10 mg, 20 mg, 40 mg enteric capsules, hard
omeprazole
What Omeprazole Pensa is and what it is used for
Omeprazole Pensa is used to treat the following conditions:
Adults:
Omeprazole Pensa 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.
- 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 in the stomach (gastric ulcer).
- Wounds that are infected by a bacterium called ” Helicobacter pylori “. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
- Gastric ulcer caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Omeprazole Pensa can also be used to prevent stomach ulcers when you are taking NSAIDs .
- Too much acid in the stomach caused by a tumor in the pancreas (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 you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
What you need to know before you use Omeprazole Pensa
Do not use Omeprazole Pensa
- 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 Pensa.
Warnings and cautions
Talk to your doctor or pharmacist before using Omeprazole Pensa.
- if you are going to have a specific blood test (chromogranin A)
Omeprazole Pensa can mask the symptoms of other diseases. Therefore, if any of the following occur before you take Omeprazole Pensa 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 severe liver problems.
- If you have ever had a skin reaction after treatment with a medicine like Omeprazol Pensa 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 taking Omeprazole Pensa. Also remember to mention any other side effects, such as joint pain.
Using proton pump inhibitors such as Omeprazole Pensa and especially if you use Omeprazole Pensa for more than a year, may increase the risk of having 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.
If you are taking Omeprazole Pensa for a long time (over a year), your doctor will probably check you regularly. You should discuss any new or unusual symptoms and circumstances with your doctor.
Other medicines and Omeprazole Pensa
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This is because Omeprazole Pensa can affect the way other medicines work and other medicines can affect the effect of Omeprazole Pensa.
Do not take Omeprazole Pensa 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 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 Pensa.
- 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 Pensa.
- 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 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 Omeprazole Pensa
If your doctor has prescribed antibiotics, amoxicillin, and clarithromycin, in combination with Omeprazole Pensa to treat stomach ulcers caused by Helicobacter pylori infection, you must tell your doctor if you are also taking other medicines.
Omeprazole Pensa 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. Your doctor will decide if you can take Omeprazole Pensa during that time.
Your doctor will decide if you can take Omeprazole Pensa if you are breastfeeding.
Driving and using machines
Omeprazole Pensa 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 Pensa contains sucrose
Omeprazole Pensa 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.
How to use Omeprazole Pensa
Always use 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.
Adults:
For the treatment of symptoms of heartburn and acid reflux caused by gastroesophageal reflux disease ( GERD ):
- 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 recommended dose after the esophagus has healed is 10 mg once daily.
- If your esophagus is not damaged, the usual dose is 10 mg once a day.
For the treatment of duodenal ulcers ( duodenal ulcers ) :
- The recommended dose is 20 mg once daily for 2 weeks. Your doctor may recommend that you take 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 recommended 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 recurrence of duodenal and gastric ulcers :
- The recommended dose is 10 or 20 mg capsules once daily. 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 recommended dose is 20 mg once daily for 4-8 weeks.
To prevent duodenal and gastric ulcers if you are taking NSAIDs :
- The recommended dose is 20 mg once daily.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent recurrence of wounds:
- The recommended dose is 20 mg Omeprazole Pensa twice daily for 1 week.
- Your doctor will also recommend that you take two antibiotics of amoxicillin, clarithromycin and metronidazole.
For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome) :
- The recommended dose is 60 mg daily.
- Your doctor will adjust the dose according to your needs and will also decide how long you should take the 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 Omeprazole Pensa. Dosage one is based on the weight of the child and the correct dose one is decided by the doctor.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent recurrence of wounds:
- Children over 4 years of age can be treated with Omeprazole Pensa. Dosage one is based on the weight of the child and the correct dose one is decided by the doctor.
- Your doctor will also prescribe two antibiotics for your child, amoxicillin and clarithromycin.
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 tablets contain coated granules that prevent the medicine from being broken down by acid in the stomach. It is important that the granules are not damaged.
What you can do if you or your child have difficulty swallowing the tablets
- If you or your child have difficulty swallowing the capsules:
- Divide 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 Pensa than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital in Finland: (09) 471 977) for risk assessment and advice.
If you forget to take Omeprazole Pensa
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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Omeprazole Pensa 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
| Very common: | occurs in more than 1 in 10 users |
| Usual: | occurs in 1 to 10 out of 100 users |
| Unusual: | occurs in 1 to 10 out of 1000 users |
| Rare: | occurs in 1 to 10 out of 10,000 users |
| Very rare: | occurs in less than 1 in 10,000 users |
| No known frequency: | can not be calculated from available data |
Other side effects include:
Common side effects are
- Headache.
- Effects on the stomach or intestines: diarrhea, abdominal pain, constipation, flatulence (flatulence).
- Nausea or vomiting.
- Benign polyps are in the stomach.
Unusual side effects are
- 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 (if Omeprazole Pensa is used in high doses and for a long time).
Rare side effects
- 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
- 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.
Omeprazole Pensa 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.
No known frequency
- Inflammation of the intestine (causes diarrhea).
- If you use Omeprazole Pensa 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.
Do not worry about this list of possible side effects. You may not be affected by any of them.
How to store Omeprazole Pensa
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. or EXP. The expiration date is the last day of the specified month.
Blister Aluminum/aluminum: Do not store above 30 ° C. Store the blister in the original packaging. Moisture sensitive.
Blister PVC-PVDC / aluminum: Do not store above 25 ° C. Store the blister in the original packaging. Moisture sensitive.
Plastic jar: No special temperature instructions. Close the jar tightly. 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 pack and other information
Content declaration
- The active substance is omeprazole. Each capsule contains 10, 20 or 40 mg of omeprazole.
- The other ingredients are: Granules: sucrose, maize starch, hypromellose, disodium phosphate dihydrate, methacrylic acid-ethyl acrylate copolymer, talc, triethyl citrate, sodium lauryl sulfate, polysorbate 80, titanium dioxide (E171). Capsule cover: gelatin, titanium dioxide (E171). Marking ink: shellac, black iron oxide (E172).
What the medicine looks like and contents of the pack
Appearance:
Omeprazole Pensa 10 mg: Opaque white capsule marked “OM 10”. Contains white to light beige round granules.
Capsule size 4 (length 14.5 mm)
Omeprazole Pensa 20 mg: Opaque white capsule marked “OM 20”. Contains white to light beige round granules.
Capsule size 3 (length 15.8 mm)
Omeprazole Pensa 40 mg: Opaque white capsule marked “OM 40”. Contains white to light beige round granules.
Capsule size 1 (length 19.5 mm)
Pack sizes:
Omeprazole Pensa 10 mg:
Blister: 7, 14, 28, 56 enteric capsules
Plastic jars with screw caps containing drying capsule: 16, 32, 100 (2×50), 100 (1×100), 104, 105 enteric capsules
Omeprazole Pensa 20 mg:
Blister: 7, 14, 28, 56 enteric capsules
Plastic jars with screw caps containing drying capsules: 16, 28, 32, 56 enteric capsules, 100 (2×50), 100 (1×100), 104 (2×52), 104 (1×104), 105, 250, 500 enteric capsules
Omeprazole Pensa 40 mg:
Blister: 7, 14, 28, 56 enteric capsules
Plastic jars with screw caps containing drying capsules: 16, 30, 32, 100 (2×50), 100 (1×100), 104, 105, enteric capsules
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Pensa Pharma AB, Norrlandsgatan 10, 111 43 Stockholm
Tel: 08-440 3730
Manufacturer:
TOWA PHARMACEUTICAL EUROPE, SL
c / de Sant Martí 75-97
08107 Martorelles (Barcelona)
Spain
This medicinal product is authorized under the European Economic Area under the names:
| Country: | Product name: |
| SE, DK, NO: | Omeprazole Pensa |