Toramat

Leaflet attached to the packaging: information for the user

Toramat, 25 mg, coated tablets

Toramat, 50 mg, coated tablets

Toramat, 100 mg, coated tablets

Toramat, 200 mg, coated tablets

Topiramate
This medicinal product is subject to additional monitoring. This will allow for the quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicinal product has been prescribed to you specifically. Do not pass it on to others. The medicinal product may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Toramat is and what it is used for
• 2. Important information before taking Toramat
• 3. How to take Toramat
• 4. Possible adverse reactions
• 5. How to store Toramat
• 6. Contents of the packaging and other information

1. What Toramat is and what it is used for

Toramat belongs to a group of medicinal products called antiepileptic medicinal products. It is used:

• as a single medicinal product for the treatment of epileptic seizures in adults and children over 6 years of age,
• in combination with other medicinal products 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 taking Toramat

When not to take Toramat

• if the patient is allergic to topiramate or any of the other ingredients of this medicinal product (listed in section 6).

Migraine prevention

• Toramat must not be taken during pregnancy.
• If the patient is of childbearing potential, Toramat must not be taken without the use of highly effective contraception during treatment. See below under "Pregnancy, breastfeeding and fertility - important advice for women".

Epilepsy treatment

• Toramat must not be taken if the patient is pregnant, unless no other treatment method provides sufficient control of epileptic seizures.
• If the patient is of childbearing potential, Toramat must not be taken without the use of highly effective contraception during treatment. The only exception is when Toramat is the only medicinal product that provides sufficient control of seizures and the patient plans to become pregnant. The patient should discuss this with their doctor to ensure that they have been informed about the risk of taking Toramat during pregnancy and the risk of seizures during pregnancy, which may put the patient or the unborn child at risk.

You must read the Patient Guide provided by your doctor or scan the QR code (see section 6 "Contents of the packaging and other information").
A patient card is attached to the packaging of Toramat, which reminds you of the risk associated with pregnancy.
If the patient is not sure whether any of the above situations apply to them, they should consult their doctor or pharmacist before taking this medicinal product.

Warnings and precautions

Before starting to take this medicinal product, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney disease, especially kidney stones or is undergoing dialysis
• the patient has previously experienced blood or body fluid disorders (metabolic acidosis)
• the patient has liver disease
• the patient has eye diseases, especially glaucoma
• the patient has growth disorders
• the patient is on a high-fat diet (ketogenic diet)
• the patient is a woman of childbearing potential. Toramat taken during pregnancy may harm the unborn child. During treatment and for at least 4 weeks after the last dose of Toramat, a highly effective method of contraception should be used. Further information can be found in the "Pregnancy and breastfeeding" section.
• the patient is pregnant. Toramat taken during pregnancy may harm the unborn child.

If the patient is not sure whether any of the above situations apply to them, they should consult their doctor before taking this medicinal product.
If the patient has epilepsy, it is important not to stop taking the medicinal product without consulting a doctor.
The patient should consult their doctor before taking any medicinal product containing topiramate that has been prescribed to them as a substitute for Toramat.
During treatment with Toramat, the patient may lose weight, so their body weight should be regularly monitored during treatment with this medicinal product. If the patient loses too much weight or if a child taking this medicinal product does not gain enough weight, they should consult their doctor.
In a small number of people who have taken antiepileptic medicinal products such as Toramat, thoughts of self-harm or suicide have occurred. If such thoughts ever occur to the patient, they should contact their doctor immediately.
Toramat may cause severe skin reactions; if a rash or blisters appear on the skin, the doctor should be informed immediately (see also section 4 "Possible adverse reactions").
Toramat may rarely cause an increase in blood ammonia levels (detected in blood tests), which can cause changes in brain function, especially if the patient is also taking a medicinal product containing valproic acid or sodium valproate. Since this can be a serious condition, the doctor should be informed immediately if the following adverse reactions occur (see also section 4 "Possible adverse reactions"):

• difficulty thinking, remembering or solving problems,
• decreased alertness or awareness,
• feeling of strong drowsiness with lack of energy.

The risk of these symptoms may increase when taking high doses of Toramat.

Toramat and other medicinal products

The patient should tell their doctor or pharmacist about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take.
Toramat may interact with other medicinal products. Therefore, it may sometimes be necessary to adjust the dose of the medicinal products taken by the patient or to change the dose of Toramat accordingly.
In particular, the doctor or pharmacist should be informed if the patient is taking:

• other medicinal products that have a harmful effect or reduce thinking, concentration or muscle coordination (e.g. central nervous system depressants, such as muscle relaxants and sedatives),
• hormonal contraceptives. Toramat may reduce the effectiveness of hormonal contraceptives. A additional barrier method of contraception, such as a condom or diaphragm/cervical cap, should be used. The patient should discuss with their doctor the best method of contraception to use while taking Toramat.

The patient should tell their doctor if their menstrual bleeding changes while taking hormonal contraceptives and Toramat. Irregular menstrual bleeding may occur. In such cases, the patient should continue to take hormonal contraceptives and inform their doctor.
The patient should keep a list of all the medicinal products they are taking. When starting to take a new medicinal product, the patient should show this list to their doctor and pharmacist.
The patient should discuss with their doctor or pharmacist the use of other medicinal products, such as other antiepileptic medicinal products, 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 as an anticoagulant.
If the patient is not sure whether any of the above situations apply to them, they should consult their doctor or pharmacist before taking this medicinal product.

Taking Toramat with food and drink

Toramat can be taken with or without food. During treatment with Toramat, the patient should drink plenty of fluids throughout the day to prevent the formation of kidney stones. During treatment with Toramat, the patient should avoid drinking alcohol.

Pregnancy and breastfeeding

Important advice for women of childbearing potential
Toramat may harm the unborn child. Women of childbearing potential should discuss with their doctor the possibility of using other treatment methods instead of Toramat. If the decision is made to start treatment with Toramat, the patient should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Toramat.

• Women of childbearing potential should discuss with their doctor the possibility of using other treatment methods instead of Toramat. If the decision is made to start treatment with Toramat, the patient should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Toramat.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception, such as a contraceptive pill, in combination with a mechanical method of contraception (such as a condom or diaphragm/cervical cap), should be used. The patient should discuss with their doctor which method of contraception will be most suitable for them.

If the patient is taking hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, a additional barrier method of contraception, such as a condom or diaphragm/cervical cap, should be used.
If irregular menstrual bleeding occurs, the patient should inform their doctor.
Taking Toramat during breastfeeding:The active substance of Toramat, topiramate, passes into breast milk. In children breastfed by mothers taking this medicinal product, adverse reactions such as diarrhea, drowsiness, irritability, and poor weight gain have occurred. Therefore, the doctor will discuss with the patient whether to stop breastfeeding or stop taking Toramat. The doctor will consider the importance of the medicinal product for the mother and the risk for the child.
Mothers who are taking Toramat during breastfeeding should immediately inform their doctor if they notice any change in their child's behavior.
Before taking any medicinal product, the patient should consult their doctor or pharmacist.

Driving and using machines

During treatment with Toramat, dizziness, fatigue, and vision disturbances may occur. The patient should not drive or operate any tools or machines until they have consulted their doctor.

Toramat contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Toramat.
Toramat, 50 mg, coated tablets contain orange yellow S (E110), which may cause allergic reactions.
The bottles of Toramat contain a desiccant with silica gel as a moisture-absorbing agent.
The desiccant should not be swallowed.

Other ingredients

This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which means that it is essentially "sodium-free".

3. How to take Toramat

Toramat should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Girls and women of childbearing potential:
Treatment with Toramat should be started and supervised by a doctor with experience in the treatment of epilepsy or migraine. The patient should visit their doctor at least once a year for a check-up.

• The doctor will usually recommend starting treatment with a low dose of Toramat and gradually increasing it until the appropriate dose for the patient is established.
• Toramat tablets should be swallowed whole. It is not recommended to chew the tablets, as they may have a bitter taste.
• Toramat can be taken before, during, or after meals. During treatment with Toramat, the patient should drink plenty of fluids to avoid the formation of kidney stones.

Taking a higher dose of Toramat than recommended

• The patient should immediately contact their doctor. They should take the packaging of the medicinal product with them.
• The patient may feel drowsy, tired, or weak, have difficulty coordinating their movements, have difficulty speaking or concentrating, or experience double vision or blurred vision, dizziness due to low blood pressure, feeling depressed or agitated, or stomach pain or seizures.

Adverse reactions due to overdose may also occur when taking other medicinal products with Toramat.

Missing a dose of Toramat

• If a dose is missed, the patient should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose and continue treatment. If two or more doses are missed, the patient should consult their doctor.
• The patient should not take a double dose (two doses at the same time) to make up for the missed dose.

Stopping treatment with Toramat

The patient should not stop treatment unless their doctor advises them to do so. After stopping treatment, the symptoms of the underlying disease may return. If the doctor decides to stop treatment, they will recommend gradually reducing the dose of Toramat over a few days.
If the patient has any further doubts about taking this medicinal product, they should consult their doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, Toramat can cause adverse reactions, although not everybody gets them.

If the following adverse reactions occur, the patient should immediately tell their doctor or seek medical attention:

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

• Depression (onset or worsening of symptoms already present)

Common (may affect up to 1 in 10 people)

• Epileptic seizures (seizures)
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration disorders, slowed thinking, memory loss, memory disorders (onset for the first time, sudden change or worsening of symptoms)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Metabolic acidosis (may cause breathing disorders, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Decreased or absent sweating (especially in young children, if they are in a high-temperature environment)
• Thoughts of severe self-harm
• Loss of part of the visual field

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

• Glaucoma - 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 of strong drowsiness with lack of energy - may be symptoms of high blood ammonia levels (hyperammonemia), which can cause changes in brain function (hyperammonemic encephalopathy).
• 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 may develop into severe, widespread skin damage (exfoliation and erosion of the skin and mucous membranes), which can have life-threatening consequences.

Frequency not known (cannot be estimated from the available data)

• Eye inflammation (uveitis) with the following symptoms: eye redness, pain, sensitivity to light, tearing, blurred vision or double vision.

Other adverse reactions that the patient should tell their doctor or pharmacist about if they get worse:

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

• Feeling of nasal congestion, runny nose or sore throat
• Numbness, pain and/or tingling of different parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anemia (reduced number of red blood cells)
• Allergic reactions (such as skin rash, redness, itching, swelling of the face, hives)
• Loss of appetite or decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty falling asleep or waking up
• Difficulty speaking or speech disorders, slurred speech
• Difficulty walking or lack of coordination, feeling of imbalance while walking
• Decreased ability to perform routine tasks
• Decreased, lost or absent sense of taste
• Involuntary trembling or seizures; rapid uncontrolled eye movements
• Visual disturbances, such as double vision, blurred vision, impaired vision, vision problems
• Feeling of spinning (dizziness), ringing in the ears (tinnitus), ear pain
• Shortness of breath
• Cough
• Nosebleeds
• Fever, malaise, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, gastrointestinal infections
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle cramps and spasms, muscle pain or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelet count (blood cells responsible for blood clotting), decreased white blood cell count, which helps protect the body against infection, decreased potassium levels in the blood
• Increased liver enzyme activity, increased eosinophil count in the blood (a type of white blood cell)
• Swollen lymph nodes in the neck, armpits or groin
• Increased appetite
• Elevated mood
• Hearing, seeing or feeling things that do not exist, severe mental disorders (psychosis)
• Inability to feel and express emotions, excessive suspicion, panic attacks
• Difficulty reading, speech disorders, difficulty with handwriting
• Restlessness, increased mental and physical activity
• Slowed thinking, decreased alertness
• Weakened or slowed movements, involuntary, abnormal or repetitive muscle contractions
• Fainting/spontaneous falls
• Abnormal sensation of touch; disturbed sense of touch
• Abnormal, disturbed sense of smell or its absence
• Abnormal sensations or feelings that may precede the onset of migraine or certain types of seizures
• Dryness of the eye mucosa, increased sensitivity of the eyes to light, involuntary eyelid twitching, tearing
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling of heartbeat in the chest
• Low blood pressure or decrease in blood pressure when changing position to standing (which may cause a feeling of fainting, dizziness or loss of consciousness in some people taking Toramat)
• Redness of the skin, hot flashes
• Pancreatitis
• Excessive gas, heartburn, feeling of fullness in the stomach or bloating
• Nosebleeds, excessive salivation, drooling, bad breath
• Excessive thirst, excessive fluid intake
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, urinary incontinence, sudden urge to urinate, pain in the side or kidney area
• Sexual dysfunction, sexual disorders
• Flu-like symptoms
• Feeling of cold hands and feet
• Feeling of intoxication
• Difficulty learning

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

• Abnormal elevated mood
• Loss of consciousness
• Loss of vision in one eye, transient blindness, night blindness
• Lazy eye syndrome
• Swelling of the tissues around the eyes
• Numbness, tingling and color change of the skin (white, blue and then red) of the fingers and toes after exposure to cold
• Hepatitis, liver function disorders
• Unpleasant body odor
• Unpleasant sensation in the hands and feet
• Kidney function disorders

Frequency not known (frequency cannot be estimated from the available data)

• Macular degeneration, yellow spot disease - the part of the eye responsible for sharp vision. If vision changes or vision impairment occur, the patient should consult their doctor

Children

Adverse reactions that occur in children are usually similar to those that occur in adults, but some adverse reactions may occur more frequently in children than in adults.

• Concentration problems
• Metabolic acidosis
• Thoughts of severe self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty falling asleep or waking up
• Feeling of imbalance while walking
• Malaise
• Decreased potassium levels in the blood
• Inability to feel and express emotions
• Tearing
• Slow or irregular heartbeat

Other adverse reactions that may occur in children are:

Common (may affect up to 1 in 10 people)

• Feeling of spinning (dizziness)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophil count in the blood (a type of white blood cell)
• Hyperactivity
• Feeling of heat
• Difficulty learning

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should tell their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information can be gathered on the safety of the medicinal product.

5. How to store Toramat

The medicinal product should be stored out of the sight and reach of children.
Toramat should not be taken after the expiry date stated on the blister pack after EXP and on the carton or bottle after the expiry date (EXP). The expiry date refers to the last day of the month.
Plastic bottles
Do not store above 25°C.
Keep the bottle tightly closed to protect from moisture.
Blisters
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Toramat contains

• The active substance of Toramat is topiramate (Topiramatum). Each coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate.
• The other ingredients are:
• tablet core: lactose monohydrate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (type A), magnesium stearate,
• tablet coating: hypromellose 5 cP, macrogol 400, polysorbate 80, titanium dioxide (E171).

Toramat, 50 mg, coated tablets also contain: orange yellow S (E110) and iron oxide yellow (E172).
Toramat, 100 mg and 200 mg, coated tablets also contain: iron oxide red (E172) and iron oxide yellow (E172).

What Toramat looks like and contents of the packaging

Toramat, 25 mg, coated tablets are round, white, coated tablets with the letter "G" embossed on one side and the number "25" on the other side.
Toramat, 50 mg, coated tablets are round, yellow, coated tablets with the letter "G" embossed on one side and the number "50" on the other side.
Toramat, 100 mg, coated tablets are round, yellow, coated tablets with the letter "G" embossed on one side and the number "100" on the other side.
Toramat, 200 mg, coated tablets are round, pink, coated tablets with the letter "G" embossed on one side and the number "200" on the other side.
Toramat, 25 mg, 50 mg, 100 mg and 200 mg, coated tablets are available in plastic bottles with a child-resistant closure and a screw cap, containing 28, 30, 56, 60 tablets and a desiccant. The desiccant should not be swallowed.
Toramat, 25 mg, 50 mg, 100 mg and 200 mg, coated tablets are also available in blisters of aluminum foil containing 28, 30, 56, 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer

Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green, Hertfordshire
WD18 8YA
United Kingdom
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For further information about this medicinal product, the patient should contact their local representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
info-poland@neuraxpharm.com
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic: Topimark 25 mg, 50 mg, 100 mg film-coated tablets
Netherlands: Topiramaat Glenmark 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Germany: Topiramat Glenmark 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Poland: Toramat
Slovakia: Topimark 25 mg, 50 mg, 100 mg film-coated tablets

Date of last revision of the leaflet:

Other sources of information
The latest approved information (Patient Guide) about this medicinal product is available after scanning the following QR code with a smartphone.
The same information is also available on the following website (URL):
https://rejestry.ezdrowie.gov.pl/rpl/search/public
After moving to the website, the patient should enter the name of the medicinal product and then open "Materials to download"