Topiramate Mylan Generics: detailed information

Patient Information Leaflet

Topiramato Mylan Generics 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets

Topiramate
Generic Medicine

This medicine is under additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:
1. What Topiramato Mylan Generics is and what it is used for
2. What you need to know before taking Topiramato Mylan Generics
3. How to take Topiramato Mylan Generics
4. Possible side effects
5. How to store Topiramato Mylan Generics
6. Contents of the pack and other information

1. What Topiramato Mylan Generics is and what it is used for

Topiramato Mylan Generics belongs to a group of medicines called "antiepileptic drugs".
It is used:

alone to treat epileptic seizures in adults and children aged over 6 years
in combination with other medicines to treat epileptic seizures in adults and children aged 2 years and older
to prevent migraine in adults.

2. What you need to know before taking Topiramate Mylan Generics

Do not take Topiramate Mylan Generics:

if you are allergic to topiramate or to any of the other ingredients of this medicine (listed in section 6).
Prevention of migraine
- You must not take Topiramate Mylan Generics if you are pregnant.
- If you are a woman of childbearing potential, you must not take Topiramate Mylan Generics unless you use a highly effective method of contraception (contraceptive) during treatment. See below under “Pregnancy, breastfeeding and fertility – Important warning for women”.

Treatment of epilepsy

You must not take Topiramate Mylan Generics if you are pregnant, unless no other treatment has been able to provide sufficient control of seizures.
If you are a woman of childbearing potential, you must not take Topiramate Mylan Generics unless you use a highly effective method of contraception (contraceptive) during treatment. The only exception is if Topiramate Mylan Generics is the only treatment that provides sufficient control of seizures and you are planning a pregnancy. You should consult your doctor to ensure you have received information about the risks of taking Topiramate Mylan Generics during pregnancy and the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important warning for women”.

Make sure you have read the patient guide provided by your doctor.
A patient alert card is included in the Topiramate Mylan Generics packaging to remind you of the risks during pregnancy.
If you are unsure whether the conditions listed above apply to you, speak with your doctor or pharmacist before using Topiramate Mylan Generics.

Warnings and precautions
Talk to your doctor before taking Topiramate Mylan Generics if you:

have kidney problems, particularly:
- kidney stones
- high levels of calcium in the urine
- if a family member has or has had kidney stones
- or if you are undergoing kidney dialysis
have a history of blood and body fluid imbalances (metabolic acidosis) which may be associated with:
- severe breathing problems
- severe or prolonged diarrhoea
- surgery
- or a high-fat, low-carbohydrate (ketogenic) diet
have liver problems
have eye problems, particularly glaucoma
have growth problems
are a woman of childbearing potential. Topiramate Mylan Generics may harm the unborn baby if taken during pregnancy. You must use a highly effective contraceptive method during treatment and for at least 4 weeks after the last dose of Topiramate Mylan Generics. See section “Pregnancy and breastfeeding” for further information.
are pregnant. Topiramate Mylan Generics may harm the unborn baby if taken during pregnancy.

If you are unsure whether any of the above apply to you, consult your doctor before taking Topiramate Mylan Generics.
If you have epilepsy, it is important that you do not stop taking this medicine without first consulting your doctor.
You should also talk to your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to Topiramate Mylan Generics.

During treatment
During treatment with topiramate, you may lose weight. Therefore, your weight should be monitored regularly while taking this medicine. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.
A small number of people treated with antiepileptic medicines such as Topiramate Mylan Generics have experienced suicidal thoughts or self-harming thoughts. If at any time you have such thoughts, contact your doctor immediately.
Topiramate may cause serious skin reactions. Inform your doctor immediately if you develop a rash and/or blisters (see also section 4, 'Possible side effects').
Topiramate may, in rare cases, cause high levels of ammonia in the blood (detected in blood tests), which may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a serious condition, inform your doctor immediately if you experience any of the following symptoms (see also section 4, “Possible side effects”):

difficulty thinking, remembering information, or solving problems
reduced alertness or awareness
feeling very drowsy with low energy

At higher doses of topiramate, the risk of developing these symptoms may increase. You may experience an increase in seizures (epilepsy) or different types of epileptic seizures; in this case, consult your doctor. If you experience vision and/or eye problems, you must contact your doctor immediately.

Other medicines and Topiramate Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate Mylan Generics and certain other medicines may affect each other. Sometimes, the dose of some of the medicines you are taking or of Topiramate Mylan Generics may need to be adjusted. In particular, talk to your doctor or pharmacist if you are taking:

other medicines that impair or reduce thinking, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives like diazepam)
hormonal contraceptives. Topiramate Mylan Generics may reduce the effectiveness of hormonal contraceptives. You must use an additional barrier contraceptive method such as a condom or diaphragm/pessary. Talk to your doctor to discuss the most appropriate contraceptive method to use while taking Topiramate Mylan Generics. Report any changes in your menstrual bleeding while taking hormonal contraceptives and Topiramate Mylan Generics to your doctor. Irregular menstrual bleeding may occur. In this case, continue taking your hormonal contraceptives and discuss this with your doctor.

Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting any new medicine. Other medicines to discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, haloperidol (used to treat mental health conditions), metformin, pioglitazone, glibenclamide (used to treat diabetes), amitriptyline, moclobemide, imipramine (used to treat depression), propranolol, diltiazem, digoxin (used to treat heart conditions), flunarizine (used to treat migraine), proguanil (used to prevent malaria), omeprazole (used to treat digestive problems), venlafaxine (a medicine used for depression), St John’s wort (Hypericum perforatum, a herbal preparation used for the treatment of depression), warfarin (used to thin the blood).

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Topiramate Mylan Generics.

Topiramate Mylan Generics and alcohol
You may take Topiramate with or without food. During treatment with Topiramate Mylan Generics, you should avoid drinking alcohol.

Pregnancy, breastfeeding and fertility
Important information for women of childbearing potential
Topiramate Mylan Generics may harm the unborn baby. If you are a woman of childbearing potential, consult your doctor to discuss other possible treatments. Consult your doctor to review your treatment and discuss risks at least once a year.

Prevention of migraine

For migraine prevention, you must not take Topiramate Mylan Generics if you are pregnant.
For migraine prevention, you must not take Topiramate Mylan Generics if you are a woman of childbearing potential unless you are using a highly effective method of contraception.
If you are a woman of childbearing potential, a pregnancy test must be performed before starting treatment with Topiramate Mylan Generics.

Treatment of epilepsy

For epilepsy, you must not take Topiramate Mylan Generics if you are pregnant, unless no other treatment has been able to provide sufficient control of seizures.
For epilepsy, you must not take Topiramate Mylan Generics if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if Topiramate Mylan Generics is the only treatment that provides sufficient control of seizures and you are planning a pregnancy. You should consult your doctor to ensure you have received information about the risks of taking Topiramate Mylan Generics during pregnancy and the risks of seizures during pregnancy, which may pose risks to you or the unborn baby.
If you are a woman of childbearing potential, a pregnancy test must be performed before starting treatment with Topiramate Mylan Generics.

Risks associated with topiramate if taken during pregnancy (regardless of the condition for which
topiramate is used):
The use of Topiramate Mylan Generics during pregnancy carries risks for the unborn baby.

If you take Topiramate Mylan Generics during pregnancy, your baby has a higher risk of developing congenital malformations. Approximately 4–9 out of 100 babies born to women taking topiramate have congenital malformations. The rate is 1–3 out of 100 for babies born to women without epilepsy who are not taking antiepileptic treatment. In particular, cleft lip (separation of the upper lip) and cleft palate (separation of the palate) have been observed. Male newborns may also have a penile malformation (hypospadias). These defects may develop early in pregnancy, even before you know you are pregnant.
If you take Topiramate Mylan Generics during pregnancy, your baby may have a 2–3 times higher risk of developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to babies born to women with epilepsy who are not taking antiepileptic medicines.
If you take Topiramate Mylan Generics during pregnancy, your baby may be smaller and weigh less than expected at birth. In one study, 18% of babies born to mothers who took topiramate during pregnancy were smaller and weighed less than expected at birth, compared to 5% of babies born to mothers without epilepsy who did not take antiepileptic medicines.
Consult your doctor if you have questions about these risks during pregnancy.
There may be other medicines to treat your condition that carry a lower risk of congenital malformations.

Need for contraception in women of childbearing potential:

If you are a woman of childbearing potential, consult your doctor to discuss other possible treatments instead of Topiramate Mylan Generics. If you decide to use Topiramate Mylan Generics, you must use a highly effective contraceptive method during treatment and for at least 4 weeks after the last dose of Topiramate Mylan Generics.
You must use a highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a combined oral contraceptive pill together with a barrier method (such as a condom or diaphragm/pessary). Consult your doctor to discuss which contraceptive method is most appropriate for you.
If you are taking hormonal contraceptives, the hormonal contraceptive may be less effective due to topiramate. Therefore, you must use an additional barrier contraceptive method (such as a condom or diaphragm/pessary).
Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Mylan Generics in girls:
If you are a parent or caregiver of a girl being treated with Topiramate Mylan Generics, you must contact the doctor immediately when the girl has her first menstrual period (menarche). The doctor will inform you about the risks to the unborn baby from exposure to topiramate during pregnancy and the need to use a highly effective contraceptive method.

If you wish to become pregnant while taking Topiramate Mylan Generics:

Make an appointment with your doctor.
Do not stop using your contraceptive method without first discussing it with your doctor.
If you are taking Topiramate Mylan Generics for epilepsy, do not stop taking it without first discussing it with your doctor, as your condition may worsen.
Your doctor will review your treatment and consider alternative therapeutic options. Your doctor will inform you about the risks associated with Topiramate Mylan Generics during pregnancy. You may also be referred to another specialist.

If you become pregnant or suspect pregnancy while taking Topiramate Mylan Generics:

Make an urgent appointment with your doctor.
If you are taking Topiramate Mylan Generics to prevent migraine, stop taking the medicine immediately and contact your doctor to discuss alternative treatments.
If you are taking Topiramate Mylan Generics for epilepsy, do not stop taking this medicine without first discussing it with your doctor, as your condition may worsen. Worsening epilepsy may pose risks to you or the unborn baby.
Your doctor will review your treatment and consider alternative therapeutic options. Your doctor will inform you about the risks associated with Topiramate Mylan Generics during pregnancy. You may also be referred to another specialist.
If you take Topiramate Mylan Generics during pregnancy, you will need to be closely monitored to assess fetal development.

Make sure you have read the patient guide provided by your doctor.
A patient alert card is included in the Topiramate Mylan Generics packaging to remind you of the risks associated with topiramate during pregnancy.

Driving and using machines
During treatment with Topiramate Mylan Generics, dizziness, fatigue, and vision problems may occur. Do not drive or operate tools or machinery without first discussing this with your doctor.

Sodium content
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially “sodium-free”.
[Film-coated tablets 200 mg only]

Content of sunset yellow aluminium lake (E110) and allura red aluminium lake (E129)
This medicine contains sunset yellow aluminium lake (E110) and allura red aluminium lake (E129), which may cause allergic reactions.

3. How to take Topiramato Mylan Generics

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or
pharmacist.

Girls and women who could become pregnant:
Treatment with Topiramato Mylan Generics must be initiated and supervised by a specialist doctor experienced in the treatment of epilepsy or migraine. Consult your doctor to review the treatment at least once a year.

Your doctor will usually start you on a low dose of topiramate and gradually increase it until the optimal dose for you is reached.
Topiramato Mylan Generics tablets must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
Topiramato Mylan Generics can be taken before, during, or after a meal. Drink plenty of fluids throughout the day, especially when exercising, in hot temperatures, or when engaging in activities that expose you to heat, to reduce the risk of kidney stone formation while taking topiramate. Other formulations of this medicine are available that may be more suitable for patients who have difficulty swallowing tablets; please consult your doctor or pharmacist for advice.

If you take more Topiramato Mylan Generics than you should

Contact a doctor immediately. Take the medicine pack with you.
You may feel drowsy, tired, or less alert; you may experience lack of coordination; difficulty speaking or concentrating; blurred or double vision; dizziness due to low blood pressure; feelings of depression or agitation; abdominal pain; or sudden seizures (convulsions).
If you are taking other medicines together with Topiramato Mylan Generics, an overdose may occur.

If you forget to take Topiramato Mylan Generics

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular 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 forgotten dose.

If you stop taking Topiramato Mylan Generics
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to discontinue this medicine, your dose may need to be gradually reduced over several days.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Inform your doctor or seek immediate medical help if you experience any of the following side effects:

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

Depression (new onset or worsening).

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

Seizures (convulsive fits)
Anxiety, irritability, confusion, disorientation, mood or behavioural changes, including anger, nervousness, sadness
Difficulty concentrating, slowed thinking, memory loss, memory problems (new onset, sudden change or increased severity)
Kidney stones, frequent or painful urination, calcium deposits in the kidneys
Allergic reaction (such as skin rash, redness, itching, and swelling of the face, including swelling of the nose, lips, eyelids and tongue, hives)
Decreased vision.

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

Increased number of infections with sore throat, fever, chills or mouth ulcers, which may be due to a reduced number of white blood cells detected by blood tests
Increase in acid levels in the blood (may cause breathing difficulties, including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness and rapid or irregular heartbeat)
Decreased or absent sweating which may cause a severe rise in body temperature with hot, dry skin, feeling unwell, headache, dizziness and fainting
Thoughts of severe self-harm, attempts to cause severe self-harm
Hearing, seeing or sensing things that are not there, severe mental disturbances (psychosis)
Loss of control over muscle movements needed to walk in a straight line, which may be detected by medical tests
Decreased or loss of hearing
Severe pain in the middle of the abdomen (belly), which may be swollen, with fever and feeling unwell (pancreatitis, inflammation of the pancreas)
Pain in the kidney area and/or bladder caused by kidney stones or crystals that may move into the bladder or other parts of the urinary system. You may have severe back pain and lower stomach pain, and little or no urine.

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

Decreased urine output, confusion, muscle cramps, irregular heartbeat (renal tubular acidosis)
Feeling of irritability and excitability with mood and behavioural changes
Glaucoma, which is a blockage of fluid in the eyes causing increased eye pressure, pain and decreased vision, blindness in one eye, temporary blindness
Yellowing of the skin and eyes (liver inflammation, liver impairment)
Severe skin reactions, including Stevens-Johnson Syndrome, a life-threatening skin disease in which the top layer of skin separates from the lower layer, which may present with sores in multiple mucosal sites (such as mouth, nose and eyes) and erythema multiforme, a condition characterised by red raised patches that may lead to blister formation.
Difficulty thinking, remembering information, or solving problems, being less alert or aware, feeling very drowsy with little energy – these symptoms may be a sign of high ammonia levels in the blood (hyperammonaemia), which may lead to a change in brain function (hyperammonaemic encephalopathy).

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

Maculopathy, a disease of the macula, the small part of the retina where vision is sharpest. You may notice a change or decrease in vision.
Toxic epidermal necrolysis, a life-threatening condition related to Stevens-Johnson Syndrome but even more severe, characterised by widespread blistering and shedding of the outer layers of the skin (see rare side effects).

Other possible side effects

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

Weight loss
Tingling, pain and/or numbness in various parts of the body
Lethargy, drowsiness or tiredness
Dizziness
Diarrhoea
Feeling unwell (nausea)
Stuffy, runny nose and sore throat.

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

Weight gain
Decreased or loss of appetite
Feeling tired, shortness of breath with paleness – this may be due to a reduced number of red blood cells
Difficulty falling asleep or staying asleep
Speech problems or speech disorders, slurred speech
Clumsiness or lack of coordination, feeling unsteady when walking
Reduced ability to complete routine activities
Tremor or uncontrollable shaking of arms, hands or legs
Reduced sense of touch or sensations
Uncontrolled eye movements
Altered taste
Vision disturbances, such as blurred vision, double vision, difficulty focusing
Sensation of spinning, ringing in the ears, ear pain
Shortness of breath
Nosebleeds
Feeling unwell (vomiting)
Constipation
Gastritis, stomach pain or discomfort
Indigestion
Dry mouth
Tingling or numbness of the mouth
Hair loss
Joint pain or swelling
Muscle spasms, muscle contractions, muscle weakness or muscle pain
Chest pain (caused by muscles and bones in the chest)
Fever
Loss of strength
General feeling of being unwell
Cough.

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

Abnormal blood count, including reduced platelets (may present as a tendency to bleed or bruise more easily than usual) or increased eosinophils
Increased liver enzymes
Elevated mood
Lack of emotional expression or feeling, abnormal suspiciousness, panic attack
Irregular heartbeat or slowed heartbeat
Swelling of glands in the neck, armpits or groin
Problems with verbal communication
Loss of saliva
Restlessness or increased mental and physical activity
Decreased wakefulness or alertness
Unusual sensation or aura that may precede a migraine attack or certain type of seizure
Loss of consciousness
Fainting and feeling faint
Excessive drowsiness
Slowed or reduced movements, uncontrollable repetitive muscle contractions
Poor sleep quality or disturbed sleep (e.g. waking up early in the morning)
Distorted or impaired sense of smell
Problems with writing or speaking, such as stuttering or constantly repeating words
Sensation of movement under the skin
Eye problems, including dry eyes, light sensitivity, involuntary contractions, tearing, dilated pupils, seeing flashes of light, abnormal sensations in the eyes
Hoarseness
Flatulence or intestinal gas
Heartburn
Loss of sensitivity to touch or altered sense of touch that may be unpleasant and may affect mouth or face
Bleeding gums
Feeling of fullness or bloating
Sensation of pain or burning in the mouth
Bad breath
Loss of taste
Involuntary loss of urine and/or faeces, blood in urine
Urgent need to urinate
Change in skin colour
Localised skin swelling
Facial swelling
Joint swelling
Musculoskeletal stiffness or muscle fatigue
Low levels of potassium in the blood
Increased appetite
Increased thirst and excessive intake of fluids
Low blood pressure or drop in blood pressure upon standing, which may cause dizziness or fainting
Shortness of breath, especially after physical activity
Hot flushes, feeling of warmth
Influenza-like illness
Coldness in the extremities (e.g. hands and face)
Feeling of drunkenness
Learning difficulties
Sexual function disorders (erectile dysfunction, loss of libido)
Hallucinations
Decreased verbal communication
Feeling sad or crying spells.

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

Feeling hopeless
Uncontrollable tremor that may affect tongue, hands or head during activities
Reduced or unresponsive body movements
Excessive skin sensitivity
Impaired sense of smell
Odour
Swelling of tissues around the eye, problems with night vision, lazy eye
Raynaud's syndrome. A disorder affecting blood vessels in fingers, toes, ears, causing pain and sensitivity to cold.
Decreased bicarbonate levels in the blood, detected by blood tests.

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

Swelling of the transparent membrane covering the surface of the eye (conjunctiva)
Inflammation of the eye (uveitis) with symptoms such as redness, pain, light sensitivity, tearing, blurred or disturbed vision with the appearance of small floating spots in front of the eyes.

Additional side effects in children and adolescents
Side effects in children are generally similar to those observed in adults. However, some side effects occur more frequently and/or may be more severe in children than in adults. Side effects that may be more severe include reduced or loss of sweating and increased acid levels in the blood. Side effects that may occur more frequently in children include upper respiratory tract infections.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Topiramate Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if you notice any change in the colour of the tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Topiramato Mylan Generics contains
The active substance is topiramate.
Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate.
The other components are:
Tablet core: microcrystalline cellulose, povidone K29-32, anhydrous colloidal silica, sodium starch
glycolate (type A), magnesium stearate.
Film coating: titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate 80 (E433) (only in
25 mg tablets), yellow iron oxide (E172) (only in 50 mg and 100 mg tablets), allura red (E129), sunset yellow (E110) (see section 2 “Topiramato 200 mg contains aluminium lake of sunset yellow (E110) and aluminium lake of allura red (E129)”), and indigo carmine (E132) (only in 200 mg tablets).

Description of the appearance of Topiramato Mylan Generics and contents of the pack
Your medicine is in the form of film-coated tablets, which are as follows:
25 mg: white, round, film-coated tablets, biconvex on both sides, engraved with “G” on one side and “TO” above “25” on the other.
50 mg: yellow, round, film-coated tablets, biconvex on both sides, engraved with “G” on one side and “TO” above “50” on the other.
100 mg: yellow, round, film-coated tablets, biconvex on both sides, engraved with “G” on one side and “TO” above “100” on the other.
200 mg: red, round, film-coated tablets, biconvex on both sides, engraved with “G” on one side and “TO” above “200” on the other.

The medicine is available in aluminium blisters in packs of 10, 15, 20, 28, 30, 50, 60, 90, 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer responsible for batch release
McDermott Laboratories / Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Topiramat Mylan
Greece: Topiramate / Mylan film-coated tablets 25 mg, 50 mg, 100 mg
Italy: Topiramato Mylan Generics
Netherlands: Topiramaat Mylan 25 mg, 50 mg, 100 mg, 200 mg filmohulde tabletten
United Kingdom: Topiramate 25 mg, 50 mg, 100 mg, 200 mg Film-coated Tablets