Intended use for children over six years old, teenagers, and adults
Read thoroughly all the leaflet for the drug before intake as it is an important information
• Do not throw out this leaflet. You may probably need to read it again
• In case of additional information, consult a doctor or a pharmacist
• The drug is prescribed only for you. Do not give it to some else. It may cause harm even if the symptoms are similar
• In case of side effects consult a doctor or a pharmacist. Side effects intend also those not listed in the leaflet
Content of leaflet:
1. What Flucaps is and its usage
2. What it is necessary to know before Flucaps use
3. How to take Flucaps
4. Eventual side effects
5. How to store Flucaps
6. Content of pack and other information

1. What Flucaps is and its usage
Flucaps is administered for treatment of influenza in adults and children over six. It is also administered for influenza symptoms and if influenza virus is known to spread in your region.
Flucaps can be administered to adults and children over 6 as a preventive measure if they contacted sick persons.
Flucaps can also be administered to children over 6 as a preventive measure only as an exception like flu epidemic (flu pandemic) conditions and seasonal flu vaccine cannot provide sufficient protection.
Flucaps is not a substitute for vaccination
Flucaps composition: Ostelmavir is a member of a new class of antiviral agents Neuraminidase Inhibitors. These agents prevent the influenza virus spread in organism. They assist in relieving and prevention of influenza virus infection.
Influenza is a virus infection. Flu signs are often like a sudden fever (higher than 37.8oC), cough, rhinitis and stuffiness in nose, headache, muscle pains, and high fatigue. These symptoms can also be caused by other infections. More often flu infection occurs during annual episodes (epidemics) when flu viruses spread among the population. Beyond epidemic periods flu symptoms are caused by other types of diseases.

2. What it is necessary to know before Flucaps use
Do not take Flucaps, capsules, in the conditions below:
Allergy (hypersensitivity) to Ostelmavir or any other components of Flucaps listed in section 6.
Inform your physician hereabout. Do not take Flucaps!

Warnings and safety measures
Consult your physician or pharmacist before intake of Flucaps:
- If you have allergy to other drugs;
- If you have kidney diseases. In this case dose correction may be needed;
- If you have a severe diseases requiring an immediate hospitalization;
- If you have immune disorders;
- If you have chronic heart and/or respiratory diseases.
In the period of treatment with Flucaps inform immediately your physician:
If you notice behavior and mood alteration (neuropsychic disorder), in particular in children and teenagers. These may be the signs of rare but severe side effects.
Flucaps is not a flu vaccine
Flucaps is not a flu vaccine, it cures the infection or prevents flu virus spreading. The vaccine produces antibodies to virus. Flucaps does not affect flu vaccine efficacy and your physician will prescribe both vaccine and Flucaps to you.

Intake of Flucaps and other drugs
Inform your physician or pharmacist if you take other drugs now or not long ago. These are also OTC drugs. The following ones are especially important:
- Chlorpropamide (for diabetes);
- Methotrexate (for rheumatoid arthrosis, for example);
- Phenylbutazone (for pains and inflammation);
- Probenecid (for podagra).

Pregnancy and breastfeeding period
You shall inform your physician if you are pregnant, if you think you are pregnant or try to get pregnant, then the physician will decide if Flucaps is suitable.
Impact on infants is unknown. If you breast-feed, you shall inform your physician and he will take the decision whether Flucaps is suitable for you.
Before using the drug consult a doctor or pharmacist.

Effect on ability of operating motor vehicles and mechanisms
Flucaps does not affect your ability to drive or operate mechanisms.

3. How to take Flucaps
Take the drug exactly following your physician’s indications. If you are not sure consult your physician or pharmacist.
Start Flucaps intake as soon as possible, ideally within two days after the manifestation of flu symptoms.

Dosage
Recommended dose:
2 capsules daily for influenza treatment. Usually one capsule in the morning and one capsule in the afternoon are very suitable. It is important to maintain 5-day course even if you feel better rapidly.
For patients with weak immune system the course of cure is 10 days.
For prevention of flu and after contacts with infected person take 1 capsule a day for 10 days. It is better to take a capsule during breakfast.
In special situations like a widely spread influenza or in patients with weak immune system the prevention course can last from 6 to 12 weeks.
Recommended dose depends on patient’s body weight. You shall take your does and as many peroral capsules as administered by a physician

Adults and teenagers of 13 years old and over
Body weight Recommended dose for flu cure during 5 days * Recommended dose for flu cure in patients with weak immune system during 10 days Recommended dose for flu prevention during 10 days
>40 kg 75 mg** 2 times daily 75 mg** 2 times daily 75 mg** 1 time daily
* For patients with weak immune system, course of treatment is 10 days.
** 75 mg dose can be composed of capsule 30 mg and capsule 45 mg.

Children from 6 years old to over 12
Body weight Recommended dose for flu treatment during 5 days * Recommended dose for flu cure in patients with weak immune system during 10 days Recommended dose for flu prevention during 10 days
10  15 kg 30 mg 2 times daily 30 mg 2 times daily 30 mg 1 time daily
15-23 kg 45 mg 2 times daily 45 mg 2 times daily 45 mg 1 time daily
23-40 kg 60 mg 2 times daily 60 mg 2 times daily 60 mg 1 time daily
>40 kg 75 mg** 2 times daily 75 mg** 2 times daily 75 mg** 1 time daily
* For patients with weak immune system, course of treatment is 10 days.
** 75 mg dose can be composed of capsule 30 mg and capsule 45 mg.
Route of administration
Swallow an integral capsule with water. Do not open and do not masticate the capsule.
Swallow Flucaps with or without meal, still intake with meal can reduce an eventual ailment or nausea (or vomit).
Patients may use liquid dosage forms of Ostelmavir if experience difficulty to swallow the capsules.

If the dose of Flucaps taken exceeded the prescribed one
Cease Flucaps intake and immediately call the doctor or pharmacist.
In most overdose events the patients did not report side effects. If so, they were similar as of common doses indicated in section 4.
It is reported that the rate of Ostelmavir overdose in children is more often than in adults and teenagers. Take precautions before administer the drug to children.

If you forgot to take your dose of Flucaps
Do not take a double dose to recover lost capsules

If you interrupted Flucaps intake
In case of termination of Flucaps intake side effects are not reported. Still, if you interrupted Flucaps intake prior to doctor’s indications, the symptoms can eventually recur. Always follow the course of treatment prescribed by your physician.
If you need additional information about the drug call you physician or pharmacist.

