TALOXA 600 mg /5 Ml Оральная Суспензия

Содержание инструкции

1. TALOXA 600 mg tablets
   1. What is Taloxa and what is it used for
   2. What you need to know before you take Taloxa
   3. How to take Taloxa
   4. Possible side effects
   5. How to store Taloxa
   6. Contents of the pack and other information
2. TALOXA 600 mg/5 ml oral suspension
   1. What is Taloxa and what is it used for
   2. What you need to know before taking Taloxa
   3. How to take Taloxa
   4. Possible side effects
   5. How to store Taloxa
   6. Package contents and other information

TALOXA 600 mg tablets

felbamate

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Taloxa and what is it used for

What is Taloxa
Taloxa is an antiepileptic medicine.

What is Taloxa used for
Taloxa is not indicated for the treatment of children under 4 years of age.
Taloxa is used in adult patients and children 4 years of age and older with Lennox-Gastaut syndrome whose epileptic disorders are not controlled by other antiepileptic agents. Taloxa
tablets are used in association with other medicines to control epileptic seizures and
convulsions.

2. What you need to know before you take Taloxa

Do not take Taloxa

• if you are allergic to felbamate or any of the other ingredients of this medicine (listed in section 6).
• if you have a history of blood problems (such as anemia, low red blood cell count, bleeding disorders, bruising, frequent infections) or liver problems (such as jaundice [yellowing of the whites of the eyes or skin] or hepatitis). If you have had blood or liver problems in the past, inform your doctor before taking Taloxa tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking Taloxa:

• If you have had an unusual reaction (such as hives, shortness of breath and other breathing problems) to the tablets or any of the other ingredients.
• If you develop a rash, fever, swelling of the eyes, nose and throat, hives, contact your doctor immediately.
• Make sure you are always well hydrated and drink plenty of fluids when using this medicine in order to avoid the formation of crystals in the urine and ensure it is eliminated from your body.
• A small number of patients treated with antiepileptic drugs, such as felbamate, have developed self-harmful or suicidal thoughts. If thoughts of this kind emerge at any time, contact your doctor immediately.
• If you are regularly taking Taloxa or other medicines to control seizures, do not suddenly stop treatment with the medicine without your doctor's advice.
• If you are a woman of childbearing potential, you should use adequate contraceptive precautions during treatment and for up to 1 month after the end of treatment. Therapy with felbamate may decrease the effectiveness of oral contraceptives, therefore another effective method must be used.

Blood tests
During the intake of this medicine, your doctor will prescribe frequent blood tests (every
2 weeks) in order to monitor your condition.

Children and adolescents
For children or adolescents who are in traffic (e.g. who are cycling) it
must be considered that dizziness and weakness may occur (see section
“Driving and using machines”).

Other medicines and Taloxa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking other medicines to control seizures so that
they can establish a dose suitable for your needs.
Taloxa may interfere with the effectiveness of oral contraceptives. Consult your doctor if you are
taking oral contraceptives.
If you are taking Taloxa tablets in combination with other antiepileptic medicines, you may notice an
increase in undesirable effects. Consult your doctor if an undesirable effect becomes problematic.

Taloxa with food and drink
Taloxa tablets are not affected by food and therefore can also be taken during meals.

Pregnancy and breastfeeding
Taloxa should not be used during pregnancy unless it is strictly necessary. If you are
a woman of childbearing potential, you must use adequate contraceptive precautions during treatment and
for up to 1 month after the end of treatment. Therapy with felbamate may decrease the effectiveness of
oral contraceptives, therefore another effective method must be used.
If you are pregnant or planning a pregnancy, contact your doctor immediately, you should not
stop taking the medicine until you have spoken to your doctor. The doctor may
decide to change the treatment.
Taloxa is not recommended for women who are breastfeeding. Felbamate passes into breast milk. This
may harm the baby, especially with damage to the blood or liver.
If you are breastfeeding a baby, your doctor will advise you whether to continue taking Taloxa.
If you are pregnant, suspect you are pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Do not use tools and machinery. If you experience dizziness and weakness while using
this medicine, do not drive and do not use machinery. When Taloxa is administered to children
and adolescents, it must be considered that dizziness and weakness may also occur
while they are in traffic (e.g. while cycling).

Taloxa tablets contains
Taloxa contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, lo
contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take Taloxa

Take Taloxa following the doctor's instructions exactly at all times. If you have any doubts, consult your doctor or
pharmacist.

How much Taloxa to take
The usual dose of Taloxa tablets should be taken in two (every 12 hours) or three administrations
(every 8 hours) every day with water. Some people may require 4 doses per day (approximately every 6 hours).
The doctor will determine the dosage and timing of administration suitable for you. During the first few weeks
your dosage may require adjustments by the doctor. Once the dosage has been established, make sure you take the medicine at the same time every day. Taloxa tablets are not affected by
food and can also be taken during meals.
If you feel that the effect of Taloxa tablets is too strong or too weak, consult your
doctor or pharmacist.

If you or your child takes more Taloxa than you should
Contact your doctor immediately.

If you or your child forgets to take Taloxa
Take the dose you forgot as soon as possible unless it is almost time to take the next
dose.
Do not take a double dose to make up for a missed dose.
It is important to return to your regular dosing schedule as soon as possible.

If you or your child stops taking Taloxa
Do not stop taking the medicine without your doctor's advice. Sudden discontinuation
of antiepileptic drugs, including Taloxa, may increase the risk of seizures.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Taloxa may cause side effects, although not everybody gets them.
The use of Taloxa tablets has been associated with rare cases of severe blood and liver disorders
that can be life-threatening.

Contact your doctor immediately if you experience:

• unusual symptoms while taking Taloxa tablets, such as bleeding, bruising, frequent infections, fatigue, jaundice (yellowing of the whites of the eyes and skin), weight loss, vomiting, and abdominal pain.
• blisters in the mouth, nose and eyes or if the skin develops blisters or peels; if you have muscle and joint pain, fever, rash, uncontrollable vomiting, swelling or constipation.

Common side effects (may affect up to 1 in 10 people)
Weight loss, loss of appetite, insomnia, feeling sleepy, unsteady walking, dizziness,
headache, changes in vision such as double vision or blurred vision, nausea, vomiting, stomach discomfort, abdominal pain, diarrhoea, fatigue.
Uncommon side effects (may affect up to 1 in 100 people)
Abnormal and low levels of phosphates in the blood (hypophosphataemia), difficulty speaking, depression, confusion,
anxiety, skin rashes, abnormal walking.
Rare side effects (may affect up to 1 in 1,000 people)
Blood changes, including thrombocytopenia (decreased platelets), leucopenia
(decreased white blood cells), neutropenia (decreased white blood cells) and anaemia
(decreased red blood cells). Combinations of these effects may occur including a decrease in
all three types together with a depression of the bone marrow responsible for the production of all three
types of cells.
Increased frequency of epileptic seizures (convulsions), anaphylactic shock (severe
allergic reaction throughout the body), other serious allergic reactions including blisters in the mouth, nose, eyes or in
other mucous membranes (Stevens-Johnson syndrome, blistering eruptions), toxic epidermal necrolysis
(blisters and peeling of the upper layer of skin), muscle and joint pain,
fever.
Very rare side effects (may affect up to 1 in 10,000 people)
Constipation, liver disorders that can be severe and include fatal liver failure,
crystals in the urine.

Additional side effects in children and adolescents
Children have shown similar side effects. In addition, upper respiratory tract infections have been frequently observed in children; however, a correlation with treatment
is unlikely.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Taloxa

Keep this medicine out of the sight and reach of children.
Do not use Taloxa after the expiry date which is stated on the pack. The expiry date refers
to the last day of that month.
Keep the blister in the outer packaging.
Keep the blister well closed to protect the medicine from moisture.
Do not store at a temperature above 25°C.
Do not use Taloxa without consulting your doctor or pharmacist if you notice changes in the appearance of Taloxa.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Taloxa contains
The active ingredient is felbamate. Each Taloxa tablet contains 600 mg of felbamate.
The other ingredients are:
Pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate,
magnesium stearate.

Description of the appearance of Taloxa and contents of the pack
Taloxa 600 mg tablets.
White capsule-shaped tablets, with a score line. On one side of the score line there is the
Schering-Plough trademark and on the other “600”.
The score line on the tablet is to facilitate breaking it to make swallowing easier and not to divide it into equal doses.
Taloxa 600 mg tablets is available in:
40, 50, 60, 90, 100, 120, 200, 400 tablets in blisters (Aclar/PELD/PVC Alu)
40, 50, 60, 90, 100, 120, 200, 400 tablets in bottle (HDPE)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
BE: Taloxa-Tabs 600 mg comprimés
DE: Taloxa 600
FR: Taloxa 600 mg comprimé
IT: Taloxa 600 mg compresse
LU: Taloxa-Tabs 600 mg comprimés
NL: Taloxa-TABS 600 mg, tabletten
PT: Taloxa, 600 mg comprimidos

TALOXA 600 mg/5 ml oral suspension

felbamate

Read this leaflet carefully before taking this medicine as 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Taloxa and what is it used for

What is Taloxa
Taloxa is an antiepileptic medicine. Epileptic seizures are also known as epilepsy or convulsive crises (convulsions).

What is Taloxa used for
Taloxa is not indicated for the treatment of children under four years of age.
Taloxa is used in adult patients and children aged 4 years or older with Lennox-Gastaut syndrome and whose epileptic disorders are not controlled by other antiepileptic agents. Taloxa is used in association with other medicines to control epileptic seizures and convulsions.

2. What you need to know before taking Taloxa

Do not take Taloxa

• if you are allergic to felbamate or any of the other ingredients of this medicine (listed in section 6).
• if you have a history of blood problems (such as anemia, low red blood cell count, bleeding disorders, bruising, frequent infections) or liver problems (such as jaundice [yellowing of the whites of the eyes or skin] or hepatitis). If you have had blood or liver problems in the past, tell your doctor before taking Taloxa.

Warnings and precautions
Talk to your doctor or pharmacist before taking Taloxa:

• If you have had an unusual reaction (such as hives, shortness of breath and other breathing problems) to the oral suspension or any of the other ingredients.
• If you develop a skin rash; fever; inflammation of the eyes, nose and throat; hives; contact your doctor immediately.
• Make sure you are always well hydrated and drink plenty of fluids when using this medicine in order to avoid kidney stones in the urine and ensure it is eliminated from your body.
• A small number of patients treated with antiepileptic medicines, such as felbamate, have developed self-harming or suicidal thoughts. If thoughts of this kind emerge at any time, contact your doctor immediately.
• If you are regularly taking Taloxa or other medicines to control seizures, do not suddenly stop treatment with the medicine without your doctor's advice.
• If you are a woman of childbearing potential, you must use adequate contraceptive precautions during treatment and for up to 1 month after the end of treatment. Therapy with felbamate may decrease the effectiveness of oral contraceptives, therefore another effective method must be used.

Blood tests
During the use of this medicine, your doctor will prescribe frequent blood tests (every
2 weeks) in order to monitor your condition.

Children and adolescents
For children or adolescents who are in traffic (e.g. cycling) it
should be considered that dizziness and weakness may occur (see section
“Driving and using machines”).

Other medicines and Taloxa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• Tell your doctor if you are taking other medicines to control seizures so that they can establish a dosage suitable for your needs.
• Taloxa may interfere with the effectiveness of oral contraceptives. Consult your doctor if you are taking oral contraceptives.
• If you are taking Taloxa in combination with other antiepileptic medicines, you may notice an increase in side effects. Consult your doctor if a side effect becomes problematic.

Taloxa with food and drink
Taloxa is not affected by food and therefore can also be taken during meals.

Pregnancy and breastfeeding
Taloxa should not be used during pregnancy unless it is strictly necessary. If you are
a woman of childbearing potential, you must use adequate contraceptive precautions during treatment and
up to 1 month after the end of treatment. Therapy with felbamate may decrease the effectiveness of
oral contraceptives, therefore another effective method must be used.
If you are pregnant or planning a pregnancy, consult your doctor immediately, you should not
stop taking the medicine until you have spoken to your doctor. The doctor may
decide to change the treatment.
Taloxa is not recommended for women who are breastfeeding. Felbamate passes into breast milk. This
may harm the baby, especially with damage to the blood or liver.
If you are breastfeeding a baby, your doctor will advise you whether to continue taking Taloxa.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Do not use tools and machinery. If you experience dizziness and weakness while using
this medicine, do not drive and do not use machines. When Taloxa is administered to children
and adolescents, it should be considered that dizziness and weakness may also occur
while they are in traffic (e.g. while cycling).

Taloxa oral suspension contains

• 1.05 g of sorbitol in every 5 ml of syringe equivalent to 210 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or the child) take this medicine. Sorbitol may cause gastrointestinal problems and have a mild laxative effect.
• methyl and propyl parahydroxybenzoate which may cause allergic reactions (even delayed).
• less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially “sodium-free”.
• 10 mg of sodium benzoate in every 5 ml equivalent to 2 mg/ml.

3. How to take Taloxa

You or your child should take Taloxa following the doctor's instructions exactly at all times. If you or your
child have any doubts, consult your doctor or pharmacist.

How much Taloxa to take

• The doctor will determine the correct dose and the time of administration of this medicine suitable for you or your child.
• Taloxa should be taken in two (every 12 hours) or three doses (every 8 hours) every day with water. Some people need four doses a day (approximately every 6 hours).
• The doctor will tell you or your child and the pharmacist what the dose is in milliliters (ml) and how many doses you or your child should take each day.

During the first few weeks:
The dose may need to be adjusted by the doctor.
Once the dosage is established:
Make sure to take the medicine at the same time every day.

How to take a dose of Taloxa

• Make sure to shake the bottle well before measuring each dose.
• The dose for you or your child should be administered using the oral dosing syringe contained in the package.
• 1. Measurement: The dose is measured with the provided 5.0 ml oral dosing syringe. The plastic oral dosing syringe consists of two parts, an opaque cylinder and a white plunger that fits into the cylinder. The plunger is marked with graduations every 0.1 ml starting from 0.5 ml (at the top of the plunger) and ending at 5 ml.
• A. Insert the assembled dosing syringe into the Taloxa oral suspension bottle.
• B. Keeping the tip in the liquid, pull back the plunger. As the solution fills the syringe, you or your child will see the numbers on the plunger rise.
• C. Pull back the plunger until you or your child can read the correct number of ml for the dose being measured.
• D. Remove the oral dosing syringe from the bottle and check that the correct amount appears at the bottom of the syringe. If for you or your child it is

too much or too little, try again until you get the correct
amount.

• 2. Dispensing: Hold the syringe near your or your child's mouth and release the dose into the mouth by pushing on the plunger. Swallow the dose.
• 3. Rinse: Disassemble the syringe and rinse it with water after each use.

If you or your child feel that the effect of Taloxa is too strong or too weak,
consult your doctor or pharmacist.

If you or your child takes more Taloxa than you should
Contact your doctor immediately.

If you or your child forgets to take Taloxa
Take the forgotten dose as soon as possible unless it is almost time to take the next
dose.
Do not take a double dose to make up for a missed dose.
It is important to return to your regular dosing schedule as soon as possible.

If you or your child stops taking Taloxa
Do not stop taking the medicine without your doctor's advice. Suddenly stopping
taking antiepileptic drugs, including Taloxa, may increase the risk of seizures.
For further questions regarding the use of this medicine by you or your child, ask your
doctor or pharmacist.

4. Possible side effects

Like all medicines, Taloxa may cause side effects, although not everybody gets them.
The use of Taloxa oral suspension has been associated with rare cases of severe blood and liver
disorders that can be life-threatening.

Contact your doctor immediately if you experience:

• unusual symptoms while taking Taloxa oral suspension, such as bleeding, bruising, frequent infections, fatigue, jaundice (yellowing of the whites of the eyes and skin), weight loss, vomiting and abdominal pain.
• blisters in the mouth, nose and eyes or if the skin develops blisters or peels; if you have muscle and joint pain, fever, rash, uncontrollable vomiting, swelling or constipation.

