diarrhoea).
• If you take Omeprazole Aurobindo for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness or 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 may decide to carry out periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazole Aurobindo may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of your general health, or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, you should consult your doctor as soon as possible so that a deficiency in white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Omeprazole Aurobindo

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.
PVC/PE/PVdC/Al blisters: Store below 25 °C; keep in the original packaging to protect the medicine from moisture.
HDPE bottles: This medicine does not require any special storage conditions; keep the bottle tightly closed 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 contains

• The active substance is omeprazole. Omeprazolo Aurobindo gastro-resistant hard capsules (gastro-resistant capsules) contain 10 mg, 20 mg or 40 mg of omeprazole.
• The other ingredients are sugar spheres (composed of maize starch and sucrose), magnesium hydroxide, maize starch, disodium phosphate, hypromellose, sodium lauryl sulfate, mannitol (E421), sodium starch glycolate, talc, titanium dioxide (E171), macrogol, polysorbate 80 and methacrylic acid-ethyl acrylate copolymer (1:1).
• The 10 mg gelatin capsules contain: Brilliant Blue FCF (E133), yellow iron oxide (E172), titanium dioxide (E171) and gelatin.
• The 20 mg gelatin capsules contain: indigotine (E132), titanium dioxide (E171) and gelatin.
• The 40 mg gelatin capsules contain: black iron oxide (E172), titanium dioxide (E171) and gelatin.

Description of the appearance of Omeprazolo Aurobindo and pack contents
Omeprazolo Aurobindo 10 mg gastro-resistant capsules: Hard gelatin capsule approximately 14.3 mm long, with a green cap and white body, containing spherical granules ranging from white to off-white or cream-white in colour.
Omeprazolo Aurobindo 20 mg gastro-resistant capsules: Hard gelatin capsule approximately 14.3 mm long, with a blue cap and white body, containing spherical granules ranging from white to off-white or cream-white in colour.
Omeprazolo Aurobindo 40 mg gastro-resistant capsules: Hard gelatin capsule approximately 15.9 mm long, with a white cap and grey body, containing spherical granules ranging from white to off-white or cream-white in colour.

Pack sizes:
Omeprazolo Aurobindo 10 mg is available in PVC/PE/PVdC//Alu blisters containing 7, 14, 15, 28 and 30 gastro-resistant hard capsules or in HDPE bottles containing 7, 14, 15, 28 and 30 gastro-resistant hard capsules.
Omeprazolo Aurobindo 20 mg is available in PVC/PE/PVdC//Alu blisters containing 7, 14, 15, 28 and 30 gastro-resistant hard capsules or in HDPE bottles containing 7, 14, 15, 28 and 30 gastro-resistant hard capsules.
Omeprazolo Aurobindo 40 mg is available in PVC/PE/PVdC//Alu blisters containing 7, 14, 15, 28 and 30 gastro-resistant hard capsules or in HDPE bottles containing 7, 14, 15, 28 and 30 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) Srl
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer:
Laboratorios Liconsa, S.A.
Avenida Miralcampo, 7
Poligono Industrial Miralcampo
19200 – Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic: Ignayol
Bulgaria: Omeprazole PI 10 mg Cтомашно-устойчива таблета
France: Ignayol 20 mg gélule gastro-résistante
Italy: Omeprazolo Aurobindo