Omeprazole Healthkern 20 mg gastro-resistant hard capsules
Omeprazole
Read the entire package insert carefully before you start taking this medicine, because it contains
information important to you
Follow exactly the instructions for administering the medicine contained in this leaflet or the
indicated by your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need advice or more information, ask your pharmacist.
- If you experience adverse effects, please consult your doctor or pharmacist, even if they are
adverse events not listed in this brochure. See section 4.
- You should consult a doctor if it gets worse or does not improve after 14 days.
Contents of the leaflet
1. What is Omeprazole Healthkern and what is it used for
2. What you need to know before you start taking Omeprazole Healthkern
3. How to take Omeprazole Healthkern
4. Possible adverse effects
5 Preservation of Omeprazole Healthkern
6. Package contents and additional information
1 What is Omeprazole Healthkern and what is it used for
Omeprazole Healthkern contains omeprazole as active ingredient. It belongs to a group of medicines
called "proton pump inhibitors." These drugs work by reducing the amount of
acid produced by the stomach.
Omeprazole Healthkern is indicated in adults for the short-term treatment of symptoms of
reflux (e.g., burning, acid regurgitation)
Reflux is the rise of acid from the stomach into the esophagus, which can become inflamed and painful. This can cause you to
cause symptoms such as a painful burning sensation in the chest that goes up into the throat
(burning) and a sour taste in the mouth (acid regurgitation).
You may have to take the capsules for 2-3 consecutive days to achieve an improvement in
symptoms.
You should see a doctor if it gets worse or does not get better after 14 days.
2. What you need to know before you start taking Omeprazole Healthkern
Do not take Omeprazole Healthkern:
if you are allergic to omeprazole or any of the other components of this medicine (including
in section 6).
if you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole,
lansoprazole, rabeprazole, esomeprazole).
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if you are taking a medicine that contains nelfinavir (used for HIV infection).
Warnings and precautions
Check with your doctor or pharmacist before you start taking Omeprazole Healthkern.
Do not take Omeprazole Healthkern for more than 14 days without consulting your doctor. If you do not experience
relief, or feel that your symptoms are getting worse, consult your doctor.
Omeprazole may hide the symptoms of other diseases. Therefore, consult your doctor
immediately if you experience any of the following conditions before starting omeprazole
or during treatment:
He loses a lot of weight for no apparent reason and has trouble swallowing.
You have stomach pain or indigestion.
You begin to vomit food or vomit blood.
Your stools are black (bloody stools).
You have severe or persistent diarrhea, because omeprazole has been associated with a mild
increased infectious diarrhea.
You have a history of gastric ulcer or gastrointestinal surgery.
You are receiving ongoing treatment for indigestion or heartburn
for four weeks or more.
You have been suffering from indigestion or heartburn for 4 weeks or more
You have jaundice or severe liver disease.
You are over 55 years old and your symptoms have recently changed or are new.
If you have ever had a skin reaction after treatment with a medication
similar to Omeprazol Healthkern to reduce stomach acidity.
A specific blood test (Chromogranin A) is planned.
If you get a rash, especially on sun-exposed areas of your skin, consult your doctor as soon as possible.
as soon as possible, as treatment with Omeprazole Healthkern may need to be stopped. Remember
mention any other symptoms you might notice, like joint pain.
Patients should not take omeprazole as a preventive medication.
Taking Omeprazole Healthkern with other medications
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to
take any other medication, including over-the-counter. Omeprazole may affect
mechanism of action of some drugs and some drugs may affect omeprazole .
Do not take omeprazole if you are taking a medicine containing nelfinavir (used to treat
HIV infection).
You should specifically tell your doctor if you are taking clopidogrel (used to prevent blood clots).
blood (thrombi)).
Tell your doctor or pharmacist if you are taking any of the following medicines:
Ketoconazole, posoconazole, itraconazole, or voriconazole (used to treat
mushrooms)
Digoxin (used to treat heart problems)
Diazepam (used to treat anxiety, relax muscles or in epilepsy)
phenytoin (used in epilepsy) If you are taking phenytoin, your doctor will
keep you under control when you start or stop omeprazole treatment
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Drugs used to prevent blood clots, such as warfarin
or other vitamin K antagonists. Your doctor will need to keep you under control when
start or stop treatment with omeprazole
Rifampicin (used to treat tuberculosis)
Atazanavir (used to treat HIV infection)
Tacrolimus (in cases of 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)
Erlotinib (used to treat cancer)
Methotrexate (a chemotherapy drug used in high doses to treat cancer) - if
is taking a high dose of methotrexate, your doctor will have to temporarily stop the
omeprazole treatment
Taking Omeprazole Healthkern with food and drink
You can take your capsules with food or on an empty stomach. Do not chew or crush the capsules.
Swallow the capsules whole with a glass of water.
Pregnancy and Breastfeeding
Before taking omeprazole , tell your doctor if you are pregnant or trying to get pregnant.
Your doctor will decide if you can take omeprazole during this time.
Your doctor will decide if you can take omeprazole if you are breast-feeding.
