20 mg enteric-tablet is
pantoprazole
What Pantoprazole Mylan is and what it is used for
Pantoprazole Mylan 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 Mylan is used for:
Adults and children over 12 years:
- treatment of 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 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 at-risk patients who need this type of drug continuously.
Pantoprazole contained in Pantoprazole Mylan 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 Mylan
Do not take Pantoprazole Mylan:
- 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 Mylan:
- 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 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 because you have an increased risk of gastrointestinal complications. Any increased risk will be investigated about your personal 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 atazanavir (for HIV treatment ) while taking pantoprazole, talk to your doctor for special advice.
- if you have ever had a skin reaction after treatment with medicine like Pantoprazole Mylan that reduces stomach acid.
- if you are going to have a specific blood test (chromogranin A).
Contact your doctor immediately if you notice any of the following symptoms:
- unintentional weight loss
- repeated vomiting
- difficulty swallowing
- bloody vomiting
- you look pale and feel weak ( anemia )
- you note blood in the stool
- severe and/or persistent diarrhea, when a link has been found between pantoprazole and a small increase in infectious diarrhea
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 Mylan. Also remember to mention any other side effects, such as joint pain.
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 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.
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 are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
Other medicines and Pantoprazole Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Pantoprazole Mylan may be effective.
- Medicines such as ketoconazole, itraconazole, and posaconazole (for the treatment of fungal infections) or erlotinib (for the treatment of certain cancers) as pantoprazole may cause these and other similar medicines to not work properly.
- Warfarin and phenprocoumon which affect the consistency of the blood. You may need additional controls.
- Atazanavir (for the treatment of HIV infection ) (see section 2 Warnings and precautions).
- Methotrexate (for the treatment of rheumatoid arthritis, psoriasis, and cancer) as pantoprazole may increase the levels of methotrexate in the 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
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 Mylan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take Pantoprazole Mylan
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 Mylan?
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 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 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 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 and gastric ulcers in patients who need NSAIDs regularly:
The recommended dose is one tablet per day.
Special patient groups:
- If you have severe liver problems, do not take more than one 20 mg tablet per day.
- Children under 12 years of age: These tablets are not recommended for children under 12 years of age.
If you take more Pantoprazole Mylan than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
There are no known symptoms of overdose.
If you forget to take Pantoprazole Mylan
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
If you stop taking Pantoprazole Mylan
Do not stop taking the medicine without first discussing it with your 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:
Rare (may affect up to 1 in 1,000 people):
- Severe allergic reaction: 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.
- A reduction in the number of white and red blood cells and/or platelets , can be seen in blood tests. You may notice an increased incidence of infection, or that you get more bruises or bleed more than normal.
Has been reported (occurs in an unknown number of users):
- Severe skin reactions: 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, multiforme erythema), skin rash, possibly with joint pain and photosensitivity.
- Other serious conditions: 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 pain in the lower back (severe kidney inflammation that can lead to kidney failure ). Inflammation of the colon causes persistent watery diarrhea. If you use pantoprazole for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, states of ambiguity in time and space, 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.
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 stomach discomfort, skin rash, hives, rash, itching, lethargy or general malaise, insomnia, hip, wrist, or vertebral fractures. - Rare (may affect up to 1 in 1000 people):
altered sense of taste or total loss of taste, visual disturbances ex. blurred vision, hives, joint pain, muscle aches, weight changes, increased body temperature, swelling of the arms and legs (peripheral edema ), depression, and enlarged breasts in men. - Has been reported (occurs in an unknown number of users):
hallucinations, confusion (especially in patients who have previously had such symptoms), tingling, and numbness.
Side effects identified by blood tests:
- Uncommon (may affect up to 1 in 100 people): higher levels of liver enzymes.
- Rare (may affect up to 1 in 1,000 people): increase in bilirubin, higher levels of blood fats.
- Has been reported (occurs in an unknown number of users): decreased sodium content in the blood.
How to store Pantoprazole Mylan
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 package after EXP. The expiration date is the last day of the specified month.
For blisters: No special storage instructions.
For plastic cans: The contents of opened plastic cans must be consumed within 100 days. Close the jar tightly. Moisture sensitive.
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 sodium sesquihydrate equivalent to 20 mg pantoprazole.
- The other ingredients are anhydrous sodium carbonate, mannitol, crospovidone, povidone, and calcium stearate. The tablet coating contains methacrylic acid-ethyl acrylate copolymer (1: 1), sodium lauryl sulfate, polysorbate 80, triethyl citrate, hypromellose, titanium dioxide, macrogol 400, and yellow iron oxide.
What the medicine looks like and the contents of the pack
The tablets are dark yellow, film-coated, oblong, approximately 4.3 mm x 8.4 mm, biconvex and unmarked. Pantoprazole Mylan is available in plastic jars and blister packs.
HDPE plastic jars with screw caps containing 14, 28, 30, 50, 56, 60, 90, 98, 100 and 250 enteric tablets . The jar also contains a small plastic container with silica gel, or a bag with silica gel and activated carbon, which protects the tablets from moisture.
The container or bag cannot be eaten and should not be removed from the jar.
Cartons of blister packs of aluminum with or without a layer of desiccant containing 7, 14, 14 x 1, 28, 28 x 1, 30, 56, 70, 70 x 1, 96, and 98 enteric tablets .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer:
Gerard Laboratories, 35/36, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
Mylan Germany GmbH
Branch release Bad Homburg vd Höhe
Benzstrasse 1, 61352 Bad Homburg vd Höhe, Germany
Logiters, Logistica Portugal, SA
Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal