OMEPRAZOLO 10 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Omeprazolo Hexal A/S 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules
   1. What is Omeprazolo Hexal A/S and what is it used for
   2. What you need to know before taking Omeprazolo Hexal A/S
   3. How to take Omeprazolo Hexal A/S
   4. Possible side effects
   5. How to store Omeprazolo Hexal A/S
   6. Package contents and other information

Omeprazolo Hexal A/S 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules

Generic medicine

Read this leaflet carefully before you start taking this medicineas 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Omeprazolo Hexal A/S is and what it is used for
• 2. What you need to know before you take Omeprazolo Hexal A/S
• 3. How to take Omeprazolo Hexal A/S
• 4. Possible side effects
• 5. How to store Omeprazolo Hexal A/S
• 6. Contents of the pack and other information

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

Omeprazolo Hexal A/S contains the active ingredient 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 for the treatment of the following conditions:
Adults:

• Gastro-oesophageal reflux disease’ (GORD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If you suffer from this disease, 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 Hexal A/S can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome). Children and adolescents: Children aged over 1 year and with a body weight of 10 kg or more
• Gastro-oesophageal reflux disease’ (GORD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, the symptoms of this disease also include the return of stomach contents into the mouth (regurgitation), discomfort (vomiting) and poor weight gain. Adolescents and children aged over 4 years
• Ulcers infected by a bacterium called ‘ Helicobacter pylori’. If the child suffers from this disease, 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 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 above conditions apply to you.
If you are unsure, ask 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
can mask the symptoms of other diseases. Therefore, if you find yourself in any of the situations
described below before taking Omeprazolo Hexal A/S or while you are taking it, contact your doctor
immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stools (presence of blood in the stools).
• Severe or persistent diarrhoea, because 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 stomach acid.

If you take Omeprazolo Hexal A/S for a long time (more than 1 year) your doctor will prescribe regular
check-ups. Tell your doctor if you notice the appearance of new and unusual symptoms.
During treatment with omeprazole, inflammation of your kidneys may occur. Signs and symptoms
may include a reduced urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rashes and joint stiffness. Report these signs to your doctor.
If you take a proton pump inhibitor such as Omeprazolo Hexal A/S, especially for a period
longer than one year, there may be a slight increase in the risk of fracture of the hip, wrist or
spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase
the risk of osteoporosis) consult your doctor.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your
doctor as soon as possible, as you may need to stop therapy with Omeprazolo
Hexal A/S. Remember to report any other adverse effects such as joint pain.
Children
Some children with chronic illnesses may require long-term treatment even if it is
not recommended. Do not give this medicine to children under 1 year of age or <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 can affect the way some medicines work and in turn some medicines can affect the action of Omeprazolo Hexal A/S.
Do not take Omeprazolo Hexal A/S if you are taking a medicine containing nelfinavir(used for
the treatment of HIV infections).
Tell 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 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 medicine used at high doses for cancer treatment) - if your doctor has prescribed you amoxicillin and clarithromycin antibiotics together with Omeprazolo Hexal A/S for the treatment of ulcers caused by Helicobacter pyloriinfections, it is very important that you tell your doctor 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, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole is excreted in breast milk but it is unlikely to have an effect on the baby when
used at therapeutic doses. The doctor will decide whether you can take Omeprazolo Hexal A/S if you are
breastfeeding.

Driving and using machines
It is unlikely that Omeprazolo Hexal A/S will affect your ability to drive vehicles or use
tools or machinery. Adverse reactions such as dizziness and visual disturbances may occur
(see section 4). If you suffer from these, you should not drive vehicles or operate machinery.

Omeprazolo Hexal A/S contains sucrose and sodium
This medicine contains sucrose. If you have been diagnosed with intolerance to some
sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard gastro-resistant capsule, i.e.
essentially “sodium-free”.

3. How to take Omeprazolo Hexal A/S

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The 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:

• If your doctor has told you that your esophagus is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the recommended dose is 10 mg once a day.

For the treatment of ulcers in the upper part of the intestine(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. The doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 4 weeks.

For the treatment of stomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. The doctor may extend the intake of this dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer is not completely healed, the dose may be increased to 40 mg once a day for 8 weeks.

