Sandoz Oseltamivir: Uses, Side Effects and Dosage

What is Sandoz Oseltamivir used for?

Sandoz Oseltamivir is used to treat or prevent the onset of the flu in adults and children 1 year and older.

How does Sandoz Oseltamivir work?

The flu (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 goes into the air and can be inhaled by anyone nearby.

Sandoz Oseltamivir works by stopping the flu virus from spreading through your body.

When Sandoz Oseltamivir is taken within 2 days of you feeling symptoms of the flu, it can help you feel better sooner.

When Sandoz Oseltamivir is taken within 2 days after coming into contact with someone with flu symptoms, it can help prevent you from getting sick with the flu.

What are the ingredients in Sandoz Oseltamivir?

Medicinal ingredients: Oseltamivir (as oseltamivir phosphate)

Non-medicinal ingredients: Black ink, croscarmellose sodium, gelatin, iron oxide black, iron oxide yellow (30 mg and 75 mg), iron oxide red (75 mg), isopropyl alcohol, povidone, pregelatinized maize starch, sodium lauryl sulfate (SLS) (75 mg), sodium stearyl fumarate, talc, and titanium dioxide.

Sandoz Oseltamivir comes in the following dosage forms:

Sandoz Oseltamivir 30 mg are available as hard gelatin capsules with light yellow opaque cap/body printed with “30” on cap and “OP” on the body in black ink.

Sandoz Oseltamivir 45 mg are available as hard gelatin capsules with grey opaque cap/body printed with “45” on cap and “OP” on body in black.

Sandoz Oseltamivir 75 mg are available as hard gelatin capsules with cream cap and brown body printed with “OP” on cap and “75” printed on body.

Do not use Sandoz Oseltamivir if:

You are allergic or sensitive to the medicinal ingredient of Sandoz Oseltamivir or any other ingredient in Sandoz Oseltamivir (see “What are the ingredients in Sandoz Oseltamivir?”).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Oseltamivir. Talk about any health conditions or problems you may have, including if you:

• Are allergic to other medicines, food and dyes
• Have any type of kidney disease
• Have liver disease

• Are pregnant or plan on becoming pregnant

• Are breast-feeding or planning to breast-feed

Tell your healthcare professional about all the medicines you take or plan on taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take Sandoz Oseltamivir:

• Your doctor has prescribed Sandoz 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 Sandoz Oseltamivir to anyone else.
• Sandoz Oseltamivir does not replace the flu shot. If you are at high risk of developing complications from the flu, you should continue to get your flu shot as recommended by your doctor. You may still get the flu even though you got your annual flu shot.
• It is important that you start taking Sandoz Oseltamivir as soon as possible from the first appearance of your flu symptoms. If your flu symptoms, most notably fever, do not begin to improve in the first day or two after you start Sandoz Oseltamivir, speak with your doctor.

• Sandoz Oseltamivir can be taken with food. As with many medicines, if you take Sandoz

  Oseltamivir with a light snack, milk, or a meal, you may reduce possible stomach upset.

• 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 Sandoz Oseltamivir with anyone, even if they have the same symptoms.

Note: Sandoz Oseltamivir is not approved for a 6 mg / mL oseltamivir oral suspension.

Usual dose:

Treatment with Sandoz Oseltamivir (adults, adolescents and children (1 year and older))

You should start taking Sandoz Oseltamivir no more than two days after flu symptoms have started. Typical symptoms of the flu include sudden onset of fever, headache, tiredness, muscular weakness, runny or stuffy nose, sore throat and cough.

• Sandoz Oseltamivir should be taken twice a day (once in the morning and once in the evening) for five days.

Emergency Home Preparation of an Oral Suspension from Sandoz Oseltamivir:

When oseltamivir phosphate oral suspension is not available, and if directed by your doctor or pharmacist, you may mix the contents of Sandoz Oseltamivir with sweetened liquids to prepare an oral suspension (liquid form) for children, immediately before giving to the child. Please follow your doctor’s (or pharmacist’s) instructions carefully to ensure you are giving the right amount of medicine:

• 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 (no more than one teaspoon) of a sweetened liquid (such as chocolate syrup (regular or sugar-free), cherry syrup, sugar water, dessert toppings) that the child will finish.
• Stir the mixture and give the entire amount to the child.
• Rinse the bowl with a bit of sweetened liquid and administer the rinse to the child.
• Repeat these steps every time you need to give the medicine.

Prevention with Sandoz Oseltamivir (adults, adolescents and children (1 year and older))

You should start taking Sandoz Oseltamivir within 2 days after coming into contact with someone with flu symptoms. Typically, about one in ten people get the flu during an outbreak, although this can change. 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 people).

• Sandoz Oseltamivir should be taken once a day for 10 days or longer as recommended by your doctor if you have come into contact with someone who has the flu. It is important that you start taking Sandoz Oseltamivir as soon as possible after you were in contact.

Overdose:

If you think you, or a person you are caring for, have taken too much Sandoz Oseltamivir, contact a 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 Sandoz Oseltamivir, take it as soon as possible, then continue 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 Sandoz Oseltamivir unless instructed to do so by your doctor.

What are possible side effects from using Sandoz Oseltamivir?

These are not all the possible side effects you may have when taking Sandoz Oseltamivir. If you experience any side effects not listed here, tell your healthcare professional.

Sandoz Oseltamivir is generally well tolerated. The most common/possible unwanted effects are:

• Nausea
• Vomiting
• Abdominal pain
• Headache

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

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/health-canada/services/drugs-health-products/medeffect-canada/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.

Storage:

• Keep out of the reach and sight of children.
• Store away from heat.

• Keep Sandoz Oseltamivir in their original labeled container at room temperature at 15°C -

  30°C and keep them in a dry place.

• Do not use this medicine after the expiry date on the package or written label on the emergency compounded oral suspension.
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

If you want more information about Sandoz Oseltamivir:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-800-361-3062.

Last revised: SEP 09, 2024