Tamiflu 6 mg/ml powder for oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tamiflu 6mg/ml powder for oral suspension
oseltamivir
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Leaflet contents
- What Tamiflu is and what it is used for
- What you need to know before taking Tamiflu
- How to take Tamiflu
- Possible side effects
- How to store Tamiflu
- Contents of the pack and other information
1. What Tamiflu is and what it is used for
- Tamiflu is used in adults, adolescents, children, and infants (including full-term newborn babies) for the treatment of influenza (influenza). It may be used when you have influenza symptoms and it is known that the influenza virus is circulating in the community.
- Tamiflu may also be prescribed to adults, adolescents, children, and infants older than 1 year of age for prevention of influenza on a case-by-case basis, for example, if you have been in close contact with someone who has influenza.
- Tamiflu may be prescribed to adults, adolescents, children, and infants (including full-term newborn babies) as prophylactic treatment under exceptional circumstances, for example, during a global influenza outbreak (an influenza pandemic) and when the seasonal influenza vaccine may not provide sufficient protection.
Tamiflu contains oseltamivir, which belongs to a group of medicines known as neuraminidase inhibitors. These medicines prevent the spread of the influenza virus within the body. They help to relieve or prevent symptoms caused by infection with the influenza virus.
Influenza is a viral infection. Signs of influenza often include sudden fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches, and extreme tiredness. These symptoms may also be caused by other infections. True influenza infection occurs only during annual outbreaks (epidemics), when influenza viruses are circulating in the population. Outside epidemic periods, influenza-like symptoms are usually due to other illnesses.
2. What you need to know before taking Tamiflu
Do not take Tamiflu
- if you are allergic (hypersensitive) to oseltamivir or to any of the other ingredients of Tamiflu listed in section 6.
If this applies to you, consult your doctor. Do not take Tamiflu.
Warnings and precautions
Before taking Tamiflu, make sure your doctor knows if you:
- are allergic to other medicines
- have a kidney disease. If so, your dose may need to be adjusted.
- have a serious illness requiring immediate hospitalization.
- have a poorly functioning immune system.
- have chronic heart or respiratory disease.
During treatment with Tamiflu, contact a doctor immediately if:
- you notice changes in your behaviour or mood (neuropsychiatric events), especially if they occur in children and adolescents. These may be signs of rare but serious side effects.
Tamiflu is not an influenza vaccine
Tamiflu is not a vaccine: it is used to treat infection or prevent the spread of the influenza virus. A vaccine provides antibodies against the virus. Tamiflu does not affect the effectiveness of the influenza vaccine, and your doctor may prescribe both.
Taking Tamiflu with other medicines
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
The following medicines are particularly important:
- chlorpropamide (used to treat diabetes)
- methotrexate (used to treat, for example, rheumatoid arthritis)
- phenylbutazone (used to treat pain and inflammation)
- probenecid (used to treat gout)
Pregnancy and breastfeeding
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so your doctor can decide whether Tamiflu is suitable for you.
The effects on infants are unknown. Inform your doctor if you are breastfeeding so they can decide whether Tamiflu is appropriate for you.
Consult your doctor or pharmacist before using this medicine.
Driving and using machines
Tamiflu has no effect on your ability to drive or operate machinery.
Tamiflu contains sorbitol
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, speak with your doctor before taking or receiving this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
5 ml of oseltamivir suspension contains 0.9 g of sorbitol.
7.5 ml of oseltamivir suspension contains 1.3 g of sorbitol.
10 ml of oseltamivir suspension contains 1.7 g of sorbitol.
12.5 ml of oseltamivir suspension contains 2.1 g of sorbitol.
Tamiflu contains sodium benzoate
Sodium benzoate (E211) may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
5 ml of oseltamivir suspension contains 2.5 mg of sodium benzoate.
7.5 ml of oseltamivir suspension contains 3.75 mg of sodium benzoate.
10 ml of oseltamivir suspension contains 5.0 mg of sodium benzoate.
12.5 ml of oseltamivir suspension contains 6.25 mg of sodium benzoate.
Tamiflu contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per single dose (based on a maximum dose of 75 mg); therefore, it is essentially "sodium-free".
3. How to take Tamiflu
Follow exactly the Tamiflu dosing instructions provided by your doctor. Consult your doctor or pharmacist if you have any questions.
Always use the oral dispenser included in the package, which has markings indicating the dose in milliliters (ml).
Take Tamiflu as soon as possible, ideally within two days after the onset of flu symptoms.
Recommended doses
For the treatment of influenza, take two doses daily. It is generally advisable to take one dose in the morning and one in the evening. It is important to complete the full 5-day course of treatment, even if you start feeling better quickly.
For patients with a weakened immune system, treatment will continue for 10 days.
For the prevention of influenza or after exposure to an infected person, take one dose daily for 10 days. It is best to take this dose each morning with breakfast.
In special situations, such as widespread influenza outbreaks or in patients with a weakened immune system, treatment may continue for up to 6 or 12 weeks.
The recommended dose depends on the patient's body weight. You should use the amount of Tamiflu prescribed by your doctor. Tamiflu oral suspension can be used in individuals who cannot swallow capsules. See instructions below for preparing and administering the dose.
Adults and adolescents aged 13 years and older
Body weight | Influenza treatment: dose | Influenza treatment (in immunocompromised patients): dose | Influenza prevention: dose |
40 kg or more | 12.5 ml** twice daily | 12.5 ml** twice daily | 12.5 ml** once daily |
*For patients with a weakened immune system, the treatment duration is 10 days.
**12.5 ml can be prepared using one 5 ml dose plus one 7.5 ml dose.
Children from 1 to 12 years old
Body weight | Influenza treatment: dose for 5 days | Influenza treatment (in immunocompromised patients): dose for 10 days* | Influenza prevention: dose for 10 days |
10 to 15 kg | 5.0 ml twice daily | 5.0 ml twice daily | 5.0 ml once daily |
Over 15 kg up to 23 kg | 7.5 ml twice daily | 7.5 ml twice daily | 7.5 ml once daily |
Over 23 kg up to 40 kg | 10.0 ml twice daily | 10.0 ml twice daily | 10.0 ml once daily |
Over 40 kg | 12.5 ml** twice daily | 12.5 ml** twice daily | 12.5 ml** once daily |
*For children with a weakened immune system, treatment is 10 days.
**12.5 ml is constituted with one 5 ml dose plus one 7.5 ml dose
Infants under 1 year of age (0 to 12 months)
The administration of Tamiflu to children under 1 year of age for the prevention of influenza during a pandemic should be carried out based on medical judgment after considering the potential benefit against any potential risk to the child.
An oral dispenser of 3 ml (graduated with 0.1 ml markings) should be used for dosing in children under 1 year of age who require 1 to 3 ml of Tamiflu oral suspension.
Body weight | Influenza treatment: dose | Influenza treatment (in immunocompromised patients): dose | Influenza prevention: dose | Syringe size to be used |
3 kg | 1.5 ml twice daily | 1.5 ml twice daily | 1.5 ml once daily | 3 ml |
3.5 kg | 1.8 ml twice daily | 1.8 ml twice daily | 1.8 ml once daily | 3 ml |
4 kg | 2.0 ml twice daily | 2.0 ml twice daily | 2.0 ml once daily | 3 ml |
4.5 kg | 2.3 ml twice daily | 2.3 ml twice daily | 2.3 ml once daily | 3 ml |
5 kg | 2.5 ml twice daily | 2.5 ml twice daily | 2.5 ml once daily | 3 ml |
5.5 kg | 2.8 ml twice daily | 2.8 ml twice daily | 2.8 ml once daily | 3 ml |
6 kg | 3.0 ml twice daily | 3.0 ml twice daily | 3.0 ml once daily | 3 ml |
>6 to 7 kg | 3.5 ml twice daily | 3.5 ml twice daily | 3.5 ml once daily | 10 ml |
>7 to 8 kg | 4.0 ml twice daily | 4.0 ml twice daily | 4.0 ml once daily | 10 ml |
>8 to 9 kg | 4.5 ml twice daily | 4.5 ml twice daily | 4.5 ml once daily | 10 ml |
>9 to 10 kg | 5.0 ml twice daily | 5.0 ml twice daily | 5.0 ml once daily | 10 ml |
- For patients with a weakened immune system, the treatment duration is 10 days.
If you take more Tamiflu than you should
Stop taking Tamiflu and consult your doctor or pharmacist immediately.
In many cases of overdose, no adverse effects were reported. When adverse effects were reported, they were similar to those observed with normal doses and listed in section 4.
Overdoses of Tamiflu have been reported more frequently in children than in adults and adolescents. Caution must be exercised when preparing liquid Tamiflu for children and when administering Tamiflu capsules or liquid to children.
If you forget to take Tamiflu
Do not take a double dose to make up for missed doses.
If you stop taking Tamiflu
No adverse effects occur when you stop taking Tamiflu. However, if you stop taking Tamiflu before the time prescribed by your doctor, flu symptoms may return. Always complete the course of treatment prescribed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Many of these adverse effects may be due to influenza itself.
Since the marketing of oseltamivir, the following serious adverse effects have rarely been reported:
- Anaphylactic and anaphylactoid reactions: severe allergic reactions, with swelling of the face and skin, itchy rash, low blood pressure, and difficulty breathing.
- Hepatic disorders (fulminant hepatitis, liver function disorders, and jaundice): yellowing of the skin and whites of the eyes, change in stool color, changes in behavior.
- Angioneurotic edema: sudden, severe swelling of the skin, mainly around the head and neck area, including eyes and tongue, with difficulty breathing.
- Stevens-Johnson syndrome and toxic epidermal necrolysis: a severe, potentially life-threatening allergic reaction, with serious inflammation of the outer and possibly inner skin layers, initially presenting with fever, sore throat, fatigue, skin rash, blistering, peeling, and large areas of skin shedding, possible breathing difficulties, and low blood pressure.
- Gastrointestinal hemorrhage: prolonged bleeding from the large intestine or vomiting blood.
- Neuropsychiatric disorders, as described below.
If you notice any of these symptoms, seek medical help immediately.
The most frequently reported adverse effects (very common and common) for Tamiflu are malaise or discomfort (nausea, vomiting), stomach pain, stomach discomfort, headache, and pain. These adverse effects usually occur after the first dose of the medicine and generally resolve during the course of treatment. The frequency of these effects is reduced if the medicine is taken with food.
Rare but serious adverse effects: seek medical help immediately
(These may affect up to 1 in 1,000 people)
Rare adverse effects have been reported during treatment with Tamiflu, including:
- seizures and delirium, including altered levels of consciousness
- confusion, abnormal behavior
- delirious disorders, hallucinations, agitation, anxiety, nightmares
These events were mainly reported in children and adolescents and often began suddenly and resolved quickly. In very rare cases, these events resulted in self-harm, some with fatal outcomes. These neuropsychiatric events have also been reported in influenza patients who were not taking Tamiflu.
- Patients, especially children and adolescents, should be closely monitored for the behavioral changes described above.
If you notice any of these symptoms, especially in younger patients, seek medical help immediately.
Adults and adolescents aged 13 years and older
Very common adverse effects
(may affect more than 1 in 10 people)
- Headache
- Nausea
Common adverse effects
(may affect up to 1 in 10 people)
- Bronchitis
- Chills
- Cough
- Dizziness
- Fever
- Pain
- Limb pain
- Runny nose
- Difficulty sleeping
- Sore throat
- Stomach pain
- Fatigue
- Feeling of fullness in the upper abdomen
- Upper respiratory tract infections (inflammation of nose, throat, and sinuses)
- Stomach discomfort
- Vomiting
Uncommon adverse effects
(may affect up to 1 in 100 people)
- Allergic reactions
- Altered level of consciousness
- Convulsion
- Changes in heart rhythm
- Mild to severe liver function disorders
- Skin reactions (skin inflammation, red itchy rash, scaly skin)
Rare adverse effects
(may affect up to 1 in 1,000 people)
- Thrombocytopenia (reduced number of platelets)
- Vision disorders
Children aged 1 to 12 years
Very common adverse effects
(may affect more than 1 in 10 people)
- Cough
- Nasal congestion
- Vomiting
Common adverse effects
(may affect up to 1 in 10 people)
- Conjunctivitis (red, watery, or painful eyes)
- Ear inflammation and other ear disorders
- Headache
- Nausea
- Runny nose
- Stomach pain
- Feeling of fullness in the upper abdomen
- Stomach upset
Uncommon adverse effects
(may affect up to 1 in 100 people)
- Skin inflammation
- Tympanic membrane disorder (eardrum)
Infants under 1 year of age
Adverse effects reported in children aged 0 to 12 months are mostly similar to those reported in older children (aged 1 year and above). In addition, diarrhea and diaper dermatitis have been reported.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist. However,
- ? if you or your child have repeated episodes of illness, or
- ? if influenza symptoms worsen or fever persists
Inform your doctor as soon as possible.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tamiflu
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the pack and on the bottle after EXP. The expiry date refers to the last day of the month indicated.
