Epitoram

Package leaflet: Information for the patient

Epitoram, 25 mg, coated tablets
Epitoram, 50 mg, coated tablets
Epitoram, 100 mg, coated tablets
Epitoram, 200 mg, coated tablets
Topiramate
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any side effects worsen or if new side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Epitoram is and what it is 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 Epitoram is and what it is used for

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

• as monotherapy in the treatment of epileptic seizures in adults and children above 6 years of age;
• in combination with other medicines in the treatment of epileptic seizures in adults and children aged 2 years and older;
• for the prevention of migraine headaches in adults.

2. Important information before using Epitoram

When not to use Epitoram:

• if the patient has hypersensitivity to topiramate or any of the other ingredients of this medicine (listed in section 6);
• for migraine prevention in pregnant women or women of childbearing potential who are not using effective contraception (for more detailed information, see section "Pregnancy, breastfeeding and fertility"). The patient should consult a doctor regarding the use of the most appropriate contraceptive method during treatment with Epitoram.

If the patient is unsure whether any of the situations described above apply, they should consult a doctor or pharmacist before using Epitoram.

Warnings and precautions

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

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

If the patient is unsure whether any of the symptoms described above apply, they should consult a doctor or pharmacist before using Epitoram.

It is important that the patient does not stop taking the medicine without first consulting their doctor.

The patient should consult their doctor before taking any other medicine containing topiramate prescribed as a substitute for Epitoram.

During treatment with Epitoram, the patient may experience weight loss. Therefore, body weight should be monitored regularly during therapy. If weight loss is excessive or if a child taking this medicine does not gain sufficient weight, the patient should consult their 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, the patient should contact their doctor immediately.

Epitoram may cause serious skin reactions; if a rash and/or blisters on the skin occur, the doctor should be informed immediately (see also section 4. "Possible side effects").

Epitoram may rarely cause elevated levels of ammonia in the blood (observed in blood tests), which may lead to impaired brain function, especially when the patient is also taking valproic acid or sodium valproate. The patient should inform their doctor immediately if any of the following symptoms occur, as they may indicate a serious condition (see also section 4 "Possible side effects"):

• difficulty thinking, remembering information, or solving problems;
• reduced ability to concentrate or altered level of consciousness;
• excessive sleepiness accompanied by feelings of weakness.

The risk of these symptoms may increase when higher doses of Epitoram are taken.

Epitoram and other medicines

The patient should inform their doctor or pharmacist about all medicines currently used or recently used, as well as any medicines they plan to use. Epitoram may interact with other medicines. Therefore, the dosage of other medicines taken by the patient may need to be adjusted, or the dose of Epitoram may need to be changed accordingly.

In particular, the patient should inform their doctor or pharmacist if they are using:

• other medicines that have harmful effects or reduce mental function, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives);
• hormonal contraceptives. Epitoram may reduce the effectiveness of hormonal contraceptives. The patient should consult their doctor regarding the most appropriate contraceptive method during treatment with Epitoram.

The patient should inform their doctor if they experience changes in menstrual bleeding patterns while using hormonal contraceptives together with Epitoram.

The patient should keep a list of all medicines they are taking. This list should be shown to the doctor and pharmacist when starting treatment with a new medicine.

The use of other medicines such as antiepileptic drugs, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John's wort (Hypericum perforatum) (a herbal remedy used in the treatment of depression), warfarin (an anticoagulant), should be discussed with a doctor or pharmacist.

If the patient is unsure whether the above information applies to them, they should consult a doctor or pharmacist before using Epitoram.

Taking Epitoram with food, drink and alcohol

Epitoram may be taken with or without food. The patient should drink plenty of fluids throughout the day to help prevent kidney stone formation during treatment with Epitoram. Alcohol consumption should be avoided during treatment with Epitoram.

Pregnancy and breastfeeding

Migraine prevention:

Epitoram may harm the unborn baby. Epitoram should not be used if the patient is pregnant. Epitoram should not be used for migraine prevention in women of childbearing potential unless they are using effective contraception. The patient should consult their doctor regarding the most appropriate contraceptive method and whether Epitoram is suitable for them. A pregnancy test should be performed before starting treatment with topiramate.

Epilepsy treatment:

If the patient is of childbearing age, they should consult their doctor to discuss whether an alternative treatment to Epitoram should be considered. If the doctor decides that the patient should take Epitoram, effective contraception must be used. The patient should consult their doctor regarding the most appropriate contraceptive method during treatment with Epitoram. A pregnancy test should be performed before starting treatment with topiramate.

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

If Epitoram is used during pregnancy, as with other antiepileptic medicines, there is a risk of harm to the unborn baby. The patient should ensure they understand the risks and benefits associated with using Epitoram for epilepsy treatment during pregnancy.

• If the patient takes Epitoram during pregnancy, the risk of congenital malformations in the baby increases, particularly cleft lip and cleft palate (a defect in the upper part of the mouth). Male newborns may also develop developmental abnormalities of the penis (hypospadias – a congenital condition where the opening of the urethra is located on the underside of the penis). These malformations may develop early in pregnancy, even before the patient realizes she is pregnant.
• If the patient uses Epitoram during pregnancy, the baby may be smaller than expected at birth. The patient should contact their doctor if they have any questions about this risk during pregnancy.
• Other medicines with a lower risk of causing congenital malformations in infants may be used to treat the patient's condition.
• The patient should inform their doctor immediately if they become pregnant while taking Epitoram. The doctor, in consultation with the patient, will decide whether treatment with Epitoram should continue.

Breastfeeding:

Topiramate – the active substance in Epitoram – passes into human milk. Adverse effects 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 discontinue treatment with Epitoram, taking into account the benefits of the medicine for the mother and the potential risks to the infant.

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

Driving and operating machinery

Dizziness, fatigue, and visual disturbances may occur during treatment with Epitoram. The patient should not drive, operate any machinery, or use tools without first consulting their doctor.

Epitoram contains sodium

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

3. How to use Epitoram

This medicine should always be used exactly as recommended by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

• Your doctor usually starts treatment with a low dose of Epitoram and gradually increases it until the optimal dose for the individual patient is established.
• Epitoram tablets should be swallowed whole. Chewing the tablets is not recommended, as they may leave a bitter taste.
• Epitoram can be taken before, during, or after a meal. While taking Epitoram, drink plenty of fluids to help prevent kidney stone formation.

Taking more Epitoram than recommended

• Contact your doctor immediately. Take the medicine packaging with you.
• Symptoms of overdose may include drowsiness, fatigue, or reduced ability to concentrate; coordination disturbances; speech or concentration problems; double or blurred vision; dizziness caused by low blood pressure; depression or agitation; abdominal pain or seizures.

Overdose may also occur when taking other medicines together with Epitoram.

Missing a dose of Epitoram

• If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Epitoram treatment

• Do not stop taking this medicine unless instructed by your doctor. After stopping treatment, symptoms of the underlying disease may return. If your doctor decides to discontinue treatment, the dose of the medicine may need to be gradually reduced over several days.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should contact your doctor immediately or seek medical help if any of the following adverse reactions occur:

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

• Depression (onset of depression or worsening of pre-existing depression).

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

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

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

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

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

• Glaucoma, characterised by fluid buildup in the eye chamber, leading to increased intraocular pressure, eye pain, and impaired vision.
• Impairment in thinking, information retention, or problem-solving, decreased ability to concentrate attention or level of consciousness, symptoms of excessive drowsiness with a feeling of weakness – these symptoms may indicate high blood ammonia levels (hyperammonemia), which may lead to brain function disorders, hyperammonemia-related encephalopathy.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis – may occur with or without skin rash. Skin irritation, ulcers, or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes may progress into severe, widespread skin damage (peeling of the epidermis and surface mucous membranes), which may have life-threatening consequences.

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

• Eye inflammation (uveitis) with the following symptoms: eye redness, pain, light sensitivity, tearing, floaters, or blurred vision.

Other adverse reactions are listed below. If they worsen, you should contact your doctor or pharmacist immediately.

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

• Runny nose with associated nasal congestion or sore throat.
• Tingling, pain, and/or discomfort in various parts of the body.
• Drowsiness, fatigue.
• Dizziness.
• Nausea, diarrhoea.
• Weight loss.

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

• Anaemia (reduced number of red blood cells).
• Allergic reactions (such as skin rash, redness, itching, facial swelling, urticaria).
• Decreased appetite, loss of appetite.
• Aggression, agitation, temper outbursts, abnormal behaviour.
• Difficulty falling asleep and maintaining sleep.
• Speech disorders, slurred speech.
• Lack of motor coordination or movement disorders, unsteadiness while walking.
• Reduced ability to perform routine activities.
• Taste disturbances (diminished or absent taste).
• Involuntary twitching; rapid, uncontrolled eye movements.
• Vision disturbances, such as double vision, blurred vision, impaired vision, accommodation disorders.
• Sensation of spinning (dizziness), ringing in the ears, ear pain.
• Shortness of breath.
• Cough.
• Nosebleeds.
• Fever, malaise, weakness.
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection.
• Dry mouth.
• Hair loss.
• Itching.
• Joint pain or swelling, muscle cramps and twitching, muscle pain or weakness, chest pain.
• Weight gain.

