Omeprazole Zentiva Italia

Package leaflet: Information for the patient

OMEPRAZOLE ZENTIVA ITALIA

10 mg gastro-resistant hard capsules
20 mg gastro-resistant hard capsules
Generic medicine
Please 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 for you only. Do not give it to other people, even if
their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your
doctor or pharmacist (see section 4).
Contents of this leaflet:

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

1. What Omeprazolo Zentiva Italia is and what it is used for

The name of this medicine is Omeprazolo Zentiva Italia 10 mg, 20 mg gastro-resistant hard capsules (called Omeprazolo Zentiva Italia in this leaflet).

Omeprazolo Zentiva Italia contains as its active substance omeprazole. This medicine

belongs to a group of medicines called "proton pump inhibitors". These medicines
work by reducing the amount of acid produced by the stomach.

Omeprazolo Zentiva Italia is used to treat the following conditions:

In adults:

• Gastroesophageal reflux disease (GERD). This condition occurs when acid passes from the stomach into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcer in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers complicated by infection 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 Zentiva Italia may also be used to prevent the formation of ulcers during treatment with NSAIDs.
• Excessive acid production in the stomach due to enlargement of the pancreas (Zollinger-Ellison Syndrome).

In children:
Children over 1 year of age and weighing > 10 kg

• Gastroesophageal reflux disease (GERD). This condition occurs when acid passes from the stomach into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms associated with this condition may include return of stomach contents into the mouth (regurgitation), feeling unwell (vomiting), and poor weight gain.

Children aged over 4 years and adolescents

• Ulcers complicated by infection 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 Zentiva Italia

Do not take Omeprazolo Zentiva Italia

• 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 (for example, pantoprazole, lansoprazole, rabeprazole, esomeprazole). If you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take Omeprazolo Zentiva Italia if any of the above conditions apply to you. If you are unsure, speak with your doctor or pharmacist before taking Omeprazolo Zentiva Italia.

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazolo Zentiva Italia.

Omeprazolo Zentiva Italia may mask symptoms of other diseases. Therefore, if you have any of the following conditions before taking Omeprazolo Zentiva Italia, or they occur while you are taking it, speak to your doctor immediately if:

• You experience unexplained weight loss and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• You pass black stools (blood-coloured stools).
• You develop severe or persistent diarrhoea, as Omeprazolo Zentiva Italia has been associated with a slight increase in infectious diarrhoea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Zentiva Italia that reduces gastric acidity.

Inform your doctor before taking this medicine if you are due to have 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 treatment with Omeprazolo Zentiva Italia may need to be stopped. Remember to also report any other adverse effects such as joint pain.

If you take Omeprazolo Zentiva Italia for a long time (more than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms and circumstances to your doctor as soon as they occur.

If you take Omeprazolo Zentiva Italia for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to monitor your blood magnesium levels regularly.

If you take a proton pump inhibitor such as Omeprazolo Zentiva Italia, 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 can increase the risk of osteoporosis), consult your doctor.

Other medicines and Omeprazolo Zentiva Italia

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Omeprazolo Zentiva Italia may affect the action of certain medicines, and some medicines may affect Omeprazolo Zentiva Italia.

Do not take Omeprazolo Zentiva Italia if you are taking medicines containing nelfinavir (used to treat HIV infections).

Talk to 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 in epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping omeprazole.
• Medicines used to thin the blood such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting or stopping omeprazole.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infections).
• 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 infections).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Erlotinib (used in cancer treatment).
• Methotrexate (a chemotherapeutic agent used at high doses for cancer treatment) – if you are taking a high dose of methotrexate, your doctor may ask you to temporarily stop treatment with Omeprazolo Zentiva Italia.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to omeprazole to treat ulcers caused by Helicobacter pylori infections, it is very important that your doctor knows which other medicines you are taking.

Omeprazolo Zentiva Italia with food and drink

You may take the capsules with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

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 Zentiva Italia while breast-feeding.

Driving and using machines

Omeprazolo Zentiva Italia is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Omeprazolo Zentiva Italia contains anhydrous lactose and sucrose

If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Omeprazolo Zentiva Italia

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 your age.
The recommended doses are indicated below.

Adults:
For the treatment of symptoms related to gastroesophageal reflux disease (GERD), such as heartburn and acid regurgitation:

• If your doctor has found that your digestive tract (esophagus) has been mildly damaged, the recommended 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 your esophagus has not yet healed.
• If the esophagus has healed, the recommended dose is 10 mg once daily.
• If the esophagus has not been damaged, the recommended 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. If the ulcer has not yet healed, your doctor may instruct you to continue the same dose for an additional 2 weeks.
• 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 instruct you to continue the same dose for an additional 4 weeks if your 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 the prevention of relapses of gastric and duodenal 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 gastric and duodenal ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

For the prevention of gastric and duodenal ulcers when taking NSAIDs:

• The recommended dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent relapses:

• The recommended dose is 20 mg of omeprazole twice daily for 1 week.
• Your doctor may also ask you to take two antibiotics selected from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive gastric acid secretion due to pancreatic enlargement (Zollinger–Ellison syndrome):

• The recommended 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:
For the treatment of GERD symptoms such as heartburn and acid regurgitation:

• Children over 1 year of age and weighing more than 10 kg may take omeprazole. The dose for children is based on body weight, and the doctor will determine the correct dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent relapses:

• Children over 4 years of age may take omeprazole. The dose for children is based on body weight, and the doctor will determine the correct dose.
• The doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for the child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• You may take the capsules with food or on an empty stomach.
• 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 being inactivated by stomach acid. It is important not to damage the pellets.

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

• If you or your child have difficulty swallowing the capsules:
• Open the capsules and swallow the contents directly with half a glass of water, or pour the contents into a glass of water (non-carbonated), into any 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). Drink the mixture 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.

Removing the child-resistant cap from the HDPE bottle with child-resistant closure*
The plastic bottle with a child-resistant cap must be opened as follows:

• Press down on the plastic screw cap (1) while turning it clockwise (2).
• Remove the cap.

*Only for the HDPE bottle with the following symbol on the cap

If you take more Omeprazolo Zentiva Italia than you should
If you take more Omeprazolo Zentiva Italia than prescribed by your doctor, speak to your doctor or pharmacist immediately.
If you forget to take Omeprazolo Zentiva Italia
If you forget to take a dose of omeprazole, 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 capsule.
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 will experience them.
If you experience any of the following rare but serious side effects, stop taking
Omeprazolo Zentiva Italia and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blisters or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose and genitals may also occur. These symptoms could be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.

Other side effects include:
Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, gas in the intestine (flatulence), benign stomach polyps.
• Feeling unwell (nausea) or being unwell (vomiting).

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, feeling pricked by needles or pins, feeling drowsy.
• Feeling the surroundings are spinning (vertigo).
• Changes in blood tests assessing liver function.
• Skin redness, severe rash (urticaria) and itchy skin.
• Feeling generally unwell and weak.
• Fractures of the hip, wrist or spine (see section 2 “Warnings and precautions”).

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

• Blood disorders such as reduced white blood cells or platelets. This may cause weakness, bruising or increased susceptibility to infections.
• Allergic reactions, sometimes 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.
• Altered taste.
• Vision problems such as blurred vision.
• Suddenly feeling breathless or short of breath (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Inflammation of the intestine (leading to diarrhoea).
• A fungal infection called “thrush” which may affect the intestine.
• Liver problems, including jaundice, which may cause yellow skin, dark urine and fatigue.
• 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)

• Changes in blood count including agranulocytosis (absence of white blood cells).
• Aggressive behaviour.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden appearance of severe rash, blisters or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Gynaecomastia in men.

Omeprazolo Zentiva Italia may in rare cases affect white blood cells, leading to
immune deficiency. If you develop an infection with symptoms such as fever associated with a severe
deterioration in general health, or fever with signs of a local infection such as
neck, tongue or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible
to rule out, through blood tests, a lack of white blood cells
(agranulocytosis). It is important that in this case you provide information about
the medicine you are taking.
Frequency not known (frequency cannot be estimated from the available data):

• Low levels of magnesium in the blood (hypomagnesaemia) (see section 2 “Warnings and precautions”).
• Erythema, possible joint pain.

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 national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on
the safety of this medicine.
5 How to store Omeprazolo Zentiva Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging under
“Exp.”. The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the medicine from moisture.
After first opening the bottle, the product may be stored at 25°C for a maximum of 3 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.
6 Contents of the pack and other information
What Omeprazolo Zentiva Italia contains
Each omeprazole capsule contains 10 mg or 20 mg of omeprazole (the active substance).
The other ingredients are:
Pellets: sugar spheres (containing sucrose and maize starch), anhydrous lactose,
hypromellose, hydroxypropylcellulose, sodium lauryl sulphate, dibasic sodium phosphate dodecahydrate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, macrogol 6000, talc.
The hard gelatin capsule shell contains:
Body: black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
Cap: red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
Description of the appearance of Omeprazolo Zentiva Italia and contents of the pack
Omeprazolo Zentiva Italia 10 mg are hard gastro-resistant capsules, size no. 4 (approximately 14.3 mm in length), with a light brown body and orange cap. The capsule contains spherical pellets that are whitish with a slight brownish-yellow tinge.
Omeprazolo Zentiva Italia 20 mg are hard gastro-resistant capsules, size no. 3 (approximately 15.9 mm in length), with a light brown body and red cap. The capsule contains spherical pellets that are whitish with a slight brownish-yellow tinge.
Type of container
Brown glass bottle with white HDPE screw cap, containing a desiccant
or
white HDPE bottle with white plastic screw cap, containing a desiccant and equipped with child-resistant closure and a tamper-evident seal
or
white HDPE bottle with white plastic screw cap, containing a desiccant and tamper-evident seal
or
Al-oPA/Al/HDPE/PE + desiccant/HDPE blister in cardboard box
or oPA/Al/PVC/Al blister in cardboard box.
Pack sizes: 7, 14, 15, 28, 30, 50, 56, 60, 90, 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l. - Viale Bodio, 37/b, 20158 Milano
Manufacturer
S.C. ZENTIVA S. A.
B-dul. Theodor Pallady nr. 50 sector 3, Bucuresti, cod 032266
Romania
This medicine is authorised in the Member States of the European Economic Area under the
following names: