AMIZEPIN 200 mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: Patient Information
2. Amizepin, 200 mg, Tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Amizepin and what is it used for
4. Important information before taking Amizepin
   1. When not to take Amizepin:
   2. Warnings and precautions
   3. Special caution should be exercised when taking Amizepin if:
   4. Using Amizepin in children and elderly patients
   5. Amizepin and other medicines
   6. Medicines that may interact with Amizepin (and vice versa)
   7. Combination therapy requiring special attention
   8. Using Amizepin with food, drink, and alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Amizepin contains sodium
5. How to take Amizepin
   1. Adults:
   2. Children and adolescents:
   3. Taking a higher dose of Amizepin than recommended
   4. Missing a dose of Amizepin
   5. Stopping treatment with Amizepin
6. Possible side effects
   1. Severe side effects:
   2. The patient should immediately stop taking the medicine and consult their doctor if they experience any of the following severe side effects:
   3. Other side effects:
   4. The patient should consult their doctor if they experience any of the following side effects:
   5. Reporting side effects
7. How to store Amizepin
8. Contents of the pack and other information
   1. What Amizepin contains
   2. What Amizepin looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Patient Information Leaflet: Patient Information

Amizepin, 200 mg, Tablets

Carbamazepine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Amizepin and what is it used for

Amizepin belongs to a group of antiepileptic medicines. It has anticonvulsant effects and may also modify certain types of pain and regulate mood disorders.
Amizepin is used:

• to treat certain types of epilepsy
• to treat pain that occurs in the course of certain neurological diseases, such as trigeminal neuralgia
• to prevent bipolar mood disorders (alternating episodes of depression and mania) in patients who do not respond to treatment with lithium products.

2. Important information before taking Amizepin

When not to take Amizepin:

• if the patient is allergic to carbamazepine, other similar medicines, e.g. tricyclic antidepressants, such as amitriptyline, desipramine, protriptyline or any of the other ingredients of this medicine (listed in section 6);
• if the patient has porphyria (a disorder of porphyrin production, a pigment important for liver function and blood formation);
• if the patient has atrioventricular block of the heart;
• if the patient has had severe blood diseases in the past (disorders of bone marrow function, including severe anemia);
• if the patient is being treated with antidepressant medicines called MAO inhibitors, e.g. phenelzine, selegiline, tranylcypromine (carbamazepine can be used no earlier than 14 days after discontinuation of MAO inhibitors).

Warnings and precautions

Before starting treatment with Amizepin, the patient should discuss it with their doctor or pharmacist.

Special caution should be exercised when taking Amizepin if:

• the patient has a blood disease (also caused by taking other medicines);
• the patient has ever had an allergy to oxcarbazepine or other medicines (rash or other allergic symptoms). Patients allergic to carbamazepine may (in about 1 in 4, 25%) also be allergic to oxcarbazepine;
• the patient has ever had blood count disorders, such as leukopenia, while taking other medicines;
• the patient has had an allergic reaction to the antiepileptic medicine phenytoin;
• the patient has or has had cardiovascular, liver, or kidney disease;
• the patient has kidney problems related to low sodium levels in the blood or is taking medicines that lower sodium levels in the blood (diuretics such as hydrochlorothiazide and furosemide);
• the patient has difficulty holding urine;
• the patient has glaucoma (increased pressure in the eyeball);
• the patient has a mental disorder called psychosis, which may be accompanied by symptoms such as disorientation and agitation (especially in elderly patients);
• the patient has hypothyroidism.

In case of:

• an allergic reaction, manifested by fever with simultaneous lymph node enlargement, rash, or blisters on the skin, the patient should inform their doctor or go to the nearest hospital (see section 4);
• an increase in the frequency of seizures or the occurrence of mixed seizures, including loss of consciousness, the patient should immediately inform their doctor;
• the appearance of symptoms indicating hepatitis, such as jaundice (yellowing of the skin and eyes), the patient should inform their doctor;
• the appearance of symptoms such as fever, sore throat, rash, oral ulcers, easy bruising, or petechiae, the patient should contact their doctor immediately.

Do not stop taking Amizepin without consulting a doctor. To prevent the worsening of epilepsy, the medicine should not be stopped abruptly.
There have been reports of severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) during carbamazepine treatment. The rash is often accompanied by oral ulcers, pharyngitis, or conjunctivitis (red and swollen eyes). These serious rashes are often preceded by flu-like symptoms, such as fever, headache, and bone pain. The rash can progress to blistering.
The greatest risk of serious skin reactions is in the first few months of treatment.
Severe skin reactions are more common in patients of Asian descent. In patients of Chinese and Thai descent, the risk of such reactions can be predicted based on a blood test. The doctor should advise the patient whether a blood test is needed before starting carbamazepine treatment.
If a rash or other skin symptoms appear, the patient should stop taking carbamazepine and contact their doctor immediately.
A small number of people taking antiepileptic medicines containing carbamazepine have thought about harming or killing themselves.
If the patient ever has such thoughts, they should contact their doctor immediately.
During treatment with Amizepin during pregnancy, there is a risk of harmful effects on the unborn child. If the patient is of childbearing age, she should use effective contraception during treatment with Amizepin and for two weeks after taking the last dose (see "Pregnancy and breastfeeding").

Using Amizepin in children and elderly patients

The medicine can be used in children and elderly patients, in accordance with the doctor's recommendations.
In these patients, caution should be exercised when dosing the medicine and the patient should be closely monitored.

Amizepin 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.
This is especially important for Amizepin, as many different medicines can affect its action.
Sometimes it may be necessary to change the dosage or stop taking some medicines.
Hormonal contraceptives, e.g. pills, patches, injections, or implants
Amizepin may affect the action of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. The patient should discuss with their doctor the most suitable type of contraception during treatment with Amizepin. The patient should immediately inform their doctor if they experience irregular bleeding or spotting.

Medicines that may interact with Amizepin (and vice versa)

Painkillers, anti-inflammatory medicines: dextropropoxyphene, buprenorphine, methadone, paracetamol, tramadol.
Androgenic medicines: danazol (used to treat endometriosis).
Antibiotics: macrolide antibiotics (e.g. erythromycin, clarithromycin), ciprofloxacin, doxycycline, rifabutin.
Medicines used to treat depression: fluoxetine, fluvoxamine, paroxetine, trazodone, bupropion (used to alleviate withdrawal symptoms after quitting smoking), citalopram, mianserin, sertraline, nefazodone, tricyclic antidepressants (e.g. imipramine, amitriptyline, nortriptyline, clomipramine).
Other antiepileptic medicines: vigabatrin, primidone, progabide, valproic acid, valpromide, phenytoin, fosphenytoin, oxcarbazepine, phenobarbital, clonazepam, clobazam, ethosuximide, lamotrigine, oxcarbazepine, tiagabine, topiramate, zonisamide, brivaracetam. There are also rare reports of increased serum levels of mephenytoin.
Antifungal medicines: azoles (e.g. itraconazole, ketoconazole, fluconazole, voriconazole).
Antihistamines: loratadine.
Antipsychotic medicines: olanzapine, quetiapine, clozapine, haloperidol, and bromperidol, risperidone, aripiprazole, paliperidone.
Antituberculosis medicines: isoniazid, rifampicin.
Antiviral medicines: used to treat HIV infections (e.g. ritonavir, indinavir, saquinavir).
Carbonic anhydrase inhibitors: acetazolamide (used, among other things, in glaucoma).
Cardiovascular medicines: verapamil, diltiazem, calcium channel blockers (dihydropyridine derivatives, e.g. felodipine), digoxin, simvastatin, atorvastatin, lovastatin, cerivastatin, ivabradine.
Medicines used to treat stomach ulcers: cimetidine, omeprazole.
Sedatives and tranquilizers: valnoctamide.
Anxiolytic medicines: alprazolam.
Anticancer medicines: cisplatin, doxorubicin, imatinib, cyclophosphamide, lapatinib.
Immunosuppressive medicines: cyclosporine, everolimus, tacrolimus, sirolimus (medicines used after transplants, but also in the treatment of arthritis or psoriasis).
Bronchodilators and anti-asthmatic medicines: theophylline and aminophylline.
Medicines used in dermatology: isotretinoin (a medicine used to treat acne).
Anticoagulant medicines: oral anticoagulants (e.g. dicumarol, warfarin, acenocoumarol).
Anti-emetic medicines: aprepitant.
Medicines used to treat worms: albendazole.
Corticosteroids: e.g. prednisolone or dexamethasone.
Medicines used to treat erectile dysfunction: tadalafil.
Medicines used to treat thyroid diseases: levothyroxine.
Contraceptives: hormonal contraceptives (it is recommended to consider using other methods of contraception).
Other interactions: grapefruit juice, niacinamide (in adults, only in large quantities), herbal preparations containing St. John's Wort (Hypericum perforatum), medicines containing estrogens and/or progestogens.

Combination therapy requiring special attention

Special caution should be exercised when taking Amizepin in combination with:
levetiracetam, isoniazid, lithium salts, metoclopramide, neuroleptics (e.g. haloperidol, thioridazine), certain diuretics (furosemide, hydrochlorothiazide), certain muscle relaxants (e.g. pancuronium).

Using Amizepin with food, drink, and alcohol

Carbamazepine may decrease alcohol tolerance. During treatment with Amizepin, the patient should not drink alcohol.
The patient should not eat grapefruits or drink grapefruit juice, as this may increase the action of Amizepin. Other juices, such as orange or apple, do not affect the action of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Amizepin may cause serious birth defects. If the patient takes Amizepin during pregnancy, the risk of birth defects in the child is three times higher than in women who do not take antiepileptic medicines. Serious birth defects, including neural tube defects (spina bifida), facial defects, such as cleft lip and palate, head defects, heart defects, and genital defects, have been reported. If the patient takes Amizepin during pregnancy, the unborn child should be closely monitored.
In infants born to mothers who took carbamazepine during pregnancy, developmental problems (brain development) have been reported. Some studies have shown that carbamazepine has a negative effect on the development of the nervous system in children exposed to carbamazepine in the womb, while other studies have not found such an effect. The effect on brain development cannot be ruled out.
If the patient is or thinks they may be pregnant, they should immediately tell their doctor. The patient should not stop taking the medicine until they have discussed it with their doctor.
Stopping the medicine without consulting a doctor may cause seizures, which can be dangerous for the patient and their unborn child. The doctor may decide to change the treatment.
If the patient takes Amizepin during pregnancy, there is also a risk of bleeding problems in the patient after childbirth. The doctor may prescribe a medicine to the patient and child to prevent this.
Women of childbearing age
If the patient is of childbearing age and does not plan to become pregnant, they should use effective contraception during treatment with Amizepin. Amizepin may affect the action of hormonal contraceptives, such as the contraceptive pill, and reduce their effectiveness in preventing pregnancy. The patient should discuss with their doctor the most suitable type of contraception during treatment with Amizepin. If the patient stops taking Amizepin, they should continue to use effective contraception for two weeks after stopping the medicine.
If the patient is of childbearing age and plans to become pregnant, they should consult their doctor before stopping contraception and before becoming pregnant, to change the treatment to another one that is safe for the unborn child.
Breastfeeding
Carbamazepine passes into breast milk. In special cases, if the doctor agrees to breastfeeding, the patient should monitor their child for any side effects. If side effects occur (e.g. excessive sleepiness, skin reactions, yellowing of the skin and eyes, dark urine), the patient should consult their doctor.

Driving and using machines

Amizepin may cause drowsiness, dizziness, or vision disturbances (blurred vision, double vision) or muscle coordination disorders, especially at the beginning of treatment or when increasing the dose of Amizepin. If such symptoms occur, the patient should not drive vehicles, operate machines, or perform other activities that require special attention.

Amizepin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Amizepin

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Usually, the recommended dose of Amizepin is:
Epilepsy
Treatment starts with a small daily dose, and the doctor will gradually increase the dose until the optimal effect is achieved.
The doctor may order blood tests to determine the concentration of the medicine in the blood, as this may be helpful in determining the optimal dosage.
If Amizepin is added to the existing antiepileptic treatment regimen, the doctor will introduce the medicine gradually, maintaining or, if necessary, modifying the dosage of other antiepileptic medicines.

Adults:

Adults usually start with 100 mg to 200 mg once or twice a day. The dose is gradually increased to 800 mg to 1200 mg per day, divided into several doses.
Some adults may require a dose of 1600 mg, or even 2000 mg per day, divided into several doses.

Children and adolescents:

Amizepin is not recommended for use in young children.
Children aged 5-10 years: 400 mg to 600 mg per day (2 to 3 tablets of 200 mg per day, divided into several doses).
Children and adolescents aged 10-15 years: 600 mg to 1000 mg per day (3 to 5 tablets of 200 mg per day, divided into several doses).
Adolescents over 15 years: 800 mg to 1200 mg per day (same doses as for adults).
The maximum recommended dose for children under 6 years is 35 mg/kg body weight per day.
The maximum recommended dose for children and adolescents aged 6-15 years is 1000 mg per day.
The maximum recommended dose for adolescents over 15 years is 1200 mg per day.
Trigeminal neuralgia
The initial dose is 200 mg to 400 mg per day. The dose is gradually increased until the pain subsides (usually 200 mg 3 to 4 times a day). The maximum dose is 1200 mg per day. Then the dose is reduced to the smallest dose that maintains the effect.
In elderly patients, treatment starts with a dose of 100 mg twice a day.
After the pain subsides, the dose can be gradually reduced and the medicine stopped after a few weeks of treatment, if the pain does not recur.
Mood disorders
The usual dose is 400 mg to 600 mg per day, divided into 2 or 3 doses.
Before surgery or dental procedures, the patient should inform their doctor about taking Amizepin.
Method of administration
The medicine should be taken with a small amount of liquid before, during, or between meals.
The tablets can be divided into equal doses.

Taking a higher dose of Amizepin than recommended

In case of accidental ingestion of a higher dose of the medicine than recommended, the patient should immediately contact their doctor or pharmacist.
Symptoms such as difficulty breathing, rapid or irregular heartbeat, loss of consciousness, fainting, tremors, or vomiting may indicate an overdose of the medicine.
In such cases, the patient should stop taking the medicine and immediately inform their doctor.

Missing a dose of Amizepin

In case of a missed dose, the patient should take it as soon as possible. However, if it is already time for the next dose, the missed dose should be skipped and the next dose taken at the scheduled time. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Amizepin

The patient should not stop taking Amizepin abruptly. They should first consult their doctor. The doses prescribed by the doctor may be different from those listed above. In such cases, the patient should always follow the doctor's instructions.

4. Possible side effects

Like all medicines, Amizepin can cause side effects, although not everybody gets them.
These effects often occur at the beginning of treatment and disappear after a few days of treatment.

Severe side effects:

The patient should immediately stop taking the medicine and consult their doctor if they experience any of the following severe side effects:

Frequent side effects (less than 1 in 10 people):

• lethargy, disorientation, muscle tremors, or significant worsening of epileptic symptoms, vomiting, headache (these symptoms may be due to low sodium levels in the blood).

Rare side effects (less than 1 in 1,000 people):

• yellowing of the whites of the eyes or skin (symptoms of hepatitis);
• spotting rash, mainly on the face, accompanied by a feeling of fatigue, fever, nausea, loss of appetite (symptoms of systemic lupus erythematosus).

Very rare side effects (less than 1 in 10,000 people):

• persistent fever, sore throat, rash, oral ulcers, blisters, or increased susceptibility to infections (symptoms of reduced white blood cell count, agranulocytosis);
• fatigue, headaches, shortness of breath during physical exertion, pale skin, frequent infections with fever, chills, and sore throat, increased susceptibility to bleeding and bruising, nosebleeds (reduced count of all blood cells, aplastic anemia, pancytopenia);
• swelling of the face, eyes, tongue, difficulty swallowing, wheezing, hives, and generalized itching, rash, fever, abdominal cramps, shortness of breath, or chest tightness, difficulty breathing, consciousness disorders (symptoms of angioedema or other severe allergic reactions);
• dark urine color (symptoms of porphyria or hepatitis);
• muscle stiffness, high fever, consciousness disorders, high blood pressure (symptoms of malignant neuroleptic syndrome);
• fever, nausea, vomiting, headaches, neck stiffness, sensitivity to light, seizures, and increased white blood cell count (symptoms of meningitis);
• irregular heartbeat, chest pain;
• fainting (symptoms of heart rhythm disorders: AV block and/or bradycardia);
• severe abdominal pain, vomiting, loss of appetite (symptoms of pancreatitis);
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) - skin reactions are more common in patients of Chinese and Thai descent, see section 2;
• rash, skin redness, blisters on the lips, eyes, and mouth, skin peeling accompanied by fever, chills, headache, cough, body aches (symptoms of severe skin reaction);
• decreased urine output, blood in the urine (symptoms of kidney disease).

Other side effects:

The patient should consult their doctor if they experience any of the following side effects:

Very common side effects (more than 1 in 10 people):
leukopenia (reduced white blood cell count), dizziness, coordination disorders, drowsiness, vomiting, nausea, hives, allergic skin inflammation, fatigue, changes in liver function tests (usually asymptomatic, detected in laboratory tests).
Common side effects (less than 1 in 10 people):
thrombocytopenia (reduced platelet count), eosinophilia (increased count of one type of white blood cell), edema, fluid retention, weight gain, double vision, headache, blurred vision, dry mouth, increased alkaline phosphatase activity (detected in laboratory tests).
Uncommon side effects (less than 1 in 100 people):
abnormal involuntary movements (e.g. tremors or tics), nystagmus, diarrhea, constipation, skin redness and peeling, increased liver enzyme activity (detected in laboratory tests).
Rare side effects (less than 1 in 1,000 people):
leukocytosis (increased white blood cell count), lymphadenopathy, generalized allergic reactions [such as: fever, skin rash, vasculitis, lymphadenopathy, lymphoma-like reactions (lymphadenopathy, cough, elevated body temperature, night sweats, excessive fatigue after physical exertion, weight loss, itching all over the body), joint pain, leukopenia (reduced white blood cell count), eosinophilia (increased count of one type of white blood cell), hepatosplenomegaly, and liver function disorders], decreased folate levels (detected in laboratory tests), decreased appetite, hallucinations, depression, agitation or hostility, anxiety, disorientation, involuntary and abnormal movements of the face and tongue, eye movement disorders, speech disorders, choreoathetotic disorders (uncoordinated movements of the limbs, independent of the will), peripheral neuropathy, numbness and/or tingling in the limbs, paresis, cardiovascular disorders (dizziness with flushing, headache, fatigue, nervousness), hypotension (weakness, dizziness, disorientation, blurred vision).
Very rare side effects (less than 1 in 10,000 people):
pure red cell aplasia (reduced production of red blood cells), anemia, immune system disorders, inappropriate milk secretion, gynecomastia (breast enlargement in men), psychosis reactivation (emotional and behavioral disorders), taste disorders, cataract, conjunctivitis (itching, redness, and swelling of the eyes), tinnitus or buzzing in the ears, hearing disorders, congestive heart failure, worsening of coronary artery disease, cardiac arrest, thromboembolism (e.g. pulmonary embolism), phlebitis (inflammation of the veins), respiratory disorders with fever and/or shortness of breath, pneumonia, mouth or gum pain, or redness, liver failure, increased skin sensitivity to light, skin pigmentation disorders, petechiae (bleeding into the skin), acne, increased sweating, hair loss or growth, bone softening (may manifest as pain when walking and bowing of the long bones of the legs), osteoporosis, joint pain, muscle pain or cramps, interstitial nephritis and kidney failure, proteinuria and/or increased urea and/or azotemia (detected in laboratory tests), urinary retention, frequent urination, sexual disorders, impotence, infertility in men, feeling of pressure and eye pain (symptoms of increased pressure in the eyes), increased levels of lipids in the blood (cholesterol, including HDL and triglycerides), abnormal thyroid function test results (detected in laboratory tests), increased prolactin levels in the blood (detected in laboratory tests).
Unknown frequency of side effects (frequency cannot be determined based on available data):
bone marrow suppression, severe skin reactions with poor general condition and changes in blood test results, reactivation of herpes virus (may be severe in case of weakened immune system), high ammonia levels in the blood (hyperammonemia); symptoms of hyperammonemia may include irritability, disorientation, vomiting, loss of appetite, and drowsiness, sedation, memory disorders, abdominal pain, and fever (colitis), psoriasis-like keratosis (purple or reddish-purple nodules that may be itchy), complete loss of nails, fractures, decreased bone density.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Amizepin

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 pack and other information

What Amizepin contains

• The active substance of the medicine is carbamazepine. Each tablet contains 200 mg of carbamazepine.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

What Amizepin looks like and what the pack contains

The tablets are white, round, and biconvex, with a dividing line. The tablets can be divided into equal doses.
The packaging contains 50 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: