Topiramate Sandoz: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Topiramato Sandoz 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 others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

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

Topiramato Sandoz 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
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 need to know before taking Topiramate Sandoz

Do not take Topiramate Sandoz

if you are allergic (hypersensitive) to topiramate or to any of the other ingredients of this medicine (listed in section 6)
for migraine prevention if you are pregnant or of childbearing age but are not using an adequate contraceptive method (for further information, see section “Pregnancy and breastfeeding”).

If you are unsure whether the above conditions apply to you, consult your doctor or pharmacist before using Topiramate Sandoz.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate Sandoz if:

you have kidney problems, especially 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 disorders, particularly glaucoma
you have a growth disorder
your diet is high in fat (ketogenic diet)
you are pregnant or could become pregnant (see section “Pregnancy and breastfeeding” for more information)

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before using Topiramate Sandoz.

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 topiramate-containing medicine that may be prescribed as an alternative to Topiramate Sandoz.

Weight loss may occur while taking Topiramate Sandoz, 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 Topiramate Sandoz have experienced suicidal thoughts or self-harming thoughts. If at any time you experience such thoughts, contact your doctor immediately.

Other medicines and Topiramate Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate Sandoz and certain other medicines may affect each other’s actions. Sometimes, the dose of one of the other medicines you are taking, or of Topiramate Sandoz, 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 (for example, central nervous system depressants such as muscle relaxants and sedatives)
oral contraceptives. Topiramate Sandoz may reduce the effectiveness of oral contraceptives.

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

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 you should 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 above conditions apply to you, consult your doctor or pharmacist before using Topiramate Sandoz.

Topiramate Sandoz with food and drink

You may take Topiramate Sandoz with or without food. During treatment with Topiramate Sandoz, drink plenty of fluids throughout the day to help prevent kidney stone formation.

Avoid consuming alcohol while taking Topiramate Sandoz.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Your doctor will decide whether you should take Topiramate Sandoz. As with other antiepileptic medicines, there is a risk of harm to the unborn baby if Topiramate Sandoz is used during pregnancy.

Make sure you fully understand the risks and benefits of using Topiramate Sandoz for epilepsy during pregnancy.

You must not take Topiramate Sandoz for migraine prevention if you are pregnant or of childbearing age and not using an effective contraceptive method.

Breastfeeding mothers taking Topiramate Sandoz should inform their doctor as soon as possible if the baby shows any unusual reactions.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Dizziness, tiredness, and visual disturbances may occur during treatment with Topiramate Sandoz. Do not drive or operate machinery without first consulting your doctor.

Topiramate Sandoz contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Topiramate Sandoz

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

Generally, your doctor will prescribe starting with a low dose of Topiramate Sandoz, gradually increasing it until the most appropriate dose for your condition is reached.
Topiramate Sandoz tablets should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
Topiramate Sandoz can be taken before, during, or after a meal. During treatment with Topiramate Sandoz, drink plenty of fluids throughout the day to reduce the risk of kidney stone formation.

If you take more Topiramate Sandoz than you should

Contact a doctor immediately. Take the medicine package with you.
You may feel drowsy, tired, or have difficulty concentrating; lack of coordination; difficulty speaking or concentrating; double or blurred vision; dizziness due to low blood pressure; feel depressed or agitated; or experience abdominal pain or seizures (fits).

An overdose may occur if you are taking other medicines together with Topiramate Sandoz.
If you forget to take Topiramate Sandoz

If you forget 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 Topiramate Sandoz
Do not stop taking this medicine unless instructed by your doctor. Your symptoms
may return. If your doctor decides to discontinue this medicine, they may
gradually reduce the dose over several days.
If you have any questions about using 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 go to hospital straight away if you experience 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 (fits)
Anxiety, irritability, mood changes, confusion, disorientation
Problems with concentration, slowed thinking, memory loss, memory problems (new onset, sudden change or increased severity)
Kidney stones, frequent need to urinate or pain when urinating

Uncommon (may affect up to 1 in 100 people)

Increased level of acid in the blood (can cause breathing difficulties including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness and rapid or irregular heartbeat)
Reduced sweating or absence of sweating
Having thoughts of severe self-harm, attempting to seriously harm yourself

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

Glaucoma, which involves fluid retention in the eye causing increased eye pressure, pain and loss of vision

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

Stuffy nose, runny nose and 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 red blood cell count)
Allergic reaction (such as rash, redness, itching, swelling of the face, hives)
Decreased appetite, loss of appetite
Aggressiveness, agitation, anger
Difficulty falling asleep or staying asleep
Difficulty speaking or language problems, slurred speech
Clumsiness or lack of coordination, feeling unsteady when walking
Reduced ability to perform routine tasks
Reduced, lost or absent sense of taste
Involuntary tremor or restlessness; rapid uncontrolled eye movements
Vision disorders, such as double vision, blurred vision, decreased vision, difficulty focusing
Feeling dizzy (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
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 platelets (blood cells that help stop bleeding), decreased white blood cells that help protect against infections, decreased level of potassium 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
Hallucinations (hearing, seeing or sensing things that are not there), severe mental disorders (psychosis)
Inability to express and/or perceive emotions, unjustified suspiciousness, panic attack
Problems with reading, language disorders, problems with handwriting
Restlessness, hyperactivity
Slowed thinking, decreased level of alertness and wakefulness
Reduced or slowed body movements, abnormal or repetitive involuntary muscle movements
Fainting
Abnormal sense of touch, changes in sense of touch
Impairment, alteration, or loss of sense of smell
Unusual sensation or aura that may precede a migraine attack or certain type of seizure
Dry eyes, sensitivity of eyes to light, eyelid spasms, watery eyes
Decreased or loss of hearing, hearing loss in one ear
Slow or irregular heartbeat, awareness of heartbeat in the chest
Low blood pressure, low blood pressure when standing up (as a result, some people taking Topiramato Sandoz may feel weak, dizzy, or may faint when standing up or sitting up suddenly)
Hot flushes, feeling of warmth
Pancreatitis (inflammation of the pancreas)
Excessive passing of gas or air, heartburn, feeling of fullness or bloating in the abdomen
Bleeding gums, increased salivation, drooling, bad breath
Excessive fluid intake, thirst
Change in skin colour
Muscle stiffness, flank pain
Blood in the urine, urinary incontinence (lack of control), urgent need to urinate, flank or kidney pain
Difficulty achieving or maintaining an 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 of the eye and around the eyes
Numbness, tingling and colour change (white, blue, then red) in fingers and toes when exposed to cold
Inflammation of the liver, liver failure
Stevens-Johnson syndrome, a potentially life-threatening condition that may present with sores at various mucosal sites (such as mouth, nose and eyes), rash, and blisters
Abnormal skin odour
Feeling of discomfort in arms or legs
Kidney problems

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. If you notice a change or decrease in vision, contact your doctor
Toxic epidermal necrolysis, a life-threatening condition related to and more severe than Stevens-Johnson syndrome, characterized by widespread blistering and peeling of the outer layers of the skin (see Rare side effects).

Children and adolescents
Side effects in children are generally similar to those observed in adults. However, some side effects occur more frequently in children 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 level of acid in the blood. Side effects that may occur more frequently in children include upper respiratory tract infections.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Topiramato Sandoz

Keep this medicine out of the sight and reach of children.
Do not use Topiramato Sandoz after the expiry date which is stated on the label and on the
outer packaging. The expiry date refers to the last day of the month.
HDPE container: 1 month of shelf life after first opening
Do not store above 25°C. Keep the medicine in the original packaging to protect it from moisture.
Do not dispose of any medicine 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 Topiramate Sandoz contains
The active substance is topiramate.
Topiramate Sandoz 25 mg film-coated tablets
Each film-coated tablet contains 25 mg of topiramate.
Topiramate Sandoz 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of topiramate.
Topiramate Sandoz 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of topiramate.
Topiramate Sandoz 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of topiramate.
The excipients are: monohydrate lactose, microcrystalline cellulose, starch, sodium carboxymethylstarch, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80.
Topiramate Sandoz 50/200 mg film-coated tablets: yellow iron oxide (E172).

Description of the appearance of Topiramate Sandoz and package contents
Film-coated tablets
Topiramate Sandoz 25 mg film-coated tablets: white, round, smooth on both sides.
Topiramate Sandoz 50 mg film-coated tablets: yellow, round, smooth on both sides.
Topiramate Sandoz 100 mg film-coated tablets: white, round, smooth on both sides.
Topiramate Sandoz 200 mg film-coated tablets: yellow, round, smooth on both sides.

Blister packs: 5, 6, 10, 20, 60 and 100 film-coated tablets.
HDPE container with PP cap and desiccant: 20, 28, 50, 60, 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA).

Manufacturers responsible for batch release:
LEK Pharmaceuticals d.d. – Verovskova 57 – SI-1526 Ljubljana – Slovenia
Salutas Pharma GmbH Dieselstrasse 5 – 70839 Gerlingen - Germany
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 – 39179 Barleben – Germany
LEK SA - Ul. Domaniewska 50 C – 02-672 Warszawa – Poland
Lek Pharmaceuticals d.d Trimlini 2D 9220 Lendava Slovenia.

This medicinal product has been authorized in the EEA Member States under the following names:
Austria: Topiramate Sandoz 25 mg - Film tablets
Topiramate Sandoz 50 mg – Film tablets
Topiramate Sandoz 100 mg - Film tablets
Topiramate Sandoz 200 mg - Film tablets

Belgium: Topiramate Sandoz 25 mg film-coated tablets
Topiramate Sandoz 50 mg film-coated tablets
Topiramate Sandoz 100 mg film-coated tablets
Topiramate Sandoz 200 mg film-coated tablets

Estonia: Topiramate Sandoz 25mg
Topiramate Sandoz 50mg
Topiramate Sandoz 100mg

Finland: Topiramat Sandoz 25 mg tabletti, kalvopäällysteinen
Topiramat Sandoz 50 mg tabletti, kalvopäällysteinen
Topiramat Sandoz 100 mg tabletti, kalvopäällysteinen
Topiramat Sandoz 200 mg tabletti, kalvopäällysteinen

Germany: Topiramat Sandoz 25 mg Filmtabletten
Topiramat Sandoz 50 mg Filmtabletten
Topiramat Sandoz 100 mg Filmtabletten
Topiramat Sandoz 200 mg Filmtabletten

Greece: LETOP

Ireland: Topiramate 25 mg Film-Coated Tablets
Topiramate 50 mg Film-Coated Tablets
Topiramate 100 mg Film-Coated Tablets
Topiramate 200 mg Film-Coated Tablets

Italy: TOPIRAMATO SANDOZ 25 mg film-coated tablets
TOPIRAMATO SANDOZ 50 mg film-coated tablets
TOPIRAMATO SANDOZ 100 mg film-coated tablets
TOPIRAMATO SANDOZ 200 mg film-coated tablets

Latvia: Topiramate Sandoz 25 mg coated tablets
Topiramate Sandoz 50 mg coated tablets
Topiramate Sandoz 100 mg coated tablets

Lithuania: Topiramate Sandoz 25 mg plėvele dengtos tabletės
Topiramate Sandoz 50 mg plėvele dengtos tabletės
Topiramate Sandoz 100 mg plėvele dengtos tabletės
Topiramate Sandoz 200 mg plėvele dengtos tabletės

Norway: Topiramat Sandoz 25 mg film-coated tablets
Topiramat Sandoz 50 mg film-coated tablets
Topiramat Sandoz 100 mg film-coated tablets
Topiramat Sandoz 200 mg film-coated tablets

Netherlands: Topiramaat Sandoz 25 mg tablets
Topiramaat Sandoz 100 mg tablets
Topiramaat Sandoz 200 mg tablets

Poland: TopiLek 25
TopiLek 50
TopiLek 100
TopiLek 200

Portugal: Topiramato SANDOZ 25 mg Comprimidos
Topiramato SANDOZ 50 mg Comprimidos
Topiramato SANDOZ 100 mg Comprimidos
Topiramato SANDOZ 200 mg Comprimidos

United Kingdom: Topiramate 25mg tablets
Topiramate 50mg tablets
Topiramate 100mg tablets
Topiramate 200mg tablets

Czech Republic: Topiramat Sandoz 25 mg, tbl.
Topiramat Sandoz 50 mg, tbl
Topiramat Sandoz 100 mg, tbl.
Topiramat Sandoz 200 mg, tbl.

Slovakia: Topiramát Sandoz 25 mg filmom obalené tablety
Topiramát Sandoz 50 mg filmom obalené tablety
Topiramát Sandoz 100 mg filmom obalené tablety

Slovenia: LETOP 25 mg tablete
LETOP 50 mg tablete
LETOP 100 mg tablete
LETOP 200 mg tablete

Sweden: Topiramat Sandoz

Hungary: Topiramat Sandoz 25 mg filmtabletta
Topiramat Sandoz 50 mg filmtabletta
Topiramat Sandoz 100 mg filmtabletta
Topiramat Sandoz 200 mg filmtabletta