10 mg and 20 mg enteric-coated tablets are
omeprazole
What Losec is and what it is used for
Losec 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.
Losec 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 tablets for 2-3 days in a row to achieve symptom relief.
What you need to know before taking Losec
Do not take Losec
- 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 use a medicine containing nelfinavir (used to treat HIV – infection ).
Do not take Losec if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Losec.
Warnings and cautions
Talk to your doctor or pharmacist before taking Losec.
Do not take Losec for more than 14 days without consulting your doctor. If you do not get relief, or if you experience worsening of your symptoms, consult your doctor.
Losec can mask the symptoms of other diseases. Therefore, if any of the following occur before you take Losec 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.
- You’ve ever had a skin reaction after treatment with a drug like Losec that reduces stomach acid.
- You must undergo a specific blood test (chromogranin A).
Patients should not take omeprazole as a preventative medication.
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 Losec. Also remember to mention any other side effects, such as joint pain.
Other drugs and Losec
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 Losec can affect the way other medicines work and other medicines can affect the effect of Losec.
Do not take Losec if you are taking a medicine 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, 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 when you start or stop taking Losec.
- Drugs used for blood thinning, such as warfarin or other vitamin K blockers. Your doctor may need to monitor when you start or stop taking Losec.
- Rifampicin (used to treat tuberculosis ).
- Atazanavir (used to HIV – infection )
- Tacrolimus (in organ transplantation).
- St. John’s wort ( Hypericum perforatum ) (used to treat mild depression)
- Cilostazol (used to treat “peephole”)
- Saquinavir (used for HIV – infection )
- Erlotinib (used to treat 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 Losec
Losec with food and drink
See section 3.
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.
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 Losec if you are breastfeeding.
Driving and using machines
Losec 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.
Losec enteric tablets contain sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or pharmacist before taking this medicine.
Losec enteric tablets contain less than 1 mmol (23 mg) sodium per tablet, ie are essential ‘sodium-free’.
How to take Losec
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 tablet of 20 mg or 2 tablets 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 tablets for 2-3 days in a row to achieve symptom relief.
Taking the medicine
- You should take the tablets in the morning.
- You can take the tablets with food or on an “empty stomach”.
- Swallow your tablets whole along with half a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the drug 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 tablets
- If you have problems swallowing the tablets:
- Divide the tablet 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 up. Do not use milk or carbonated water. The solid particles contain the medicine – do not chew or crush them.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Losec 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.
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 blood count 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).
- Hypomagnesemia
- Skin rash, possibly with joint pain.
Losec 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 Losec
- 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 and blister after EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C.
- Store the medicine in the original package (blister). 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 package and other information
Content declaration
- The active substance is omeprazole. Each enteric- containing tablet contains omeprazole magnesium equivalent to 10 mg or 20 mg omeprazole.
- The other ingredients are microcrystalline cellulose, glyceryl monostearate 40‑55, hydroxypropylcellulose, hypromellose, magnesium stearate, methacrylic acid ‑ ethyl acrylate ‑ copolymer (1: 1) dispersion 30%, sugar spheres, synthetic paraffin (NF), macrogol (polyethylene glycolide 6000, polyethylene glycoside 6000 sodium hydroxide (for pH adjustment), sodium stearyl fumarate, talc, triethyl citrate, iron oxide E172, titanium dioxide E171.
What the medicine looks like and contents of the pack
- Losec 10 mg enteric tablets are light pink, marked on one side and 10 mg on the other.
- Losec 20 mg enteric tablets are pink, marked on one side and 20 mg on the other.
Pack sizes:
Enterotablett 10 mg
7 pcs (print packaging, non-prescription)
14 pcs (print packaging, non-prescription)
Enterotablet 20 mg
7 pcs (print packaging, non-prescription)
14 pcs (print packaging, non-prescription)
28 pcs (print packaging, non-prescription)
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
AstraZeneca AB, 151 85 Södertälje
This medicinal product is authorized under the European Economic Area under the names:
| Member State | The name of the drug |
|---|---|
| Denmark, Iceland, Sweden | Losec |
| Norway | Losec MUPS |