20 mg enteric-tablet is
pantoprazole
What Pantoprazole Pensa is and what it is used for
Pantoprazole Pensa is a “selective proton pump inhibitor” that reduces the amount of acid formed in your stomach.
Pantoprazole Pensa is used for the temporary treatment of acid reflux and heartburn.
Pantoprazole contained in Pantoprazole Pensa may also be approved for the treatment of other conditions not mentioned in this product information. 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 using Pantoprazole Pensa
Do not take Pantoprazole Pensa
- if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other medicines that contain proton pump inhibitors.
Warnings and cautions
Talk to your doctor or pharmacist before taking Pantoprazole Pensa:
- if you have severe hepatic impairment.
- if you have been diagnosed with malabsorption of vitamin B12, ie your body has a poor ability to absorb vitamin B12 from food.
- If you are taking atazanavir (for HIV treatment ) while taking pantoprazole, talk to your doctor for special advice.
- If you are taking a medicine containing methotrexate (for the treatment of, for example, cancer or psoriasis ) at the same time as pantoprazole, talk to your doctor. Your doctor may decide to stop your pantoprazole treatment while you are taking methotrexate.
- if you have ever had a skin reaction after treatment with medicine like Pantoprazole 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 Pantoprazole Pensa. Also remember to mention any other side effects, such as joint pain.
Pantoprazole Pensa must not be used by children and adolescents under 18 years of age without a doctor’s prescription.
Contact a doctor if you have or have recently had any of the following symptoms: unjustified weight loss, repeated vomiting, difficulty swallowing, bloody vomiting, you look pale and feeling weak (maybe due to anemia ), you notice blood in your stools or if the stool is dark, severe and/or persistent diarrhea, as a link has been found between Pantoprazole Pensa and a small increase in infectious diarrhea.
Your doctor may perform an examination called an endoscopy to diagnose your condition and/or rule out malignant disease.
If you take Pantoprazole Pensa for a long time, additional risks may occur, such as:
- decreased levels of magnesium in the blood (possible symptoms: fatigue, involuntary muscle movements, confusion, cramps, dizziness, rapid heart rate). Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Talk to your doctor if you have been using this medicine for more than 4 weeks. Your doctor may measure the level of magnesium in your blood using regular blood tests.
Other medicines and Pantoprazole Pensa
Other concomitant medications may affect the efficacy and safety of this medicine. Pantoprazole Pensa may also affect the efficacy and safety of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Remember to tell your doctor that you are being treated with Pantoprazole Pensa if you are prescribed another medicine while you are being treated.
You must consult your physician before starting treatment with Pantoprazole Pensa:
- if you are taking atazanavir used to treat HIV infection
- if you are taking ketoconazole, itraconazole or posaconazole used to treat fungal infections or erlotinib used to treat certain types of cancer, as pantoprazole Pensa may cause these and other medicines to not work properly.
- if you are using blood thinners, such as warfarin or phenprocoumon, it may be necessary to perform blood coagulation tests more often.
- methotrexate (for the treatment of eg cancer or psoriasis ).
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. You should only use this medicine if your doctor thinks that the benefits to you outweigh the risks to the fetus or baby.
Pregnancy
There are no data on the use of pantoprazole in pregnant women.
Breast-feeding
Excretion in breast milk has been reported.
Driving and using machines
If you experience side effects such as dizziness and visual disturbances, do not drive or use machines.
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.
Pantoprazole Pensa contains lactose
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 Pantoprazole Pensa
Always take this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
Method of administration
Take the medicine one hour before a meal without chewing or crushing the tablet. Swallow the tablet whole with a little water.
Dosage
The recommended dose is 1 tablet (20 mg) daily.
If the symptoms have not disappeared after 14 days of treatment, you should consult a doctor, as your problems may have another cause. This is especially important for recurrent problems or swallowing difficulties.
Pantoprazole Pensa must not be used by children and adolescents under 18 years of age without a doctor’s prescription.
If you take more Pantoprazole Pensa 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 Pantoprazole Pensa
If you forget to take a dose, take it as soon as you remember, but not if it is time for your next dose. Do not take a double dose to make up for a forgotten tablet.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, stop taking the tablets and tell your doctor immediately or contact the emergency department at the nearest hospital:
- Severe allergic reaction (rare, may affect up to 1 in 1,000 people ): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (Quincke’s edema/angioedema), severe dizziness with very rapid heartbeat and severe sweating.
- Decreased white blood cell count (rare, may affect up to 1 in 1,000 people ): Pantoprazole Pensa may, in rare cases, affect white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
- Severe skin reactions ( reported, occurring in an unknown number of users): blistering of the skin and rapid deterioration of your general condition, superficial wounds (with light bleeding) in the eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme) and photosensitivity.
- Other serious conditions ( reported, occurring in an unknown number of users): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with pain associated with urinary incontinence and lower back pain ( severe nephritis).
Other side effects are:
- Common (may affect up to 1 in 10 people):
- Benign polyps are in the stomach
- Uncommon (may affect up to 1 in 100 people): headache, dizziness, diarrhea, nausea, vomiting, flatulence, constipation, dry mouth, pain and discomfort in the stomach, skin rash, hives, rash, rash, itching, feeling of weakness, lethargy or general malaise, difficulty sleeping
- Rare (may affect up to 1 in 1,000 people): altered or lack of taste experience, visual disturbances ex. blurred vision, hives, joint pain, muscle aches, weight changes, increased body temperature, high fever, swelling of arms and legs (peripheral edema ), allergic reactions, depression, enlarged breasts in men
- Very rare (may affect up to 1 in 10,000 people):disorientation
- Has been reported (occurs in an unknown number of users): hallucinations, confusion (especially in patients who have previously had such symptoms), decreased sodium content in the blood, rash, possibly joint pain, feeling of tingling, tingling, and crawling, burning or numbness, inflammation of the colon, which gives rise to persistent watery diarrhea.
Side effects identified by blood tests:
- Uncommon (may affect up to 1 in 100 people): an increase in liver enzymes
- Rare (may affect up to 1 in 1,000 people): an increase in bilirubin, higher levels of blood fats
- Very rare (may affect up to 1 in 10,000 people): a decrease in the number of platelets which can lead to you bleeding more or more easily getting bruises, a decrease in the number of white blood cells which can lead to more infection, while an abnormal reduction in the number of red and white blood cells and platelets
How to store Pantoprazole Pensa
Keep this medicine out of the sight and reach of children.
Plastic jar: No special temperature instructions. Close the jar tightly. Moisture sensitive.
Blister: Do not store above 30 ° C. Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that 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 pantoprazole. Each enteric- containing tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate).
- Other ingredients are Tablet core: microcrystalline cellulose (E 460i), lactose monohydrate, croscarmellose sodium, colloidal anhydrous silica, vegetable magnesium stearate. Tablet coating: methacrylic acid-ethyl acrylate copolymer, triethyl citrate (E 1505), talc (E 553b), Opadry II 85F32081 yellow (partially hydrolyzed polyvinyl alcohol, macrogol, titanium dioxide (E 171), talc (E – 553b), yellow iron oxide (E 172), (E-104)).
What the medicine looks like and the contents of the pack
Appearance:
Enter tablet one is a coated, yellow, oval tablet, about 9 mm long.
Pack sizes:
Plastic jars with screw caps containing drying capsules: 14 enteric tablets.
Aluminum / Aluminum foil blister: 14 enteric tablets are
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Pensa Pharma AB
Norrlandsgatan 10
111 43 Stockholm
08-440 37 30
Manufacturer:
Towa Pharmaceutical Europe SL
C / de Sant Martí 75-97,
Martortelles
08107 Barcelona, Spain