Omeprazole Hexal A/S: detailed information

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

Omeprazolo Hexal A/S 10 mg gastro-resistant hard capsules, 20 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 others, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Omeprazolo Hexal A/S is and what it is used for
What you need to know before taking Omeprazolo Hexal A/S
How to take Omeprazolo Hexal A/S
Possible side effects
How to store Omeprazolo Hexal A/S
Contents of the pack and other information

1. What Omeprazolo Hexal A/S is and what it is used for

Omeprazolo Hexal A/S 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 Hexal A/S is used to treat the following conditions:
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 caused by a bacterial infection 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 non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazolo Hexal A/S can also be used to prevent ulcers from forming if you are taking NSAIDs.
Excess acid production due to a tumour in the pancreas (Zollinger-Ellison syndrome).

Children and adolescents:

Children over 1 year of age and weighing more 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.
Adolescents and children over 4 years of age
Ulcers caused by a bacterial infection 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 Hexal A/S

Do not take Omeprazolo Hexal A/S

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 Hexal A/S if any of the conditions listed above apply to you.
If you are unsure, consult your doctor or pharmacist before taking Omeprazolo Hexal A/S.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo Hexal A/S. Omeprazolo Hexal A/S
may mask symptoms of other diseases. Therefore, if you experience any of the following conditions
before taking Omeprazolo Hexal A/S or while taking it, contact your doctor immediately:

Unintentional 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.
You need to undergo a specific blood test (Chromogranin A).
If you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Hexal A/S that reduces gastric acidity.

If you have been taking Omeprazolo Hexal A/S for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice the appearance of new and unusual symptoms.
During treatment with omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume and/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.
If you take a proton pump inhibitor such as Omeprazolo Hexal A/S, especially for more than one year, there may be a slight increase in the risk of fracture of the hip, wrist, or spine. If you have 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, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazolo Hexal A/S. Remember to also report any other adverse effects such as joint pain.
Children
Some children with chronic conditions may require long-term treatment, although this is not recommended. Do not administer this medicine to children under 1 year of age or weighing <10 kg.
Other medicines and Omeprazolo Hexal A/S
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is important because Omeprazolo Hexal A/S may affect how some medicines work, and conversely, some medicines may affect the action of Omeprazolo Hexal A/S.
Do not take Omeprazolo Hexal A/S 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 at the beginning and end of treatment with Omeprazolo Hexal A/S.
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 Hexal A/S.
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 to treat cancer)
Methotrexate (a chemotherapeutic agent used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your treatment with Omeprazolo Hexal A/S. If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo Hexal A/S for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you report if you are taking any other medicines.

Omeprazolo Hexal A/S 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, 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 Hexal A/S while breastfeeding.
Driving and using machines
It is unlikely that Omeprazolo Hexal A/S will affect your ability to drive or use 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 Hexal A/S contains sucrose and sodium
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
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 Omeprazolo Hexal A/S

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 dose is:

Adults:

For the treatment of symptoms of GORD (gastroesophageal reflux disease), such as heartburn and acid regurgitation:

If your doctor has informed you that your oesophagus 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 oesophagus has not yet fully healed.
Once the oesophagus has healed, the recommended dose is 10 mg once daily.
If the oesophagus 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 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 Omeprazolo Hexal A/S 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 daily.
Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine.

Use in children and adolescents:

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

Omeprazolo Hexal A/S 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:

Omeprazolo Hexal A/S 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 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 granules with a special coating designed to protect 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 you have taken the full dose, rinse the glass thoroughly with half a glass of water and drink the rinse water as well. The solid particles contain the medicine – do not chew or crush them.

If you take more Omeprazolo Hexal A/S than you should
If you take more Omeprazolo Hexal A/S than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Omeprazolo Hexal A/S
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 Omeprazolo Hexal A/S
Do not stop treatment with Omeprazolo Hexal A/S without first consulting 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 gets them.
If you notice any of the following rare but serious side effects, stop taking Omeprazole
Hexal A/S and contact your doctor immediately:

Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
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”.
Yellowing of the skin, dark-coloured urine and tiredness may be symptoms of liver problems.

Other side effects include:
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.
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 of the skin.
General feeling of being unwell and lack of energy.
Fracture of the hip, wrist or spine.

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.
Liver problems, including jaundice, which may cause yellowing of the skin, dark-coloured urine and tiredness.
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.
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.

Frequency not known (frequency cannot be estimated from the available data)

Inflammation of the intestine (causing diarrhoea).
If you take Omeprazole Hexal A/S 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 should decide whether to monitor your blood magnesium levels periodically.
Erythema, possible joint pain.

In very rare cases, Omeprazole Hexal A/S may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever with a severe deterioration
in general health, or fever with symptoms 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.
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 https://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 Omeprazolo Hexal A/S

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the blister/bottle after
EXP.
The expiry date refers to the last day of that month.
For blisters:
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
For bottles:
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
In-use shelf life after first opening of the bottle:
100 days
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. Package contents and other information

What Omeprazole Hexal A/S contains
The active substance is omeprazole.
Each gastro-resistant hard capsule contains 10 mg of omeprazole.
Each gastro-resistant hard capsule contains 20 mg of omeprazole.
Capsule contents:
sugar spheres (containing sucrose and maize starch)
hypromellose
sodium lauryl sulfate
povidone K25
talc
heavy magnesium oxide
1:1 copolymer of methacrylic acid and ethyl acrylate (30% dispersion)
triethyl citrate
Capsule coating
10 mg:
gelatin
titanium dioxide (E171)
yellow iron oxide (E172)
red iron oxide (E172)
May also contain: black iron oxide (E172)
20 mg:
gelatin
titanium dioxide (E171)

Description of the appearance of Omeprazole Hexal A/S and package contents
Omeprazole Hexal A/S 10 mg gastro-resistant hard capsules:
Hard gelatin capsules with light brown cap and light brown body, containing beads ranging in colour from almost white to light brown.

Omeprazole Hexal A/S 20 mg gastro-resistant hard capsules:
Hard gelatin capsules with white cap and white body, containing beads ranging in colour from almost white to light brown.

Pack sizes
Omeprazole Hexal A/S 10 mg gastro-resistant hard capsules:
Alu/Alu
Blister packs containing: 7, 14 and 28 gastro-resistant hard capsules.
White HDPE bottle with PP screw cap with child-resistant or tamper-evident closure and desiccant inserted (silica gel capsule):
14 and 28 gastro-resistant hard capsules

Omeprazole Hexal A/S 20 mg gastro-resistant hard capsules:
Alu/Alu
Blister packs containing: 7, 14 and 28 gastro-resistant hard capsules.
White HDPE bottle with PP screw cap with child-resistant or tamper-evident closure and desiccant inserted (silica gel capsule):
7, 14 and 28 gastro-resistant hard capsules

Not all pack sizes may be marketed.

Marketing Authorization Holder
HEXAL A/S, Edvard Thomsens Vej 14, 2300 Copenhagen, Denmark
Legal Representative in Italy: Sandoz S.p.A., Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers responsible for batch release
LEK S.A., Ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d, Verovskova 57, 1526 Ljubljana, Slovenia
S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Lek S.A. Ul. Podlipie 16, 95-010 Stryków, Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy OMEPRAZOLE HEXAL A/S

This Patient Information Leaflet was last revised on