Omeprazole Sandoz GmbH: detailed information

Package leaflet: Information for the patient

Omeprazolo Sandoz GmbH 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

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 pass it on to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Omeprazolo Sandoz GmbH is and what it is used for

Omeprazolo Sandoz GmbH 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 Sandoz GmbH is used to treat the following conditions:
Adults:

'Gastro-oesophageal reflux disease' (GORD). This condition occurs when acid leaks from 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 Sandoz GmbH may also be used to prevent ulcers from developing if you are taking NSAIDs.
Excess acid in the stomach caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

Children and adolescents:
Children above 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 from 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 back into the mouth, discomfort (vomiting), and poor weight gain.

Adolescents and children above 4 years of age

Ulcers infected with a bacterium called 'Helicobacter pylori'. If the 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 Sandoz GmbH

Do not take Omeprazolo Sandoz GmbH

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 Sandoz GmbH if any of the conditions listed above apply to you. If you have any
doubts, consult your doctor or pharmacist before taking Omeprazolo Sandoz GmbH.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo Sandoz GmbH.
Omeprazolo Sandoz GmbH may mask symptoms of other diseases. Therefore, if you experience any of the
following symptoms before or during treatment with Omeprazolo Sandoz GmbH, contact your doctor
immediately:

Unintentional weight loss and difficulty swallowing.
Stomach pain or indigestion.
Vomiting food or blood.
Dark-coloured stools (indicating presence of blood in the stool).
Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
Severe liver problems.
You are scheduled for a specific blood test (chromogranin A).
If you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Sandoz GmbH that reduces gastric acidity. If you have been taking Omeprazolo Sandoz GmbH 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.

During treatment with omeprazole, inflammation of the kidneys may occur. Signs and symptoms may
include reduced urine volume or 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 Sandoz GmbH, 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 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 treatment with Omeprazolo Sandoz GmbH may need to be discontinued. Remember to also
report any other adverse effects such as joint pain.
Children
Some children with chronic illnesses may require long-term treatment, even though it is not generally recommended. Do not administer this medicine to children under 1 year of age or weighing <10 kg.
Other medicines and Omeprazolo Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is important because Omeprazolo Sandoz GmbH can affect how some medicines work, and conversely, some medicines may affect the action of Omeprazolo Sandoz GmbH.
Do not take Omeprazolo Sandoz GmbH 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, 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 Sandoz GmbH.
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 Sandoz GmbH.
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 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 Sandoz GmbH.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo Sandoz
GmbH 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.
Omeprazolo Sandoz GmbH 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 a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine. Omeprazole is excreted in breast milk, but is
unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take
Omeprazolo Sandoz GmbH during breastfeeding.
Driving and using machines
It is unlikely that Omeprazolo Sandoz GmbH will affect your ability to drive or use tools or machines.
However, 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 Sandoz GmbH contains sucrose and sodium
This medicine contains sucrose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant hard capsule, i.e. it is essentially 'sodium-free'.

3. How to take OMEPRAZOLE SANDOZ GMBH

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, such as heartburn and acid regurgitation:

If your doctor has told 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 another 8 weeks if the oesophagus has not yet fully healed.
The recommended dose once the oesophagus has healed 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 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 when 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 Sandoz GmbH twice daily for one week.
Your doctor will also instruct you to take two antibiotics from the following: 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:

Omeprazole Sandoz GmbH 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 Sandoz GmbH 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 coated granules 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-fizzy), acidic fruit juice (e.g. apple, orange, or pineapple juice), or 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 it. The solid particles contain the medicine—do not chew or crush them.

If you take more Omeprazole Sandoz GmbH than you should

If you take more Omeprazole Sandoz GmbH than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Omeprazole Sandoz GmbH

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 Sandoz GmbH

Do not stop taking Omeprazole Sandoz GmbH 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 ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you notice any of the following rare but serious adverse reactions, stop taking Omeprazole Sandoz GmbH
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. There may also be severe blister formation with bleeding of the lips, eyes, mouth, nose and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
Yellowing of the skin, dark-colored urine and fatigue may be symptoms of liver problems. Other adverse reactions include:

Common adverse reactions (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 adverse reactions (may affect up to 1 in 100 people)

Swelling of 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 adverse reactions (may affect up to 1 in 1,000 people)

Changes in blood composition, such as reduced number 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, breathlessness.
Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps.
Feeling restless, confusion or depression.
Changes in taste.
Vision problems, such as blurred vision.
Sudden wheezing or breathlessness (bronchospasm).
Dry mouth.
Inflammation inside the mouth.
A fungal infection called "candidiasis" which may affect the intestine.
Liver problems, including jaundice, which may cause yellowing of the skin, dark-colored 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 adverse reactions (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 (causing diarrhoea).
Low levels of magnesium in the blood.
Erythema, possible joint pain.

If you take a proton pump inhibitor such as Omeprazole Sandoz GmbH, especially for longer 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 take Omeprazole Sandoz GmbH 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 blood levels of potassium or calcium. Your doctor may decide to perform regular blood tests to monitor your blood magnesium levels.
In very rare cases, Omeprazole Sandoz GmbH 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 signs of local infection such as neck, throat or mouth pain or difficulty urinating, you should contact your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) through a blood test. It is important that in this case you inform your doctor about the medicine you are taking.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OMEPRAZOLE SANDOZ GMBH

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 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 the bottle tightly closed to protect the medicine from light and moisture.
Duration of use after first opening of the HDPE 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. Pack contents and other information

What Omeprazolo Sandoz GmbH 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 content:
sugar spheres (containing sucrose and maize starch), hypromellose, sodium lauryl sulfate, povidone K25,
talc, magnesium stearate, methacrylic acid copolymer ethyl acrylate 1:1 (30% dispersion),
triethyl citrate
Capsule shell
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 Sandoz GmbH and pack contents
Omeprazolo Sandoz GmbH 10 mg gastro-resistant hard capsules
Gastro-resistant hard gelatin capsules with light brown cap and light brown body, containing spheres ranging in colour from almost white to light brown.

Omeprazolo Sandoz GmbH 20 mg gastro-resistant hard capsules
Gastro-resistant hard gelatin capsules with white cap and white body, containing spheres ranging in colour from almost white to light brown.

Pack sizes
Omeprazolo Sandoz GmbH 10 mg gastro-resistant hard capsules:

Alu/Alu blister: 14 gastro-resistant hard capsules.
White HDPE container with child-resistant closure or tamper-evident closure and inserted desiccant (silica gel capsule): 14 and 28 gastro-resistant hard capsules.

Omeprazolo Sandoz GmbH 20 mg gastro-resistant hard capsules

Alu/Alu blister: 14 and 28 gastro-resistant hard capsules.
White HDPE container with child-resistant closure or tamper-evident closure and inserted desiccant (silica gel capsule): 14, 15 and 28 gastro-resistant hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse, 10
6250 Kundl (Austria)
Legal Representative in Italy:
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA)

Manufacturer responsible for batch release
Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana
Slovenia
LEK S.A.
ul. Domaniewska 50 C,
02-672 Warszawa
Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
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 names:
Italy Omeprazolo Sandoz GmbH
United Kingdom Omeprazole 10 mg Gastro-resistant Capsules
Omeprazole 20 mg Gastro-resistant Capsules