Griptavir med

Patient Information Leaflet

Griptavir Med, 75 mg, hard capsules
Oseltamivirum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Griptavir Med is and what it is used for
2. What you need to know before taking Griptavir Med
3. How to take Griptavir Med
4. Possible side effects
5. How to store Griptavir Med
6. Contents of the pack and other information

1. What Griptavir Med is and what it is used for

Griptavir Med contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the influenza virus in the body. They help reduce symptoms or prevent their occurrence in case of infection with the influenza virus.

• Griptavir Med is used in adults, adolescents, children, and infants (including full-term newborns) for the treatment of influenza. It may be used when influenza symptoms occur and when it is known that the influenza virus is circulating in the community.
• Griptavir Med may also be prescribed to adults, adolescents, children, and infants over 1 year of age for prevention of influenza. Each case is considered individually—for example, if the patient has been in contact with someone diagnosed with influenza.
• Griptavir Med may be prescribed to adults, adolescents, children, and infants (including full-term newborns) as prophylactic treatment in exceptional circumstances, such as during a global influenza epidemic (pandemic), when the seasonal influenza vaccine does not provide sufficient protection.

Influenza is an infectious disease caused by a virus. Influenza symptoms often include sudden onset of fever (above 37.8°C), cough, runny or stuffy nose, headache, muscle aches, and extreme fatigue. These symptoms may also be caused by other infections. True influenza infection occurs only during seasonal outbreaks (epidemics) when the influenza virus is spreading in the local community. Outside epidemic periods, influenza-like symptoms are usually due to other illnesses.

2. Important information before using Griptavir Med

When not to use Griptavir Med

• if the patient is allergic to oseltamivir or to any of the other ingredients of this medicine (listed in section 6). In such a case, consult a doctor. Do not use Griptavir Med.

Warnings and precautions
Before starting treatment with Griptavir Med, discuss this with your doctor, pharmacist, or
nurse.
Inform the doctor who prescribed the medicine:

• if the patient is allergic to other medicines,
• if the patient has kidney disease. If so, the dose may need to be adjusted,
• if the patient has severe illnesses that may require immediate hospital treatment,
• if the immune system is not functioning properly,
• if the patient has chronic heart disease or chronic respiratory disease.

During treatment with Griptavir Med, inform the doctor immediately:

• if the patient experiences changes in behavior or mood (neuropsychiatric events), especially in children and adolescents. These symptoms may be rare but serious adverse reactions.

Griptavir Med is not an influenza vaccine
Griptavir Med is not a vaccine: it is used to treat influenza infection or to prevent the spread of
the influenza virus. Vaccines provide antibodies against the virus. Griptavir Med does not affect
the efficacy of influenza vaccination, and the doctor may prescribe both products.
Griptavir Med and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to use. This includes also medicines available
without a prescription. The following medicines are particularly important:

• chlorpropamide (used in the treatment of diabetes),
• methotrexate (used in the treatment of, for example, rheumatoid arthritis),
• phenylbutazone (used in the treatment of pain and inflammatory conditions),
• probenecid (used in the treatment of gout).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before using this medicine.
The effect of Griptavir Med on breastfed infants is unknown. Inform the doctor if the patient is
breastfeeding so that he or she can decide whether Griptavir Med is the appropriate medicine.
Before using this medicine, consult a doctor or pharmacist.
Driving and operating machinery
Griptavir Med has no influence on the ability to drive or operate machinery.
Griptavir Med contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Griptavir Med

This medicine should always be used exactly as your doctor has told you. If you are unsure,
you should consult your doctor or pharmacist.
Griptavir Med should be taken as soon as possible, preferably within the first two days after
flu symptoms appear.
Recommended dosage
For the treatment of influenza, take two doses per day, usually one in the morning and one in
the evening. It is important to complete the full 5-day treatment course, even if your
condition improves quickly.
For patients with weakened immune systems, treatment will continue for 10 days.
For prevention of influenza or after contact with an infected person, take one dose per day
for 10 days, preferably in the morning with breakfast.
In special circumstances, such as during an influenza outbreak or if the patient has a weakened
immune system, treatment may last up to 6 weeks or 12 weeks.
The recommended dose is calculated based on the patient's body weight. Take the number of
capsules or the amount of oral suspension prescribed by your doctor.
Adults and adolescents aged 13 years and older

For patients with weakened immune systems, treatment lasts 10 days.
Children aged 1 to 12 years

In children with weakened immune systems, treatment lasts 10 days.
Infants under 1 year of age (0–12 months)
The decision to administer the medicinal product Griptavir Med to infants under 1 year of age for prophylaxis during an influenza pandemic should be made by the attending physician after evaluating the potential benefits against the potential risks for the infant.

*In infants with weakened immune systems, treatment lasts 10 days.
**mg per kg = mg per each kilogram of the infant's body weight. For example:
in a six-month-old infant weighing 8 kg, the dose is 8 kg x 3 mg per kg = 24 mg
Method of administration
Capsules should be taken with water. Capsules must not be divided or chewed.
Griptavir Med may be taken with food or on an empty stomach. Taking the medicine with food
reduces the risk of nausea or vomiting.
Patients who have difficulty swallowing capsules may use oseltamivir in liquid form
(oral suspension). If the patient requires suspension but the suspension is not available at the pharmacy,
a liquid formulation of oseltamivir can be prepared from capsules. Instructions, see Preparation of the liquid formulation
of Griptavir Med at home.
Accidental overdose of Griptavir Med
Discontinue taking Griptavir Med and contact a doctor or pharmacist immediately.
In most cases of overdose, no adverse effects were reported. When adverse effects occurred, they were similar to those observed after recommended doses, as described in section 4.
Overdose has been reported more frequently following oseltamivir administration in children than in adults and adolescents. Caution must be exercised when preparing the liquid formulation of oseltamivir for children and when administering oseltamivir to children in capsule or liquid form.
Missed dose of Griptavir Med
Do not take a double dose to make up for a missed capsule.
Discontinuation of Griptavir Med
There are no adverse effects associated with stopping Griptavir Med. However, if treatment is discontinued earlier than recommended by the physician, influenza symptoms may recur. Always complete the treatment course as directed by the physician.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Many of the adverse reactions listed below may also be caused by influenza itself.
The following serious adverse reactions have been reported rarely after oseltamivir became available on the market:

• anaphylactic and anaphylactoid reactions: severe allergic reactions with facial and skin swelling, itchy rash, low blood pressure and breathing difficulties
• liver disorders (fulminant hepatitis, hepatic function abnormalities and jaundice): yellowing of the skin and whites of the eyes, change in stool colour, changes in behaviour
• angioedema: sudden, pronounced swelling of the skin, mainly affecting the head and neck area, including eyes and tongue, accompanied by breathing difficulties
• Stevens-Johnson syndrome and toxic epidermal necrolysis: complex, potentially life-threatening allergic reactions, severe inflammatory conditions affecting external and even internal layers of the skin, starting with fever, sore throat and fatigue, skin rash progressing to blisters, peeling and shedding of large areas of skin, possibly accompanied by breathing difficulties and low blood pressure
• gastrointestinal bleeding: prolonged bleeding from the large intestine or haemoptysis
• neuropsychiatric disorders, as described below. If any of these symptoms occur, seek immediate medical help.

The most frequently (very common and common) reported adverse reactions with oseltamivir are: nausea, vomiting, stomach ache, indigestion, headache and pain. These symptoms usually occur only after the first dose and typically resolve during continued treatment. The frequency of these adverse reactions decreases if the medicine is taken with food.

Rare but serious adverse reactions: consult a doctor immediately
( may occur in 1 out of 1000 people )
Rare cases have been reported during oseltamivir use:

• seizures and delirium, including disturbances of consciousness,
• confusion, abnormal behaviour,
• hallucinations, illusions, agitation, restlessness, nightmares.
  The above events, which often had a sudden onset and resolution, were observed primarily in children and adolescents. In isolated cases, they led to self-harm, sometimes resulting in death. Similar neuropsychiatric events have also been observed in influenza patients who did not receive oseltamivir.

Patients, especially children and adolescents, should be closely monitored for behavioural changes as described above. If any of these symptoms occur, especially in young individuals, seek immediate medical advice.

Adults and adolescents aged 13 years and older
Very common adverse reactions ( may occur in more than 1 out of 10 people ):

• headache, nausea.

