Topiramate Tecnigen 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Topiramate Tecnigen 100 mg film-coated tablets EFG

Topiramate

This medicine is subject to additional monitoring, which will allow rapid identification 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.

• 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the adverse reactions you experience to be serious, or if you notice any adverse reaction not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Topiramate Tecnigen is and what it is used for
2. Before you take Topiramate Tecnigen
3. How to take Topiramate Tecnigen
4. Possible side effects
5. How to store Topiramate Tecnigen
6. Further information

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

Topiramato Tecnigen belongs to a group of medicines called "antiepileptic medicines". It is used to:

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

2. Before taking Topiramato Tecnigen

Do not take Topiramato Tecnigen

• if you are allergic (hypersensitive) to topiramate or to any of the other components of Topiramato Tecnigen (listed in section 6).

Migraine prevention

• You must not take Topiramato Tecnigen if you are pregnant.
• If you are a woman of childbearing potential, you must not take Topiramato Tecnigen 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

• You must not use Topiramato Tecnigen if you are pregnant, unless no other treatment provides sufficient seizure control.
• If you are a woman of childbearing potential, you must not take Topiramato Tecnigen unless you are using a highly effective method of contraception during treatment. The only exception is if Topiramato Tecnigen 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 Topiramato Tecnigen 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 Tecnigen 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 Tecnigen.

Warnings and precautions

Before starting treatment with Topiramato Tecnigen, consult your doctor or pharmacist 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. Topiramato Tecnigen may harm a baby during pregnancy when taken during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramato Tecnigen. See section “Pregnancy and breastfeeding” for more information.
• you are pregnant. Topiramato Tecnigen may harm a baby during pregnancy when taken during pregnancy.

If you are unsure whether the above applies to you, consult your doctor before using Topiramato Tecnigen.

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

It is important that you do not stop taking your medication without first consulting your doctor.

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

You may lose weight while taking Topiramato Tecnigen, 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 being treated with antiepileptic medicines such as Topiramato Tecnigen have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, vitamins, or herbal remedies. Topiramato Tecnigen and certain medicines may affect each other. Sometimes, the dose of one or more of the medicines may need to be adjusted, including Topiramato Tecnigen.

Especially 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 Tecnigen may reduce the effectiveness of hormonal contraceptives. An additional barrier contraceptive method such as a condom or diaphragm should be used. Consult your doctor about the most appropriate contraceptive method to use while taking Topiramato Tecnigen.

Tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and Topiramato Tecnigen. Irregular bleeding may occur. In this case, continue taking the hormonal contraceptives and inform your doctor.

Keep a list of all the medicines you are taking. Show this list to your doctor and pharmacist before using Topiramato Tecnigen.

Other medicines about which you should consult your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.

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

Taking Topiramato Tecnigen with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

Important advice for women of childbearing potential:

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

Epilepsy treatment

• In case of epilepsy, you must not take Topiramato Tecnigen if you are pregnant, unless no other treatment provides sufficient seizure control.
• In case of epilepsy, you must not use Topiramato Tecnigen if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if Topiramato Tecnigen 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 Topiramato Tecnigen during pregnancy and the risks of seizures during pregnancy, which could put you or your baby at risk.
• Before starting treatment with Topiramato Tecnigen, 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 Topiramato Tecnigen is used during pregnancy.

• If you take Topiramato Tecnigen during pregnancy, your child will have a higher risk of congenital malformations. In women taking topiramate, approximately 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1–3 out of every 100 babies born to women without epilepsy who are not taking antiepileptic treatment. 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 Topiramato Tecnigen 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 antiepileptic medicines.

If you take Topiramato Tecnigen 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 to 5% of babies born to mothers without epilepsy who were not taking antiepileptic medicines.

• 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 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 Topiramato Tecnigen. If the decision is made to use Topiramato Tecnigen, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramato Tecnigen.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods (such as an oral 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 contraceptive method (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Tecnigen in girls:

If you are the parent or caregiver of a girl being treated with Topiramato Tecnigen, you must consult your doctor immediately once your daughter experiences 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 wish to become pregnant while taking Topiramato Tecnigen:

• 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 Tecnigen 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 about the risks of Topiramato Tecnigen during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.

• If you are taking Topiramato Tecnigen to prevent migraines, stop taking the medicine immediately and consult your doctor to assess whether you need an alternative treatment.

• If you are taking Topiramato Tecnigen for epilepsy, do not stop taking this medicine 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 about the risks of Topiramato Tecnigen during pregnancy. The doctor may also refer you to another specialist.

• If Topiramato Tecnigen is used during pregnancy, you will be closely monitored 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 Tecnigen to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient in Topiramato Tecnigen (topiramate) passes into breast milk. Effects have been observed in infants breastfed by treated mothers, including diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether to discontinue breastfeeding or to discontinue treatment with Topiramato Tecnigen. Your doctor will consider the importance of the benefits for the mother and the risk for the infant.

Breastfeeding mothers taking Topiramato Tecnigen should inform their doctor as soon as possible if the baby experiences anything unusual.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Dizziness, fatigue, and vision disturbances may occur during treatment with Topiramato Tecnigen. Do not drive or operate tools or machinery without first consulting your doctor.

Important information about some of the components of Topiramato Tecnigen

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Topiramate Tecnigen

Follow exactly the instructions for the administration of Topiramate Tecnigen given by your doctor. If in doubt, consult your doctor or pharmacist.

Girls and women of childbearing potential:

Treatment with Topiramate Tecnigen should be initiated and maintained 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.

Take Topiramate Tecnigen exactly as prescribed for you. Your doctor will usually start with a low dose of Topiramate Tecnigen and slowly increase your dose until the optimal dose for you is reached.

Topiramate Tecnigen tablets should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.

You may take Topiramate Tecnigen before, during, or after meals. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topiramate Tecnigen.

If you take more Topiramate Tecnigen than you should:

Contact your doctor immediately. Take the medicine with you.

You may feel drowsy or tired, experience abnormal body movements, difficulty standing or walking, feel dizzy due to a drop in blood pressure, or have irregular heartbeats or seizures.

Overdose may occur if you are taking another medicine together with Topiramate Tecnigen.

In case of overdose or accidental ingestion, you may also contact the Toxicology Information Service at telephone number 91 5620420.

If you forget to take Topiramate Tecnigen

• 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 (two doses at the same time) to make up for a missed dose.

If you stop taking Topiramate Tecnigen

Do not stop treatment unless your doctor tells you to. Your symptoms 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 Tecnigen may cause adverse effects, although not everyone experiences them.

The frequency of the possible adverse effects listed below is defined using the following convention:

• very common (affects more than 1 in 10 people)
• common (affects between 1 and 10 in 100 people)
• uncommon (affects between 1 and 10 in 1,000 people)
• rare (affects between 1 and 10 in 10,000 people)
• very rare (affects fewer than 1 in 10,000 people)
• unknown (frequency cannot be estimated from available data)

Very common adverse effects include:

• Weight loss
• Tingling in arms and legs
• Drowsiness or numbness
• Dizziness
• Diarrhea
• Nausea
• Nasal congestion, runny nose, and sore throat
• Fatigue
• Depression

Common adverse effects include:

• Mood or behavioral changes, including anger, nervousness, sadness
• Weight gain
• Decreased or loss of appetite
• Decreased number of red blood cells
• Changes in thinking or alertness, including confusion, difficulty concentrating, memory problems, or slowed thinking
• Poor speech articulation
• Clumsiness or difficulty walking
• Involuntary shaking of arms, hands, or legs
• Reduced sense of touch or sensation
• Involuntary eye movements
• Taste disturbances
• Visual disturbances, blurred vision, double vision
• Ringing in the ears
• Ear pain
• Shortness of breath
• Nosebleeds
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Redness and/or itching of the skin
• Joint pain
• Muscle spasms, muscle twitches, or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of malaise
• Allergic reaction

Uncommon adverse effects include:

• Presence of crystals in urine
• Abnormal blood count, including reduced number of white blood cells or platelets, or increased eosinophils
• Irregular heartbeat or slowed heart rate
• Swelling of lymph nodes in the neck, armpit, or groin
• Increased seizures
• Verbal communication problems
• Drooling
• Restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slowed or reduced movements
• Disturbed or poor-quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting
• Sensation of movement under the skin
• Eye problems including dry eyes, light sensitivity, involuntary eye twitching, and decreased vision
• Decreased or loss of hearing
• Hoarseness
• Pancreatitis (inflammation of the pancreas)
• Gas
• Stomach acidity
• Loss of touch sensitivity in the mouth
• Bleeding gums
• Feeling of fullness or bloating
• Painful or burning sensation in the mouth
• Bad breath
• Urinary and/or fecal incontinence
• Urgent need to urinate
• Pain in the kidney and/or bladder area due to kidney stones
• Decreased or absent sweating
• Skin discoloration
• Localized skin swelling
• Facial swelling
• Joint swelling
• Musculoskeletal stiffness
• Increased blood acidity (metabolic acidosis)
• Low potassium levels in the blood
• Increased appetite
• Increased thirst and excessive fluid intake
• Low blood pressure or drop in blood pressure upon standing
• Hot flushes
• Flu-like syndrome
• Cold extremities (e.g., hands and feet)
• Learning difficulties
• Sexual function disturbances (erectile dysfunction, loss of libido)
• Hallucinations
• Reduced verbal communication

Rare adverse effects include:

• Excessive skin sensitivity
• Loss of smell (anosmia)
• Glaucoma, which is a blockage of fluid in the eye causing increased eye pressure, pain, and vision loss
• Renal tubular acidosis
• Serious skin reactions, including Stevens-Johnson syndrome, a severe skin disease in which the upper layers of skin separate from the lower layers; and erythema multiforme, a condition characterized by raised red spots that may blister
• Unusual body odor
• Swelling of tissues around the eyes
• Raynaud's syndrome: a disorder affecting blood vessels in the fingers, toes, and ears, causing pain and cold sensitivity
• Tissue calcification (calcinosis)

Adverse effects of unknown frequency:

• Maculopathy, a disease of the macula—a small area in the retina where vision is sharpest. Consult your doctor if you notice any change or decrease in your vision.
• Swelling of the eye conjunctiva.
• Toxic epidermal necrolysis, a more severe form of Stevens-Johnson syndrome (see uncommon adverse effects).
• Inflammation of the eye (uveitis), with symptoms such as eye redness and pain, light sensitivity, tearing, seeing small floating spots, or blurred vision.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Topiramate Tecnigen

Keep out of the reach and sight of children.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at 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. Additional Information

Composition of Topiramate Tecnigen

The active substance is topiramate.

Each film-coated tablet of Topiramate Tecnigen contains 100 mg of topiramate.

The other components of Topiramate Tecnigen are listed below:
Core: Lactose monohydrate, pregelatinized corn starch, sodium carboxymethylstarch from potato, microcrystalline cellulose, magnesium stearate.
Coating layer: Eudragit EPO, sodium lauryl sulfate, stearic acid, magnesium stearate, talc, titanium dioxide (E 171), and yellow iron oxide (E 172).

Appearance of Topiramate Tecnigen and contents of the pack

Topiramate Tecnigen 100 mg is presented in packs containing 60 film-coated tablets. The film-coated tablets are round, convex, and yellow in colour.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACÉUTICA, S.A.
Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas, Spain

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

or

Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5, Condeixa-a-Nova, 3150-194 Sebal, Portugal

This leaflet has been revised in January 2024

Other sources of information: The most recently approved information for this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es