Omeprazid 20 mg x 14 capsules Nobel Pharma

Omeprazole is a non-prescription medicine that belongs to a group of medicines called „proton pump inhibitors“. They work by reducing the amount of acid produced in your stomach. It works quickly. Omeprazole is used to treat the following conditions: gastroesophageal reflux disease (GERD). This is a condition in which stomach acid flows back up into the esophagus and causes pain, inflammation, and a burning sensation behind the breastbone. Ulcers in the upper part of the small intestine (duodenal ulcer) or stomach ulcer. Ulcers that are caused by an infection with a bacterium called „Helicobacter pylori“. In this case, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. Ulcers that are caused by taking medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). If you are taking NSAIDs, omeprazole can also be used to prevent ulcers from developing. Too much acid in the stomach due to a growth in the pancreas (Zollinger-Ellison syndrome).
 
The active substance: omeprazole.
Each capsule contains 20 mg of omeprazole.
Excipients:
Capsule contents: sugar spheres (consisting of sucrose and corn starch), sodium starch glycolate, sodium lauryl sulfate, povidone, hypromellose phthalate, sucrose, hypromellose, mannitol (E421), acetylated monoglycerides, talc;
Capsule shell: titanium dioxide (E171), red iron oxide (E172), quinoline yellow aluminium foil (E104), indigo carmine aluminium foil (E132), gelatin
 
 Adults:
For the treatment of GERD symptoms such as heartburn and regurgitation of stomach acids:

20 mg once daily for 4-8 weeks.

To treat symptoms of ulcers in the upper part of the small intestine (duodenal ulcer):

20 mg OMEPRAZIDE once daily for 2 weeks.

To treat symptoms of stomach ulcers (gastric ulcer):

20 mg OMEPRAZIDE once daily for 4 weeks.

To prevent the recurrence of duodenal and stomach ulcers:

20 mg once daily.
For the treatment of duodenal and stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

20 mg OMEPRAZIDE once daily for 4-8 weeks.

To prevent the development of duodenal and stomach ulcers if you are taking NSAIDs (nonsteroidal anti-inflammatory drugs):

20 mg OMEPRAZIDE once daily.

Use in children:
For the treatment of GERD symptoms such as heartburn and regurgitation of stomach acids:

OMEPRAZIDE can be taken by children over 1 year of age and weighing over 10 kg.

The dosage for children depends on their body weight, so your doctor will decide the appropriate dose.
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

 OMEPRAZIDE can be taken by children over the age of 4. The dosage for children depends on their body weight, so your doctor will decide on the appropriate dose.
In addition, your doctor will prescribe two of the following antibiotics for your child: amoxicillin, clarithromycin, and metronidazole.

Important:
What you need to know before taking Omeprazid:
Do not take Omeprazid:
- if you are allergic (hypersensitive) 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 to treat HIV infection).
Warnings and precautions:
Talk to your doctor or pharmacist before taking Omeprazid.
Omeprazole may mask the symptoms of other conditions. Therefore, if any of the conditions listed below occur to you before you start taking Omeprazole or while you are taking it, contact your doctor immediately.
If you lose a lot of weight for no apparent reason or have difficulty swallowing.
If you have stomach pain or indigestion.
Vomiting food or blood.
Black (bloody) stools.
If you develop severe or prolonged diarrhoea, as omeprazole has been associated with a small increase in the incidence of infectious diarrhoea.
If you have serious liver problems.
If you need to have a certain type of blood test (Chromogranin A).
If you take Omeprazid for more than 1 year, your doctor will regularly monitor your condition.
Taking a proton pump inhibitor such as Omeprazole for longer than 1 year may increase your risk of fracture in the hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase your risk of osteoporosis).
How to take Omeprazid:
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
It is recommended to take the capsules in the morning.
You can take the capsules after meals or on an empty stomach.
Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as the capsules contain coated granules that prevent stomach acids from breaking down the medicine and therefore their integrity should not be compromised.
If you or your child have difficulty swallowing the capsules:
Open the capsule and swallow the contents directly with half a glass of water or pour the contents of the capsule into half a glass of water (still), some acidic fruit juice (e.g. apple, orange or pineapple) or applesauce.
Always stir the solution before drinking it (the solution will not be clear). Take the solution immediately or within 30 minutes.
To make sure you take all of the medicine, add another half glass of water and drink it. The solid particles contain the active ingredient - do not crush or chew them.
If you have taken more than the required dose of Omeprazid, contact your doctor immediately.
If you forget to take Omeprazid:
If you forget to take Omeprazole, take the capsule as soon as you remember, unless it is almost time for your next dose. If this happens, skip the missed dose.
Do not take a double dose to make up for a missed capsule.
If you stop taking Omeprazid:
Do not stop treatment before you have finished the full course of treatment, even if you feel better. You may not be completely cured and some of your symptoms may return.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Other medicines and Omeprazid:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The reason for this is that Omeprazid can affect the action of some medicines, and some medicines can affect the action of Omeprazid.
Do not take Omeprazid if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor if you are taking any of the following medicines:

Ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
Digoxin (used to treat heart disease);
Diazepam (used to treat anxiety, increased muscle tone or to treat epilepsy);
Phenytoin (used to treat epilepsy);
Medications used to reduce blood clotting – such as warfarin and other vitamin K blockers;
Rifampicin (used to treat tuberculosis);
Atazanavir (used in the treatment of HIV infection);
Tacrolimus (used in organ transplantation);
St. John's wort (used to treat mild depression);
Cilostazol (intermittent claudication);
Saquinavir (used in the treatment of HIV infection);
Clopidogrel (used to reduce the risk of developing blood clots, thrombi);

If your doctor has prescribed you to take the antibiotics amoxicillin and clarithromycin, used to treat Helicobacter pylori infection, at the same time as Omeprazid, it is important to inform him if you are taking any other medicines,
Omeprazole with food, drink and alcohol:
You can take Omeprazid capsules both after meals and on an empty stomach.
Pregnancy, lactation and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines:
There is no evidence that Omeprazole affects your ability to drive or use tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). In these cases, you should not drive or use machines.
Omeprazid contains the excipient sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
 
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 Omeprazole and contact a doctor immediately:
Sudden wheezing, swelling of your lips, tongue, throat or whole body, rash, loss of consciousness or difficulty swallowing (severe allergic reaction). Redness of the skin with blistering or peeling. Blistering and bleeding from the lips, eyes, mouth, nose and genitals may occur. Yellowing of the skin, dark urine and weakness, which may be symptoms of liver problems. Side effects occur with a certain frequency, which is defined as follows:
Very common: develops in more than 1 in 10 patients.
Common: develops in more than 1 in every 100 patients, but in less than 1 in every 10 patients.
Uncommon: develops in more than 1 in every 1,000 patients, but in less than 1 in every 100 patients.
Rare: develops in more than 1 in every 10,000 patients, but less than 1 in every 1,000 patients.
Very rare: occurs in less than 1 in 10,000 patients. Not known: frequency cannot be estimated from the available data.
Common side effects:
– Headache;- Diarrhea, abdominal pain, constipation, gas;- Nausea and vomiting;
Uncommon side effects:
– Swelling of the feet and ankles;- Sleep disturbances (insomnia);- Dizziness, numbness, tingling, drowsiness;- Vertigo (vertigo);- Changes in blood tests that show how the liver is functioning;- Skin rashes, raised rashes (hives, urticaria) and itchy skin;- General malaise and lack of energy;
Rare side effects:
– Blood problems such as low white blood cell or platelet counts. This can cause fatigue, bruising, or an increased risk of infections; – Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing; – Low sodium levels in the blood. This can cause weakness, vomiting and cramps; - Anxiety, confusion or depression; - Change in taste; - Vision problems - such as blurred vision; - Sudden onset of wheezing or shortness of breath (bronchospasm); - Dry mouth; - Mouth inflammation; - An infection called 'thrush', which can affect the gut and is caused by a fungus; - Liver problems, including jaundice - yellowing of the skin, dark urine and tiredness; - Hair loss (alopecia); - Skin rashes when exposed to the sun; - Joint pain (arthralgia) or muscle pain (myalgia); - Serious kidney problems (interstitial nephritis); - Increased sweating;
Very rare side effects:
– Changes in blood count, including agranulocytosis (lack of white blood cells);- Aggressive behaviour;- Seeing, feeling or hearing things that are not there (hallucinations);- Serious liver problems leading to liver failure and brain inflammation;- Sudden development of a severe rash or peeling skin. This may be associated with high fever and joint pain (erythema multiforte, Stevens-Johnson syndrome, toxic epidermal necrolysis);- Muscle weakness;- Breast enlargement in men;- Hypomagnesaemia (low levels of magnesium in the blood);
Not known: – It is possible that the magnesium levels in your blood may fall if you have been taking Omeprazid for more than 3 months. Low magnesium levels are manifested by tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels can lead to low levels of potassium and calcium in your blood. Your doctor may decide to carry out regular blood tests to monitor your magnesium levels.
In very rare cases, Omeprazole may affect the white blood cells, which can lead to the development of an immune deficiency. If you have an infection with symptoms such as fever and a severely deteriorated general condition, or fever with symptoms of a local infection such as pain in the neck, throat or mouth, or difficulty urinating, you should consult a doctor as soon as possible so that a blood test can be performed to rule out the possibility that your white blood cell count is low (agranulocytosis).
Do not be concerned about this list of possible side effects, because you may not develop any of them.
How to store Omeprazid:
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month,
Store in the original packaging to protect from moisture.
Store below 25°C.