TOPIRAMATO 25 mg Tabletki Powlekane

Treść ulotki

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

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

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

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

• 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 2 years and older
• to prevent migraine in adults.

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

Do not take Topiramato Sandoz

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

If you are not sure whether the above conditions apply to you, consult your doctor or
pharmacist before using Topiramato Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramato Sandoz if:

• you suffer from kidney problems, especially kidney stones, or if you are undergoing renal dialysis
• you have a history of blood and body fluid abnormalities (metabolic acidosis)
• you suffer from liver problems
• you suffer from eye problems, in particular glaucoma
• you suffer from a growth disorder
• your diet is high in fat (ketogenic diet).
• you are pregnant or might become pregnant (see section “Pregnancy and breastfeeding” for more information)

If you are not sure whether any of the above conditions apply to you, consult your doctor or
pharmacist before using Topiramato Sandoz.
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 as an alternative to Topiramato Sandoz.
With the use of Topiramato Sandoz you may lose weight, therefore while taking this medicine
your weight should be checked regularly. If you lose too much weight or if a child using this
medicine does not gain enough weight, consult your doctor.
A small number of people treated with antiepileptics like Topiramato Sandoz have experienced
self-harmful or suicidal thoughts. If at any time you have these types of
thoughts, contact your doctor immediately.

Other medicines and Topiramato Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Topiramato Sandoz and some other medicines can affect each
other’s effects. Sometimes the dosage of some of the other medicines you are taking or that of
Topiramato Sandoz will need to be adjusted.
In particular, tell your doctor or pharmacist if you are taking:

• other medicines that impair or reduce thinking, concentration or muscle coordination (for example, central nervous system depressants, such as muscle relaxants and sedatives)
• the contraceptive pill. Topiramato Sandoz can reduce the effectiveness of the contraceptive pill.

Tell your doctor if you notice a change in your menstrual bleeding while
taking the contraceptive pill and Topiramato Sandoz.
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 you should 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 preparation used to treat depression).
If you are not sure whether any of the above conditions apply to you, consult your doctor or
pharmacist before using Topiramato Sandoz.

Topiramato Sandoz with food and drink
You can take Topiramato Sandoz with or without food. During treatment with Topiramato
Sandoz drink plenty of fluids during the day in order to prevent the formation of kidney stones.
During treatment with Topiramato Sandoz you should avoid consuming alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will decide whether it is appropriate for you to take Topiramato Sandoz. As with other
antiepileptic medicines, there is a risk of harm to the fetus if Topiramato Sandoz is used during
pregnancy.
Make sure you have fully understood the risks and benefits of using Topiramato Sandoz for
epilepsy during pregnancy.
You should not take Topiramato Sandoz for the prevention of migraine if you are pregnant or
of childbearing potential and are not using effective contraception.
When taking Topiramato Sandoz, breastfeeding mothers should inform the doctor
as soon as possible if the baby shows any unusual reactions.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Dizziness, fatigue and vision disturbances may occur during treatment with Topiramato Sandoz. Do not drive or use tools or machinery until you have consulted your doctor.

Topiramato Sandoz 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 Sandoz

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

• Generally, your doctor will prescribe you to start with a low dose of Topiramato Sandoz, then gradually increase it until the most suitable dosage for your case is found.
• Topiramato Sandoz tablets must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
• Topiramato Sandoz can be taken before, during or after a meal. During treatment with Topiramato Sandoz, drink plenty of fluids throughout the day to avoid the formation of kidney stones.

If you take more Topiramato Sandoz than you should

• Consult a doctor immediately. Bring the medicine packaging with you.
• You may feel sleepy, tired or have poor attention; lack of coordination; have difficulty with speech or concentration; have double or blurred vision; have dizziness caused by low blood pressure; feel depressed or agitated; or abdominal pain, or convulsions (seizures).

If you are taking other medicines together with Topiramato Sandoz, an overdose may occur.

If you forget to take Topiramato Sandoz

• 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 Sandoz
Do not stop taking this medicine unless your doctor tells you to do so. Your symptoms
may return. If your doctor decides to stop this medicine, they may
gradually reduce the dosage over a few days.
If you have any doubts 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 everyone will experience them.

Inform your doctor or go to the hospital immediately 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)

• Convulsions (seizures)
• Anxiety, irritability, mood changes, confusion, disorientation
• Problems with concentration, slowed thinking, memory loss, problems with memory (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 acid level in the blood (may cause difficulty breathing including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and fast or irregular heartbeat)
• Decreased sweating or absence of sweating
• Having thoughts of serious self-harm, attempting to seriously harm oneself

Rare (may affect up to 1 in 1000 people)

• Glaucoma, which consists of fluid retention in the eye leading to increased eye pressure, pain, and decreased vision

