20 mg enteric capsules, hard
omeprazole
What Omezyl is and what it is used for
Omezyl contains the active substance omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced in the stomach.
Omezyl is used to treat the following conditions:
Adults:
- Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation and heartburn.
- Ulcers in the duodenum ( duodenal ulcer ) or in the stomach ( gastric ulcer ).
- Wounds that are infected by a bacterium called ” Helicobacter pylori”. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
- Gastric ulcer caused by so-called NSAIDs (non-steroidal anti-inflammatory drugs). Omezyl can also be used to prevent stomach ulcers when taking NSAIDs .
- Too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
Children over 1 year and ≥ 10 kg:
- Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation and heartburn.
In children, symptoms may include vomiting of stomach contents into the mouth, vomiting and decreased weight gain.
Children and adolescents over 4 years:
- Wounds that are infected by a bacterium called ” Helicobacter pylori”. If your child has such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
Omeprazole contained in Omezyl may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Omezyl
Do not take Omezyl
- 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 (for example pantoprazole, lansoprazole, rabeprazole, esomeprazole).
- if you are taking medicines containing nelfinavir (used to treat HIV infection ).
Talk to your doctor or pharmacist before taking Omezyl.
Warnings and cautions
Omezyl can mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Omezyl or while you are taking Omezyl, talk to your doctor immediately:
- You lose a lot of weight for no reason and have trouble swallowing.
- You get stomach pains or indigestion.
- You start vomiting food or blood.
- You get black (blood-mixed) stools.
- You get severe or persistent diarrhea, as omeprazole has been shown to be associated with a certain increase in infectious diarrhea.
- You have severe liver problems.
- If you have ever had a skin reaction after treatment with a medicine like Omezyl that reduces stomach acid.
- You must undergo a specific blood test (chromogranin A).
If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Omezyl. Also remember to mention any other side effects, such as joint pain.
If you are taking Omezyl for a long time (over a year), your doctor will probably check you regularly. You should discuss any new or unusual symptoms and circumstances with your doctor.
Using proton pump inhibitors such as Omezyl and especially if you use Omezyl for more than a year, may increase the risk of having a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
Other medicines and Omezyl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is because Omezyl can affect the way other medicines work and other medicines can affect the effect of Omezyl.
Do not take Omezyl if you are also taking medicines containing nelfinavir (used to treat HIV infection ).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Ketoconazole , posaconazole, itraconazole or voriconazole (used to treat fungal infections).
- Digoxin (used to treat heart problems).
- Diazepam (used to treat anxiety, for muscle relaxation or for epilepsy ).
- Phenytoin (used in epilepsy ). If you are taking phenytoin , your doctor will need to examine you when you start or stop taking Omezyl.
- Drugs used for blood thinning, such as warfarin or other vitamin K blockers. Your doctor may need to examine you when you start or stop taking Omezyl.
- Rifampicin (used to treat tuberculosis ).
- Atazanavir (used to treat HIV infection ).
- Tacrolimus (in organ transplantation).
- St. John’s wort ( Hypericum perforatum ) (used to treat mild depression).
- Cilostazol (used to treat “peephole”).
- Sakvinavir (used to treat HIV infection ).
- Clopidogrel (used to prevent blood clots ( thrombosis ).
- Erlotinib (used to treat various forms of cancer).
- Methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may temporarily discontinue your treatment with Omezyl.
If your doctor has prescribed antibiotics, amoxicillin, and clarithromycin, in combination with Omezyl for the treatment of stomach ulcers caused by Helicobacter pylori infection, you must tell your doctor if you are also taking other medicines.
Omezyl with food and drink
You should preferably take the capsules without food. They should NOT be chewed or crushed. They should be swallowed whole with a glass of water.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Omeprazole passes into breast milk, but it is unlikely that the baby will be affected at the recommended dose. Your doctor will decide if you can take Omezyl if you are breastfeeding.
Driving and using machines
Omezyl is unlikely to affect your ability to drive or handle tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If you are affected by these symptoms, you should not drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Omezyl contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
How to use Omezyl
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will tell you how many capsules to take and how long to take them. Dosage one depends on your condition and how old you are.
The recommended dose is:
For the treatment of GERD symptoms such as heartburn and acid reflux :
- If your doctor has found that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4-8 weeks. Your doctor may recommend that you take a dose of 40 mg for another 8 weeks if the damage to your esophagus is not healed.
- The recommended dose after the esophagus has healed is 10 mg once daily.
- If your esophagus is not damaged, the recommended dose is 10 mg once a day.
For the treatment of duodenal ulcers ( duodenal ulcers ) :
- The recommended dose is 20 mg once daily for 2 weeks. Your doctor may recommend that you take the same dose for another 2 weeks if the wound has not healed.
- If the wound has not healed completely, the dose can be increased to 40 mg once daily for 4 weeks.
For the treatment of ulcers in the stomach ( gastric ulcer ):
- The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the wound has not healed.
- If the wound has not healed completely, the dose can be increased to 40 mg once daily for 8 weeks.
To prevent 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 a day.
For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):
- The recommended dose is 20 mg once daily for 4-8 weeks.
To prevent duodenal and gastric ulcers if you are taking NSAIDs :
- The recommended dose is 20 mg once daily.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent recurrence of wounds:
- The recommended dose is 20 mg Omezyl twice daily for 1 week.
- Your doctor will also recommend that you take two amoxicillin antibiotics , clarithromycin and metronidazole.
For the treatment of excess acid in the stomach caused by a tumor of 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 for children
For the treatment of GERD symptoms such as heartburn and acid reflux :
- Children over 1 year of age and with a body weight of more than 10 kg can be treated with Omezyl. The recommended dosage is based on the child’s weight and the correct dose is decided by the doctor.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent recurrence of wounds:
- Children over 4 years of age can be treated with Omezyl. The recommended dosage is based on the child’s weight and the correct dose is decided by the doctor.
- Your doctor will also prescribe two antibiotics for your child, amoxicillin and clarithromycin.
Taking the medicine
- You should take the capsules in the morning.
- You can take the capsules with food or on an empty stomach.
- Swallow the capsules whole together with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated granules that prevent the medicine from being broken down by acid in the stomach. It is important that the granules are not damaged.
Because Omezyl is only available in strength 20 mg and the capsules are not divisible, not all dosages are possible. If you need another medicine, your doctor will prescribe another omeprazole medicine.
What you can do if you or your child have difficulty swallowing the capsules
- If you or your child have difficulty swallowing the capsules:
- Open the capsules and swallow the contents directly together with half a glass of water or pour the contents into a glass of water (not carbonated), sour fruit juice (eg apple, orange or pineapple) or apple puree.
- Always stir mixture one immediately before drinking it ( mixture one will not be ready). Drink the mixture immediately or within 30 minutes.
- To be sure that you have ingested all the medicine, rinse the glass thoroughly with another half glass of water that you drink. The solid particles contain the medicine – do not chew or crush them.
If you take more Omezyl than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Omezyl
If you forget to take a dose , take it as soon as you notice it. If it is near the time of the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose .
If you stop taking Omezyl
Do not stop taking Omezyl without first consulting your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Omezyl and contact your doctor immediately, if you notice any of the following unusual but serious side effects:
- Sudden wheezing, swelling of the lips, tongue and throat or other part of the body, rash, fainting or difficulty swallowing (severe allergic reaction ).
- Redness of the skin with blistering or flaking. Severe blistering and bleeding on the lips, eyes, mouth, nose and genitals may also occur. This can be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
- Yellowed skin, dark urine and fatigue which can 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, abdominal pain, constipation, flatulence (flatulence).
- Nausea or vomiting.
- Benign polyps are in the stomach.
Uncommon side effects ( may affect up to 1 in 100 people)
- Swelling of the feet and ankles.
- Sleep disorders (insomnia).
- Dizziness, tingling, drowsiness.
- Scams ( vertigo ).
- Changes in blood tests that show liver function.
- Skin rash, hives and itching .
- General malaise and lack of energy.
Rare side effects (may affect up to 1 in 1,000 people)
- Altered blood count such as decreased number of white blood cells or platelets . This can cause weakness, bruising or more susceptibility to infection.
- Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
- Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
- Feeling of agitation, confusion or depression.
- Taste changes.
- Vision problems, such as blurred vision.
- Sudden wheezing or shortness of breath ( bronchospasm ).
- Dry mouth .
- Inflammation of the oral cavity.
- A fungal infection called “cod” that can affect the gut 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 when staying in the sun.
- Joint pain ( arthralgia ) or muscle pain ( myalgia ).
- Severe kidney problems (interstitial nephritis).
- Increased sweating.
Very rare side effects ( may affect up to 1 in 10,000 people)
- Changes in the blood picture including agranulocytosis (lack of white blood cells ).
- Aggression.
- Hallucinations (seeing, feeling or hearing things that do not exist).
- Severe liver problems leading to liver failure and encephalitis.
- Sudden onset of severe rash, blistering or flaky skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome , toxic epidermal necrolysis ).
- Muscle weakness.
- Enlargement of the mammary glands in men.
Has been reported (occurs in an unknown number of users)
- Inflammation of the intestine (causes diarrhea).
- If you use Omezyl for more than three months, your magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
- Skin rash, possibly with joint pain.
Omezyl can in very rare cases affect the white blood cells so that the immune system is weakened. If you get an infection with symptoms such as fever and severe general malaise or fever with symptoms of local infection such as pain in the neck, throat, or mouth or difficulty urinating, you must contact a doctor as soon as possible so that any lack of white blood cells ( agranulocytosis ) can be excluded by a blood test. It is important that you then information about your medicine.
How to store Omezyl
- 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, blister or label. The expiration date is the last day of the specified month.
- For Al / Al blisters: Do not store above 30 ° C. Store in the original package. Moisture sensitive.
- For PVC-PVDC / Al blisters: Do not store above 25 ° C. Store in the original package. Moisture sensitive.
- For jar: No special storage instructions. Close the jar tightly. Moisture sensitive.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is omeprazole. Omezyl 20 mg hard enteric capsule contains 20 mg omeprazole.
- The other ingredients in the capsule are: sucrose, maize starch, hypromellose (E 464), Talc (E 553b), titanium dioxide (E 171), disodium phosphate dihydrate (E 339 ii), sodium aryl sulphate, polysorbate 80, methacrylic acid-ethyl acrylate 150 copolymer, . Capsule shell : Gelatin, thianic dioxide (E 171), printing ink (black iron oxide (E 172), potassium hydroxide and shellac) (see section 2, Omezyl contains sucrose and sodium ).
What the medicine looks like and contents of the pack
Omezyl 20 mg capsules are opaque, white, hard gelatin capsules labeled “OM 20”, containing round granules.
White HDPE cans with safety-sealed lid and desiccant containing 14, 28, 90, or 100 capsules
Al / Al blister: 14 or 28 capsules
PVC-PVDC / Al blister: 14, 28, 30 or 100 capsules
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer
Towa Pharmaceutical Europe SL
C / de Sant Marti, 75-97
Martorelles, 08107 Barcelona
Spain