Topamax: detailed information

Patient Information Leaflet: Information for the User

Topamax 15 mg Hard Capsules, 25 mg Hard Capsules

topiramate
Please read this leaflet carefully before taking this medicine because 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Topamax is and what it is used for
What you need to know before taking Topamax
How to take Topamax
Possible side effects
How to store Topamax
Contents of the pack and other information

1. What TOPAMAX is and what it is used for

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

alone, for 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 from 2 years of age
to prevent migraine in adults

2. What you should know before taking TOPAMAX

Do not take Topamax

if you are allergic (hypersensitive) to topiramate or any of the excipients of this medicine (listed in section 6).
for migraine prevention if you are pregnant or if you are a woman of childbearing potential unless you are using an adequate method of contraception (see section “Pregnancy and breastfeeding” for more information). You should discuss with your doctor which type of contraception is best to use during treatment with Topamax.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before taking Topamax.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topamax if:

you have kidney problems, particularly kidney stones, or if you are undergoing renal dialysis
you have a history of blood or body fluid disorders (metabolic acidosis)
you have liver problems
you have eye problems, particularly glaucoma
you have growth problems
your diet is high in fat (ketogenic diet)
you are taking Topamax to treat epilepsy and you are pregnant or are a woman of childbearing potential (for further information, see section “Pregnancy and breastfeeding”).

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with Topamax.

It is important that you do not stop taking this medicine without first consulting your doctor.

You should also speak with your doctor before taking any other medicine containing topiramate prescribed as an alternative to Topamax.

Weight loss may occur while taking Topamax; therefore, your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking the medicine does not gain sufficient weight, consult your doctor.

A small number of patients treated with antiepileptic medicines such as Topamax have experienced suicidal thoughts or self-harming thoughts. If you experience any such thoughts at any time, contact your doctor immediately.

Topamax may cause serious skin reactions. Inform your doctor immediately if you develop a rash and/or blisters (also see section 4 "Possible side effects").

Topamax may, in rare cases, cause elevated levels of ammonia in the blood (seen in blood tests), which may lead to changes in brain function, especially if you are 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 (also see section 4 “Possible side effects”):

difficulty thinking, remembering information, or solving problems
reduced alertness or awareness
feeling very drowsy and lacking energy

At higher doses of Topamax, the risk of developing these symptoms may increase.

Other medicines and Topamax

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topamax may interact with other medicines. Sometimes, the dose of either Topamax or your other medicines may need to be adjusted.

In particular, inform your doctor or pharmacist if you are taking:

other medicines that impair thinking, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
oral contraceptive pills. Topamax may reduce the effectiveness of oral contraceptives. Discuss with your doctor which type of contraception is best to use during treatment with Topamax.

Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and Topamax.

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, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St John’s wort (Hypericum perforatum) (an herbal preparation used to treat depression), and 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 Topamax.

Topamax with food and drink

You may take Topamax during or between meals. Drink plenty of fluids throughout the day when taking Topamax to help prevent kidney stone formation. You should avoid drinking alcohol during treatment with Topamax.

Pregnancy and breastfeeding

Migraine prevention:

Topamax may harm the unborn baby. You must not use Topamax if you are pregnant. You must not use Topamax for migraine prevention if you are a woman of childbearing potential unless you are using an effective method of contraception. Ask your doctor about the best type of contraception and whether Topamax is suitable for you. A pregnancy test must be performed before starting treatment with Topamax.

Epilepsy treatment:

If you are a woman of childbearing potential, you should discuss with your doctor other possible treatments instead of Topamax. If you decide to use Topamax, you must use an effective method of contraception. Ask your doctor about the best type of contraception to use during treatment with Topamax. A pregnancy test must be performed before starting treatment with Topamax.

As with other antiepileptic medicines, there is a risk of harm to the unborn baby if Topamax is used during pregnancy. Make sure you fully understand the risks and benefits of using Topamax for epilepsy during pregnancy.

If you take Topamax during pregnancy, your baby has an increased risk of birth defects, particularly cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth). Male newborns may also have a malformation of the penis (hypospadias). These defects may occur early in pregnancy, even before you know you are pregnant.
If you take Topamax during pregnancy, your baby may be smaller than expected at birth. Speak with your doctor if you have questions about this risk.
There may be other medicines available to treat your condition that carry a lower risk of birth defects.
Inform your doctor immediately if you become pregnant while taking Topamax. You and your doctor will need to decide whether to continue taking Topamax during pregnancy.

Breastfeeding

The active substance in Topamax (topiramate) is excreted in human milk. Effects have been observed in infants breastfed by treated mothers, including diarrhoea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether to discontinue breastfeeding or discontinue treatment with Topamax, taking into account the importance of the treatment for the mother and the potential risk to the infant.

Breastfeeding mothers taking Topamax should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Driving and using machines

Dizziness, fatigue, and vision problems may occur during treatment with Topamax. Do not drive or operate tools or machinery without first discussing this with your doctor.

Topamax contains sucrose

If your doctor has diagnosed you with a sugar intolerance, contact your doctor before taking this medicine.

Other ingredients

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e., essentially “sodium-free”.

3. How to take TOPAMAX

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will usually start you on a low dose of Topamax and then gradually increase it until the best dose for you is reached.
The hard capsules of Topamax may be swallowed whole or opened and their contents mixed with a spoonful of soft food of any kind, for example: applesauce, cream, ice cream, baby food, pudding, or yogurt. Immediately afterwards, drink fluids to make sure you have swallowed all of the mixture of food and medicine.
Hold the hard capsule upright so that you can read the word “TOP”.
Carefully unscrew the transparent portion of the capsule. This may be easier to do if you place the capsule on a small amount of food onto which you will then pour the granules.
Pour the entire contents of the capsule onto the spoonful of soft food, taking care that the full prescribed dose is poured onto the food.
Make sure you immediately swallow the entire mixture of granules and food from the spoon. Do not chew. Immediately drink fluids to ensure that the entire mixture has been swallowed.
Never store the mixture of medicine and food for later use.
Topamax may be taken before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stones while taking Topamax.

If you take more Topamax than you should

Contact a doctor immediately. Take the medicine pack with you.
You may feel drowsy, tired, or less alert; lose coordination; have difficulty speaking or concentrating; experience double or blurred vision; feel dizzy due to low blood pressure; feel depressed or agitated; or have abdominal pain or seizures. If you are taking other medicines together with Topamax, overdose may occur.

If you forget to take Topamax

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or seek immediate medical attention 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
Anxiety, irritability, mood changes, confusion, disorientation
Difficulty concentrating, slowed thinking, memory loss, memory problems (new onset, sudden change or worsening)
Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

Increased acid levels in the blood (can cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and fast or irregular heartbeat)
Decreased or absent sweating (particularly in young children exposed to high temperatures)
Thoughts of severe self-harm, attempt of severe self-harm
Loss of part of the visual field

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

Glaucoma, which involves fluid retention in the eye leading to increased eye pressure, eye pain, or vision loss
Difficulty thinking, remembering information, or solving problems, reduced alertness or awareness, feeling very drowsy and lacking energy – these symptoms may indicate high blood ammonia levels (hyperammonemia), which can lead to changes in brain function (hyperammonaemic encephalopathy)
Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis – these may appear as rashes with or without blisters. Skin irritation, mouth sores or swelling, or swelling in the throat, nose, eyes, and around the genitals. Rashes may progress to severe and widespread skin damage (exfoliation of the epidermis and superficial mucosa), with potentially life-threatening consequences.

Not known (cannot be estimated from available data)

Inflammation of the eye (uveitis) with symptoms such as redness, pain, light sensitivity, tearing, blurred or disturbed vision due to the appearance of small floating spots in front of the eyes

Other side effects include the following. If these worsen, consult your doctor or
pharmacist:
Very common (may affect more than 1 in 10 people)

Stuffy, 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 affect up to 1 in 10 people)

Anaemia (low red blood cell count)
Allergic reaction (such as rash, redness, itching, facial swelling, hives)
Loss of appetite, decreased appetite
Aggression, agitation, anger, abnormal behaviour
Difficulty falling asleep or staying asleep
Speech problems or disturbances, difficulty speaking
Clumsiness or loss of coordination, feeling unsteady when walking
Reduced ability to perform routine activities
Decreased, lost, or absent sense of taste
Involuntary tremors or shaking: rapid, uncontrollable eye movements
Vision disturbances such as double vision, blurred vision, reduced vision, difficulty focusing
Sensation of spinning (vertigo), ringing in the ears, ear pain
Shortness of breath
Cough
Nosebleeds
Fever, feeling unwell, weakness
Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
Dry mouth
Hair loss
Itching
Joint pain or swelling, muscle spasms or contractions, muscle pain or weakness, chest pain
Weight gain

Uncommon (may affect up to 1 in 100 people)

Decreased platelet count (blood cells that help stop bleeding), decreased white blood cells (which help protect against infections), decreased blood potassium levels
Increased liver enzyme levels, increased eosinophils (a type of white blood cells) in the blood
Swelling of glands in the neck, armpits, or groin
Increased appetite
Improved mood
Hearing, seeing, or feeling things that are not there, severe mental disturbances (psychosis)
Not showing and/or not feeling emotions, unusual suspiciousness, panic attack
Problems with reading, speech disorder, writing difficulties
Restlessness, hyperactivity
Slowed thinking, reduced level of consciousness or alertness
Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements
Fainting
Abnormal or impaired sense of touch
Impaired, distorted, or absent sense of smell
Unusual sensation or aura that may precede migraine or a certain type of seizure
Dry eyes, light sensitivity of the eyes, eyelid spasms, tearing
Decreased or lost hearing, hearing loss in one ear
Slow or irregular heartbeat, awareness of your heartbeat in the chest
Low blood pressure, drop in blood pressure upon standing (as a result, some people taking Topamax may feel weak, dizzy, or may faint when standing up or sitting up suddenly)
Hot flushes, feeling hot
Pancreatitis (inflammation of the pancreas)
Excessive passing of gas or air, heartburn, feeling of fullness or abdominal bloating
Bleeding gums, increased saliva, loss of saliva, bad breath
Excessive fluid intake, thirst
Skin discoloration
Muscle stiffness, flank pain
Blood in urine, urinary incontinence (loss of bladder control), urgent need to urinate, flank or kidney pain
Difficulty achieving or maintaining erection, sexual dysfunction
Flu-like symptoms
Cold fingers and toes
Feeling of drunkenness
Learning difficulties

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

Abnormally elevated mood
Loss of consciousness
Blindness in one eye, temporary blindness, night blindness
Lazy eye
Swelling inside and around the eyes
Numbness, tingling, and color changes (white, blue, then red) in fingers and toes when exposed to cold (Raynaud's phenomenon)
Liver inflammation, liver failure
Abnormal skin odour
Discomfort in arms or legs
Kidney disorder

Not known (frequency cannot be estimated from available data)

Maculopathy, a disease of the macula, the small part of the retina where vision is sharpest. If you notice a change or decrease in vision, contact your doctor.

Children
Side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than in adults:

Difficulty concentrating
Increased acid levels in the blood
Thoughts of severe self-harm
Fatigue
Decreased or increased appetite
Aggression, abnormal behaviour
Difficulty falling asleep or staying asleep
Feeling unsteady when walking
Feeling unwell
Decreased blood potassium levels
Not showing and/or not feeling emotions
Tearing
Slow or irregular heartbeat

Other side effects that may occur in children:
Common (may affect up to 1 in 10 people)

Dizziness (sensation of spinning)
Vomiting
Fever

Uncommon (may affect up to 1 in 100 people)

Increased eosinophils (a type of white blood cells) in the blood
Hyperactivity
Feeling hot
Learning difficulties

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-
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TOPAMAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/bottle after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Topamax contains

The active substance is topiramate.
Each hard capsule of Topamax contains 15 mg or 25 mg of topiramate.
The other components of Topamax are:
sugar spheres (corn starch, sucrose), povidone, cellulose acetate
capsule: gelatin, titanium dioxide (E171)
printing ink: black ink (black iron oxide (E172), shellac, and propylene glycol)

Description of the appearance of Topamax and contents of the pack

15 mg capsule: small whitish granules in a hard gelatin capsule with an opaque white body printed with "15 mg" and a transparent cap printed with "TOP".
25 mg capsule: small whitish granules in a hard gelatin capsule with an opaque white body printed with "25 mg" and a transparent cap printed with "TOP".

Opaque high-density polyethylene bottle with tamper-evident closure, containing 20, 28, 60 or 100 capsules with granules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer(s)
Janssen-Cilag SpA - Via M. Buonarroti, 23 - 20093 Cologno Monzese (MI)

MANUFACTURER
Hard capsules
Janssen-Cilag SpA Borgo San Michele – Latina (Italy)

The marketing authorization for this medicinal product has been granted in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Cyprus, Germany, Italy, Luxembourg, Malta, Poland, Portugal, Czech Republic, Slovenia:	Topamax
Denmark, Finland, Iceland, Norway, Sweden:	Topimax
France:	Epitomax
Greece:	Topamac
Ireland, Netherlands, United Kingdom (Northern Ireland):	Topamax Sprinkle
Spain:	Topamax Dispersable

This leaflet was last reviewed on:

Package leaflet: information for the user

Topamax 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets

topiramate
Please read this leaflet carefully before taking this medicine because 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 other people, even if they have the same symptoms as you, because it could be harmful. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Topamax is and what it is used for
What you need to know before taking Topamax
How to take Topamax
Possible side effects
How to store Topamax
Contents of the pack and other information

1. What TOPAMAX is and what it is used for

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

alone for 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 from 2 years of age
to prevent migraine in adults

2. What you should know before taking TOPAMAX

Do not take Topamax

if you are allergic to topiramate or to any of the excipients of this medicine (listed in section 6).
for migraine prevention if you are pregnant or if you are a woman of childbearing potential unless you are using an effective method of contraception (see section “Pregnancy and breastfeeding” for more information). You should discuss with your doctor which type of contraception is best to use during treatment with Topamax.

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before taking Topamax.

Warnings and precautions

Consult your doctor or pharmacist before taking Topamax if:

you have kidney problems, particularly kidney stones, or if you are undergoing renal dialysis
you have a history of blood or body fluid abnormalities (metabolic acidosis)
you have liver problems
you have eye problems, particularly glaucoma
you have growth problems
your diet is high in fat (ketogenic diet)
you are taking Topamax for epilepsy and you are pregnant or are a woman of childbearing potential (for further information, see section “Pregnancy and breastfeeding”).

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before starting treatment with Topamax.

It is important that you do not stop taking this medicine without first consulting your doctor.

You should also speak with your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to Topamax.

Weight loss may occur while using Topamax, therefore your weight should be monitored regularly during treatment. 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 Topamax have experienced suicidal thoughts or self-harming thoughts. If at any time you have such thoughts, contact your doctor immediately.

Topamax can cause serious skin reactions. Inform your doctor immediately if you develop a rash or blisters (see also section 4 “Possible side effects”).

Topamax may rarely cause high levels of ammonia in the blood (seen in blood tests), which may lead to changes in brain function, especially if you are 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 and lacking energy

The risk of developing these symptoms may increase at higher doses of Topamax.

Other medicines and Topamax

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topamax and certain other medicines may interact with each other. Sometimes, the dose of either Topamax or your other medicines may need to be adjusted.

In particular, inform 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).
oral contraceptive pills. Topamax may reduce the effectiveness of oral contraceptives. You should discuss with your doctor which type of contraception is best to use during treatment with Topamax.

Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and Topamax.

Keep a list of all 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, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St John’s wort (Hypericum perforatum) (a herbal preparation used for the treatment of depression), and warfarin (used to thin the blood).

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

Topamax with food and drink

Pregnancy and breastfeeding

Migraine prevention:

Epilepsy treatment:

If you are a woman of childbearing potential, you should discuss other possible treatments with your doctor instead of Topamax. If you and your doctor decide to use Topamax, you must use an effective method of contraception. Speak with your doctor about the best type of contraception to use during treatment with Topamax. A pregnancy test must be performed before starting treatment with Topamax. Speak with your doctor if you are planning a pregnancy.

If you take Topamax during pregnancy, your baby has an increased risk of birth defects, particularly cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth). Male newborns may also have a malformation of the penis (hypospadias). These defects may develop early in pregnancy, even before you know you are pregnant.
If you take Topamax during pregnancy, your baby may be smaller than expected at birth. Speak with your doctor if you have questions about this risk.
There may be other medicines available to treat your condition that carry a lower risk of birth defects.
Inform your doctor immediately if you become pregnant while taking Topamax. You and your doctor will need to decide whether to continue taking Topamax during pregnancy.

