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Details for: JAMP OSELTAMIVIR

Company: JAMP PHARMA CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02497409JAMP OSELTAMIVIROSELTAMIVIR (OSELTAMIVIR PHOSPHATE)30 MGCAPSULEORAL
02497425JAMP OSELTAMIVIROSELTAMIVIR (OSELTAMIVIR PHOSPHATE)75 MGCAPSULEORAL
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Summary Safety Review - Tamiflu (oseltamivir) and generics - Assessing the Potential Risk of Haemorrhages

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

JAMP OSELTAMIVIR is a prescription medication (a viral neuraminidase inhibitor) used to treat or prevent the onset of flu.

What it does

JAMP OSELTAMIVIR works by inhibiting an enzyme necessary for the flu virus to spread through your body.

In two large clinical treatment trials, flu patients who took oseltamivir phosphate recovered 1.3 days (30%) faster than flu patients who did not take oseltamivir phosphate. JAMP OSELTAMIVIR should also alleviate your symptoms, and help you feel better soon.

In a large clinical trial for prevention of flu in families with children 13 years and older, oseltamivir phosphate, started within 2 days of the first family member getting sick and taken for 7 days, prevented over 90% of the flu illnesses in the rest of the family.

When it should not be used

  • Do not use JAMP OSELTAMIVIR if you are allergic or sensitive to oseltamivir phosphate or any ingredient in this formulation (See “What the non-medicinal ingredients are”)
  • JAMP OSELTAMIVIR should not be used in children under 1 year of age.
  • What the medicinal ingredient is

    JAMP OSELTAMIVIR is available as capsules containing 30 mg, 45 mg or 75 mg of the active ingredient oseltamivir as oseltamivir phosphate.

    What the non-medicinal ingredients are

    JAMP OSELTAMIVIR capsules contain the following non- medicinal ingredients: pregelatinised starch, croscarmellose sodium, gelatin, iron oxides, povidone K 30, sodium stearyl fumarate, talc, titanium dioxide, shellac, propylene glycol and FD and C Blue #2 Aluminum Lake.

    What dosage form it comes in

    30 mg, 45 mg and 75 mg capsules JAMP OSELTAMIVIR 30 mg capsules are available as light yellow cap and light yellow body size ‘4’ hard gelatin capsules containing white to off white granules with “30mg” on cap and “M53” on body imprinted with blue ink.

    JAMP OSELTAMIVIR 45 mg capsules are available as grey cap and grey body size ‘4’ hard gelatin capsules containing white to off white granules with “45mg” on cap and “M54” on body imprinted with blue ink.

    JAMP OSELTAMIVIR 75 mg capsules are available as Light yellow cap and grey body size ‘2’ hard gelatin capsules containing white to off white granules with “75mg” on cap and “M55” on body imprinted with blue ink.

    Warnings and precautions

    BEFORE you use JAMP OSELTAMIVIR talk to your doctor or pharmacist if:

    • you ever had a bad reaction to oseltamivir phosphate (JAMP OSELTAMIVIR) or any of the inactive ingredients
    • you are allergic to other medicines, food and dyes
    • you are taking any other medicines, including those not prescribed by your doctor
    • you have any type of kidney disease
    • you are pregnant, plan on becoming pregnant, breast-feeding or planning to breast-feed.
    This information will help your doctor and you decide whether you should use JAMP OSELTAMIVIR and what extra care may need to be taken while you are on the medicine.
    Interactions with this medication

    Tell your doctor about all medications (prescription and non-prescription) that you are taking, or plan on taking.

    Proper use of this medication

    Your doctor has prescribed JAMP OSELTAMIVIR after diagnosing your flu condition. Other people may not benefit from taking this medicine, even though their problems may seem similar to yours. Do not give your JAMP OSELTAMIVIR to anyone else.

    JAMP OSELTAMIVIR is not a substitute for the flu shot. If you are at high risk of developing complications, you should continue to get your flu shot as recommended by your doctor. You might be surprised to find that you are still susceptible to flu even though you got your annual flu shot.

    Note: JAMP OSELTAMIVIR is not approved for a 6 mg/mL oseltamivir oral suspension.

    Treatment with JAMP OSELTAMIVIR (adults, adolescents and children (≥ 1 year))
    Treatment with JAMP OSELTAMIVIR should begin no more than two days after flu symptoms have started to appear. Typical symptoms of flu include sudden onset of fever, headache, tiredness, muscular weakness, runny or stuffy nose, sore throat and cough.

    Usual dose:

    • JAMP OSELTAMIVIR should be taken twice daily (once in the morning and once in the evening) for five days.
    • It is important that you begin your treatment with JAMP OSELTAMIVIR as soon as possible from the first appearance of your flu symptoms. If flu symptoms, most notably fever, do not begin to improve in the first day or two after you start your treatment with JAMP OSELTAMIVIR, speak with your doctor.
    • JAMP OSELTAMIVIR can be taken with food. As with many medicines, if taken with a light snack, milk, or a meal, possible stomach upset may be reduced.
    • You must complete the entire treatment recommended by your doctor, even if you are feeling better.
    • Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than prescribed by your doctor. Never share JAMP OSELTAMIVIR with anyone, even if they have the same symptoms.
    Emergency Home Preparation of an Oral Suspension from JAMP OSELTAMIVIR Capsules:

    When oseltamivir phosphate oral suspension is not available, and if directed by your doctor or pharmacist, you may mix the contents of JAMP OSELTAMIVIR capsules with sweetened liquids to prepare an oral suspension for children, immediately before dosing.

    Please follow your doctor’s (pharmacist’s) instructions carefully to ensure proper dosing:
    • Holding one capsule over a small bowl, carefully pull the capsule open and pour the complete contents of the capsule into the bowl.
    • Add a small amount of a sweetened liquid such as chocolate syrup (regular or sugarfree) that the child will consume completely.
    • Stir the mixture and give the entire dose to the child.
    • Rinse the bowl with a bit of sweetened liquid and administer the rinse to the child.
    Prevention with JAMP OSELTAMIVIR (adults, adolescents and children (≥1 year))

    Therapy should begin within 2 days after coming into contact with someone with flu symptoms. Typically, about one in ten get the flu during an outbreak, although this varies. If someone close to you (like someone living in your home) has the flu your chance of getting it yourself is higher (around one in five).

    Usual dose:
    • JAMP OSELTAMIVIR should be taken once daily for 10 days or longer as recommended by your doctor if you have contacted someone who has flu. It is important that you begin your treatment with JAMP OSELTAMIVIR as soon as possible after you are exposed.
    • JAMP OSELTAMIVIR can be taken with food. As with many medicines, if taken with a light snack, milk, or a meal, possible stomach upset may be reduced.
    • The duration of dosing was tailored by your doctor. You must complete the entire course of therapy that your doctor has prescribed for you.
    • Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than prescribed by your doctor.
    Overdose:
    If you think you have taken too much JAMP OSELTAMIVIR, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

    Missed Dose:
    If you forget to take a dose of JAMP OSELTAMIVIR take it as soon as possible, then just carry on with the regular times you take your medication. Do not take double the amount if you miss one dose.

    If you have missed several doses, inform your doctor and follow the advice given to you. Do not change your dose of JAMP OSELTAMIVIR unless instructed to do so by your doctor.
    Side effects and what to do about them

    Unwanted effects are possible with all medicines. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking JAMP OSELTAMIVIR.

    JAMP OSELTAMIVIR is generally well tolerated. The most common/possible unwanted effects are:

    • nausea
    • vomiting
    • abdominal pain
    • headache
    Taking JAMP OSELTAMIVIR with food may reduce possible stomach upset.
    Severe skin and hypersensitivity reactions have been reported since the marketing of oseltamivir phosphate. Symptoms of skin reactions include flushing, rash, itching or swelling. Symptoms of hypersensitivity reactions include dizziness or breathing problems.
      Cases of liver toxicity have also been reported, symptoms of which include, yellowing of skin or eyes and dark urine.

      People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, delirium, hallucinations, agitation, anxiety or other abnormal behaviour early during their illness. These events may occur shortly after beginning JAMP OSELTAMIVIR or may occur when flu is not treated. These events are uncommon but may result in self-injury to the patient, sometimes fatal.
      Therefore, patients should be observed for signs of unusual behaviour and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behaviour.

      Some unwanted effects may go away during treatment as your body adjusts to the medicine. If you are concerned about these or any other unexpected effects while on JAMP OSELTAMIVIR, talk with your doctor or pharmacist.

      This is not a complete list of side effects. For any unexpected effects while taking JAMP OSELTAMIVIR, contact your doctor or pharmacist.
    How to store

    • Keep this medication out of the reach and sight of children.
    • Store away from heat.
    • Keep JAMP OSELTAMIVIR capsules in their original labeled container at room temperature at 15-30°C and keep them in a dry place.
    • Do not use this medicine after the expiry date on the package.
    This leaflet does not provide all known information about JAMP OSELTAMIVIR. If you have any questions or concerns about your treatment, please speak with your doctor or pharmacist.
    Reporting side effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
    • Calling toll-free at 1-866-234-2345.

    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    More information

    What the flu is:
    The flu, or influenza, is an infection caused by influenza viruses. It is most common in the fall and winter. The flu is highly contagious. The virus usually enters the body through the mouth, nose or eyes. When a person with the flu coughs or sneezes, the virus becomes airborne and can be inhaled by anyone nearby.

    Flu occurs in local outbreaks which happen once or twice per year, usually in the winter.

    What the difference is between the flu and a cold: Both the flu and a cold are viral infections and can cause symptoms such as coughing and sore throat. A cold is a minor viral infection of the nose and throat. The flu however is usually more severe, has rapid onset of symptoms, and is associated with higher fever and aches and pains.

    If you want more information about JAMP OSELTAMIVIR:
    • Talk to your healthcare professional
    • Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpdbdpp/index-eng.jsp); by calling 1 866-399-9091 .
    This leaflet was prepared by

    Jamp Pharma Corporation
    1310 rue Nobel,
    Boucherville, Québec,
    Canada, J4B 5H3

    Last Approved: March 19, 2020
    Date modified: