OSELTAMIVIR 30 MG HARD CAPSULES - 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.

Oseltamivir 30 mg hard capsules contain ethanol

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

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:

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

Children 1 to 12 years:

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.

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: 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

Step 2: Pour all the powder into a bowl

• – Hold a 30 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors. Pour all of the powder into the bowl.

• – Open a second capsule for a 60 mg dose. 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 30 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.