Omeprazole Teva Italia: detailed information

Package leaflet: Information for the patient

Omeprazole Teva Italia 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules, 40 mg gastro-resistant hard capsules

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. See section 4.

Contents of this leaflet:

What Omeprazole Teva Italia is and what it is used for
What you need to know before taking Omeprazole Teva Italia
How to take Omeprazole Teva Italia
Possible side effects
How to store Omeprazole Teva Italia
Contents of the pack and other information

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

Omeprazolo Teva Italia 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 Teva Italia is used to treat the following conditions:

In adults:

'Gastro-oesophageal reflux disease' (GORD). This condition occurs when acid leaks out of the stomach 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 Teva Italia may also be used to prevent the formation of ulcers if you are taking NSAIDs.
Excessive acid production due to a growth in the pancreas (Zollinger-Ellison syndrome).

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

'Gastro-oesophageal reflux disease' (GORD). This condition occurs when acid leaks out of the stomach 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 into the mouth, vomiting, and poor weight gain.
Children over 4 years of age 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 Teva Italia

Do not take Omeprazolo Teva 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 (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
if you are taking a medicine containing nelfinavir (used for HIV infections).

Do not take Omeprazolo Teva Italia if any of the above conditions apply to you. If you have any
doubts, consult your doctor or pharmacist before taking Omeprazolo Teva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo Teva Italia.
Omeprazolo Teva Italia may mask symptoms of other diseases. Therefore, if you experience any of the
following symptoms before or while taking Omeprazolo Teva Italia, contact your doctor
immediately:

Unexplained weight loss and difficulty swallowing.
Stomach pain or indigestion.
Vomiting food or blood.
Dark-coloured 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.
Low body reserves or risk factors for reduced vitamin B levels and you are receiving long-term treatment with omeprazole. Like all agents that reduce acid, omeprazole may lead to reduced absorption of vitamin B.
If you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Teva Italia that reduces gastric acidity.
If you are due to have a specific blood test (Chromogranin A).

If you have been taking Omeprazolo Teva Italia 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 Teva Italia, 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 suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
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 Teva Italia. Remember to also report any other adverse effects such as joint pain.
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 Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is important because Omeprazolo Teva Italia can affect how some medicines work and, conversely, some medicines may affect the action of Omeprazolo Teva Italia.
Do not take Omeprazolo Teva Italia 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:

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 Omeprazolo Teva Italia.
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 Teva Italia.
Rifampicin (used to treat tuberculosis).
Atazanavir (used to treat HIV infection).
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)).
Erlotinib (used in cancer treatment).
Methotrexate (a chemotherapeutic agent used at high doses to treat cancer) – if you are using high doses of methotrexate, your doctor must temporarily discontinue treatment with Omeprazolo Teva Italia.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Omeprazolo Teva Italia for the treatment of ulcers caused by Helicobacter pylori infections, it is very important that you inform them if you are taking any other medicines.
Omeprazolo Teva Italia with food and drinks
See section 3.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Omeprazole is excreted in breast milk, but when used at therapeutic doses, it is unlikely to affect the infant.
Your doctor will decide whether you can take Omeprazolo Teva Italia while breastfeeding.
Driving and using machines
It is unlikely that Omeprazolo Teva Italia will affect your ability to drive or use tools or machinery. Adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
Omeprazolo Teva Italia contains sucrose
Omeprazolo Teva Italia contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Omeprazolo Teva Italia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Omeprazole Teva Italia

Take this medicine exactly as instructed 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 symptoms of gastroesophageal reflux disease (GERD), 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 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. 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 of omeprazole twice daily for one week.
Your doctor will also instruct you to take two antibiotics among amoxicillin, clarithromycin, and metronidazole.

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

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

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

Omeprazole may be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on the child's 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 may be taken by children over 4 years of age. The dose for children is based on the child's 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. The capsules must not be chewed or crushed, as they contain granules coated in such a way as 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 have difficulty swallowing the capsules
If you or the child have 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 applesauce.
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 the entire dose, 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.

If you take more Omeprazole Teva Italia than you should
If you take more Omeprazole Teva Italia than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take Omeprazole Teva Italia
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 Teva Italia
Do not stop taking Omeprazole Teva Italia without first talking to your doctor or pharmacist.
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 everyone experiences them.
If you experience any of the following side effects, which are rare but serious, stop taking
Omeprazole Teva Italia and contact your doctor immediately:

Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
Skin redness with blistering or peeling. Severe blisters and 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 tiredness 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, passing wind (flatulence).
Feeling unwell (nausea) or being unwell (vomiting).
Benign polyps in the stomach.

Uncommon: may affect up to 1 in 100 people

Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling, drowsiness.
Sensation of spinning (vertigo).
Changes in blood tests related to liver function.
Skin rash, skin rash with swelling of the skin (urticaria) and itching.
General feeling of being unwell and lack of energy.
Fracture of the hip, wrist or spine (see section 2).

Rare: 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 increase the likelihood of infections.
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.
Restlessness, confusion or depression.
Taste disturbances.
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.
Liver problems, including jaundice, which may cause yellowing of the skin, dark urine and tiredness.
Hair loss (alopecia).
Skin rash occurring during 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 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.
Sudden onset of severe skin rash or blisters and skin peeling. 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 (leading to diarrhoea).
Hypomagnesaemia. If you take Omeprazole Teva Italia 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 levels of potassium or calcium in the blood. Your doctor may decide to monitor your blood magnesium levels periodically.
Erythema, possible joint pain.

In very rare cases, Omeprazole Teva Italia 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 symptoms of a local infection such as neck, throat or mouth pain or difficulty urinating, you must consult your doctor as soon as possible, so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test. It is important that in this case you inform your doctor about the medicine you are taking.
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 the following website: 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer and inner packaging after "Exp". The expiry date refers to the last day of that month.
Blister packs:
Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
Bottles:
Do not store above 30°C. Keep the bottle tightly closed to protect the medicine from moisture.
The shelf life after first opening is 90 days.
Only for 20 mg capsules in 250 ml container:
The shelf life after first opening is 6 months.
Do not use this medicine if you notice any visible signs of deterioration.
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 Teva Italia 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,
sodium lauryl sulfate, povidone K-30, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid – ethyl
acrylate copolymer, triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide.
Capsule coating: iron oxide red (E172) (only 10 mg), erythrosine (E127), indigo carmine
(E132) (only 20 mg and 40 mg), titanium dioxide (E171), water, gelatin, quinoline yellow (E104).
Printing ink: shellac, propylene glycol, sodium hydroxide, polyvinylpyrrolidone, titanium
dioxide (E171).

Description of the appearance of Omeprazolo Teva Italia and pack contents

Omeprazolo Teva Italia 10 mg: orange body marked with “10” and red cap marked with “O”.
Omeprazolo Teva Italia 20 mg: orange body marked with “20” and blue cap marked with “O”.
Omeprazolo Teva Italia 40 mg: orange body marked with “40” and blue cap marked with “O”.

Pack sizes:
Blister packs:
available in packs of 5, 7, 14, 15, 20, 21, 28, 30, 35, 42, 50, 50x1 hospital pack, 56, 60, 98, or 100 capsules.
Not all pack sizes may be marketed.

Containers (bottles):
available in packs of 5, 7, 14, 15, 20, 21, 28, 30, 42, 50, 56 (2x28), 60 (2x30), 84 (2x42), 90, 90 (3x30), 98 (7x14),
100 (2x50), 250 (5x50) or 500 (10x50) capsules.
For the 20 mg strength:
250 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 - 20123 Milan
Italy

Manufacturers
Dosages 10, 20 and 40 mg:
Teva Pharmaceutical Works Private Limited Company
Pallagi ùt 13, 4042 Debrecen
Hungary
Teva UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C., number 4, 50016 Zaragoza
Spain
Merckle GmbH
Ludwig-Merckle-Strasse 3, 89143 Blaubeuren
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Belgium Omeprazol Teva
Germany Omeprazol-ratiopharm NT
Denmark Omeprazole Teva
Greece Omeprazole Teva Pharma
France Omeprazole Teva Pharma
Hungary Omeprazol-Teva
Ireland Omeprazole Teva
Italy Omeprazolo Teva Italia
Luxembourg Omeprazole-Ratiopharm NT
The Netherlands Omeprazol Teva
United Kingdom Omeprazole 10, 20 & 40mg gastro-resistant hard capsules