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1. OMEPRAZOLO ALTER 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules
   1. WHAT OMEPRAZOLO ALTER IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING OMEPRAZOL ALTER
   3. HOW TO TAKE OMEPRAZOLO ALTER
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE OMEPRAZOLO ALTER
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

OMEPRAZOLO ALTER 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules

Omeprazolo

Equivalent 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any undesirable effects occur, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

• 1. What Omeprazolo Alter is and what it is used for
• 2. What you need to know before you take Omeprazolo Alter
• 3. How to take Omeprazolo Alter
• 4. Possible side effects
• 5. How to store Omeprazolo Alter 6 Package contents and Other information

1. WHAT OMEPRAZOLO ALTER IS AND WHAT IT IS USED FOR

Omeprazolo Alter contains the active ingredient omeprazole. It belongs to a group of medicines
called “proton pump inhibitors”, which work by reducing the production of acid in the
stomach.
Omeprazolo Alter is used to treat:

• “Gastroesophageal reflux disease” (GERD). When acid from the stomach rises into the esophagus (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 when associated with infection by “ Helicobacter pylori”. If you have this disease your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazolo Alter can also be used in the prevention of ulcers when undergoing treatment with NSAIDs.
• Excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome).

Children over 1 year of age and ≥ 10 kg

• “Gastroesophageal reflux disease” (GERD). When acid from the stomach rises into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, symptoms may include the return of stomach contents into the mouth (regurgitation), vomiting and poor growth. Children and adolescents over 4 years of age
• Ulcers when associated with infection by “ Helicobacter pylori”. If your child has this disease the doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. WHAT YOU NEED TO KNOW BEFORE TAKING OMEPRAZOL ALTER

Do not take Omeprazolo Alter

• If you are allergic (hypersensitive) to omeprazole or any of the excipients of Omeprazolo Alter.
• 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 doubts, consult your doctor or pharmacist before taking Omeprazolo Alter.

Warnings and precautionsConsult your doctor before taking Omeprazolo Alter:

• if you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Alter that reduces stomach acid;
• if you are 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
Alter. Remember to also report any other undesirable effects such as joint pain.
Omeprazolo Alter can mask the symptoms of other diseases. Therefore, if you experience the symptoms
described below before taking Omeprazolo Alter or while taking it, contact your doctor
immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stool (presence of blood in the stool).
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Serious liver problems.

Taking proton pump inhibitors can cause alterations in the results of the urea breath test
for the detection of Helicobacter pylori. Therefore, the administration of omeprazole must be suspended
2 weeks before the test.
If you take Omeprazolo Alter for a long time (more than 1 year), your doctor will probably prescribe
regular check-ups. You should report any new and exceptional symptoms and circumstances
whenever you see your doctor.
If you take a proton pump inhibitor such as Omeprazolo Alter, 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.

Taking Omeprazolo Alter with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription. This is because Omeprazolo Alter can affect the
mechanism of action of some medicines and some medicines can affect Omeprazolo
Alter.
Do not take Omeprazolo Alter if you are taking a medicine that contains nelfinavir(used for the
treatment of HIV infection).
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 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 Alter.
• 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 Alter.
• Rifampicin (used for the treatment of tuberculosis)
• Atazanavir (used for the treatment of HIV infection)
• Tacrolimus (in case of organ transplantation)
• St. John's Wort (Hypericum perforatum) (used in 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 the formation of blood clots (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapeutic medicine used in high doses for the treatment of cancer) - if you are taking methotrexate in high doses, your doctor may temporarily interrupt treatment with Omeprazolo Alter.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Omeprazolo Alter
to treat ulcers caused by Helicobacter pyloriinfection, it is very important to inform your
doctor of any other medicine you are taking.

Taking Omeprazolo Alter with food and drink
You can take the capsules with food or on an empty stomach

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Before taking Omeprazolo Alter, tell your doctor if you are pregnant or planning to become pregnant. The doctor
will decide if you can take Omeprazolo Alter during this period.
Your doctor will decide if you can take Omeprazolo Alter during breastfeeding

Driving and operating machinery
There is no evidence of effects on the ability to drive vehicles or operate machinery. Side effects such as dizziness and visual disturbances (see section 4) may occur. If you experience these
symptoms, you should not drive or operate machinery.

Important information about some excipients of Omeprazolo Alter
Omeprazolo Alter contains sucrose. If your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.

3. HOW TO TAKE OMEPRAZOLO ALTER

Always take Omeprazolo Alter exactly as your doctor has instructed. 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 health condition and
age.
The usual doses are given below.
Adults:
Treatment of GERD symptoms such as heartburn and acid reflux:

• If your doctor has found mild damage to your digestive tract (esophagus), the usual dose is 20 mg once a day for 4-8 weeks. Your doctor will tell you to take a 40 mg dose for another 8 weeks if the esophagus has not yet fully healed.
• The usual dose after the esophagus has healed is 10 mg once a day.
• If there is no damage to the esophagus, the usual dose is 10 mg once a day. Treatment of ulcers in the upper part of the intestine (duodenal ulcer):
• The usual dose is 20 mg once a day for 2 weeks. Your doctor will tell you to take the same 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.

Treatment of ulcers in the stomach (gastric ulcer):

• The usual dose is 20 mg once a day for 4 weeks. Your doctor will tell you to take the same 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.

In the prevention of recurrence of duodenal and gastric ulcers:

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

Treatment of duodenal and gastric ulcers caused by NSAIDs(non-steroidal anti-inflammatory
drugs):

• The usual dose is 20 mg once a day for 4-8 weeks.

Prevention of duodenal and gastric ulcers if you are taking NSAIDs:

• The usual dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pyloriinfections and to prevent the formation of
recurrences:

• The usual dose of Omeprazolo Alter is 20 mg twice a day for one week.
• Your doctor will also prescribe you two antibiotics from amoxicillin, clarithromycin and metronidazole.

Treatment of high gastric acidity caused by pancreatic cancer (Zollinger-Ellison
syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and decide how long you should take the medication.

Children:
Treatment of GERD symptoms such as heartburn and acid reflux:

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

Treatment of ulcers causedby Helicobacter pyloriinfections and to prevent the formation of
recurrences:

• Children over 4 years of age can take Omeprazolo Alter. The dose for children is based on the child's body weight and the doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Administration

• Try to take the capsules in the morning.
• The capsules can be taken with or without food.
• Take the capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain pellets coated that prevent the medicine from breaking down in contact with stomach acid. It is important not to damage the pellets.

What to do if you or your child has difficulty swallowing the capsules

• If you or your child has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly with half a glass of water or put the contents in a glass with water (non-carbonated), with fruit juice of any kind (e.g. apple, orange or pineapple) or apple sauce.
• Always stir the solution before drinking it (the solution will not be clear). Then drink the contents of the glass immediately or within 30 minutes.
• To be sure you have drunk all the medicine, rinse the glass with half a glass of water and drink its contents. The granules contain the medicine - they must not be chewed or crushed.

If you take more Omeprazolo Alter than you should
If you have taken more Omeprazolo Alter than prescribed by your doctor, you should contact your
doctor or pharmacist immediately.

If you forget to take Omeprazolo Alter
If you forget a dose, take it as soon as you remember. However, if this is the time to take 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 Alter
If you have any doubts about using Omeprazolo Alter, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Omeprazolo Alter can cause side effects, although not everybody gets them.

If you notice any of the following rare but serious side effects, stop taking Omeprazolo
Alter 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).
• Reddening of the skin with blisters or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine and fatigue, which can be symptoms of kidney 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: diarrhoea, stomach pain, constipation, passing gas (flatulence).
• Feeling unwell (nausea) or feeling sick (vomiting).

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, a pins and needles sensation in the limbs, drowsiness.
• Feeling faint.
• 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.

Rare side effects

• Blood disorders such as a decrease in white blood cells or platelets. This can cause weakness, bruising or increased susceptibility to infections.
• Allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This may cause weakness, feeling sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste disturbances.
• Vision problems such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called "candidiasis" that can affect the intestines and is caused by a fungus.
• Inflammation of the intestine (resulting in diarrhoea)
• 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 things that are not real (hallucinations).
• Serious liver disorders that can cause liver failure and inflammation of the brain.
• Sudden appearance of a severe rash or blisters or peeling of the skin. These may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in males.

Frequency not known
If you take Omeprazolo Alter 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. Low magnesium levels can also
lead to a decrease in blood potassium or calcium levels. The doctor should decide whether
to periodically check magnesium levels in the blood.
Erythema and possible joint pain may also occur.
Alteration of the urea breath test(see section 2).
In very rare cases, Omeprazolo Alter affects white blood cells causing immunodeficiency. If you
have an infection with symptoms such as fever, associated with a severedeterioration of general conditions or
fever with symptoms of a local infection such as sore throat, sore throat or mouth or difficulty urinating,
you should consult a doctor as soon as possible in order to rule out a deficiency of white blood cells
(agranulocytosis) by performing blood tests. It is important that you provide information
regarding the medicine you are taking during this period.
Do not be worried by this list of possible side effects. You may not experience them. If any
of the side effects worsen, or if you notice any side effect

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through

the national reporting system at www.agenziafarmaco.gov.it/it/responsabili”. The

reporting of side effects helps to provide more information on the safety of

this medicine.

5. HOW TO STORE OMEPRAZOLO ALTER

Keep OMEPRAZOLO ALTER out of the sight and reach of children.
Do not use OMEPRAZOLO ALTER after the expiry date which is stated on the packaging after
Exp.and for 28 days after first opening the bottle.

The expiry date refers to the last day of the month
This medicine does not require any particular storage temperature. Store in the
original packaging.
The period of validity after first opening the bottle (record the date of first opening
in the designated space on the carton)is 28 days. Close the bottle tightly after use.
Medicines should not be disposed of via wastewater 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 the medicine contains
OMEPRAZOLO ALTER 10 mg gastro-resistant hard capsules:
Each gastro-resistant hard capsule contains :

Active ingredient: omeprazole 10 mg

Excipients: hypromellose, talc, titanium dioxide (E171), disodium phosphate dihydrate, methacrylic acid
ethyl acrylate copolymer, triethyl citrate, sucrose spheres.
Capsule shell :titanium dioxide (E171), purified water, gelatin, black ink.

OMEPRAZOLO ALTER 20 mg gastro-resistant hard capsules:
Each gastro-resistant hard capsule contains:

Active ingredient: omeprazole 20 mg

Excipients:hypromellose, talc, titanium dioxide (E171), disodium phosphate dihydrate, methacrylic acid
ethyl acrylate copolymer, triethyl citrate, sucrose spheres.
Capsule shell :titanium dioxide (E171), purified water, gelatin, black ink

DESCRIPTION OF THE APPEARANCE OF OMEPRAZOLO ALTER AND CONTENTS OF THE
PACK
Gastro-resistant hard capsules
Omeprazolo Alter 10 mg gastro-resistant hard capsules: a bottle contains 14 gastro-resistant
hard capsules of 10 mg
Omeprazolo Alter 20 mg gastro-resistant hard capsules: a bottle contains 14 gastro-resistant
hard capsules of 20 mg

Marketing Authorisation Holder
Laboratori Alter S.r.L. – Via Egadi 7 – 20144 Milano

MANUFACTURER
Laboratorios Dr. Esteve, S.A. – Sant Martì, s/n, Pol. Industrial La Roca - 08107 Martorelles –
Barcelona (Spain)

MEDICINE: