Topiramate Cinfa 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

topiramato cinfa 50 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you

• Keep this leaflet, as 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 they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What topiramato cinfa is and what it is used for

2. What you need to know before taking topiramato cinfa

3. How to take topiramato cinfa

4. Possible side effects

5. How to store topiramato cinfa

6. Package contents and other information

1. What topiramate cinfa is and what it is used for

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

• treat seizures in adults and children over 6 years of age when given alone
• treat seizures in adults and children aged 2 years and older when given together with other medicines
• prevent migraine in adults

2. What you need to know before taking topiramate cinfa

Do not take topiramate cinfa

• if you are allergic to topiramate, soybean oil, or any of the other ingredients of this medicine (listed in section 6). This medicine contains soybean oil. It should not be used if you are allergic to peanuts or soy.

• Migraine prevention

  • You must not take topiramate cinfa if you are pregnant.
  • If you are a woman of childbearing potential, you must not take topiramate cinfa unless you are using a highly effective method of contraception during treatment. See below under “Pregnancy and breastfeeding – Important advice for women”.

• Epilepsy treatment

  • You must not use topiramate cinfa if you are pregnant, unless no other treatment provides sufficient seizure control.
  • If you are a woman of childbearing potential, you must not take topiramate cinfa unless you are using a highly effective method of contraception during treatment. The only exception is if topiramate cinfa is the only treatment providing sufficient seizure control and you plan to become pregnant. You must consult your doctor to ensure you have received information about the risks of taking topiramate cinfa during pregnancy and the risks of seizures during pregnancy. See below under “Pregnancy and breastfeeding – Important advice for women”.

Make sure to read the patient leaflet you will receive from your doctor.

A patient card is provided with the packaging of topiramate cinfa to remind you of the risks during pregnancy.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using topiramate cinfa.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take topiramate cinfa if:

• you have kidney problems, especially kidney stones, or are undergoing dialysis
• you have a history of blood or body fluid disorders (metabolic acidosis)
• you have liver problems
• you have eye problems, especially glaucoma
• you have growth problems
• you are on a high-fat diet (ketogenic diet)
• you are a woman who could become pregnant. Topiramate cinfa may harm an unborn baby if taken during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of topiramate cinfa. See section “Pregnancy and breastfeeding” for more information.
• you are pregnant. Topiramate cinfa may harm an unborn baby if taken during pregnancy.

If you are unsure whether any of the above applies to you, consult your doctor before using topiramate cinfa.

If you have epilepsy, it is important not to stop taking your medication without first consulting your doctor.

You should consult your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to topiramate cinfa.

You may lose weight while taking topiramate, 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, you should consult your doctor.

A small number of people treated with antiepileptic medicines such as topiramate have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately.

Topiramate may rarely cause high levels of ammonia in the blood (seen in blood tests), which may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a serious condition, speak to your doctor immediately if you experience any of the following symptoms (also see section 4 “Possible side effects”):

• difficulty thinking, remembering information, or solving problems
• reduced alertness or consciousness
• feeling drowsy with low energy

The risk of developing these symptoms may increase at higher doses of topiramate.

Taking topiramate cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Topiramate and certain medicines may interact with each other. Sometimes, the dose of one or both medicines may need to be adjusted.

In particular, inform your doctor or pharmacist if you are taking:

• other medicines that impair or reduce your thinking, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramate cinfa may reduce the effectiveness of hormonal contraceptives. An additional barrier contraceptive method such as a condom or diaphragm should be used. Discuss with your doctor the best contraceptive method to use while taking topiramate cinfa.

Tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and topiramate cinfa. Irregular bleeding may occur. 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 any new medicine.

Other medicines you should discuss with your doctor or pharmacist 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 to treat depression), and warfarin (used to prevent blood clotting).

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking topiramate.

Taking topiramate cinfa with food and drinks

You may take topiramate with or without food. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking topiramate. You should avoid drinking alcohol while taking topiramate.

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topiramate cinfa may harm an unborn baby. If you are a woman of childbearing potential, talk to your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year.

Migraine prevention:

• In case of migraine, you must not take topiramate cinfa if you are pregnant.
• In case of migraine, you must not use topiramate cinfa if you are a woman of childbearing potential unless you are using a highly effective method of contraception.
• Before starting treatment with topiramate cinfa, a pregnancy test must be performed in women of childbearing potential.

Epilepsy treatment:

• In case of epilepsy, you must not take topiramate cinfa if you are pregnant, unless no other treatment provides sufficient seizure control.
• In case of epilepsy, you must not use topiramate cinfa if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if topiramate cinfa is the only treatment providing sufficient seizure control and you plan to become pregnant. You must consult your doctor to ensure you have received information about the risks of taking topiramate cinfa during pregnancy and the risks of seizures during pregnancy, which may put you or your unborn baby at risk.
• Before starting treatment with topiramate cinfa, a pregnancy test must be performed in women of childbearing potential.

Risks of taking topiramate during pregnancy (regardless of the condition for which topiramate is used):

There is a risk of harm to the unborn baby if topiramate cinfa is used during pregnancy.

• If you take topiramate cinfa during pregnancy, your baby has a higher chance of having congenital malformations. In women taking topiramate, about 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1 to 3 out of every 100 babies born to women who do not have epilepsy and are not taking antiepileptic medicines. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Newborn boys may also have a penile malformation (hypospadias). These defects may develop early in pregnancy, even before you know you are pregnant.

• If you take topiramate cinfa during pregnancy, your baby may have a 2 to 3 times higher risk of developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to babies born to women with epilepsy who are not taking antiepileptic medicines.

• If you take topiramate cinfa during pregnancy, your baby may be smaller and weigh less than expected at birth. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, compared with 5% of babies born to mothers without epilepsy who were not taking antiepileptic medicines.

• Consult your doctor if you have questions about these pregnancy risks.

• There may be other medicines available to treat your condition with a lower risk of congenital malformations.

Need for contraception in women of childbearing potential:

• If you are a woman of childbearing potential, consult your doctor about other possible treatments instead of taking topiramate cinfa. If the decision is made to use topiramate cinfa, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of topiramate cinfa.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods (such as a contraceptive pill together with a barrier method such as a condom or diaphragm) should be used. Discuss with your doctor which contraceptive methods are most appropriate for you.
• If you are taking hormonal contraceptives, there is a possibility of reduced effectiveness due to topiramate. Therefore, an additional barrier contraceptive (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of topiramate cinfa in girls:

If you are the parent, guardian, or caregiver of a girl being treated with topiramate cinfa, you should consult your doctor immediately once your daughter has her first menstrual period (menarche). The doctor will inform you about the risks to an unborn baby due to exposure to topiramate during pregnancy and the need to use highly effective contraceptive methods.

If you plan to become pregnant while taking topiramate cinfa:

• Schedule an appointment with your doctor.
• Do not stop using your contraceptive method until you have discussed this with your doctor.
• If you take topiramate cinfa for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition could worsen.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you on the risks of topiramate cinfa during pregnancy and may refer you to another specialist.

If you become pregnant or think you might be pregnant while taking topiramate cinfa:

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate cinfa to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking topiramate cinfa for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition could worsen. Worsening epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you on the risks of topiramate cinfa during pregnancy and may refer you to another specialist.
• If topiramate cinfa is used during pregnancy, you will be monitored closely to check your baby’s development.

Make sure to read the patient leaflet you will receive from your doctor.

A patient card is provided with the packaging of topiramate cinfa to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient in topiramate cinfa (topiramate) passes into breast milk. Effects have been observed in breastfed infants of treated mothers, including diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether you should stop breastfeeding or discontinue treatment with topiramate. Your doctor will consider the importance of the benefits for the mother and the risks for the infant. Breastfeeding mothers taking topiramate should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Driving and using machines

Topiramate may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying disease itself, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.

topiramate cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

3. How to take topiramate cinfa

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Your doctor will usually start you on a low dose of topiramate and slowly increase your dose until the best dose for you is found.
• Topiramate tablets should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
• You may take topiramate before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking topiramate.

Girls and women of childbearing potential:

Treatment with topiramate cinfa should be initiated and continued under the supervision of a physician experienced in the treatment of epilepsy or migraine. Visit your doctor to review your treatment at least once a year.

If you take more topiramate cinfa than you should

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

You may experience an overdose if you are taking another medicine together with topiramate.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take topiramate cinfa

• 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 with your regular schedule. Consult your doctor if you miss two or more doses.
• Do not take a double dose to make up for forgotten doses.

If you stop taking topiramate cinfa

Do not stop treatment unless your doctor tells you to. Symptoms of your condition may return. If your doctor decides you should stop taking this medicine, your dose will be gradually reduced over several days.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Consult your doctor or seek immediate medical attention if you experience any of the following adverse effects:

Very common (may affect more than 1 in 10 people)

• Depression (new or worsened)

Common (may affect up to 1 in 10 people)

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Difficulty concentrating, slowed thinking, memory loss, memory problems (initial, 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 (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
• Decreased or absent sweating (especially in young children exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious injury to oneself
• 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, reduced alertness or consciousness, feeling of lethargy with low energy – these symptoms may be signs of high levels of ammonia in the blood (hyperammonemia), which may lead to changes in brain function (hyperammonaemic encephalopathy)

Frequency not known (cannot be estimated from available data)

• Inflammation of the eyes (uveitis) with symptoms such as redness and eye pain, light sensitivity, tearing, seeing small spots or blurred vision

Other adverse effects include the following. If they are severe, please consult your doctor or pharmacist:

Very common (may affect more than 1 in 10 people)

• Nasal congestion, runny nose or 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)

• Anaemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behaviour
• Difficulty falling or staying asleep
• Speech problems or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine tasks
• Decreased, lost or absent sense of taste
• Tremors or involuntary shaking; rapid, uncontrollable eye movements
• Vision 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
• Nosebleeds
• Fever, general malaise, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle spasms or twitches, muscle pain or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells (which help protect against infections), decreased blood potassium levels
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of neck, armpit or groin lymph nodes
• Increased appetite
• Elevated mood
• Hearing, seeing or feeling things that are not there, severe mental disorder (psychosis)
• Lack of emotional expression and/or feeling, unusual distrust, panic attack
• Reading difficulties, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slowed thinking, reduced level of wakefulness or alertness
• Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch; altered touch sensation
• Impaired, distorted or absent sense of smell
• Unusual feeling or sensation that may precede a migraine or certain types of seizures
• Dry eyes, light sensitivity, eyelid twitching, watery eyes
• Hearing loss, decreased hearing, hearing loss in one ear
• Slow or irregular heartbeat, awareness of heartbeat in the chest
• Decreased blood pressure, drop in blood pressure upon standing (as a result, some people taking topiramate may faint, feel dizzy or lose consciousness when standing up or sitting down suddenly)
• Flushing or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excess gas or flatulence, stomach acidity, feeling full or bloated
• Bleeding gums, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in urine, urinary incontinence (lack of control), urgency to urinate, side or kidney pain
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• 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 eyes and around the eyes
• Numbness, tingling and colour change (white, then blue, followed by red) in fingers and toes when exposed to cold (Raynaud's phenomenon)
• Liver inflammation, liver failure
• Stevens-Johnson syndrome, a potentially life-threatening condition that may present with ulcers in various mucosal areas (such as mouth, nose and eyes), skin rash and blisters
• Unusual odour of the skin
• Discomfort in arms and legs
• Kidney impairment

Frequency not known (cannot be estimated from available data)

• Maculopathy is a disease of the macula, a small area in the retina where vision is sharpest. Consult your doctor if you notice a change or decrease in your vision.
• Toxic epidermal necrolysis, a life-threatening condition, even more severe than Stevens-Johnson syndrome, characterized by widespread blistering and shedding of the outer layers of the skin (see rare adverse effects).

Other adverse effects in children

In general, adverse effects observed in children are similar to those seen in adults, but the following adverse effects may be more common in children than in adults:

• Difficulty concentrating
• Increased level of acid in the blood
• Thoughts of self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling or staying asleep
• Feeling of unsteadiness when walking
• General malaise
• Decreased blood potassium levels
• Lack of emotional expression and/or feeling
• Watery eyes
• Slow or irregular heartbeat

Other adverse effects that may occur in children include:

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 cell) in blood
• Hyperactivity
• Feeling hot
• Learning difficulties

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of topiramate cinfa

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of topiramate cinfa

• The active substance is topiramate.

Each topiramate cinfa film-coated tablet contains 50 mg of topiramate.

• The other components are:

Tablet core: mannitol, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.
Coating layer: Opadry II Yellow 85G32312 (polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol, soybean lecithin (E-322), and yellow iron oxide (E-172)).

Appearance of the product and contents of the pack

Light yellow, cylindrical, film-coated, biconvex tablets with the code "V3" on one side.

Presented in aluminum/aluminum blisters or in HDPE bottles with LDPE caps.

Each container contains 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Manufacturer:

BALKANPHARMA DUPNITSA AD
3 Samokovsko Shosse Str., Dupnitsa 2600 – Bulgaria

or

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: January 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69136/P_69136.html

QR code to: https://cima.aemps.es/cima/dochtml/p/69136/P_69136.html

The most recently approved information on the Patient Guide for this medicine is available by scanning the following QR code with a smartphone. The same information is also available on the following website (3252 (aemps.es)):

QR code to: 3252 (aemps.es)