Omeprazole PensA

Package leaflet: Information for the patient

OMEPRAZOLE PENSA 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 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

OMEPRAZOLO PENSA contains the active substance omeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.
OMEPRAZOLO PENSA is used to treat:

In adults:

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach and enters 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). OMEPRAZOLO PENSA may also be used to prevent recurrence of these ulcers.
• Ulcers associated with a bacterium called Helicobacter pylori. If you have this condition, OMEPRAZOLO PENSA alone is not sufficient; your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers (both duodenal and gastric) caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). OMEPRAZOLO PENSA may also be used to prevent the development of ulcers if you are taking NSAIDs.
• Reflux oesophagitis (acute inflammation of the oesophagus caused by acid reflux from the stomach rising into the oesophagus).
• Excessive stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).
• Patients with healed reflux oesophagitis who require long-term treatment.

In children:
Children older than 1 year and with body weight greater than or equal to 10 kg:

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach and enters 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 (return of stomach contents into the mouth), vomiting, and poor weight gain.

Children older than 4 years and adolescents:

• Ulcers associated with a bacterium called Helicobacter pylori. If the child has this condition, the doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking OMEPRAZOLO PENSA

Do not take OMEPRAZOLO PENSA

• if you are allergic (hypersensitive) to omeprazole or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar medicines (proton pump inhibitors such as pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if you are taking a medicine containing nelfinavir (used for HIV infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking OMEPRAZOLO PENSA:

• if you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLO PENSA that reduces gastric acidity. If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as treatment with OMEPRAZOLO PENSA may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
• if you need to undergo a specific blood test (Chromogranin A).

OMEPRAZOLO PENSA may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking OMEPRAZOLO PENSA, 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).

Exercise particular caution with OMEPRAZOLO PENSA in the following cases:

• if you have low levels of vitamin B12 or are at risk of vitamin B12 deficiency, as this medicine may reduce absorption of vitamin B12 (cyanocobalamin); keep this in mind especially if treatment is prolonged and inform your doctor.
• if you have been taking OMEPRAZOLO PENSA for a long time (more than 1 year). In this case, your doctor will prescribe regular check-ups, as there may be a slightly increased risk of fractures of the hip, wrist, or spine.
• if you have bone problems (osteoporosis) or are an elderly patient. Consult your doctor, as you may need vitamin D and calcium supplementation.
• if you have low levels of magnesium in the blood (hypomagnesemia), as this medicine may further reduce magnesium levels, leading to symptoms such as fatigue, dizziness, heart problems, and muscle spasms during treatment lasting at least three months.

This medicine may cause a slight increase in the risk of stomach and intestinal infections caused by bacteria (Salmonella and Campylobacter).
Children
Long-term use of this medicine is not recommended in children.
Other medicines and OMEPRAZOLO PENSA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because OMEPRAZOLO PENSA may affect how some medicines work, and some medicines may affect the action of OMEPRAZOLO PENSA.
Do not take OMEPRAZOLO PENSA if you are taking a medicine containing nelfinavir (used for the treatment of HIV infections).
Inform your doctor or pharmacist if you are taking one or more of the following medicines:

• Ketoconazole, itraconazole, voriconazole, posaconazole (used to treat fungal infections).
• Erlotinib (used to treat tumours).
• 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 at the beginning and end of treatment with OMEPRAZOLO PENSA.
• 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 PENSA.
• Rifampicin (used to treat tuberculosis).
• Clarithromycin (an antibiotic used against bacterial infections).
• Atazanavir (used to treat HIV infection); concomitant use with omeprazole is not recommended.
• Tacrolimus (used in organ transplants).
• 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)).
• 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 PENSA.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with OMEPRAZOLO PENSA for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform them if you are taking any other medicines.
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 OMEPRAZOLO PENSA.
Your doctor will decide whether you can take OMEPRAZOLO PENSA during pregnancy and while breastfeeding.
Driving and using machines
It is unlikely that OMEPRAZOLO PENSA will affect your ability to drive or operate machinery. However, adverse reactions such as dizziness and visual disturbances may occur (see section “Undesired effects”). If you experience these, do not drive or operate machinery.
OMEPRAZOLO PENSA contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take OMEPRAZOLE PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, 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.
Take the capsules in the morning with food or on an empty stomach. Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. The capsules contain coated granules designed to prevent the medicine from being broken down by stomach acid. It is important not to damage the granules.

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 acidic fruit juice (such as 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 you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink the rinse. The solid particles contain the medicine – do not chew or crush them.

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

• If your doctor has told you that your oesophagus is slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for a further 8 weeks if the oesophagus has not yet fully healed.
• Once the oesophagus has healed, the usual dose is 10 mg once daily.
• If the oesophagus 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 usual 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 usual 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.

To prevent recurrence of 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.

