Epitoram

Leaflet included in the packaging: patient information

Epitoram, 25 mg, coated tablets
Epitoram, 50 mg, coated tablets
Epitoram, 100 mg, coated tablets
Epitoram, 200 mg, coated tablets
Topiramate
You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further questions.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Epitoram and what is it used for
• 2. Important information before taking Epitoram
• 3. How to take Epitoram
• 4. Possible side effects
• 5. How to store Epitoram
• 6. Contents of the packaging and other information

1. What is Epitoram and what is it used for

Epitoram belongs to a group of medicines called antiepileptic medicines. It is used:

• as the only medicine for the treatment of epileptic seizures in adults and children over 6 years of age;
• in combination with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age;
• to prevent migraine headaches in adults.

2. Important information before taking Epitoram

When not to take Epitoram:

• for the prevention of migraines in pregnant women and women of childbearing age, if they do not use effective contraception (for more information, see the section "Pregnancy, breastfeeding and fertility"). You should consult a doctor about the best method of contraception during treatment with Epitoram.

If you are not sure if any of the above situations apply to you, you should consult a doctor or pharmacist before taking Epitoram.

Warnings and precautions

Before starting treatment with Epitoram, you should discuss with your doctor or pharmacist if you:

• have kidney problems, especially kidney stones or dialysis;
• have blood and body fluid disorders (metabolic acidosis);
• have liver problems;
• have eye diseases, especially glaucoma;
• have growth disorders;
• are on a high-fat diet (ketogenic diet). Before taking Epitoram, you should consult a doctor or pharmacist (for more information, see the section "Pregnancy, breastfeeding and fertility"), if you have epilepsy and are taking Epitoram and become pregnant or are of childbearing age.

If you are not sure if any of the above symptoms apply to you, you should consult a doctor or pharmacist before taking Epitoram.

It is essential that you do not stop taking the medicine without consulting your doctor.

You should consult your doctor before taking any other medicine that contains topiramate, which has been prescribed to you as a substitute for Epitoram.

During treatment with Epitoram, you may experience weight loss, so you should have it checked regularly. If you experience excessive weight loss or if a child taking this medicine does not gain enough weight, you should consult your doctor.

In a small number of people taking antiepileptic medicines, such as Epitoram, thoughts of self-harm or suicide have occurred. If such thoughts occur, you should contact your doctor immediately.

Epitoram may cause severe skin reactions; if a rash or blisters appear on the skin, you should immediately inform your doctor (see also section 4, "Possible side effects").

Epitoram may rarely cause high blood ammonia levels (observed in blood tests), which can lead to brain function disorders, especially if you are also taking valproic acid or sodium valproate. You should immediately tell your doctor if you experience the following symptoms, as they may indicate a severe condition (see also section 4, "Possible side effects"):

• thinking, memory, or problem-solving disorders;
• decreased attention or awareness;
• symptoms of excessive drowsiness with a feeling of weakness.

The risk of these symptoms may increase during treatment with higher doses of Epitoram.

Epitoram and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Epitoram may interact with other medicines. In some cases, you may need to adjust the dose of the medicines you are taking or change the dose of Epitoram.

In particular, you should inform your doctor or pharmacist if you are taking:

• other medicines that can harm or slow down thinking, concentration, or muscle coordination (e.g., central nervous system depressants, such as muscle relaxants and sedatives);
• contraceptives. Epitoram may reduce the effectiveness of contraceptives. You should consult a doctor about the best method of contraception during treatment with Epitoram.

You should inform your doctor if you experience any changes in your menstrual cycle while taking contraceptives with Epitoram.

You should keep a list of all the medicines you are taking. When starting a new medicine, you should show this list to your doctor and pharmacist.

Taking other medicines, such as antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John's wort (Hypericum perforatum) (a herbal medicine used to treat depression), warfarin (an anticoagulant), should be discussed with your doctor or pharmacist.

If you are not sure if the above information applies to you, you should consult a doctor or pharmacist before taking Epitoram.

Taking Epitoram with food, drink, and alcohol

You can take Epitoram with or without food. You should drink plenty of fluids throughout the day to prevent kidney stone formation while taking Epitoram. During treatment with Epitoram, you should avoid consuming alcohol.

Pregnancy and breastfeeding

Migraine prevention:

Epitoram may harm the fetus. You should not take Epitoram if you are pregnant. You should not take Epitoram for migraine prevention if you are of childbearing age, unless you use effective contraception. You should consult a doctor about the best method of contraception, as well as whether Epitoram is suitable for you. Before starting treatment with topiramate, you should have a pregnancy test.

Epilepsy treatment:

If you are of childbearing age, you should consult your doctor about whether to use an alternative treatment method instead of Epitoram. If your doctor decides that you should take Epitoram, you should use effective contraception. You should consult a doctor about the best method of contraception during treatment with Epitoram. Before starting treatment with topiramate, you should have a pregnancy test.

You should consult a doctor if you want to become pregnant.

If you are taking Epitoram during pregnancy, like other antiepileptic medicines, there is a risk of harm to the fetus. You should make sure you have the necessary knowledge about the risks and benefits of taking Epitoram during pregnancy.

• If you are taking Epitoram during pregnancy, the risk of birth defects in the child increases, especially cleft lip and cleft palate (upper part of the mouth). In male newborns, developmental disorders of the genitalia (hypospadias - a congenital defect in which the urethra opens on the underside of the penis) may also occur. These defects can develop early in pregnancy, even before you realize you are pregnant.
• If you are taking Epitoram during pregnancy, the child may be smaller than expected. You should consult a doctor if you have any questions about this risk during pregnancy.
• Other medicines may be used to treat your illness with a lower risk of birth defects in infants.
• You should immediately inform your doctor if you become pregnant while taking Epitoram. Your doctor, in consultation with you, will decide whether to continue treatment with Epitoram.

Breastfeeding:

Topiramate, the active substance of Epitoram, passes into breast milk. Adverse reactions reported in breastfed infants of mothers treated with topiramate include diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will advise you whether to stop breastfeeding or discontinue Epitoram treatment. Your doctor will weigh the benefits of taking the medicine for you against the risk to your baby.

Mothers taking Epitoram during breastfeeding should immediately inform their doctor if they notice any changes in their child's behavior.

Driving and operating machinery

While taking Epitoram, you may experience dizziness, fatigue, and vision disturbances. Without consulting your doctor, you should not drive vehicles, operate mechanical devices, or use tools.

Epitoram contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is considered "sodium-free".

3. How to take Epitoram

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.

• Your doctor will usually start treatment with a low dose of Epitoram and gradually increase it until the optimal dose for you is determined.
• Epitoram tablets should be swallowed whole. It is not recommended to chew the tablets, as they may leave a bitter taste.
• Epitoram can be taken before, during, or after a meal. While taking Epitoram, you should drink plenty of fluids to avoid kidney stone formation.

Taking a higher dose of Epitoram than recommended

• You should immediately contact a doctor. You should take the packaging of the medicine with you.
• You may experience drowsiness, fatigue, or decreased attention; coordination disorders; speech or concentration disorders; double or blurred vision; dizziness caused by low blood pressure; depression or excitement; abdominal pain or seizures.

Overdose can also occur when taking other medicines with Epitoram.

Missing a dose of Epitoram

• If you miss a dose, you should take it as soon as possible. However, if it is close to the time of taking the next dose, you should skip the missed dose and continue treatment. If you miss two or more doses, you should consult a doctor.
• You should not take a double dose (two doses at the same time) to make up for the missed dose.

Stopping treatment with Epitoram

You should not stop taking this medicine unless your doctor advises you to do so. After stopping treatment, the symptoms of the underlying disease may return. If your doctor decides to stop treatment, the dose of the medicine may be gradually reduced over several days.

If you have any further questions about taking the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Epitoram can cause side effects, although not everybody gets them.

You should immediately contact a doctor or seek medical attention if you experience any of the following side effects:

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

• Depression (occurrence of depression or worsening of existing depression).

Common (may affect up to 1 in 10 people):

• Seizures.
• Anxiety, irritability, mood changes, confusion, disorientation.
• Concentration problems, slowed thinking, memory loss, memory problems (new cases, sudden change or worsening).
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people):

• Increased blood acid levels (may cause breathing difficulties, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, rapid or irregular heartbeat).
• Decreased sweating or lack of sweating (especially in small children prone to high temperatures).
• Thoughts of severe self-harm, attempts at self-harm.
• Loss of part of the visual field.

Rare (may affect up to 1 in 1000 people):

• Glaucoma, which is characterized by fluid accumulation in the eye chamber, leading to increased pressure in the eyeball, pain, and impaired vision.
• Thinking disorders, memory problems, or problem-solving difficulties, decreased attention or awareness, symptoms of excessive drowsiness with a feeling of weakness - these symptoms may indicate high blood ammonia levels (hyperammonemia), which can lead to brain function disorders, encephalopathy associated with hyperammonemia.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis - may occur in the form of a rash with blisters or without. Skin irritation, ulcers, or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes

may develop into severe, extensive skin damage (peeling of the skin and mucous membranes), which can be life-threatening.

Frequency not known (cannot be estimated from the available data):

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

Other side effects are listed below. If they get worse, you should immediately contact a doctor or pharmacist.

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

• Rhinorrhea with accompanying nasal congestion or throat pain.
• Paresthesia, 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 (decreased red blood cell count).
• Allergic reactions (such as skin rash, redness, itching, facial swelling, hives).
• Decreased or increased appetite.
• Aggression, excitement, mood swings, abnormal behavior.
• Sleep disturbances and maintenance of sleep.
• Speech disorders, slurred speech.
• Ataxia or coordination disorders, unsteadiness while walking.
• Decreased ability to perform routine activities.
• Taste disorders (reduced or absent taste).
• Involuntary muscle twitches; rapid, uncontrolled eye movements.
• Vision disturbances, such as double vision, blurred vision, impaired vision, accommodation disorders.
• Vertigo (dizziness), tinnitus, ear pain.
• Shortness of breath.
• Cough.
• Nosebleeds.
• Fever, malaise, weakness.
• Vomiting, constipation, abdominal pain or discomfort, nausea, gastrointestinal infections.
• Dry mouth.
• Hair loss.
• Itching.
• Pain or swelling of the joints, muscle cramps and twitches, muscle weakness.
• Weight gain.

Uncommon (may affect up to 1 in 100 people):

• Decreased platelet count (blood cells responsible for stopping bleeding), decreased white blood cell count responsible for protecting against infection, decreased potassium levels in the blood.
• Increased liver enzyme levels, increased eosinophil levels (a type of white blood cell) in the blood.
• Swelling of the lymph nodes in the neck, armpits, and groin.
• Increased appetite.
• Euphoria.
• Hearing, seeing, or feeling non-existent phenomena, severe mental disorders (psychosis).
• Lack of emotional expression and (or) lack of emotional feelings, increased suspiciousness, panic attacks.
• Reading difficulties, speech disorders, difficulties with writing legibly.
• Restlessness, increased mental and physical activity.
• Slowed thinking, disorders of thinking and decreased sensitivity.
• Limited or slowed movements, involuntary abnormal or repetitive muscle movements.
• Fainting.
• Abnormal sensation; decreased sensitivity.
• Taste disorders.
• Symptoms that may indicate a migraine attack or a specific type of seizure.
• Dry eye, increased sensitivity to light, eyelid twitching, tearing, blurred vision.
• Hearing loss, hearing loss in one ear.
• Slow or irregular heartbeat, feeling of heartbeat in the chest (palpitations).
• Hot flashes.
• Pancreatitis.
• Increased gas, heartburn, feeling of fullness in the stomach or bloating.
• Bleeding from the gums, increased saliva production, drooling, difficulty swallowing.
• Excessive fluid intake, excessive thirst.
• Skin discoloration.
• Muscle stiffness, muscle pain.
• Blood in the urine, urinary incontinence, sudden urge to urinate, kidney or flank pain.
• Difficulty achieving or maintaining an erection, sexual function disorders.
• Flu-like symptoms.
• Feeling of cold (e.g., fingers and toes).
• Feeling of intoxication.
• Difficulty learning.

Rare (may affect up to 1 in 1000 people):

• Loss of consciousness.
• Vision loss in one eye, temporary blindness, night blindness.
• Lazy eye syndrome.
• Eye and surrounding tissue swelling.
• Numbness, tingling, and color change (white, blue, then red) of fingers and toes when exposed to cold.
• Liver inflammation, liver failure.
• Unpleasant body odor.
• Arm or leg problems.
• Kidney disorders.

Frequency not known (cannot be estimated from the available data):

• Macular degeneration is a disease of the macula, the part of the retina responsible for sharp vision. If you experience vision disturbances or impaired vision, you should contact your doctor.

Children

Side effects that occur in children are similar to those observed in adults. However, the following side effects may occur more frequently in children than in adults:

• Concentration problems.
• Increased blood acid levels.
• Thoughts of severe self-harm.
• Fatigue.
• Decreased or increased appetite.
• Aggression, abnormal behavior.
• Sleep disturbances.
• Unsteadiness while walking.
• Malaise.
• Decreased potassium levels in the blood.
• Lack of emotional expression and (or) lack of emotional feelings.
• Tearing.
• Slow or irregular heartbeat.

Other side effects that may occur in children include:

Common (may affect up to 1 in 10 people):

• Dizziness.
• Vomiting.
• Fever.

Uncommon (may affect up to 1 in 100 people):

• Increased eosinophil levels (a type of white blood cell) in the blood.
• Increased mental and physical activity.
• Feeling of warmth.
• Difficulty learning.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].

You can also report side effects to the marketing authorization holder or its representative in Poland.

By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Epitoram

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month stated. The batch number is stated after "Lot".

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Epitoram contains

• The active substance of Epitoram is topiramate. Each coated tablet contains 25 mg, 50 mg, 100 mg, or 200 mg of topiramate.
• The other ingredients are: methylcellulose (E461), sodium croscarmellose (E468), magnesium stearate (E470b), silica, colloidal, anhydrous (E551), hypromellose (E464), hydroxypropylcellulose (E463), macrogol, and titanium dioxide (E171). The 50 mg and 100 mg tablets contain yellow iron oxide (E172) as a colorant. The 200 mg tablets contain red iron oxide (E172) as a colorant.

What Epitoram looks like and contents of the pack

You should make sure you are taking the correct medicine:

• Epitoram, 25 mg, coated tablet is white, round, with "APO" on one side and "TP 25" on the other.
• Epitoram, 50 mg, coated tablet is light yellow, round, with "APO" on one side and "TP 50" on the other.
• Epitoram, 100 mg, coated tablet is mustard-colored, round, with "APO" on one side and "TP 100" on the other.
• Epitoram, 200 mg, coated tablet is reddish-brown, round, with "APO" on one side and "TP 200" on the other.

Pack sizes:

Epitoram is available in blister packs of 28 and 60 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta

Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino

S.S. 16 Zona Industriale
73010 Zollino (LE)
Italy

Date of last revision of the leaflet: 04/2022