Lansoprazole

Lansoprazole

The lansoprazole is a proton pump inhibitor drug (Proton Pump Inhibitor, PPI), used to counteract gastric acidity. It is normally used in the therapy of gastritis and of duodenitis, of the disease from reflux gastro-esophageal (GERD), in the treatment of gastric and duodenal ulcer, and in gastric protection in patients who are taking chronic anti-inflammatory therapy (for example acetyl salicylic acid, or aspirinette). It is also used, for short periods, in association with antibiotic therapy in the eradicating treatment for H.pylori, a bacterium that colonizes the stomach, with symptoms and even significant consequences.

Lansoprazole is a relatively safe active ingredient with few side effects, and is available as a generic drug or under the trade name of Lansox. Other acid inhibitor drugs of the same family as lansoprazole are omeprazole, pantoprazole, and esomeprazole.

What is Lansoprazole and what is it used for?

Lansoprazole belongs to a group of medicines called 'proton pump inhibitors'. Proton pump inhibitors, such as lansoprazole, reduce the amount of acid your stomach produces. If you have been prescribed lansoprazole, it is because there is a condition caused by your stomach producing acid.
Your doctor may prescribe Lansoprazole Teva for:
  • treatment of ulcers in the stomach or duodenum
  • Treatment or prevention of inflammation in the esophagus. This disease is called Gastroesophageal Reflux Disease
  • Treatment of an infection caused by the bacterium Helicobacter pylori, together with antibiotics suitable for the treatment of stomach or duodenal ulcers (eradication therapy)
  • Relief of the unpleasant symptoms often associated with these conditions,
  • Preventing these conditions from recurring.
  • Treatment or prevention of stomach or duodenal ulcer in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation).
  • Treatment of acid regurgitation.
Lansoprazole is sometimes prescribed to patients whose stomach produces too much acid; this includes
a condition called Zollinger-Ellison syndrome. Your doctor may have prescribed Lansoprazole for
other indication or with a strength other than that stated in the package leaflet. Follow your doctor's instructions for taking the medicine.

What you need to know before taking Lansoprazole?

Do not take Lansoprazole Teva Italy
  • if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and Precautions

Talk to your doctor or pharmacist before taking Lansoprazole.
  • if you suffer from liver problems. Your doctor may need to adjust the dosage.
  • treatment with lansoprazole may slightly increase the risk of gastrointestinal infections such as those caused by Salmonella and Campylobacter, contact your doctor immediately if you experience diarrhea while taking Lansoprazole.
  • if your doctor has prescribed Lansoprazole as an addition to other medicines to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases: please also read the package leaflet of these medicines carefully .
  • if you are about to have surgery and anesthesia (including dental work). Tell your doctor or dentist that you are taking Lansoprazole.
  • if you take lansoprazole for a long time (more than 1 year), your doctor will probably ask you to see you regularly so that they can check you. Tell your doctor if you notice any symptoms affecting your vision or if any of your symptoms get worse.
  • if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole that reduces stomach acid. If you notice skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop taking Lansoprazole. Remember to also mention any other side effects such as joint pain.
If you take a proton pump inhibitor such as Lansoprazole, especially for longer than one year, you may experience a slightly increased risk of hip, wrist or spine fractures. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), please consult your doctor.
Your doctor might have you do an endoscopic exam (where a very small camera is passed through your esophagus (food tube) to look into your stomach). This will help find out what's causing the symptoms and can help rule out more serious causes like stomach cancer.

Other medicines and Lansoprazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine In particular, tell your doctor if you are taking any of these medicines:
  1. theophylline, which is sometimes used to treat asthma
  2. antacids used for heartburn or acid regurgitation
  3. sucralfate which is used to heal ulcers
  4. fluvoxamine, which is sometimes used to treat depression
  5. St. John's wort (Hypericum perforated), which is sometimes used to treat mild depression
  6. ketoconazole is itraconazole, which are used to treat fungal infections
  7. rifampicin, which is used to treat infections
  8. digoxin, which is used to treat heart problems
  9. protease inhibitors, which are used to treat viral infections
  10. macrolides, which are used to treat bacterial infections
  11. tacrolimus, which is used to control the body's immune response after organ transplantation.

Lansoprazole with food and drink

Lansoprazole should be taken on an empty stomach (at least 30 minutes before meals).

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding please consult the
doctor or pharmacist before taking any medicine. Your doctor will decide if you should take Lansoprazole.

Driving and using machines

If you experience side effects such as dizziness, vertigo, tiredness and visual disturbances, your ability to react may be reduced. This should be taken into consideration when driving or using machines. You alone are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks that require increased concentration. The use of medicines is one of the factors that can reduce the ability to perform these actions safely, due to their effects or side effects. Descriptions of these effects can be found in other paragraphs. Read all the information in the package leaflet as a guide.
If you are unsure about something, discuss it with your doctor, nurse or pharmacist.

Does Lansoprazole contain sucrose?

Lansoprazole tablets and capsules may contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take lansoprazole

How is lansoprazole taken? The capsules should be swallowed whole. If you find it difficult to swallow the capsule, you can take a glass of water at the same time to facilitate the operation. The capsules must not be chewed or crushed, as this would compromise their effectiveness. Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist. If you take Lansoprazole Teva once a day, try to always take it at the same time. You may get better results if you take Lansoprazole Teva first in the morning. If you take Lansoprazole twice a day, you should take the first dose in the morning and the second dose in the evening.
The usual doses of Lansoprazole Teva capsules for adults are provided below. Sometimes your doctor may prescribe a different dose and will tell you how long the treatment should last. If you have liver problems, your doctor may limit the dose to one capsule a day. The recommended dose is:

Treatment of stomach ulcers

The recommended dose is one 30 mg capsule every day for 4 weeks. Prevention of ulcer and relief of symptoms during treatment with NSAIDs, that is, non-steroidal anti-inflammatory drugs, for example, aspirin, ibuprofen (Moment, Nurofen), ketoprofen (Oki), diclofenac (Voltaren). The recommended dose is one 15 mg capsule each day, your doctor may adjust the dose to one 30 mg capsule each day.

Treatment of inflammation of the esophagus (Gastroesophageal reflux disease)

The recommended dose is one 30 mg capsule a day for 4 weeks to treat your esophagus and / or relieve symptoms.

Long-term prevention of reflux oesophagitis

The recommended dose is one 15 mg capsule each day, your doctor may adjust the dose to one 30 mg capsule each day.

Duodenal ulcer

The recommended dose is one 30 mg capsule every day for 2 weeks. Your doctor may prescribe an additional 15 mg capsule a day to prevent your ulcer from coming back.

Treatment of stomach or duodenal ulcers caused by NSAIDs

The recommended dose is one 30 mg capsule every day for 4 weeks.

Treatment of heartburn and acid regurgitation

The recommended dose is one 15 mg or 30 mg capsule for 4 weeks. If symptoms persist you should tell your doctor. If symptoms are not relieved within 4 weeks, contact your doctor.

Zollinger-Ellison syndrome

Zolliger Ellison syndrome is a condition in which your stomach produces too much acid. The usual starting dose is 2 capsules of 30 mg per day. Your doctor may then adjust the dose based on your response to the dose your doctor thinks is most suitable.

Eradication of the bacterium Helicobacter pylori

The recommended dose is one 30 mg capsule twice a day for one week, in combination with one of the following three combinations with two different antibiotics in the evening:
amoxicillin 1 g 2 times a day + clarithromycin 250-500 mg 2 times a day
clarithromycin 250 mg 2 times a day + metronidazole 400-500 mg 2 times a day
amoxicillin 1 g 2 times a day + metronidazole 400-500 mg 2 times a day
Please note: these combinations are the most commonly used, but do not take into account particular situations related to the local antibiotic-resistance of the bacterium, as well as to previous attempts at eradication therapy. Therefore, other antibiotics such as tetracyclines, levofloxacin or other drugs such as bismuth could be used,
The treatment will be every day for a period of 7 to 14 days. If you are treating your infection because you have an ulcer, it is likely that the ulcer will not return if the infection is successfully treated. To get the best results from this therapy, take your medicine at the scheduled times and never miss a dose.
For more information, read the antibiotic package leaflet

Use of lansoprazole in children

Lansoprazole is not recommended for children, ask your doctor for advice.

If you take more Lansoprazole than expected

If you take more Lansoprazole than prescribed for you, contact your doctor or pharmacist immediately.

If you forget to take Lansoprazole

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose, and continue as planned.

If you stop taking Lansoprazole

You must continue to take this medicine for as long as your doctor has told you. Do not stop taking the treatment early if your symptoms have improved. Your condition may not be fully cured and may return if the treatment period does not end. If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody has them
manifest. These are usually mild and disappear when you stop taking the medicine.
The following side effects are very serious and if you get any of these side effects
unwanted must
seek urgent medical attention
:
Uncommon:
may affect up to 1 in 100 people
changes in blood cell counts with a reduction in the number of platelets, an increase in
certain types of white blood cells (eosinophilia), reduction in the number of all white blood cells.
Rare: may affect up to 1 in 1,000 people
allergic reaction (angioedema): eg swelling of the face, lips, tongue or throat or
difficulty in breathing or swallowing
decreased urine volume, dark colored urine, blood in urine, difficulty passing urine
(inflammation of the kidneys)
yellow to white discoloration of the eyes or yellowing of the skin (jaundice)
severe back pain (inflammation of the pancreas)
inflammation of the liver (hepatitis)
seeing things that are not there (hallucinations)
confusion
skin bleeding
Very rare: may affect up to 1 in 10,000 people
circular skin rashes that develop into peeling blisters (Syndrome of
Stevens-Johnson).
severe skin disease with blistering (toxic epidermal necrolysis)
severe reduction in the number of some white blood cells (agranulocytosis), reduced production of all
blood cells (symptoms include sudden fever, sore throat, tiredness, bruising or
unexplained bleeding, mouth ulcers).
high fever, difficulty in breathing, swelling of the lips, face, mouth (allergic shock).
severe pain in the abdomen (inflammation of the colon)
Not known: frequency cannot be estimated from the available data
low levels of magnesium can be manifested by fatigue, involuntary muscle contractions,
disorientation, convulsions, dizziness and increased heart rate. If you get any of these
symptoms consult
immediately
his doctor.
erythema, possible joint pain
Other effects
unwanted include:
Common: may affect up to 1 in 10 people
nausea, vomiting, diarrhea, stomach pain, constipation, wind, dryness or pain in the mouth or throat
- skin rash, hives, itching
- headache, dizziness
- changes in liver enzyme values
- tiredness
Uncommon: may affect up to 1 in 100 people
- depression
- water retention or swelling
Document made available by AIFA on
18/10/2016
Any dispute concerning industrial property rights and patent protection of data relating to the AIC of the
medicines and, therefore, the Agency cannot be held responsible in any way for any violations by the holder of the authorization
marketing (or marketing authorization holder).
- slightly increased risk of hip, wrist or spine fractures if you take
Lansoprazole Teva Italy for a period of more than one year.
Rare: may affect up to 1 in 1,000 people
- fungal infections of the esophagus, inflammation of the tongue (glossitis), change in the sense of taste.
- hair loss, excessive sweating, redness of the skin, rash like urticaria, bruises,
photosensitivity.
- restlessness, sleepiness, light-headedness, tremor, numbness / tingling.
- insomnia.
- anemia (reduction in the number of red blood cells).
- changes in vision.
- fever, loss of appetite, impotence.
- muscle and joint pain.
Very rare: may affect up to 1 in 10,000 people
- inflammation of the mucous membrane of the mouth.
- enlargement of the mammary gland in males, milky secretions from the nipple.
- increased levels of cholesterol and blood fats.
If you take Lansoprazole Teva for more than three months, it is possible that your blood levels of magnesium
decrease. Low levels of magnesium can be manifested by fatigue, muscle twitching
involuntary, disorientation, convulsions, dizziness and increased heart rate. If you warn one of
these symptoms, consult your doctor immediately. Low magnesium levels can also result
a decrease in blood levels of potassium or calcium. The doctor should decide whether to check regularly
blood magnesium levels.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet
doctor or pharmacist. You can also report side effects directly via the system
national reporting address
www.agenziafarmaco.gov.it/it/responsabili
.
Reporting the effects
side effects you can help provide more information on the safety of this medicine.
5.
How to store Lansoprazole Teva Italy
Do not store above 30 ° C.
Keep this medicine out of the sight and reach of children.
Do not use Lansoprazole Teva after the expiry date which is stated on the carton after “EXP”. The date
expiry refers to the last day of the month.
Do not use Lansoprazole Teva if you notice
any visible signs of deterioration.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6.
Contents of the pack and other information
What Lansoprazole Teva Italia contains
The active ingredient is lansoprazole.
The excipients are:
granules of sugar (sucrose, corn starch), sodium carboxymethyl starch, sodium
lauryl sulfate,
povidone, trisodium phosphate, hypromellose,
copolymer
methacrylic acid
–Ethylacrylate 1: 1
,
triethyl
citrate, titanium dioxide (E171), talc.
The capsule shell contains:
gelatin, titanium dioxide (E171), water.
Document made available by AIFA on
18/10/2016
Any dispute concerning industrial property rights and patent protection of data relating to the AIC of the
medicines and, therefore, the Agency cannot be held responsible in any way for any violations by the holder of the authorization
marketing (or marketing authorization holder).
The printing ink on the capsules contains the following additional excipients: shellac, alcohol
anhydrous ethyl, isopropyl alcohol, propylene glycol, N-butyl alcohol, ammonium hydroxide, potassium
hydroxide, black iron oxide (E172).
What Lansoprazole Teva looks like and contents of the pack
The hard gelatin capsule with an opaque white colored cap marked using black ink with
an “L” and an opaque white body marked using black ink with the number “15”. Contains
gastro-resistant white-beige microgranules of 15 mg of lansoprazole.
The hard gelatin capsule with an opaque white colored cap marked using black ink with
an “L” and an opaque white body marked using black ink with the number “30”. Contains
gastro-resistant white-beige microgranules of 30 mg of lansoprazole.
Lansoprazole Teva Italia 15 mg hard gastro-resistant capsules is supplied in blisters of 7, 14, 28 or 56 (2 × 28)
gastro-resistant capsules.
Lansoprazole Teva Italia 30 mg hard gastro-resistant capsules is supplied in blisters of 7, 14, 28 or 56.
(2 × 28) gastro-resistant capsules
Not all packs may be marketed.
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