10 mg and 20 mg hard enteric capsule
omeprazole
What Omeprazole Bluefish is and what it is used for
Omeprazole Bluefish 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.
Omeprazole Bluefish 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 Bluefish may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Omeprazole Bluefish
Do not use Omeprazole Bluefish
- 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 ).
If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Bluefish.
Warnings and cautions
Talk to your doctor before taking this medicine if:
- You must undergo a specific blood test (chromogranin A).
Do not take Omeprazole Bluefish for more than 14 days without consulting your doctor. If you do not get relief, or if your symptoms worsen, consult a doctor.
Omeprazole Bluefish can mask the symptoms of other diseases. Therefore, you should contact your doctor immediately if any of the following occur before you start taking Omeprazole Bluefish or while you are taking them:
- 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 stomach ulcers or undergone surgery in the gastrointestinal tract.
- You have been using continuous symptom treatment for acid reflux or heartburn for 4 weeks or longer.
- You have had acid reflux 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 drug like Omeprazole Bluefish that reduces stomach acid.
- You get a rash, especially in areas exposed to the sun, you should tell your doctor as soon as possible as you may need to stop treatment with Omeprazole Bluefish. Also remember to mention any other side effects , such as joint pain.
You should not take omeprazole as preventative medicine.
Other medicines and Omeprazole Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Omeprazole Bluefish can affect the way other medicines work and other medicines can affect the effect of Omeprazole Bluefish.
Do not take Omeprazole Bluefish if you are also taking medicines containing nelfinavir (used to treat HIV infection ).
In particular, you should tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots ( thrombosis )).
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, for muscle relaxation or for epilepsy ).
- Phenytoin (used in epilepsy ). If you are taking phenytoin , your doctor will need to monitor when you start or stop taking Omeprazole Bluefish.
- 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 Bluefish.
- 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 ).
Omeprazole Bluefish with food and drink
You can take your capsules with a meal or on an “empty stomach”.
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.
Driving and using machines
Omeprazole Bluefish 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 attention. 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 Bluefish 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 Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 10 mg and 20 mg capsules, ie essentially ‘sodium-free’.
How to take Omeprazole Bluefish
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 1 capsule of 20 mg or 2 capsules of 10 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 micro-pellets (granular grains) contain the active substance omeprazole and are gastro-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 capsule and mix in a tablespoon of water (not carbonated), any 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. Do not use milk or carbonated water. The solid particles contain the medicine – do not chew or crush them.
If you take more Omeprazole Bluefish than you should
If you have ingested too much medicine, or if e.g. If a child has ingested the medicine by mistake, always contact a doctor or hospital for risk assessment and advice.
If you forget to take Omeprazole Bluefish
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, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Omeprazole Bluefish 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 can be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
- Yellowed skin, dark urine and fatigue, which can be symptoms of liver problems.
Side effects can occur with certain frequencies, which are defined as follows:
| Very common: | may occur in more than 1 in 10 users |
| Usual: | may affect up to 1 in 10 users |
| Uncommon: | may affect up to 1 in 100 users |
| Rare: | can occur in up to 1 in 1,000 users |
| Very rare: | may affect up to 1 in 10,000 users |
| Has been reported: | occurs in an unknown number of users |
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.
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 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 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)
- Skin rash, possibly with joint pain.
- Low levels of magnesium in the blood ( hypomagnesaemia ). This can cause weakness, vomiting, cramps, tremors and changes in heart rhythm ( arrhythmias ). Omeprazole Bluefish 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 ruled out by a blood test. It is important that you then inform about your medicine.
Do not worry about this list of possible side effects. You may not be affected by any of them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Omeprazole Bluefish
Do not store above 30 ° C.
Close the jar tightly. Moisture sensitive. Store in the original package.
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 after EXP. The expiration date is the last day of the specified month.
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. Each capsule contains enterogranulate with 10 mg or 20 mg of omeprazole.
The other ingredients are sugar spheres (sucrose, maize starch), sodium starch glycolate type A, sodium lauryl sulfate, povidone K30, sodium hydroxide, hypromellose, methacrylic acid – ethyl acrylate copolymer (1: 1), trisodium phosphate ( (E104), gelatin, shellac, polyvinylpyrrolidone, sodium hydroxide, red iron oxide (E172) (in 10 mg capsules) or indigo carmine (E132) (in 20 mg capsules).
What the medicine looks like and contents of the pack
10 mg capsule: opaque red top and opaque orange bottom. Contains white to beige granules. Marked with O10.
20 mg capsule: opaque blue top and opaque orange bottom. Contains white to beige granules. Marked with O20.
Omeprazole Bluefish is available in all-alu blisters and jars in packs of 5, 7, 14, 15, 20, 21, and 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm, Sweden
Teva Pharma, SLU,
C / C, No. 4, Poligono Industrial Malpica
50016 Zaragoza, Spain