Ontozry 50 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ontozry 12.5 mg tablets
Ontozry 25 mg film-coated tablets
Ontozry 50 mg film-coated tablets
Ontozry 100 mg film-coated tablets
Ontozry 150 mg film-coated tablets
Ontozry 200 mg film-coated tablets
cenobamate
This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report these adverse reactions.
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Ontozry is and what it is used for
- What you need to know before taking Ontozry
- How to take Ontozry
- Possible adverse reactions
- How to store Ontozry
- Contents of the pack and other information
1. What Ontozry is and what it is used for
Ontozry contains the active substance cenobamate. It belongs to a group of medicines called "antiepileptic drugs". These medicines are used to treat epilepsy, a condition that causes seizures or epileptic fits due to abnormal brain activity.
Ontozry is used in combination with other antiepileptic medicines in adult patients with epilepsy who have not achieved adequate seizure control despite treatment with at least two antiepileptic medicines, to treat a type of epilepsy characterized by focal-onset seizures, with or without secondary generalization. Focal-onset seizures are caused by abnormal brain activity that begins in one area of the brain located on one side, and secondary generalization means that this abnormal activity spreads to both sides of the brain. This medicine can only be used in adults.
2. What you need to know before taking Ontozry
Do not take Ontozry
- if you are allergic to cenobamate or any of the other ingredients of this medicine
(listed in section 6).
- if you were born with heart problems involving changes in the heart's electrical activity,
associated with a rare condition called familial short QT syndrome.
Warnings and precautions
Talk to your doctor or pharmacist before starting Ontozry or during treatment if:
- You have thoughts of harming yourself or of suicide. Some people treated with antiepileptic medicines, such as Ontozry, have had thoughts of harming themselves or of suicide. If you ever have such thoughts, contact your doctor immediately.
- You experience a serious skin reaction, which may include fever and flu-like symptoms, rash on the face, rash spreading to other parts of the body, swollen glands (swollen lymph nodes); and elevated levels of liver enzymes and of a type of white blood cell (eosinophilia) in blood tests.
Children and adolescents
The use of Ontozry in children and adolescents under 18 years of age is not recommended, as it has not been studied in this group.
Other medicines and Ontozry
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Ontozry together with other medicines may affect how those medicines work or how Ontozry works. Do not start or stop taking any other medicines without first consulting your doctor or pharmacist.
Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted:
- Medicines to help you sleep, such as barbiturates or benzodiazepines.
- Other medicines to treat epilepsy, such as clobazam, phenytoin and phenobarbital, lamotrigine.
- Birth control medicines (oral contraceptives), as they may be less effective when taken with Ontozry. Your doctor may prescribe alternative methods to prevent pregnancy while you are taking this medicine and for up to 4 weeks after stopping treatment with this medicine.
- Medicines that are metabolized in the body by specific groups of enzymes, such as midazolam (a medicine used to stop sudden, acute and prolonged seizures, for sedation, and for sleep disorders), bupropion (a medicine used to help stop smoking), omeprazole (a medicine used to treat heartburn or stomach ulcers), baricitinib (a medicine used to treat painful joint inflammation or skin eczema), cefaclor (an antibiotic), empagliflozin (a medicine used to treat high blood glucose in diabetes), benzylpenicillin (an antibiotic), ritobegron (a medicine used to treat overactive bladder), sitagliptin (a medicine used to control high blood glucose in diabetes).
Use of Ontozry with alcohol
You must not take this medicine with alcohol. Ontozry may enhance the effects of alcohol, such as tiredness or drowsiness, and therefore you should not drink alcohol while taking Ontozry.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. During pregnancy, take Ontozry only if you and your doctor decide it is absolutely necessary. You should use appropriate contraceptive methods while receiving cenobamate and for up to 4 weeks after stopping treatment. Ask your doctor for advice on effective contraceptive methods.
You must stop breastfeeding while taking Ontozry.
Driving and using machines
- You may experience drowsiness, dizziness, fatigue, and may experience reduced visual ability while taking Ontozry.
- These effects are more likely at the beginning of treatment or after a dose increase.
- You must not drive, ride a bicycle, or use tools or machinery if your reaction ability is impaired and until you know how this medicine affects you.
Ontozry contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Ontozry
Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
You will take Ontozry together with other medicines for treating epilepsy.
The recommended dose is
Your treatment with Ontozry will start with one 12.5 mg tablet daily for the first 2 weeks, followed by one 25 mg tablet once daily for the next 2 weeks. After that, the dose will be gradually adjusted every 2 weeks until reaching the optimal dose for you. Your doctor will calculate the appropriate daily dose for you, which may need to be adjusted over time.
The recommended daily dose is between 200 mg and 400 mg once daily.
Method of administration
You should take the recommended dose once daily at approximately the same time. You may take Ontozry at any time of day or night, with or without food.
Swallow the tablets whole with a glass of water. Do not split the tablets in half, as they are not suitable for dividing into two equal doses.
If you take more Ontozry than you should
Contact your doctor. You may experience dizziness, fatigue, and drowsiness.
If you forget to take Ontozry
Take the missed dose as soon as you remember, provided that less than 12 hours have passed since it was due. 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 missed dose.
If you stop taking Ontozry
Do not reduce the dose or stop taking Ontozry without consulting your doctor. Your doctor will explain how to discontinue treatment with Ontozry by gradually reducing the dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Tell your doctor immediately if you experience any of the following serious adverse effects: Rare adverse effects (may affect up to 1 in 1,000 people):
- Severe skin reaction which may include fever and other flu-like symptoms, rash on the face, rash spreading to other areas of the body, or gland inflammation (swollen lymph nodes). Increased levels of liver enzymes and of a type of white blood cell (eosinophilia) in blood tests.
In addition, this medicine may cause the following adverse effects. Inform your doctor if you experience any of these:
Very common adverse effects (may affect more than 1 in 10 people):
- Drowsiness (somnolence), sedation or extreme tiredness (exhaustion)
- Dizziness
- Sensation of spinning (vertigo)
- Difficulty coordinating movements, problems walking or maintaining balance (ataxia, gait disturbance and abnormal coordination)
- Headache
Common adverse effects (may affect up to 1 in 10 people):
- Memory impairment, confusion
- Excitability
- Difficulty pronouncing words or trouble speaking
- Rapid, involuntary eye movements (nystagmus), blurred vision, double vision
- Nausea (queasiness), vomiting, constipation or diarrhea
- Dry mouth
- Skin rash, itching
- Swelling of the eyelids, swelling of the limbs
- Increased levels of certain liver enzymes in blood tests
Uncommon adverse effects (may affect up to 1 in 100 people):
- Allergic reactions
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ontozry
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ontozry
- The active substance is cenobamate.
One Ontozry 12.5 mg tablet contains 12.5 mg of cenobamate.
One Ontozry 25 mg film-coated tablet contains 25 mg of cenobamate.
One 50 mg film-coated tablet contains 50 mg of cenobamate.
One 100 mg film-coated tablet contains 100 mg of cenobamate.
One 150 mg film-coated tablet contains 150 mg of cenobamate.
One 200 mg film-coated tablet contains 200 mg of cenobamate.
- The other components are microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate, colloidal anhydrous silica (E551), and magnesium stearate (E470b).
25 mg and 100 mg film-coated tablets: indigo carmine aluminium lake (E132), red iron oxide (E172), yellow iron oxide (E172), macrogol, partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171).
50 mg film-coated tablets: yellow iron oxide (E172), macrogol, partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171).
150 mg and 200 mg film-coated tablets: red iron oxide (E172), yellow iron oxide (E172), macrogol, partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171).
Nature of the product and pack contents
Ontozry 12.5 mg are uncoated round tablets, white to off-white in colour, marked with “AV” on one side and “12” on the other.
Ontozry 25 mg are film-coated round tablets, brown in colour, marked with “AV” on one side and “25” on the other.
Ontozry 50 mg are film-coated round tablets, yellow in colour, marked with “AV” on one side and “50” on the other.
Ontozry 100 mg are film-coated round tablets, brown in colour, marked with “AV” on one side and “100” on the other.
Ontozry 150 mg are film-coated round tablets, light orange in colour, marked with “AV” on one side and “150” on the other.
Ontozry 200 mg are film-coated oval tablets, light orange in colour, marked with “AV” on one side and “200” on the other.
The starter pack of Ontozry contains 14 tablets of 12.5 mg and 14 film-coated tablets of 25 mg.
Film-coated tablets of Ontozry 50 mg, 100 mg, 150 mg, and 200 mg are available in packs of 14, 28, or 84 tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Angelini Pharma S.p.A
Viale Amelia 70, 00181
Roma - Italy
Manufacturer
Swiss Caps GmbH
Grassingerstrasse 9
83043 Bad Aibling
Germany
Aziende Chimiche Riunite Angelini Francesco ACRAF SPA
Via Vecchia del Pinocchio, 22
60100 Ancona (AN), Italy
Date of the most recent revision of this leaflet: …….
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.