Omestad 10 mg, 20 mg, and 40 mg enteric omeprazole hard capsules
What Omestad Is And What Omestad Used For
Omestad contains the drug 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.
Omestad 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/heartburn.
- Ulcers in the duodenum ( duodenal ulcer ) or the stomach ( gastric ulcer ).
- Wounds that are infected by a bacterium called ” Helicobacter pylori. ” If you have such wounds, your doctor may prescribe antibiotics to treat the infection and allow wound healing.
- Gastric ulcers are caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Omestad can also be used to prevent stomach ulcers when taking NSAIDs.
- Too much acid in the stomach is caused by a pancreas tumor (Zollinger-Ellison syndrome).
Children:
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/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 prescribe antibiotics to treat the infection and allow wound healing.
Omeprazole found in Omestad may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before Using Omestad
Do Not Take Omestad:
- If you are allergic to omeprazol omestad or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to medicines that contain other proton pump inhibitors (for example, pantoprazole, lansoprazole, rabeprazole, and esomeprazole).
- If you are taking medicines containing nelfinavir (used to treat HIV infection ).
If unsure, talk to your doctor or pharmacist before taking Omestad.
Warnings And Cautions
Talk to your doctor or pharmacist before taking Omestad.
Omestad can hide symptoms of other diseases. Therefore, if any of the following occur before you start taking Omestad or while you are taking it, contact 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 is 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 Omestad that reduces stomach acid.
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 Omestad. Also, remember to mention any other side effects, such as joint pain.
If you have been taking Omestad for a long time (over a year), your doctor will probably check on you regularly. It would be best if you discussed any new or unusual symptoms and circumstances with your doctor.
Using proton pump inhibitors such as Omestad, especially if you have used Omestad for more than a year, may increase the risk of getting a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis or are taking medicines called corticosteroids, as they may increase the risk of osteoporosis.
Blood test results may be affected by omeprazole treatment. If you have a blood sample taken for analysis, tell your doctor that you are taking Omestad.
Other Medicines And Omestad
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Omestad can affect how other drugs work, and other drugs can affect the effect of Omestad.
Do not take Omestad if you also take nelfinavir medicines (used to treat HIV infection ).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Ketoconazole , itraconazole or voriconazole (used to treat fungal infections).
- Digoxin (used to treat heart problems)
- Diazepam (used to treat anxiety, muscle relaxation, or epilepsy ).
- Phenytoin (used in epilepsy ). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Omestad.
- Drugs such as warfarin or other vitamin K blockers are used for blood thinning. Your doctor may need to monitor when you start or stop taking Omestad.
- 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”)
- Saquinavir (used to treat HIV infection )
- Clopidogrel (used to prevent blood clots ( thrombosis )
- Erlotinib (used to treat cancer)
- Methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – if you take high doses of methotrexate, your doctor may temporarily discontinue your treatment with Omestad.
Suppose your doctor has prescribed antibiotics, amoxicillin, and clarithromycin, in combination with Omestad, to treat stomach ulcers caused by Helicobacter pylori infection. In that case, you must tell your doctor if you are also taking other medicines.
Displaced With Food, Drink, And Alcohol
It would help if you preferably took your capsules without food. The capsules should NOT be chewed or crushed. Swallow the capsules 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 or pharmacist for advice before taking this medicine. Your doctor will decide if you can take Omestad during that time.
Driving And Using Machines
Omestad 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 can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
Omestad Contains Sucrose And Sodium
If your doctor has told you 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.’ is next to “sodium-free.”
How To Use Omestad
- 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 listed below.
- Use for adults:
- For the treatment of symptoms of heartburn and acid reflux caused by gastroesophageal reflux disease ( GERD ):
- Use for adults:
- If your doctor has found that your esophagus is slightly damaged, the usual dose is 20 mg once a day 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 usual dose after the esophagus has healed is 10 mg once a day.
- If your esophagus is not damaged, the usual dose is 10 mg once a day.
For the treatment of duodenal ulcers ( duodenal ulcers ) :
- The usual dose is 20 mg once daily for 2 weeks. Your doctor may recommend taking 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 usual 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 repetition of duodenal and gastric ulcers :
- The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.
For the treatment of stomach ulcers caused by NSAIDs (Non-steroidal anti-inflammatory drugs):
- The usual dose is 20 mg once daily for 4-8 weeks.
To prevent duodenal and gastric ulcers if you are taking NSAIDs :
- The usual dose is 20 mg once a day.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent the recurrence of wounds:
- The usual dose is 20 mg twice daily for 1 week.
- Your doctor will also recommend you take two antibiotics from the amoxicillin group, clarithromycin, and metronidazole.
For the treatment of excess acid in the stomach caused by a tumor of the pancreas ( Zollinger-Ellison syndrome ):
- The usual dose is 60 mg daily.
- Your doctor will adjust the dose according to your needs and decide how long you should take 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 Omestad. Dosage one is based on the child’s weight, and the doctor decides the correct dose.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent the recurrence of wounds:
- Children over the age of 4 can be treated with Omestad. Dosage one is based on the child’s weight, and the doctor decides the correct dose.
- Your doctor will also prescribe two antibiotics for your child, amoxicillin, and clarithromycin.
Method of administration
- It is recommended that you take the capsules in the morning.
- It would help if you preferably took the capsules without food.
- Swallow your capsules whole, along 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 the acid in the stomach. The granules mustn’t be damaged.
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 capsule and swallow the contents immediately with half a glass of water, or mix the contents in a glass of water (not carbonated), any acidic liquid (for example, apple, orange, or pineapple juice), or apple puree.
- Always stir one immediately before drinking it ( mixture one will not be ready). Drink the mixture immediately or within 30 minutes.
- To ensure you have ingested all the medicine, rinse thoroughly with another half glass of water you drink. The solid particles contain the medicine – do not chew or crush them.
Use For Children And Adolescents
If You Use Too Much Omestad
If you have ingested too much medicine or if, e.g., a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If You Forget To Use Omestad
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 have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Omestad Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Stop taking Omestad and contact your doctor immediately if you notice any of the following rare but serious side effects:
- Sudden wheezing, lips, tongue, throat, or body swelling, rash, fainting, or difficulty swallowing (severe allergic reaction ).
- Redness of the skin with blistering or flaking. Severe blistering and bleeding from 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 can be symptoms of liver problems.
Other side effects may include:
Common (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 (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 (may affect up to 1 in 1,000 people)
- Altered blood count, such as a reduced number of white blood cells or platelets. This can cause weakness, an increased tendency to bruise, or susceptibility to infection.
- Allergic reactions, sometimes very severe, include swollen lips, tongue, and throat, fever, and wheezing.
- Low levels of sodium in the blood. This can cause feelings of 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” can affect the gut and is caused by a fungus.
- Liver problems include jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
- Hair loss ( alopecia ).
- Skin rash when sunbathing.
- Joint pain ( arthralgia ) or muscle pain ( myalgia ).
- Severe kidney problems (interstitial nephritis).
- Increased sweating.
Very rare (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 lead to liver failure and encephalitis.
- Sudden onset of severe skin 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.
Omestad can, in very rare cases, affect the white blood cells so that the immune system is weakened. Get an infection with symptoms such as fever and severe general malaise or 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 a blood test can exclude any lack of white blood cells ( agranulocytosis ). It is important that you then information about your medicine.
No known frequency (occurs in an unknown number of users)
- If you use Omestad for more than three months, your magnesium levels may drop. Low magnesium levels 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 magnesium levels can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the magnesium level in your blood using regular blood tests.
- Inflammation of the intestine (which causes diarrhea)
- Skin rash, possibly with joint pain.
How To Store Omestad
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
- HDPE can, after opening:
- Omestad 10 mg and 40 mg: Use within 100 days after opening. Close the plastic jar tightly after use.
- Omestad 20 mg: Use within 105 days after opening. Close the plastic jar tightly after use.
- Do not store above 25 ° C.
- OPA / Al / PVC-Al blister: Store in the original package. Moisture sensitive.
- HDPE can: Close the plastic can tightly. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are 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. Each Omestad enteric capsule contains 10 mg, 20 mg, or 40 mg of omeprazole.
Other ingredients are:
- Capsule contents: sugar spheres (containing maize starch and sucrose), sodium lauril phosphate, disodium phosphate, mannitol (E421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171) and methacrylic acid-ethyl acrylate polymer
- Capsule shell: gelatin, titanium dioxide (E171), shellac, black iron oxide (E172), propylene glycol, ammonium hydroxide.
What The Medicine Looks Like And The Contents Of The Pack
- Omestad 10 mg: Opaque white capsules marked with “OM 10” containing off-white to creamy white round micro granules.
- Omestad 20 mg: Opaque white capsules marked with “OM 20” containing off-white to creamy white round micro granules
- Omestad 40 mg: Opaque white capsules marked with “OM 40” containing off-white to creamy white round micro granules.
- Omestad 10 mg and 40 mg enteric capsules, hard:
- The capsules come in blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280, and 500 capsules and HDPE cans of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90 and 100 capsules.
- Omestad 20 mg enteric capsules, hard:
- The capsules come in blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280, and 500 capsules and HDPE cans of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 105 and 250 (hospital packaging) capsules.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers:
Liconsa Laboratories, SA
Adv. Miralcampo, no. 7, Polygon
Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara)
Spain
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark