Acomicil 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acomicil 200 mg film-coated tablets EFG

topiramate

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

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

Leaflet contents:

1. What Acomicil is and what it is used for
2. What you need to know before taking Acomicil
3. How to take Acomicil
4. Possible side effects
5. How to store 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 drugs". It is used to:

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

2. What you need to know before starting to take Acomicil

Do not take Acomicil

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

Migraine prevention

• Do not take Acomicil if you are pregnant.

• If you are a woman of childbearing age, you must 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

• You must not use Acomicil if you are pregnant, unless no other treatment provides sufficient seizure control.
• If you are a woman of childbearing age, you must 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 sufficient control of your seizures and you plan to become pregnant. You must 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. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

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

A patient card is provided with the Acomicil packaging 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 Acomicil.

Warnings and precautions

Consult your doctor or pharmacist before starting Acomicil 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 a woman who could become pregnant. Acomicil may harm an unborn baby when taken 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 when taken during pregnancy.

If you are unsure whether the above applies to your case, consult your doctor or pharmacist before using Acomicil.

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

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

You may lose weight while taking Acomicil, so your weight should be monitored regularly during treatment with this medicine. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, you should consult your doctor.

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

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

Acomicil may rarely cause high levels of ammonia in the blood (detected 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 (see also 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 Acomicil.

Other medicines and Acomicil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. Acomicil and certain medicines may interact with each other. Sometimes, the dose of either Acomicil or the other medicine 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. Acomicil 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 Acomicil.

Tell your doctor if you experience changes in your menstrual bleeding while taking hormonal contraceptives and Acomicil. Irregular bleeding may occur. In this case, continue taking your 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 starting any new medicine.

Other medicines about which you should consult your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John’s wort (Hypericum perforatum) (a herbal preparation used to treat depression), and warfarin, which is used to prevent blood clotting.

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

Taking Acomicil with food, drinks, and alcohol

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

Pregnancy, lactation and fertility

Pregnancy

Important advice for fertile women:

Acomicil can 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.

Migraine prevention:

• If you have migraine, you must not take Acomicil if you are pregnant.
• If you have migraine, you must not use 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 must be performed in women of childbearing potential.

Epilepsy treatment:

• If you have epilepsy, you must not take Acomicil if you are pregnant, unless no other treatment provides sufficient seizure control.
• If you have epilepsy, you must not use 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 sufficient seizure control and if you are planning to become pregnant. You must 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 could endanger you or your unborn baby.
• Before starting treatment with Acomicil, a pregnancy test must be performed in women of childbearing potential.

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

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

• If you take Acomicil during pregnancy, your child has an increased 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 who do not have epilepsy and are not taking antiepileptic medication. 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 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 babies born to mothers who took topiramate during pregnancy were smaller and weighed less than expected at birth, compared with 5% of babies born to mothers without epilepsy who were not taking antiepileptic medication.

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

• There may be other medications available to treat your condition that carry 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 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 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 (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 or caregiver of a girl being treated with Acomicil, 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 about the need to use highly effective contraceptive methods.

If you wish 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 could worsen.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Acomicil during pregnancy and may refer you to another specialist.

If you become pregnant or think you might 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 evaluate whether you need an 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 could worsen. Worsening of your epilepsy could endanger you or your unborn baby.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Acomicil during pregnancy and may refer you to another specialist.
• If Acomicil is used during pregnancy, you will be monitored closely to check your baby's development during gestation.

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

Breastfeeding

The active ingredient in Acomicil (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 to discontinue breastfeeding or discontinue treatment with Acomicil, taking into account the importance of the benefits for the mother and the potential risk to the infant. Breastfeeding mothers taking Acomicil should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Driving and use of machines

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

3. How to take Acomicil

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

• Your doctor will usually start with a low dose of Acomicil and slowly 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 may take Acomicil before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Acomicil.

Girls and women of childbearing potential:

Treatment with Acomicil must 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

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; experience double 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 together with Acomicil.

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

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 a missed dose.

If you stop taking Acomicil

Do not stop treatment without first being instructed 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

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

• Depression (new or worsened)

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Increased blood acid levels (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 harm 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 eye pressure, pain, or vision loss)
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling drowsy with low energy—these symptoms may indicate high levels of ammonia in the blood (hyperammonemia), which can lead to changes in brain function (hyperammonemic encephalopathy).
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which may appear as rashes with or without blisters. Skin irritation, ulcers or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes may progress to widespread skin damage (detachment of the epidermis and superficial mucous membranes), which can be life-threatening.

Not known (cannot be estimated from available data):

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

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

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

• Nasal congestion, runny nose, or sore throat
• Tingling, pain, and/or numbness in various parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells (which help protect against infections), decreased blood potassium levels
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of 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, light sensitivity, eyelid twitching, watery eyes
• Decreased or hearing loss, hearing loss in one ear
• Slow or irregular heartbeat, awareness of heartbeat in the chest
• Low blood pressure, drop in blood pressure upon standing (as a result, 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 flatulence, stomach acidity, feeling full or bloated
• Bleeding gums, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in urine, 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
• 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
• Liver inflammation, liver failure
• 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.

Other adverse effects in children

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

• Difficulty concentrating
• Increased blood acid levels
• 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 (dizziness)
• 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 Acomicil

Keep this medicine out of sight and reach of children.

Store below 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acomicil

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

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

Appearance of the product and contents of the pack

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

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 - 2nd floor

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 most recent revision of this leaflet: June 2024.

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

The most recently approved information; educational material (patient guide) 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.