TOPIRAMATO 25 mg Film-Coated Tablets

Зміст інструкції

1. Topiramato Aurobindo 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Topiramato Aurobindo and what is it used for
   2. What you need to know before you take Topiramato Aurobindo
   3. How to take Topiramato Aurobindo
   4. Possible side effects
   5. How to store Topiramato Aurobindo
   6. Package contents and other information

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

Generic medicine
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Topiramato Aurobindo belongs to a group of medicines called “antiepileptic drugs”. It is used:

• alone for the treatment of epileptic seizures in adults and children over 6 years of age;
• with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age;
• to prevent migraine in adults.

2. What you need to know before you take Topiramato Aurobindo

Do not take Topiramato Aurobindo

• if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6);
• for the prevention of migraine if you are pregnant or if you are a woman of childbearing potential unless you are using adequate contraception (see section “Pregnancy and breastfeeding” for more information). You should talk to your doctor about the best type of contraception to use while taking Topiramato Aurobindo. If you are unsure whether the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Topiramato Aurobindo.

Warnings and precautions
Consult your doctor or pharmacist before taking Topiramato Aurobindo coated tablets if:

• you have kidney problems, especially kidney stones, or if you are undergoing kidney dialysis
• you have a history of blood and fluid imbalances in the body (metabolic acidosis)
• you have liver problems
• you have eye problems, especially glaucoma
• you have growth problems
• your diet is high in fat (ketogenic diet)
• you are taking Topiramato Aurobindo to treat epilepsy and if you are pregnant or if you are a woman of childbearing potential (see section “Pregnancy and breastfeeding” for further information). If you are unsure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Topiramato Aurobindo.

It is important that you do not stop taking the medicine without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate that is given to you in
alternative to Topiramato Aurobindo.
With the use of Topiramato Aurobindo you may lose weight, so while taking this medicine, your weight should
be checked regularly. If you lose too much weight or if a child taking the medicine does not gain
enough weight, consult your doctor.
A small number of people treated with antiepileptics such as Topiramato Aurobindo have experienced self-harming or suicidal thoughts. If at any time you have these types of thoughts, contact
your doctor immediately.
Topiramato Aurobindo can, in rare cases, cause high levels of ammonia in the blood (detected in
blood tests) which can lead to a change in brain function, especially if you
are taking a medicine called valproic acid or sodium valproate. As this can
be a serious condition, immediately inform your doctor if you experience the following symptoms
(see also section 4 “Possible side effects”):

• difficulty thinking, remembering information or solving problems
• being less alert or aware
• feeling very sleepy and lacking energy.

At higher doses of Topiramato Aurobindo the risk of developing these symptoms may increase.

Other medicines and Topiramato Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Topiramato Aurobindo and some other medicines can interact with each other.
Sometimes the dose of some of the other medicines you are taking or of Topiramato Aurobindo will need to be
changed.
In particular, tell your doctor or pharmacist if you are taking:

• other medicines that impair or reduce thinking, concentration or muscle coordination (e.g., medicines that depress the central nervous system such as muscle relaxants and sedatives).
• contraceptive pill. Topiramato Aurobindo may reduce the effectiveness of the contraceptive pill. You should talk to your doctor about the best type of contraception to use while taking Topiramato Aurobindo. Tell your doctor if you notice a change in your menstrual bleeding while taking the contraceptive pill and Topiramato Aurobindo.

Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting to
take a 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, St John's Wort (Hypericum perforatum) (a herbal remedy used
to treat depression).
If you are unsure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before
using Topiramato Aurobindo.

Topiramato Aurobindo with food, drinks and alcohol
You can take Topiramato Aurobindo with or without food. Drink plenty of fluids during the day while taking
Topiramato Aurobindo, to prevent the formation of kidney stones. During treatment with Topiramato
Aurobindo you should avoid drinking alcohol.

Pregnancy and breastfeeding
Migraine prevention:
Topiramato Aurobindo can harm the unborn child. You should not use Topiramato Aurobindo if you are pregnant. You should not
use Topiramato Aurobindo for the prevention of migraine if you are a woman of childbearing potential unless you are
using effective contraception. Ask your doctor about the best type of contraception and whether
Topiramato Aurobindo is suitable for you.
A pregnancy test must be performed before starting treatment with Topiramato Aurobindo.

Treatment of epilepsy:
If you are a woman of childbearing potential, you should talk to your doctor about other possible treatments instead of Topiramato
Aurobindo. If you decide to use Topiramato Aurobindo, you must use effective contraception. Consult
your doctor about the best type of contraception to use while taking Topiramato
Aurobindo. A pregnancy test must be performed before starting treatment with Topiramato Aurobindo.

Talk to your doctor if you wish to become pregnant.
As with other antiepileptic medicines, there is a risk of harm to the fetus if Topiramato Aurobindo is used in
pregnancy. Make sure you clearly understand what the risks and benefits of using Topiramato Aurobindo are for
epilepsy during pregnancy.

• If you take Topiramato Aurobindo during pregnancy, your baby has an increased risk of birth defects, in particular, 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 can develop early in pregnancy, even before you know you are pregnant.
• If you take Topiramato Aurobindo during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have questions about this risk during pregnancy.
• There may be other medicines to treat your condition that have a lower risk of birth defects.
• Immediately inform your doctor if you become pregnant while taking Topiramato Aurobindo, you and your doctor need to decide whether to continue taking Topiramato Aurobindo during pregnancy.

Breastfeeding
The active substance in Topiramato Aurobindo (topiramate) passes into breast milk. Effects have been observed in
infants breastfed by treated mothers, including diarrhea, drowsiness, irritability and poor
weight gain. Therefore your doctor will discuss with you whether to stop breastfeeding or to stop
treatment with Topiramato Aurobindo. The doctor will consider the importance of the medicine for the
mother and the risk to the child.
Mothers who are breastfeeding while taking Topiramato Aurobindo should inform their doctor
as soon as possible if the baby shows anything unusual.
Mothers who are breastfeeding while taking Topiramato Aurobindo should inform their doctor as soon as
possible if the baby shows anything unusual.

Driving and using machines
Dizziness, fatigue and vision problems can occur during treatment with Topiramato Aurobindo. Do
not drive, or use tools or machines, until you have spoken to your doctor.

Topiramato Aurobindo contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Topiramato Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or your
pharmacist.

• Your doctor will usually give you a low dose of Topiramato Aurobindo, then gradually increase it until the best dose for you is found.
• 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 during the day to avoid the formation of kidney stones while taking Topiramato Aurobindo.

If you take more Topiramato Aurobindo than you should

• Consult a doctor immediately. Bring the medicine packaging with you.
• You may feel sleepy, tired or less alert; experience lack of coordination; have problems 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). Overdosage can 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 the next dose, skip the forgotten dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

If you stop taking Topiramato Aurobindo
Do not stop taking this medicine unless your doctor tells you to do so. Symptoms may return.
If your doctor decides to stop this medicine, the dose may be gradually reduced over
several days.
If you have any questions about the use of 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.
manifest 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 (convulsions)
• Anxiety, irritability, mood changes, confusion, disorientation
• Problems with concentration, slowness of thought, memory loss, memory problems (new onset, sudden change or increase in severity)
• Kidney stones, frequent or painful urination

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

• Increased acid level in the blood (can cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness and fast or variable heartbeat)
• Reduced or absent sweating (particularly in young children exposed to high temperatures)
• Having thoughts about harming yourself seriously, attempting to harm yourself seriously
• Loss of part of your 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, pain or reduced vision
• Difficulty thinking, remembering information or solving problems, being less alert or aware, feeling very sleepy and lacking energy - these symptoms may be a sign of a high level of ammonia in the blood (hyperammonemia), which can lead to a change in brain function (hyperammonemic 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):

