Pantoprazom Orion 20 mg enteric tablets
pantoprazole
What Pantoprazole Orion is and what it is used for
Pantoprazole Orion contains the active substance pantoprazole. Pantoprazole 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 Orion is used to treating
- adults and children over 12 years
- symptoms (eg heartburn, acid reflux, pain when swallowing) associated with diseases of the esophagus caused by reflux of acid from the stomach
- long-term treatment and prevention of recurrence 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 at-risk patients who need this type of drug continuously. Pantoprazole contained in Pantoprazole Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pantoprazole Orion
Do not use Pantoprazole Orion
Do not take Pantoprazole Orion
- 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 Orion
- 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 Orion as a long-term treatment. If liver enzymes increase, treatment should be discontinued.
- if you need to take so-called NSAIDs (for example for inflammation and pain) regularly and receive Pantoprazole Orion 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 B 12 in your body or risk factors for reduced vitamin B 12 and receive pantoprazole as a long-term treatment. As with any acid-lowering drug, pantoprazole may lead to reduced absorption of vitamin B 12.
- 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.
- use of proton pump inhibitors such as pantoprazole and especially over more than one 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 use Pantoprazole Orion for more than three months, the amount of magnesium in your blood may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, states of uncertainty about time and space, cramps, dizziness, or 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 need to check your blood magnesium level with regular blood tests.
- if you have ever had a skin reaction after treatment with medicine like Pantoprazole Orion which 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 Orion. Also remember to mention any other side effects, such as joint pain.
- if you are going to have a specific blood test (chromogranin A).
Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be a sign of another, more serious illness.
- unintentional weight loss
- vomiting, especially if it happens repeatedly
- bloody vomiting, it may look like dark, ground coffee in the vomit
- you notice blood in the stool, which may have a black or tar-like appearance
- difficulty swallowing or pain when swallowing
- you look pale and feel weak ( anemia )
- chest pain
- abdominal pain
- severe and/or persistent diarrhea, as a link has been found between this drug 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 Orion as a long-term treatment (longer than 1 year), your doctor will probably call you for regular check-ups. At each doctor’s visit, you should tell about new and unusual symptoms and disease events.
Children and young people
Pantoprazole Orion is not recommended for use in children due to a lack of data on safety and efficacy in children under 12 years of age.
Other medicines and Pantoprazole Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is because Pantoprazole Orion may affect the effectiveness of other medicines:
- medicines such as ketoconazole, itraconazole, and posaconazole (for the treatment of fungal infections) or erlotinib (for the treatment of certain cancers) as Pantoprazole Orion may cause these and other medicines to not work properly
- warfarin and phenprocoumon which have a thinning or thickening effect on 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 Orion as pantoprazole may increase the amount 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 by
- rifampicin (for the treatment of infections )
- St. John’s wort ( Hypericum perforatum) (for the treatment of depression).
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.
There are only a limited amount of data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported.
You should only use this medicine during pregnancy and breastfeeding if your doctor considers that the benefits to you outweigh the potential risk to the fetus or baby.
Driving and using machines
Driving and using machines
Pantoprazole Orion is not expected to affect the ability to drive and use 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.
Ingredients
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Pantoprazole Orion
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults and adolescents over 12 years
- For the treatment of symptoms (eg heartburn, acid reflux, and pain when swallowing) in connection with esophageal disorders caused by reflux of acid from the stomach
The recommended dose is one 20 mg 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 reflux oesophagitis from recurring
The recommended dose is one 20 mg tablet daily. If the disease returns, your doctor may double the dose and you can use 40 mg tablets instead, one tablet daily. When the symptoms have disappeared, you can reduce the dose one to one tablet of 20 mg per day.
Adults
- To prevent ulcers in the stomach and duodenum one in patients who need to take NSAIDs regularly.
The recommended dose is one 20 mg tablet daily.
Use for children and adolescents
These tablets are not recommended for children under 12 years.
Patients with kidney problems
If you have kidney problems, do not take Pantoprazole Orion against the bacterium Helicobacter pylori.
Patients with liver problems
If you have severe liver problems, do not take more than one 20 mg tablet per day.
If you have moderate to severe liver problems, do not take Pantoprazole Orion against the bacterium Helicobacter pylori.
How to take Pantoprazole Orion
Take the tablet one hour before a meal without chewing or crushing it. Swallow the tablet whole with water.
If you use more Pantoprazole Orion 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, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.
There are no known symptoms of overdose.
If you forget to use Pantoprazole Orion
Do not take a double dose to make up for a forgotten tablet. Take the next normal dose at the usual time.
If you stop using Pantoprazole Orion
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.
Tell a doctor immediately or contact the emergency department at the nearest hospital if you get any of the following serious side effects. Stop taking the medicine immediately, but take this leaflet and/or tablets with you.
- Severe allergic reactions (rare: may affect up to 1 in 1,000 people ): swelling of the tongue and/or throat, difficulty swallowing or difficulty breathing, hives, allergic swelling of the face (Quincke’s edema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating.
- Severe skin reactions (reported: occurs in an unknown number of users ): blistering of the skin and rapid deterioration of your general condition, superficial sores (with light bleeding) in eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme) and photosensitivity.
- Other serious reactions (Reported: occurs 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). This can lead to kidney failure.
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 ):
- difficulty sleeping, headache, dizziness, diarrhea, nausea, vomiting, bloating and flatulence, constipation, dry mouth, stomach pain and discomfort, skin rash, exanthema (uniform rash/dots), sore rash (eruption), itching, hip, wrist or vertebral fracture, a sensation of weakness or fatigue or general malaise.
Rare ( may affect up to 1 in 1,000 people ):
- weight changes, depression, altered or lack of taste experience, visual disturbances such as blurred vision, hives, joint pain, muscle aches, enlarged breasts in men, elevated body temperature, high fever, swelling of arms and legs (peripheral edema ), allergic reactions.
Very rare ( may affect up to 1 in 10,000 people ):
- state of uncertainty about time and space (disorientation).
Has been reported ( occurs in an unknown number of users ):
- decreased amount of sodium in the blood, decreased amount of magnesium in the blood (see section 2 Warnings and precautions), hallucinations, confusion (especially in patients who have previously had these symptoms), crawling, tingling, numbness or burning sensation, inflammation of the colon, which gives rise to persistent watery diarrhea, 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, and high fever are associated with a sharp decrease in granulocytes (a type of white blood cell ) in the blood.
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 more easily getting bruises, a reduction in the number of white blood cells which can lead to more infections, while an abnormal reduction in the number of red and white blood cells and platelets.
How to store Pantoprazole Orion
Do not store above 30 ° C.
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 label, carton, or blister. 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 pantoprazole. Each tablet contains pantoprazole sodium sesquihydrate equivalent to 20 mg pantoprazole.
- The other ingredients are tablet core: mannitol (E421), crospovidone, sodium carbonate, hydroxypropylcellulose, calcium stearate coating: methacrylic acid-ethyl acrylate copolymer (1: 1), hypromellose, triethyl citrate, yellow iron oxide
What the medicine looks like and the contents of the pack
Enterotablett.
Light yellow, oval, biconvex tablets, 8.7 mm x 4.5 mm.
Pack sizes:
7, 14, 15, 28, 30, 56, 60, 98, 100 and 500 enteric tablets in blister packs.
14, 56, 60, 98, 100, 280 and 500 enteric tablets in a plastic jar.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd, medinfo@orionpharma.com