Tamiflu 75 mg, 10 caps

Trade Name:

Tamiflu

Oseltamivir 75 mg

10 hard gelatin capsules

Composition:

Each hard capsule contains: 

Oseltamivir 75 mg 

Inactive ingredients: 

Pregelatinized starch, talc, povidone, croscarmellose sodium and sodium 

stearyl fumarate, gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) and titanium dioxide (E171),shellac (E904), titanium dioxide (E171) FD and C Blue 2 (indigo carmine E132).

Properties:

Tamiflu contains oseltamivir, which 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. 

Indications:

-for treating flu (influenza) in adults, adolescents, children and infants (when you have flu symptoms, or flu virus is known to be going round in your community);

-preventing flu in adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis (for example, if you have been in contact with someone who has flu);

– as preventive treatment in exceptional circumstances (for example a flu pandemic, if  seasonal flu vaccine may not provide sufficient protection) in adults, adolescents, children and infants (including full-term newborn babies). 

Dosage and administration:

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

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

-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 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 or suspension prescribed by the doctor.

-For adults and adolescents 13 years and over and weighing more than 40 kg, the recommended dose for treating flu is 75 mg twice daily for 5 days.

-For adults and adolescents 13 years and over and weighing more than 40 kg, the recommended dose for treating flu in patients with a weak immune system is 75 mg twice daily for 10 days.

-For adults and adolescents 13 years and over and weighing more than 40 kg, the recommended dose for preventing flu is 75 mg once daily for 10 days.

-For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for treating flu is 30 mg twice daily for 5 days.

-For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for treating flu in children with a weak immune system is 30 mg twice daily for 10 days.

-For children aged 1 to 12 years and weighing 10 kg to 15 kg, the recommended dose for preventing flu is 30 mg once daily for 10 days.

-For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for treating flu is 45 mg twice daily for 5 days.

-For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for treating flu in children with a weak immune system is 45 mg twice daily for 10 days.

-For children aged 1 to 12 years and weighing more than 15 kg and up to 23 kg, the recommended dose for preventing flu is 45 mg once daily for 10 days.

-For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for treating flu is 60 mg twice daily for 5 days.

-For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for treating flu in children with a weak immune system is 60 mg twice daily for 10 days.

-For children aged 1 to 12 years and weighing more than 23 kg and up to 40 kg, the recommended dose for preventing flu is 60 mg once daily for 10 days.

-For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu is 75 mg twice daily for 5 days.

-For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu in children with a weak immune system is 75 mg twice daily for 10 days.

-For children aged 1 to 12 years and weighing more than 40 kg, the recommended dose for treating flu is 75 mg once daily for 10 days.

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

Side effects: 

Serious:

• 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 behavior; 
• 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 life- threatening 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;

Please, get medical help at once.

Rare:

• Convulsions and delirium, including altered level of consciousness;
• Confusion, abnormal behavior; 
• Delusions, hallucinations, agitation, anxiety, nightmares( primarily among children and adolescents);

Adults and adolescents 13 and over:

Very common:

• Headache, Nausea. 

Common: 

• 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:

• 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:

• Thrombocytopenia (low platelet count) 
• Visual disturbances. 

Children 1 to 12 years:

Very common:

• Cough, Nasal congestion, Vomiting. 

Common:

• 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:

• 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, diarrhea and diaper rash have been reported. 

• 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

Contraindications:

-Hypersensitivity to oseltamivir or any of the other ingredients of Tamiflu

Warnings and precautions: 

• Before you take Tamiflu, inform your doctor if you are allergic to other medicines, if you have problems with your kidneys,  if you have a severe medical condition, which may require immediate hospitalization, if your immune system is not working or if you have chronic heart disease. 
• Tamiflu is not a flu vaccine.
• Tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor. 
• Tell your doctor or pharmacist if you are taking any other medicines, particularly important: 

-chlorpropamide

-methotrexate

-phenylbutazone

-probenecid 

• Pregnancy and breast-feeding:

You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Tamiflu 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 Tamiflu is right for you. 

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

Storage:

Store at temperature not exceeding 25°C

Package:

Carton box holds a blister of 10 capsules and paper instructions