Ventra

Ventra

esomeprazole

Manufacturer:

Ethypharm Industries

Distributor:

International Med
Full Prescribing Info
Contents
Esomeprazole.
Description
Ventra capsules come in two strengths containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate).
Excipients/Inactive Ingredients: Capsule content: sugar spheres (sucrose and maize starch), hypromellose, dimethicone emulsion 35% (containing dimethicone, propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitan monolaureate, octylphenoxy polyethoxy ethanol and propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (containing copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulfate and polysorbate 80), triethyl citrate, stearoyl macrogolglycerides and purified water.
Capsule shell: black iron oxide (E 172), shellac, ammonia, propylene glycol, potassium hydroxide, gelatin, yellow iron oxide (E 172) and titanium dioxide (E 171).
Action
Ventra contains a medicine called esomeprazole, which belongs to a group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid that the stomach produces.
Indications/Uses
Ventra is used to treat the following conditions: Adults and adolescents aged 12 years and above: 'Gastro-esophageal reflux disease' (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach) causing pain, inflammation and heartburn.
Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called 'Helicobacter pylori'. The doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Adults: Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Ventra can also be used to stop stomach ulcers from forming when taking NSAIDs.
Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole.
Dosage/Direction for Use
Always take this medicine exactly as the doctor or pharmacist has instructed. Check with the doctor or pharmacist if not sure.
Ventra is not recommended for children less than 12 years old.
If the patient is not taking this medicine for a long time, the doctor will want to monitor the patient (particularly if the patient is taking it for more than a year).
If the doctor has instructed to take this medicine as and when needed, tell the doctor if the symptoms change.
Taking this medicine: Capsules can be taken at any time of the day.
Capsules can be taken with food or on an empty stomach.
Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain coated granules which stop the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.
What to do if the patient has trouble swallowing the capsules: If the patient has trouble swallowing the capsules: 1) Open the capsule carefully above a glass of still (non-fizzy) water and empty the content of the capsule (granules) into the glass. Do not use any other liquids.
2) Stir. Then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.
3) To make sure that all of the medicine was taken, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.
If the patient cannot swallow at all, the content of the capsule can be mixed with some water and put into a syringe. It can then be given through a tube directly into the stomach ('gastric tube').
How much to take: The doctor will instruct how many capsules to take and how long to take them for. This will depend on the condition and how well the liver works.
The recommended doses are given as follows.
To treat heartburn caused by gastro-esophageal reflux disease (GERD): Adults and children aged 12 or above: If the doctor has found that the food pipe (gullet) has been slightly damaged, the recommended dose is one capsule of Ventra 40 mg once a day for 4 weeks. The doctor may tell the patient to take the same dose for a further 4 weeks if the gullet has not yet healed.
The recommended dose once the gullet has healed is one capsule of Ventra 20 mg once a day.
If the gullet has not been damaged, the recommended dose is one capsule Ventra 20 mg each day. Once the condition has been controlled, the doctor may tell the patient to take the medicine as and when needed, up to a maximum of one capsule of Ventra 20 mg each day.
If the patient has severe liver problems, the doctor may give a lower dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back: Adults and children aged 12 or above: The recommended dose is one capsule of Ventra 20 mg twice a day for one week.
The doctor will also tell the patient to take antibiotics called amoxicillin and clarithromycin.
To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): Adults aged 18 and above: The recommended dose is one capsule of Ventra 20 mg once a day for 4 to 8 weeks.
To prevent stomach ulcers when taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): Adults aged 18 and above: The recommended dose is one capsule of Ventra 20 mg once a day.
To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome): Adults aged 18 and above: The recommended dose is one capsule of Ventra 40 mg twice a day.
The doctor will adjust the dose depending on the patient's needs and will also decide how long to take the medicine for. The maximum dose is 80 mg twice a day.
Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole: The recommended dose is one capsule of Ventra 40 mg once a day for 4 weeks.
Children under the age of 12 years: Ventra is not recommended for children less than 12 years old.
Elderly: Dose adjustment is not required in the elderly.
If the patient forgets to take Ventra: If the patient forgets to take a dose, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
For any further questions on the use of this medicine, ask the doctor or pharmacist.
Overdosage
If the patient takes more Ventra than prescribed by the doctor, talk to the doctor or pharmacist straight away.
Contraindications
Do not take Ventra: if the patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in Description).
If the patient is allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
If the patient is taking a medicine containing nelfinavir (used to treat HIV).
Do not take Ventra if any of those previously mentioned applies. If not sure, talk to the doctor or pharmacist before taking Ventra.
Special Precautions
Talk to the doctor or pharmacist before taking Ventra: if the patient has severe liver problems; if the patient has severe kidney problems; if the patient has ever had a skin reaction after treatment with a medicine similar to Ventra that reduces stomach acid; if the patient is due to have a specific blood test (Chromogranin A).
If a rash on the skin develops, especially in areas exposed to the sun tell the doctor as soon as possible, as treatment with Ventra may need to be stopped. Remember to also mention any other ill-effects like pain in the joints.
Ventra may hide the symptoms of other diseases. Therefore, if any of the following happens before starting Ventra or while taking it, talk to the doctor straight away: A lot of weight loss for no reason and problems swallowing; stomach pain or indigestion; vomiting food or blood; passing black stools (blood-stained faeces).
Taking a proton pump inhibitor like Ventra, especially over a period of more than one year, may slightly increase the risk of fracture in the hip, wrist or spine. Tell the doctor if the patient has osteoporosis or is taking corticosteroids (which can increase the risk of osteoporosis).
If the patient has been prescribed Ventra "on demand", contact the doctor if the symptoms continue or change in character.
Talk to the doctor, pharmacist or nurse before taking Ventra.
Ventra contains sucrose and parahydroxybenzoates: Ventra contains sucrose, which is a type of sugar, propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxybenzoate (E218): If the patient has an intolerance to some sugars, talk to the doctor before taking this medicine.
Parahydroxybenzoates may cause allergic reactions (possibly delayed).
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Concomitant use of Proton Pump Inhibitors (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate. Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping VENTRA. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Driving and using machines: Ventra is not likely to affect the ability to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see Side Effects). If affected, do not drive or use machines.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine. The doctor will decide whether Ventra can be taken during this time.
It is not known if Ventra passes into breast milk. Therefore, Ventra should not be taken if breast-feeding.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop taking Ventra and contact a doctor immediately: Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulties to swallow (severe allergic reaction).
Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be 'Stevens-Johnson syndrome' or 'toxic epidermal necrolysis'.
Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
These effects are rare, affecting less than 1 in 1,000 people.
Other side effects include: Common (may affect up to 1 in 10 people): Headache; Effects on the stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence); Feeling sick (nausea) or being sick (vomiting); Benign polyps in the stomach.
Uncommon (may affect up to 1 in 100 people): Swelling of the feet and ankles; Disturbed sleep (insomnia); Dizziness; Tingling feelings such as "pins and needles"; Feeling sleepy; Spinning feeling (vertigo); Dry mouth; Changes in blood tests that check how the liver is working; Skin rash, lumpy rash (hives) and itchy skin; Fracture of the hip, wrist or spine (if Ventra is used in high doses and over long duration).
Rare (may affect up to 1 in 1,000 people): Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
Feeling agitated, confused or depressed.
Taste changes.
Eyesight problems such as blurred vision.
Suddenly feeling wheezy or short of breath (bronchospasm).
An inflammation of the inside of the mouth.
An infection called "thrush" which can affect the gut and is caused by a fungus.
Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash on exposure to sunshine.
Joint pains (arthralgia) or muscle pains (myalgia).
Generally feeling unwell and lacking energy.
Increased sweating.
Very rare (may affect up to 1 in 10,000 people): Changes in blood count including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not there (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Severe kidney problems.
Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data): If the patient is on Ventra for more than three months it is possible that the levels of magnesium in the blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If any of these symptoms occur, please tell the doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor the levels of magnesium.
Inflammation in the gut (leading to diarrhoea).
Rash, possibly with pain in the joints.
Ventra may in very rare cases affect the white blood cells leading to immune deficiency. If the patient has an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, consult the doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important to give information about the medication at this time.
Reporting of side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed.
Drug Interactions
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. This includes medicines that can be bought without a prescription. This is because Ventra can affect the way some medicines work and some medicines can have an effect on Ventra.
Do not take Ventra if the patient is taking a medicine containing nelfinavir (used to treat HIV).
Tell the doctor or pharmacist if the patient is taking any of the following medicines: Atazanavir or saquinavir (used to treat HIV).
Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
Erlotinib (used to treat cancer).
Citalopram, imipramine or clomipramine (used to treat depression).
Diazepam (used to treat anxiety, relax muscles or in epilepsy).
Phenytoin (used in epilepsy): If the patient is taking phenytoin, the doctor will need to monitor him/her when starting or stopping Ventra.
Medicines that are used to thin the blood, such as warfarin: The doctor may need to monitor the patient when starting or stopping Ventra.
Cilostazol (used to treat intermittent claudication - a pain in the legs when walking which is caused by an insufficient blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Clopidogrel (used to treat or prevent blood clots).
Tacrolimus (organ transplantation).
Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if the patient is taking a high dose of methotrexate, the doctor may temporarily stop Ventra treatment.
Rifampicin (used for treatment of tuberculosis).
St. John's wort (Hypericum perforatum) (used to treat depression).
If the doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Ventra to treat ulcers caused by Helicobacter pylori infection, it is very important to tell the doctor about any other medicines being taken.
Ventra with food and drink: Capsules can be taken with food or on an empty stomach.
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Store below 25°C.
Keep this medicine in the original container in order to protect from moisture.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Gastro-resistant cap 20 mg (opaque yellow cap and an opaque white body, with "20 mg" printed in black both on the cap and on the body) x 28's. 40 mg (opaque yellow cap and an opaque yellow body, with "40 mg" printed in black both on the cap and on the body) x 28's.
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