Package leaflet: Information for the user

Omeprazolo P-Care 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

Equivalent 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, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Omeprazolo P-Care is and what it is used for
What you need to know before taking Omeprazolo P-Care
How to take Omeprazolo P-Care
Possible side effects
How to store Omeprazolo P-Care
Contents of the pack and other information

1. What Omeprazolo P-Care is and what it is used for

Omeprazolo P-Care 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 by the stomach.
Omeprazolo P-Care is used to treat the following conditions:

In adults:

'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.
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 P-Care may also be used to prevent ulcers from forming if you are taking NSAIDs.
Excessive acid production in the stomach caused by abnormal growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year and weighing more than or equal to 10 kg
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'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 condition may also include regurgitation of stomach contents back 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 Omeprazolo P-Care

Do not take Omeprazolo P-Care

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 P-Care if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Omeprazolo P-Care.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo P-Care.
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 P-Care.
Stop using Omeprazolo P-Care and contact a doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazolo P-Care.
Remember to also report any other adverse effects such as joint pain.
Omeprazolo P-Care may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Omeprazolo P-Care, contact your doctor immediately:

Unintentional weight loss and difficulty swallowing.
Stomach pain or indigestion.
Vomiting of food or blood.
Dark-colored stools (indicating presence of blood in stools).
Severe or persistent diarrhoea, because omeprazole has been associated with a slight increase in infectious diarrhoea.
Severe liver problems.
If you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo P-Care that reduces stomach acid. 2/10
If you are scheduled for a specific blood test (Chromogranin A).

If you have been taking Omeprazolo P-Care 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 are taking a proton pump inhibitor such as Omeprazolo P-Care, 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 blood in the urine and/or hypersensitivity reactions such as fever, skin rashes, and joint stiffness. Report such signs to your doctor.
Children
Some children with chronic conditions may require long-term treatment, although this 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 P-Care
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Omeprazolo P-Care can affect how some medicines work, and some medicines can affect how Omeprazolo P-Care works.
Do not take Omeprazolo P-Care 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 P-Care.
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 P-Care.
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 to treat cancer) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with Omeprazolo P-Care. 3/10

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo P-Care to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.
Omeprazolo P-Care with food and drink
The capsules can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Omeprazolo P-Care during this time.
Omeprazole is excreted in breast milk, but it is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide whether you can take Omeprazolo P-Care while breastfeeding.
Driving and using machines
It is unlikely that Omeprazolo P-Care will affect your ability to drive or use tools or machines. 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 P-Care contains saccarose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Omeprazolo P-Care 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 P-Care

Take this medicine 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 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.
The recommended dose once the esophagus has healed is 10 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 NSAID use (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 taking 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 of Omeprazole P-Care twice daily for one week.
Your doctor will also instruct you to take two antibiotics from the following: 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 daily.
Your doctor will adjust the dose according to your needs and will also decide how long you should continue treatment.

Use in children and adolescents

For the treatment of GERD symptoms, such as heartburn and acid regurgitation:

Omeprazole P-Care may be taken by children over one 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 P-Care may be taken by children over four 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 called 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. Do not chew or crush the capsules, 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), acidic fruit juice (e.g., apple, orange, or pineapple juice), or apple puree.
Always shake the mixture before drinking (the mixture will not be clear), and drink it 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 it. The solid particles contain the medicine—do not chew or crush them.

If you take more Omeprazole P-Care than you should

If you take more Omeprazole P-Care than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Omeprazole P-Care

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 forgotten dose.

If you stop taking Omeprazole P-Care

Do not stop taking Omeprazole P-Care without first talking to your doctor or pharmacist. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 P-Care 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. There may also be severe blistering with bleeding of the lips, eyes, mouth, nose and genitals. This could 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)
Generalised red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis). (Rare)
Yellowing of the skin, dark urine and tiredness could be symptoms of liver problems. (Rare)

Other side effects are listed below by frequency:
Common side effects (may affect up to 1 in 10 people)
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Headache
Stomach or bowel problems: diarrhoea, stomach ache, 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
Difficulty sleeping (insomnia)
Dizziness, tingling, drowsiness
Feeling of spinning (vertigo)
Changes in blood tests related to liver function
Skin rash, skin rash with swelling of the skin (urticaria) and itching of the skin
General feeling of being unwell and lack of energy
If you take a proton pump inhibitor such as Omeprazole P-Care, 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.

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 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 bowel and is caused by a fungus.
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).
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).
Aggression.
Seeing, feeling or hearing things that are not real (hallucinations).
Serious liver problems up to liver failure and inflammation of the brain.

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Sudden onset of severe skin rash or blisters and peeling of the skin. These effects may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
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 Omeprazole P-Care for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness and 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 check your blood magnesium levels periodically.
Reduction in calcium levels in the blood (hypocalcaemia). Low calcium levels may result from very low magnesium levels.
Reduction in potassium levels in the blood (hypokalaemia).
Erythema, possible joint pain.

In very rare cases, Omeprazole P-Care may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration in your general health, or fever with signs of a local infection such as neck, throat or mouth pain or difficulty urinating, you should contact your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) through a blood test. It is important that you inform your doctor about the medicine you are taking in this case.
Do not be alarmed by the list of possible side effects. You may not experience any of them.

Reporting of side effects
If you get any side effects, including ones 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
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Omeprazole P-Care

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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.
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6. Package contents and other information

What Omeprazolo P-Care 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.
Other ingredients are: Capsule core: sugar spheres (sucrose and maize starch), sodium carboxymethylamidum (Type A), sodium lauryl sulfate, povidone, dodecahydrate trisodium phosphate, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide. Capsule cap: iron oxide red (E172) (only for 10 mg), erythrosine (E127), indigo carmine (E132) (only for 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 P-Care and package contents
Omeprazolo P-Care 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 pelletted microgranules of white to beige colour.
Blister packs containing 14 and 28 capsules.
Omeprazolo P-Care 20 mg:
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 pelletted microgranules of white to beige colour.
Blister packs containing 14 and 28 capsules.
Omeprazolo P-Care 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 pelletted microgranules of white to beige colour.
Blister packs containing 14 capsules.

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

Marketing Authorization Holder for Sales
ACCORD HEALTHCARE S.R.L.
Viale Monza, 265 - 20165 Milano
Italy
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Manufacturer
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C, number 4
50016 Zaragoza - Spain
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