Topiramate Pensapharma 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Topiramate Pensa Pharma 200 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you consider any of the adverse reactions you experience to be severe, or if you notice any adverse reaction not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Topiramato Pensa Pharma is and what it is used for

Topiramato Pensa Pharma belongs to a group of medicines called "antiepileptic drugs". It is used for:

• treating seizures in adults and children over 6 years of age when given as monotherapy
• treating seizures in adults and children aged 2 years and older when given in combination with other medicines
• preventing migraine in adults.

2. What you need to know before starting to take Topiramato Pensa Pharma

Do not take Topiramato Pensa Pharma

• If you are allergic (hypersensitive) to topiramate or to any of the other components of this medicine (listed in section 6).

• For migraine prevention:

  • Do not take Topiramato Pensa Pharma if you are pregnant.
  • If you are a woman of childbearing potential, do not take Topiramato Pensa Pharma unless you are using a highly effective method of contraception during treatment. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

• Epilepsy treatment:

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

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

A patient card is provided with the packaging of Topiramato Pensa Pharma 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 Topiramato Pensa Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Topiramato Pensa Pharma if you:

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

If you are unsure whether the above applies to you, consult your doctor or pharmacist before using Topiramato Pensa Pharma.

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

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 Topiramato Pensa Pharma.

You may lose weight while taking Topiramato Pensa Pharma, 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, consult your doctor.

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

Topiramato Pensa Pharma 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. As 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 level of alertness or consciousness
• feeling drowsy with low energy

The risk of developing these symptoms may increase at higher doses of Topiramato Pensa Pharma.

Other medicines and Topiramato Pensa Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Topiramato Pensa Pharma and certain medicines may interact with each other. Sometimes, the dose of one of the other medicines or of Topiramato Pensa Pharma 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. Topiramato Pensa Pharma may reduce the effectiveness of hormonal contraceptives. An additional barrier method of contraception such as a condom or diaphragm should be used. Consult your doctor about the most appropriate contraceptive method to use while taking Topiramato Pensa Pharma.

Tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and Topiramato Pensa Pharma. 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, 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 applies to you, consult your doctor or pharmacist before taking Topiramato Pensa Pharma.

Taking Topiramato Pensa Pharma with food and drink

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

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topiramato Pensa Pharma may harm a baby during pregnancy. If you are a woman of childbearing potential, consult your doctor about other possible treatments. Visit your doctor to review your treatment and discuss risks at least once a year.

Migraine prevention:

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

Epilepsy treatment:

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

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

There is a risk of harm to the baby if Topiramato Pensa Pharma is used during pregnancy.

• If you take Topiramato Pensa Pharma during pregnancy, your child has a higher chance of being born with birth defects. In women taking topiramate, about 4 to 9 out of every 100 babies will have birth defects. This compares with 1–3 out of every 100 babies born to women who do not have epilepsy and are not taking an antiepileptic medicine. 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 malformation of the penis (hypospadias). These defects may develop early in pregnancy, even before you know you are pregnant.
• If you take Topiramato Pensa Pharma during pregnancy, your child may have a 2 to 3 times higher risk of developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking an antiepileptic medicine.
• If you take Topiramato Pensa Pharma during pregnancy, your child 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 an antiepileptic medicine.
• Consult your doctor if you have questions about these risks during pregnancy.
• There may be other medicines available to treat your condition with a lower risk of birth defects.

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 Topiramato Pensa Pharma. If the decision is made to use Topiramato Pensa Pharma, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramato Pensa Pharma.
• A highly effective method of contraception (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. Consult your doctor about the most appropriate contraceptive methods for you.
• If you are taking hormonal contraceptives, there is a possibility of reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, an additional barrier method of contraception (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Pensa Pharma in girls:

If you are the parent or caregiver of a girl being treated with Topiramato Pensa Pharma, 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 the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topiramato Pensa Pharma:

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

If you become pregnant or think you may be pregnant while taking Topiramato Pensa Pharma:

• Schedule an urgent appointment with your doctor.
• If you are taking Topiramato Pensa Pharma for migraine prevention, stop taking the medicine immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking Topiramato Pensa Pharma for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition may 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 about the risks of Topiramato Pensa Pharma during pregnancy. The doctor may also refer you to another specialist.
• If Topiramato Pensa Pharma is used during pregnancy, you will be monitored closely to check your baby’s development during pregnancy.

Make sure to read the patient guide you will receive from your doctor. A patient card is provided with the packaging of Topiramato Pensa Pharma to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active substance in Topiramato Pensa Pharma (topiramate) passes into breast milk. Effects have been observed in infants breastfed by treated mothers, including diarrhea, sleepiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether you should stop breastfeeding or discontinue treatment with Topiramato Pensa Pharma. Your doctor will consider the benefits of treatment for the mother and the potential risks for the infant.

Breastfeeding mothers taking Topiramato Pensa Pharma should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Driving and using machines

Dizziness, fatigue, and visual disturbances may occur during treatment with Topiramato Pensa Pharma. Do not drive or operate tools or machinery without first talking to your doctor.

Topiramato Pensa Pharma contains soya lecithin

Topiramato Pensa Pharma contains lecithin derived from soya oil. It should not be used if you are allergic to peanuts or soya.

3. How to take Topiramato Pensa Pharma

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

• Your doctor will usually start with a low dose of Topiramato Pensa Pharma and slowly increase your dose until the best dose for you is found.

• Topiramato Pensa Pharma tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

• You may take Topiramato Pensa Pharma before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topiramato Pensa Pharma.

Girls and women of childbearing potential:

Treatment with Topiramato Pensa Pharma 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 Topiramato Pensa Pharma than you should:

Contact your doctor immediately. Take the medicine with you.

You may feel drowsy, tired, or less alert, have lack of coordination, difficulty speaking or concentrating; blurred or double vision; feel dizzy due to a drop in blood pressure; feel depressed or restless; or have abdominal pain or seizures (attacks).

You may experience an overdose if you are taking another medicine together with Topiramato Pensa Pharma.

In case of overdose or accidental ingestion, you may also contact the Toxicology Information Service, Telephone: 91 562 04 20.

If you forget to take Topiramato Pensa Pharma

• 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 as usual. Consult your doctor if you forget two or more doses.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Topiramato Pensa Pharma

Do not stop treatment without being told to do so by your doctor. Symptoms of your condition may return. If your doctor decides that 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Topiramate Pensa Pharma can have adverse effects, although not everyone experiences 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 (sudden onset, sudden change, or increased severity)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased levels 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)
• 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 vision loss
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling drowsy 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 (hyperammonemic encephalopathy).

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 behavior
• Difficulty falling or staying asleep
• Problems with speech or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary shaking; rapid, uncontrollable eye movements
• Vision disturbances, such as double vision, blurred vision, decreased 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 that help protect against infections, decreased blood potassium levels
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of lymph nodes in the neck, armpit, or groin
• Increased appetite
• Euphoric 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, decreased 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, sensitivity of the eyes to light, eyelid twitching, watery eyes
• Hearing loss, decreased hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling your heart beating in your chest
• Decreased blood pressure, drop in blood pressure upon standing (as a result, some people may faint, feel dizzy, or lose consciousness when standing up or sitting up suddenly)
• Flushing or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excess gas or flatulence, stomach acid, feeling full or bloated
• Bleeding gums, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (lack of control) when urinating, 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 (amblyopia)
• Swelling of the eyes and around the eyes
• Numbness, tingling, and color changes (white, blue then 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 mucosal areas (such as mouth, nose, and eyes), skin rash, and blisters
• Abnormal skin odor
• Discomfort in arms and legs
• Kidney impairment

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.
• Inflammation of the eyes (uveitis) with symptoms such as redness and eye pain, light sensitivity, tearing, seeing small floating spots, or blurred 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 observed in adults, but the following adverse effects may be more common in children than in adults:

• Difficulty concentrating
• Increased levels of acid in the blood
• Thoughts of self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty falling or staying asleep
• Feeling unsteady 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, pharmacist, or nurse, 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 Pensa Pharma

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

No special storage conditions are required.

Store in the original outer packaging to protect it from moisture.

Do not use Topiramate Pensa Pharma after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Topiramato Pensa Pharma

The active substance is topiramate.

Each film-coated tablet of Topiramato Pensa Pharma contains 200 mg of topiramate.

The other components of Topiramato Pensa Pharma are listed below: mannitol, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, purified water. Coating layer: polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, soya lecithin (E-322) and red iron oxide (E-172).

Appearance of Topiramato Pensa Pharma and contents of the pack

Topiramato Pensa Pharma 200 mg is presented as salmon-coloured, oval, film-coated tablets.

It is available in packs containing 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of latest revision of this package leaflet: April 2024

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

Other sources of information

The most recently approved patient guide information for this medicinal product is available by scanning the following QR code with a smartphone. The same information is also available at the following web address (URL): https://cima.aemps.es/cima/DocsPub/16/3252

[Include QR code]