Breastfeeding

The active substance in Topamax (topiramate) is excreted in human milk. Effects have been observed in infants of treated mothers, including diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether to discontinue breastfeeding or to discontinue treatment with Topamax, taking into account the importance of the medicine to the mother and the potential risk to the infant.

Mothers who are breastfeeding while taking Topamax should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Driving and using machines

Dizziness, fatigue, and vision problems may occur during treatment with Topamax. Do not drive or operate tools or machinery without first discussing this with your doctor.

Topamax contains lactose

If your doctor has diagnosed you with a sugar intolerance, consult your doctor before taking this medicine.

Other components

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take TOPAMAX

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will usually start you on a low dose of Topamax, then gradually increase it until the best dose for you is reached.
Topamax tablets must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
Topamax can be taken before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topamax.

If you take more Topamax than you should

Contact a doctor immediately. Take the medicine pack with you.
You may feel drowsy, tired, or less alert; experience loss of coordination; have difficulty speaking or concentrating; suffer from blurred or double vision; feel dizzy due to low blood pressure; feel depressed or agitated; or have abdominal pain or seizures.

If you are taking other medicines together with Topamax, an overdose may occur.
If you forget to take Topamax

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 Topamax
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 be gradually reduced over several days.
If you have any doubts 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 gets them.
Tell your doctor or contact your doctor immediately 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
Anxiety, irritability, mood changes, confusion, disorientation
Difficulty concentrating, slowed thinking, memory loss, memory problems (new onset, sudden change or increased severity)
Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

Increased blood acidity (can cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness and fast or irregular heartbeat)
Decreased or absent sweating (particularly in young children exposed to high temperatures)
Thoughts of severe self-harm, attempt of severe self-harm
Loss of part of the visual field

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

Glaucoma, which involves fluid retention in the eye leading to increased eye pressure, eye pain or vision loss
Difficulty thinking, remembering information or solving problems, being less alert or aware, feeling very drowsy and lacking energy – these symptoms may indicate high levels of ammonia in the blood (hyperammonemia), which can lead to changes in brain function (hyperammonemic encephalopathy)
Serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis
These may appear as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, nose, eyes and around the genitals. Rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), which can be life-threatening.

Not known (cannot be estimated from the available data)

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

Other side effects include the following. If these worsen, consult your doctor or
pharmacist:
Very common (may affect more than 1 in 10 people)

Stuffy, 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 affect up to 1 in 10 people)

Anaemia (low red blood cell count)
Allergic reaction (such as rash, redness, itching, facial swelling, hives)
Loss of appetite, decreased appetite
Aggressiveness, agitation, anger, abnormal behaviour
Difficulty falling asleep or staying asleep
Speech problems or disturbances, difficulty speaking
Clumsiness or loss of coordination, feeling unsteady when walking
Reduced ability to perform routine tasks
Decreased, lost, or absent sense of taste
Involuntary tremors or shaking: rapid, uncontrollable eye movements
Vision problems such as double vision, blurred vision, decreased vision, difficulty focusing
Sensation of spinning (vertigo), ringing in the ears, ear pain
Shortness of breath
Cough
Nosebleeds
Fever, feeling unwell, weakness
Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
Dry mouth
Hair loss
Itching
Joint pain or swelling, muscle spasms or cramps, muscle pain or weakness, chest pain
Weight gain

Uncommon (may affect up to 1 in 100 people)

Decreased platelet count (blood cells that help stop bleeding), decreased white blood cells (which help protect against infections), decreased blood potassium levels
Increased liver enzyme levels, increased eosinophils (a type of white blood cell) in the blood
Swelling of glands in the neck, armpits or groin
Increased appetite
Improved mood
Hearing, seeing or sensing things that are not there, severe mental disturbances (psychosis)
Inability to show and/or feel emotions, unusual suspiciousness, panic attack
Problems with reading, speech disorder, writing difficulties
Restlessness, hyperactivity
Slowed thinking, reduced level of wakefulness or alertness
Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements
Fainting
Abnormal or impaired sense of touch
Impaired, distorted or absent sense of smell
Unusual sensation or aura that may precede migraine or a certain type of seizure
Dry eyes, light sensitivity, eyelid spasms and tearing
Decreased or lost hearing, hearing loss in one ear
Slow or irregular heartbeat, awareness of your heartbeat in the chest
Low blood pressure, drop in blood pressure upon standing (as a result, some people taking Topamax may feel weak, dizzy or may faint when standing up or sitting up suddenly)
Hot flushes, feeling hot
Pancreatitis (inflammation of the pancreas)
Excessive passing of gas or air, heartburn, feeling of fullness or abdominal bloating
Bleeding gums, increased saliva, decreased saliva, bad breath
Excessive fluid intake, thirst
Skin discoloration
Muscle stiffness, flank pain
Blood in urine, urinary incontinence (loss of bladder control), urgent need to urinate, flank or kidney pain
Difficulty achieving or maintaining erection, sexual dysfunction
Flu-like symptoms
Cold fingers and toes
Feeling of drunkenness
Learning difficulties

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

Abnormally elevated mood
Loss of consciousness
Blindness in one eye, temporary blindness, night blindness
Lazy eye
Swelling around and within the eyes
Numbness, tingling and colour change (white, blue, then red) in fingers and toes when exposed to cold (Raynaud’s phenomenon)
Liver inflammation, liver failure
Abnormal skin odour
Discomfort in arms or legs
Kidney disorder

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

Maculopathy, a disease of the macula, the small central part of the retina where vision is sharpest. If you notice any change or decrease in vision, contact your doctor.

Children
Side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than in adults:

Difficulty concentrating
Increased blood acidity
Thoughts of severe self-harm
Tiredness
Decreased or increased appetite
Aggressiveness, abnormal behaviour
Difficulty falling asleep or staying asleep
Feeling unsteady when walking
Feeling unwell
Decreased blood potassium levels
Inability to show and/or feel emotions
Tearing
Slow or irregular heartbeat

Other side effects that may occur in children:
Common (may affect up to 1 in 10 people)

Dizziness (sensation of spinning)
Vomiting
Fever

Uncommon (may affect up to 1 in 100 people)

Increased eosinophils (a type of white blood cell) in the blood
Hyperactivity
Feeling hot
Learning difficulties

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 TOPAMAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/bottle after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Blister packs: store in the original packaging to protect the tablets from moisture.
Bottles: store in the original packaging and keep the bottle tightly closed to protect the tablets from moisture.
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 Topamax contains
The active substance is topiramate.

Each Topamax tablet contains 25, 50, 100, or 200 mg of topiramate.
The other components of Topamax are: core: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate

Coating:

OPADRY white, yellow, pink, carnauba wax

OPADRY contains hypromellose, macrogol, polysorbate 80 and, as colourants, titanium dioxide E171 (all strengths), yellow iron oxide E172 (50 and 100 mg), and red iron oxide E172 (200 mg).
Description of the appearance of Topamax and contents of the package

25 mg tablet: white, round, 6 mm in diameter, with "TOP" engraved on one side and "25" on the other.
50 mg tablet: light yellow, round, 7 mm in diameter, with "TOP" engraved on one side and "50" on the other.
100 mg tablet: yellow, round, 9 mm in diameter, with "TOP" engraved on one side and "100" on the other.
200 mg tablet: salmon pink, round, 10 mm in diameter, with "TOP" engraved on one side and "200" on the other.

Opaque plastic bottle with tamper-evident closure containing 20, 28, 30, 50, 56, 60, 100 or 200 (2x100) tablets. Each bottle contains a desiccant container which must not be ingested.
Aluminium/aluminium strip blister packs. Packs of 10, 20, 28, 30, 50, 56, 60 or 100 tablets; multiple pack containing 200 (2 x 100) tablets. Individual (alu/alu) blisters are packed inside a folding carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer(s)
Janssen-Cilag SpA - Via M. Buonarroti, 23 - 20093 Cologno Monzese (MI)
MANUFACTURER
Janssen Pharmaceutica N.V. Beerse (Belgium)
and
Janssen-Cilag SpA Borgo San Michele – Latina (Italy)
and
Lusomedicamenta – Sociedade Técnica Farmacêutica S.A. Queluz da Baixo Barcarena (Portugal)
The marketing authorisation for this medicinal product has been granted in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Cyprus, Estonia, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Slovakia, Slovenia, Spain, Hungary:	Topamax
Denmark, Finland, Iceland, Norway, Sweden:	Topimax
France:	Epitomax
Greece:	Topamac

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