4. Eventual side effects
Like all other drugs this can cause side effects though they appear not in all the patients. Many of side effects listed below can be provoked by influenza.
Serious side effects listed below have been reported rarely since Ostelmavir appeared in the market:
- Anaphylactic and anaphylactoid reactions: severe allergic reactions with facial and cutaneous edema, pruritic rash, hypotension and heavy breathing
- Hepatic disorder (fulminant hepatitis, hepatic dysfunction and jaundice), yellow skin and sclera (white of the eye), stool color change and changes in the behavior
- Antineurotic edema: sudden severe cutaneous edema mainly around the head and neck, swelling eye and tongue, heavy breathing
- Stevens-Jonson syndrome and toxic epidemic necrosis: severe allergic reaction eventually dangerous for life, acute cutaneous inflammation, initially with fever, sore throat and fatigue, skin rash causing the formation of cutaneous blisters, loss of hair on large areas of skin, possible heavy breathing and hypotension
- Gastrointestinal disorder with bleeding: prolonged colon bleeding or regurgitation with blood
- Psychoneurotic disorders described below.
If you evidenced any of these symptoms call immediately for medical assistance.
Most often (very often and often) side effects: nausea, vomit, abdominal pains, dyspepsia, headache, dizziness.
These side effects mainly appear after the first dose of the drug and usually disappear during the treatment course. The frequency rate of side effects diminishes when you take Ostelmavir with meal.
Rare cases were reported during treatment with Ostelmavir like convulsions and deliria, cognitions alteration, abnormal behavior, delirium, hallucinations, excitation, anxiety, nightmare. They are more often in children and teenagers, begin mainly unexpectedly and are resolved very soon. Some cases of self-mutilation were reported, even with fatal outcome. Similar psychoneurological events were reported also in patients with influenza who did not take Ostelmavir.
Patients, in particular children and teenagers, are subject to a careful control for behavior changes described above.
If you observe some of these symptoms in young people seek for medical assistance immediately.
Adults and teenagers of 13 and over
Very often side effects (can appear in over 1/10 persons): headache, nausea
Often side effects (can appear in over 1/100 persons): bronchitis, herpes simplex, nasopharyngitis, upper airways infections (nose, throat and sinus inflammation), cough, rhinitis, sore throat, dizziness, high temperature, limb pain, fatigue, abdominal pain, gastric disorder, vomit, insomnia.
Not often side effects (can appear in over 1/1000 persons): allergic reactions, confused consciousness, convulsions, cardiac rhythm disturbance, slight to severe hepatic disorder, skin reactions (cutaneous inflammation, red and itch rush, skin desquamation).
Rare side effects (can appear in over 1/10000 persons): thrombocytopenia (low concentration of thrombocytes), vision disorder.
Children of 6 to 12
Very often side effects (can appear in over 1/10 persons): cough, stuffiness in nose, vomit
Often side effects (can appear in over 1/100 persons): conjunctivitis (red eyes and discharge or pain in eyes), ear pain, middle ear inflammation, rhinitis, nausea, abdominal pain, gastric disorder.
Not often side effects (can appear in over 1/1000 persons): cutaneous inflammation, tympanic membrane disease.
If some of these side effects are severe or you notice side effects not listed in the leaflet, inform your physician or pharmacist.
If you or your child is often ill or if the symptoms of influenza deteriorate or the fever resists inform your physician as soon as possible,
Reports on side effects.
If you notice undesirable reactions inform your physician. These are all undesirable reactions not mentioned in the leaflet. You may also send the report on undesirable reactions (actions) to the drug in database including the communications about lack of effect of the drugs revealed in The Republic of Belarus (Center for Expertize and Trials in Healthcare UP under Ministry of health of The Republic of Belarus http:www.rceth.by). The reports on undesirable reactions will help to get more data on safety of drugs.

5. How to store Flucaps
Store away from children

Shelf-life 2 years
Use before the expiration date indicated on the pack. Expiration date intends the last day of month indicated on the pack.
Store protected from moisture at 25°C.
Do not dispose the drug in waste waters or with household wastes. Consult a pharmacist how to dispose the drugs you do not need anymore. These measures will help to protect the environment

6. Content of pack and other information
What is the composition of Flucaps
Hard Gelatine Capsule composition: Ostelmavir phosphate, equivalent to 75 mg, 45 mg or 30 mg of Ostelmavir.

Capsule content: pre-gelatinized potato starch, Povidone K 30, Croscarmellose Sodium, talc, Sodium stearyl fumarate, Silicon dioxide colloidal (Aerosil 200).
30 mg-capsule shell composition: Gelatine, Water purified, Titanium dioxide E-171.
45 mg-capsule and 75 mg-capsule shell composition: Gelatine, Water purified, Titanium dioxide E-171, Iron oxide E-172.

Description
• Hard Gelatine Capsule of cylindrical shape, rounded hemispherical ends, white body and white cap (dose 30 mg)
• Hard Gelatine Capsule of cylindrical shape, rounded hemispherical ends, white body and light yellow cap (dose 45 mg)
• Hard Gelatine Capsule of cylindrical shape, rounded hemispherical ends, light yellow body and cap (dose 75 mg)
Capsule fill: white or off-white powder.

Dosage form
Blister #10, 1 blister per pack with leaflet

Sale conditions
Under doctor’s prescription