Jamp-Oxcarbazepine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

JAMP-OXCARBAZEPINE belongs to a group of medicines called anticonvulsants or antiepileptics (medicines to treat epilepsy).

Epilepsy is a brain disorder that causes people to have recurring seizures and convulsions. 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 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 secondarily 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.

JAMP-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. JAMP-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:

JAMP-OXCARBAZEPINE is thought to work by keeping the brain’s “overexcitable” nerve cells under control, which may

help to suppress or reduce the frequency of such seizures.

When it should not be used:

If you are allergic (hypersensitive) to JAMP-Oxcarbazepine or to any of the other substances listed in 'What the nonmedicinal ingredients are’.

What the medicinal ingredient is:

JAMP-Oxcarbazepine.

What the nonmedicinal ingredients are:

Each tablet also contains: hypromellose, microcrystalline cellulose, crospovidone, colloidal silica anhydrous, magnesium stearate, titanium dioxide, macrogol 8000, iron oxide yellow, iron oxide red and talc.

What dosage forms it comes in:

JAMP-OXCARBAZEPINE is available in tablets of 150 mg, 300 mg and 600 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Blood: Although infrequently reported, serious adverse effects affecting blood cell counts have been observed during the use of JAMP-OXCARBAZEPINE. Other side effects include: low white blood cell count, bone marrow depression and hepatitis. Close clinical and frequent laboratory supervision with your doctor should be maintained throughout treatment with JAMP-OXCARBAZEPINE in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue JAMP-OXCARBAZEPINE, if there is significant evidence of a bone marrow depression.

• Skin: Serious and sometimes fatal skin reactions known as

  Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported with JAMP-OXCARBAZEPINE. Other serious skin reactions such as Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) and maculopapular rash have also been reported. Although very rare, serious forms of DRESS and AGEP may also lead to death. Since some cases of these skin reactions have been genetically linked, your doctor may recommend a blood test to determine whether you belong to an at-risk population.

• Contact your doctor immediately if you are developing a rash or any serious skin reactions such as red skin, blistering of the lips, eyes or mouth, and skin peeling accompanied by fever. Your doctor will determine if it is indeed drug-related, and discontinue JAMP-OXCARBAZEPINE in this case.

Important points you must tell your doctor before taking

JAMP-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 JAMP-OXCARBAZEPINE.

• If you have a kidney disease.
• If you have a 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 a 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 are taking other medicines (see

  INTERACTIONS WITH THIS MEDICATION: ‘Can you use JAMP-OXCARBAZEPINE if you are taking other medicines?’).

• If you have a history, or family history, of bone disease.

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 a hormonal contraceptive (such as “the pill”), JAMP-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 JAMP-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 JAMP-OXCARBAZEPINE without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly.

Will JAMP-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. JAMP-OXCARBAZEPINE 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 at the beginning of treatment, and may affect your ability to operate machinery, including a vehicle.

What special precautions should pregnant or breast-feeding women take?

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 JAMP-OXCARBAZEPINE.

Do not stop your treatment with JAMP-OXCARBAZEPINE during pregnancy without first checking with your doctor.

During pregnancy there can be a gradual decrease in the amount of the active ingredient in JAMP-

OXCARBAZEPINE in your blood. As a precaution to check that the blood levels of the active ingredient are adequate for controlling your seizures, your doctor may recommend periodic blood testing throughout your pregnancy.

The active ingredient in JAMP-OXCARBAZEPINE passes into breast milk. This could cause side effects for breast-fed babies. Therefore, you should not use JAMP-

OXCARBAZEPINE 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 JAMP-OXCARBAZEPINE, if you are taking other medicines?

Before taking any medicine at the same time as JAMP-OXCARBAZEPINE talk to your doctor or pharmacist. This applies to both prescription and non-prescription (over-the-counter) medicines, and especially to:

• Hormonal contraceptives (such as the birth-control pill).

  (see WARNINGS AND PRECAUTIONS)

• Other antiepileptic drug (such as carbamazepine, phenobarbital or phenytoin).
• Calcium antagonists (such as 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

  (such as cyclosporine).

What foods and drinks should be avoided?

Alcohol may increase the sedative effects (making you more sleepy) of JAMP-OXCARBAZEPINE. Avoid alcohol as much as possible and ask your doctor for advice.

PROPER USE OF THIS MEDICATION

JAMP-OXCARBAZEPINE can be taken with or without food.

Usual dose:

Take your medicine exactly as your doctor or pharmacist tells you.

JAMP-OXCARBAZEPINE should be taken twice a day, every day, at about the same time of day, unless the doctor tells you otherwise. Taking JAMP-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 JAMP-OXCARBAZEPINE.

The usual starting dose of JAMP-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.

If JAMP-OXCARBAZEPINE is being taken with another antiepileptic, best results may be obtained with a dose between 600 and 1200 mg per day. Your doctor will decide the best dose of JAMP-OXCARBAZEPINE if you are taking 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 JAMP-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 your doctor, the nearest hospital or regional Poison Control Center immediately, even though you may not feel sick. You may require medical attention.

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

The most common side-effects may include:

• Fatigue, sleepiness, dizziness, unsteadiness,
• Headache

• Nausea, vomiting, abdominal pain, diarrhea,

  constipation

• Double vision, uncontrolled eye movement, blurred

  vision

  • Anxiety, nervousness, feeling of depression, mood swing, memory problems, difficulty concentrating, apathy (feeling indifferent/loss of interest), agitation, confusion,
  • Trembling, problems with muscle coordination, weakness
  • Acne, hair loss

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures in patients on long term-treatment with JAMP-OXCARBAZEPINE.

If any of the side effects affects you severely, or if you notice any side effect not listed in this leaflet, please tell you doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking JAMP-OXCARBAZEPINE, contact your doctor or pharmacist.

HOW TO STORE IT

The tablets should be stored at room temperature (15° - 30°C). Do not use JAMP-OXCARBAZEPINE after the expiry date which is printed on the label.

Do not use any JAMP-OXCARBAZEPINE pack that is damaged or show signs of tampering.

Keep JAMP-OXCARBAZEPINE out of the reach and sight of the children.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffet;
• By calling 1-866-234-2345 (toll-free);

• By completing a Patient Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

    Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffet.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the distributer, JAMP Pharma Corporation., at 1-866-399-9091

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

JAMP Pharma Corporation

1380-203 newton

Boucherville, Québec

J4B 5H2 Canada

Date of preparation: May 1, 2015