Leaflet: information for the user

Acomicil 200 mg film-coated tablets EFG

topiramate

? This medicine is subject to additional monitoring, which will speed up 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 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 should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Acomicil belongs to a group of medications called “antiepileptic medications”. It is used for:

• treatment of seizures in adults and children over 6 years old when administered alone
• treatment of seizures in adults and children 2 years old or more when administered with other medications
• prevention of migraine in adults

Do not take Acomicil

• if you are allergic to topiramate or any of the other ingredients in this medicine (listed in section 6).
• Acomicil contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

Prevention of migraines

• Do not take Acomicil if you are pregnant.

• If you are a fertile woman, do not take Acomicil unless you are using a highly effective contraceptive method during your treatment. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Treatment of epilepsy

• Do not use Acomicil if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, do not take Acomicil unless you are using a highly effective contraceptive method during your treatment. The only exception is if Acomicil is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking Acomicil during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Make sure to read the patient leaflet that your doctor will give you.

A patient leaflet is provided with the packaging of Acomicil to remind you of the risks during pregnancy.

If you are unsure if anything above applies to you, consult your doctor or pharmacist before usingAcomicil.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acomicil if you:

• have kidney problems, especially kidney stones, or are receiving dialysis

• have a history of blood or fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• are following a high-fat diet (ketogenic diet)
• are a woman who may become pregnant. Acomicil may cause harm to a baby during pregnancy when taken during pregnancy. Highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Acomicil. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Acomicil may cause harm to a baby during pregnancy when taken during pregnancy.

If you are unsure if anything above applies to your case, consult your doctor or pharmacist before usingAcomicil.

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

You must consult your doctor before taking any other medicine containing topiramate that is given as an alternative to Acomicil.

You may lose weight if you take Acomicil, 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 being treated with antiepileptic medicines like Acomicil have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.

Acomicil 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”).

Acomicil 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”):

-difficulty thinking, remembering information or solving problems

-decreased alertness or consciousness

-feeling drowsy with low energy

You may increase the risk of developing these symptoms at higher doses of Acomicil.

Other medicines and Acomicil

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine. Acomicil 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:

• other medicines that impair or reduce your thoughts, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).

hormonal contraceptives. Acomicil may make hormonal contraceptives less effective. You should use an additional barrier method such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking Acomicil.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and Acomicil. You may experience irregular 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 to treat depression) and warfarin used to prevent blood clotting.

If you are unsure if anything above applies to you, consult your doctor or pharmacist before taking Acomicil.

TakingAcomicilwith food, drinks and alcohol

You can takeAcomicilwith or without food. Drink plenty of fluids during the day to prevent kidney stone formation while takingAcomicil.You should avoid drinking alcohol while takingAcomicil.

Pregnancy, breastfeeding and fertility

Pregnancy

Important advice for fertile women:

Acomicil 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:

• Do not take Acomicil if you are pregnant.

• Do not use Acomicil if you are a fertile woman, unless you are using a highly effective contraceptive method.

• Before starting treatment with Acomicil, a pregnancy test should be performed in a fertile woman.

Treatment of epilepsy:

• Do not take Acomicil if you are pregnant, unless no other treatment offers sufficient control of seizures.

• Do not use Acomicil if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if Acomicil is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking Acomicil during pregnancy and about the risks of seizures during pregnancy, which may put you or your baby during pregnancy at risk.

• Before starting treatment with Acomicil, a pregnancy test should be performed in a fertile woman.

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 Acomicil is used during pregnancy.

• If you take Acomicil during pregnancy, your child may have a higher chance of having birth defects. In women taking topiramate, around 4 to 9 out of 100 children will have birth defects. This compares with 1-3 out of 100 children born to women with epilepsy who are not taking an antiepileptic medicine. In particular, a cleft lip (a division in the upper lip) and a cleft palate (a division in the palate) have been observed. Newborn boys may also have a genital malformation (hypospadias). These defects may develop in the early stages of pregnancy, even before you know you are pregnant.

• If you take Acomicil during pregnancy, your child may have a 2-3 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 Acomicil during pregnancy, your child may be smaller and weigh less than expected at birth. In a study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while 5% of children born to mothers without epilepsy who were not taking an antiepileptic medicine were smaller and weighed less than expected at birth.

• Consult your doctor if you have questions about this risk during pregnancy.

• There may be other medicines to treat your condition with a lower risk of birth defects.

Need for contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking Acomicil. If you decide to use Acomicil, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Acomicil.

• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods (such as a hormonal contraceptive pill together with a barrier method (such as a condom or diaphragm)) should be used. Consult your doctor about the most suitable contraceptive methods for you.

• If you are taking hormonal contraceptives, there may be a reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, an additional barrier method (such as a condom or diaphragm) should be used.

• Inform your doctor if you experience irregular menstrual bleeding.

Use of Acomicil in girls:

If you are the parent/caregiver of a girl treated with Acomicil, 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 Acomicil:

• 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 Acomicil for epilepsy, do not stop taking it until you have consulted with your doctor, as your condition may worsen.

• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Acomicil during pregnancy. The doctor may also refer you to another specialist.

If you have become pregnant or think you may be pregnant while taking Acomicil:

• Schedule an urgent appointment with your doctor.

• If you are taking Acomicil for migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need an alternative treatment.

• If you are taking Acomicil for epilepsy, do not stop taking it until you have consulted with your doctor, as your condition may worsen. A worsening of your epilepsy may put you or your baby during pregnancy at risk.

• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Acomicil during pregnancy.

• If Acomicil is used during pregnancy, you will be closely monitored to check how your baby is developing during pregnancy.

Make sure to read the patient leaflet that your doctor will give you. A patient leaflet is provided with the packaging of Acomicil to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient in Acomicil (topiramate) passes into breast milk. Severe effects have been observed in breastfed babies of mothers treated with Acomicil, including diarrhea, drowsiness, irritability, and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or whether to stop taking Acomicil. 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 takingAcomicilshould inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and operating machinery

You may experience dizziness, fatigue, and visual disturbances during treatment with Acomicil. Do not drive or operate tools or machinery without talking to your doctor first..

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

• Your doctor will usually start with a low dose of Acomicil and gradually increase your dose to find the best one for you.
• Acomicil tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take Acomicil before, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while taking Acomicil.

Girls and fertile women:

Treatment with Acomicil 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 Acomicil than you should

Consult your doctor immediately. Bring the medication with you.

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

You may experience an overdose if you are taking another medication with Acomicil.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Acomicil

• If you forgot to take a dose, take it as soon as you remember. However, if it is almost time to take your next dose, skip the missed dose and continue as usual. Consult your doctor if you miss two or more doses.
• Do not take a double dose (two doses at the same time) to compensate for the missed dose.

If you interrupt treatment with Acomicil

Do not stop treatment without your doctor's permission. Your symptoms may return. 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 medicines, this medicine 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)

• Depression (new or worsened)

Common (may affect up to 1 in 10 people)

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Difficulty concentrating, slow thinking, memory loss, problems with memory (initial, sudden change or worsening)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased blood acidity (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Decreased or loss of sweating (especially in small children exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious injuries
• Loss of part of the visual field

Rare (may affect up to 1 in 1,000 people)

• Glaucoma (blockage of fluid in the eye that causes increased eye pressure, pain, or decreased vision)
• Difficulty thinking, remembering information, or solving problems, decreased state of alertness or consciousness, feeling of numbness with low energy – these symptoms may be a sign of high levels of ammonia in the blood (hyperammonemia), which can cause a change in brain function (encephalopathy)
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin eruptions with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin eruptions can become generalized skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

Unknown (cannot be estimated from available data):

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

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

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

• Congestion, runny nose, or sore throat
• Tickling, pain, and/or numbness in several parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, swelling of the face, urticaria)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty falling or staying asleep
• Speech or language disorders, poor pronunciation when speaking
• Ataxia or lack of coordination, feeling of instability when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary movements; rapid, uncontrollable eye movements
• Visual 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 feeling of illness, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or inflammation, 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 prevent bleeding), decreased white blood cells (which help protect against infections), decreased potassium levels in the blood
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood
• Swelling of the lymph nodes in the neck, armpits, or groin
• Increased appetite
• Exalted mood
• Seeing, hearing, or feeling things that are not there, severe mental disorder (psychosis)
• Not showing or feeling emotions, unusual distrust, panic attack
• Difficulty reading, speech disorders, difficulty writing by hand
• Restlessness, hyperactivity
• Slow thinking, decreased state of alertness or consciousness
• Abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch, altered touch
• Altered, distorted, or absent sense of smell
• Unusual sensation that may precede a migraine or certain type of seizure
• Dry eyes, sensitivity to light, eyelid tremor, watery eyes
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling the heart beating in the chest
• Decreased blood pressure, decreased blood pressure when standing (consequently, some people may faint, feel dizzy, or lose consciousness when standing or sitting suddenly)
• Flush or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excessive gas or flatulence, stomach acid, feeling full or bloated
• Encysted bleeding, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Decoloration of the skin
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss 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
• Sensation of intoxication
• Difficulty learning

Rare (may affect up to 1 in 1,000 people)

• Abnormally exalted mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Wandering eye
• Swelling of the eyes and around the eyes
• Numbness, tingling, and color change (white, blue, and then red) of the fingers of the hands and feet when exposed to cold
• Inflammation of the liver, liver insufficiency
• Unusual odor of the skin
• Discomfort in the arms and legs
• Renal alteration

Unknown (cannot be estimated from available data)

• Maculopathy is a disease of the macula, a small area in the retina where vision is more acute. Consult your doctor if you notice a change or decrease in your vision.

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:

• Difficulty concentrating
• Increased blood acidity
• Having thoughts of self-harm
• Fatigue
• Increased or decreased appetite
• Aggression, abnormal behavior
• Difficulty falling or staying asleep
• Feeling of instability when walking
• General feeling of illness
• Decreased potassium levels in the blood
• Not showing or feeling emotions
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may appear in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Average eosinophils (a type of white blood cell) in the blood
• Hyperactivity
• Feeling hot
• Difficulty learning

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 medicine.

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

Store below 25°C.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAcomicil

The active ingredient is topiramate. Each film-coated tablet of Acomicil contains 200 mg of topiramate.

The other components of Acomicil are listed below:Tablet core:mannitol, pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate.Coating layer: polyvinyl alcohol, titanium dioxide (E-171), Macrogol 3350, talc, soy lecithin (E-322), and iron oxide red (E-172).

Appearance of the product and contents of the packaging

Acomicil 200 mg: oval-shaped, salmon-colored film-coated tablets.

It is packaged in an HDPE bottle containing 60 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Aravaca – Madrid

Spain

Responsible manufacturer:

Coripharma ehf

Reykjavikurvegi, 78, P.O. Box 420

IS-220 Hafnarfjordur (Iceland)

or

TOLL Manufacturing Services

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

Last review date of this leaflet:June 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

The most recent approved information; educational material (patient guide) about this medication is available by scanning the following QR code with a smartphone. The same information is also available on the following website (URL):https://cima.aemps.es/cima/DocsPub/16/3252.