Common adverse reactions ( may occur in up to 1 out of 10 people ):

• bronchitis, herpes labialis, cough, dizziness, fever, pain, limb pain, watery nasal discharge, sleep disturbances, sore throat, stomach pain, fatigue, feeling of fullness in the upper abdomen, upper respiratory tract infections (rhinitis, pharyngitis and sinusitis), indigestion, vomiting.

Uncommon adverse reactions ( may occur in up to 1 out of 100 people ):

• allergic reactions, disturbances of consciousness, seizures, cardiac arrhythmias, mild to severe hepatic function disorders, skin reactions (dermatitis, red and itchy rash, skin peeling).

Rare adverse reactions ( may occur in up to 1 out of 1000 people ):

• thrombocytopenia (low platelet count), visual disturbances.

Children aged 1 to 12 years
Very common adverse reactions ( may occur in more than 1 out of 10 people ):

• cough, nasal mucosal congestion, vomiting.

Common adverse reactions ( may occur in up to 1 out of 10 people ):

• conjunctivitis (red eyes with discharge or eye pain), otitis and other ear disorders, headache, nausea, watery nasal discharge, stomach pain, feeling of fullness in the upper abdomen, dyspepsia.

Uncommon adverse reactions ( may occur in up to 1 out of 100 people ):

• dermatitis, tympanic membrane disorders.

Infants under 1 year of age
Adverse reactions reported in infants aged 0 to 12 months are most commonly similar to those reported in older children (aged 1 year and above). In addition, diarrhoea and diaper rash have been reported.
If any adverse reaction worsens, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

• if the patient or their child vomits repeatedly, or
• if influenza symptoms worsen or fever persists, inform the doctor as soon as possible.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Griptavir Med

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "Tw".
The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Griptavir Med contains

• The active substance is oseltamivir phosphate. Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
• The other ingredients are:
  Capsule filling: pregelatinized maize starch, povidone K30, sodium croscarmellose, talc, sodium stearyl fumarate.
  Capsule shell (body and cap): gelatin, yellow iron oxide (E 172), erythrosine (E 127).

What Griptavir Med looks like and contents of the pack
Griptavir Med is an elongated, orange, hard capsule with a smooth surface, size “2”, measuring approximately 6.13 × 17.79 mm, containing a white or off-white granular or loosely compressed powder.
One pack contains 10 hard capsules in blisters made of OPA/Aluminium/PVC/Aluminium or PVC/PVDC/Aluminium, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Product Information
Tel.: (22) 742 00 22
E-mail: [email protected]

Information for the user
For patients who have difficulty swallowing capsules, including very young children, oseltamivir is available as an oral liquid suspension.
If the liquid formulation is not available, a suspension can be prepared in the pharmacy from Griptavir Med capsules (see Information intended exclusively for healthcare professionals). The pharmacy-prepared formulation is preferred.
If the pharmacy-prepared formulation is also unavailable, the liquid form of Griptavir Med can be prepared at home from the capsules.
The doses are the same for both treatment and prevention of influenza. The difference lies in the frequency of administration.

Preparation of the liquid form of Griptavir Med at home

• If the patient has the appropriate capsules for the required dose (75 mg dose), open the capsule and mix its contents with a teaspoon (or less) of a suitable sweetened food product. This dose is generally suitable for children over 1 year of age. See the first part of the instructions.
• If the patient requires a lower dose, preparing the liquid form of Griptavir Med from capsules involves additional steps. These are appropriate for younger children and infants who usually require an oseltamivir dose lower than 30 mg. See the second part of the instructions.

Adults, adolescents aged 13 years and older, and children weighing 40 kg or more
To prepare a 75 mg dose, the following are required:

• One Griptavir Med 75 mg capsule
• Sharp scissors
• One small bowl
• One teaspoon (5 ml)
• Water
• A sweet food to mask the bitter taste of the powder, e.g.: chocolate or cherry syrup, or dessert toppings such as caramel or nougat sauce. Alternatively, sugar water can be prepared: mix one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Check that the dose is correct
To determine the correct dose, locate the patient’s body weight in the left column of the table. Then check the number of capsules required for a single dose in the right column. The amount is the same for both treatment and prevention of influenza. Only 75 mg capsules should be used to prepare the 75 mg dose.

Not intended for children weighing less than 40 kg.
Doses less than 75 mg should be prepared for children weighing less than 40 kg.
See below.
Step 2: Pour all the powder into a bowl
Hold the 75 mg capsule vertically over the bowl and carefully cut off the rounded end with scissors.
Pour all the powder into the bowl.
Handle the powder with care, as it may be irritating to the skin and eyes.

Step 3: Sweeten the powder and administer the dose
Add a small amount – no more than one teaspoon – of sweet food to the
powder in the bowl.
This is to neutralize the bitter taste of Griptavir Med powder. Mix well.

Immediately administer the entire contents of the bowl to the patient.
If any residue of the mixture remains in the bowl, rinse the bowl with a small amount of water and
give the patient all of the rinse to drink.
Repeat these steps each time the medicine is administered.
Infants under 1 year of age and children weighing less than 40 kg
To prepare a smaller dose, the following will be needed:

• One 75 mg capsule of Griptavir Med
• Sharp scissors
• Two small bowls
• One large oral dosing device to measure water – a 5 or 10 ml dosing syringe
• One small oral dosing device marked in 0.1 ml increments, for administering the dose
• One teaspoon (5 ml volume)
• Water
• Sweet food to neutralize the bitter taste of Griptavir Med, e.g., chocolate or cherry syrup, or dessert toppings such as caramel or nougat sauce. Alternatively, sugar water can be prepared: mix one teaspoon of water with three quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl
Hold the 75 mg capsule vertically over one of the bowls and carefully cut off the rounded end
with scissors. Handle the powder with care, as it may be irritating to the skin and eyes.
Pour all the powder into the bowl, regardless of the dose being prepared.
The amount is the same for both treatment and prevention of influenza.

Step 2: Add water to dissolve the medicine
Use the larger dosing device to draw up 12.5 ml of water. Add the water to the powder in the bowl.
Mix the contents with a spoon for about 2 minutes.

Do not be concerned if some of the powder does not dissolve. The undissolved powder is inactive ingredient.
Step 3: Select the volume appropriate for the child's body weight
Find the child's body weight in the left column of the table.
The right column of the table indicates the volume of the liquid mixture to be administered.
Children under 1 year of age (including full-term newborns)

Children aged 1 year or older, with body weight less than 40 kg

Step 4: Draw up the liquid mixture
Ensure that the correct volume dispenser is used.
Draw up the appropriate amount of liquid mixture from the first container.
Do this carefully to avoid introducing air bubbles. Gently squeeze the correct dose into the second container.

Step 5: Sweeten and administer to the child
Add a small amount – no more than one teaspoon – of sweet food to the second container. This will help neutralize the bitter taste of Griptavir Med.
Mix the sweet food thoroughly with the liquid form of Griptavir Med.

Immediately administer the entire contents of the second container (the liquid mixture of Griptavir Med with the sweet food) to the child.
If any amount remains in the second container, rinse the container with a small amount of water, and give the child all of it to drink. For children unable to drink from a container, use a spoon or a baby feeding bottle to administer the remaining liquid.
Give the child something to drink.
Dispose of any unused liquid form remaining in the first container.
Repeat the above steps each time the medicine is administered.

Information intended exclusively for healthcare professionals

Patients unable to swallow capsules:
Manufactured oseltamivir oral suspension powder (6 mg/ml)
is the preferred product for children, adolescents, and adult patients who have difficulty
swallowing capsules or when lower doses are required. When oseltamivir oral suspension powder
is not available on the market, the pharmacist may prepare an oral suspension (6 mg/ml) from Griptavir Med capsules. If pharmacy-prepared suspension is also unavailable, patients may prepare the suspension at home from the capsules.
Oral dosing devices (oral syringes) of appropriate volume and graduations should be provided
to administer both pharmacy-prepared suspensions and for procedures related to home preparation of the product. In both cases, dosing devices should be clearly marked with the correct volumes. When preparing the suspension at home, separate dosing devices should be used to measure the correct amount of water and to measure the Griptavir Med mixture with water. To measure 12.5 ml of water, 10 ml dosing devices should be used.
The appropriate dosing device capacity to be used for measuring the correct volume of Griptavir Med suspension (6 mg/ml) is shown below.
Infants under 1 year of age (including full-term newborns):

Children aged one year or older, with body weight less than 40 kg: