TOLEP 300 mg Tablet

Зміст інструкції

1. Tolep 300 mg tablets, 600 mg tablets
   1. What Tolep is and what it is used for
   2. What you need to know before taking Tolep
   3. How to take Tolep
   4. Possible side effects
   5. How to store Tolep
   6. Contents of the pack and other information

Tolep 300 mg tablets, 600 mg tablets

oxcarbazepine

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

1. What Tolep is and what it is used for

What Tolep is
The active substance of Tolep is oxcarbazepine.
Tolep belongs to a group of medicines called antiepileptics.

What Tolep is used for
Tolep is used in the therapy of certain forms of epilepsy.
Epilepsy is a brain disorder that causes people to experience repeated seizures
or convulsions. Seizures occur due to a temporary defect in the electrical activity
of the brain. The brain cells normally coordinate the body's movements by sending signals to the
muscles, in an organized and orderly manner, through the nerves. In epilepsy, the brain cells
send too many signals in a disorganized way. This can lead to uncoordinated muscle activity
defined as an epileptic seizure.
Tolep is used for the treatment of partial seizures with or without tonic-clonic seizures
with secondary generalization. Partial epileptic seizures involve a limited area of the brain
but can spread throughout the brain and cause generalized tonic-clonic seizures. There
are two types of partial epileptic seizures: simple and complex. During simple partial seizures
the patient remains conscious while in complex partial seizures the patient's consciousness is altered.
Tolep, by keeping the "overexcitable" nerve cells of the brain under control, suppresses or reduces the
frequency of these seizures.
Tolep can be used alone or in combination with other antiepileptic medicines.
Generally, the doctor will try to find the medicine that works best for you or your
child. However, in some cases, it may be necessary to resort to a combination of two or more
medicines to control seizures.
The use of Tolep is reserved for adults and children aged 6 years and over.

2. What you need to know before taking Tolep

Follow all the instructions that your doctor has given you carefully. They may be different from the general information contained in this leaflet.

Monitoring during treatment with Tolep
Before and during treatment with Tolep, your doctor may take blood samples to determine the appropriate dose of Tolep for you. Your doctor will tell you when to have these blood tests.

Do not take Tolep

• if you are allergicto oxcarbazepine, eslicarbazepine or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

Warnings and precautions
Talk to your doctor before taking Tolep if any of the following conditions apply to you:

• if you have ever shown unusual sensitivity(skin rash or other signs of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the chances that you may also have an allergic reaction to oxcarbazepine (Tolep) are approximately 1 in 4 (25%-30%);
• if you have a kidney disease;
• if you have severe liver disease;
• if you are taking diuretics(medicines used to help the kidneys eliminate salts and water by increasing the amount of urine produced); if you are taking non-steroidal anti-inflammatory drugs (e.g. indometacin);
• if you have heart problems(e.g. heart failure, cardiac decompensation, atrioventricular block, arrhythmia), shortness of breath and/or swelling of the feet or legs due to fluid retention;
• if blood tests show that you have low levels of sodium in your blood(see section 4 “Possible side effects”);
• if you are a woman taking hormonal contraceptives (such as “the pill”), Tolep may block the action of the contraceptive. Use a different or additional (non-hormonal) method of contraception while taking Tolep. This helps to prevent unwanted pregnancy;
• if you are of Asian origin (particularly Han Chinese, Thai, Filipino or Malaysian) as, in this case, you are more likely to develop severe skin reactions after taking carbamazepine or chemically related substances. In this case, before starting treatment with Tolep, your doctor will perform a specific blood test to predict your risk of developing these severe reactions.

Stop taking Tolep immediately and contact your doctor or go to the nearest hospital emergency room if you develop any of the following symptoms after starting treatment with Tolep:

• if you experience an allergic reactionafter starting treatment with Tolep. Symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen glands, skin rash or blisters on the skin;
• if you notice symptoms of hepatitis, such as jaundice (yellowing of the skin or the whites of the eyes);
• if you experience an increase in the frequency of seizures. This is particularly important for children but can also occur in adults;
• if you notice possible symptoms of blood disorders, such as fatigue, shortness of breath during activity, paleness, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, bleeding or bruising that develops more easily than normal, nosebleeds, reddish or purplish spots, or spots on the skin of which you do not know

the cause;

• a small number of people treated with antiepileptic medicines like Tolep have had thoughts of suicide or self-harm. If, at any time, you have these thoughts, contact your doctor immediately.
• if your heartbeat is fast or unusually slow.

Children and adolescents
In children, the doctor may recommend monitoring thyroid function before and during treatment.

Other medicines and Tolep
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is especially important for:

• hormonal contraceptives, such as the pill (see “Warnings and precautions”);
• other antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin or lamotrigine, valproic acid;
• medicines that reduce the level of sodium in the blood, such as diuretics (used to help the kidneys eliminate salts and water by increasing the amount of urine produced), desmopressin and non-steroidal anti-inflammatory drugs, such as indometacin;
• lithium and monoamine oxidase inhibitors (medicines used to treat mood changes and some forms of depression).
• medicines that control the immune system, such as cyclosporine and tacrolimus.
• rifampicin, an antibiotic used to treat tuberculosis.

Tolep with food and drink
Tolep can be taken with or without food.
Alcohol can increase the sedative effects of Tolep. Avoid drinking alcohol while taking Tolep.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is important to control seizures during pregnancy. However, taking antiepileptic medicines during pregnancy can pose a risk to your baby.

Birth defects
Studies have not shown an increased risk of birth defects associated with the use of oxcarbazepine during pregnancy, however, the risk of birth defects to the unborn child cannot be completely excluded.

Neurological development disorders
Some studies have shown that exposure to oxcarbazepine in the womb negatively affects the development of brain function (neurological development) in children, while other studies have not found such an effect. The possibility of an effect on neurological development cannot be excluded.
Your doctor will inform you about the benefits and potential risks and help you decide whether to take Tolep.
Do not stop taking Tolep during pregnancy without first consulting your doctor.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.

Breastfeeding
If you are taking this medicine, ask your doctor for advice before starting to breastfeed.
The active ingredient of Tolep passes into breast milk. Although available data suggest that the amount of Tolep that passes to a breastfed baby is low, the risk of side effects for the baby cannot be excluded. Your doctor will discuss with you the benefits and potential risks of breastfeeding while taking Tolep. If you are breastfeeding while taking Tolep and believe your baby has side effects such as excessive sleepiness or poor weight gain, inform your doctor immediately.

Driving and using machines
Tolep can cause drowsiness or dizziness, blurred vision, double vision, lack of muscle coordination or a reduced level of consciousness, especially at the beginning of treatment or when doses are increased, and may therefore impair your ability to drive or operate machinery.
It is important to consult your doctor about the possibility of driving vehicles or operating machinery while taking this medicine.

3. How to take Tolep

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

How much Tolep to take
Use in adults

• The initialusualdose of Tolep for adults (including elderly patients) is 600 mg per day.
• Take one 300 mg tablet twice a day.
• The doctor may gradually increase the dose to find the best one for you. The best results are usually obtained with doses between 600 and 2,400 mg per day.
• If you are taking another antiepileptic medicine, the dose remains the same.
• If you have a kidney disease (which impairs kidney function), the initial dose is half the usual initial dose.
• If you have a severe liver disease, the doctor may modify the doses.

Use in children
Tolep is not recommended in children under 6 years of age.
Tolep can only be taken by children aged 6 years and over.
The dosage in children depends on their weight.

• The initial dose is 8-10 mg per kg of body weight, administered in two separate doses.
• The doctor may gradually increase the dose to find the best one for your child. The best results are usually obtained with a dose of 30 mg per kg of body weight per day. The maximum dose for a child is 46 mg per kg of body weight per day.

How to take Tolep

• Swallow the tablets with a little water.
• If necessary, the tablets can be halved to make them easier to swallow. Do not break the tablet to take only half the dose. The fracture line is not intended to divide the tablet into equal doses.

When and for how long to take Tolep
Take Tolep twice a day, every day, at about the same time of day, unless your doctor
gives you other instructions. This will produce the best effect on seizure control. It will also help you
remember when to take the tablet(s).
The doctor will tell you how long your treatment (or your child's) with Tolep will last.
The duration of treatment will depend on the type of your seizures or those of your child.
Controlling seizures may require treatment for several years. Do not
change the dose or stop treatment without talking to your doctor.
As with other antiepileptic drugs, treatment with Tolep should be discontinued gradually
to minimize the risk of an increase in the frequency of seizures.

If you take more Tolep than you should
In case of accidental ingestion/taking of an excessive dose of Tolep, immediately inform your
doctor or go to the nearest hospital. In the hospital, you will be subjected to adequate intervention protocols.
Symptoms of Tolep overdose may include: drowsiness, dizziness, nausea, vomiting,
increased uncontrolled movements, lethargy, confusion, muscle contractions or significant
worsening of seizures, difficulty with coordination and/or involuntary eye movements,
double or blurred vision, low blood pressure, decreased breathing rate.

If you forget to take Tolep
If you have forgotten to take a dose, take it as soon as you remember. However, if it is time
to take the next dose, do not take the forgotten dose. Return to the normal schedule.
Do not take a double dose to make up for the forgotten tablet.
If you are not sure or have forgotten to take more doses, contact your doctor.

If you stop taking Tolep
Do not stop taking this medicine unless your doctor tells you to.
To prevent a sudden worsening of seizures, never stop taking the medicine abruptly.
If you need to stop treatment, you must do so gradually following your doctor's instructions.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
persone li manifestino.

Some side effects may be serious: seek immediate medical attention
The following are signs of very rare side effects (may affect up to
1 in 10,000 people) but potentially serious, which may require urgent medical treatment.

• Swelling of the lips, eyelids, face, throat or mouth, accompanied by difficulty breathing, speaking or swallowing (signs of anaphylactic reactions and angioedema) or other signs of hypersensitivity reactions such as rash, fever, joint swelling and muscle and joint pain.
• Mental confusion, altered level of consciousness, coma (signs of hepatic encephalopathy).
• Presence of protein in the urine, inflammation of the kidneys, reduced kidney function (renal failure).
• Difficulty breathing, fluid in the lungs (pulmonary edema), chronic inflammation of the airways (asthma), abnormal contraction of the bronchi (bronchospasm), inflammation of lung tissue.
• Severe blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (signs of severe allergic reactions, including Lyell's syndrome, Stevens-Johnson syndrome and erythema multiforme).
• Fatigue, shortness of breath during physical activity, paleness, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nosebleeds, reddish or purplish spots or patches on the skin of unknown cause (signs of a reduction in the number of platelets or blood cells).
• Rash with red spots mainly on the face, which may be accompanied by fatigue, fever, feeling unwell (nausea) or loss of appetite (signs of systemic lupus erythematosus).
• Lethargy, confusion, muscle spasms or significant worsening of seizures, encephalopathy, visual disturbances (e.g. blurred vision), vomiting, nausea, folic acid deficiency (possible symptoms of low blood sodium levels) (see “Warnings and precautions”).
• Flu-like symptoms with jaundice (yellowing of the skin or whites of the eyes) (signs of hepatitis).
• Severe pain in the upper abdomen, feeling unwell (vomiting), loss of appetite (signs of pancreatitis).
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs that the thyroid gland is working less). Seek immediate medical attention or go to the nearest hospital emergency room if youexperience any of the above side effects.The doctor will also decide whether to immediately stop treatment with Tolep and how to continue further care.

Other side effects: see a doctor as soon as possible
Common(may affect up to 1 in 10 people):

• Tremor; coordination problems; involuntary eye movements; anxiety and nervousness; depression, mood swings; rash. Very rare(may affect up to 1 in 10,000):
• Irregular heartbeat or a very fast or slow heartbeat. Not known(frequency cannot be estimated based on available data):
• Speech disorders. See a doctor as soon as possible if you experience any of the above side effects.They may require medical treatment.

Other side effects: see your doctor if these bother you
These side effects due to Tolep are generally mild to moderate in intensity. Many of
these effects are transient and generally decrease over time.

Very common(may affect more than 1 in 10 people):

• Fatigue; headache; dizziness; drowsiness; nausea; double vision. Common(may affect up to 1 in 10 people):
• Weakness; memory problems; difficulty concentrating; apathy; agitation; confusion; blurred vision; constipation; diarrhea; stomach pain (abdominal pain); acne; hair loss; balance disorders (vertigo), decreased blood sodium levels; weight gain. Uncommon(may affect up to 1 in 100 people):
• Hives.
• Taking Tolep can also increase the levels of enzymes (lipase, amylase, alkaline phosphatase). Not known(frequency cannot be estimated based on available data):
• High blood pressure.
• Falls.
• Decreased levels of the thyroid hormone T4.
• Insufficient production of blood cells by the bone marrow.
• Reduction in the number of red blood cells due to various causes (aplastic anemia).
• Reduction in the number of white blood cells in the blood (agranulocytosis).
• Reduction in the number of all blood cells (pancytopenia).
• Reduction in the number of some white blood cells in the blood (neutropenia). See a doctor if any of the above side effects become severe.Cases of bone disease including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported. Contact your doctor or pharmacist if you have been taking an antiepileptic medicine for a long time, if you have a history of osteoporosis or if you are taking steroids. Cases of: have also been reported with unknown frequency:
• Rash accompanied by high concentrations of certain white blood cells (eosinophils) in the blood, enlarged lymph nodes and fever (signs of a drug reaction with eosinophilia and systemic symptoms, DRESS)
• Drowsiness, nausea, dizziness, decreased concentration of blood particles, vomiting, headache, confusion (signs of inappropriate secretion of antidiuretic hormone, SIADH)
• Rash with the formation of pustules (acute generalized exanthematous pustulosis, AGEP).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Tolep

• This medicine does not require any special storage conditions.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the packaging after Expires. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice that the packaging is damaged or if you notice signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tolep contains

• The active ingredient is oxcarbazepine.
• The other ingredients are anhydrous colloidal silica, microcrystalline cellulose, hypromellose, red iron oxide, yellow iron oxide, magnesium stearate, sodium carboxymethylcellulose. Each Tolep 300 mg tablet contains 300 mg of oxcarbazepine. Each Tolep 600 mg tablet contains 600 mg of oxcarbazepine.

Description of Tolep and contents of the pack
Each pack of Tolep 300 mg tablets contains 50 tablets.
Each pack of Tolep 600 mg tablets contains 50 tablets.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy

Distributor for sales
Chiesi Farmaceutici S.p.A.
Parma

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy