OMEPRAZOLO 10 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Omeprazolo Aurobindo 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules
   1. What is Omeprazolo Aurobindo and what is it 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. Package Contents and Other Information

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

omeprazolo
Generic medicine

Read 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 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. 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 you take 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 is Omeprazolo Aurobindo and what is it used for

Omeprazolo Aurobindo 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 Aurobindo is used for the treatment of the following conditions:
In adults:

• Treatment of ‘Gastro-oesophageal Reflux Disease’ (GERD). This condition occurs when stomach acid leaks back 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 the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘ Helycobacter 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 can also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess 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 weighing 10 kg or more

• Treatment of ‘Gastro-oesophageal Reflux Disease’ (GERD). This condition occurs when

stomach acid leaks back into the oesophagus (the tube that connects the throat to the stomach) causing
pain, inflammation and heartburn.

• In children, the symptoms of this condition may 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 ‘ Helycobacter pylori’. If the 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

Do not take Omeprazolo 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 for HIV infections).

Do not take Omeprazolo Aurobindo if any of the above applies to you. If you are unsure,
ask your doctor or pharmacist before taking Omeprazolo Aurobindo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo 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 treatment with omeprazole. 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.
Omeprazolo Aurobindo may mask the symptoms of other diseases. Therefore, if you should experience any
of the symptoms described below before starting to take Omeprazolo Aurobindo or while you are
taking it, contact your doctor immediately:

• You are losing a lot of weight without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Darkening of the stools (presence of blood in the stools).
• You experience severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• You have serious liver problems.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Aurobindo that reduces stomach acid.
• A specific blood test (chromogranin A) is scheduled.

While taking omeprazole, inflammation of the 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, rash and joint stiffness. Report these signs to your doctor.
If you take Omeprazolo Aurobindo for a long time (more than 1 year), your doctor will probably keep
you under regular surveillance. You should report any new and unusual symptoms whenever
you visit your doctor.
Taking a proton pump inhibitor such as Omeprazolo Aurobindo, especially for
a period longer than one year, may slightly increase 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.
If a rash appears, especially in areas exposed to the sun, inform your doctor as
soon as possible, as it may be necessary to stop treatment with Omeprazolo Aurobindo. Remember to report any other adverse effects as well, such as joint pain.

Children
Some children with chronic illnesses may require long-term treatment, although
it is not recommended. Do not give this medicine to children under 1 year of age or weighing <10
kg.

Other medicines and Omeprazolo Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. This includes medicines you bought without a prescription. This is because
Omeprazolo Aurobindo can affect the way some medicines work and some medicines
can have an effect on the action of Omeprazolo Aurobindo.
Do not take Omeprazolo Aurobindo if you are taking a medicine containing nelfinavir (used
for the treatment of HIV infections).
Tell 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 you start or stop treatment with Omeprazolo Aurobindo.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor may need to monitor you when you start or stop treatment with Omeprazolo Aurobindo.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in case of 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 medicine used at high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Omeprazolo Aurobindo.

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

Omeprazolo Aurobindo with food and drink
See section 3.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
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 Omeprazolo Aurobindo if you are breastfeeding
with breast milk.

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

Omeprazolo Aurobindo contains sucrose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.

Omeprazolo 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 Omeprazolo Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
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 reported below.

Use in adults:
To treat the symptoms of GERD, such as heartburn and acid reflux:

• If your doctor has told you that your food pipe (esophagus) has been slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to increase the dose to 40 mg for another 8 weeks if the esophagus is not yet healed.
• The recommended 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.

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

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

To treat stomach ulcers(gastric ulcer):

• the recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcers are 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. Your doctor may increase the dose to 40 mg once a day.

To treat 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 duodenal and gastric ulcersif you are taking NSAIDs:

• the recommended dose is 20 mg once a day.

To treat ulcers caused by infection with Helycobacter pyloriand prevent their recurrence:

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

To treat excessive amount of acid in the stomach caused by an increase of the pancreas
(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 for how long you will have to take the medicine.

Use in children and adolescents
To treat the symptoms of GERD, such as heartburn and acid reflux:

• Children over 1 year of age and weighing more than 10 kg can take Omeprazolo Aurobindo. The dose for children is based on the child's weight and the doctor will decide the exact dose.

