15 mg, 30 mg enteric capsules, hard
Lansoprazole
What Lansoprazole Pensa is and what it is used for
The active substance in Lansoprazole Pensa is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced in the stomach.
Your doctor may prescribe Lansoprazole Pensa for the following indications:
- treatment of ulcers in the stomach and duodenum
- treatment of inflammation of the esophagus ( reflux esophagitis )
- prevention of reflux oesophagitis
- treatment of heartburn and acid reflux
- treatment or prevention of ulcers in the stomach or duodenum in patients requiring continued NSAID therapy ( NSAID therapy is used for pain or inflammation )
- treatment of Zollinger-Ellison syndrome.
Lansoprazole contained in Lansoprazole Pensa 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 take Lansoprazole Pensa
Do not take Lansoprazole Pensa:
- if you are allergic to lansoprazole or any of the other ingredients of Lansoprazol Pensa (listed in section 6).
- if you are taking a medicine containing the active substance atazanavir (used to treat HIV ).
Warnings and cautions
Talk to your doctor before taking Lansoprazole Pensa:
- if you have severe liver disease. Your doctor may need to adjust your dose .
- if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Pensa that reduces stomach acid.
- if you are going to have 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 taking Lansoprazole Pensa. Also remember to mention any other side effects, such as joint pain.
Your doctor may or may have done another test called an endoscopy to diagnose your disease and/or rule out malignant disease.
If diarrhea occurs during treatment with Lansoprazole Pensa, you should contact your doctor immediately, as Lansoprazole Pensa has been associated with a slightly increased incidence of infectious diarrhea.
If your doctor has prescribed you Lansoprazole Pensa together with anti-inflammatory drugs for the treatment of pain or rheumatic disease: also read the package leaflets for these drugs carefully.
Using proton pump inhibitors such as Lansoprazole Pensa and especially if you use Lansoprazol 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 ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.
If you are taking Lansoprazole Pensa for a long time (longer than 1 year), your doctor will probably check you regularly. You should report any new and unusual symptoms and details when you see your doctor.
Other medicines and Lansoprazole Pensa
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking medicines that contain any of the following active substances, as Lansoprazole Pensa may affect the way these medicines work:
- ketoconazole , itraconazole, rifampicin (used to treat infections )
- digoxin (used to treat heart problems)
- theophylline (used to treat asthma )
- tacrolimus (used to prevent transplant rejection )
- fluvoxamine (used to treat depression and other psychiatric disorders)
- antacids (antacids used to treat heartburn or acid reflux)
- sucralfate (used to heal stomach ulcers )
- St. John’s wort ( Hypericum perforatum ) (used to treat mild depression).
Lansoprazole Pensa with food and drink
For best results with this medicine, you should take Lansoprazole Pensa at least 30 minutes before eating.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Side effects such as dizziness, dizziness, fatigue, and visual disturbances sometimes occur in patients taking Lansoprazole Pensa. If you get such side effects, you should be careful, as your ability to react may be impaired.
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.
Lansoprazole Pensa contains sucrose
Lansoprazole Pensa also 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.
How to take Lansoprazole Pensa
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsules, your doctor may advise you on other ways to take the medicine. Do not crush or chew these capsules or the contents of an emptied capsule, as this will prevent them from working properly.
If you are taking Lansoprazole Pensa once a day, try to take the medicine at the same time each day. You can get the best results if you take Lansoprazole Pensa immediately in the morning.
If you take Lansoprazole Pensa twice a day, you should take the first dose one in the morning and the second dose one in the evening.
The dose of Lansoprazole Pensa depends on your condition. Usual doses of Lansoprazole Pensa for adults are listed below. Your doctor will sometimes prescribe a different dose and will tell you how long your treatment should last.
Treatment of heartburn and acid reflux: one 15 mg or 30 mg capsule daily for 4 days
weeks. If symptoms persist, tell your doctor. If symptoms persist within 4 weeks, consult a physician.
Treatment of duodenal ulcers: one 30 mg capsule daily for 2 weeks.
Treatment of ulcers in the stomach: one 30 mg capsule daily for 4 weeks.
Treatment of inflammation of the esophagus ( reflux esophagitis ) a 30 mg capsule daily for 4 weeks.
Long-term prevention of reflux oesophagitis: one 15 mg capsule daily, the doctor may adjust the dose to one 30 mg capsule daily.
Treatment of ulcers in duodenum one or stomach of patients who require continued NSAID treatment: one 30 mg capsule every day for 4 weeks.
Prevention of ulcers in duodenum one or stomach of patients who require continued NSAID treatment: one 15 mg capsule every day, the physician may adjust the dose of one to one 30 mg capsule every day.
Zollinger-Ellison syndrome: The usual dose is two 30 mg capsules each day, to begin with, then depending on how you respond to the treatment, your doctor will decide which dose is best for you.
Use for children
Lansoprazole Pensa should not be given to children.
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Possible side effects
Like all medicines, Lansoprazole Pensa can cause side effects, although not everybody gets them.
The following side effects are common (affects more than 1 patient in 100):
- headache, dizziness
- diarrhea, constipation, abdominal pain, nausea, vomiting, gas, dry mouth or mouth or throat pain
- rash, itching
- altered values from liver function tests
- fatigue
- benign polyps in the stomach.
The following side effects are uncommon (affects less than 1 in 100 people):
- Depression
- joint or muscle pain
- fluid retention or swelling
- altered blood cell count .
- hip, wrist or vertebral fractures (if Lansoprazole Pensa is used in high doses and for a long time).
The following side effects are rare (affects less than 1 in 1,000 people):
- fever
- restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
- taste changes, loss of appetite, inflammation of the tongue ( glossitis )
- skin reactions such as burning or stinging sensation under the skin, bruising, redness and excessive sweating
- photosensitivity
- hair loss
- ant crawling ( paresthesia ), trembling
- anemia (pallor)
- kidney problems
- pancreatitis
- hepatitis (may manifest as yellowing of the skin or eyes)
- breast swelling in men, impotence
- candida infection (fungal infection, may affect skin or mucous membranes)
- angioedema . You should see a doctor immediately if you get symptoms of angioedema , such as swollen face, tongue or throat, difficulty swallowing, hives and difficulty breathing.
The following side effects are very rare (affects less than 1 in 10,000 patients):
- severe hypersensitivity reaction including shock . Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a drop in blood pressure.
- inflammation of the mouth ( stomatitis )
- colitis ( inflammation of the intestine)
- altered test values such as sodium , cholesterol and triglyceride levels
- very severe skin reactions with redness , blistering, severe inflammation and skin waste
- In very rare cases, Lansoprazole Pensa may cause a decrease in the number of white blood cells , which may reduce the risk of infection. If you get an infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection such as sore throat / throat / mouth or difficulty urinating, you should see a doctor immediately. A blood sample will be taken to check if the number of white blood cells has decreased ( agranulocytosis ).
No known frequency
- If you use Lansoprazole 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
- Visual hallucinations.
How to store Lansoprazol Pensa
Keep this medicine out of the sight and reach of children.
Blister: Do not store above 25 ° C.
Plastic jar: Do not store above 30 ° C. Close the jar tightly. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the blister/label after EXP and after EXP. on the carton. 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 lansoprazole
- Other ingredients are:Capsule: hypromellose (E 464), talc, titanium dioxide (E 171), methacrylic acid – ethyl acrylate copolymer (1: 1), triethyl citrate, sugar spheres (sucrose and corn starch)Capsule shell: titanium dioxide (E 171), gelatin, purified water.Marking ink: shellac and black iron oxide (E 172).
What the medicine looks like and contents of the pack
Appearance:
Lansoprazole Pensa 15 mg: Opaque, hard, white capsule.
Each capsule is marked “LAN 15” and contains white to beige enteric-coated granules.
Lansoprazole Pensa 30 mg: Opaque, hard, white capsule.
Each capsule is marked “LAN 30” and contains white to beige enteric-coated granules.
Pack sizes:
15 mg
7, 14, 28, 42, and 56 enteric capsules in blister packs
56 (2×28) and 100 (2×50) enteric capsules in a plastic jar
30 mg
7, 14, 28, 42, and 56 enteric capsules in blister packs
28, 56 (2×28) and 100 (2×50) enteric capsules in plastic jar
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pensa Pharma AB
Birger Jarlsgatan 22
114 34 Stockholm
Manufacturer
Esteve Pharmaceuticals, SA
San Marti 75-97, Polígono Industrial
08107 Martorelles (Barcelona)
Spain
This medicine is authorized in the European Economic Area under the name
DK, NO and SE: Lansoprazole Pensa
DE: Lansoprazol Apomed