Driving and using machines
Omeprazole is not likely to affect your ability to drive or use tools or machines.
Adverse effects such as dizziness and visual disturbances may occur (see section 4). If they occur,
should not be driving or using machines.
Omeprazole Healthkern contains Sucrose
If your doctor has told you that you have an intolerance to certain sugars, check with him or her before taking
this medicine.
3. How to take Omeprazole Healthkern
Follow exactly the instructions for administering the medicine contained in this leaflet or the
indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is one 20 mg capsule once a day for 14 days. Contact your doctor or pharmacist.
your doctor if the symptoms do not go away after this time.
You may have to take the capsules for 2-3 consecutive days to achieve an improvement in your
symptoms.
How to take this medicine
It is recommended to take the capsules in the morning.
You can take your capsules 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
contain coated granules that prevent the drug from being broken down by the action of the
stomach acid. It's important not to damage the granules. These granules contain omeprazole as
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active ingredient and have an enteric coating that protects them and prevents them from breaking when
pass through the stomach. The granules release the active ingredient into the intestine, where it is absorbed by
the body to have an effect.
What to do if you have trouble swallowing the capsules
If you have trouble swallowing the capsules:
Open the capsules and swallow the contents directly with half a glass of water or pour the contents
in a glass of non-carbonated water, an acidic fruit juice (e.g., apple, orange, or pineapple), or
apple.
Always shake the mixture just before drinking it (the mixture will not be transparent). Then,
drink the mixture immediately or within 30 minutes.
To make sure you have taken all of the medicine, fill the water glass half full,
rinse it well and drink the water. Do not use milk or sparkling water. The solid parts contain the
medicine; do not chew or crush them.
If you take more Omeprazole Healthkern than you should
If you have taken more omerpazole than recommended, immediately consult your doctor or pharmacist.
If you forget to take Omeprazole Healthkern
If you miss a dose, take it as soon as you remember. However, if there is not enough time for the
next intake, skip the missed dose. Do not take a double dose to make up for a missed one.
4. Possible side effects
Like all medications, this drug can produce adverse effects, although not all
people suffer from them.
If you experience any of the following rare but serious adverse effects, stop taking omeprazole and
consult 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 blistering or peeling You may also experience
intense blistering and bleeding in the lips, eyes, mouth, nose and genitals. It could be
"Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
Yellowing of the skin, dark urine, and fatigue, which may be symptoms of
Liver.
Other adverse effects are:
Frequent adverse effects (can affect up to 1 in 10 people)
Headache.
Effects on the stomach or intestine: diarrhea, stomach pain, constipation, and gas (flatulence)
Nausea or vomiting.
Benign stomach polyps.
Rare adverse effects (may affect up to 1 out of 100 people)
Swelling of the feet and ankles.
sleep disorders (insomnia)
dizziness, tingling sensation, drowsiness
feeling that everything is spinning (vertigo)
changes in the blood tests used to check liver function
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Skin rash, wheal and itching.
Feeling of general malaise and lack of energy.
Rare adverse effects (can affect up to 1 in 1,000 people)
Blood problems, such as low white blood cells or platelets This can cause
weakness or bruising and increase the chance of getting infections. Allergic reactions, to
sometimes very intense, including swelling of the lips, tongue, and throat, fever, and wheezing.
low sodium concentration in the blood May cause weakness, vomiting, and cramping. agitation
confusion or depression.
Taste alterations.
visual problems, such as blurred vision
sudden sensation of labored breathing (bronchospasm)
dry mouth
swelling inside the mouth
An infection called "candidiasis" that can affect the intestine and is caused by a fungus.
Liver problems, such as jaundice, which can cause yellow skin, dark urine, and
tiredness.
Hair loss (alopecia).
skin rash from exposure to sunlight
joint pain (arthralgias) or muscle pain (myalgias)
Severe kidney problems (interstitial nephritis).
increased sweating
Very rare adverse effects (may affect up to 1 in 10,000 people)
Alterations in blood count, such as agranulocytosis (lack of white blood cells) aggressiveness
Seeing, feeling, or hearing things that are not there (hallucinations).
Severe liver problems that lead to liver failure and brain swelling. Appearance
sudden intense rash, blistering, or peeling skin. You can go to
accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome,
toxic epidermal necrolysis).
Muscle weakness.
Breast enlargement in males
Adverse effects of unknown frequency (cannot be estimated from available data)
Inflammation in the intestine (which causes diarrhea).
Hypomagnesaemia
Skin rash, possibly with joint pain
In very rare cases, omeprazole can affect the white blood cells and cause
immunodeficiency. If you have an infection with symptoms such as fever with a very
impaired or fever with symptoms of local infection, such as neck, throat or mouth pain or difficulties
to urinate, you should see your doctor as soon as possible for a blood test and
rule out a lack of white blood cells (agranulocytosis) It is important that at this point
provide information about the medication you are taking.
Do not worry about this list of possible adverse effects. You may not have any of them. If
considers any of the adverse effects you suffer to be serious or if you notice any adverse effects you do not
mentioned in this leaflet, inform your doctor or pharmacist
