PACKAGE LEAFLET: INFORMATION FOR THE USER
Tamiflu 75 mg hard capsules
Oseltamivir
Read all of this leaflet carefully before taking this medicine.
-Keep this leaflet, You may need to read it.
-If you have further questions, ask your doctor or pharmacist.
-This medicine is for you, so other people should not pass it. It may harm them (even if their symptoms are the same as yours).
-If you experience any serious side effects or notice any not listed
side effects, tell your doctor or pharmacist.
Leaflet
1. What is Tamiflu, and to whom it is used
2nd Before you take Tamiflu
3rd How to use of Tamiflu
4th Possible side effects
5th Tamiflu is regarded as
6th Other information
1. WHAT IS TAMIFLU AND WHAT IT IS USED
-Tamiflu is prescribed to you for treatment of influenza or avoid it.
-Tamiflu belongs to the so-called “neuraminidase inhibitors” of a class. These drugs prevent the spread of influenza viruses in the body, thus helping to ease the symptoms associated with influenza virus infection or prevent disease.
-Influenza is a contagious disease caused by the influenza virus. Flu symptoms (symptoms) – the sudden onset of fever (greater than 37.8 ° C), cough, runny or stuffy nose, headache, muscle aches, and often – extreme fatigue. These symptoms may also occur not only for influenza illness, but also other communicable diseases. True influenza infection only occurs during annual bout (epidemics) of influenza virus is spreading in the local (community). Non-epidemic period, these symptoms usually
caused by various infections or diseases.
2nd BEFORE YOU TAKE TAMIFLU
Tamiflu should not be
-If you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu.
Take special care with Tamiflu
Before you take Tamiflu purchase, make sure that your prescribing doctor knows if you have:
-You are allergic to other drugs
-Have problems with your kidneys.
Other medicines using.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Tamiflu can be used in combination with paracetamol, ibuprofen or acetylsalicylic acid (aspirin). It is believed that Tamiflu should not change any other medicines.
Are there any interactions with influenza vaccination?
Tamiflu does not replace the flu vaccination. Tamiflu, the influenza vaccine will not replace
effectiveness. Even if you have been vaccinated against influenza, the doctor may give you Tamiflu.
Taking Tamiflu with food and drink
Swallow Tamiflu with water. Tamiflu can be taken with or
without food, but it is advisable to take Tamiflu with food to reduce the chance feeling or being sick (nausea or vomiting).
Pregnancy and lactation
Before taking any medicine, it is necessary to consult with your doctor or pharmacist. If you are pregnant, think you could get pregnant or trying to get pregnant, you must tell your doctor that you can decide if Tamiflu is right for you.
Effect on breast-fed infants has not been established. If you are breast-feeding, you must tell your doctor that you can decide if Tamiflu is right for you.
Driving and using machines
Tamiflu is your ability to drive or operate machines.
3rd HOW TO TAKE TAMIFLU
Tamiflu purchase is always exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist. Take Tamiflu as soon as soon as you get appointed – it will help slow the spread of influenza virus in the body. Swallow Tamiflu capsules whole with water. Tamiflu capsules should not be crushed or chewed.
The usual dose is below.
Treatment of influenza
-Teens (13-17 years) and adults. Treatment of influenza take one drug
the capsule as soon as you get the prescription and then take one capsule twice a day (usually convenient to take one capsule in the morning and one in the evening for five days).
Even if you quickly start to feel better, it is important to complete the whole 5 day course.
Instead, 75 mg capsules for adults and adolescents may take 30 mg and 45 mg capsules.
-1 Years old and older infants and children aged 2-12. You can take Tamiflu
oral suspension, or 30 mg and 45 mg capsules.
Children weighing more than 40 kg who can swallow capsules may be prescribed Tamiflu purchase
75 mg capsules – one capsule twice a day for 5 days.
-Younger than 12 months in infants. Data on the pharmacokinetic
and safety of children under 2 years of age is limited. Was carried out in these
Pharmacokinetic data modeling, as well as the use of adults and older children 1 year of studies. These results suggest that infants 3-12 months after administration of 3 mg / kg / dose twice a day and 1-3 months for infants given 2.5 mg / kg / dose twice daily exposure is similar to the clinically effective exposure of adults and older than 1 year in children (dosing recommendations based on weight, in the table below). Until now, data on the use of Tamiflu in children below 1 month of age.
Age recommended therapeutic dose for 5 days
From> 3 months to 12 months after the 3 mg / kg twice daily
> 1 month and 3 months after 2.5 mg / kg twice daily
From 0 to 1 month after 2 mg / kg body weight twice a day
Younger than one year of Tamiflu purchase for infants must be given to the doctor’s decisions, to assess the potential therapeutic benefits and risks of the baby.
To prevent influenza
Tamiflu purchase can also be used to prevent influenza who haved contact with an infected person, eg., A family member.
-Teens (13-17 years) and adults. When used to prevent flu from contact with an infected individual, for example., A family member, Tamiflu should be taken once daily for 10 days. The best dose in the morning with breakfast.
-Older than 1 year in infants and children aged 2-12. You can take Tamiflu
oral suspension, or 30 mg and 45 mg capsules.
Children weighing more than 40 kg who can swallow capsules, can be given Tamiflu, 75 mg capsules – one capsule once a day for 10 days.
If Tamiflu purchase is prescribed to prevent influenza, your doctor will advise how long to drink it.
-Younger than 12 months in infants. The recommended dose is less than 12 months for infants, given the prevention of influenza during a pandemic, is awarded half of the treatment once a day. This is based on the age of 1 year for children and adults, clinical data, which show that half of the treatment allocated to a daily dose equal to the dose for prevention of clinically effective protection against influenza. Following the recommended dosage regimen is less than 1 year in infants given prophylaxis according to their body weight. Age recommended prophylactic dose for 10 days
From> 3 months to 12 months of 3 mg / kg body weight once a day
> 1 month and 3 months of 2.5 mg / kg body weight once a day
From 0 to 1 month, 2 mg / kg body weight once a day
Younger than one year of Tamiflu purchase for infants must be given to the doctor’s decisions, to assess the potential benefits and risks of preventive child.
If purchase Tamiflu oral suspension is not available
When trade in manufactured Tamiflu oral suspension is not quickly available,
adults, adolescents or children who can not swallow capsules of Tamiflu purchase doses may be necessary to give life after first opening the capsules and their contents to the addition of small quantities (no more than 1 teaspoon) sound sweet food such as sugar-sweetened water, chocolate syrup, cherry syrup products used to decorate desserts (eg, candies or other sweet sauce), to feel bitter. Contents to be mixed and the entire mixture to give the patient. The mixture should be swallowed immediately after preparation.
Preparation purchase of doses of Tamiflu under the age of 1 year in infants of 75 mg capsules
Infants weighing 10 kg or less, it should be 30 mg or lower doses of Tamiflu.
To prepare a dose of Tamiflu to these babies, will open the capsules of Tamiflu purchase, prepared powder and water mixture and the appropriate volume of the mixture to mix with food.
You will need:
1. One 75-mg capsules of Tamiflu purchase.
2nd Dosing regimens, so you can calculate the exact amount of the medicine (see the
3 instruction with the dosing regimen of Tamiflu).
3rd Scissors.
4th Two small bowls, one for children (for each child to use two separate bowls).
5th One 5-ml (five milliliters) by volume of oral syringe, graduated in increments every 0.2 ml (two to the tenth part of a milliliter).
6th One good oral drug dosing syringe, graduated in increments every 0.1 ml (one-tenth of a milliliter). Ask your pharmacist for the proper syringe (1 ml, 2 ml or 3 ml).
7th One teaspoon.
8th One of the following food products in order not to feel bitter taste of Tamiflu powder:
Sugar-sweetened water (if you plan to use sugar-sweetened water, pre-make up this mixture in a separate bowl or taurel?je; mix teaspoon of water and three-fourths [3 / 4] teaspoon sugar);
-Chocolate syrup;
-Cherry syrup;
-Products used to decorate desserts, such as., Caramel or other sweet sauce.
Tamiflu (10 mg / ml) of a mixture of preparation under the age of 1 year in infants of 75 mg of
capsules
Here’s how to produce one dose of purchase Tamiflu to be used immediately.
1. Carefully open one of Tamiflu 75 mg capsule over the first small bowl.
To open the capsule and hold it perpendicular to the scissors and then cut round the top (see picture below). Discard the powder into a bowl. The powder with care because they can irritate the skin and eyes.
2nd Follow the instructions given in the table below. Purchase using a 5 ml dosage syringe to add the first 5.0 ml of water and add it to the bowl with the powder. Then add a further 2.5 ml of water and add it to the bowl with the powder. Stir about 2 minutes.
Tamiflu purchase capsules required quantity of water
One 75 mg capsule of 7.5 ml (seven and a half a milliliter)
3rd Follow the instructions given in the table below. In the left column of the table, find your child’s weight and then look to the right table column and row you will find the necessary Tamiflu powder and water content, which should be included in the dosing syringe. In a small bowl first in the dosing syringe to the objectives of powder and water content, and then gently push it from the dosing syringe to the second bowl.
Tamiflu dosage table for babies 1-12 months.
I. Body weight (rounded to the nearest 0.5 kg)
II.Required dose of Tamiflu purchase
II.Tamiflu powder and water mixture content to be included in the dosing syringe
4 kg of 10 mg / ml of 1.00
4.5 kg 11.25 mg of 1.10 ml
5 kg or 12.5 mg of 1.30-ml
5.5 kg 13.75 mg of 1.40-ml
6 kg of 15 mg / ml of 1.50
7 kg in 21 ml of 2.10 mg
8 kg of 24 mg of 2.40-ml
9 kg of 27 mg of 2.70-ml
? 10 kg of 30 mg of 3.00-ml
Purchase Tamiflu dosage table below 1 month of age.
I. Body weight (rounded to the nearest 0.5 kg)
II.Required dose of Tamiflu
III.Tamiflu purchase powder and water mixture content to be included in the dosing syringe
3 kg, 6 mg of 0.60-ml
3.5 kg of 7 mg ml of 0.70
4 kg 8 mg / 0.80 ml
4.5 kg of 9 mg of 0.90-ml
4th In a second small bowl, add one of the sweet food products (in his, place no more than 1 teaspoon). These products will help to suppress infusion powder and water mixture tastes.
5th Mix well sweet foods and powder and water mixture.
6th The full contents of the second bowl (sweet food and powder and water mix) to give drink to the child.
7th Give any child with some good drink.
8th Unused remainder of the first bowl of powder and water mixture discard.
(Note: It may not dissolve all the contents of capsules. Therefore do not worry, since the undissolved material is neveikliosios medicinal parts.)
Preparation of doses of Tamiflu purchase to 1 year of age and older children, if you have only 75 mg capsules
Children weighing less than 40 kg, less than 75 mg doses of Tamiflu.
To prepare a dose of Tamiflu purchase to these children, will open Tamiflu 75 mg capsule, prepared powder and water mixture and the appropriate volume of the mixture to mix with food.
You will need:
1. One 75-mg capsules of Tamiflu.
2nd Dosing regimens, so you can calculate the exact amount of the medicine (see section 3 for further instruction to the dosing regimen).
3rd Scissors.
4th Two small bowls for one child (each child to use two separate bowls).
5th One 5-ml (five milliliters) by volume of oral syringe, graduated in increments every 0.2 ml (two to the tenth part of a milliliter).
6th One good oral drug dosing syringe, graduated in increments every 0.1 ml (one-tenth of a milliliter). Ask your pharmacist for the proper syringe (1 ml, 2 ml or 3 ml).
7th One teaspoon.
8th One of the following food products in order not to feel bitter taste of Tamiflu powder:
Sugar-sweetened water (if you plan to use sugar-sweetened water, pre-make up this mixture in a separate bowl or cup; mix tearoom
teaspoon of water and three-fourths [3 / 4] teaspoon sugar);
-Chocolate syrup;
-Cherry syrup;
-Products used to decorate desserts, such as., purchase Caramel or other sweet sauce.
Tamiflu is a mixture of Preparation 1 year of age and older children, if you have only 75 mg of
capsules
Here’s how to produce one dose of Tamiflu purchase to be used immediately.
1. Carefully open one of Tamiflu 75 mg capsule over the first small bowl.
To open the capsule and hold it perpendicular to the scissors and cut the round
its top (see picture below). Discard the powder into a bowl. The powder with care because they can irritate the skin and eyes.
2nd Using a 5 ml syringe with the powder in a bowl, add 5 ml of water. Stir about 2 minutes.
(Note: It may not dissolve all the contents of capsules. Therefore do not worry, since the undissolved material is passive medicinal parts.)
3rd The following is the first small bowl into the dosing syringe to the objectives of powder and water content, and then gently push it from the dosing syringe to the second bowl.
You have to find out what the objectives of the mixture of powder and water level should be included in the dosing syringe. If you know the child’s body weight, following the first table in the left column, locate your child’s weight meets the line. Then look at the secondary column, which contains the necessary powder and water content, which should be included in the dosing syringe.
If you do not know the child’s body weight, the second table in the left column, locate your child’s age in line with the line. Then look at the secondary column, which contains the necessary powder and water content, which should be included in the dosing syringe.
Body weight of the mixture number of doses of Tamiflu purchase, mg
Up to 15 kg 2 ml = 1 dose of 30 mg
From 15 kg to 23 kg, 3 ml = 1 dose of 45 mg
From 23 kg to 40 kg in 4 ml = 1 dose of 60 mg
Age number of doses of Tamiflu purchase, a mixture, mg
From 1 to 2 years 2 ml = 1 dose of 30 mg
From 3 to 5 years 3 ml = 1 dose of 45 mg
From 6 to 9 years 4 ML = 1 dose of 60 mg
When the dosing syringe to add the necessary powder and water content, followed by
gently push the dosing syringe to the second bowl.
4th In a second small bowl, add one of the sweet food products to the
not to feel bitter powder and water mixture taste.
5th Mix well sweet foods and powder and water mixture.
6th The full contents of the second bowl (sweet food and powder and water mix) to give drink to the child.
7th Unused remainder of the first bowl of powder and water mixture discard.
Repeat this procedure every time you need to take medicine.
If you take a large dose of Tamiflu purchase
Immediately contact your doctor or pharmacist.
If you forget to take Tamiflu
Do not take a double dose to make up missed the capsule.
If you stop taking Tamiflu
Tamiflu purchase is discontinued when the drink sooner than recommended by your doctor, no adverse
effects absent. If you stop to take Tamiflu before your doctor tells you, flu-like symptoms of a return.
If you have further questions about this medicine, ask your doctor or
pharmacist.
4th POSSIBLE SIDE EFFECTS
Tamiflu, like other drugs can cause side effects, although not everybody gets them.
Frequently occurring side effects of Tamiflu purchase
Tamiflu is the most common side effects – nausea, vomiting,
diarrhea, stomach pain and headache. These events generally occur only after the first dose and usually resolve with continued therapy. Side effects
less frequent, if the product is taken with food.
Less common side effects of Tamiflu purchase
Adults and adolescents (13 years and older)
Other less common side effects, which may also be caused by influenza A virus, a feeling of fullness in the upper abdomen, stomach and intestinal bleeding, bronchitis, upper respiratory tract infection, dizziness, fatigue, sleep disturbances, skin reactions,
mild, moderate and severe hepatic dysfunction, visual disorders and
abnormal heart rhythm.
With influenza may be related to various neurological and behavioral symptoms, for example., Hallucinations, delusions or abnormal behavior, in some cases, for an episode of their death.
These events can occur in encephalitis (inflammation of the brain) or encephalopathy but can occur for no apparent serious illness.
History of influenza and Tamiflu-treated patients occurred in seizures or delusions (including symptoms such as altered level of consciousness, confusion, abnormal behavior, delusions, hallucinations, agitation, anxiety, nightmares), which is very rare in patients or their injuries are to the death. These effects are most common in children and adolescents, they often occur suddenly and quickly resolved. Tamiflu purchase is on the emergence of these phenomena is unknown. Such neurological and psychiatric disorders also reported a history of influenza, Tamiflu, but naive patients.
Children (1 – 12 years)
Other less common side effects, which may also cause the flu – is inflammation of the ear, inflammation of the lungs, sinuses (sinusitis), inflammation of the bronchi (bronchitis), suffering from bronchial asthma deterioration, bleeding from the nose, ear problems, skin inflammation of the lymph node swelling, conjunctivitis, visual disturbances, and abnormal heart rhythms.
Infants (6 – 12 months)
Report side effects of Tamiflu purchase, the drug was administered 6 – 12 months in infants for treatment of influenza, were similar to side effects seen in older children (1 year and older). This information is read in the previous paragraph.
Infants (0 – 6 months)
Report of Tamiflu side effects when administered USED FOR 1 – 6 months in infants for treatment of influenza, were similar to side effects seen in 6 to 12 months for infants and older children (1 year and older). Data on the use of purchase Tamiflu in children below 1 month of age. This information is read in the previous paragraph.
If you or your child are often sick, you should inform your doctor.
It should also tell your doctor immediately if flu symptoms get worse or
the fever.
If you experience any serious side effects or notice any not listed
side effects, tell your doctor or pharmacist.
5th HOW TO STORE TAMIFLU
Keep out of reach and sight of children.
On the carton and blister after EXP after the expiry date, Tamiflu, should not be used. Refers to the last day of the month.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. How do I dispose of medicines no longer required. These measures will help protect the environment.
6th OTHER INFORMATION
Purchase Tamiflu is the composition
-Active substance is oseltamivir phosphate (oseltamivir 75 mg Each hard capsule).
-The other ingredients are:
capsule contents: pregelatinized starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate;
capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) and titanium dioxide (E171);
printing ink: shellac (E904), titanium dioxide (E171) and indigo carmine (E132).
Tamiflu purchase is the appearance and contents of the pack
The hard capsule is gray opaque body bearing the imprint “ROCHE” and yellow opaque cap imprinted with “75 mg”. Imprints are blue.
Tamiflu 75 mg hard capsules are supplied in blister packs of 10 capsules in a packet.
Marketing Authorization Holder and Manufacturer
Roche Registration Limited
6 Falcon Way Roche Pharma AG
Shire Park Emil-Barell-Str. 1,
Welwyn Garden City D-79639 Grenzach-Wyhlen
AL7 1TW Germany
United Kingdom
If information about this medicine, please contact the Marketing Authorization Holder
representative.
This leaflet was last approved in 2009 October. 23
Source: The European Medicines Agency (EMEA)