10 mg and 20 mg enteric capsules, hard
omeprazole
What Omeprazole Teva is and what it is used for
Omeprazole Teva contains the drug omeprazole. It belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid produced in the stomach.
Omeprazole Teva is used in adults for the short-term treatment of reflux symptoms (eg heartburn, acid regurgitation).
Reflux is the reflux of acid from the stomach to the esophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest that rises towards the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
It may be necessary to take the capsules for 2-3 days in a row to achieve symptom relief.
Omeprazole contained in Omeprazole Teva may also be approved for the treatment of other conditions not mentioned in this product information. 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 you take Omeprazole Teva
Do not take Omeprazole Teva
- 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 ).
Do not take Omeprazole Teva if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Teva.
Warnings and cautions
Do not take Omeprazole Teva for more than 14 days without consulting your doctor. If your symptoms do not improve, or if your symptoms worsen, consult your doctor.
Talk to your doctor or pharmacist before taking Omeprazole Teva
Omeprazole Teva can mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Omeprazole Teva 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 has been shown to be associated with a certain increase in infectious diarrhea.
- You have had previous gastric ulcers or gastrointestinal surgery.
- You have been using continuous symptomatic treatment for dyspepsia or heartburn for 4 weeks or longer.
- You have had dyspepsia or heartburn for 4 weeks or longer.
- You have jaundice or severe liver disease
- You are older than 55 years with new or recently changed symptoms.
- Have you ever had a skin reaction after treatment with a medicine similar to Omeprazole Teva that reduces stomach acid.
- You must undergo a specific blood test (chromogranin A).
Using proton pump inhibitors such as Omeprazole Teva, and especially if you use Omeprazole Teva for more than a year, may slightly increase the risk of 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.
You should not take omeprazole as preventative medicine.
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 taking Omeprazole Teva. Also remember to mention any other side effects, such as joint pain.
Other medicines and Omeprazole Teva
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 Omeprazole Teva can affect the way other medicines work and other medicines can affect the effect of Omeprazole Teva.
Do not use Omeprazole Teva if you are also taking nelfinavir-containing medicines (used to treat HIV infection ).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Ketoconazole , itraconazole, posaconazole 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 monitor you when you start or stop taking Omeprazole Teva.
- Drugs used for blood thinning, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Omeprazole Teva.
- 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 certain cancers).
- 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 Omeprazole Teva.
Omeprazole Teva with food and drink
See section 3.
Pregnancy and breastfeeding
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.
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 Omeprazole Teva if you are breastfeeding.
Driving and using machines
Omeprazole Teva 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.
Omeprazole Teva contains sucrose and sodium
Omeprazole Teva contains sucrose
Omeprazole Teva contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Omeprazole Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
How to take Omeprazole Teva
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 2 capsules of 10 mg or 1 capsule of 20 mg once daily for 14 days. Contact a doctor if you are not asymptomatic after this period.
It may be necessary to take the capsules for 2-3 days in a row to achieve symptom relief.
Taking the medicine
- You should take the capsules in the morning.
- You can take the capsules with food or on an empty stomach.
- Swallow your capsules whole along with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain covered granules that prevent the medicine from being broken down by acid in the stomach. It is important that the granules are not damaged. These microgranules (granules) contain the active substance omeprazole and are gastritis resistant, which protects them from being broken down during the passage through the stomach. The granules release the active ingredient into the intestine, where it is absorbed by the body to give an effect.
What you can do if you have difficulty swallowing the capsules
- If you have problems swallowing the capsules:
- Open the capsules and swallow the contents directly with half a glass of water or add the contents to a glass of water (non-carbonated), some acidic liquid (for example apple, orange or pineapple juice) 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 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 Omeprazole Teva 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 Omeprazole Teva
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 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 Omeprazole Teva 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 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 could 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 the blood picture that show the function of the liver.
- Skin rash, hives and itching .
- General malaise and lack of energy.
- Hip, wrist or vertebral fractures (see section 2).
Rare side effects: (may affect up to 1 in 1,000 people)
- Altered blood count such as reduced number of white blood cells or platelets. This may cause weakness, bruising or susceptibility to infection.
- Allergic reactions, sometimes very severe, such as 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 intestines.
- Liver problems including 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 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 Omeprazole Teva for more than three months, your blood 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
Omeprazole Teva 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 have information about your medication.
How to store Omeprazole Teva
Keep this medicine out of the sight and reach of children.
Used before the expiry date which is stated after “EXP”. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Packaging containing aluminum/aluminum blisters:
Store in the original package. Moisture sensitive.
HDPE plastic jar: Keep the jar tightly closed. Moisture sensitive.
Shelf life after first opening: 90 days.
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: Omeprazole Teva 10 mg, each capsule contains 10 mg omeprazole; Omeprazole Teva 20 mg, each capsule contains 20 mg omeprazole.
- Other ingredients are:
- Capsule contents: Sugar spheres (maize starch and sucrose), sodium starch glycolate, sodium lauryl sulphate, povidone K-30, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, sodium hydroxide, tal 17 sodium hydroxide.
- Capsule shell: Gelatin, red iron oxide (E172) (only 10 mg), erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171), indigo carmine (E132) (only 20 mg) and water.
- Ink: Shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).
What the medicine looks like and contents of the pack
Enter capsule, hard.
Omeprazole Teva 10 mg: Capsule with orange lower part marked ’10’ and a red upper part marked ‘O’. The capsule contains white to off-white micro granules. Omeprazole Teva 20 mg: Capsule with orange lower part marked ’20’ and a blue upper part marked ‘O’. The capsule contains white to off-white micro granules.
The capsules are packed in HDPE plastic jars with 7, 14, 15, or 28 capsules. The 20 mg capsules are also available in blister packs of 14 or 28 capsules.
Not all pack sizes may be marketed.