Oxcarbazepine Tecnigen
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxcarbazepine TecniGen 300 mg tablets
Equivalent medicine
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, pharmacist, or nurse.
- 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 adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Oxcarbazepine TecniGen is and what it is used for.
- What you need to know before taking Oxcarbazepine TecniGen.
- How to take Oxcarbazepine TecniGen.
- Possible side effects.
- How to store Oxcarbazepine TecniGen.
- Contents of the pack and other information.
1. WHAT OXCARBAZEPINE TECNIGEN IS AND WHAT IT IS USED FOR
What Oxcarbazepine TecniGen is
The active substance of Oxcarbazepine TecniGen is oxcarbazepine.
Oxcarbazepine TecniGen belongs to a group of medicines called anticonvulsants or antiepileptics.
What Oxcarbazepine TecniGen is used for
Medicines such as Oxcarbazepine TecniGen are the standard treatment for epilepsy.
Patients who are diagnosed with epilepsy have experienced seizures or convulsions. Seizures occur due to a temporary malfunction in the brain's electrical system. Normally, brain cells coordinate body movements by sending organized and orderly signals through nerves to the muscles.
In epilepsy, brain cells send out too many signals in a disorganized way. This may lead to uncoordinated muscle activity known as an epileptic seizure.
Oxcarbazepine TecniGen is used to treat partial 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 in complex partial seizures, consciousness is impaired.
By controlling the "overexcitable" nerve cells in the brain, Oxcarbazepine TecniGen suppresses or reduces the frequency of these seizures.
Oxcarbazepine TecniGen may 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 more severe cases of epilepsy, it may be necessary to use a combination of two or more medicines to control seizures.
The use of Oxcarbazepine TecniGen is restricted to adults and children aged 6 years and older.
2. WHAT YOU SHOULD KNOW BEFORE TAKING OXCARBAZEPINE TECNIGEN
Follow all instructions given by your doctor, even if they differ from the information contained in this leaflet.
Do not take Oxcarbazepine TecniGen
- If you are allergic to oxcarbazepine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxcarbazepine TecniGen.
Talk to your doctor before taking Oxcarbazepine TecniGen if any of the following apply to you:
- if you have ever had an unusual sensitivity (skin rash or other signs of allergy) to carbamazepine or to any other medicine. If you are allergic to carbamazepine, there is approximately a 1 in 4 chance (25%) that you may also have an allergic reaction to oxcarbazepine;
- 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 the amount of urine produced);
- if you have heart problems, shortness of breath and/or swelling in the feet or legs due to fluid retention;
- if blood tests show 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, Oxcarbazepine TecniGen may reduce the effectiveness of the contraceptive. Use a different or additional contraceptive method (non-hormonal) while taking Oxcarbazepine TecniGen. This helps prevent unintended pregnancy. Contact your doctor immediately if you experience vaginal bleeding or irregular vaginal discharge. If you have any questions about this, speak to your doctor or a healthcare professional.
If you develop any of the following symptoms after starting treatment with Oxcarbazepine TecniGen, contact your doctor immediately or go to the nearest hospital emergency department:
- if you experience an allergic reaction after starting treatment with Oxcarbazepine TecniGen. 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 and whites of the eyes);
- if you experience an increase in the frequency of epileptic seizures. This is particularly important for 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 unexplained marks on the skin;
- a small number of people treated with antiepileptic medicines such as Oxcarbazepine TecniGen have had suicidal thoughts or self-harming thoughts. If at any time you have such thoughts,
contact your doctor immediately.
If you develop any of the following symptoms after starting treatment with Oxcarbazepine TecniGen, contact your doctor as soon as possible:
- If your heart rate is fast or unusually slow.
Children and adolescents
In children, your doctor may recommend monitoring thyroid function before and during treatment.
Other medicines and Oxcarbazepine TecniGen
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;
- medicines that lower sodium levels in the blood, such as diuretics (used to help the kidneys eliminate salts and water by increasing urine output), desmopressin, and non-steroidal anti-inflammatory drugs such as indometacin;
- lithium or monoamine oxidase inhibitors (medicines used to treat mood changes or certain forms of depression);
- medicines that affect the immune system, such as cyclosporine and tacrolimus.
Oxcarbazepine TecniGen with food, drinks and alcohol
Oxcarbazepine TecniGen can be taken with or without food.
Alcohol may increase the sedative effect of Oxcarbazepine TecniGen. Avoid drinking alcohol as much as possible and consult your doctor.
Pregnancy and breastfeeding
Pregnancy
Talk to your doctor if you are pregnant or planning to become pregnant.
It is important to control epileptic seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic medicines during pregnancy. Your doctor will inform you about the benefits and potential risks involved and help you decide whether to take Oxcarbazepine TecniGen.
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.
Neurological developmental disorders
Some studies have shown that exposure to oxcarbazepine in utero negatively affects brain function development (neurological development) in children, while other studies have not found such an effect. The possibility of an effect on neurological development cannot be excluded.
Do not stop treatment with Oxcarbazepine TecniGen 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, consult your doctor before starting to breastfeed. The active ingredient in Oxcarbazepine TecniGen passes into breast milk. Although available data suggest that the amount of Oxcarbazepine TecniGen passing 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 Oxcarbazepine TecniGen. If you are breastfeeding while taking Oxcarbazepine TecniGen and think your baby may be experiencing side effects such as excessive sleepiness or poor weight gain, inform your doctor immediately.
Driving and using machines
Oxcarbazepine TecniGen may cause drowsiness or dizziness.
It is important to consult your doctor about whether you can drive or operate machinery while taking this medicine.
3. HOW TO TAKE OXCARBAZEPINE TECNIGEN
Take this medicine exactly as directed by your doctor or pharmacist, even if
these instructions differ from those contained in this leaflet. If you have any doubts, consult your doctor or pharmacist.
How much Oxcarbazepine TecniGen to take
Dosage for adults
- The usual starting dose of Oxcarbazepine TecniGen for adults (including elderly patients) is 300 mg twice daily.
- Your doctor may gradually increase the dose to find the optimal dose for you. Best results are generally achieved with daily doses between 600 and 2400 mg.
- If you are taking another antiepileptic medicine, the dose remains the same.
- If you have kidney disease (impaired renal function), the starting dose is half the usual starting dose.
- If you have severe liver disease, your doctor may adjust your dose.
Dosage for children
Oxcarbazepine TecniGen may be used in children aged 6 years and older.
Dosage in children depends on body weight.
- The initial dose is 8–10 mg per kg of body weight per day, given in two divided doses. For example, a 30 kg child should start treatment with half a 300 mg tablet twice daily.
- Your doctor may gradually increase the dose to achieve the optimal dose for your child. Best results are generally achieved at 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 Oxcarbazepine TecniGen
- Swallow the tablets with water.
- If necessary, the tablets may be divided into two equal halves.
- For young children who cannot swallow tablets or for whom the required dose cannot be administered in tablet form, oxcarbazepine is available as an oral suspension.
When and for how long to take Oxcarbazepine TecniGen
Take Oxcarbazepine TecniGen twice daily, every day, at approximately the same time each day, unless your doctor has instructed otherwise. This will provide better control of epilepsy and help you remember when to take the tablet(s).
Your doctor will inform you how long your or your child’s treatment with Oxcarbazepine TecniGen will last.
The duration of treatment depends on the type of seizures you or your child has. Treatment may be required for many years to control seizures. Do not change the dose or stop treatment without first consulting your doctor.
If you take more Oxcarbazepine TecniGen than you should
If you have taken more tablets than prescribed, contact your doctor or the nearest hospital immediately. Symptoms of overdose with Oxcarbazepine TecniGen may include: drowsiness, dizziness, feeling unwell (nausea), illness (vomiting), increased involuntary movements, lethargy, confusion, muscle twitching, or significant worsening of seizures, problems with coordination and/or involuntary eye movements.
If you forget to take Oxcarbazepine TecniGen
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Return to your regular dosing schedule.
Never take a double dose.
If you are unsure or have missed several doses, consult your doctor.
If you stop taking Oxcarbazepine TecniGen
Do not stop treatment with this medicine unless your doctor tells you to.
To prevent a sudden worsening of seizures, do not stop taking the medicine abruptly.
If you need to stop treatment, it must be done gradually, following your doctor’s instructions.
If you have any further 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. These side effects may occur with certain frequencies defined as follows:
- Very common: affects more than 1 in 10 people.
- Common: affects 1 to 10 in 100 people.
- Uncommon: affects 1 to 10 in 1,000 people.
- Rare: affects less than 1 in 10,000 people.
- Not known: frequency cannot be estimated from the available data.
Some side effects may be serious: seek immediate medical help
The following are symptoms of very rare but potentially serious side effects that may require urgent medical treatment.
- Swelling of 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, muscle and joint pain.
- Severe blistering of the skin and/or mucous membranes of lips, eyes, mouth, nasal cavity or genitals (signs of a severe allergic reaction including Lyell's syndrome, Stevens-Johnson syndrome and erythema multiforme). The risk of severe skin reactions associated with the use of carbamazepine or chemically related compounds in patients of Han Chinese or Thai ethnicity can be predicted by performing a blood test in these patients. Your doctor should be able to advise you whether a blood test is necessary before taking oxcarbazepine.
- 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 reduced platelet count or reduced blood cell counts).
- Rash with red spots mainly on the face, possibly accompanied by fatigue, fever, feeling unwell (nausea), loss of appetite (signs of systemic lupus erythematosus).
- Lethargy, confusion, muscle twitching, or significant worsening of seizures (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 of underactive thyroid).
Contact your doctor immediately or go to the nearest hospital emergency department if you
experience any of the side effects listed above. Your doctor will decide whether treatment with Oxcarbazepina TecniGen must be stopped immediately and how to proceed with further treatment.
Other side effects: contact your doctor as soon as possible
Common:
- tremor, coordination problems, involuntary eye movements, anxiety and nervousness, depression, rash.
Rare: - irregular heartbeat or very fast or very slow heartbeat.
Contact your doctor as soon as possible if you experience any of the above side effects. They may require medical evaluation.
Other side effects: contact your doctor if these effects concern you
These side effects due to Oxcarbazepina TecniGen are generally mild to moderate. Many of these effects are transient and usually diminish over time.
Very common:
- fatigue, headache, dizziness, drowsiness, feeling unwell (nausea), malaise (vomiting), double vision.
Common: - weakness, memory problems, impaired concentration, apathy, agitation, confusion, blurred vision, visual disturbances, constipation, diarrhoea, stomach (abdominal) pain, acne, hair loss, balance disorders.
Uncommon: - urticaria (hives). You may have increased liver enzyme levels while taking Oxcarbazepina TecniGen.
Not known: - high blood pressure.
Contact your doctor if any of the side effects listed above become severe.
Cases of bone disorders 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.
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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE OXCARBAZEPINE TECNIGEN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
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. PACK CONTENTS AND OTHER INFORMATION
What Oxcarbazepina TecniGen contains
- The active substance in Oxcarbazepina TecniGen is oxcarbazepine. Each tablet contains 300 mg of oxcarbazepine.
- The other components are microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, colloidal silicon dioxide, yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Oxcarbazepina TecniGen and pack contents
Oxcarbazepina TecniGen 300 mg tablets are oblong, bright pink tablets, with a score line on one side and the number 3 engraved on the other side.
The tablets are available in blisters containing 50 tablets.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxcarbazepine TecniGen 600 mg tablets
Equivalent medicine
Oxcarbazepine
Please read this entire 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, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Oxcarbazepine TecniGen is and what it is used for.
- What you need to know before taking Oxcarbazepine TecniGen.
- How to take Oxcarbazepine TecniGen.
- Possible side effects.
- How to store Oxcarbazepine TecniGen.
- Contents of the pack and other information.
1. WHAT OXCARBAZEPINE TECNIGEN IS AND WHAT IT IS USED FOR
What Oxcarbazepine TecniGen is
The active substance in Oxcarbazepine TecniGen is oxcarbazepine.
Oxcarbazepine TecniGen belongs to a group of medicines called anticonvulsants or antiepileptics.
What Oxcarbazepine TecniGen is used for
Medicines such as Oxcarbazepine TecniGen are standard treatment for epilepsy.
Patients who are diagnosed with epilepsy have experienced seizures or convulsions. Seizures occur due to a temporary malfunction in the brain's electrical system. Brain cells normally coordinate body movements by sending signals out to the muscles in an organized and orderly manner through the nerves.
In epilepsy, brain cells send out too many signals in a disorganized way. This may result in uncoordinated muscle activity known as an epileptic seizure.
Oxcarbazepine TecniGen is used to treat partial seizures, with or without secondary generalization into tonic-clonic seizures. Partial epileptic seizures involve a limited area of the brain but may 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, whereas in complex partial seizures, consciousness is impaired.
By controlling the "overexcitable" nerve cells in the brain, Oxcarbazepine TecniGen suppresses or reduces the frequency of these seizures.
Oxcarbazepine TecniGen may 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 more severe cases of epilepsy, it may be necessary to use a combination of two or more medicines to control seizures.
The use of Oxcarbazepine TecniGen is restricted to adults and children aged 6 years and older.
2. WHAT YOU SHOULD KNOW BEFORE TAKING OXCARBAZEPINE TECNIGEN
Follow all instructions given to you by your doctor, even if they differ from the information contained in
this leaflet.
Do not take Oxcarbazepine TecniGen
- If you are allergic to oxcarbazepine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxcarbazepine TecniGen.
Talk to your doctor before taking Oxcarbazepine TecniGen 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, the likelihood that you may also have an allergic reaction to oxcarbazepine is approximately 1 in 4 (25%);
- 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 the amount of urine produced);
- if you have heart problems, shortness of breath and/or swelling in 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, Oxcarbazepine TecniGen may interfere with the effectiveness of the contraceptive. Use a different or additional method of contraception (non-hormonal) while taking Oxcarbazepine TecniGen. This helps prevent an unintended pregnancy. Contact your doctor immediately if you experience vaginal bleeding or irregular vaginal discharge. If you have any questions about this, speak to your doctor or a healthcare professional.
If you develop any of the following symptoms after starting treatment with Oxcarbazepine TecniGen, contact your
doctor immediately or go to the nearest hospital emergency department:
-
if you experience an allergic reaction after starting treatment with Oxcarbazepine TecniGen. 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 and whites of the eyes);
-
if you experience an increase in the frequency of epileptic seizures. This is particularly important for 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, reddish or purplish spots or unexplained spots on the skin;
-
a small number of people being treated with antiepileptic medicines such as Oxcarbazepine TecniGen have had suicidal thoughts or self-harming thoughts. If at any time you have such thoughts, contact your doctor immediately.
If you develop any of the following symptoms after starting treatment with Oxcarbazepine TecniGen, contact your
doctor as soon as possible: -
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 Oxcarbazepine TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This especially includes:
- hormonal contraceptives, such as the pill (see Warnings and precautions);
- other antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, or lamotrigine;
- medicines that lower sodium levels in the blood, such as diuretics (used to help the kidneys eliminate salts and water by increasing urine output), desmopressin, and non-steroidal anti-inflammatory drugs, such as indomethacin;
- lithium or monoamine oxidase inhibitors (medicines used to treat mood changes or certain forms of depression);
- medicines that affect the immune system, such as cyclosporine and tacrolimus.
Oxcarbazepine TecniGen with food, drinks and alcohol
Oxcarbazepine TecniGen can be taken with or without food.
Alcohol may increase the sedative effect of Oxcarbazepine TecniGen. Avoid drinking alcohol as much as possible and consult your doctor.
Pregnancy and breastfeeding
Pregnancy
Talk to your doctor if you are pregnant or planning to become pregnant.
It is important to control epileptic seizures during pregnancy. However, there may be a risk to your unborn child if you take antiepileptic medicines during pregnancy. Your doctor will inform you about the benefits and potential risks involved and help you decide whether to take Oxcarbazepine TecniGen.
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.
Neurological developmental disorders
Some studies have shown that in utero exposure to oxcarbazepine negatively affects brain function development (neurological development) in children, while other studies have not found such an effect. The possibility of an effect on neurological development cannot be excluded.
Do not stop treatment with Oxcarbazepine TecniGen 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, consult your doctor before starting to breastfeed. The active substance of Oxcarbazepine TecniGen passes into breast milk. Although available data suggest that the amount of Oxcarbazepine TecniGen transferred to a breastfed infant is low, the risk of side effects in the infant cannot be ruled out.
Your doctor will discuss with you the benefits and potential risks of breastfeeding while taking Oxcarbazepine TecniGen. If you are breastfeeding while taking Oxcarbazepine TecniGen and notice side effects in your baby such as excessive sleepiness or poor weight gain, inform your doctor immediately.
Driving and using machines
Oxcarbazepine TecniGen may cause drowsiness or dizziness.
It is important to consult your doctor regarding your ability to drive or operate machinery while taking this medicine.
3. HOW TO TAKE OXCARBAZEPINE TECNIGEN
Take this medicine exactly as directed by your doctor or pharmacist, even if
these instructions differ from those contained in this leaflet. If you have any doubts, consult your doctor or pharmacist.
How much Oxcarbazepine TecniGen to take
Dosage for adults
- The usual starting dose of Oxcarbazepine TecniGen for adults (including elderly patients) is 300 mg twice daily.
- Your doctor may gradually increase the dose to find the optimal dose for you. Best results are generally achieved with daily doses between 600 mg and 2400 mg.
- If you are taking another antiepileptic medicine, the dose remains the same.
- If you have kidney disease (impaired kidney function), the starting dose is half the usual starting dose.
- If you have severe liver disease, your doctor may adjust your dose.
Dosage for children
Oxcarbazepine TecniGen may be taken by children aged 6 years and older.
Dosage in children depends on body weight.
- The starting dose is 8–10 mg per kg of body weight per day, given in two divided doses. For example, a child weighing 30 kg should start treatment with half a 300 mg tablet twice daily.
- Your doctor may gradually increase the dose to reach the optimal dose for your child. Best results are generally achieved at 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 Oxcarbazepine TecniGen
- Swallow the tablets with a little water.
- If necessary, the tablets may be divided into two equal halves.
- For young children who cannot swallow tablets or for whom the required dose cannot be administered in tablet form, oxcarbazepine is available as an oral suspension.
When and for how long to take Oxcarbazepine TecniGen
Take Oxcarbazepine TecniGen twice daily, every day, at approximately the same times each day, unless
your doctor has instructed you otherwise. This will provide better control of epilepsy and will also help you
remember when to take your tablet(s).
Your doctor will inform you how long your treatment with Oxcarbazepine TecniGen, or that of your child, will last.
The duration of treatment depends on the type of seizures you or your child has. Controlling seizures may require treatment for many years. Do not change the dose or stop treatment without speaking to your doctor.
If you take more Oxcarbazepine TecniGen than you should
If you have taken more tablets than prescribed by your doctor, contact your doctor or the nearest hospital immediately. Symptoms of overdose with Oxcarbazepine TecniGen may include: drowsiness, dizziness, feeling unwell (nausea), illness (vomiting), increased involuntary movements, lethargy, confusion, muscle twitching or marked worsening of seizures, problems with coordination and/or involuntary eye movements.
If you forget to take Oxcarbazepine TecniGen
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Return to your regular dosing schedule.
Never take a double dose.
If you are unsure or have forgotten to take several doses, consult your doctor.
If you stop taking Oxcarbazepine TecniGen
Do not stop treatment with this medicine unless your doctor has told you to do so.
To prevent a sudden worsening of seizures, do not stop taking the medicine abruptly.
If you need to stop treatment, it should be done gradually, following your doctor's instructions.
If you have any further questions about using this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These adverse effects may occur with certain frequencies defined as follows:
- Very common: affects more than 1 in 10 people.
- Common: affects 1 to 10 in 100 people.
- Uncommon: affects 1 to 10 in 1,000 people.
- Very rare: affects fewer than 1 in 10,000 people.
- Not known: frequency cannot be estimated from the available data.
Some adverse effects may be serious: seek immediate medical help
The following are symptoms of very rare but potentially serious adverse effects that may require urgent medical treatment.
- Swelling of lips, eyelids, face, throat or mouth accompanied by difficulty in breathing, speaking or swallowing (signs of anaphylactic reactions and angioedema), or other signs of hypersensitivity reactions such as rash, fever, and muscle or joint pain.
- Severe blistering of the skin and/or mucous membranes of lips, eyes, mouth, nasal cavities or genitals (signs of a severe allergic reaction including Lyell’s syndrome, Stevens-Johnson syndrome and erythema multiforme). The risk of severe skin reactions associated with the use of carbamazepine or chemically related compounds in patients of Han Chinese or Thai descent can be predicted by performing a blood test on these patients.
Your doctor should be able to advise you whether a blood test is necessary before taking oxcarbazepine.
- 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 reduced platelet count or reduced blood cell counts).
- Skin rash with red spots mainly on the face, possibly accompanied by fatigue, fever, feeling unwell (nausea), loss of appetite (signs of systemic lupus erythematosus).
- Lethargy, confusion, muscle twitching, or significant worsening of seizures (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, feeling unwell (vomiting), loss of appetite (signs of pancreatitis).
- Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs of underactive thyroid).
Contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the adverse effects listed above. Your doctor will decide whether treatment with Oxcarbazepina TecniGen should be immediately discontinued and how to proceed with further treatment.
Other adverse effects: contact your doctor as soon as possible
Common:
- tremor, coordination problems, involuntary eye movements, anxiety and nervousness, depression, skin rash.
Very rare: - irregular heartbeat, very fast or very slow heartbeat.
Contact your doctor as soon as possible if you experience any of the adverse effects listed above. These may require medical evaluation.
Other adverse effects: contact your doctor if these effects concern you
These adverse effects due to Oxcarbazepina TecniGen are generally mild to moderate. Many of these effects are transient and usually diminish over time.
Very common:
- fatigue, headache, dizziness, drowsiness, feeling unwell (nausea), malaise (vomiting), double vision.
Common: - weakness, memory problems, reduced concentration ability, apathy, agitation, confusion, blurred vision, visual disturbances, constipation, diarrhoea, stomach (abdominal) pain, acne, hair loss, balance disorders.
Uncommon: - urticaria (hives). You may have increased liver enzyme levels while taking Oxcarbazepina TecniGen.
Not known: - high blood pressure.
Contact your doctor if any of the adverse effects listed above become severe.
Cases of bone disorders, 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.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE OXCARBAZEPINE TECNIGEN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 PACKAGE AND OTHER INFORMATION
What Oxcarbazepina TecniGen contains
- The active substance in Oxcarbazepina TecniGen is oxcarbazepine. Each tablet contains 600 mg of oxcarbazepine.
- The other components are microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, colloidal silicon dioxide, yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Oxcarbazepina TecniGen and contents of the pack
Oxcarbazepina TecniGen 600 mg tablets are oblong, bright pink tablets, with a score line on one side and the number 6 engraved on the other side.
The tablets are available in blisters containing 50 tablets.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal.