TOLEP

Patient Information Leaflet

Tolep 300 mg tablets, 600 mg tablets

oxcarbazepine
Please read this leaflet carefully before 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 treatment of certain types of epilepsy.
Epilepsy is a brain disorder that causes people to have repeated seizures or convulsions.
Seizures occur due to a temporary disturbance in the brain's electrical activity.
Normally, brain cells coordinate body movements by sending signals in an organized and orderly manner to the muscles through the nerves. In epilepsy, brain cells send too many signals in a disorganized way. This may result in uncoordinated muscle activity known as an epileptic seizure.

Tolep is used for the treatment of partial epileptic seizures, with or without secondary generalized tonic-clonic seizures. Partial epileptic seizures involve a limited area of the brain but may spread throughout the brain and cause generalized tonic-clonic convulsions. There are two types of partial epileptic seizures: simple and complex. During simple partial seizures, the patient remains conscious, whereas during complex partial seizures, the patient's consciousness is impaired.

By controlling overexcitable nerve cells in the brain, Tolep suppresses or reduces the frequency of these seizures.

Tolep can be used alone or in combination with other antiepileptic medicines.
Generally, your doctor will try to find the medicine that works best for you or your child. However, in some cases, it may be necessary to use a combination of two or more medicines to control seizures.

The use of Tolep is restricted to adults and children aged 6 years and older.

2. What you should know before taking Tolep

Follow carefully all instructions given to you by your doctor. These may differ 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 these blood tests should be performed.
Do not take Tolep

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

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

• if you have previously shown unusual sensitivity (skin rash or other signs of allergy) to carbamazepine or to any other medicine. If you are allergic to carbamazepine, your chance of having an allergic reaction to oxcarbazepine (Tolep) is approximately 1 in 4 (25%-30%);
• if you have 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 urine production); if you are taking non-steroidal anti-inflammatory drugs (e.g. indomethacin);
• if you have heart problems (e.g. heart failure, decompensated heart failure, 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 the blood (see section 4 “Possible side effects”);
• if you are a woman taking hormonal contraceptives (such as “the pill”), Tolep may reduce the effectiveness of the contraceptive. Use a different or additional method of contraception (non-hormonal) while taking Tolep. This helps prevent unintended pregnancy;
• if you are of Asian origin (particularly Han Chinese, Thai, Filipino, or Malaysian) as you may have a higher risk of developing severe skin reactions after taking carbamazepine or chemically related substances. In such cases, your doctor will perform a specific blood test before starting treatment with Tolep to assess your risk of developing these serious reactions.

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

• if you experience an allergic reaction after starting treatment with Tolep. Symptoms include swelling of the lips, eyelids, face, throat, or mouth, sudden breathing difficulties, 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 whites of the eyes);

• if you experience an increase in the frequency of epileptic seizures. This is particularly important in children but may also occur in adults;

• if you notice possible symptoms of blood disorders, such as 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, red or purple spots or patches on the skin of unknown cause;

• a small number of people treated with antiepileptic medicines such as Tolep have had suicidal thoughts or self-harming thoughts. If at any time you have such thoughts, contact your doctor immediately.

• if your heart rate is unusually fast or slow.

Children and adolescents
In children, your 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
medicine.
This is particularly 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 sodium levels in the blood, such as diuretics (used to help the kidneys eliminate salts and water by increasing urine production), desmopressin, and non-steroidal anti-inflammatory drugs such as indomethacin;
• lithium and monoamine oxidase inhibitors (medicines used to treat mood changes and certain 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 may increase the sedative effects of Tolep. Avoid drinking alcohol during treatment
with Tolep.
Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
It is important to control epileptic seizures during pregnancy. However, taking antiepileptic
medicines during pregnancy may pose a risk to your baby.
Congenital malformations
Studies have not shown an increased risk of congenital malformations associated with the use of
oxcarbazepine during pregnancy; however, the risk of congenital malformations in the unborn child cannot be completely ruled out.
Neurodevelopmental disorders
Some studies have shown that in utero exposure to oxcarbazepine negatively affects brain function development (neurodevelopment) in children, while other studies have not found such an effect. The possibility of an effect on neurodevelopment cannot be excluded.
Your doctor will inform you about the benefits and potential risks and help you decide whether or not to take Tolep.
Do not stop treatment with Tolep during pregnancy without first consulting your doctor.
Consult your doctor or pharmacist before taking any medicine during pregnancy.
Breastfeeding
If you are taking this medicine, consult your doctor before starting breastfeeding.
The active substance of Tolep passes into breast milk. Although available data suggest that the amount of Tolep passed to a breastfed infant is low, the risk of side effects in the infant 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 notice side effects in your baby such as excessive drowsiness or poor weight gain, inform your doctor immediately.
Driving and using machines
Tolep may cause drowsiness or dizziness, blurred vision, double vision, lack of muscle coordination, or reduced level of consciousness, particularly 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 whether you can drive or operate machinery while taking this medicine.

3. How to take Tolep

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How much Tolep to take
Use in adults

• The usual initial dose of Tolep for adults (including elderly patients) is 600 mg per day.
• Take one 300 mg tablet twice daily.
• Your doctor may gradually increase the dose to find the most suitable dose for you. Best results are usually achieved 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 kidney disease (which impairs kidney function), the initial dose is half the usual initial dose.
• If you have severe liver disease, your doctor may adjust the dose.

Use in children
Tolep is not recommended for children under 6 years of age.
Tolep may only be used in children aged 6 years and older.
Dosage in children depends on their body weight.

• The initial dose is 8–10 mg per kg of body weight, given in two divided doses.
• Your doctor may gradually increase the dose to find the best dose for your child. Best results are usually achieved 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 may be halved to make swallowing easier. Do not break the tablet to take only half the dose. The score line is not intended to divide the tablet into equal doses.

When and for how long to take Tolep
Take Tolep twice daily, every day, at approximately the same time each day, unless your doctor
instructs otherwise. This will provide the best effect in controlling epilepsy. It will also help you
remember when to take the tablet(s).
Your doctor will tell you how long your treatment (or your child’s treatment) with Tolep will last.
The duration of treatment will depend on the type of seizures you or your child has.
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 medicines, treatment with Tolep should be discontinued gradually
to minimize the risk of increased seizure frequency.
If you take more Tolep than you should
If you accidentally take too much Tolep, contact your doctor immediately or go to the nearest hospital. In the hospital, you will receive appropriate medical treatment.
Symptoms of Tolep overdose may include: drowsiness, dizziness, nausea, vomiting, increased uncontrolled movements, lethargy, confusion, muscle contractions, or significant worsening of seizures, lack of coordination and/or involuntary eye movements, double or blurred vision, low blood pressure, reduced breathing rate.
If you forget to take Tolep
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Resume your normal dosing schedule. Do not take a double dose to make up for a forgotten tablet.
If you are unsure or have missed more than one dose, consult your doctor.
If you stop taking Tolep
Do not stop treatment with 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 discontinue treatment, it must be done gradually, following your doctor’s instructions.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects may be serious: seek immediate medical attention
The following are signs of very rare (may affect up to 1 in 10,000 people) but potentially serious side effects, 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 skin 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, kidney inflammation, 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, nose or genitals (signs of severe allergic reactions, including Lyell syndrome, Stevens-Johnson syndrome and erythema multiforme).
• Fatigue, shortness of breath during physical activity, pallor, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nosebleeds, reddish or purplish spots or marks on the skin of unknown cause (signs of reduced platelet count or reduced blood cell count).
• Skin rash with red patches mainly on the face, possibly 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 sodium levels in the blood) (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, malaise (vomiting), loss of appetite (signs of pancreatitis).
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs indicating reduced thyroid gland activity). Seek immediate medical advice or go to the nearest hospital emergency department if you experience any of the above side effects. Your doctor will decide whether to immediately discontinue treatment with Tolep and how to proceed with further care.

Other side effects: contact your 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; skin rash.
  Very rare (may affect up to 1 in 10,000 people):
• Irregular heartbeat or very fast or very slow heartbeat.
  Not known (frequency cannot be estimated from available data):
• Speech disorders.
  Contact your doctor as soon as possible if you experience any of the above side effects. They may require medical treatment.

Other side effects: contact your doctor if they concern you
These side effects due to Tolep are generally mild to moderate in intensity. Many of these effects are transient and usually diminish over time.
Very common (may affect more than 1 in 10 people):

• Fatigue; headache; dizziness; drowsiness; nausea (vomiting); double vision.
  Common (may affect up to 1 in 10 people):
• Weakness; memory problems; difficulty concentrating; apathy; agitation; confusion; blurred vision; visual disturbances; constipation; diarrhoea; stomach pain (abdominal pain); acne; hair loss; balance problems (vertigo); decreased sodium levels in the blood; weight gain.
  Uncommon (may affect up to 1 in 100 people):
• Urticaria (hives).
  While taking Tolep, levels of certain enzymes (lipase, amylase, alkaline phosphatase) may increase.
  Not known (frequency cannot be estimated from available data):
• High blood pressure.
• Falls.
• Decreased levels of the thyroid hormone T4.
• Inadequate production of blood cells by the bone marrow.
• Reduction in the number of red blood cells due to various causes (aplastic anaemia).
• 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 certain white blood cells in the blood (neutropenia).
  Contact your 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 are on long-term treatment with an antiepileptic medicine, if you have a history of osteoporosis, or if you are taking steroids. Cases have also been reported with unknown frequency of:
• Skin rash accompanied by elevated levels of certain white blood cells (eosinophils) in the blood, swollen lymph nodes and fever (signs of drug reaction with eosinophilia and systemic symptoms, DRESS).
• Drowsiness, nausea, dizziness, reduced concentration of blood particles, vomiting, headache, confusion (signs of syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Skin rash with pustule formation (acute generalized exanthematous pustulosis, AGEP).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after Exp. 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 there are signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tolep contains

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

Description of the appearance of Tolep and package contents
Each package of Tolep 300 mg tablets contains 50 tablets.
Each package of Tolep 600 mg tablets contains 50 tablets.
Marketing Authorization Holder
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy
Selling Authorization Holder
Chiesi Farmaceutici S.p.A.
Parma
Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy