Omeprazole Alter

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Omeprazole
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 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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

1. What Omeprazole Alter is and what it is used for
2. What you need to know before taking Omeprazole Alter
3. How to take Omeprazole Alter
4. Possible side effects
5. How to store Omeprazole Alter
6. Contents of the pack and other information

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

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

• Gastro-oesophageal reflux disease (GORD). This is when acid from the stomach flows back 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 associated with infection by "Helicobacter pylori". If you have this condition, 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). Omeprazole Alter may also be used to prevent ulcers in patients being treated with NSAIDs.
• Excess acid production due to a tumour of the pancreas (Zollinger-Ellison syndrome).

Children over 1 year of age and ≥ 10 kg

• Gastro-oesophageal reflux disease (GORD). When acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms may include regurgitation of stomach contents into the mouth, vomiting, and poor growth. Children and adolescents over 4 years of age
• Ulcers associated with infection by "Helicobacter pylori". If your child has this condition, the doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OMEPRAZOLE ALTER

Do not take OMEPRAZOLE ALTER

• If you are allergic (hypersensitive) to omeprazole or to any of the excipients of Omeprazole Alter.
• If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazolo, 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 Alter.
Warnings and precautions Consult your doctor before taking Omeprazole Alter:

• if you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Alter that reduces gastric acidity;
  • if you need to undergo a specific blood test (chromogranin A).

If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazole Alter. Remember to also report any other adverse effects such as joint pain.
Omeprazole Alter may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Omeprazole Alter, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Dark-colored 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.

The use of proton pump inhibitors may alter the results of the urea breath test for detecting Helicobacter pylori. Therefore, omeprazole treatment should be discontinued at least 2 weeks before the test.
If you have been taking Omeprazole Alter for a long time (more than 1 year), your doctor will likely prescribe regular check-ups. You should report any new or unusual symptoms or circumstances whenever you see your doctor.
If you are taking a proton pump inhibitor such as Omeprazole Alter, 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 suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Taking Omeprazole Alter with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. This is because Omeprazole Alter may affect the action of certain medicines, and some medicines may affect Omeprazole Alter.
Do not take Omeprazole Alter if you are taking a medicine containing 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 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 Alter.
• 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 Alter.
• 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 in high doses for cancer treatment) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with Omeprazole Alter.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole Alter to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor about any other medicines you are taking.
Taking Omeprazole Alter with food and drinks
You may 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 Omeprazole Alter, inform your doctor if you are pregnant or if you plan to become pregnant. Your doctor will decide whether you may take Omeprazole Alter during this period.
Your doctor will decide whether you may take Omeprazole Alter during breastfeeding.
Driving and using machines
There is no evidence of effects on the ability to drive or use machines. However, side effects such as dizziness and visual disturbances may occur (see section 4). If these symptoms occur, you must not drive or use machines.
Important information about some excipients of Omeprazole Alter
Omeprazole Alter contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE OMEPRAZOLE ALTER

Always take Omeprazole Alter 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 usual doses are listed below.

Adults:
Treatment of gastroesophageal reflux disease (GERD) symptoms such as heartburn and acid regurgitation:

• If your doctor has found mild damage to your digestive tract (esophagus), the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may instruct you to take a dose of 40 mg for an additional 8 weeks if the esophagus is not yet fully healed.
• The usual maintenance dose after healing of the esophagus is 10 mg once daily.
• If there is no damage to the esophagus, the usual dose is 10 mg once daily.

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 instruct you to continue 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 daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may instruct you to continue 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 daily for 8 weeks.

For prevention of recurrent 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.

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

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

Prevention of duodenal and gastric ulcers in patients taking NSAIDs:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of recurrence:

• The usual dose of Omeprazole Alter is 20 mg twice daily for one week.
• Your doctor will also prescribe two antibiotics among amoxicillin, clarithromycin, and metronidazole.

Treatment of excessive gastric acid caused by pancreatic tumour (Zollinger-Ellison syndrome):

• The usual dose is 60 mg daily.
• Your doctor will adjust the dose according to your needs and determine how long you should take the medicine.

