Topiramate Aurobindo

Package leaflet: Information for the user

Topiramate Aurobindo 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets

Generic medicine
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 their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What Topiramate Aurobindo is and what it is used for

Topiramate Aurobindo belongs to a group of medicines called "antiepileptic drugs". It is used:

• as monotherapy 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 over 2 years of age;
• for the prevention of migraine in adults.

2. What you need to know before taking Topiramate Aurobindo

Do not take Topiramate Aurobindo

• if you are allergic to topiramate or to any of the other ingredients 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 must speak with your doctor about the most suitable type of contraception to use while taking Topiramate Aurobindo. If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Topiramate Aurobindo.

Warnings and precautions
Consult your doctor or pharmacist before taking Topiramate Aurobindo film-coated tablets 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 Topiramate Aurobindo to treat epilepsy and you are pregnant or are a woman of childbearing potential (see section “Pregnancy and breastfeeding” for further information). If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Topiramate Aurobindo.

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 Topiramate Aurobindo.
Weight loss may occur while taking Topiramate Aurobindo, so 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 Topiramate Aurobindo have experienced suicidal thoughts or self-harming thoughts. If at any time you experience such thoughts, contact your doctor immediately.
Topiramate Aurobindo may rarely cause increased levels of ammonia in the blood (detected in blood tests), which may lead to changes in brain function, particularly if you are taking a medicine called valproic acid or sodium valproate. Since this may be a serious condition, inform your doctor immediately if any of the following symptoms occur (also see 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 Topiramate Aurobindo.
Other medicines and Topiramate Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Topiramate Aurobindo and certain other medicines may interact with each other.
Sometimes, the dose of some of the other medicines you are taking or of Topiramate Aurobindo 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. Topiramate Aurobindo may reduce the effectiveness of oral contraceptives. You must talk to your doctor about the most suitable type of contraception to use while taking Topiramate Aurobindo. Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and Topiramate Aurobindo.

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, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, and St John’s wort (Hypericum perforatum) (a herbal preparation used to treat depression).
If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Topiramate Aurobindo.
Topiramate Aurobindo with food, drinks and alcohol
You may take Topiramate Aurobindo with or without food. Drink plenty of fluids throughout the day when taking Topiramate Aurobindo to help prevent the formation of kidney stones. During treatment with Topiramate Aurobindo, you must avoid drinking alcohol.
Pregnancy and breastfeeding
Migraine prevention:
Topiramate Aurobindo may harm the unborn baby. You must not use Topiramate Aurobindo if you are pregnant. You must not use Topiramate Aurobindo for migraine prevention if you are a woman of childbearing potential unless you are using effective contraception. Ask your doctor about the most suitable type of contraception and whether Topiramate Aurobindo is appropriate for you.
A pregnancy test must be performed before starting treatment with Topiramate Aurobindo.
Epilepsy treatment:
If you are a woman of childbearing potential, you should discuss with your doctor other possible treatments instead of Topiramate Aurobindo. If Topiramate Aurobindo is used, effective contraception is required. Speak with your doctor about the most suitable type of contraception to use while taking Topiramate Aurobindo. A pregnancy test must be performed before starting treatment with Topiramate Aurobindo.
Talk to your doctor if you are planning a pregnancy.
As with other antiepileptic medicines, there is a risk of harm to the unborn baby if Topiramate Aurobindo is used during pregnancy. Make sure you fully understand the risks and benefits of using Topiramate Aurobindo for epilepsy during pregnancy.

• If you take Topiramate Aurobindo during pregnancy, your baby has a higher risk of being born with 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 Topiramate Aurobindo during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have any questions about this risk during pregnancy.
• 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 Topiramate Aurobindo. You and your doctor will need to decide whether to continue taking Topiramate Aurobindo during pregnancy.

Breastfeeding
The active substance in Topiramate Aurobindo (topiramate) passes into breast 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 Topiramate Aurobindo. The doctor will consider the importance of the medicine for the mother and the risk to the infant.
Mothers who are breastfeeding while taking Topiramate Aurobindo must inform their doctor as soon as possible if the baby shows any unusual symptoms.
Mothers who are breastfeeding while taking Topiramate Aurobindo must inform their doctor as soon as possible if the baby shows any unusual symptoms.
Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment with Topiramate Aurobindo. Do not drive or operate tools or machinery without first discussing this with your doctor.
Topiramate Aurobindo contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Topiramato Aurobindo

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 Topiramato Aurobindo and then gradually increase it to find the best dose for you.
• Topiramato Aurobindo tablets must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
• Topiramato Aurobindo can be taken before, during, or after a meal. Drink plenty of fluids throughout the day to reduce the risk of kidney stone formation while taking Topiramato Aurobindo.

If you take more Topiramato Aurobindo than you should

• Contact a doctor immediately. Take the medicine package with you.
• You may feel drowsy, tired, less alert; experience lack of coordination; have difficulty speaking or concentrating; see double or have blurred vision; feel dizzy due to low blood pressure; feel depressed or agitated; have abdominal pain or seizures (convulsions). Overdose may occur if you are taking other medicines together with Topiramato Aurobindo.

If you forget to take Topiramato Aurobindo

• 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 as usual. 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.

If you stop taking Topiramato Aurobindo
Do not stop taking this medicine unless your doctor tells you to. Symptoms may return.
If your doctor decides to discontinue this medicine, the dose may need to 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 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 (convulsions)
• 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 level of acid in the blood (can cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness and fast or irregular heartbeat)
• Reduced or absent sweating (particularly in young children exposed to high temperatures)
• Having thoughts of seriously harming yourself, attempting to seriously harm yourself
• Loss of part of the visual field

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

• Glaucoma – blockage of fluid in the eye causing increased pressure in the eye, eye pain or reduced vision
• Difficulty thinking, remembering information or solving problems, being less alert or aware, feeling very drowsy and lacking energy – these symptoms may be signs of high levels of ammonia in the blood (hyperammonemia), which can lead to changes in brain function (hyperammonaemic encephalopathy).

Other side effects include the following; if they worsen, tell your doctor or pharmacist:
Very common (may affect more than 1 in 10 people):

• Stuffy or runny nose, or sore throat
• Tingling, pain and/or numbness in various parts of the body
• Drowsiness, tiredness
• Dizziness
• Nausea, diarrhoea
• Weight loss

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

• Anaemia (low blood count)
• Allergic reactions (such as rash, redness, itching, swelling of the face, hives)
• Loss of appetite, reduced appetite
• Aggression, agitation, anger, abnormal behaviour
• Difficulty falling asleep or staying asleep
• Problems speaking, speech disorders, slurred speech
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine tasks
• Reduced, lost or absent sense of taste
• Involuntary tremor or shaking; rapid, uncontrolled eye movements
• Vision problems, such as double vision, blurred vision, reduced vision, difficulty focusing
• Sensation of spinning (dizziness), ringing in the ears, earache
• 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 loss

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

• Reduced platelet count (blood cells that help stop bleeding), reduced white blood cells that help protect you from infections, reduced levels of potassium in the blood
• Increased liver enzymes, increased eosinophils (a type of white blood cells) in the blood
• Swelling of glands in the neck, armpits or groin
• Increased appetite
• Elevated mood
• Experiencing things that are not real (hallucinations), severe mental disorder (psychosis)
• Showing and/or feeling no emotions, unusual suspiciousness, panic attack
• Reading problems, speech disorders, writing problems
• Restlessness, hyperactivity
• Slowed thinking, reduced alertness or vigilance
• Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch; impaired sense of touch
• Impaired, distorted or absent sense of smell
• Unusual sensation or perception that may precede migraine or certain types of epileptic seizures
• Dry eyes, sensitivity of the eyes to light, eyelid twitching, watery eyes
• Reduced or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, sensation of heartbeat in the chest
• Low blood pressure, low blood pressure when standing up (as a result, some people taking topiramate may feel faint, dizzy or faint upon standing up suddenly)
• Hot flushes, feeling of warmth
• Pancreatitis (inflammation of the pancreas)
• Excessive passing of gas or air, heartburn, fullness or bloating of the abdomen
• Bleeding gums, increased salivation, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, pain in one side of the body
• Blood in urine, urinary incontinence (lack of control), urgent need to urinate, pain in one side or in the kidney
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• Feeling drunk
• Inability to learn

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 of the eyes or around the eyes
• Numbness, tingling or colour change (white, red, then blue) in fingers or toes when exposed to cold
• Liver inflammation, liver failure
• Stevens-Johnson syndrome, a potentially life-threatening condition that may present with sores in mucosal areas (such as mouth, nose and eyes), rash and blisters
• Abnormal odour of the skin
• Discomfort in arms or legs
• Kidney disorders

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

• Maculopathy is a disease of the macula, the smallest part of the retina where vision is sharpest. You must call your doctor if you notice any change or reduction in vision.
• Toxic epidermal necrolysis, a life-threatening condition related to Stevens-Johnson syndrome but more severe, characterised by widespread blisters and peeling of the outer layers of the skin (see rare side effects)

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

• Difficulty concentrating
• Increased level of acid in the blood
• Thoughts of serious self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling asleep or staying asleep
• Feeling unsteady when walking
• Feeling unwell
• Decreased level of potassium in the blood
• Not showing and/or not feeling emotions
• Tearing (watery eyes)
• Slow or irregular heartbeat

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

• Sensation of spinning (dizziness)
• 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Topiramato Aurobindo

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 or blister after EXP. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not dispose of medicines 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 Topiramato Aurobindo 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, lactose monohydrate, pregelatinized starch (maize), sodium starch glycolate (Type A), magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, yellow iron oxide (E172) (only in Topiramato Aurobindo 50 mg and 100 mg), red iron oxide (E172) (only in Topiramato Aurobindo 200 mg).

Description of the appearance of Topiramato Aurobindo and package contents
Film-coated tablet.
Topiramato Aurobindo 25 mg film-coated tablets:
White, round, biconvex, film-coated tablet, marked with "E" on one side and "22" on the other side.
Topiramato Aurobindo 50 mg film-coated tablets:
Yellow, round, biconvex, film-coated tablet, marked with "E" on one side and "33" on the other side.
Topiramato Aurobindo 100 mg film-coated tablets:
Dark yellow, round, biconvex tablet with bevelled edges, film-coated, marked with "E" on one side and "23" on the other side.
Topiramato Aurobindo 200 mg film-coated tablets:
Pink, round, biconvex tablet with bevelled edges, film-coated, marked with "E" on one side and "24" on the other side.
Topiramato Aurobindo film-coated tablets are available in blister packs made of polyamide/aluminum/PVC and in HDPE bottles with polypropylene caps and desiccant (silica gel).
Pack sizes:
Blister packs:
60 film-coated tablets
Bottle pack:
60 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Cyprus: Topiramate Aurobindo 25 mg/50 mg/100 mg/200 mg film-coated tablets
France: TOPIRAMATE AUROBINDO 50 mg/100 mg/200 mg, comprimé pelliculé
Italy: Topiramato Aurobindo
Malta: Topiramate 25 mg/50 mg/100 mg/200 mg film-coated tablets
Netherlands: Topiramaat Aurobindo 25 mg/50 mg/100 mg/200 mg filmomhulde tabletten
Spain: TOPIRAMATO AUROBINDO 25 mg/50 mg/100 mg/200 mg comprimidos recubiertos con película EFG
United Kingdom: Topiramate 25 mg/50 mg/100 mg/200 mg film-coated tablets