Oseltamivir 45 mg capsule hard – patient leaflet, side effects, dosage

1. WHAT OSELTAMIVIR IS AND WHAT IT IS USED FOR

• Oseltamivir is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
• Oseltamivir can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.
• Oseltamivir may be prescribed for adults, adolescents, children and infant (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.

Oseltamivir belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection. Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

OSELTAMIVIR

Do not take Oseltamivir:

• if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor if this applies to you. Do not take Oseltamivir.

Warnings and precautions:

Before you take Oseltamivir, make sure the prescribing doctor knows:

• if you are allergic to other medicines
• if you have problems with your kidneys. If so, your dose may need adjustment
• if you have a severe medical condition, which may require immediate hospitalisation
• if your immune system is not working
• if you have chronic heart disease or respiratory disease. During treatment with Oseltamivir, tell a doctor immediately:
• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.

Oseltamivir is not a flu vaccine

Oseltamivir is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Oseltamivir will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.

Other medicines and Oseltamivir

Tell your doctor or pharmacist if you are taking any other rmedicines, or have rcently taken any. This includes medicines obtained without a prescription. The following medicines are particularly important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat e.g. rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant or are planning to have a baby, you must tell your doctor. Your doctor can decide if Oseltamivir is right for you. The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Oseltamivir is right for you. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Oseltamivir has no effect on your ability to drive or use machines.

Information about some of the ingredients of Oseltamivir

This product contains small amounts of ethanol (alcohol), less than 100 mg per dose. Ethanol originates from the ink used on the capsule.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE OSELTAMIVIR

Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take Oseltamivir as soon as possible, ideally within two days of the flu symptoms starting.

The recommended doses

For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course, even if you start to feel better quickly. For adult patients with a weak immune system, treatment will continue for 10 days.

For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast.

In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.

The recommended dose is based on the patient’s body weight. You must use the amount of oral capsules prescribed by the doctor.

Adults, and adolescents 13 years and over:

*For patients with a weak immune system, treatment is for 10 days

** 75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

Children 1 to 12 years:

* For children with a weak immune system, treatment is for 10 days

** 75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

Infants less than 1 year (0 to 12 months)

Giving Oseltamivir to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.

* For infants with a weak immune system, treatment is for 10 days

**mg per kg = mg for each kilogram of the infant’s body weight. For example:

If a 6-month-old weighs 8 kg, the dose is

8 kg x 3mg per kg = 24 mg

Method of administration

Swallow the capsules whole with water. Do not break or chew the capsules.

Oseltamivir can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).

People who find it hard to take capsules can use a liquid medicine, oseltamivir powder for oral suspension, which may be available and is the preferred product. A pharmacy compounded suspension can not be prepared from the capsules.

If you need a liquid medicine, but it’s not available, you can make a liquid form of Oseltamivir from these capsules (see Making liquid Oseltamivir at home). If you take more Oseltamivir than you should

Stop taking Oseltamivir and contact a doctor or pharmacist immediately.

In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4. Overdose has been reported to have occurred more frequently when Oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Oseltamivir for children and when administering Oseltamivir capsules or liquid Oseltamivir to children. If you forget to take Oseltamivir

Do not take a double dose to make up for a forgotten capsule.

If you stop taking Oseltamivir

There are no side effects when you stop Oseltamivir. But if Oseltamivir is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Many of the side effects listed below may also be caused by influenza.

The following serious side effects have been rarely reported since oseltamivir has been marketed:

• Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
• Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour
• Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing
• Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly lifethreatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure
• Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood
• Neuropsychiatric disorders, as described below. If you notice any of these symptoms, get medical help immediately.

The most frequently (very common and common) reported side effects of Oseltamivir are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food. Rare but serious effects: get medical help at once

(These may affect up to 1 in 1,000 people) During Oseltamivir treatment, rare events have been reported that include

• Convulsions and delirium, including altered level of consciousness
• Confusion, abnormal behaviour
• Delusions, hallucinations, agitation, anxiety, nightmares These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Oseltamivir.
• Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.

If you notice any of these symptoms, especially in younger people, get medical help immediately. Adults and adolescents 13 and over:

Very common side effects

(may affect more than 1 in 10 people)

• Headache
• Nausea.

Common side effects

(may affect up to 1 in 10 people)

• Bronchitis
• Cold sore virus
• Cough
• Dizziness
• Fever
• Pain
• Pain in limb
• Runny nose
• Sleeping difficulties
• Sore throat
• Stomach ache
• Tiredness
• Upper abdominal fullness
• Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
• Upset stomach
• Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Convulsion
• Heart rhythm abnormalities
• Mild to severe liver function disorders
• Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).

Rare side effects

(may affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Visual disturbances.

Children 1 to 12 years:

Very common side effects

(may affect more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting.

Common side effects

(may affect up to 1 in 10 people)

• Conjunctivitis (red eyes and discharge or pain in the eye)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach ache
• Upper abdominal fullness
• Upset stomach.

Uncommon side effects

(may affect up to 1 in 100 people)

• Inflammation of the skin
• Tympanic membrane (eardrum) disorder. Infants less than 1 year:

The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. However,

• if you or your child are repeatedly sick, or
• if the influenza symptoms get worse or the fever continues

Tell your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OSELTAMIVIR

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store below 30 °C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Oseltamivir contains

Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.

The other ingridients are:

• Capsule content: pregelatinized starch, povidone, croscarmellose sodium, talc and sodium stearyl fumarate
• Capsule shell: gelatin, black iron oxide (E172) and titanium dioxide (E171)
• Printing ink: shellac (E904), ethanol anhydrous (E1510), black iron oxide (E172), propanol, butanol, propylene glycol (E1520), ammonia solution (E527) and potassium hydroxide (E525).

What Oseltamivir looks like and contents of the pack

The 45 mg hard capsule consists of a grey opaque body with a black colour band, imprinted with “M” and a grey opaque cap imprinted with “45 mg”. Imprints are black. Oseltamivir 45 mg hard capsules are available in blister packs of 10.

Marketing Authorisation Holder

Mercury Pharmaceuticals Limited

Dashwood House, 69 Old Broad Street,

London, EC2M 1QS, United Kingdom

Manufacturer

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park, Paola, PLA3000, Malta This leaflet was last revised in December 2023.

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INFORMATION FOR THE USER For people who find it hard to take capsules, including very young children, a liquid medicine, Oseltamivir powder for oral suspension, may be available. If you need a liquid medicine, but it’s not available, you can make liquid Oseltamivir from these capsules at home. The dose is the same for treating or preventing flu. The difference is how often it is given.

Making liquid Oseltamivir at home

• If you have the right capsule for the dose needed (a 45 mg), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is usually suitable for children over 1 year. See the upper set of instructions.
• If you need smaller doses, making liquid Oseltamivir from capsules involves extra steps. This is suitable for younger children and babies: they usually need a Oseltamivir dose of less than 45 mg. See the lower set of instructions.

Children 1 to 12 years

To make a 45 mg dose, you need:

• One 45 mg Oseltamivir capsule
• Sharp scissors
• One small bowl
• Teaspoon (5 ml spoon)
• Water
• Sweet food to hide the bitter taste of the powder. Examples are chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar. Step 1: Check the dose is correct

To find the correct amount to use, find the patient’s weight on the left of the table.

Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.

You should use only 45 mg capsules for 45 mg doses. Do not try to make a 30 mg, 60 mg or 75 mg dose by using the contents of 45 mg capsules. Use the appropriate size capsule instead. Speak to your doctor or pharmacist if you are not sure.

45 mg dose

Step 2: Pour all the powder into a bowl

• Hold a 45 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors. Pour all of the powder into the bowl.
• Be careful with the powder, because it may irritate your skin and eyes.

Step 3: Sweeten the powder and give the dose

• Add a small amount – no more than 1 teaspoonful – of sweet food to the powder in the bowl. This is to hide the bitter taste of the Oseltamivir powder.
• Stir the mixture well.

Give the whole contents of the bowl to the patient straight away.

If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.

Repeat this procedure every time you need to give the medicine.

Infants less than 1 year

To make a smaller single dose, you need:

• One 45 mg Oseltamivir capsule
• Sharp scissors
• Two small bowls (use separate pairs of bowls for each child)

• One large oral dose dispenser to measure out water

  • a 5 or 10 ml dispenser
• One small oral dose dispenser showing measurements of 0.1 ml, to give the dose
• Teaspoon (5 ml spoon)
• Water
• Sweet food to hide the bitter taste of the Oseltamivir. Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar. Step 1: Pour all the powder into a bowl
• Hold a 45 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate your skin and eyes.
• Pour all of the powder into the bowl, whatever the dose you are making. The amount is the same whether you are treating or preventing flu.

Step 2: Add water to dilute the medicine

• Use the larger dispenser to draw up 7.5 ml of water.
• Add the water to the bowl
• Stir the mixture with the teaspoon for about 2 minutes.

Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients. Step 3: Choose the correct amount for your child’s weight

• Look up the child’s weight on the left side of the table.
• The column on the right of the table shows how much of the liquid mixture you will need to draw up. Infants less than 1 year (including full-term new-born babies)

Step 4: Draw up the liquid mixture

• Make sure you have the right size dispenser.
• Draw up the correct amount of liquid mixture from the first bowl.
• Draw it up carefully so as not to include air bubbles.
• Gently squirt the correct dose into the second bowl.

Step 5: Sweeten the powder and give the dose

• Add a small amount – no more than 1 teaspoonful – of sweet food to second bowl. This is to hide the bitter taste of the Oseltamivir powder.
• Mix the sweet food and the Oseltamivir liquid well.

Give the whole content of the second bowl (Oseltamivir liquid mixture with sweet food added) to the child straight away.

If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.

Give the child something to drink.

Throw away any unused liquid left in the first bowl.

Repeat this procedure every time you need to give the medicine.

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