Oritop

Package Leaflet: Information for the User

Oritop 25 mg, 50 mg, 100 mg, coated tablets

Topiramate
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See section 4 for how to report side effects.

You should carefully read all of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet:

• 1. What Oritop is and what it is used for
• 2. Important information before taking Oritop
• 3. How to take Oritop
• 4. Possible side effects
• 5. How to store Oritop
• 6. Contents of the pack and other information

1. What Oritop is and what it is used for

Oritop belongs to a group of medicines called antiepileptic medicines.
It is used:

• as a single medicine to treat seizures in adults and children over 6 years of age
• with other medicines to treat seizures in adults and children over 2 years of age
• to prevent migraine headaches in adults.

2. Important information before taking Oritop

When not to take Oritop

• if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6)

Migraine prevention

• Oritop must not be taken during pregnancy.
• If you are of childbearing potential, you should not take Oritop without using highly effective contraception during treatment. See below under “Pregnancy, breastfeeding and fertility - important advice for women”.

Epilepsy treatment

• Oritop must not be taken if you are pregnant, unless no other treatment provides adequate control of seizures.
• Oritop must not be taken if you are of childbearing potential, unless you are using highly effective contraception during treatment. The only exception is if Oritop is the only medicine that provides adequate control of seizures and you plan to become pregnant. You should discuss this with your doctor to ensure you have received information about the risk of taking Oritop during pregnancy and the risk of seizures during pregnancy, which may put you or your unborn baby at risk.
• Before taking Oritop, women of childbearing potential must have a pregnancy test.

You must read the patient information leaflet provided by your doctor or scan the QR code (see section 6 "Other sources of information").
A patient card is included in the packaging of Oritop, which reminds you of the risk associated with pregnancy.
If you are not sure if any of the above applies to you, you should talk to your doctor or pharmacist before taking Oritop.

Warnings and precautions

Before taking Oritop, you should discuss with your doctor if you have:

• kidney disease, especially kidney stones or dialysis
• blood and body fluid abnormalities (metabolic acidosis)
• liver disease
• eye diseases, especially glaucoma
• growth disorders
• you are on a high-fat diet (ketogenic diet)
• you are a woman of childbearing potential. Oritop taken during pregnancy may harm your unborn baby. During treatment and for at least 4 weeks after the last dose of Oritop, you should use highly effective contraception. More information can be found in the section “Pregnancy and breastfeeding”.
• you are pregnant. Oritop taken during pregnancy may harm your unborn baby.

If you are not sure if any of the above applies to you, you should talk to your doctor before taking Oritop.
If you have epilepsy, it is important not to stop taking your medicine without first consulting your doctor.
You should consult your doctor before taking any other medicine containing topiramate, which has been prescribed for you as a substitute for Oritop.
During treatment with Oritop, you may lose weight, so you should regularly check your body weight during treatment with this medicine. If you lose too much weight or if your child taking this medicine does not gain enough weight, you should consult your doctor.
In a small number of people taking antiepileptic medicines, such as Oritop, thoughts of self-harm or suicide have occurred. If you ever have these thoughts, you should contact your doctor immediately.
Oritop may cause severe skin reactions; if you get a rash or blisters on your skin, you should contact your doctor immediately (see also section 4 "Possible side effects").
Oritop may rarely cause an increase in blood ammonia levels (detected in blood tests), which can lead to changes in brain function, especially if you are also taking a medicine containing valproic acid or sodium valproate. Because this can be a serious condition, you should immediately tell your doctor if you experience any of the following side effects:

• difficulty thinking, remembering, or solving problems
• decreased alertness or awareness
• feeling very sleepy with a lack of energy.

The risk of these symptoms may increase with high doses of Oritop.
Warning! The tablet container contains a desiccant. Do not swallow.