Other side effects include the following, if they worsen, contact 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, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anemia (low red blood cell count)
• Allergic reaction (such as skin 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 speech problems, slurred speech
• Clumsiness or lack of coordination, feeling unsteady when walking
• Decreased ability to complete routine actions
• Decreased, loss, or lack of taste
• Involuntary tremor or agitation; rapid, uncontrollable eye movements
• Vision disturbances, such as double vision, blurred vision, decreased vision, difficulty focusing
• Feeling of dizziness (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nosebleed
• Fever, malaise, 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 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 perceiving things that are not there, severe mental disorders (psychosis)
• Inability to show and/or perceive emotions, unjustified suspicion, panic attack
• Problems with reading, speech disorders, problems with handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased state of wakefulness and alertness
• Reduced or slowed body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch, changes in the sense of touch
• Impaired, altered, or loss of sense of smell
• Unusual sensation or feeling that may precede a migraine or certain type of seizure
• Dry eye, sensitivity of the eyes to light, eyelid spasms, tearing of the eyes
• Decreased or loss of hearing, hearing loss in one ear
• Slow or irregular heartbeat, perception 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 getting up or sitting down suddenly)
• Hot flashes, feeling of warmth
• Pancreatitis (inflammation of the pancreas)
• Excessive passage of gas or air, heartburn, feeling of fullness or bloating
• Bleeding gums, increased salivation, drooling, bad breath
• Excessive fluid intake, thirst
• Changes in skin color
• Muscle stiffness, flank pain
• Blood in the urine, incontinence (loss of control) of urine, urgent need to urinate, flank or kidney pain
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• Feeling of intoxication
• Difficulty learning

Rare (may affect up to 1 in 1000 people)

• Abnormally elevated mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Lazy eye
• Swelling around the eye and around the eyes
• Numbness, tingling, and color change (white, blue, then red) in the fingers and toes when exposed to cold
• Inflammation of the liver, liver failure
• Stevens-Johnson syndrome, a potentially life-threatening condition that can present with sores in various mucosal sites (such as the mouth, nose, and eyes), skin rash, and blisters
• Abnormal skin odor
• Feeling of discomfort in arms or legs
• Kidney problem

Not known (frequency cannot be estimated based on available data)

• Maculopathy, a disease of the macula, the small portion of the retina where vision is most acute. 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 shedding 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 are observed more frequently in children and/or may be more
severe in children than in adults. Side effects that may be more severe include
decreased or loss of sweating and increased acid level in the blood. Side effects that may occur more frequently in children include upper respiratory tract infections.
Reporting of side effects
If you experience any side effects, including 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
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 validity after first opening
Do not store at a temperature above 25°C. Store the medicine in its original
packaging to protect it from moisture.
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. Content of the pack and other information

What Topiramato Sandoz contains
The active ingredient is topiramate.
Topiramato Sandoz 25 mg film-coated tablets
Each film-coated tablet contains 25 mg of topiramate.
Topiramato Sandoz 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of topiramate.
Topiramato Sandoz 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of topiramate.
Topiramato Sandoz 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of topiramate.
The excipients are: lactose monohydrate, microcrystalline cellulose, starch, sodium carboxymethylamide,
magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80.
Topiramato Sandoz 50/200 mg film-coated tablets: yellow iron oxide (E172).

Description of the appearance of Topiramato Sandoz and contents of the pack
Film-coated tablets
Topiramato Sandoz 25 mg film-coated tablets: film-coated tablets, white,
round, smooth on both sides.
Topiramato Sandoz 50 mg film-coated tablets: film-coated tablets, yellow,
round, smooth on both sides.
Topiramato Sandoz 100 mg film-coated tablets: film-coated tablets, white,
round, smooth on both sides.
Topiramato Sandoz 200 mg film-coated tablets: film-coated tablets, yellow,
round, smooth on both sides.
Blisters: 5, 6, 10, 20, 60 and 100 film-coated tablets.
HDPE container with PP cap and with desiccant: 20, 28, 50, 60, 100 and 200 film-coated
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 is authorised in the member states of the EEA under the following
names:
Austria: Topiramat Sandoz 25 mg - Filmtabletten
Topiramat Sandoz 50 mg – Filmtabletten
Topiramat Sandoz 100 mg - Filmtabletten
Topiramat Sandoz 200 mg - Filmtabletten
Belgium: Topiramate Sandoz 25 mg filmomhulde tabletten
Topiramate Sandoz 50 mg filmomhulde tabletten
Topiramate Sandoz 100 mg filmomhulde tabletten
Topiramate Sandoz 200 mg filmomhulde tabletten
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 compresse rivestite con film
TOPIRAMATO SANDOZ 50 mg compresse rivestite con film
TOPIRAMATO SANDOZ 100 mg compresse rivestite con film
TOPIRAMATO SANDOZ 200 mg compresse rivestite con film
Latvia: Topiramate Sandoz 25 mg apvalkotās tabletes
Topiramate Sandoz 50 mg apvalkotās tabletes
Topiramate Sandoz 100 mg apvalkotās tabletes
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 filmdrasjerte tabletter
Topiramat Sandoz 50 mg filmdrasjerte tabletter
Topiramat Sandoz 100 mg filmdrasjerte tabletter
Topiramat Sandoz 200 mg filmdrasjerte tabletter
Netherlands: Topiramaat Sandoz 25 mg tabletten
Topiramaat Sandoz 100 mg tabletten
Topiramaat Sandoz 200 mg tabletten
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