To treat ulcers caused by infection with Helycobacter pyloriand to prevent their recurrence:

• Children over 4 years of age can take Omeprazolo Aurobindo. The dose for children is based on the child's weight and the doctor will decide the exact dose.
• The doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to the 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 present in the stomach. It is important not to damage the granules.

What to do if you or the child has problems swallowing the capsules
If you or your child has problems 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 still water (not sparkling), acidic fruit juice (for example apple, orange or pineapple) or applesauce.
• Always shake the contents just 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 Aurobindo than you should
If you take an amount of Omeprazolo Aurobindo higher than that prescribed by your doctor, contact
your doctor or pharmacist immediately.

If you forget to take Omeprazolo Aurobindo
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for
the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

If you stop taking Omeprazolo Aurobindo
Do not stop taking Omeprazolo Aurobindo before talking to your doctor or pharmacist. If
you have any doubts about the use of this medicine, contact 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 (may affect up to 1 in 1,000) or very rare (may affect up to 1 in 10,000) but serious side effects, stop taking
Omeprazolo Aurobindo 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) (rare).
• Reddening of the skin with blisters or peeling. Blisters may also occur severely and bleeding in the lips, eyes, mouth, nose and genitals. This may be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare).
• Widespread skin rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• A red, scaly and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue, which can be symptoms of liver problems (rare).

Other side effects include:

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

• Headache
• Effects on the stomach or intestines: diarrhoea, 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 giddy (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, rash with nodules (urticaria) and itching.
• General feeling of discomfort and lack of energy.

Rare side effects (may affect up to 1 in 1,000 people)

• Changes in blood cell counts, such as a decrease in the number of white blood cells or platelets. This can cause weakness and bruising, or may make you more likely to get infections.
• 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 feeling of wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash after 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 count of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems causing liver failure and brain inflammation.
• Erythema multiforme.
• 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 Omeprazolo Aurobindo for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor magnesium levels in the blood.
• Skin rash, possibly with joint pain.

In very rare cases Omeprazolo Aurobindo can affect white blood cells leading to immunodeficiency.
If you develop an infection with symptoms such as fever with a serious deterioration of your general condition or fever with symptoms of local infection such as sore throat, sore throat or difficulty urinating, you should consult a doctor as soon as possible, so that a deficiency of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you inform your 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 Omeprazolo Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
PVC/PE/PVdC/Al blisters: Store at a temperature below 25 °C; store 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 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. Package Contents and Other Information

What Omeprazolo Aurobindo Contains

• The active ingredient is omeprazole. The gastro-resistant hard capsules of Omeprazolo Aurobindo (gastro-resistant capsules) contain 10 mg, 20 mg or 40 mg of omeprazole.
• The other ingredients are sugar spheres (composed of corn starch and sucrose), magnesium hydroxide, corn 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 Package Contents
Omeprazolo Aurobindo 10 mg gastro-resistant capsules: Hard gelatin capsule of approximately 14.3 mm, with
green cap and white body, containing spherical granules of colour from white to off-white or cream.
Omeprazolo Aurobindo 20 mg gastro-resistant capsules: Hard gelatin capsule of approximately 14.3 mm, with
blue cap and white body, containing spherical granules of colour from white to off-white or cream.
Omeprazolo Aurobindo 40 mg gastro-resistant capsules: Hard gelatin capsule of approximately 15.9 mm, with
white cap and grey body, containing spherical granules of colour from white to off-white or cream.
Package sizes:
Omeprazolo Aurobindo 10 mg is available in PVC/PE/PVdC//Alu blisters of 7, 14, 15, 28 and 30
gastro-resistant hard capsules or in HDPE bottles of 7, 14, 15, 28 and 30 gastro-resistant hard capsules.
Omeprazolo Aurobindo 20 mg is available in PVC/PE/PVdC//Alu blisters of 7, 14, 15, 28 and 30
gastro-resistant hard capsules or in HDPE bottles of 7, 14, 15, 28 and 30 gastro-resistant hard capsules.
Omeprazolo Aurobindo 40 mg is available in PVC/PE/PVdC//Alu blisters of 7, 14, 15, 28 and 30
gastro-resistant hard capsules or in HDPE bottles of 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 Member States of the European Economic Area 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