Common side effects (may affect up to 1 in 10 people)
Weight loss, loss of appetite, insomnia, feeling sleepy, unsteady walking, dizziness,
headache, changes in vision such as double vision or blurred vision, nausea, vomiting, stomach discomfort, abdominal pain, diarrhea, fatigue.
Uncommon side effects (may affect up to 1 in 100 people)
Abnormal and low levels of phosphates in the blood (hypophosphataemia), difficulty speaking, depression, confusion, anxiety, skin rashes (rash), abnormal walking.
Rare side effects (may affect up to 1 in 1,000)
Blood changes, including thrombocytopenia (decreased platelets), leucopenia
(decreased white blood cells), neutropenia (decreased white blood cells) and anaemia
(decreased red blood cells). Combinations of these effects may occur, including a decrease in
all three types together with a depression of the bone marrow responsible for the production of all three
types of cells.
Increased frequency of seizures (convulsions), anaphylactic shock (severe allergic
reaction throughout the body), other serious allergic reactions including blisters in the mouth, nose, eyes or in
other mucous membranes (Stevens-Johnson syndrome, bullous eruptions), toxic epidermal necrolysis
(blisters and peeling of the upper layer of skin), muscle and joint pain,
fever.
Very rare side effects (may affect up to 1 in 10,000)
Constipation, liver disorders which can be severe and include fatal hepatic failure,
crystals in the urine.

Additional side effects in children and adolescents
Children have shown similar side effects. In addition, upper respiratory tract infections have been frequently observed in children; however, a correlation with treatment
is unlikely.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Taloxa

Keep this medicine out of the sight and reach of children.
Before the first opening of the bottle
Do not use Taloxa after the expiry date which is stated on the bottle/box. The expiry date refers to
the last day of that month.
After the first opening of the bottle
The period of validity is 1 month.
Keep the bottle tightly closed to protect the medicine from humidity. Dispose of the Taloxa bottle
1 month after the first opening.
Do not store at a temperature above 25°C.
Do not use Taloxa without consulting your doctor or pharmacist if you notice changes in the appearance of Taloxa.
Do not dispose of any medicine in drain water or household waste. Ask your pharmacist how to
dispose of medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Taloxa contains
The active ingredient is felbamate. Each 5 ml of Taloxa oral suspension contains 600 mg of
felbamate.
The other ingredients are (see section 2):
sorbitol (E420), glycerol (E422), dispersible cellulose (microcrystalline cellulose + croscarmellose
sodium), simeticone emulsion, sodium saccharin, methyl parahydroxybenzoate (E218), polysorbate 80,
propyl parahydroxybenzoate (E216), sodium benzoate (E211), Prosweet “G” #859 (glycerol (E422),
vanillin, ethyl maltol), purified water.

Description of Taloxa and package contents
Taloxa 600 mg/5 ml oral suspension is a white to off-white, opaque and
viscous suspension.
Taloxa 600 mg/5 ml oral suspension is available in:
bottle (glass) of 50 ml
bottle (glass) of 100 ml
bottle (glass) of 230 ml
bottle (glass) of 250 ml
bottle (glass) of 450 ml
bottle (glass) of 2300 ml
bottle (HDPE) of 50 ml
bottle (HDPE) of 100 ml
bottle (HDPE) of 230 ml
bottle (HDPE) of 250 ml
bottle (HDPE) of 450 ml
bottle (HDPE) of 2300 ml
A 5.0 ml oral application syringe with CE marking is included.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under
the following denominations:
BE: Taloxa-Susp 600 mg/5 ml Suspension buvable
DE: Taloxa Saft
FR: Taloxa 600 mg/5 ml suspension buvable
IT: Taloxa 600 mg/5 ml sospensione orale
LU: Taloxa suspension 600 mg/5 ml
NL: Taloxa-SUSP
PT: Taloxa 600 mg/5 ml suspensão oral