Package leaflet: Information for the user

Oritop 25 mg, 50 mg, 100 mg, film-coated tablets
Topiramate
This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. You can also help by reporting any adverse reactions that occur after using the medicine.
For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before taking the medicine, as it contains important
information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Oritop is and what it is used for
Important information before taking Oritop
How to take Oritop
Possible side effects
How to store Oritop
Contents of the pack and other information

1. What Oritop is and what it is used for

Oritop belongs to a group of medicines known as antiepileptic drugs.
It is used:

as monotherapy in the treatment of epileptic seizures in adults and children over 6 years of age
in combination with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age
for the prevention of migraine headaches in adults.

2. Important information before using Oritop

When not to use Oritop

if the patient is allergic to topiramate or any of the other ingredients of this medicine (listed in section 6)

Prophylaxis of migraine

Oritop must not be used during pregnancy.
If the patient is of childbearing potential, Oritop must not be taken without using a highly effective method of contraception during treatment. See below in the section "Pregnancy, breastfeeding and fertility – important advice for women".

Treatment of epilepsy

Oritop must not be used if the patient is pregnant, unless no other treatment method provides sufficient control of epileptic seizures.
If the patient is of childbearing potential, Oritop must not be taken without using a highly effective method of contraception during treatment. The only exception is when Oritop is the only medicine providing sufficient seizure control and the patient plans to become pregnant. Talk to the doctor to ensure that the patient has received information about the risks of using Oritop during pregnancy and the risk of seizures occurring during pregnancy. See below in the section "Pregnancy, breastfeeding and fertility – important advice for women".

Please make sure to read the patient leaflet provided by your doctor or scan the
QR code (see section 6 "Other sources of information").
A patient card reminding of the risks associated with
pregnancy is attached to the Oritop packaging.
If the patient is unsure whether any of the symptoms described above apply, they should
consult a doctor or pharmacist before using Oritop.
Warnings and precautions
Before starting treatment with Oritop, discuss with the doctor if any of the following apply:

kidney disorders, especially kidney stones or dialysis
abnormalities in blood and body fluids (metabolic acidosis)
liver disorders
eye disorders, especially glaucoma
growth disorders
the patient is on a high-fat diet (ketogenic diet)
the patient is a woman of childbearing potential. Oritop taken during pregnancy may harm the unborn child. A highly effective method of contraception must be used during treatment and for at least 4 weeks after the last dose of Oritop. Further information is provided in the section "Pregnancy and breastfeeding".
the patient is pregnant. Oritop taken during pregnancy may harm the unborn child.

If the patient is unsure whether any of the symptoms described above apply, they should
consult a doctor before using Oritop.
If the patient has epilepsy, it is important not to stop taking the medicine without first
consulting their doctor.
The patient should consult their doctor before taking any medicine containing topiramate prescribed as a substitute for Oritop.
During treatment with Oritop, the patient may lose weight; therefore, body weight should be monitored regularly during treatment. If the patient loses too much weight or if a child taking this medicine does not gain sufficient weight, consult the doctor.
In a small number of people treated with antiepileptic medicines such as Oritop, thoughts of self-harm or suicide have occurred. If such thoughts occur, contact the doctor immediately.
Oritop may cause severe skin reactions; if a rash and/or blisters appear on the skin, inform the doctor immediately (see also section 4. "Possible side effects").
Oritop may rarely cause increased blood ammonia levels (detected in blood tests), which may lead to changes in brain function, especially if the patient is also taking a medicine containing valproic acid or sodium valproate. Since this may be an acute condition, inform the doctor immediately if any of the following adverse effects occur:

difficulty thinking, remembering or solving problems
reduced alertness or consciousness
feeling very sleepy with lack of energy.

The risk of these symptoms may increase when high doses of Oritop are used.
Warning! The tablet container contains a desiccant packet. Do not swallow.
Oritop and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Oritop may interact with other medicines. Therefore, the dose of the patient's medicines may sometimes need to be adjusted, or the dose of Oritop may need to be changed accordingly.
In particular, inform the doctor or pharmacist if any of the following are being used:

other medicines that have harmful effects or reduce thinking, concentration, or muscle coordination (e.g. medicines that depress the central nervous system, such as muscle relaxants and sedatives)
hormonal contraceptives. Oritop may reduce the effectiveness of hormonal contraceptives. An additional barrier method of contraception, such as a condom or diaphragm/cervical cap, should be used. Talk to the doctor about the best method of contraception to use during treatment with Oritop.

Inform the doctor if menstrual bleeding patterns change while using hormonal contraceptives together with Oritop. Irregular bleeding may occur. In such a case, continue using hormonal contraceptives and inform the doctor.
Keep a list of all medicines being taken. Show this list to the doctor and pharmacist when starting a new treatment.
The use of other medicines such as antiepileptic drugs, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St John's wort (Hypericum perforatum) (a herbal preparation used in the treatment of depression), warfarin used to thin the blood, should be discussed with the doctor or pharmacist.
If the patient is unsure whether the above text applies to them, they should consult a doctor or pharmacist before using Oritop.
Oritop with food, drink and alcohol
Oritop can be taken with or without food. Drink plenty of fluids during the day to help prevent kidney stones while taking Oritop. Avoid drinking alcohol while taking Oritop.
Pregnancy and breastfeeding
Important advice for women of childbearing potential
Oritop may harm the unborn child. Women who are of childbearing potential should talk to their doctor about other possible treatment options. At least once a year, visit the doctor to review treatment and discuss risks.
Prevention of migraine:

In case of migraine, Oritop must not be used during pregnancy.
In case of migraine, Oritop must not be used if the patient is of childbearing potential unless she uses a highly effective method of contraception.
Before starting treatment with Oritop in women of childbearing potential, a pregnancy test should be performed.

Treatment of epilepsy:

In case of epilepsy, Oritop must not be used if the patient is pregnant, unless no other treatment method provides sufficient control of epileptic seizures.
In case of epilepsy, Oritop must not be used if the patient is of childbearing potential unless she uses a highly effective method of contraception. The only exception is when Oritop is the only medicine providing sufficient seizure control and the patient plans to become pregnant. Talk to the doctor to ensure that the patient has received information about the risks of using Oritop during pregnancy and the risk of seizures occurring during pregnancy, which may put the patient or unborn child at risk.
Before starting treatment with Oritop in women of childbearing potential, a pregnancy test should be performed.

Risk of using topiramate during pregnancy (regardless of the disease for which topiramate is used):
If Oritop is used during pregnancy, there is a risk of harm to the fetus.

Using Oritop during pregnancy increases the risk of congenital malformations in the child. In women taking topiramate, congenital malformations occur in approximately 4–9 out of 100 children. For comparison, this rate is 1–3 out of 100 children born to women who do not have epilepsy and do not take antiepileptic medicines. In particular, cleft lip (split upper lip) and cleft palate (split palate) have been observed. In male newborns, a developmental disorder of the penis (hypospadias) may also occur. These defects may develop early in pregnancy, even before the patient knows she is pregnant.
When Oritop is used during pregnancy, the risk of autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) in the child may be 2 to 3 times higher than in children born to women with epilepsy who do not take antiepileptic medicines.
When Oritop is used during pregnancy, the baby may be smaller and have lower than expected birth weight. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected, compared to 5% of newborns in women without epilepsy who did not take antiepileptic medicines.
If in doubt, ask the doctor about risks during pregnancy.
Other medicines used to treat this condition, which carry a lower risk of congenital malformations, may be available.

Necessity of using contraception in women of childbearing potential:

Women of childbearing potential should talk to their doctor about the possibility of using alternative treatment options instead of Oritop. If the decision is made to start treatment

with Oritop, a highly effective method of contraception must be used during treatment and for at least 4 weeks after the last dose of Oritop.

One highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception, such as an oral contraceptive pill combined with a mechanical method (such as a condom or diaphragm/cervical cap), should be used. Talk to the doctor to find out which method of contraception is most suitable for the patient.
If the patient uses hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, an additional barrier method of contraception (such as a condom or diaphragm/cervical cap) should be used.
If irregular menstrual bleeding occurs, inform the doctor.

Use of Oritop in girls:
Parents or guardians of a girl being treated with Oritop must contact the doctor immediately when the girl has her first menstrual period. The doctor will inform them about the risk to the unborn child from exposure to topiramate during pregnancy and the need to use a highly effective method of contraception.
If the patient wishes to become pregnant while taking Oritop:

Make an appointment with the doctor.
Do not stop using contraception until this issue has been discussed with the doctor.
If the patient is taking Oritop for epilepsy, do not stop taking it without consulting the doctor, as the condition may worsen.
The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risks of using Oritop during pregnancy. The doctor may also refer the patient to another specialist.

If the patient becomes pregnant or suspects she may be pregnant while taking Oritop:

Make an urgent appointment with the doctor.
If Oritop is being used for migraine prophylaxis, stop taking the medicine immediately and contact the doctor, who will assess whether alternative treatment is necessary.
If the patient is taking Oritop for epilepsy, do not stop taking it without consulting the doctor, as this may worsen the condition. Worsening epilepsy may put the patient or unborn child at risk.
The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risks of using Oritop during pregnancy. The doctor may also refer the patient to another specialist.
If Oritop is used during pregnancy, the patient will remain under close monitoring to check the development of the unborn child.

Please make sure to read the patient leaflet provided by your doctor. The patient guide can also be obtained by scanning the QR code, see section 6 "Other sources of information".
A patient card reminding of the risks associated with
using topiramate during pregnancy is attached to the Oritop packaging.
Breastfeeding
The active substance of Oritop (topiramate) passes into human milk. Adverse effects such as diarrhoea, drowsiness, irritability and poor weight gain have been reported in infants breastfed by mothers taking this medicine. Therefore, the doctor will discuss with the patient whether to stop breastfeeding or discontinue Oritop. The doctor will consider the importance of the medicine for the mother and the risk to the child.
Mothers taking Oritop during lactation must inform the doctor immediately if they notice any changes in their child's behaviour.
Driving and operating machinery
Dizziness, fatigue and vision problems may occur while taking Oritop. Do not drive, operate any machinery or use tools before consulting a 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 (as monohydrate lactose). If the patient has previously been diagnosed with intolerance to certain sugars, they should contact the doctor before taking the medicine.
Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Oritop

This medicine should always be used exactly as directed by the physician or pharmacist.
If in doubt, consult a doctor or pharmacist.

The physician usually starts treatment with a low dose of Oritop and gradually increases it until the optimal dose for the individual patient is established.
Oritop tablets should be swallowed whole. Chewing the tablets is not recommended, as they may leave a bitter aftertaste.
Oritop can be taken before, during, or after meals. While taking Oritop, it is important to drink plenty of fluids to help prevent kidney stone formation.

Girls and women of childbearing age:
Treatment with Oritop should be initiated and supervised by a physician experienced in treating epilepsy or migraine. A medical check-up to monitor treatment should be performed at least once a year.

Taking more Oritop than prescribed

Contact a doctor immediately. Take the medicine package with you.
The patient may experience drowsiness, fatigue, or difficulty concentrating; lack of coordination; speech or concentration difficulties; double or blurred vision; dizziness due to low blood pressure; depressive mood or agitation; abdominal pain or seizures.

Overdose may also occur when Oritop is taken together with other medicines.

If you miss a dose of Oritop

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

Stopping Oritop treatment
Do not stop treatment unless instructed by a doctor. After stopping therapy, symptoms of the underlying disease may return. If the doctor decides to discontinue treatment, the dose of the medicine may be gradually reduced over several days.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should contact a doctor immediately or seek medical help if the patient experiences any of the following adverse reactions:
Very common ( may occur in more than 1 in 10 patients ):

depression (new onset or worsening of existing depression).

Common ( may occur in 1 in 10 patients ):

seizures (epileptic fits)
anxiety, irritability, mood changes, confusion, disorientation
concentration difficulties, slowed thinking, memory loss, memory disorders (new cases, sudden changes or increased severity)
kidney stones, frequent or painful urination.

Uncommon ( may occur in 1 in 100 patients ):

increased levels of acid in the blood (which may cause breathing difficulties, including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
reduced sweating or absence of sweating (especially in young children, if exposed to high temperatures)
thoughts of self-harm – harming oneself, attempts to cause serious self-injury
partial loss of visual field

Rare ( may occur in 1 in 1,000 patients ):

glaucoma, characterized by fluid buildup in the eye chamber, leading to increased pressure inside the eyeball, eye pain, and impaired vision.
difficulties with thinking, remembering, or problem-solving, reduced alertness or consciousness, feeling extremely drowsy – may be symptoms of high blood ammonia levels (hyperammonemia), which may lead to brain dysfunction (hyperammonemia-related encephalopathy)
severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis – may present with or without blisters. Skin irritation, ulcers, or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes may progress to severe, widespread skin damage (detachment of the epidermis and surface mucous membranes), which may be life-threatening.

Not known ( frequency cannot be estimated from available data ):

inflammation of the eye (uveitis) with the following symptoms: eye redness, pain, light sensitivity, tearing, floaters, or blurred vision.

Other adverse reactions include the following; if they become severe, contact a doctor or pharmacist:
Very common ( may occur in more than 1 in 10 patients ):

runny nose with associated nasal congestion or sore throat
tingling, pain, and (or) numbness in various parts of the body
drowsiness, fatigue
dizziness
nausea, diarrhoea
weight loss.

Common ( may occur in 1 in 10 patients ):

anaemia (reduced number of red blood cells)
allergic reactions (such as rash, redness, itching, facial swelling, urticaria)
loss of appetite, reduced appetite
aggression, agitation, anger, unusual behaviour
difficulty falling asleep or maintaining sleep
difficulty speaking or speech disorders, so-called slurred speech
lack of motor coordination or unsteadiness while walking
reduced ability to perform routine tasks
taste disturbances, loss or absence of taste sensation
involuntary tremors or twitching, rapid involuntary eye movements
visual disturbances, such as double vision, blurred vision, reduced vision, decreased visual acuity
sensation 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 twitching, muscle pain or weakness, chest pain
weight gain.

Uncommon ( may occur in 1 in 100 patients ):

reduced platelet count (blood cells that help stop bleeding), reduced white blood cell count (which help protect against infection), reduced blood potassium levels
increased liver enzyme activity, increased number of eosinophils (a type of white blood cell) in the blood
swelling of lymph nodes in the neck, armpits, and groin
increased appetite
elevated mood
hallucinations (hearing, seeing, or sensing things that are not there), severe mental disturbances (psychoses)
lack of expression and (or) lack of emotional experience, excessive suspicion, panic attacks
reading difficulties, speech disorders, difficulties with handwriting
restlessness, hyperactivity
slowed thinking, reduced mental clarity or alertness
limited or slow body movements, involuntary abnormal or repetitive muscle movements
fainting
reduced sensation, disturbances in touch perception
disturbances, distortion, or loss of the sense of smell
unusual sensations, which may precede migraine or certain types of seizures
dry eyes, light sensitivity, eyelid twitching, excessive tearing
decreased or complete hearing loss, hearing loss in one ear
slow or irregular heartbeat, palpitations
low blood pressure, low blood pressure upon standing (as a result, some patients taking Oritop may experience weakness, dizziness, or fainting when standing up or sitting up suddenly)
hot flushes, sensation of warmth
pancreatitis
excessive gas or flatulence, heartburn, feeling of fullness or bloating in the abdomen
bleeding gums, excessive saliva production, drooling, bad breath
excessive fluid intake, increased thirst
skin discoloration
muscle stiffness, flank pain
blood in urine, urinary incontinence (lack of control over urination), urgency to urinate, kidney pain, flank pain
difficulties achieving or maintaining erection, sexual dysfunction
flu-like symptoms
cold fingers and toes
feeling of intoxication
learning difficulties.

Rare ( may occur in 1 in 1,000 patients ):

sudden mood changes
loss of consciousness
unilateral blindness, transient blindness, night blindness
reduced vision (amblyopia)
swelling of tissues around the eye
numbness, tingling, and color changes (white, blue to red) in fingers and toes triggered by cold
hepatitis, liver failure
unpleasant body odour
discomfort felt in arms and legs
kidney disorders.

Not known ( frequency cannot be estimated from available data ):

macular degeneration, a disease of the macula, a small area in the retina of the eye responsible for sharpest vision. If changes in vision or blurred vision are noticed, contact a doctor.

Children
Adverse reactions in children are similar to those observed in adults, but the following adverse reactions may occur more frequently in children than in adults:

concentration problems
increased levels of acid in the blood
thoughts of serious self-injury
feeling of fatigue
decreased or increased appetite
aggression, unusual behaviour
difficulty falling asleep or insomnia
feeling of unsteadiness while walking
malaise
decreased blood potassium levels
lack of emotional expression and (or) lack of emotional experience
excessive tearing
slow or irregular heartbeat.

Other adverse reactions that may occur in children include:
Common ( may occur in 1 in 10 patients ):

sensation of spinning (dizziness)
vomiting
fever.

Uncommon ( may occur in 1 in 100 patients ):

increased number of eosinophils (a type of white blood cell) in the blood
hyperactivity
sensation of warmth
learning difficulties.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Oritop

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Do not use this medicine if you notice any discolouration or other signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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, pregelatinized corn starch, sodium carboxymethylstarch (type A), magnesium stearate. Tablet coating: Hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, and additionally yellow iron oxide (E172) in the 50 mg and 100 mg tablets.

What Oritop looks like and contents of the pack
Round, biconvex, coated tablets with the imprint "E" on one side.
Oritop 25 mg coated tablets: white tablets with the imprint "22" on the other side.
Oritop 50 mg coated tablets: light yellow tablets with the imprint "33" on the other side.
Oritop 100 mg coated tablets: dark yellow tablets with bevelled edges and the imprint "23" on the other side.
Pack sizes: 60 and 100 coated tablets in HDPE bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation, Orion Pharma
PO Box 65
FI-02101 Espoo
Finland

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmovertrukne tabletter
Estonia: Topiramate Orion 25 mg, 50 mg, 100 mg, 200 mg õhukese polümeerikattega tabletid
Finland: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg tabletti, kalvopäällysteinen; Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmdragerad tablett
Latvia: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg apvalkotās tabletes
Lithuania: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg plėvele dengtos tabletės
Poland: Oritop 25 mg, 50 mg, 100 mg, coated tablets
Sweden: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmdragerad tablett

Other sources of information
The most up-to-date approved information (patient leaflet and patient guide) for this medicinal product is available by scanning the QR code below with a smartphone. The same information is also available at the following website (URL): qr.orionproductsafety.com/topiramate/pl/
QR code to URL: http://qr.orionproductsafety.com/topiramate/pl/