Prospect: information for the patient
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
This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.
Read this prospect carefully before starting to take this medicine,because it contains important information for you.
1.What is Topiramato Sandoz and what is it used for
2.What you need to know beforestarting totake Topiramato Sandoz
3.How to take Topiramato Sandoz
4.Possible adverse effects
5Storage of Topiramato Sandoz
6.Contents of the pack and additional information
Topiramato belongs to a group of medicines called “antiepileptic medicines”. It is used for:
Do not take Topiramato Sandoz:
if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6),
Prevention of migraines
Treatment of epilepsy
Make sure to read the patient leaflet that you will receive from your doctor or scan the QR code to obtain it (see section 6 “Other sources of information”.
A patient leaflet is provided with the packaging of Topiramato Sandoz to remind you of the risks during pregnancy.
If you are unsure whether anything above applies to you, consult your doctor or pharmacist before using topiramate.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Topiramato Sandoz if:
If you are unsure whether anything above applies to you, consult your doctor or pharmacist before using topiramate.
If you have epilepsy, it is essential not to stop taking your medication without consulting your doctor first.
It is essential not to stop taking your medication without consulting your doctor first.
You must consult your doctor before taking any other medication that contains topiramate that is given as an alternative to topiramate.
You may lose weight if you take topiramate, so your weight should be monitored regularly while taking this medicine. If you lose too much weight or if a child taking this medicine does not gain enough weight, you must consult your doctor.
A small number of people taking antiepileptic medicines like topiramate have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.
Topiramate may cause severe skin reactions, contact your doctor immediately if you develop a skin rash and/or blisters (see also section 4 “Possible side effects”).
Topiramate may cause high levels of ammonia in the blood (seen in blood tests) which may cause a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this can be a serious condition, talk to your doctor immediately if you experience any of the following symptoms (see also section 4 “Possible side effects”):
You may be at increased risk of developing these symptoms at higher doses of topiramate.
Other medicines and Topiramato Sandoz
Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.Topiramate and certain medicines may affect each other. Sometimes, the dose of one or both medicines may need to be adjusted.
Especially, inform your doctor or pharmacist if you are taking:
Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and topiramate. You may experience irregular menstrual bleeding. In this case, continue taking the hormonal contraceptives and inform your doctor.
Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before starting a new medicine.
Other medicines that you should consult your doctor or pharmacist about 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), warfarin used to prevent blood clotting.
If you are unsure whether anything above applies to you, consult your doctor or pharmacist before taking topiramate.
Topiramato Sandoz with food, drinks and alcohol
You can take topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stone formation while taking topiramate.
You should avoid drinking alcohol while taking topiramate.
Pregnancy, breastfeeding and fertility
Important advice for fertile women:
Topiramate may cause harm to a baby during pregnancy. If you are a fertile woman, consult your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year.
Prevention of migraines
Treatment of epilepsy
The risks of topiramate when taken during pregnancy (regardless of the condition for which topiramate is used) are as follows:
There is a risk of harm to a baby during pregnancy if topiramate is used during pregnancy.
Need for contraceptive methods for fertile women:
You should use a highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a hormonal contraceptive with a barrier method (such as a condom or diaphragm). Consult your doctor about the most suitable contraceptive methods for you.
Use of topiramate in girls:
If you are the parent/caregiver of a girl treated with topiramate, you should consult your doctor immediately once your daughter experiences her first menstrual period (menarche). The doctor will inform you about the risks to a baby during pregnancy due to exposure to topiramate during pregnancy and about the need to use highly effective contraceptive methods.
If you want to become pregnant while taking topiramate:
If you have become pregnant or think you may be pregnant while taking topiramate:
Make sure to read the patient leaflet that you will receive from your doctor or scan the QR code to obtain it (see section 6 “Other sources of information”.
A patient leaflet is provided with the packaging of Topiramato Sandoz to remind you of the risks during pregnancy. With the packaging of topiramate, a patient leaflet is provided to remind you of the risks during pregnancy.
Breastfeeding
The active ingredient topiramate passes into breast milk. There have been reports of effects in breastfed babies of mothers treated with topiramate, including diarrhea, feeling sleepy, feeling irritable and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or whether to stop taking topiramate. Your doctor will take into account the importance of the benefits for the mother and the risk to the baby.
Mothers who are breastfeeding and taking topiramate should inform their doctor as soon as possible if the baby experiences anything unusual.
Driving and operating machines
You may experience dizziness, fatigue and visual disturbances during treatment with topiramate. Do not drive or operate tools or machines without talking to your doctor first.
Topiramato Sandoz contains lactose and sodium
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; this is essentially “sodium-free”.
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Girls and fertile women:
Topiramato treatment should begin and continue under the supervision of a doctor experienced in treating epilepsy or migraine. Visit your doctor to review your treatment at least once a year.
If you take more Topiramato Sandoz than you should
You may experience an overdose if you are taking another medication with topiramato.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 5620420, indicating the medication and the amount ingested.
If you forgot to take Topiramato Sandoz
If you interrupt treatment with Topiramato Sandoz
Do not stop treatment without your doctor's instructions. Your symptoms may reappear. If your doctor decides that you should stop taking this medication, they will gradually reduce your dose over several days.
If you have any other questions about using this medication, ask your doctor or pharmacist.
Like all medications, this medication may cause side effects, although not everyone will experience them.
Consult your doctor or seek medical attention immediately if you experience the following side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (cannot be estimated from available data):
Other side effects include the following, if severe, please consult your doctor or pharmacist:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (cannot be estimated from available data)
Other side effects in children
Generally, side effects observed in children are similar to those observed in adults, but the following side effects may be more common in children than in adults:
Other side effects that may occur in children are:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keepthis medicationout of the sight and reach of children.
Do not use Topiramato Sandoz after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.
Do not store at a temperature above25°C.
Container:
Once opened, do not store at a temperature above 25ºC.
Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.
Composition of Topiramato Sandoz
Each tablet contains 25 mg oftopiramate.
Each tablet contains 50 mg oftopiramate.
Each tablet contains 100 mg oftopiramate.
Each tablet contains 200 mg oftopiramate.
Topiramato Sandoz 25 mg: opadry white 13B58802 (hypromellose, titanium dioxide (E171), macrogol, and polisorbate 80).
Topiramato Sandoz 50 mg:opadry yellow 13B52425 (hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), and polisorbate 80).
Topiramato Sandoz 100 mg: opadry white 13B58802 (hypromellose, titanium dioxide (E171), macrogol, and polisorbate 80).
Topiramato Sandoz 200 mg:opadry yellow 13B52425 (hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), and polisorbate 80).
Appearance of the product and contents of the package
Topiramato Sandoz 25 mg: are white film-coated tablets, rounded and flat on both sides.
Topiramato Sandoz 50 mg:are yellow film-coated tablets, rounded and flat on both sides.
Topiramato Sandoz 100 mg: are white film-coated tablets, rounded and flat on both sides.
Topiramato Sandoz 200 mg: are yellow film-coated tablets, rounded and flat on both sides.
They are presented in HDPE bottles with a safety closure or in blisters of 60 or 500 (clinical pack) tablets in aluminum/aluminum.
Only some package sizes may be marketed.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Responsible manufacturer
Sandoz GmbH
Biochemiestrasse 10 -A- 6250
Kundl
Austria
or
Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava
Eslovenia
or
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Eslovenia
Last revision date of thisleaflet:January 2024
Other sources of information
The most recent approved information from the patient guide information for this medication is available by scanning the following QR code with a smartphone. The same information is also available on the following website: https://cima.aemps.es/cima/DocsPub/16/3252:
The most recent approved information is available on the following website:http://www.aemps.gob.es/
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