20 mg enteric-tablet is
pantoprazole
What Pantoprazole Actavis is and what it is used for
Pantoprazole Actavis contains the active substance pantoprazole.
Pantoprazole Actavis 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 Actavis is used to treat adults and children over 12 years of age
- in the 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.
- as long-term treatment and preventive treatment of reflux esophagitis (esophageal inflammation accompanied by acid reflux).
Pantoprazole Actavis is used to treat adults
- as a preventive treatment for 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 Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you take Pantoprazole Actavis
Do not take Pantoprazole Actavis
- 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, pharmacist, or nurse before taking Pantoprazole Actavis
- if you have severe liver problems. Tell your doctor if you have ever had problems with your liver before. Your doctor will then check your liver enzymes more often, especially if you are taking Pantoprazole Actavis 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 Actavis 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 long-term treatment with pantoprazole. 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.
- Use of proton pump inhibitors such as pantoprazole and especially if you use pantoprazole 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 have been told that you are at risk for osteoporosis (eg if you are taking medicines called corticosteroids ).
- if you use pantoprazole for more than three months, your blood manganese 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 medicine like Pantoprazole Actavis 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 Actavis. 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, during or after treatment, if you notice any of the following symptoms. These could be signs of another, more serious, medical condition.
- 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, 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 Actavis 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
Pantoprazole Actavis is not recommended for use in children below 12 years of age due to a lack of data in this age group.
Other medicines and Pantoprazole Actavis
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 Actavis can affect the way other medicines work, 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 Actavis may cause these and other medicines to malfunction.
- warfarin and phenprocoumon which affect the thickness of the blood. You may need additional controls.
- drugs for the treatment of HIV infection, such as atazanavir.
- methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily stop your treatment with Pantoprazole Actavis as pantoprazole may increase methotrexate levels 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 mild depression).
Pregnancy and breastfeeding
There are no data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported.
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.
Driving and using machines
Pantoprazole Actavis has no or negligible effect on 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.
Pantoprazole Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Pantoprazole Actavis
Always take this medicine exactly as your doctor or pharmacist has told you. 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.
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 problems 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 reflux oesophagitis from recurring
The recommended dose is one tablet daily. If the disease returns, your doctor may double the dose and you can then use Pantoprazole Actavis 40 mg tablets instead, one tablet daily. After healing, you can reduce the dose one to one tablet of 20 mg per day.
Adults
To prevent duodenal ulcers one in patients who need NSAIDs regularly
The recommended dose is one tablet daily.
Patients with renal impairment
If you have severe liver problems, do not take more than one 20 mg tablet per day.
Children and young people
These tablets are not recommended for children under 12 years.
If you take more Pantoprazole Actavis than you should
Contact a doctor or pharmacist. There are no known symptoms of overdose.
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 Actavis
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
If you stop taking Pantoprazole Actavis
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 (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 heavy sweating.
- Severe skin reactions (reported; occurs in unknown numbers of users): you may notice one or more of the following symptoms: blistering of the skin and rapid deterioration of your general condition, superficial sores (with light bleeding) in the eyes, nose, mouth/lips or genitals, or sensitive skin/rash, especially on skin areas exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (eg in the armpits), and blood tests may show changes in certain white blood cells or liver enzymes (Steven-Johnson syndrome, Lyell’s syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
- Other serious conditions (reported; occurs in unknown numbers 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, which 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 ): headache, dizziness, diarrhea, nausea, vomiting, flatulence, constipation, dry mouth, pain and discomfort in the stomach, rash, hives, rash, itching, feeling of weakness, lethargy, or general malaise, difficulty sleeping, hip, wrist or vertebral fractures.
- Rare ( may affect up to 1 in 1,000 people ): distortion or total lack of taste, visual disturbances such as 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), feeling of tingling, tingling, and crawling, burning or numbness; muscle spasm due to electrolyte disturbances (change in salt levels in the body), 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: high fever associated with a sharp decrease in circulating granular white blood cells.
- Very rare ( may affect up to 1 in 10,000 people): a decrease in the number of platelets which may cause you to bleed more or more easily get bruises, a decrease in the number of white blood cells which may lead to more infections: concomitant abnormal reduction of the number of red and white blood cells as well as platelets, which can cause fatigue, shortness of breath and pallor.
- Has been reported (occurs in an unknown number of users): decreased amount of sodium, magnesium, calcium, or potassium in the blood (see section 2).
How to store Pantoprazole Actavis
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 the jar after EXP. The expiration date is the last day of the specified month.
HDPE can: Do not store above 30 ° C.
Blister packs: No special storage instructions.
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. One tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
– The other ingredients are:
Tablet core:
mannitol
sodium carbonate
sodium starch glycolate (type A)
butylated methacrylate copolymer, basic (Eudragit E PO)
calcium stearate
hypromellose
titanium dioxide (E171)
talc
macrogol 400
sodium lauryl sulfate
Drag:
methacrylic acid-ethyl acrylate copolymer dispersion
propylene glycol
yellow iron oxide (E172)
titanium dioxide (E171)
talc
What the medicine looks like and the contents of the pack
Elliptical, biconvex, slightly yellow enteric tablet.
Pack sizes:
Blisters: 7, 14, 15, 20, 28, 30, 56, 60, 98, 100 tablets and 10 x 14 tablets (for hospital use).
HDPE jar: 30, 100, 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland