Oxcarbazepine Teva 300 Mg Film-Coated Tablets
TEVA UK Ref: 231-30-87238-Y LEA OXCARBAZEPINE A/S FC TAB TUK Version: 1 23 February 2016
Oxcarbazepine Teva 150 mg, 300 mg and 600 mg Film-coated Tablets Oxcarbazepine
Package leaflet:Information for the user
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
Pharma code 92 (011101)
First bar is 105mm from the top edge of the leaflet.
1. What Oxcarbazepine Teva Film-coated Tablets are and what they are used for
2. what you need to know before you take Oxcarbazepine Teva Film-coated Tablets
3. How to take Oxcarbazepine Teva Film-coated Tablets
4. Possible side effects
5. How to store Oxcarbazepine Teva Film-coated Tablets
6. Contents of the pack and other information
OWhat Oxcarbazepine Teva Film-coated Tablets are and what they are used for
What Oxcarbazepine Teva Film-coated Tablets are
The active ingredient of Oxcarbazepine Teva Film-coated Tablets is oxcarbazepine.
Oxcarbazepine belongs to a group of medicines called anticonvulsants or antiepileptics.
What Oxcarbazepine Teva Film-coated Tablets are used for
Medicines such as Oxcarbazepine Teva Film-coated Tablets are the standard treatment for epilepsy.
Epilepsy is a brain disorder that causes people to have recurring seizures and convulsions(also known as fits). Seizures happen because of a temporary fault in the brain's electrical activity. Normally brain cells coordinate body movements by sending out signals through the nerves to the muscles in an organised, orderly way. In epilepsy, brain cells send out too many signals in a disorderly fashion. The result can be uncoordinated muscular activity that is called an epileptic seizure.
Oxcarbazepine Teva Film-coated Tablets are used to treat partial seizures with or without secondarily generalised tonic-clonic seizures. Partial seizures involve a limited area of the brain, but may spread to the whole brain and may cause generalised tonic-clonic seizure. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, whereas in complex partial seizures, patients consciousness is altered. Oxcarbazepine Teva Film-coated Tablets work by keeping the brain's "overexcitable" nerve cells under control. This suppresses or reduces the frequency of such seizures.
Oxcarbazepine Teva Film-coated Tablets can be used alone or in combination with other antiepileptic medicines.
Usually, the doctor will try to find the one medicine that works best for you or your child. However, with more severe epilepsy, a combination of two or more medicines may be needed to control seizures.
Oxcarbazepine Teva Film-coated Tablets are for use in adults and in children of 6 years of age and above.
OWhat you need to know before you take Oxcarbazepine Teva Film-coated Tablets
Follow all the doctor's instructions carefully. They may differ from the general information contained in this leaflet.
Monitoring during your treatment with Oxcarbazepine Teva Film-coated Tablets
Before and during your treatment with Oxcarbazepine Teva film-coated tablets, your doctor may perform blood tests to determine the dose for you. Your doctor will tell you when to have the tests.
Do not take Oxcarbazepine Teva Film-coated Tablets:
• If you are allergic to oxcarbazepine or to any of the other ingredients of this medicine(listed in section 6).
If this applies to you, tell your doctor before taking Oxcarbazepine Teva Film-coated Tablets . If you think you may be allergic, ask your doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxcarbazepine Teva Film-coated Tablets:
• If you have ever shown unusual sensitivity ( rash or other signs of allergy) to carbamazepine, or to any other medicines. If you are allergic to carbamazepine, the chances are approximately a 1 in 4 (25%) that you could also have an allergic reaction to oxcarbazepine.
• If you have kidney disease • If you have serious liver disease .
• If you are taking diuretics (medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced)
• If you have heart disease, shortness of breath and/or swelling of the feet or legs due to fluid build-up
• If your blood level of sodium is low as shown by blood tests (see section 4 Possible side effects)
• If you are a woman taking a hormonal contraceptive (such as the
birth-control pill') oxcarbazepine may stop your contraceptive from working. Use a different or extra (non-hormonal) method of contraception while taking Oxcarbazepine Teva Film-coated Tablets . This should help to prevent an unwanted pregnancy. Tell your doctor immediately if you get irregular vaginal bleeding or spotting. If you have any questions about this, ask your doctor or health professional
The risk of serious skin reactions in patients of Han Chinese or Thai origin associated with carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking oxcarbazepine.
If you develop any of the following symptoms after starting Oxcarbazepine Teva Film-coated Tablets tell your doctor immediately or go to the emergency department at your nearest hospital:
• if you experience an allergic reaction after starting Oxcarbazepine Teva Film-coated Tablets . Symptoms include swelling of lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen glands, rash or skin blistering.
• if you notice symptoms of hepatitis, such as jaundice (yellowing of skin or the whites of the eyes).
• if you experience an increase in the frequency of seizures. This is particularly important for children but may also occur in adults.
• if you notice possible symptoms of blood disorders such as tiredness, being short of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin.
• a small number of people being treated with antiepileptics such as Oxcarbazepine Teva Film-coated Tablets have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
• if you have a fast or unusually slow heart beat.
Children and adolescents
In children, your doctor may recommend thyroid function monitoring before therapy and during therapy.
Other medicines and Oxcarbazepine Teva Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• Hormonal contraceptives, such as the pill (see 'Warnings and precautions')
• Other antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin or lamotrigine
• Medicines that reduce the levels of sodium in your blood, such as diuretics (used to help the kidneys get rid of salt 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 swings and some types of depression)
• Medicines that control the body's immune system, such as ciclosporin and tacrolimus.
Oxcarbazepine Teva Film-coated Tablets with food, drink and alcohol
Oxcarbazepine Teva Film-coated tablets can be taken with or without food. Alcohol may increase the sedative effects of Oxcarbazepine Teva Film-coated Tablets . Avoid alcohol as much as possible and ask your doctor for advice. Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
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 tell you the benefits and potential risks involved and help you to decide whether you should take Oxcarbazepine Teva Film-coated Tablets .
Do not stop your treatment with Oxcarbazepine Teva Film-coated Tablets during pregnancy without first checking with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Breast-feeding
You should not breast-feed while taking Oxcarbazepine Teva Film-coated Tablets . The active substance in Oxcarbazepine Teva Film-coated Tablets passes into breast milk. This could cause side effects for breast-fed babies. Ask your doctor or pharmacist for advice before taking any medicine while you are brest-feeding.
Driving and using machines
Oxcarbazepine Teva Film-coated Tablets may make you feel sleepy or dizzy, or may cause blurred vision, double vision, lack of muscle coordination or a depressed level of consciousness, especially when starting treatment or increasing the dose.
It is important to discuss with your doctor whether you can drive a vehicle or operate machines while taking this medicine
Oxcarbazepine Teva Film-coated Tablets contains lactose and sunset yellow (E110)
Patients who are intolerant to lactose should note that Oxcarbazepine Teva Film-coated Tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains sunset yellow (E110) and may cause allergic reactions.
How to take Oxcarbazepine Teva Film-coated Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take Dose for adults:
• The usual starting dose of Oxcarbazepine Teva Film-coated Tablets for adults (including elderly patients is 600 mg per day..
• Take one 300 mg tablet twice daily or two 150 mg tablets twice daily.
• Your doctor may increase the dose gradually to find the best dose for you. The best results are usually with doses between 600 and 2,400 mg per day.
• If you take another antiepileptic medicine, the dose is the same.
• If you have kidney disease (with impaired kidney function), the starting dose is half the usual starting dose.
• If you have severe liver disease, your doctor may adjust your dose.
Use in children
Oxcarbazepine Teva Film-coated Tablets can be taken by children aged 6 years or above.
The dosage for children depends on their weight.
Children aged 6 years and over:
• The starting dose is 8-10 mg/kg body weight a day given in 2 divided doses.
Top of page cut-off to middle of registration mark: 44 mm.
For example, a 30-kg child would start treatment with one 150 mg tablet twice daily.
Your doctor may increase the dose gradually to find the best dose for your child. The best results are usually with a dose of 30 milligrams per kilogram of bodyweight per day. The maximum dose for a child is 46 milligrams per kilogram of bodyweight per day.
Children aged under 6 years old:
Oxcarbazepine is not recommended for children aged under 6 years as its safety and efficacy have not been established in this age group.
How to take Oxcarbazepine Teva Film-coated Tablets
• Swallow the tablets with a little water.
• If necessary, the tablets can be broken in half to help swallow them. Do not break the tablets to take only half of the dose. The score line was not designed for dividing the tablet into equal doses.
• For small children who cannot swallow the tablets, or who cannot be given the necessary dose in tablet form, other pharmaceutical forms of oxcarbazepine are available.
When and for how long to take Oxcarbazepine Teva Film-coated Tablets
Take Oxcarbazepine Teva Film-coated Tablets twice a day, every day, at about the same time of day, unless the doctor tells you otherwise.This will have the best effect on controlling epilepsy. It will also help you to remember when to take the tablet(s).
Your doctor will tell you how long your or your child's treatment with Oxcarbazepine Film-coated Tablets will last. The length of treatment will depend on your or your child's seizure type. Treatment may be needed for many years to control the seizures. Do not change the dose or stop treatment without talking to your doctor.
If you take more Oxcarbazepine Teva Film-coated Tablets than you should
If you have taken more tablets than your doctor prescribed, contact the nearest hospital or your doctor immediately. Symptoms of overdose with Oxcarbazepine Teva Film-coated Tablets may include: drowsiness, dizziness, feeling sick (nausea), being sick (vomiting), increased uncontrolled movements, lethargy, confusion, muscular twitching or significant worsening of convulsions, problems with coordination and/or involuntary movement of the eyes.
If you forget to take Oxcarbazepine Teva Film-coated Tablets
If you have forgotten one dose, take it as soon as you remember. However if it is almost time for your next dose, do not take the missed dose. Go back to your regular dosing timetable.. Do not take a double dose to make up for a forgotten tablet.
If you are unsure or have forgotten to take several doses, contact your doctor. If you stop taking Oxcarbazepine Teva Film-coated Tablets
Do not stop taking your medicine, unless your doctor tells you to.
To prevent sudden worsening of your seizures, never discontinue your medicine abruptly.
If your treatment is stopped, it should be done gradually as instructed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
14 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious: get medical help immediately
The following are signs of very rare, but potentially serious side effects that may require urgent medical treatment.
• Swelling of the 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 skin rash, fever, and pain in the muscles and joints
• Severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (signs of a serious allergic reaction including Lyell's syndrome, Stevens-Johnson syndrome and erythema multiforme)
• Tiredness, shortness of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin (signs of a decrease in the number of blood platelets or decrease in the number of blood cells)
• Red blotchy rash mainly on face which may be accompanied by fatigue, fever, feeling sick (nausea) or loss of appetite (signs of systemic lupus erythematosus)
• Lethargy, confusion, muscle twitching or significant worsening of convulsions (possible symptoms of low sodium levels in the blood) (see 'Special warnings and precautions')
• Flu-like symptoms with jaundice (yellowing of the skin or the whites of the eyes (signs of hepatitis)
• Severe upper stomach (abdominal) pain, being sick (vomiting), loss of appetite (signs of inflammation of the pancreas)
• Weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of under active thyroid gland)
Tell your doctor immediately or go to the emergency department at your nearest hospital if you get any of the above side effects. The doctor will also decide whether Oxcarbazepine Teva Film-coated Tablets has to be stopped immediately and how to continue further medical care.
Other side effects: tell a doctor as soon as possible Common (may affect up to 1 in 10 people):
• Trembling, coordination problems; involuntary movement of the eyes; anxiety and nervousness; depression, mood swing; rash
Very rare (may affect up to 1 in 10,000 people):
• Irregular heart beat or a very fast or slow heart rate
Not known (frequency cannot be estimated from the available data):
• Speech disorder
Tell your doctor as soon as possible if you get any of the above side effects.
They may require medical attention.
Other side effects: tell a doctor if they worry you
These are usually mild to moderate side effects of Oxcarbazepine Teva Film-coated Tablets, Most of these effects are transient and ususally diminish over time.
Very common (may affect more than 1 in 10 people):
• Tiredness; headache; dizziness; drowsiness; feeling sick (nausea); being sick (vomiting); double vision
Common (may affect up to 1 in 10 people):
• Weakness; memory disturbances; impaired concentration; apathy; agitation; confusion; blurred vision; visual disturbance; constipation; diarrhoea; stomach (abdominal) pain; acne; hair loss; balance disturbances
Uncommon (may affect up to 1 in 100 people):
• Hives. You may also have raised levels of liver enzymes while taking Oxcarbazepine Teva Film-coated Tablets
Not known (frequency cannot be estimated from the available data):
• High blood pressure, fall.
Tell your doctor if any of the above side effects gets severe.
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
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How to store Oxcarbazepine Teva Film-coated Tablets
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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Oxcarbazepine Teva Film-coated Tablets contains
• The active substance is oxcarbazepine. Each film-coated tablet contains either 150, 300 or 600 mg oxcarbazepine.
• The other ingredients are:
Tablet core: lactose monohydrate, maize starch, crospovidone, povidone (K-30), cellulose microcrystalline, sodium starch glycolate (type A), silica colloidal anhydrous and magnesium stearate.
Film-coating: hypromellose, macrogol 6000, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), sunset yellow aluminium lake (E110). What Oxcarbazepine Teva Film-coated Tablets look like and contents of the pack
Film-coated tablet
Oxcarbazepine Teva 150 mg Film-coated Tablets are yellow to dark yellow, film coated capsule shaped tablets. One side of the tablet is scored in half and debossed with "9" on one side of the score and "3" on the other. The other side of the tablet is scored in half and debossed with "72" on one side of the score and "81" on the other. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Oxcarbazepine Teva 300 mg Film-coated Tablets are yellow to dark yellow, film coated capsule shaped tablets. One side of the tablet is scored in half and debossed with "9" on one side of the score and "3" on the other. The other side of the tablet is scored in half and debossed with "72" on one side of the score and "82" on the other. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Oxcarbazepine Teva 600 mg Film-coated Tablets are yellow to dark yellow, film coated capsule shaped tablets. One side of the tablet is scored in half and debossed with "9" on one side of the score and "3" on the other. The other side of the tablet is scored in half and debossed with "72" on one side of the score and "83" on the other. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Oxcarbazepine Teva 150 mg Film-coated Tablets are available in pack sizes of 1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital pack: 500 film-coated tablets.
Oxcarbazepine Teva 300 mg Film-coated Tablets are available in pack sizes of 1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500 film-coated tablets.
Oxcarbazepine Teva 600 mg Film-coated Tablets are available in pack sizes of 1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in February 2016 PL 00289/1084, 1085 and 1086