Ruzexin Film-Coated Tablets

RUZEXIN contains the active substance oxcarbazepine. RUZEXIN belongs to a group of medicines called anticonvulsants or antiepileptics. RUZEXIN is used to treat epilepsy (a brain disorder that causes people to have recurring seizures and convulsions). RUZEXIN is used to treat partial seizures [a condition that causes temporary abnormalities in muscle tone or movements (stiffness, twitching or limpness), behaviours, sensations or states of awareness, with or without secondarily generalised tonic - clonic seizures. RUZEXIN 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 for your child. However, with more severe epilepsy, a combination of two or more medicines may be needed to control seizures. RUZEXIN is for use in adults and in children aged 1 month and above.

Do not take RUZEXIN:

• If you are hypersensitive (allergic) to oxycarbazepine, eslicarbazepine or any of the other ingredients of RUZEXIN (listed in section 6).

Warnings and precautions

Take special care with RUZEXIN:

• if you have ever shown an allergic reaction (rash or any other signs of allergy) to carbamazepine or to any other medicines. If you are allergic to carbamazepine, the chances are that you could also have an allergic reaction to oxcarbazepine (RUZEXIN).
• if you have low levels of sodium in the blood (see section 4).
• If you have a condition in which your thyroid gland doesn't produce enough of certain crucial hormones (hypothyroidism).
• if you have serious liver disease.
• if you have 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 a heart failure, shortness of breath and/or swelling of the feet or legs due to fluid build-up.
• if you have thoughts of harming or killing themselves.
• if you are a woman taking and you are taking hormonal contraceptive (birth-control pills), RUZEXIN may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking RUZEXIN. 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, ask your doctor or healthcare professional.
• if you drink alcohol.

If any of the above applies to you, tell your doctor before you take RUZEXIN. Do not stop your treatment with RUZEXIN without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly.

If you develop any of the following symptoms after starting RUZEXIN, tell your doctor immediately or go to the emergency department at your nearest hospital:

• If you have an allergic reaction after starting RUZEXIN. 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 RUZEXIN 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 RUZEXIN

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

• Hormonal contraceptives, such as the pill (see warnings and precautions).
• other antiepileptic and enzyme including medicines such as phenobarbitone, phenytoin, carbamazepine, lamotrigine, rifampicin and valproic acid.
• medicines that can lower sodium levels in the blood (e.g., diuretics (used to help the kidneys get rid of salt and water by increasing, desmopressin and non-steroid anti-inflammatory medicines such as indomethacin and ibuprofen).
• 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.

Do not share medicines prescribed for you with any other person. Always take RUZEXIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if not sure.

Dose for adults and elderly patients

• The usual starting dose of RUZEXIN is 600 mg per day (8 - 10 mg/kg/day) given in 2 divided doses.
• The maintenance doses are usually with doses between 600 mg and 2400 mg per day.
• 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.

Dose for children

The dosage for children depends on their weight.

• The starting dose is 8 to 10 milligrams per kilogram of bodyweight per day given in two divided doses. For example, a 30 - kg child would start treatment with one 150 mg tablet twice daily. The maximum dose for a child is 60 mg per kg bodyweight per day.

Swallow the tablets with a little water. If necessary, the tablets can be broken in half to help swallow them.

If you take more RUZEXIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center.

If you forget to take RUZEXIN

Do not take a double dose to make up for forgotten individual doses.

RUZEXIN can have side effects. Not all side effects reported for RUZEXIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RUZEXIN, please consult your health care provider for advice.

If any of the following happens, stop taking RUZEXIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to RUZEXIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• chest pain,
• angina,
• changes in the way your heart beats, for example, if you notice it beating faster,
• signs of recurrent infections such as fever or sore throat.

These are all serious side effects. You may need urgent medical attention.

Frequent side effects:

• trembling,
• coordination problems,
• involuntary movement of the eyes,
• tiredness,
• headache,
• dizziness,
• drowsiness,
• feeling sick (nausea),
• being sick (vomiting),
• double vision,
• weakness,
• memory disturbances,
• confusion,
• constipation,
• diarrhoea,
• stomach pain,
• hair loss,
• weight increased,
• speech disorder.

Less frequent side effects:

• irregular heartbeat or a very fast or slow heart rate,
• High blood pressure,
• raised level of liver enzymes,
• osteoporosis (thinning of the bone).

If you notice any side effects not mentioned in this leaf, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. or to the Holder of certificate of registration through the mail: [email protected]. By reporting side effects, you can help provide more information on the safety of RUZEXIN.

Store all medicines out of reach of children

Store at or below 25 °C

Store in the original package

Protect from light/ moisture

Do not use after the expiry date stated on the label

Return all unused medicine to your pharmacist

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).