20 mg enteric capsules, hard
omeprazole
What Omeprazole Apofri is and what it is used for
Omeprazole Apofri 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 Apofri 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 Apofri 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 you use Omeprazole Apofri
Do not use Omeprazole Apofri
– 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 (eg 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 Apofri.
Warnings and cautions
Do not take Omeprazole Apofri for more than 14 days without consulting a doctor. If you do not get relief, or if your symptoms worsen, consult a doctor.
Omeprazole Apofri may mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Omeprazole Apofri or while you are taking them, 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 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 Omeprazole Apofri 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 Omeprazole Apofri. Also remember to mention any other side effects, such as joint pain.
Patients should not take omeprazole as a preventative medication.
Other medicines and Omeprazole Apofri
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Omeprazole Apofri can affect the way other medicines work and other medicines can affect the effect of Omeprazole Apofri.
Do not take Omeprazole Apofri if you are also taking nelfinavir-containing medicines (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:
- Atazanavir (used to treat HIV infection )
- Ketoconazole , itraconazole or voriconazole (used to treat fungal infections)
- Digoxin (used to treat heart problems)
- 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 Apofri.
- Phenytoin (used in epilepsy ). If you are taking phenytoin , your doctor will need to monitor you when you start or stop taking Omeprazole Apofri.
- Diazepam (used to treat anxiety, for muscle relaxation or for epilepsy )
- St. John’s wort ( Hypericum perforatum ) (used to treat mild depression).
- Rifampicin (used to treat tuberculosis ).
- Tacrolimus (in organ transplantation).
- Cilostazol (used to treat “peephole”).
- Sakvinavir (used to treat HIV infection ).
- Methotrexate (used in rheumatic pain, psoriasis and various types of cancer).
Omeprazole Apofri with food and drink
You can take the capsules with a meal or on an “empty stomach”.
Pregnancy and breastfeeding
Tell your doctor or pharmacist if you are pregnant or trying to become pregnant before taking Omeprazole Apofri. Your doctor will decide if you can take Omeprazole Apofri during that time.
Your doctor will decide if you can take Omeprazole Apofri if you are breastfeeding.
Driving and using machines
Omeprazole Apofri is unlikely to affect your ability to drive or use 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 Apofri contains sucrose
Omeprazole Apofri enteric capsules contain 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 Apofri contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie it is essentially ‘sodium-free’.
How to use Omeprazole Apofri
Always take Omeprazole Apofri exactly as instructed in this leaflet. Ask your doctor or pharmacist if you are unsure.
The usual dose is 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 the capsules whole together with half a glass of water. Do not chew or crush the capsules.
What can you do if you have difficulty swallowing the capsules?
- If you have problems swallowing the capsules:
- Open the capsule and mix the contents of 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 drugs – do not chew or crush them.
If you use more Omeprazole Apofri 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 Apofri
If you forget to take a dose, take one as soon as you remember. If it is close to the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Omeprazole Apofri can cause side effects, although not everybody gets them.
Stop taking Omeprazole Apofri 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.
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.
No known frequency
- Inflammation of the intestine (causes diarrhea)
- Skin rash, possibly with joint pain.
- Hypomagnesemia .
Omeprazole Apofri 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 Omeprazole Apofri
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”: and on the blister after “EXP”. The expiration date is the last day of the specified month.
Packaging containing aluminum/aluminum blister: Do not store above 25 ° C. Store in the original package. Moisture sensitive.
Packaging containing PVC-PE-PVDC-aluminum blister: Do not store above 25 ° C. Store in the original package. Moisture sensitive.
Plastic jar: No temperature instructions. Close the jar tightly. Moisture sensitive.
The medicine 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 20 mg of omeprazole.
- Other ingredients are:
- Capsule contents: sugar beads (consisting of maize starch and sucrose), magnesium hydroxide , anhydrous disodium phosphate, hypromellose, sodium lauryl sulphate, mannitol, sodium starch glycolate, talc, titanium dioxide (E171), macrogols, polysorbate, and methacrylic acid polymer;
- Capsule shell: gelatin, indigo carmine (E132) and titanium dioxide (E171).
What the medicine looks like and contents of the pack
Enter capsule, hard
Opaque blue and opaque white hard gelatin capsule containing off-white to cream-colored, round micro granules, length about 14 mm.
The capsules are packaged in blister packs (PVC-PE-PVDC aluminum foil or aluminum foil/aluminum foil) with 7, 14, 15, 28, and 30 capsules;
and in plastic jars with 5, 7, 14, 15, 28, and 30 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder :
Evolan Pharma AB
Box 120
SE-182 12 Danderyd
Information provided by:
Apofri AB
Box 120
182 12 Danderyd
Phone: 08-544 960 30
Email: info@apofri.se
LABORATORIOS LICONSA, SA
Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN