20 mg enteric-tablet is
pantoprazole
What Pantoprazole Krka is and what it is used for
Pantoprazole Krka is a selective proton pump inhibitor that reduces the amount of acid formed in your stomach. It is used to treat acid-related diseases of the stomach and intestines.
Pantoprazole Krka 20 mg enteric-tablet is used for:
Adults and children over 12 years:
- treatment of symptoms (eg heartburn, acid reflux, pain when swallowing) in connection with diseases of the esophagus caused by reflux of acid from the stomach.
- long-term treatment and preventive treatment of reflux esophagitis (esophageal inflammation accompanied by acid reflux).
Adults:
- preventive treatment of ulcers in the duodenum and in the stomach caused by non-steroidal anti-inflammatory drugs (so-called NSAIDs such as ibuprofen ) in patients at risk who need this type of drug continuously
Pantoprazole contained in Pantoprazole Krka 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 using Pantoprazole Krka
Do not use Pantoprazole Krka
- if you are allergic to pantoprazole, sorbitol, 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 Krka.
- If you have severe liver problems. Tell your doctor if you have ever had problems with your liver. Your doctor will then check your liver enzymes more often, especially if you are taking Pantoprazole Krka as a long-term treatment. If liver enzymes increase, treatment should be discontinued.
- If you need to take so-called NSAIDs (for eg inflammation and pain) regularly and receive Pantoprazole Krka because you have an increased risk of stomach or intestinal complications. Any increased risk will be investigated about your risk factors such as your age (over 65 years), previous ulcers in the stomach or duodenum, or bleeding in the stomach or intestines.
- If you have a reduced ability to store vitamin B12 in your body or risk factors for reduced vitamin B12 and receive pantoprazole as a long-term treatment. As with any acid-lowering drug, pantoprazole may lead to reduced absorption of vitamin B12.
- If you are taking HIV protease inhibitors at the same time as pantoprazole, e.g. atazanavir (for the treatment of HIV infection ), you should talk to your doctor for special advice.
- Using proton pump inhibitors such as Pantoprazole Krka and especially if you use Pantoprazole Krka for more than a year, may increase the risk of 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 use Pantoprazole Krka 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, 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.
- If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Krka 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 Pantoprazole Krka. Also remember to mention any other side effects, such as joint pain.
- If you are going to have a specific blood test (chromogranin A)
Contact your doctor immediately if you notice any of the following symptoms:
- unjustified weight loss
- vomiting, especially if it happens repeatedly
- bloody vomiting, can look like coffee grounds in the vomit
- bloody stools, which then look black or tar-like
- difficulty swallowing or pain when swallowing
- you look pale and feel weak (which may be due to anemia )
- chest pain
- magnet
- severe and/or persistent diarrhea, when a link has been found between Pantoprazole Krka and a small increase in infectious diarrhea
Your doctor may decide that you need to undergo some tests to rule out serious illness as pantoprazole may also relieve the symptoms of cancer and could delay such a diagnosis. If your symptoms persist despite your treatment, further examinations should be considered.
If you are taking Pantoprazole Krka as a long-term treatment (longer than 1 year), your doctor will probably call you for regular check-ups. You should tell your doctor about new and unusual symptoms and illnesses.
Children and young people
These tablets are not recommended for children under 12 years.
Other medicines and Pantoprazole Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pantoprazole Krka can affect the effectiveness of other medicines, so tell your doctor if you are taking:
- medicines such as ketoconazole, itraconazole, and posaconazole (for the treatment of fungal infections) or erlotinib (for the treatment of certain cancers), as Pantoprazole Krka may cause these and other medicines to malfunction.
- warfarin or phenprocoumon affects the thickness of the blood. You may need additional controls.
- drugs for the treatment of HIV infection such as atazanavir.
- methotrexate (for the treatment of rheumatism, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop your treatment with Pantoprazole Krka as pantoprazole may increase the level of methotrexate in your blood.
- fluvoxamine (for the treatment of depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce the dose one.
- rifampicin (for the treatment of infections ).
- St. John’s wort ( Hypericum perforatum ) (for the treatment of depression).
Pantoprazole Krka with food, drink, and alcohol
Take the tablets 1 hour before a meal. Swallow the tablets whole with water, without chewing or dividing them.
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.
There are no data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported. You should only use this medicine if your doctor considers that the benefits to you outweigh the risks to the fetus or baby.
Driving and using machines
Pantoprazole Krka has no or negligible effect on the ability to drive and use machines.
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.
If you experience side effects such as dizziness and visual disturbances, do not drive or use machines.
Pantoprazole Krka contains sorbitol and sodium
This medicine contains 18 mg of sorbitol per tablet.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Pantoprazole Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
When and how to take Pantoprazole Krka?
Take the medicine one hour before a meal without chewing or crushing the tablet. Swallow the tablet whole with a little water.
Unless your doctor tells you otherwise, the recommended dose is:
Adults and adolescents over 12 years:
For the treatment of symptoms (eg heartburn, acid reflux, and pain when swallowing) in connection with mild forms of esophageal disorders caused by reflux of acid from the stomach:
The recommended dose is one tablet daily. This dose usually provides relief within 2-4 weeks, sometimes an additional 4 weeks of treatment is needed. Your doctor will tell you how long to take the medicine. Thereafter, recurrent symptoms can be controlled by taking one tablet daily as needed.
For long-term treatment and to prevent the recurrence of reflux esophagitis :
The recommended dose is one tablet per day.
If the disease returns, your doctor may double the dose and you can then use Pantoprazole Krka 40 mg tablets instead. After healing, you can reduce the dose one to one tablet of 20 mg per day.
Adults:
To prevent duodenal ulcers in patients who need NSAIDs regularly:
The usual dose is one tablet a day.
Special patient groups:
If you have severe liver problems, do not take more than one 20 mg tablet per day.
Use for children and adolescents
Children under 12 years:
These tablets are not recommended for children under 12 years
If you use more Pantoprazole Krka than you should
If you have ingested too much medicine, or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice. There are no known symptoms of overdose.
If you forget to use Pantoprazole Krka
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
If you stop using Pantoprazole Krka
Do not stop taking these tablets without first talking to a doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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: frequency: rare (may affect up to 1 in 1,000 people):
- swelling of the tongue and/or throat
- difficulty swallowing
- hives
- breathing difficulties
- allergic facial swelling (Quincke’s edema/angioedema)
- severe dizziness with the very fast heartbeat and heavy sweating
Severe skin reactions: frequency: has been reported (occurs 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, and multiform erythema )
- photosensitivity.
Other serious conditions: frequency: has been reported (occurs in an unknown number of users):
- yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice)
- fever
- rash
- enlarged kidneys sometimes with pain associated with urinary incontinence and pain in the lower back (severe kidney inflammation that can lead to kidney failure ).
If you use Pantoprazole Krka 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.
Frequency: rare (may affect up to 1 in 1,000 people):
- the sharp reduction in the number of white blood cells, which increases the risk of infection. Report any symptoms of sudden fever, sore throat, and extreme fatigue as this may be a sign of infection.
Frequency: very rare (may affect up to 1 in 10,000 people):
- a reduction in the number of platelets which can lead to you bleeding more or getting bruises more easily. Report any unexplained bruising or bleeding to your doctor.
Other side effects are:
Common (may affect up to 1 in 10 people):
- benign polyps in the stomach
Uncommon (may affect up to 1 in 100 people):
- headache
- dizziness
- diarrhea
- nausea, vomiting
- weather voltage
- constipation
- dry mouth
- pain and discomfort in the stomach
- rash, hives, rash
- itching
- hip, wrist, or vertebral fractures
- a feeling of weakness, lethargy, or general malaise
- difficulty sleeping
Rare (may affect up to 1 in 1,000 people):
- visual disturbances such as blurred vision
- hives
- joint pain
- muscle aches
- weight changes
- elevated body temperature
- swelling of the arms and legs (peripheral edema )
- allergic reactions
- Depression
- enlarged breasts in men
- changed taste experience
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
- decreased levels of calcium in the blood
- decreased levels of potassium in the blood
- a feeling of tingling, tingling, and crawling, burning, or numbness
- inflammation of the colon, which gives rise to persistent watery diarrhea
- muscle cramps
- skin rash, possibly with joint pain
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 reduction in the number of white blood cells which can lead to more infections you
- a sharp decrease in blood cells which can lead to weakness, bruising, or increase the risk of infection
How to store Pantoprazole Krka
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 after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Blister: Store in the original package. Moisture sensitive.
Jar: Close the jar tightly. Moisture sensitive.
The shelf life of broken packaging is 3 months.
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).
The other ingredients are mannitol, crospovidone (type A, type B), sodium carbonate, sorbitol (E420), calcium stearate in the tablet core and hypromellose, povidone (K25), titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, methacrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the film coating. See section 2 “Pantoprazole Krka contains sorbitol and sodium”.
What the medicine looks like and the contents of the pack
20 mg entero-tablet is a light yellow-brown, oval, slightly biconvex tablet.
Pack sizes:
Cartons containing 7, 14, 15, 20, 28, 30, 50, 50 x 1, 56, 60, 84, 90, 98, 100, 100×1, 112 and 140 enteric tablets in blister cards.
A plastic jar containing 100 or 250 enteric tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer:
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße, 5, 27472 Cuxhaven, Germany