For the treatment of duodenal and gastric ulcers caused by taking NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs):

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

To prevent the formation of duodenal and gastric ulcers while using NSAIDs:

• The usual dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of their
recurrence:

• The usual dose is 20 mg of OMEPRAZOLE PENSA twice daily for one week.
• Your doctor will instruct you to also take two antibiotics selected from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by overgrowth of tissue in the pancreas (Zollinger-Ellison
syndrome):

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

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

• OMEPRAZOLE PENSA 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 PENSA 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.

If you take more OMEPRAZOLE PENSA than you should
If you accidentally take too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take OMEPRAZOLE PENSA
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 a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach ache, constipation, passing wind (flatulence).
• Feeling unwell (nausea) or being unwell (vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Insomnia.
• Dizziness, tingling sensations, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal liver function blood tests.
• Skin rash, skin rash with skin swelling (urticaria), and itching.
• Feeling unwell and fluid retention in hands and feet (peripheral oedema).
• Increased risk of fractures of the hip, wrist or spine, especially with long-term treatment, if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

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

• Changes in blood composition, such as reduced numbers of white blood cells (leucopenia) or platelets (thrombocytopenia).
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, and wheezing. In such cases, stop taking OMEPRAZOLO PENSA and contact your doctor immediately.
• Low levels of sodium in the blood (hyponatraemia).
• Feelings of restlessness, confusion or depression.
• Altered taste.
• Blurred vision.
• Sudden wheezing or breathlessness (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth with development of sores.
• An infection called “gastrointestinal candidiasis” which may affect the intestine and is caused by a fungus.
• Liver disease called “hepatitis” with or without jaundice (yellowing of the skin and whites of the eyes).
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Reduction in all types of blood cells (pancytopenia), including agranulocytosis (lack of white blood cells).
• Aggression.
• Hallucinations (seeing or hearing things that are not real).
• Severe liver problems (hepatic failure) and inflammation of the brain (in patients with pre-existing liver failure).
• 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.

In very rare cases, OMEPRAZOLO PENSA 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 local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that in this case you inform your doctor about the medicine you are taking.

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

• Reduction in magnesium levels in the blood (hypomagnesaemia) (see section “Warnings and precautions”).
• Reduction in calcium levels in the blood (see section “Warnings and precautions”).
• Inflammation of the intestine, resulting in diarrhoea (microscopic colitis).
• Erythema, possible joint pain.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 OMEPRAZOLE PENSA

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 "Expiry".
The expiry date refers to the last day of that month.
HDPE bottle:
After first opening of the container (note the date of first opening in the designated space on the carton),
the medicine should be used within 28 days. After this period, any unused medicine must be discarded.
Store below 30°C in the original packaging.
Blister
20 mg gastro-resistant hard capsules: Store below 30°C in the original packaging;
10 mg gastro-resistant hard capsules: Store below 25°C in the original packaging;
Do not dispose of any medicine via 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 PENSA contains
OMEPRAZOLO PENSA 10 mg gastro-resistant hard capsules

• The active substance is omeprazole. Each capsule contains 10 mg of omeprazole.
• The other components of the capsule core are:
  o Granules: Hypromellose, talc, titanium dioxide (E171), methacrylic acid copolymer ethyl acrylate, triethyl citrate, sucrose spheres, disodium phosphate dihydrate.
  o Capsule shell: titanium dioxide (E171), gelatin, purified water, black ink.

OMEPRAZOLO PENSA 20 mg gastro-resistant hard capsules

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components of the capsule core are:
  o Granules: Hypromellose, talc, titanium dioxide (E171), methacrylic acid copolymer ethyl acrylate, triethyl citrate, sucrose spheres, disodium phosphate dihydrate.
  o Capsule shell: titanium dioxide (E171), gelatin, purified water, black ink.

OMEPRAZOLO PENSA 40 mg gastro-resistant hard capsules

• The active substance is omeprazole. Each capsule contains 40 mg of omeprazole.
• The other components of the capsule core are:
  o Granules: Hypromellose, talc, titanium dioxide (E171), methacrylic acid copolymer ethyl acrylate, triethyl citrate, sucrose spheres, disodium phosphate dihydrate.
  o Capsule shell: titanium dioxide (E171), gelatin, purified water, black ink.

Description of the appearance of OMEPRAZOLO PENSA and package contents
Gastro-resistant hard capsules. Bottles containing 14, 28 and 56 capsules of 10 mg or 20 mg. Cartons containing 14, 28 and 56 capsules of 10 mg or 20 mg in blisters.
Gastro-resistant hard capsules. Bottle containing 14 capsules of 40 mg.

Marketing Authorization Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milano, Italy.

Manufacturer
Esteve Pharmaceuticals, S.A. - San Martì, 75-97 - 08107 Martorelles – Barcelona, Spain.