Patient Medication Information: uses, side effects, how to take - Novo-Oxcarbazepine
ABOUT THIS MEDICATION
What the medication is used for:
NOVO-OXCARBAZEPINE is one of a group of medicines called anticonvulsants or antiepileptics (medicines to treat epilepsy).
Antiepileptic medicines such as NOVO-OXCARBAZEPINE are the standard treatment for epilepsy.
Patients diagnosed with epilepsy have had repeated seizures, or convulsions. Seizures happen because of a temporary fault in the brain’s electrical system. 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 uncontrolled movements of muscles that we call an epileptic seizure.
There are two main classes of epileptic seizures, generalized and partial. Generalized seizures involve a wide area of the brain, cause loss of consciousness and can, affect the whole body. There are two main types of generalized seizures: tonic-clonic seizures (grand mal) and absence seizures (petit mal).
Partial seizures involve a limited area of the brain (i.e., focal origin), but may spread to the whole brain and may cause a generalized tonic-clonic (grand mal) 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 lose consciousness.
NOVO-OXCARBAZEPINE is used to treat partial seizures.
Usually, the doctor will attempt to find the one drug that works best but, with more severe epilepsy, a combination of two or more drugs may be needed to control seizures, NOVO-OXCARBAZEPINE can be used alone (i.e., monotherapy) or in combination with other antiepileptic drugs.
This medicine has been prescribed for you personally (or your child) and you should not give it to others.
What it does:
NOVO-OXCARBAZEPINE works by keeping the brain’s “overexcitable” nerve cells under control, thereby suppressing or reducing the frequency of such seizures.
When it should not be used:
If you have ever shown unusual sensitivity (rash or any other sign of allergy) to oxcarbazepine.
If you have ever shown unusual sensitivity to any of the other substances listed in ‘What the important nonmedicinal ingredients are’.
What the medicinal ingredient is:
The active ingredient in NOVO-OXCARBAZEPINE tablets is oxcarbazepine.
What the important nonmedicinal ingredients are:
The tablets also contain the following non-medicinal ingredients: colloidal silicon dioxide, crospovidone, D&C Yellow #10, FD&C Yellow #6, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, titanium dioxide and yellow iron oxide.
What dosage forms it comes in:
NOVO-OXCARBAZEPINE is available in tablets of 150 mg, 300 mg and 600 mg.
WARNINGS AND PRECAUTIONS
Important points you must tell your doctor before taking NOVO-OXCARBAZEPINE
- If you have ever shown unusual sensitivity (rash or any other signs of allergy) to carbamazepine or to any other drugs. If you have had an allergic reaction to carbamazepine you have a 25%-30% chance of being allergic to NOVO-OXCARBAZEPINE.
- If you have a serious kidney 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 suffer from heart disease with shortness of breath and swelling of the feet or legs due to fluid retention.
- If you know that your blood level of sodium is low.
- If you are pregnant, breast-feeding or planning to become pregnant (see ‘What special precautions should pregnant or breast-feeding women take?’).
If you notice symptoms suggestive of liver problems, such as
nausea, vomiting, itching, jaundice (yellow skin or eyes), abdominal pain, tell your doctor immediately.
If you are taking other medicines (see INTERACTIONS
WITH THIS MEDICATION: Can you use NOVO-OXCARBAZEPINE if you are taking other medicines?’).
You should also tell your doctor if any of these statements were applicable at any time in the past.
If you are a woman taking an oral contraceptive (“the pill”), NOVO-OXCARBAZEPINE may render this contraceptive ineffective. Therefore, you should use either a different method of contraception or an additional non-hormonal method of contraception while you are taking NOVO- OXCARBAZEPINE. This should help to prevent an unwanted pregnancy. Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, check with your doctor or health professional.
Do not stop your treatment with NOVO-OXCARBAZEPINE without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly.
Will NOVO-OXCARBAZEPINE affect your ability to drive or use machines?
It is important to discuss with your doctor if you can drive a vehicle or operate machines. NOVO-OXCARBAZEPINE may make you feel sleepy or dizzy, especially at the beginning of treatment.
What special precautions should pregnant or breast-feeding women take?
You should tell your doctor if you are pregnant, breast-feeding, 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 drugs during pregnancy. Your doctor will tell you the benefits and potential risks involved and help you to decide whether you should take NOVO-OXCARBAZEPINE.
Do not stop your treatment with NOVO-OXCARBAZEPINE during pregnancy without first checking with your doctor.
The active ingredient in NOVO-OXCARBAZEPINE passes into breast milk. This could cause side effects for breast-fed babies. Therefore, NOVO-OXCARBAZEPINE should not be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while you are breast-feeding.
INTERACTIONS WITH THIS MEDICATION
Can you use NOVO-OXCARBAZEPINE if you are taking other medicines?
Before taking any medicine at the same time as NOVO-OXCARBAZEPINE talk to your doctor or pharmacist. This applies to both prescription and non-prescription (over-the-counter) medicines, and especially to:
Oral contraceptives (the birth-control pill). (see
WARNINGS AND PRECAUTIONS)
- Other antiepileptic drug (e.g. carbamazepine, phenobarbital or phenytoin).
- Calcium antagonists (e.g. felodipine) (type of medicine used to treat high blood pressure).
- Medicines which reduce the level of sodium in your blood, e.g. diuretics (used to help the kidneys get rid of salt and water by increasing the amount of urine produced).
Medicines which control your body’s immune system (e.g.
cyclosporine).
What foods and drinks should be avoided?
Alcohol may increase the sedative effects (making you more sleepy) of NOVO-OXCARBAZEPINE. Avoid alcohol as much as possible and ask your doctor for advice.
PROPER USE OF THIS MEDICATION
Usual dose:
Take your medicine exactly as your doctor or pharmacist tells you.
NOVO-OXCARBAZEPINE should be taken twice a day, every day, at about the same time of day, unless the doctor tells you otherwise. Taking NOVO-OXCARBAZEPINE at the same time each day will have the best effect on controlling epilepsy. It will also help you to remember when to take NOVO-OXCARBAZEPINE.
The usual starting dose of NOVO-OXCARBAZEPINE for adults (including elderly patients) is 600 mg per day. Take one 300 mg tablet twice daily or two 150 mg tablets twice daily. This dosage may be gradually increased if necessary until the best results are obtained. This is usually achieved at a dose between 600 and 2400 mg per day.
The dosage is the same if NOVO-OXCARBAZEPINE is being taken with another antiepileptic.
The starting dose in patients with kidney disease (with impaired renal function) is half the usual starting dose.
The dosage for children will be calculated by your doctor and depends on your child’s weight. The starting dose is 8-10 mg/kg bodyweight per day given in two divided doses.
Your doctor will tell you how long your/your child’s treatment with NOVO-OXCARBAZEPINE will last. The duration of treatment is based on your/your child’s seizure type; and ongoing treatment for many years may be necessary to control the seizures. Do not change the dose or stop treatment without talking to your doctor.
Overdose:
If you have taken many more tablets than your doctor prescribed, contact the nearest hospital, your doctor or regional Poison Control Centre immediately.
Missed Dose:
If you have only forgotten one dose, take it as soon as you remember. However, if it is time for your next dose, do not take the missed dose. Just go back to your regular dosing timetable. Do not double the dose at any time.
If you have forgotten to take several doses, contact your doctor.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like most medicines, besides the beneficial effects, NOVO-OXCARBAZEPINE can have side effects. The side effects are often mild and usually occur at the start of treatment, and normally wear off with time.
In rare cases, NOVO-OXCARBAZEPINE may cause a fall in your blood level of sodium, which may or may not be accompanied by symptoms. If you get symptoms of sodium deficiency (lack of energy, confusion, muscular twitching or significant worsening of convulsions, see SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM), tell your doctor immediately. The doctor will keep you under close observation.
If an allergic reaction happens such as swelling of the lips, eyelids, face, throat, mouth, sudden breathing problems, fever with lymph nodes swelling, rash or skin blistering, tell your doctor immediately or go to the emergency department at your nearest hospital (or make sure that someone else can take you there) (See SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM).Your doctor may have switched you to NOVO-OXCARBAZEPINE because you are allergic to carbamazepine or other anticonvulsants. If you are allergic to carbamazepine, there is a 25%-30% chance that you could also have an allergic reaction to oxcarbazepine (NOVO-OXCARBAZEPINE).
If you notice symptoms suggestive of blood disorders such as tiredness, being short of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, ulcers in the mouth, bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin, tell your doctor immediately.
If any of the following side effects occur, tell your doctor as soon as possible since they may require medical attention.
Common (between 1 and 10 in every 100 people): trembling, problems with muscle coordination; involuntary movement of the eyes; feeling of anxiety and nervousness; feeling of depression.
Very rare (less than 1 in every 10,000 people): irregular heart beats or very fast or slow heart rate.
Tell your doctor if you have any of the following side effects and if they worry you:
Very Common (10 or more in every 100 people): tiredness; drowsiness, headache; dizziness; nausea; vomiting; double vision.
Common: weakness; memory disturbances; impaired concentration; apathy (indifference); agitation; confusion; blurred vision; constipation; diarrhea; abdominal pain, acne, hair loss; disturbance of balance.
Very rare: NOVO-OXCARBAZEPINE has been associated with high blood pressure and vitamin B9 (folic acid) deficiency. Some of the signs of vitamin B9 deficiency are: diarrhea, feeling of depression and signs of decrease in the number of blood cells (see table below).
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
| Symptom/Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist† | ||
| Only if severe | In all cases | |||
| Uncommon | Frequent infections leading to fever, sore throat, ulcers in the mouth (signs of decrease in the number of white blood cells) | 9 | ||
| Very Rare | Allergic reactions Swelling of the lips, eyelids, face, throat or mouth, accompanied by difficulty in breathing, speaking or swallowing (signs of anaphylactic reactions and angioedema) Skin rash, fever, swelling of the lymph nodes, and pain in the joints (signs of hypersensitivity reactions) | 9† 9† | ||
Blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (signs of serious skin reaction) Red blotchy rash mainly on face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of sytemic lupus erythematosus) | 9† 9† | |||
Blood Disorders Tiredness, being short of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, ulcers in the mouth (signs of decrease in the number of blood cells) Bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin (signs of decrease in the number of blood platelets) | 9 9 | |||
Low sodium level in blood Lack of energy, confusion, muscular twitching or significant worsening of convulsions | 9 | |||
| Very rare | Liver and pancreas disorders Symptoms include nausea, loss of appetite, vomiting combined with itching, upper abdominal pain, | 9† |
| yellowing of the skin or eyes (signs of hepatitis) | ||||
| Flu-like symptoms accompanied with liver disorders | 9 |
† If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking NOVO-OXCARBAZEPINE, contact your doctor or pharmacist.
HOW TO STORE IT
The tablets should be stored at room temperature (15- 30o C). Do not use NOVO-OXCARBAZEPINE after the expiry date which is printed on the label.
Do not use any NOVO-OXCARBAZEPINE pack that is damaged or show signs of tampering.
Keep NOVO-OXCARBAZEPINE out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax 866-678-6789
Online: www.healthcanada.gc.ca/medeffect
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting Novopharm Limited at:
1-800-268-4127 ext. 5005 (English);
1-877-777-9117 (French)
or druginfo@novopharm.com
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9