Powder: Do not store above 30 °C.
After reconstitution, the suspension may be stored at room temperature (below 25 °C) for 10 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tamiflu
- The active substance is:
- oseltamivir (6 mg/ml of oseltamivir after reconstitution).
- The other components are: sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum (E415), sodium benzoate (E211), sodium saccharin (E954), titanium dioxide (E171), and tutti frutti flavour (containing maltodextrins (corn), propylene glycol, gum arabic E414, and flavouring substances identical to natural ones (mainly banana, pineapple, and peach flavours)) (see section 2 "Tamiflu contains sorbitol, sodium benzoate, and sodium").
Nature of the product and contents of the pack
Powder for oral solution.
The powder is a granule or agglomerated granule of white to pale yellow colour.
Tamiflu 6 mg/ml powder for oral suspension is available in bottles containing 13 g of powder to be mixed with 55 ml of water.
The pack also contains 1 plastic measuring cup (55 ml), 1 plastic bottle adapter (to assist in inserting the product into the dispenser), 1 plastic oral dispenser of 3 ml, and 1 plastic oral dispenser of 10 ml (to administer the correct amount of medicine orally). The oral dispenser has millilitre (ml) markings for the medicine (see figures in Instructions for the User).
For further details on how to prepare the oral suspension and how to measure and take the medicine, please read the Instructions for the User page.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 79639 Grenzach-Wyhlen
Germany
Further information on this medicine is available upon request to the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium N.V. Roche S.A. Tel/Tel: +32 (0) 2 525 82 11 | Lithuania UAB “Roche Lietuva” Tel: +370 5 2546799 |
| Luxembourg/Luxembourg (See/siehe Belgium/Belgium) |
Czech Republic Roche s. r. o. Tel: +420 - 2 20382111 | Hungary Roche (Hungary) Kft. Tel: +36 - 1 279 4500 |
Denmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 99 | Malta (See Ireland) |
Germany Roche Pharma AG Tel: +49 (0) 7624 140 | Netherlands Roche Nederland B.V. Tel: +31 (0) 348 438050 |
Estonia Roche Eesti OÜ Tel: + 372 - 6 177 380 | Norway Roche Norge AS Tlf: +47 - 22 78 90 00 |
Greece Roche (Hellas) A.E. Tel: +30 210 61 66 100 | Austria Roche Austria GmbH Tel: +43 (0) 1 27739 |
Spain Roche Farma S.A. Tel: +34 - 91 324 81 00 | Poland Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88 |
France Roche Tél: +33 (0) 1 47 61 40 00 | Portugal Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00 |
Croatia Roche d.o.o Tel: +385 1 4722 333 | Romania Roche România S.R.L. Tel: +40 21 206 47 01 |
Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700 | Slovenia Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00 |
Iceland Roche Pharmaceuticals A/S c/o Icepharma hf Tel: +354 540 8000 | Slovakia Roche Slovensko, s.r.o. Tel: +421 - 2 52638201 |
Italy Roche S.p.A. Tel: +39 - 039 2471 | Finland/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500 |
Cyprus G.A.Stamatis & Sia Ltd. Tel: +357 - 22 76 62 76 | Sweden Roche AB Tel: +46 (0) 8 726 1200 |
Latvia Roche Latvija SIA Tel: +371 - 6 7039831 |
Date of the most recent review of this leaflet: {MM/AAAA}.
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu/.
Instructions for the user
Do not use if the packaging is damaged, or if any of the supplied materials are missing or damaged.
