Omeprazole Pharmacare

Patient Information Leaflet: Information for the User

OMEPRAZOLE PHARMACARE 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 you take 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OMEPRAZOLO PHARMACARE is and what it is used for

OMEPRAZOLO PHARMACARE contains the active substance omeprazole. It belongs to a
group of medicines known as 'proton pump inhibitors', which work by reducing the amount
of acid produced by the stomach.
OMEPRAZOLO PHARMACARE is used to treat the following conditions:

In adults:

• Treatment of gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Healed reflux oesophagitis.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer), and their prevention.
• Ulcers infected with a bacterium called Helicobacter pylori. If you suffer from 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 PHARMACARE may also be used to prevent ulcer formation if you are taking NSAIDs.
• Excess stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

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In children:
Children aged over 1 year and weighing more than or equal to 10 kg

• Treatment of gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disease may also include regurgitation of stomach contents into the mouth, discomfort (vomiting), and poor weight gain.
• Treatment of symptoms of heartburn (acid reflux) and acid regurgitation due to gastro-oesophageal reflux disease.

Children aged over 4 years and adolescents
Ulcers infected with a bacterium called Helicobacter pylori. If the child suffers from 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 PHARMACARE

Do not take OMEPRAZOLO PHARMACARE

• 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 OMEPRAZOLO PHARMACARE if you fall into any of the above categories. If you have any
doubts, consult your doctor or pharmacist before taking OMEPRAZOLO PHARMACARE.
Warnings and precautions
Talk to your doctor or pharmacist before taking OMEPRAZOLO PHARMACARE.
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 OMEPRAZOLO PHARMACARE. Stop using OMEPRAZOLO PHARMACARE and contact a doctor immediately if you experience any of the symptoms related to these serious skin reactions described in section 4.
OMEPRAZOLO PHARMACARE may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or during treatment with OMEPRAZOLO PHARMACARE, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Vomiting food or blood.
• Dark-coloured stools (indicating presence of blood in stools).
• Stomach pain or indigestion.
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in the risk of infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLO PHARMACARE that reduces gastric acidity.
• If you are scheduled to undergo a specific blood test (chromogranin A).

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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 OMEPRAZOLO PHARMACARE. Remember to also report any other adverse effects such as joint pain.
If you have been taking OMEPRAZOLO PHARMACARE 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.
If you take a proton pump inhibitor such as OMEPRAZOLO PHARMACARE, 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.
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, skin rash, and joint stiffness. Report such signs to your doctor.
Children
Some children with chronic conditions may require long-term treatment, even though it is not recommended.
Do not give this medicine to children under 1 year of age or weighing less than 10 kg.
Other medicines and OMEPRAZOLO PHARMACARE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines. This is important because OMEPRAZOLO PHARMACARE may affect how some medicines work, and conversely, some medicines may affect the action of OMEPRAZOLO PHARMACARE.
Do not take OMEPRAZOLO PHARMACARE 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:

• Posaconazole, ketoconazole, itraconazole, 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 OMEPRAZOLO PHARMACARE.
• 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 OMEPRAZOLO PHARMACARE.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used in organ transplants).

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• 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 PHARMACARE.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with OMEPRAZOLO PHARMACARE for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.
OMEPRAZOLO PHARMACARE with food and drink
The capsules can be taken with food or on an empty stomach.
Pregnancy and breastfeeding
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.
Your doctor will decide whether you can take OMEPRAZOLO PHARMACARE if you are pregnant or breastfeeding.
Omeprazole is excreted in breast milk, but it is unlikely to affect the breastfed infant when used at therapeutic doses. Your doctor will decide whether you can take OMEPRAZOLO PHARMACARE during breastfeeding.
Driving and using machines
It is unlikely that OMEPRAZOLO PHARMACARE will affect your ability to drive or operate machinery. However, adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
OMEPRAZOLO PHARMACARE contains sucrose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
OMEPRAZOLO PHARMACARE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant hard capsule, i.e. essentially "sodium-free".

3. How to take OMEPRAZOLE PHARMACARE

Take this medicine exactly as directed 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 age.
The recommended doses are:
Adults
For the treatment of GERD symptoms, 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 necessary, the dose may be increased to 20–40 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 using 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 (or 40 mg) of OMEPRAZOLE PHARMACARE twice daily for one week.
• Your doctor will also instruct you to take two antibiotics, selected from amoxicillin, clarithromycin, 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 determine how long you should take the medicine.

Use in children and adolescents
For the treatment of GERD symptoms, such as heartburn and acid regurgitation:

• OMEPRAZOLE PHARMACARE 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:

• OMEPRAZOLE PHARMACARE 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, amoxicillin and clarithromycin, for your child.

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 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 an 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 the full dose is taken, 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.

Special populations:
If you are an elderly patient and/or if your kidneys are not functioning properly, you may take
OMEPRAZOLE PHARMACARE at the recommended doses.
If liver function is impaired, a daily dose of 10–20 mg is recommended.

If you take more OMEPRAZOLE PHARMACARE than you should
If you take more OMEPRAZOLE PHARMACARE than prescribed by your doctor, contact your doctor or pharmacist immediately.
Reported symptoms include nausea, vomiting, dizziness, abdominal pain, diarrhea, and headache. In isolated cases, apathy, depression, and confusion have also been observed. Symptoms are transient and no serious consequences have been reported.

If you forget to take OMEPRAZOLE PHARMACARE
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 missed one.

If you stop taking OMEPRAZOLE PHARMACARE
Do not stop taking OMEPRAZOLE PHARMACARE without first discussing it with your doctor or pharmacist.
If you have any questions about using this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice one 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 PHARMACARE 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 blistering with bleeding of 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)
• Generalized red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis). (Rare)
• Yellowing of the skin, dark urine and fatigue could be symptoms of liver problems. (Rare)

The side effects listed below are arranged by frequency:
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 (peripheral oedema)
• Disturbed sleep (insomnia)
• Dizziness, tingling, drowsiness
• Sensation of dizziness (vertigo)
• Changes in blood tests related to liver function
• Dermatitis, skin rash, skin rash with skin swelling (urticaria) and itching of the skin
• General feeling of unwellness and lack of energy
• Fracture of the hip, wrist or spine (see section “Warnings and Precautions”)
• If you take a proton pump inhibitor such as OMEPRAZOLE PHARMACARE, 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.

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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 very 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.
• Feeling restless, confused or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or breathlessness (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” which may affect the intestine and is caused by a fungus.
• 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 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 things that are not real (hallucinations).
• Severe liver problems up to liver failure and inflammation of the brain.
• Muscle weakness.
• Breast enlargement in men.

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

• If you take OMEPRAZOLE PHARMACARE for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, 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 to periodically monitor your blood magnesium levels.
• Erythema, possible joint pain.
• Reduced levels of calcium in the blood (hypocalcaemia). Reduced calcium levels may result from very low magnesium levels.
• Reduced levels of potassium in the blood (hypokalaemia).
• Inflammation of the intestine (resulting in diarrhoea).

Do not be alarmed by this list of possible side effects. You may not experience any of them.
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 website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OMEPRAZOLE PHARMACARE

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 carton after Exp. The expiry
date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What OMEPRAZOLO PHARMACARE contains

• The active substance is omeprazole. Each capsule contains 10 mg, 20 mg or 40 mg of omeprazole in the form of gastro-resistant granules.
• The other components are:
• Capsule core: sugar spheres (sucrose and maize starch), sodium carboxymethylcellulose (Type A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide.
• Capsule cap: red iron oxide (E172) (only in 10 mg), erythrosine (E127), indigo carmine (E132) (only in 20 mg and 40 mg), titanium dioxide (E171), water, gelatin.
• Capsule body: quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171), water, gelatin.
• Printing ink: shellac, povidone, propylene glycol, sodium hydroxide, titanium dioxide (E171).

Description of the appearance of OMEPRAZOLO PHARMACARE and contents of the pack
OMEPRAZOLO PHARMACARE 10 mg:
Hard gelatin capsules, size 3, with an opaque red cap and an opaque orange body.
The letter “O” is printed in white ink on the cap and the number “10” on the body.
The capsules are filled with pelletized microgranules of white to beige colour.
Blister packs containing 14 and 28 capsules.
OMEPRAZOLO PHARMACARE 20 mg:
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Hard gelatin capsules, size 2, with an opaque blue cap and an opaque orange body.
The letter “O” is printed in white ink on the cap and the number “20” on the body.
The capsules are filled with pelletized microgranules of white to beige colour.
Blister packs containing 14 and 28 capsules.
OMEPRAZOLO PHARMACARE 40 mg:
Hard gelatin capsules, size 0, with an opaque blue cap and an opaque orange body.
The letter “O” is printed in white ink on the cap and the number “40” on the body.
The capsules are filled with pelletized microgranules of white to beige colour.
Blister packs containing 14 and 28 capsules.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29 - 20149 Milano
Italy

Manufacturer
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C., number 4, 50016 Zaragoza, Spain
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