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

• Reduced platelet count (blood cells responsible for stopping bleeding), reduced white blood cell count responsible for protection against infection, decreased blood potassium levels.
• Increased liver enzyme levels, increased eosinophil levels (a type of white blood cell) in the blood.
• Swelling of lymph nodes in the neck, armpits, and groin.
• Increased appetite.
• Euphoria.
• Hallucinations (seeing, hearing, or feeling things that are not there), severe psychiatric disorders (psychoses).
• Lack of emotional expression and/or inability to feel emotions, increased suspicion, panic attacks.
• Reading difficulties, speech disorders, difficulty with handwriting.
• Restlessness, increased mental and physical activity.
• Slowed thinking, thought process disorders, and reduced alertness.
• Limited or slowed movements, involuntary abnormal or repetitive muscle movements.
• Fainting.
• Abnormal sense of touch; reduced sensation.
• Smell disturbances.
• Sensations or symptoms that may herald a migraine attack or a specific type of seizure.
• Dry eyes, eye sensitivity to light, eyelid twitching, watery eyes.
• Hearing loss or reduced hearing, hearing loss in one ear.
• Slow or irregular heartbeat, palpitations (awareness of heart beating in the chest).
• Low blood pressure or reduced blood pressure upon standing (as a result, patients taking Epitoram may experience faintness, dizziness, or fainting associated with sudden change to upright or sitting position).
• Hot flushes, sensation of warmth.
• Pancreatitis.
• Excessive flatulence, heartburn, feeling of fullness in the stomach or bloating.
• Bleeding gums, excessive saliva production, drooling, bad breath.
• Excessive fluid intake, excessive thirst.
• Skin discolouration.
• Muscle stiffness, muscle pain.
• Blood in urine, urinary incontinence, sudden urge to urinate, kidney or flank pain.
• Difficulty achieving or maintaining erection, sexual dysfunction.
• Flu-like symptoms.
• Cold sensation (e.g. in fingers of hands and feet).
• Feeling of intoxication.
• Learning difficulties.

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

• Loss of consciousness.
• Vision loss in one eye, temporary blindness, night blindness.
• Lazy eye syndrome (amblyopia).
• Eye swelling and periorbital tissue swelling.
• Numbness, tingling, and colour change (white, blue, then red) in fingers of hands and feet upon cold exposure.
• Cholangitis, liver failure.
• Unpleasant body odour.
• Discomfort in arms or legs.
• Kidney disorders.

Not known (frequency cannot be estimated from available data):

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

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

• Difficulty concentrating.
• Increased levels of acid in the blood.
• Thoughts of severe self-harm.
• Fatigue.
• Decreased or increased appetite.
• Aggression, abnormal behaviour.
• Difficulty falling asleep and maintaining sleep.
• Unsteadiness while walking.
• Malaise.
• Decreased blood potassium levels.
• Lack of emotional expression and/or inability to feel emotions.
• Watery eyes.
• Slow or irregular heartbeat.

Other adverse reactions that may occur in children include:

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

• Sensation of spinning (dizziness).
• Vomiting.
• Fever.

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

• Increased eosinophil levels (a type of white blood cell) in the blood.
• Increased mental and physical activity.
• Sensation of warmth.
• Learning difficulties.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to: Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Epitoram

• Keep this medicine out of the sight and reach of children.
• Store below 25 °C. Keep in the original packaging to protect from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer used. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Epitoram contains

• The active substance 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), colloidal anhydrous silica (E551), hypromellose (E464), hydroxypropylcellulose (E463), macrogol, and titanium dioxide (E171). Tablets of 50 mg and 100 mg contain yellow iron oxide (E172) as a colouring agent. Tablets of 200 mg contain red iron oxide (E172) as a colouring agent.

What Epitoram looks like and contents of the pack
The patient should ensure they are taking the correct medicine:

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

Pack sizes:
Epitoram is available in blister packs containing 28 or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok.27
01-909 Warszawa
Poland

Manufacturers:
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