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 personally. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 antiepileptics. 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:

• if the patient has been found to be hypersensitive to topiramate or any of the other ingredients of this medicine (listed in section 6);
• for the prevention of migraines in pregnant women and women of childbearing age, unless they are using effective contraception (for more information, see the section "Pregnancy, breastfeeding and fertility"). You should consult your doctor about the best method of contraception during treatment with Epitoram.

If the patient is unsure whether any of the above situations apply to them, they should consult their doctor or pharmacist before taking Epitoram.

Warnings and precautions

Before starting treatment with Epitoram, the patient should discuss with their doctor or pharmacist if they have:

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

If the patient is unsure whether any of the above symptoms apply to them, they should consult their doctor or pharmacist before taking Epitoram.

Epitoram and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Epitoram may interact with other medicines.In this regard, the patient's doctor may sometimes need to adjust the dose of the medicines they are taking or adjust the dose of Epitoram.

• In particular, the patient should inform their doctor or pharmacist if they are taking:
• other medicines that have a negative effect 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. The patient should consult their doctor about the best method of contraception during treatment with Epitoram.

The patient should inform their doctor if they experience any changes in their menstrual cycle while taking contraceptives with Epitoram.

Taking Epitoram with food, drink, and alcohol

Epitoram can be taken with or without food. The patient should drink plenty of fluids throughout the day to prevent the formation of kidney stones while taking Epitoram. The patient should avoid consuming alcohol while taking Epitoram.

Pregnancy and breastfeeding

Migraine prevention:

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

Epilepsy treatment:

If the patient is of childbearing age, they should consult their doctor about whether to use an alternative treatment method instead of Epitoram. If the doctor decides that the patient should take Epitoram, the patient should use effective contraception. The patient should consult their doctor about the best method of contraception during treatment with Epitoram. Before starting treatment with topiramate, the patient should have a pregnancy test.

The patient should consult their doctor if they wish to become pregnant.

If Epitoram is used during pregnancy, as with other antiepileptic medicines, there is a risk of harm to the fetus. The patient should ensure they have the necessary knowledge about the risks and benefits of using Epitoram during pregnancy.

• If the patient takes Epitoram during pregnancy, the risk of birth defects in the child increases, particularly cleft lip and cleft palate (upper part of the mouth). In newborn males, 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 in the early stages of pregnancy, even before the patient realizes they are pregnant.
• If the patient takes Epitoram during pregnancy, the child may be smaller than expected. The patient should consult their doctor about this risk during pregnancy.
• Other medicines can be used to treat the patient's illness with a lower risk of birth defects in infants.
• The patient should inform their doctor immediately if they become pregnant while taking Epitoram. The doctor, in agreement with the patient, will decide whether to continue treatment with Epitoram.

Breastfeeding:

Topiramate, the active substance in 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, the doctor will advise the patient whether to stop breastfeeding or stop taking Epitoram. The doctor will weigh the benefits of taking the medicine for the mother against the risk to the baby.

Mothers who take Epitoram during breastfeeding should inform their doctor immediately if they notice any changes in their baby's behavior.

Driving and using machines

While taking Epitoram, the patient may experience dizziness, fatigue, and vision disturbances. Without consulting a doctor, the patient 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 the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.

• The doctor usually starts treatment with a low dose of Epitoram and gradually increases it until the optimal dose for the patient 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, the patient should drink plenty of fluids to avoid the formation of kidney stones.

Taking a higher dose of Epitoram than recommended

• The patient should contact their doctor immediately. They should take the packaging of the medicine with them.
• The patient may experience drowsiness, fatigue, or decreased concentration; coordination disorders; speech or concentration disorders; double or blurred vision; dizziness due to 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 the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose and continue treatment. If the patient misses two or more doses, they should consult their doctor.
• The patient should not take a double dose (two doses at the same time) to make up for the missed dose.

Stopping treatment with Epitoram

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

If the patient has any further questions about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should contact their doctor or seek medical attention immediately if they 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, slowing of thought processes, 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 self-harm, attempts at self-harm.
• Loss of part of the visual field.

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

• Glaucoma, which is characterized by fluid accumulation in the eye chamber, leading to increased pressure in the eyeball, pain, and impaired vision.
• Cognitive impairment, memory impairment, or problem-solving difficulties, decreased concentration, or decreased awareness - these symptoms may indicate high blood ammonia levels (hyperammonemia), which can lead to brain function disorders, hyperammonemic encephalopathy.
• 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 can transform into severe, extensive skin damage (peeling of the skin and mucous membranes), which can be life-threatening.

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

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

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

Other side effects are listed below. If they get worse, the patient should contact their doctor or pharmacist immediately.

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

• Rhinitis with accompanying nasal congestion or sore throat.
• 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 (reduced red blood cell count).
• Allergic reactions (such as skin rash, redness, swelling, facial edema, urticaria).
• Decreased or increased appetite.
• Aggression, excitement, mood swings, abnormal behavior.
• Sleep disturbances and difficulty maintaining 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.
• Visual 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.
• Edema.
• Pain or swelling of joints, muscle cramps and spasms, muscle weakness, chest pain.
• Weight gain.

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

• Decreased platelet count (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 count (a type of white blood cell) in the blood.
• Swelling of 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 feeling, increased suspiciousness, panic attacks.
• Reading difficulties, speech disorders, difficulty writing legibly.
• Restlessness, increased mental and physical activity.
• Slowing of thought processes, disorders of thinking and decreased awareness.
• Limited or slowed movements, involuntary abnormal or repetitive muscle movements.
• Fainting.
• Abnormal sensation or decreased sensation.
• Taste disorders.
• Phenomena or symptoms that may herald 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).
• Decreased blood pressure or decreased blood pressure when standing up (in patients taking Epitoram, this may cause a feeling of fainting, dizziness, or fainting related to a sudden change in body position to standing or sitting).
• Hot flashes, feeling of heat.
• 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 dysfunction.
• Flu-like symptoms.
• Feeling of cold (e.g., fingers and toes).
• Feeling of intoxication.
• Difficulty learning.

Rare (may affect up to 1 in 1,000 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 upon exposure to cold.
• Liver inflammation, liver failure.
• Unpleasant body odor.
• Shoulder 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 the patient experiences vision disturbances or impaired vision, they should consult their doctor.

Children

Adverse reactions in children are similar to those observed in adults. However, the following adverse reactions may occur more frequently in children than in adults:

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

Other adverse reactions that may occur in children include:

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

• Vertigo (dizziness).
• Vomiting.
• Fever.

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

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

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to:

Department of Adverse Reaction Monitoring of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.

Side effects can also be reported to the marketing authorization holder or its representative in Poland.

By reporting side effects, it is possible to 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:

Expiry date (EXP). The expiry date refers to the last day of the month stated. The batch number is stated after the "Lot" abbreviation.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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

The patient should make sure they are taking the correct medicine:

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