Ontozry 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg Cenobamate film-coated tablets
What Ontozry Is And What Ontozry Used For
Ontozry contains the active substance cenobamate. It belongs to a group of medicines called antiepileptics. These drugs are used to treat epilepsy, a disease that causes seizures due to abnormal activity in the brain.
Ontozry is used in combination with other antiepileptic drugs in adult patients with epilepsy, who have not achieved adequate seizure control despite previous treatment with at least two antiepileptic drugs. Ontozry is used for treating focal seizures, with or without secondary generalization. Focal seizures are caused by abnormal brain activity, which starts in a limited part of the brain and one-half of the brain, and secondary generalization means that the abnormal activity spreads to both sides of the brain. The drug should only be used in adults.
What You Need To Know Before Using Ontozry
Do Not Take Ontozry
- If you are allergic to ontozry cenobamate or any of the other ingredients of this medicine (listed in section 6).
- You have congenital heart problems, with altered electrical activity in the heart related to a rare disease called congenital short QT syndrome.
Warnings And Cautions
Talk to your doctor or pharmacist before taking Ontozry or during treatment if:
- You have thoughts of harming yourself or committing suicide. A few patients treated with antiepileptic drugs such as Ontozry have had thoughts of harming themselves or committing suicide. If you have such thoughts at any time, contact your doctor immediately.
- You get a severe skin reaction that can include high fever and other flu-like symptoms , rash on the face, rash that spreads to other parts of the body, swollen glands (enlarged lymph nodes ) and blood tests that show elevated liver values and a type of white blood cell ( eosinophilia) . ).
Children And Young People
Ontozry is not recommended for use in children and adolescents below 18 years of age, as it has not been studied in this group.
Other Drugs And Ontozry
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If Ontozry is taken at the same time as certain other medicines, this may affect how the other medicines work or how Ontozry works. Do not start taking or stop taking other medicines without first talking to a doctor or pharmacist.
Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted:
- Drugs used to make it easier to fall asleep, e.g.
- Barbiturates
- Benzodiazepines
- Other drugs for epilepsy , e.g.
- Clobazam
- Phenytoin
- Phenobarbital
- Lamotrigine
- Contraceptives ( birth control pills ) as they may be less effective when combined with Ontozry. Your doctor may prescribe alternative methods to prevent pregnancy while you are taking this medicine and up to 4 weeks after you stop taking this medicine.
- Drugs that are broken down in the body by specific enzyme groups, such as
- Midazolam (a drug used to stop prolonged, acute [sudden] seizures
- To induce sedation / calm or to treat sleep problems)
- Bupropion (a drug used to help with smoking cessation)
- Omeprazole (a medicine used to treat heartburn or stomach ulcers )
- Baricitinib (a medicine used to treat painful inflammation of the joints or skin eczema)
- Cefaclor (an antibiotic )
- Empagliflozin (a medicine used to treat high blood sugar in diabetes )
- Penicillin G (an antibiotic)
- Ritobegron (a medicine used to treat overactive bladder)
- Sitagliptin (a medicine used to control high blood sugar in diabetes ).
Ontozry With Alcohol
Do not take this medicine with alcohol. Ontozry may intensify the effects of alcohol, such as fatigue or drowsiness, and you should not drink alcohol with this medicine.
Pregnancy And Breastfeeding
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.
Only take Ontozry during pregnancy if you and your doctor think it is necessary. You must use effective contraception during treatment with cenobamate and up to four weeks after stopping the medicine. Ask your doctor for advice on effective birth control measures. Do not breast-feed while taking Ontozry.
Driving And Using Machines
You may feel drowsy, dizzy, or tired, and your vision may be impaired while you are taking Ontozry. These effects are more likely at the beginning of treatment or after a dose increase. Do not drive, cycle or use tools or machines if your ability to react is impaired, and until you know how the medicine affects you
Ontozry Contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How To Take Ontozry
- Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- You will take Ontozry with other medicines for epilepsy.
- Recommended dose
- You will start taking Ontozry with a daily dose of 12.5 mg tablet for the first 2 weeks, followed by a 25 mg tablet once daily for the next 2 weeks. Thereafter, your dose will be adjusted gradually every two weeks until you reach the dose that works best. Your doctor will give you the right daily dose, and this may need to be adjusted over time.
- The recommended dose is between 200 mg and 400 mg once daily.
- Method of use
- Take the recommended dose once a day at about the same time. You can take ontozry tablets at any time, either during the day or in the evening, with food or between meals.
- Swallow the tablets whole with a glass of water. Do not break the tablets in half, as the tablets are not suitable for splitting.
If You Take More Ontozry Than You Should
Talk to your doctor. You may feel dizzy, tired, and sleepy.
If You Forget To Take Ontozry
Take the next missed dose as soon as you remember, if less than 12 hours have passed since you took it. If more than 12 hours have passed, skip the missed dose and take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose
If You Stop Taking Ontozry
You should not reduce the dose one or stop taking Ontozry without checking with your doctor. Your doctor will explain how to stop your treatment with Ontozry by gradually reducing the dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Ontozry Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following serious side effects:
Rare side effects ( affects up to 1 in 1,000 people)
- A severe skin reaction, which may include fever and other flu-like symptoms , rash on the face, rash that spreads to other areas of the body and swollen glands (enlarged lymph nodes ). Blood tests may show elevated levels of liver enzymes and a type of white blood cell ( eosinophilia ).
You can get the following other side effects with this medicine. Tell your doctor if you get any of the following:
Very common side effects ( may affect more than 1 in 10 people):
- Drowsiness ( somnolence ), fatigue or severe fatigue (fatigue)
- Dizziness
- Feeling of instability ( vertigo )
- Problems with coordination of movements
- Difficulty walking or balance difficulties
- Ataxia
- Gait disorders
- Abnormal coordination
- Headache
Common side effects ( affects up to 1 in 10 people):
- Impaired memory
- Confusion
- Irritability
- Difficulty finding words or speech difficulties
- Rapid and involuntary movements of the eyes ( nystagmus )
- Blurred vision
- Double vision
- Nausea
- Vomiting
- Constipation or diarrhea
- Dry mouth
- Rash
- Itching
- Swollen eyelids
- Swollen arms and legs
- Blood tests showing increased levels of certain liver enzymes
Uncommon side effects ( may affect up to 1 in 100 people):
- Allergic reactions
How To Store Ontozry
- 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 carton and blister after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Package And Other Information
Content Declaration
- The active substance is cenobamate.
- One 12.5 mg tablet contains 12.5 mg cenobamate.
- One 25 mg film-coated tablet contains 25 mg cenobamate.
- One 50 mg film-coated tablet contains 50 mg cenobamate.
- One 100 mg film-coated tablet contains 100 mg cenobamate.
- One 150 mg film-coated tablet contains 150 mg cenobamate.
- One 200 mg film-coated tablet contains 200 mg cenobamate.
- The other ingredients are microcrystalline cellulose (E460), lactose monohydrate , sodium starch glycolate, anhydrous colloidal silica (E551), magnesium stearate (E470b)
- 25 mg and 100 mg film-coated tablets: indigo carmine aluminum lacquer (E132), red iron oxide (E172), yellow iron oxide (E172), macrogol, partially hydrolyzed poly (vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171)
- 50 mg film-coated tablets: yellow iron oxide (E172), macrogol, partially hydrolyzed poly (vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171)
- 150 mg and 200 mg film-coated tablets: red iron oxide (E172), yellow iron oxide (E172), macrogol, partially hydrolyzed poly (vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171)
What The Medicine Looks Like And Contents Of The Pack
- Ontozry tablets 12.5 mg are uncoated, round, white to off-white tablets with “OFF” on one side and “12” on the other side.
- Ontozry 25 mg are round, brown, film-coated tablets with “OFF” on one side and “25” on the other side.
- Ontozry 50 mg are round, yellow, film-coated tablets with “OFF” on one side and “50” on the other side.
- Ontozry 100 mg are round, brown, film-coated tablets with “OFF” on one side and “100” on the other side.
- Ontozry 150 mg are round, light orange, film-coated tablets with “OFF” on one side and “150” on the other side.
- Ontozry 200 mg are oval, light orange, film-coated tablets with “OFF” on one side and “200” on the other side.
- Ontozry 12 mg and 25 mg are packaged for treatment initiation. The pack contains 14 12.5 mg tablets and 14 25 mg film-coated tablets.
- Ontozry 50 mg, 100 mg, 150 mg, and 200 mg film-coated tablets are available in packs of 14, 28, or 84 film-coated tablets.
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
Angelini Pharma SpA
Viale Amelia 70, 00181
Rome – Italy
Manufacturer
Swiss Caps GmbH
Grassingerstrasse 9
83043 Bad Aibling
Germany
Aziende Chimiche Riunite Angelini Francesco ACRAFSpA
Via Vecchia del Pinocchio, 22 60100
Ancona (AN), Italy