ACOMICIL 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Acomicil 25 mg Film-Coated Tablets EFG

Topiramate

This medication is subject to additional monitoring, which will make it easier to detect new information on its safety. You can contribute by reporting any side effects you may have. The last part of section 4 contains 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Acomicil is and what it is used for

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

• treat seizures in adults and children over 6 years old given alone
• treat seizures in adults and children over 2 years old given with other medicines
• to prevent migraine in adults

2. What you need to know before you take Acomicil

Do not take Acomicil

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

Migraine prevention

• Do not take Acomicil if you are pregnant.

• If you are a woman of childbearing potential, do not take Acomicil 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 take Acomicil if you are pregnant unless no other treatment provides adequate control of your seizures.

• If you are a woman of childbearing potential, do not take Acomicil unless you are using a highly effective method of contraception during treatment. The only exception is if Acomicil is the only treatment that provides adequate control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure 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 unborn baby at risk.

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

A patient card is provided with the pack of Acomicil to remind you of the risks during pregnancy.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Acomicil.

Warnings and precautions

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

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

• have a history of blood or body fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• follow a high-fat diet (ketogenic diet)
• are a woman who may become pregnant. Acomicil may harm an unborn baby during pregnancy. Highly effective contraceptive methods must be used during 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 harm an unborn baby during pregnancy.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Acomicil

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

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

You may lose weight if you take Acomicil, so your weight should be checked regularly while you are taking this medicine. If you lose too much weight or if a child taking this medicine does not gain enough weight, you should consult your doctor.

A small number of people being treated with antiepileptic drugs such as Acomicil have had thoughts of harming themselves or taking their own lives. If at any time you have these thoughts, contact your doctor immediately.

Acomicil may cause serious skin reactions, contact your doctor immediately if you develop a skin rash and/or blisters (see also section 4 “Possible side effects”).

Acomicil may rarely cause high levels of ammonia in the blood (seen in blood tests) which can 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 disease, 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 of numbness with low energy

The risk of developing these symptoms may increase with higher doses of Acomicil.

Other medicines and Acomicil

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

In particular, tell 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 contraceptive 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 your menstrual bleeding changes while you are taking hormonal contraceptives and Acomicil. You may experience irregular bleeding. In this case, continue taking your hormonal contraceptives and consult your doctor.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start taking a new medicine.

Other medicines that you should tell 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 not sure if any of the above applies to you, consult your doctor or pharmacist before taking Acomicil.

Taking Acomicil with food, drinks, and alcohol

You can take Acomicil with or without food. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking Acomicil. You should avoid drinking alcohol while taking Acomicil.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important advice for women of childbearing potential:

Acomicil may harm an unborn 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 the risks at least once a year.

Migraine prevention:

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

Epilepsy treatment:

• In the case of epilepsy, do not take Acomicil if you are pregnant unless no other treatment provides adequate control of your seizures.

• In the case of epilepsy, do not take Acomicil if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if Acomicil is the only treatment that provides adequate control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure 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 unborn baby at risk.

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

Risks of topiramate when taken during pregnancy (regardless of the condition for which topiramate is used) are:

There is a risk of harm to the unborn baby during pregnancy if Acomicil is used during pregnancy

• If you take Acomicil during pregnancy, your child will have a higher chance of having birth defects. In women taking topiramate, about 4 to 9 out of 100 children will have birth defects. This compares to 1-3 out of 100 children born to women who do not have epilepsy and are not taking antiepileptic treatment. In particular, cleft lip (a division in the upper lip) and cleft palate (a division in the palate) have been observed. Newborn boys may also have a malformation of the penis (hypospadias). These defects can 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 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 medication.

• If you take Acomicil during pregnancy, your child may be smaller and weigh less than expected at birth. In one 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 and not taking antiepileptic medication 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.

congenital.

Need for contraceptive methods for women of childbearing potential:

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

• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a contraceptive pill with a barrier contraceptive 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 is a possibility of reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, an additional barrier contraceptive (such as a condom or diaphragm) should be used.

• Tell your doctor if you experience irregular menstrual bleeding.

Use of Acomicil in girls:

If you are the parent or 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 an unborn 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 discussed this with your doctor, as your condition may worsen.

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

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

• Schedule an urgent appointment with your doctor.

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

• If you are taking Acomicil for epilepsy, do not stop taking this medicine until you have discussed this with your doctor, as your condition may worsen. Worsening of your epilepsy may put you or your unborn baby at risk.

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

The doctor may also refer you to another specialist.

• 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 guide that your doctor will give you. A patient card is provided with the pack of Acomicil to remind you of the risks during pregnancy.

Breastfeeding

The active substance of Acomicil (topiramate) passes into breast milk. Effects have been seen 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 to stop treatment with Acomicil. Your doctor will take into account the importance of the benefits for the mother and the risk for the baby. Breastfeeding mothers taking Acomicil should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, fatigue, and vision disturbances may occur during treatment with Acomicil. Do not drive or operate tools or machines without talking to your doctor first.

3. How to take Acomicil

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist.

• Your doctor will usually start with a low dose of Acomicil and gradually increase your dose until the best dose for you is found.
• 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 fluids during the day to prevent the formation of kidney stones while taking Acomicil.

Girls and women of childbearing potential:

Treatment with Acomicil should be started and continued under the supervision of a doctor experienced in the treatment of 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. Take the medicine with you.

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

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

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Acomicil

• 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 the missed dose.

If you stop taking Acomicil

Do not stop treatment without your doctor telling you to do so. Your symptoms may come back. If your doctor decides you need to stop taking this medicine, your dose will be gradually decreased over several days.

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

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Consult your doctor or seek medical attention immediately if you have 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
• Concentration problems, slow 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 blood acid levels (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeats)
• Decreased or lost sweating (especially in young children exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious harm
• Loss of part of the visual field

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

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

Not Known (cannot be estimated from available data):

• Eye inflammation (uveitis) with symptoms such as eye redness and pain, sensitivity to light, tearing, blurred vision, or seeing small dots.

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)

• Congestion, runny nose, or sore throat
• Numbness, pain, and/or tingling of various 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, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty staying or falling asleep
• Speech problems or speech disorders, poor pronunciation when speaking
• Clumsiness 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
• Vision changes, such as double vision, blurred vision, decreased vision, difficulty focusing
• Feeling 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
• Pain or inflammation of the joints, muscle spasms or twitches, muscle pain or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelet count (blood cells that help prevent bleeding), decreased white blood cell count (which helps 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 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 emotion, unusual distrust, panic attack
• Reading problems, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or wakefulness
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch, altered touch
• Altered, distorted, or absent sense of smell
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Dry eyes, eye sensitivity to light, eyelid twitching, 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 up (consequently, some people taking Acomicil 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 bloating, stomach acidity, feeling of fullness or bloating
• Nosebleeds, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss of bladder control), urgent need to urinate, side or kidney pain
• Difficulty getting or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold fingers or toes
• Feeling of intoxication
• 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 color change (white, blue, and then red) of the fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Abnormal skin odor
• Discomfort in the arms and legs
• Kidney alteration

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.

Other Adverse Effects in Children

Generally, the adverse effects observed in children are similar to those observed in adults, but the following adverse effects may be more frequent in children than in adults:

• Concentration problems
• Increased blood acid levels
• Having thoughts of self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling of instability when walking
• General malaise
• Decreased potassium levels in the blood
• Lack of emotion
• Watery eyes
• Slow or irregular heartbeat

Other adverse effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Feeling of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophils (a type of white blood cell) in the blood
• Hyperactivity
• Feeling hot
• Learning difficulties

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Acomicil

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

Store below 25°C.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAcomicil

The active ingredient is topiramate. Each Acomicil tablet contains 25 mg of topiramate.

The other components are:

Core:mannitol, pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate.

Coating:polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, and talc.

Appearance of the Product and Package Contents

Acomicil 25 mg: film-coated tablets, round, biconvex, and white.

It is packaged in an HDPE bottle containing 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Aravaca – Madrid

Spain

Manufacturer:

Coripharma ehf

Reykjavikurvegi, 78, P.O. Box 420

IS-220 Hafnarfjordur . Iceland

or

TOLL Manufacturing Services

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

Date of the Last Revision of this Prospectus:June 2024.

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