Oritop and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Oritop may interact with other medicines. As a result, sometimes the dose of the medicines you are taking may need to be adjusted or the dose of Oritop may need to be changed.
In particular, you should inform your doctor or pharmacist if you are taking:

• other medicines that can harm or decrease thinking, concentration, or muscle coordination (such as central nervous system depressants, such as muscle relaxants and sedatives)
• hormonal contraceptives. Oritop may decrease the effectiveness of hormonal contraceptives. You should use an additional barrier method of contraception, such as a condom or diaphragm/cervical cap. You should discuss with your doctor the best method of contraception to use during treatment with Oritop.

You should tell your doctor if you experience any changes in your menstrual bleeding while taking hormonal contraceptives with Oritop. You may experience irregular menstrual bleeding. In this case, you should continue to use hormonal contraceptives and inform your doctor.
You should keep a list of all the medicines you are taking. When starting a new medicine, you should show this list to your doctor and pharmacist.
Taking other medicines, such as antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John's Wort (Hypericum perforatum) (a herbal preparation used to treat depression), warfarin, used to thin the blood, should be discussed with your doctor or pharmacist.
If you are not sure if the above applies to you, you should talk to your doctor or pharmacist before taking Oritop.

Oritop with food, drink, and alcohol

Oritop can be taken with or without food.
You should drink plenty of fluids during the day to prevent kidney stones from forming while taking Oritop.
You should avoid drinking alcohol while taking Oritop.

Pregnancy and breastfeeding

Important advice for women who are able to become pregnant

Oritop may harm your unborn baby. Women who are able to become pregnant should talk to their doctor about other possible treatments.
You should visit your doctor at least once a year to review your treatment and discuss the risks.
Migraine prevention:

• Oritop must not be taken during pregnancy.
• Oritop must not be taken if you are of childbearing potential unless you are using highly effective contraception.
• Before taking Oritop, women of childbearing potential must have a pregnancy test.

Epilepsy treatment:

• Oritop must not be taken if you are pregnant unless no other treatment provides adequate control of seizures.
• Oritop must not be taken if you are of childbearing potential unless you are using highly effective contraception. The only exception is if Oritop is the only medicine that provides adequate control of seizures and you plan to become pregnant. You should discuss this with your doctor to ensure you have received information about the risk of taking Oritop during pregnancy and the risk of seizures during pregnancy, which may put you or your unborn baby at risk.
• Before taking Oritop, women of childbearing potential must have a pregnancy test.

Risk of taking topiramate during pregnancy (regardless of the condition being treated):
If Oritop is taken during pregnancy, there is a risk of harm to the fetus.

• Taking Oritop during pregnancy increases the risk of birth defects in the baby. In women taking topiramate, birth defects occur in about 4-9 out of 100 babies. For comparison, this figure is 1-3 out of 100 babies born to women who do not have epilepsy and are not taking antiepileptic medicines. In particular, cleft lip (cleft lip) and cleft palate (cleft palate) have been observed. In newborn boys, a developmental abnormality of the penis (hypospadias) may also occur. These abnormalities can develop early in pregnancy, even before you know you are pregnant.
• Taking Oritop during pregnancy may increase the risk of autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) in the baby by 2 to 3 times compared to babies born to women with epilepsy who are not taking antiepileptic medicines.
• Taking Oritop during pregnancy may result in the baby being smaller and having a lower birth weight than expected. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected, while this was the case for 5% of newborns born to women without epilepsy who were not taking antiepileptic medicines.
• If you have any doubts, you should ask your doctor about the risks during pregnancy.
• There may be other medicines used to treat this condition that are associated with a lower risk of birth defects.

Need for contraception in women of childbearing potential:

• Women of childbearing potential should discuss with their doctor the possibility of using other treatments instead of Oritop. If the decision is made to start treatment with Oritop, you should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Oritop.

You should use one highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods, such as a contraceptive pill, in combination with a barrier method (such as a condom or diaphragm/cervical cap). You should discuss with your doctor which contraceptive method is most suitable for you.

• If you are taking hormonal contraceptives, topiramate may decrease their effectiveness. Therefore, you should use an additional barrier method of contraception (such as a condom or diaphragm/cervical cap).
• If you experience irregular menstrual bleeding, you should inform your doctor.

Taking Oritop in girls:
Parents or guardians of girls taking Oritop should immediately contact their doctor when their daughter has her first menstrual period. The doctor will inform them about the risk to the unborn baby from exposure to topiramate during pregnancy and the need for highly effective contraception.
If you want to become pregnant while taking Oritop:

• You should make an appointment with your doctor.
• You should not stop using contraception until you have discussed this with your doctor.
• If you are taking Oritop for epilepsy, you should not stop taking it without consulting your doctor, as your condition may worsen.
• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risk of taking Oritop during pregnancy. They may also refer you to another specialist.

If you become pregnant or think you may be pregnant while taking Oritop:

• You should make an urgent appointment with your doctor.
• If you are taking Oritop for migraine prevention, you should stop taking it immediately and contact your doctor, who will assess whether alternative treatment is needed.
• If you are taking Oritop for epilepsy, you should not stop taking it without consulting your doctor, as this may worsen your condition. Worsening of epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risk of taking Oritop during pregnancy. They may also refer you to another specialist.
• If Oritop is taken during pregnancy, you will be closely monitored to check the development of your unborn baby.

You must read the patient information leaflet provided by your doctor or scan the QR code (see section 6 "Other sources of information").
A patient card is included in the packaging of Oritop, which reminds you of the risk associated with taking topiramate during pregnancy.
Breastfeeding
The active substance of Oritop, topiramate, passes into breast milk. In children breastfed by mothers taking this medicine, side effects such as diarrhea, drowsiness, irritability, and poor weight gain have occurred. Therefore, your doctor will discuss with you whether to stop breastfeeding or stop taking Oritop. Your doctor will consider the importance of the medicine for you and the risk for your baby.
Mothers taking Oritop during breastfeeding should immediately inform their doctor if they notice any changes in their baby's behavior.

Driving and using machines

While taking Oritop, you may experience dizziness, tiredness, and vision problems.
You should not drive or operate any tools or machines without first consulting your doctor.

Oritop contains lactose

Oritop coated tablets contain 20.1 mg (25 mg tablets), 40.2 mg (50 mg tablets), or 80.4 mg (100 mg tablets) of lactose (in the form of lactose monohydrate). If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Oritop

This medicine should always be taken exactly as your doctor or pharmacist has told you.
If you are not sure, you should ask your doctor or pharmacist.

• Your doctor will usually start you on a low dose of Oritop and gradually increase it until the optimal dose for you is reached.
• Oritop tablets should be swallowed whole. It is not recommended to chew the tablets, as they may have a bitter taste.
• Oritop can be taken before, during, or after meals. While taking Oritop, you should drink plenty of fluids to avoid the formation of kidney stones.

Girls and women of childbearing potential:
Treatment with Oritop should be started and supervised by a doctor experienced in the treatment of epilepsy or migraine. You should visit your doctor at least once a year to review your treatment.

Taking a higher dose of Oritop than recommended

• You should immediately contact your doctor. You should take the packaging of the medicine with you.
• You may feel sleepy, tired, or weak; lack coordination; have difficulty speaking or concentrating; have double vision or blurred vision; may feel dizzy due to low blood pressure; may feel depressed or agitated; may have stomach pain or seizures.

Overdose may also occur when taking other medicines with Oritop.

Missing a dose of Oritop

• If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and continue with your regular dosing schedule. If you miss two or more doses, you should contact your doctor.
• You should not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping treatment with Oritop

You should not stop treatment unless your doctor tells you to. If you stop taking your medicine, your condition may worsen. If your doctor decides to stop your treatment, your dose of Oritop may be gradually decreased over a few days.
If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should immediately contact your doctor or seek medical attention if you experience any of the following side effects:

Very common ( may affect more than 1 in 10 people):

• depression (new or worsening)

Common ( may affect up to 1 in 10 people):

• seizures (seizure attacks)
• anxiety, irritability, mood changes, confusion, disorientation
• concentration disorders, slowing of thought processes, memory loss, memory disorders (new cases, sudden changes, or increased severity)
• kidney stones, frequent or painful urination.

Uncommon ( may affect up to 1 in 100 people):

• increased blood acid levels (which can cause breathing difficulties, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeats)
• decreased sweating or lack of sweating (especially in young children, if exposed to high temperatures)
• thoughts of self-harm - harming oneself, attempting severe self-injury
• partial loss of vision

Rare ( may affect up to 1 in 1,000 people):

• glaucoma, which is characterized by fluid accumulation in the eye chamber, causing increased pressure in the eyeball, pain, and impaired vision.
• difficulty thinking, remembering, or solving problems, decreased alertness or awareness, feeling very sleepy with a lack of energy - may be symptoms of high blood ammonia levels (hyperammonemia), which can lead to changes in brain function (encephalopathy associated with hyperammonemia)
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis - may occur as a rash with blisters or without. Skin irritation, ulcers, or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes can transform into severe, widespread skin damage (peeling of the skin and mucous membranes), which can be life-threatening.

Unknown ( frequency cannot be estimated from the available data):

• eye inflammation (uveitis) with symptoms such as eye redness, pain, sensitivity to light, tearing, or blurred vision.

Other side effects are as follows; if they become serious, you should contact your doctor or pharmacist:

Very common ( may affect more than 1 in 10 people):

• runny nose with accompanying nasal congestion or sore throat
• tingling, pain, and (or) numbness in different parts of the body
• drowsiness, fatigue
• dizziness
• nausea, diarrhea
• weight loss.

Common ( may affect up to 1 in 10 people):

• anemia (decreased red blood cell count)
• allergic reactions (such as rash, redness, itching, swelling of the face, hives)
• loss of appetite, decreased appetite
• aggression, agitation, anger, abnormal behavior
• difficulty sleeping or maintaining sleep continuity
• difficulty speaking or speech disorders, slurred speech
• ataxia or lack of coordination, feeling unsteady while walking
• decreased ability to perform routine tasks
• taste disorders, loss of taste or lack of taste
• involuntary trembling or seizures, rapid, involuntary eye movements
• vision disorders, such as double vision, blurred vision, impaired vision, decreased visual acuity
• feeling of spinning (dizziness), ringing in the ears, ear pain
• shortness of breath
• cough
• nosebleeds
• fever, malaise, weakness
• vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infections
• dry mouth
• hair loss
• itching
• joint pain or swelling, muscle cramps or muscle spasms, muscle pain or weakness, chest pain
• weight gain.

Uncommon ( may affect up to 1 in 100 people):

• decreased platelet count (blood cells that help stop bleeding), decreased white blood cell count, which helps protect against infection, decreased potassium levels in the blood
• increased liver enzyme activity, increased eosinophil count (a type of white blood cell) in the blood
• swollen lymph nodes in the neck, armpits, and groin
• increased appetite
• elevated mood
• hearing, seeing, or feeling things that are not there, severe mental disorders (psychosis)
• lack of emotional expression and (or) lack of emotional feeling, excessive suspicion, panic attacks
• difficulty reading, speech disorders, difficulty with manual writing
• restlessness, hyperactivity
• slowed thinking, decreased mental clarity or alertness
• limited or slow body movements, involuntary abnormal or repetitive movements
• fainting
• impaired sensation, disorders of the sense of touch
• disorders, distortion, or loss of the sense of smell
• unusual sensation or feeling, which may precede a migraine or a certain type of seizure
• dry eyes, eye sensitivity to light, eyelid twitching, tearing
• decreased or complete loss of hearing, hearing loss in one ear
• slow or irregular heartbeat, feeling of heartbeat in the chest
• low blood pressure, low blood pressure when standing up from a sitting or lying position (which may cause some patients taking Oritop to feel weak, dizzy, or faint when standing up quickly)
• hot flashes
• pancreatitis
• excessive gas or bloating, heartburn, feeling of fullness in the stomach or bloating
• gum bleeding, excessive saliva production, drooling, bad breath
• excessive fluid intake, increased thirst
• skin discoloration
• muscle stiffness, side pain
• blood in the urine, urinary incontinence (loss of bladder control), urgent need to urinate, pain in the kidneys and side pain
• difficulty achieving or maintaining an erection, sexual disorders
• flu-like symptoms
• cold hands and feet
• feeling of intoxication
• difficulty learning.

Rare ( may affect up to 1 in 1,000 people):

• sudden mood changes
• loss of consciousness
• one-sided blindness, transient blindness, night blindness
• amblyopia (lazy eye)
• swelling of the tissues around the eye
• numbness, tingling, and color change (white, blue to red) in the fingers of the hands and feet in response to cold
• liver inflammation, liver failure
• unpleasant body odor
• feeling of discomfort in the arms and legs
• kidney disorders.

Unknown ( frequency cannot be estimated from the available data):

• macular degeneration, which is a disease of the macula, a small area of the retina of the eye, the part of the eye responsible for central vision. If you notice any changes in your vision or blurred vision, you should contact your doctor.

Children

Side effects in children are similar to those seen in adults, but the following side effects may occur more frequently in children than in adults:

• concentration problems
• increased blood acid levels
• thoughts of self-harm
• feeling tired
• decreased or increased appetite
• aggression, abnormal behavior
• difficulty sleeping or insomnia
• feeling unsteady while walking
• malaise
• decreased potassium levels in the blood
• lack of emotional expression and (or) lack of emotional feeling
• tearing
• slow or irregular heartbeat.

Other side effects that may occur in children include:

• feeling of spinning (dizziness)
• vomiting
• fever.

Uncommon ( may affect up to 1 in 100 people):

• increased eosinophil count (a type of white blood cell) in the blood
• hyperactivity
• feeling hot
• difficulty learning.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oritop

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 or bottle after EXP. The expiry date refers to the last day of that month.
Store in a cool, dry place, below 30°C.
Do not use this medicine if you notice any visible signs of deterioration.
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 protect the environment.

6. Contents of the pack and other information

What Oritop contains

• The active substance is topiramate. Each coated tablet contains 25 mg, 50 mg, or 100 mg of topiramate.
• The other ingredients are: Tablet core:Microcrystalline cellulose, lactose monohydrate, maize starch, sodium carboxymethylcellulose (type A), magnesium stearate. Coating:Hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, and iron oxide yellow (E172) in 50 mg and 100 mg tablets.

What Oritop looks like and contents of the pack

Round, biconvex, coated tablets with a logo on one side.
Oritop 25 mg coated tablets: white tablets with a logo "22" on the other side.
Oritop 50 mg coated tablets: light yellow tablets with a logo "33" on the other side.
Oritop 100 mg coated tablets: dark yellow tablets with a logo "23" on the other side.
Pack sizes: 60 and 100 coated tablets in HDPE bottles.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
PO Box 65
FI-02101 Espoo
Finland
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Estonia:
Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Finland: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg tablets, film-coated;
Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Latvia:
Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Lithuania:
Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Poland:
Oritop 25 mg, 50 mg, 100 mg, coated tablets
Sweden:
Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Date of last revision of the leaflet:08.05.2024

Other sources of information

The latest approved information (patient card and patient guide) about this medicine is available after scanning the following QR code with your smartphone. The same information is also available on the website (URL): qr.orionproductsafety.com/topiramate/pl/
QR code to URL: http:// qr.orionproductsafety.com/topiramate/pl/