• Blocked or runny nose, or sore throat
• Tingling, pain and/or numbness in various parts of the body
• Sleepiness, tiredness
• Dizziness
• Nausea, diarrhea
• Weight loss

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

• Anemia (low blood count)
• Allergic reactions (such as skin rash, redness, itching, swelling of the face, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty falling asleep or staying asleep
• Problems with speaking, speech disorders, slurred speech
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine activities
• Reduced, loss or lack of taste
• Involuntary trembling or shaking; rapid and uncontrollable eye movements
• Visual 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
• Nosebleed
• 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 loss

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

• Reduced platelets (blood cells that help stop bleeding), reduced white blood cells that help protect you from infections, reduced potassium levels in the blood
• Increased liver enzymes, increased eosinophils (a type of white blood cells) in the blood
• Swelling of the glands in the neck, armpits or groin
• Increased appetite
• Elevated mood
• Feeling, seeing or hearing things that are not there, severe mental disorder (psychosis)
• Not showing and/or feeling any emotion, unusual suspiciousness, panic attack
• Problems with reading, speech disorders, problems with writing
• Restlessness, hyperactivity
• Slowed thinking, reduced alertness or vigilance
• Slow 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
• Strange sensation or perception that may precede migraine or a certain type of seizures
• Dry eyes, sensitivity of the eyes to light, eyelid twitching, watery eyes
• Reduced or loss of 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 pass out when getting up or pulling up suddenly)
• Hot flushes, sensation of heat
• Pancreatitis (inflammation of the pancreas)
• Excessive passing of gas or air, heartburn, fullness or bloating
• Bleeding gums, increased salivation, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, pain in a side
• Blood in the urine, incontinence (loss of control) of urine, urgent need to urinate, pain in a side or 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 change in color (white, red and then blue) of the fingers and toes if exposed to the cold
• Inflammation of the liver, liver failure
• Stevens-Johnson syndrome, a potentially life-threatening condition that can present with sores in many parts of the mucous membrane (such as mouth, nose and eyes), skin rash and pustules
• Abnormal body odor
• Discomfort of the arms or legs
• Kidney disorders

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

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

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

• Problems with concentration
• Increased acid level in the blood
• Having thoughts of serious self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty falling asleep or staying asleep
• Feeling unsteady when walking
• Feeling unwell
• Decreased potassium levels in the blood
• Not showing and / or not feeling emotions
• 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 (vertigo)
• 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
• Difficulty learning.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa. By reporting side effects you 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 which is stated on the package and on the bottle or blister after
EXP. The expiry date refers to the last day of that month.
Store at a temperature below 25  C.
Do not dispose of any medicine in 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 ingredient is topiramate. Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate (Type A), magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, iron oxide yellow (E172) (only in Topiramato Aurobindo 50 and 100 mg), iron oxide red (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 tablet, film-coated with “E” imprinted on one side and “22” on the other side.
Topiramato Aurobindo 50 mg film-coated tablets:
Yellow, round, biconvex tablet, film-coated with “E” imprinted on one side and “33” on the other side.
Topiramato Aurobindo 100 mg film-coated tablets:
Dark yellow, round, biconvex tablet, with beveled edges, film-coated with “E” imprinted on one side and “23” on the other side.
Topiramato Aurobindo 200 mg film-coated tablets:
Pink, round, biconvex tablet, with beveled edges, film-coated with “E” imprinted on one side and “24” on the other side.
The film-coated tablets of Topiramato Aurobindo are available in blister packs of polyamide/aluminum/PVC and in HDPE tablet containers with a polypropylene cap with a desiccant (silica gel).
Packs:
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 Member States of the European Economic Area with 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, coated tablet
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 film-coated tablets
Spain: TOPIRAMATO AUROBINDO 25 mg/50 mg/100 mg/200 mg film-coated tablets EFG
United Kingdom: Topiramate 25 mg/50 mg/100 mg/200 mg film-coated tablets