Toramat

Package leaflet: 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 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 taking the medicine. For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Toramat is and what it is used for

Toramat belongs to a group of medicines called 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 aged 2 years and older,
• for the prevention of migraine attacks in adults.

2. Important information before using Toramat

When not to use Toramat

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

Migraine prophylaxis

• Toramat must not be used during pregnancy.
• If the patient is a woman of childbearing potential, Toramat 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".

Epilepsy treatment

• Toramat must not be used if the patient is pregnant, unless no other treatment provides adequate seizure control.
• If the patient is a woman of childbearing potential, Toramat must not be used without using a highly effective method of contraception during treatment. The only exception is when Toramat is the only medicine providing adequate 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 Toramat during pregnancy and the risk of seizures occurring during pregnancy. See below in the section "Pregnancy, breastfeeding and fertility – important advice for women".

It is essential to read the Patient Guide provided by the doctor or scan the
QR code (see section 6 "Contents of the pack and other information").
A patient card is included in the Toramat packaging, reminding of the risks associated with pregnancy.
If the patient is unsure whether any of the situations described above apply, they should consult a
doctor or pharmacist before using this medicine.
Warnings and precautions
Before starting to use this medicine, discuss with the doctor or pharmacist if:

• The patient has kidney problems, especially kidney stones or is undergoing dialysis
• The patient has previously had abnormalities in blood and body fluids (metabolic acidosis)
• The patient has liver disease
• The patient has eye disorders, particularly 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. A highly effective method of contraception must be used during treatment and for at least 4 weeks after the last dose of Toramat. Further information is provided in the section "Pregnancy and breastfeeding".
• The patient is pregnant. Toramat taken during pregnancy may harm the unborn child.

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

• 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 Toramat are used.
Toramat 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.
Toramat may interact with other medicines. Therefore, the dose of other medicines taken by the patient may need to be adjusted, or the dose of Toramat may need to be changed accordingly.
In particular, inform the doctor or pharmacist if the patient is taking:

• Other medicines that have harmful effects or reduce thinking, concentration, or muscle coordination (for example: central nervous system depressants such as muscle relaxants and sedatives),
• Hormonal contraceptives. Toramat may reduce the effectiveness of hormonal contraceptives. An additional barrier method of contraception, such as a condom or diaphragm/cervical cap, should be used. Discuss with the doctor the best method of contraception to use during treatment with Toramat.

Tell the doctor if menstrual bleeding changes while using hormonal contraceptives and Toramat. Irregular bleeding may occur. In such a case, continue using hormonal contraceptives and inform the doctor.
Keep a list of all medicines the patient is taking. Show this list to the doctor and pharmacist when starting a new medicine.
Discuss with the doctor or pharmacist the use of other medicines such as other antiepileptic drugs, 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 unsure whether any of the situations described above apply, they should consult a doctor or pharmacist before using this medicine.
Taking Toramat with food and drink
Toramat may be taken with or without food. While taking Toramat, drink plenty of fluids throughout the day to help prevent kidney stones. Avoid drinking alcohol while taking Toramat.
Pregnancy and breastfeeding
Important advice for women of childbearing potential
Toramat may harm the unborn child. Women who are of childbearing age should discuss other possible treatment options with their doctor. Visit the doctor at least once a year to review treatment and discuss risks.
Migraine prophylaxis

• For migraine, Toramat must not be used during pregnancy.
• For migraine, Toramat must not be used if the patient is of childbearing potential unless she uses a highly effective method of contraception.
• A pregnancy test must be performed before starting treatment with Toramat in women of childbearing potential.

Epilepsy treatment

• For epilepsy, Toramat must not be used if the patient is pregnant, unless no other treatment provides adequate seizure control.
• For epilepsy, Toramat 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 Toramat is the only medicine providing adequate 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 Toramat during pregnancy and the risk of seizures occurring during pregnancy, which may put the patient or unborn child at risk.
• A pregnancy test must be performed before starting treatment with Toramat in women of childbearing potential.

Risk of using topiramate during pregnancy (regardless of the condition being treated with topiramate):
There is a risk of harm to the unborn child if Toramat is used during pregnancy.

• Using Toramat 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 abnormality of the penis (hypospadias) may also occur. These malformations may develop early in pregnancy, even before the patient knows she is pregnant.
• When Toramat 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 Toramat 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 born to 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 may be available that carry a lower risk of congenital malformations.

Necessity of contraception in women of childbearing potential:

• Women of childbearing potential should discuss with their doctor the possibility of using alternative treatments instead of Toramat. If the decision is made to start treatment with Toramat, a highly effective method of contraception must be used during treatment and for at least 4 weeks after the last dose of Toramat.

• One highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception, such as an oral contraceptive combined with a mechanical method (such as a condom or
  diaphragm/cervical cap), should be used. Discuss with the doctor 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 Toramat in girls: Parents or guardians of a girl being treated with Toramat must contact the doctor immediately when the girl has her first 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 Toramat:

• 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 Toramat 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 Toramat 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 Toramat:
• Make an urgent appointment with the doctor.
• If Toramat 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 Toramat 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 Toramat during pregnancy. The doctor may also refer the patient to another specialist.
• If Toramat is used during pregnancy, the patient will remain under close monitoring to check the development of the unborn child.

It is essential to read the Patient Guide provided by the doctor. The Patient Guide can also be obtained by scanning the QR code; see section 6 "Contents of the pack and other information".
A patient card is included in the Toramat packaging, reminding of the risks associated with using topiramate during pregnancy.
Breastfeeding
The active substance in Toramat (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 Toramat treatment, taking into account the benefit of the medicine for the mother and the risk to the child.
Mothers taking Toramat during breastfeeding must inform the doctor as soon as possible if they notice any changes in their child's behaviour.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Dizziness, fatigue, and visual disturbances may occur while taking Toramat. Do not drive, use tools, or operate machinery until the patient has consulted the doctor.
Toramat contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult the doctor before taking this medicine. Toramat 50 mg film-coated tablets contain sunset yellow, which may cause allergic reactions.
Toramat bottles contain a desiccant with silica gel as a moisture absorber. The desiccant must not be swallowed.
Other ingredients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Toramat

Toramat should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Girls and women of childbearing age:
Treatment with Toramat should be initiated and supervised by a doctor experienced in the treatment of epilepsy or migraine. A medical check-up to review treatment should be carried out at least once a year.

• Your doctor will usually recommend starting treatment with a low dose of Toramat, gradually increasing it until the appropriate dose for the individual patient is established.
• Toramat tablets should be swallowed whole. Chewing the tablets is not recommended, as they may leave a bitter taste.
• Toramat may be taken before, during, or after meals. While taking Toramat, it is important to drink plenty of fluids to help prevent the formation of kidney stones.

Taking more Toramat than prescribed

• Contact your doctor immediately. Take the medicine package with you.
• Symptoms may include drowsiness, fatigue, reduced alertness, lack of coordination, difficulty speaking or concentrating, double or blurred vision, dizziness due to low blood pressure, feelings of depression or agitation, abdominal pain, or seizures.

Symptoms of overdose may also occur when Toramat is taken together with other medicines.

Missing a dose of Toramat

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

Stopping Toramat

Do not stop taking Toramat unless your doctor tells you to. After stopping treatment, symptoms of the underlying disease may return. If your doctor decides to discontinue treatment, they will advise gradually reducing the dose 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, Toramat can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, tell your doctor immediately or
seek medical help:

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

• Depression (new onset or worsening of pre-existing symptoms)

Common (may occur in less than 1 in 10 people)

• Seizures (convulsions)
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration difficulties, slowed thinking, memory loss, memory disturbances (new onset, sudden change or worsening of symptoms)
• Kidney stones, frequent or painful urination

Uncommon (may occur in less than 1 in 100 people)

• Metabolic acidosis (may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
• Decreased or absent sweating (especially in young children exposed to high temperatures)
• Thoughts or attempts of severe self-harm
• Loss of part of the visual field

Rare (may occur in less than 1 in 1,000 people)

• Glaucoma – fluid buildup in the eye chamber causing increased intraocular pressure, eye pain, and blurred vision
• Difficulties with thinking, remembering, or problem-solving, reduced alertness or awareness, feeling extremely sleepy and lacking energy – may be signs 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 as blistering or non-blistering rash. Skin irritation, ulcers or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes may progress to severe, widespread skin damage (peeling of the skin and mucous membranes), which may be life-threatening

Frequency not known (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 that should be reported to your doctor or pharmacist if they worsen:

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

• Nasal congestion, runny nose, 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 less than 1 in 10 people)

• Anaemia (reduced number of red blood cells)
• Allergic reactions (such as skin rash, redness, itching, facial swelling, hives)
• Loss or decrease in appetite
• Aggression, restlessness, anger, unusual behaviour
• Difficulty falling asleep or waking up
• Difficulty speaking or speech disturbances, slurred speech
• Involuntary movements or lack of motor coordination, feeling unsteady when walking
• Reduced ability to perform routine tasks
• Decreased, lost, or absent sense of taste
• Involuntary tremors or shaking; rapid uncontrolled eye movements
• Vision disturbances such as double vision, blurred vision, reduced vision, problems with visual focus
• Sensation of spinning (dizziness), ringing (tinnitus) in the ears, ear pain
• Shortness of breath
• Cough
• Nosebleeds
• Fever, malaise, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach and intestinal infections
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle cramps and twitching, muscle pain or muscle weakness, chest pain
• Weight gain

Uncommon (may occur in less than 1 in 100 people)

• Reduced platelet count (blood cells responsible for blood clotting), reduced white blood cell count (which help protect the body from infection), low blood potassium levels
• Increased liver enzyme activity, increased number of eosinophils in blood (a type of white blood cell)
• Swelling of lymph nodes in the neck, armpits, or groin
• Increased appetite
• Elevated mood
• Hallucinations (seeing, hearing, or feeling things that are not real), severe mental disturbances (psychoses)
• Inability to feel or express emotions, excessive suspicion, panic attacks
• Reading difficulties, speech disturbances, handwriting difficulties
• Restlessness, increased mental and physical activity
• Slowed thinking, reduced alertness
• Slowed or reduced movements, involuntary, unusual, or repetitive muscle contractions
• Fainting or falls
• Abnormal sensation to touch; disturbed sense of touch
• Impaired, distorted, or absent sense of smell
• Unusual sensations or feelings that may precede migraine or certain types of seizures
• Dryness of the eye mucosa, light sensitivity, involuntary eyelid twitching, tearing
• Reduced or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, palpitations
• Low blood pressure or drop in blood pressure upon standing (orthostatic hypotension) (in some people taking Toramat, this may result in feeling faint, dizzy, or losing consciousness when suddenly standing up or sitting up)
• Skin redness, hot flushes
• Pancreatitis
• Excessive gas, heartburn, feeling of fullness in the stomach or bloating
• Bleeding gums, excessive saliva production, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in urine, urinary incontinence, sudden urge to urinate, side or kidney area pain
• Erectile dysfunction, sexual dysfunction
• Flu-like symptoms
• Cold sensation in fingers and toes
• Feeling of alcohol intoxication
• Learning difficulties

Rare (may occur in less than 1 in 1,000 people):

• Unusually elevated mood
• Loss of consciousness
• Vision loss in one eye, transient blindness, night blindness
• Lazy eye syndrome
• Swelling of tissues around the eyes
• Numbness, tingling, and skin color changes (pale, blue, then red) in fingers and toes upon cold exposure (Raynaud's phenomenon)
• Hepatitis, liver function abnormalities
• Unpleasant body odour
• Unpleasant sensations in hands and feet
• Kidney function disorders

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

• Macular degeneration, macular disease of the retina – the area of sharpest vision. If any change or worsening of vision occurs, contact your doctor

Children
Adverse reactions in children are generally similar to those 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, unusual behaviour
• Difficulty falling asleep or waking up
• Feeling unsteady when walking
• Malaise
• Low blood potassium levels
• Inability to feel or express emotions
• Tearing
• Slow or irregular heartbeat

Other adverse reactions that may occur in children:

Common (may occur in less than 1 in 10 people)

• Sensation of spinning (dizziness)
• Vomiting
• Fever

Uncommon (may occur in less than 1 in 100 people)

• Increased number of eosinophils in blood (a type of white blood cell)
• Hyperactivity
• Feeling of warmth
• Learning difficulties

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Toramat

Keep this medicine out of sight and reach of children.
Do not use Toramat after the expiry date stated on the blister after EXP and on the outer carton or bottle after Expiry (EXP). The expiry date refers to the last day of the stated month.
Plastic bottles
Do not store above 25°C.
Keep the bottle tightly closed to protect from moisture.
Blister packs
Do not store above 25°C.
Keep in the original immediate packaging to protect from moisture.
Medicines must 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 Toramat contains

• The active substance 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, pregelatinized maize starch, sodium carboxymethyl starch (type A), magnesium stearate,
  • tablet coating: hypromellose 5 cP, macrogol 400, polysorbate 80, titanium dioxide (E171).

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

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

Marketing Authorisation 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, contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
[email protected]

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Czech Republic: Topimark 25 mg, 50 mg, 100 mg potahované tablety
Netherlands: Topiramaat Glenmark 25 mg, 50 mg, 100 mg, 200 mg filmomhulde tabletten
Germany: Topiramat Glenmark 25 mg, 50 mg, 100 mg, 200 mg Filmtabletten
Poland: Toramat
Slovakia: Topimark 25 mg, 50 mg, 100 mg filmom obalené tablety

Other sources of information
The most up-to-date approved information (Patient Information Leaflet) 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):
https://rejestry.ezdrowie.gov.pl/rpl/search/public
After accessing the website, enter the name of the medicinal product and then open "Materials for download".