- Contact your doctor or pharmacist if the dispenser is missing or damaged (e.g., the dose marking is no longer clearly visible or it is difficult to handle). They will advise you on how to continue taking your medication.
Use and clean the oral dispenser as described in these instructions to avoid any possible contamination.
Wash your hands before and after using the product.
There are two steps to take the oral suspension.
Step 1 Prepare a new bottle of medicine
Your pharmacist may have already prepared the medicine when you collected your prescription. If not, you can easily prepare it yourself. See the first set of instructions. You only need to do this once, when starting treatment.
Step 2 Measure and administer the correct dose
Shake the suspension well and withdraw the appropriate recommended dose using the dispenser. See the second set of instructions. You will need to do this every time you need to take a dose.
Step 1 Prepare a new bottle of medicine
You will need:
? The bottle containing Tamiflu powder (in the medicine package), with the bottle cap attached
? A plastic measuring cup (in the medicine package)
? The plastic bottle adapter (in the medicine package)
? Water
? Tap the bottle to loosen the powder
Gently tap the closed bottle several times to loosen the powder
? Use the cup to measure 55 mL of water
The measuring cup included in the package has a marked line to show you the exact amount.
Fill it with water up to the indicated level.
? Add water, close and shake
Pour all the water from the cup into the bottle, over the powder.
Always use 55 mL of water, regardless of the dose required.
Put the cap on the bottle. Shake the bottle well for 15 seconds.
? Press in the adapter
Open the bottle and firmly press the bottle adapter into the neck of the bottle.
? Close the bottle again
Screw the cap tightly onto the top of the bottle, which now includes the adapter. This will ensure that the adapter fits securely in the bottle in the correct position.
You now have a prepared bottle of Tamiflu oral suspension ready for measuring and administering a dose. You will not need to prepare it again until you start a new bottle.
Step 2: Measure and administer the correct dose
You will need:
? A prepared bottle of Tamiflu oral suspension
? Depending on the required dose, you will need either the 3 mL oral dispenser (orange plunger, 0.1 mL graduations) or the 10 mL oral dispenser (transparent plunger, 0.5 mL graduations) included in the package.
? For doses from 1.0 mL to 3.0 mL, use the 3 mL oral dispenser. For doses above 3.0 mL up to 10 mL, use the 10 mL oral dispenser.
Always use the oral dispenser supplied in the package to measure the correct dose.
? Shake the bottle
Ensure the bottle is tightly closed, then shake the Tamiflu oral suspension bottle.
Always shake well before use.
? Prepare the oral dispenser
Depending on the required dose, use either the 3 mL oral dispenser (orange plunger) or the 10 mL oral dispenser (transparent plunger) provided in the package.
Press the plunger fully down to the tip of the dispenser.
? Fill the dispenser with the correct dose
Unscrew the cap from the bottle.
Insert the tip of the dispenser into the adapter on the bottle.
Rotate the assembly (bottle and dispenser together) until the top is in the inverted position.
Slowly pull the plunger to draw the medicine into the dispenser.
Stop at the graduation mark corresponding to the dose required.
Rotate the assembly back to the upright position.
Remove the dispenser from the bottle.
? Administer the medicine directly into the mouth
To avoid choking or vomiting, ensure the person is in an upright position. Place the oral dispenser into the mouth with the tip along the cheek. Slowly push the plunger fully down, and do not forcefully inject into the back of the throat.
Ensure that all the medicine has been swallowed.
After taking the medicine, the person may drink fluids or eat food.
? Close the bottle and store safely
Replace the cap on the bottle. Keep out of sight and reach of children.
Store the medicine below 25 °C for up to 10 days. See section 5. Storage of Tamiflu, in this leaflet.
- Clean the dispenser
Immediately after administration, separate the parts of the dispenser and wash both parts under tap water until all residue is removed. If tap water is not available, rinse with clean water (e.g., distilled water).
Do not sterilize or boil the oral dispenser, or place it in boiling water, to avoid damage. Allow the dispenser to air-dry before next use.
For storage, keep the dispenser dry and protected from direct sunlight.
Do not discard the oral dispenser, as it must be used multiple times. Only after final use, dispose of the oral dispenser according to local regulations.