OMEPRAZOL-

OMEPRAZOL Zentiva 20 mg for heartburn

Important notes (mandatory information)

Omeprazole Zentiva 20 mg for heartburn, enteric-coated hard capsules Active ingredient: Omeprazole, area of application: for the short-term treatment of reflux symptoms (e.g. heartburn, acid reflux).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!

Patient information: Information for the user
Omeprazole Zentiva 20 mg for heartburn, enteric-coated hard capsules
Active ingredient: Omeprazole

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
- If you do not feel better or if you feel worse after 14 days, contact your doctor.

What is in this package leaflet
1. WHAT IS OMEPRAZOLE ZENTIVA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING OMEPRAZOLE ZENTIVA?
3. HOW SHOULD OMEPRAZOLE ZENTIVA BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD OMEPRAZOLE ZENTIVA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS OMEPRAZOLE ZENTIVA AND WHAT IS IT USED FOR?
Omeprazole Zentiva enteric-coated hard capsules contain the active ingredient omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These work by reducing the amount of acid your stomach produces.
Omeprazole Zentiva is used in adults for the short-term treatment of reflux symptoms (e.g. heartburn, acid reflux).
Reflux is the backflow of acid from the stomach into the oesophagus, which can become inflamed and cause pain. This can cause you to experience symptoms such as a burning sensation in the chest that rises up into the throat (heartburn) and a sour taste in the mouth (acid reflux). It may be necessary to take the enteric-coated hard capsules for 2-3 consecutive days to achieve an improvement in symptoms.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING OMEPRAZOLE ZENTIVA?
Omeprazole Zentiva should not be taken,
o if you are allergic (hypersensitive) to omeprazole or any of the other ingredients listed in section 6.
o if you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
o if you are taking a medicine containing nelfinavir (for HIV infection).
If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Zentiva.

Warnings and precautions

Do not take Omeprazole Zentiva for longer than 14 days without consulting your doctor. If your symptoms do not improve or if your symptoms worsen, see your doctor. Omeprazole Zentiva can mask the signs of other conditions. Therefore, talk to your doctor immediately if any of the following apply to you before or during the use of Omeprazole Zentiva

o You lose a lot of weight for no apparent reason and have problems swallowing.
o You get stomach pain or indigestion.
o You vomit food or blood.
o You pass black stools (blood in the stools).
o You suffer from severe or persistent diarrhoea. Omeprazole is associated with a small increased risk of infectious diarrhoea.
o You have had a stomach ulcer or surgery on your stomach or intestines in the past.
o You have been receiving continuous symptomatic treatment for indigestion or heartburn for 4 or more weeks.
o You have persistent indigestion or heartburn for 4 or more weeks.
o You have jaundice or severe liver disease.
o You are over 55 years of age and have new or recently changed symptoms.
Patients should not take omeprazole as a preventive measure. If treatment with Omeprazole Zentiva is continued beyond the recommended maximum of 14 days, the following should be considered: If you use Omeprazole Zentiva for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can manifest themselves as fatigue, involuntary muscle contractions, confusion, convulsions, dizziness and increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a decrease in potassium and calcium levels in the blood. Your doctor may perform regular blood tests to monitor your magnesium levels.

Taking Omeprazole Zentiva with other medicines
Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. This is important because Omeprazole Zentiva can affect the way some medicines work and some medicines can have an effect on how Omeprazole Zentiva works. Do not take Omeprazole Zentiva if you are using a medicine containing nelfinavir (for the treatment of HIV infection). You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots [clots]).

Please tell your doctor or pharmacist if you are taking any of the following medicines

o Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus)
o Digoxin (used to treat heart problems)
o Diazepam (used to treat anxiety, to relax muscles or in epilepsy)
o Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole Zentiva.
o Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor may need to monitor you when you start or stop taking Omeprazole Zentiva.
o Rifampicin (used to treat tuberculosis)
o Atazanavir (used to treat HIV infection)
o Tacrolimus (in the case of organ transplants)
o St. John's wort (Hypericum perforatum) (used to treat mild depression)
o Cilostazol (used to treat the so-called window disease [claudicatio intermittens])
o Saquinavir (used to treat HIV infection)
o Clopidogrel (used to prevent blood clots [clots])
o Erlotinib (used to treat cancer)
o Methotrexate (a medicine used in high doses in chemotherapy to treat cancer) - if you are taking methotrexate in high doses, your doctor may temporarily discontinue your treatment with Omeprazole Zentiva.

Taking Omeprazole Zentiva with food and drink
You can take your enteric-coated hard capsules with food or on an empty stomach.

Pregnancy and breastfeeding
Tell your doctor or pharmacist before taking Omeprazole Zentiva if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take Omeprazole Zentiva during this time. Your doctor will decide whether you can take Omeprazole Zentiva if you are breastfeeding.

Driving and operating machinery
It is unlikely that Omeprazole Zentiva will affect your ability to drive or operate tools or machinery. Side effects such as dizziness and visual disturbances may occur (see section 4. "What side effects are possible?"). You should not drive or operate machinery if you are impaired.

Omeprazole Zentiva contains lactose and sucrose (sugar).
Please only take Omeprazole Zentiva after consulting your doctor if you know that you are intolerant to certain sugars.

3. HOW SHOULD OMEPRAZOLE ZENTIVA BE TAKEN?
Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The usual dose is one 20 mg enteric-coated hard capsule once daily for 14 days. Tell your doctor if you are not symptom-free after this period. It may be necessary to take the enteric-coated hard capsules for 2-3 consecutive days to achieve an improvement in symptoms.

Method of administration
o It is recommended that you take your enteric-coated hard capsule in the morning.
o You can take your enteric-coated hard capsule with food or on an empty stomach.
o Swallow your enteric-coated hard capsule whole with half a glass of water.
Do not chew or crush the enteric-coated hard capsule, as it contains coated micropellets that prevent the medicine from being broken down by the acid in the stomach. It is important that the micropellets are not damaged. These micropellets contain the active ingredient omeprazole and are enteric-coated, which protects them from being broken down during passage through the stomach. The micropellets release the active ingredient in the intestine, where it is absorbed by your body to exert its effect.

What to do if you have difficulty swallowing the enteric-coated hard capsule

If you have difficulty swallowing the enteric-coated hard capsule

- Open the enteric-coated hard capsule and swallow the contents immediately with half a glass of water.
- You can also put the contents of the capsule in a glass with an acidic fruit juice (e.g. apple, orange or pineapple), applesauce or non-carbonated water. Always stir the mixture immediately before taking it. Then take the liquid immediately or within 30 minutes.
- To make sure you have taken all of the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine - they must not be chewed or crushed.
- The capsule can also be sucked and the solid particles then swallowed with half a glass of water. The solid particles must not be chewed or crushed.

If you have taken more Omeprazole Zentiva than you should
If you have taken more Omeprazole Zentiva than recommended, talk to your doctor or pharmacist immediately.

If you forget to take Omeprazole Zentiva
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 a forgotten dose.

4. WHAT SIDE EFFECTS ARE POSSIBLE?
What side effects are possible?

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 Omeprazole Zentiva and contact a doctor immediately

o Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
o Reddening of the skin with blistering or peeling. Serious blistering and bleeding of the lips, eyes, mouth, nose and genitals may also occur. These could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
o Yellow skin, dark urine and fatigue can be signs of liver problems.

Side effects can occur with certain frequencies, which are defined as follows

The following categories are used to describe the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Other side effects include

Common side effects
o Headache.
o Effects on your stomach or intestines: diarrhoea, abdominal pain, constipation, flatulence (flatulence).
o Nausea or vomiting.

Uncommon side effects
o Swelling of the feet and ankles.
o Sleep disturbances (insomnia).
o Dizziness, tingling like "ants running", drowsiness.
o Vertigo (vertigo).
o Altered blood test results that check how the liver is working.
o Rash, hives (urticaria) and itchy skin.
o General malaise and lack of drive.

Rare side effects
o Blood problems, such as decreased white blood cell or platelet count. This can cause weakness, bruising or make it more likely that you will get an infection.
o Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
o Low sodium levels in the blood. This can lead to weakness, nausea (vomiting) and cramps.
o Feeling of excitement, confusion, depression.
o Changes in taste.
o Visual disturbances such as blurred vision.
o Sudden feeling of wheezing or shortness of breath (bronchospasm).
o Dry mouth.
o Inflammation of the inside of the mouth.
o Bowel inflammation (leading to diarrhoea).
o An infection known as "thrush" that can affect the intestines and is caused by a fungus.
o Liver problems, including jaundice, which can lead to yellowing of the skin, darkening of the urine and fatigue.
o Hair loss (alopecia).
o Rash from sunlight.
o Joint pain (arthralgia) or muscle pain (myalgia).
o Severe kidney problems (interstitial nephritis).
o Increased sweating.

Very rare side effects
o Changes in blood count including agranulocytosis (lack of white blood cells).
o Aggression.
o Seeing, feeling and hearing things that are not there (hallucinations).
o Severe liver problems leading to liver failure and brain inflammation.
o Sudden onset of severe rash or blistering or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
o Muscle weakness.
o Enlargement of the breasts in men.

Not known frequencies
o Low magnesium levels in the blood (hypomagnesemia) (see section 2. "Warnings and precautions").

In very rare cases, Omeprazole Zentiva can affect the white blood cells, leading to a weakened immune system. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulty urinating, you must see your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to inform your doctor about your current medicine.

Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the
Federal Institute for Drugs and Medical Devices
Dept. of Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD OMEPRAZOLE ZENTIVA BE STORED?
Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister packs. The expiry date refers to the last day of the month indicated. Do not store above 25 °C. Store in the original package to protect from moisture. After opening the bottle, the medicine can be stored for 3 months at a temperature below 25 °C.
Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Omeprazole Zentiva contains
The active ingredient is omeprazole. Each enteric-coated hard capsule contains 20 mg omeprazole. The other ingredients are:
- Capsule contents: Sugar-starch pellets (consisting of sucrose and corn starch), lactose, hypromellose 2910/6, hyprolose, sodium dodecyl sulfate, sodium monohyd