To preventthe recurrence of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

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

• The recommended dose is 20 mg once a day for 4-8 weeks.

To prevent the formation of duodenal and gastric ulcersif you are using NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers causedby infection byHelicobacter pyloriand prevention of their
recurrence :

• The recommended dose is 20 mg of Omeprazolo Hexal A/S twice a day for one week.
• The doctor will tell you to also take two antibiotics among amoxicillin, clarithromycin and metronidazole.

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

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

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

• Omeprazolo Hexal A/S can 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 weight and the exact dose will be decided by the doctor.

For the treatment and prevention of the recurrence of ulcers causedby infection byHelicobacter
pylori:

• Omeprazolo Hexal A/S can be taken by children over 4 years of age. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.
• The doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed 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 the acid in the stomach. 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 capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass very well with half a glass of water and drink the contents. 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 an amount of Omeprazolo Hexal A/S greater than that 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 to
take the next dose, skip the missed dose. Do not take a double dose to make up for the
missed dose.

If you stop taking Omeprazolo Hexal A/S
Do not stop taking Omeprazolo Hexal A/S without first consulting your doctor or pharmacist.
If you have any doubts about the use of 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.

If you notice any of the following rare but serious side effects, stop taking Omeprazolo
Hexal A/S and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with the appearance of blisters or peeling. A severe formation of blisters with bleeding of the lips, eyes, mouth, nose and genitals may also appear. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine and fatigue may be symptoms of liver problems.

Other side effects include:

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

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, passing gas (flatulence).
• Feeling unwell (nausea) or feeling sick (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, feeling sleepy.
• Feeling of spinning (vertigo).
• Changes in blood tests related to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of discomfort and lack of energy.
• Fracture of the hip, wrist or spine.

Rare side effects (may affect up to 1 in 1000 people)

• Changes in blood composition, such as a decrease in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may make you more likely to get infections.
• Allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Problems with vision, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash during exposure to the sun.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10000 people)

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells)
• Aggression.
• Seeing, feeling or hearing events that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Sudden appearance of a severe 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.
• Enlargement of the breasts in men.

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

• Inflammation of the intestine (causing diarrhea).
• If you take Omeprazolo Hexal A/S for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to check magnesium levels in the blood periodically.
• Erythema, possible joint pain.

In very rare cases Omeprazolo Hexal A/S can affect white blood cells leading to an immuno-
deficiency. If you should develop an infection with symptoms such as fever with a severedeterioration
of general health or fever with symptoms of local infection such as sore throat, sore throat
or mouth or difficulty urinating, you should consult your doctor as soon as possible, in order to rule out a
lack of white blood cells (agranulocytosis) by performing a blood test. It is important in this
case to inform the doctor about the medicine you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package or blister/bottle after
EXP.
The expiry date refers to the last day of that month.
For blisters
Do not store at a temperature above 25°C.
Store in the original package to protect the medicine from light and moisture.
For bottles:
Do not store at a temperature above 25°C.
Store in the original package to protect the medicine from light and moisture.
Shelf life after first opening of the bottle:
100 days
Do not dispose of any medicine in 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 Hexal A/S contains
The active ingredient is omeprazole.
Each gastro-resistant hard capsule contains 10 mg of omeprazole.
Each gastro-resistant hard capsule contains 20 mg of omeprazole.
Capsule content:
sugar spheres (containing sucrose and corn 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 Omeprazolo Hexal A/S and package contents
Omeprazolo Hexal A/S 10 mg gastro-resistant hard capsules:
Hard gelatin capsules with light brown cap, light brown body, containing pellets of colour from
almost white to light brown
Omeprazolo Hexal A/S 20 mg gastro-resistant hard capsules:
Hard gelatin capsules with white cap, white body, and containing pellets of colour from almost white to
light brown.
Packs

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

Omeprazolo Hexal A/S 20 mg gastro-resistant hard capsules:
Alu/Alu
Blisters in packs of: 7, 14 and 28 gastro-resistant hard capsules.
White HDPE bottle with PP screw cap with child-resistant or tamper-evident closure with
desiccant inserted (silica gel capsule):
7, 14 and 28 gastro-resistant hard capsules
Not all pack sizes may be marketed

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Italy OMEPRAZOLO HEXAL A/S