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

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

Treatment of ulcers caused by Helicobacter pylori infection and prevention of recurrence:

• Children over 4 years of age may take Omeprazole Alter. The dose for children is based on body weight, and the doctor will determine 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.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets that prevent the medicine from breaking down upon 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 mix the contents in a glass of water (non-carbonated), fruit juice of any kind (e.g., apple, orange, or pineapple), or apple puree.
• Always mix the mixture before drinking (the solution will not be clear). Then drink the contents of the glass immediately or within 30 minutes.
• To ensure you have taken all the medicine, rinse the glass with half a glass of water and drink it. The granules contain the medicine – they must not be chewed or crushed.

If you take more Omeprazole Alter than you should
If you have taken more Omeprazole Alter than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take Omeprazole Alter
If you forget 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 stop taking Omeprazole Alter
If you have any doubts about using Omeprazole Alter, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Omeprazole Alter may cause adverse reactions, although not everybody gets them.
If you notice any of the following rare but serious adverse reactions, stop taking Omeprazole Alter and contact a 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. 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 may be symptoms of kidney problems.

Adverse reactions may occur with a certain frequency as defined below:

Other adverse effects include:
Common adverse effects

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, passing wind (flatulence).
• Feeling unwell (nausea) or being unwell (vomiting).

Uncommon adverse effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, a sensation of pins and needles in the limbs, drowsiness.
• Feeling of dizziness.
• Changes in blood tests relating to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching of the skin.
• Feeling generally unwell and lack of energy.

Rare adverse effects

• Blood disorders such as a decrease in white blood cells or platelets. This may cause weakness, bruising or increased susceptibility to infections.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, breathlessness.
• Low levels of sodium in the blood. This could cause weakness, feeling sick (vomiting) and cramps.
• Feeling restless, confused or depressed.
• Taste disturbances.
• Vision problems such as blurred vision.
• Sudden breathlessness or difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• A fungal infection called "candidiasis" which may affect the intestine.
• Inflammation of the intestine (resulting in diarrhoea).
• Liver problems, including jaundice, which may cause yellowing of the skin, dark urine and tiredness.
• Hair loss (alopecia).
• Skin rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver disorders which may lead to liver failure and brain inflammation.
• Sudden onset of severe rash, 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.
• Breast enlargement in males.

Frequency not known
If you take Omeprazolo Alter 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, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to monitor your blood magnesium levels periodically.
Skin redness 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 severe worsening of your general condition or fever with signs 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 deficiency of white blood cells (agranulocytosis) by means of blood tests. It is important that you provide information about the medicines you are currently taking.
Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili". Reporting adverse effects helps to provide more information on the safety of this medicine.

5. HOW TO STORE OMEPRAZOLE ALTER

Keep OMEPRAZOLE ALTER out of the sight and reach of children.
Do not use OMEPRAZOLE ALTER after the expiry date stated on the packaging after
Exp. and after 28 days from the first opening of the bottle.
The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage temperature. Store in the
original packaging.
The shelf life after first opening of 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 must 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 PACKAGE AND OTHER INFORMATION

What it contains
OMEPRAZOLE ALTER 10 mg gastro-resistant hard capsules:
Each gastro-resistant hard capsule contains:
Active substance: omeprazole 10 mg
Excipients: hypromellose, talc, titanium dioxide (E171), disodium phosphate dihydrate, methacrylic acid copolymer ethyl acrylate, triethyl citrate, sucrose spheres.
Capsule shell: titanium dioxide (E171), purified water, gelatin, black ink.

OMEPRAZOLE ALTER 20 mg gastro-resistant hard capsules:
Each gastro-resistant hard capsule contains:
Active substance: omeprazole 20 mg
Excipients: hypromellose, talc, titanium dioxide (E171), disodium phosphate dihydrate, methacrylic acid copolymer ethyl acrylate, triethyl citrate, sucrose spheres.
Capsule shell: titanium dioxide (E171), purified water, gelatin, black ink.

DESCRIPTION OF THE APPEARANCE OF OMEPRAZOLE ALTER AND THE CONTENTS OF THE PACKAGE
Gastro-resistant hard capsules.
Omeprazole Alter 10 mg gastro-resistant hard capsules: one bottle contains 14 gastro-resistant hard capsules of 10 mg.
Omeprazole Alter 20 mg gastro-resistant hard capsules: one bottle contains 14 gastro-resistant hard capsules of 20 mg.

Marketing Authorization Holder
Laboratori Alter S.r.L. – Via Egadi 7 – 20144 Milan, Italy

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

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: