15 mg orodispersible tablets. 30 mg orodispersible tablets.
lansoprazole
What Lansoprazole Mylan is and what it is used for
The active substance in Lansoprazole Mylan is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced in the stomach.
Your doctor may prescribe Lansoprazole Mylan for the following:
- treatment of duodenal and gastric ulcers
- treatment of inflammation of the esophagus ( reflux esophagitis )
- prevention of reflux oesophagitis
- treatment of heartburn and acid reflux
- Treatment of infection is caused by the bacterium Helicobacter pylori when given with antibiotics
- treatment or prevention of duodenal or gastric ulcer in patients requiring continued NSAID therapy ( NSAID therapy is used for pain or inflammation )
- treatment of Zollinger-Ellison syndrome
Lansoprazole contained in Lansoprazole Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Lansoprazole Mylan
Do not take Lansoprazole Mylan:
- if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Lansoprazole Mylan if:
- you have liver problems. Your doctor may need to adjust your dose .
- you have ever had a skin reaction after treatment with a drug similar to lansoprazole that reduces stomach acid.
- you must undergo a specific blood test (chromogranin A)
- You have low levels of vitamin B12 or risk factors for low levels of vitamin B12 and are on long-term treatment with this medicine. As with all antacids, medication with Lansoprazol Mylan may reduce vitamin B12 uptake .
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 lansoprazole. Also remember to mention any other side effects, such as joint pain.
If your doctor has prescribed you Lansoprazol Mylan in addition to other medicines for the treatment of an infection caused by the bacterium Helicobacter pylori ( antibiotics ) or together with anti-inflammatory medicines for the treatment of pain or rheumatic disease, also read the package leaflets for these medicines carefully.
Your doctor may or may have done another test called an endoscopy to diagnose your disease and/or rule out malignant disease.
If you take Lansoprazole Mylan for more than three months, the magnesium levels in your blood may become very low. If you become very tired, confused, dizzy, or have muscle twitching, cramps, or increased heart rate, contact your doctor immediately as the magnesium levels in your blood may be below (see section 4 “Possible side effects”). Your doctor may measure the level of magnesium in your blood regularly.
The use of proton pump inhibitors such as Lansoprazole Mylan, and especially when used for more than a year, may increase the risk of hip, wrist, or vertebral fractures (bone fractures). Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids s ( cortisone ) because they may increase the risk of osteoporosis.
If you are taking Lansoprazole Mylan for a long time (longer than 1 year), your doctor will probably check you regularly. You should report any new and unusual symptoms and details when you see your doctor.
During treatment
If diarrhea occurs during treatment with Lansoprazole Mylan, you should contact your doctor immediately, as lansoprazole has been associated with a slightly increased incidence of infectious diarrhea.
Other medicines and Lansoprazole Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking medicines that contain any of the following:
- HIV – protease inhibitors such as atazanavir or nelfinavir (used to treat HIV )
- methotrexate (used to treat autoimmune diseases and cancer)
- ketoconazole (used to treat Cushing’s syndrome – when the body produces an excess of cortisol )
- itraconazole (used to treat fungal infections)
- rifampicin (used to treat tuberculosis )
- digoxin (used to treat heart problems)
- warfarin (used to treat blood clots)
- theophylline (used to treat asthma )
- tacrolimus (used to prevent transplant rejection )
- fluvoxamine (used to treat depression and other psychiatric conditions)
- antacids (used to treat heartburn or acid reflux, such as aluminum hydroxide or magnesium carbonate)
- sucralfate (used to heal stomach ulcers )
- St. John’s wort ( Hypericum perforatum ) (used to treat mild depression).
Pregnancy and breastfeeding
The use of Lansoprazole Mylan during pregnancy is not recommended as information is lacking.
It is unknown whether lansoprazole is excreted in human milk. Discuss with your doctor if you should continue to take this medicine or if you should breastfeed your baby.
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.
Driving and using machines
Side effects such as dizziness, dizziness (a feeling that everything is spinning when sitting or standing still), drowsiness, and vision problems sometimes occur in patients taking Lansoprazole Mylan. If you get such side effects, be careful, as your ability to react may be impaired.
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.
Lansoprazole Mylan contains sucrose, aspartame and sodium
Each 15 mg orodispersible tablet contains 5.97 mg of aspartame per tablet.
Each 30 mg orodispersible tablet contains 11.93 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free.
How to take Lansoprazole Mylan
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dosing one of Lansoprazole Mylan depends on your condition. The recommended dose of Lansoprazole Mylan for adults is listed below. Your doctor will sometimes prescribe a different dose and will tell you how long your treatment should last.
Treatment of heartburn and acid reflux: one 15 mg or 30 mg orodispersible tablet every day for 4 weeks. If symptoms persist, tell your doctor. If symptoms persist within 4 weeks, consult a physician.
Treatment of duodenal ulcers: one 30 mg orodispersible tablet every day for 2 weeks.
Treatment of ulcers in the stomach: one 30 mg orodispersible tablet every day for 4 weeks.
Treatment of inflammation of the esophagus ( reflux esophagitis ): one 30 mg orodispersible tablet every day for 4 weeks.
Long-term prevention of reflux oesophagitis: one 15 mg orodispersible tablet daily, the doctor may adjust the dose one to one 30 mg tablet daily.
Treatment of infection caused by Helicobacter pylori: The recommended dose is one 30 mg orodispersible tablet in combination with two different antibiotics in the morning and one 30 mg orodispersible tablet in combination with two different antibiotics in the evening. The treatment usually lasts every day for 7 days.
Recommended combinations of antibiotics are:
30 mg Lansoprazole Mylan together with 250-500 mg clarithromycin and 1,000 mg amoxicillin.
30 mg Lansoprazole Mylan tablet together with 250 mg clarithromycin and 400-500 mg metronidazole.
If you are being treated for infection because you have a stomach ulcer, it is unlikely that the stomach ulcer will return if the treatment of the infection is successful. For the medicine to work best, you should take it at the right time and not miss a dose.
Treatment of ulcers in duodenum one or stomach of patients who require continued NSAID treatment: one 30 mg orodispersible tablet every day for 4 weeks.
F PREVENTIVE of ulcers in duodenum one or stomach of patients who require continued NSAID treatment: one 15 mg orodispersible tablet every day, the physician may adjust the dose of one to 30 mg orodispersible tablet every day.
Zollinger-Ellison syndrome: The recommended dose is two 30 mg orodispersible tablets each day, to begin with, then depending on how you respond to Lansoprazole Mylan, your doctor will decide which dose is best for you.
Use in patients with liver problems
If you have moderate or severe liver problems, your doctor may give you half of the recommended dose.
Use for the elderly
If you are older, your doctor may give you a dose that is lower than the recommended dose. The highest recommended dose for elderly patients is 30 mg per day.
Use for children
Lansoprazole Mylan should not be given to children.
How to take the medicine
For best results with this medicine, you should take Lansoprazole Mylan at least 30 minutes before eating.
If you are taking Lansoprazole Mylan once a day, try to take the medicine at the same time each day. You can get the best results if you take Lansoprazole Mylan immediately in the morning.
If you are taking Lansoprazole Mylan twice a day, you should take the first dose one in the morning and the second dose one in the evening.
Lansoprazole Mylan breaks down easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may then dissolve.
For perforated blisters, hold the blister card by the edges and separate one blister unit from the rest of the card by gently tearing along the perforation.
Carefully pull off the underside. For non-perforated blisters, be careful not to peel off the underside of nearby tablets.
Gently push out the tablet.
4. Put the tablet in your mouth. It will dissolve directly in the mouth, making it easier to swallow. You can also swallow the tablet whole with a glass of water.
Your doctor may instruct you to take the tablet with a syringe if you have severe difficulty swallowing.
If you use a syringe:
- Pull the plunger out of the syringe (use a syringe of at least 5 ml for a 15 mg tablet and at least 10 ml for a 30 mg tablet)
- Place the tablet in the syringe barrel
- Put the plunger back in the syringe
- For the 15 mg tablet: Draw 4 ml of tap water into the syringe
- For the 30 mg tablet: Drain 10 ml of tap water into the syringe
- Turn the syringe upside down and draw in 1 ml of air
- Gently shake the syringe for 10-20 seconds until the tablet is dissolved
- The contents can be emptied directly into the mouth
- Refill the syringe with 2–5 ml of tap water to flush the residue out of the syringe into the mouth.
- Repeat the previous step if necessary.
If you are using a nasogastric tube:
The suitability of the syringe and probe must be carefully tested. The recommended diameter of the nasogastric probe is 3.3 mm (10 French Units) or larger.
- Pull the plunger out of the syringe (use a syringe of at least 25 ml for a 15 mg tablet and at least 50 ml for a 30 mg tablet)
- Place the tablet in the syringe barrel
- Put the plunger back in the syringe
- For the 15 mg tablet: Draw 10 ml of tap water into the syringe
- For the 30 mg tablet: Draw 25 ml of tap water into the syringe
- Turn the syringe upside down and draw in 5 ml of air
- Gently shake the syringe for 10-20 seconds until the tablet is dissolved
- Connect the syringe to the probe and empty the contents of the syringe into the nasogastric probe.
- For the 15 mg tablet: Refill the syringe with 10 ml of tap water and empty the contents of the syringe into the tube
- For the 30 mg tablet: Refill the syringe with 25 ml of tap water and empty the syringe contents into the probe.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you think you have any of the following side effects, stop taking this medicine and contact your doctor or see your nearest hospital emergency department immediately.
- An increased incidence of infection causes fever, severe chills, sore throat and respiratory infections. These may be signs of a low white blood cell count ( leukopenia – uncommon, may affect up to 1 in 100 people)
- You may also experience fatigue, cold hands and feet, and pale skin with unexplained bruising or abnormally prolonged bleeding. These can be signs of a sharp decrease in all types of blood cells (pancytopenia – very rare, may occur in up to 1 in 10,000 users)
- A sudden onset of pain in the upper abdomen. The pain may move to your back and may worsen after you eat. This may be a sign of inflammation of the pancreas (rare, may affect up to 1 in 1,000 people)
- Yellowing of the skin or whites of the eyes, loss of appetite, nausea, light stools or dark urine. These can be signs of severe liver problems (rare, may affect up to 1 in 1,000 people)
- Swelling of the face, lips, tongue or throat, which causes difficulty swallowing or breathing, fever, rash commonly known as hives , swelling and sometimes a rapid drop in blood pressure. These may be signs of severe allergic reactions including anaphylactic shock (rare, may affect up to 1 in 1,000 people)
- Little or no urine production, cloudy urine or blood in the urine, pain when urinating or pain in the lower back. These may be signs of severe kidney problems (rare, may affect up to 1 in 1,000 people)
- Skin redness, blistering, severe inflammation or scaly skin and skin waste. These can be signs of serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare, may affect up to 1 in 10,000 users)
- Severe or persistent diarrhea. Tell your doctor about this side effect as this medicine has been linked to a slight increase in infectious diarrhea (very rare, may affect up to 1 in 10,000 people)
- Skin rash, possibly with joint pain (no known frequency, can not be calculated from the available data).
Other possible side effects:
Common (may affect up to 1 in 10 people):
- headache, dizziness
- diarrhea, constipation, abdominal pain, nausea or vomiting, gas, dry mouth or throat
- rash, itching
- increased levels of liver enzymes in the blood, which can be detected with blood tests
- fatigue
- benign polyps in the stomach.
Uncommon (may affect up to 1 in 100 people):
- Depression
- joint or muscle pain
- hip, wrist or vertebral fracture (bone fracture)
- fluid retention or swelling
- altered blood cell count .
Rare (may affect up to 1 in 1,000 people):
- fever
- Pain when swallowing or difficulty swallowing with white dots in the back of the throat. These can be signs of a fungal infection in the esophagus
- restlessness, drowsiness
- confusion, experiences of hearing, seeing or feeling things that are not real (hallucinations), sleep problems (insomnia)
- vision problem
- a feeling that everything is spinning when you stand still (dizziness)
- taste changes, loss of appetite, swelling of the tongue ( glossitis )
- skin reactions such as burning or stinging sensation under the skin, bruising, redness and excessive sweating
- photosensitivity of the skin
- hair loss
- ant crawling ( paresthesia ), trembling
- anemia (pallor)
- breast swelling in men, impotence
Very rare (may affect up to 1 in 10,000 people):
- inflammation of the mouth ( stomatitis )
- decreased sodium levels in the blood, elevated levels of cholesterol and other fats in the blood, which can be detected with blood tests.
No known frequency (can not be calculated from the available data):
- visual hallucinations
- if you use Lansoprazole Mylan 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.
How to store Lansoprazole Mylan
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
Jar: Used within 100 days after opening. Close the jar tightly. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the EXP. 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 lansoprazole
- The other ingredients are: sugar spheres, light magnesium subcarbonate (E504), crospovidone (E1202), hydroxypropylcellulose (E463), methacrylic acid-ethyl acrylate copolymer (1: 1), triethyl citrate (E1505), sodium hydroxide (E524b), talc (E524b) (talc) , macrogol, iron oxide red (E172), iron oxide yellow (E172), mannitol (E421), microcrystalline cellulose (E460), sodium starch glycolate, aspartame (E951), sodium lauryl sulphate, sodium bicarbonate (E500), citric acid monohydrate (magnesium). (See section 2 “Lansoprazole Mylan contains sucrose, aspartame and sodium”).
What the medicine looks like and contents of the pack
The drug is in the form of orodispersible tablets (in solid form to be taken by mouth) that dissolve and release gastric juice-resistant micro granules.
Lansoprazole Mylan 15 mg orodispersible tablets are white to off-white with orange to dark brown spots. The tablets are round, smooth with beveled edges, and marked with “LP1” on one side and “M” on the other side.
Lansoprazole Mylan 30 mg orodispersible tablets are white to off-white with orange to dark brown spots. The tablets are round, smooth with beveled edges, and marked with “LP2” on one side and “M” on the other side.
Lansoprazole Mylan 15 mg and 30 mg orodispersible tablets are available in:
- Blister packs of 7, 14, 28, 30, 56, 90 and 98 tablets respectively
- Single-dose blister packs of 28×1 tablets
- Plastic jars with absorbent cotton and screw caps of 30, 100 and 500 tablets respectively.
Not all packaging may be marketed.
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer
McDermott Laboratories Ltd t / a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK.
Mylan Hungary Kft, H-2900, Komárom Mylan utca 1, Hungary.
Mylan UK Healthcare Limited, Building 20, Station Close, Potters Bar, EN6 1TL, UK.