CARBAMAZEPINA 200 mg Tablet

Зміст інструкції

1. CARBAMAZEPINA EG 200 mg Tablets, 400 mg Tablets
   1. What is CARBAMAZEPINA EG and what it is used for
   2. What you need to know before taking CARBAMAZEPINA EG
   3. How to take CARBAMAZEPINA EG
   4. Possible side effects
   5. How to store CARBAMAZEPINA EG
   6. Contents of the pack and other information

CARBAMAZEPINA EG 200 mg Tablets, 400 mg Tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CARBAMAZEPINA EG is and what it is used for
• 2. What you need to know before you take CARBAMAZEPINA EG
• 3. How to take CARBAMAZEPINA EG
• 4. Possible side effects
• 5. How to store CARBAMAZEPINA EG
• 6. Contents of the pack and other information

1. What is CARBAMAZEPINA EG and what it is used for

CARBAMAZEPINA EG contains the active substance carbamazepine. CARBAMAZEPINA EG belongs to
a group of medicines known as antiepileptics .
CARBAMAZEPINA EG is indicated in adults for the treatment:

• of some forms of epilepsy, such as psychomotor or temporal epilepsy, generalized tonic-clonic seizures, mixed forms, focal seizures;
• of a painful condition of the face called trigeminal neuralgia (essential trigeminal neuralgias);
• of manic states.

Your doctor may prescribe CARBAMAZEPINA EG alone or in combination with other medicines.
CARBAMAZEPINA EG does not act on some forms of epilepsy such as "petit mal" and
myoclonic attacks.

2. What you need to know before taking CARBAMAZEPINA EG

Do not take CARBAMAZEPINA EG

• if you are allergic to carbamazepine, to medicines similar to carbamazepine (e.g. tricyclic antidepressants) or to any of the other ingredients of this medicine (listed in section 6);
• if you have a heart conduction disorder (atrioventricular block);
• if you have had a reduction in bone marrow activity with a consequent decrease in the number of blood cells;
• if you have a blood disease called hepatic porphyria e.g. acute intermittent porphyria, variegated porphyria, porphyria cutanea tarda;
• if you are using medicines for the treatment of depression and Parkinson's disease (monoamine oxidase inhibitors); see section “Other medicines and Carbamazepina EG”;
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking CARBAMAZEPINA EG.

Tell your doctor before takingCARBAMAZEPINA EG if:

• you have or have had problems with your liver: your doctor will have tests done at the beginning and during treatment;
• you have or have had heart problems;
• you have or have had kidney problems;
• you have kidney problems associated with low levels of sodium in the blood or if you are using medicines that reduce sodium levels in the blood e.g. diuretics to reduce blood pressure and medicines that counteract the activity of a hormone called aldosterone. Your doctor will check sodium levels in the blood before starting therapy with Carbamazepina EG, then after about two weeks and subsequently once a month for the first three months of therapy, or as needed.
• you have had adverse effects that have affected the blood after treatments with other medicines or after previous cycles of carbamazepine therapy;
• you are of Chinese, Thai, Japanese or other Asian origin because serious skin side effects have been reported. If you are part of one of the populations listed above, the risk of having these side effects can be predicted through a blood test;
• you have had or have severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) on previous treatments with Carbamazepina EG, because you should no longer use Carbamazepina EG;
• you are allergic to phenytoin, primidone or phenobarbital (medicines for epilepsy) because you may also be allergic to carbamazepine contained in Carbamazepina EG;
• you suffer from hypothyroidism, i.e. the thyroid gland does not work properly because the doctor will monitor you and assess whether to change the dose of Carbamazepina EG;
• you suffer from high pressure inside the eye;
• you suffer from urinary retention.

Stop treatment with Carbamazepina EG and tell your doctor immediatelyif:

• you experience signs and symptoms of severe skin reactions, such as round red spots or circular patches that are often accompanied by blisters in the central part of the trunk, ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes) often accompanied by symptoms similar to those of the flu, because these are signs of severe skin reactions that can also be fatal. These reactions are more likely in the first few months of treatment.
• you experience signs and symptoms of a severe allergic reaction to Carbamazepina EG, such as fever, rash, inflammation of blood vessels, swollen lymph nodes, joint pain, changes in some blood parameters, problems with the liver, spleen, lungs and other organs.

Tell your doctor immediately if during treatment:

• you experience fever, sore throat, rash or any sign of skin reactions, ulcers in the mouth, capillary fragility, small red spots on the skin (petechiae) or reddish-purple bleeding, because these are signs of toxicity and blood problems. See also “Important information”.
• you are being treated with Carbamazepina EG for mixed seizures (including typical and atypical absences) and notice a worsening of seizures, because it may be necessary to stop treatment
• you have a worsening of liver problems or if you develop liver problems, because it may be necessary to stop treatment with Carbamazepina EG
• you have a reduction in sodium levels in the blood (visible from blood tests)
• you develop thoughts or a tendency to suicide
• you are using oral contraceptives to avoid pregnancy, because their effectiveness may be reduced or canceled by treatment with Carbamazepina EG. Discuss with your doctor the use of alternative contraceptive methods (see section “Pregnancy, breastfeeding and fertility”)
• you experience dizziness, drowsiness, decreased blood pressure, confusion, sedation or disturbances of voluntary movements that can lead to falls.

Important information:

• If you have had allergic reactions to carbamazepine, you may also have an allergic reaction to oxcarbazepine.
• During treatment with Carbamazepina EG, your doctor will have periodic urine and blood tests done.
• During treatment with Carbamazepina EG, a decrease in the number of platelets and white blood cells may occur; cases of reduction in the number of red blood cells (aplastic anemia) and severe reduction in the number of white blood cells (agranulocytosis) have also been reported. Your doctor will monitor you closely and have a complete blood test done before treatment and periodically during treatment.
• Treatment with Carbamazepina EG may reveal hidden mental illnesses and cause agitation and confusion in elderly patients.

The use of Carbamazepina EG during pregnancy carries the risk of harm to the fetus. Women of childbearing potential
must use effective contraceptive methods during treatment with Carbamazepina EG and for two
weeks after the last dose (see Pregnancy and breastfeeding).

Other medicines and CARBAMAZEPINA EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not use Carbamazepina EG if you are using:

• medicines for the treatment of depression and Parkinson's disease (monoamine oxidase inhibitors). Before using Carbamazepina EG, the administration of monoamine oxidase inhibitors must be stopped for at least 2 weeks or for a longer period (see section “Do not use Carbamazepina EG”).

Consult your doctor before using Carbamazepina EG if you are using:

• levetiracetam (medicine for epilepsy)
• isoniazid (antibiotic)
• lithium (medicine for mood disorders)
• metoclopramide (antiemetic medicine)
• neuroleptics (psychotropic drugs): haloperidol, thioridazine
• diuretics (medicines that promote urine elimination): hydrochlorothiazide, furosemide
• muscle relaxants e.g.: pancuronium
• direct-acting oral anticoagulants e.g.: rivaroxaban, dabigatran, apixaban, edoxaban.

Tell your doctor if you are using one or more of the medicines listed below, because these increase the effects of Carbamazepina EG:

• medicines to reduce pain and inflammation: destromethorphan, ibuprofen
• hormonal medicines (androgens): danazol
• antibiotics: erythromycin, troleandomycin, josamycin, clarithromycin, ciprofloxacin
• medicines against depression: desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine.
• medicines for epilepsy and seizures: stiripentol, vigabatrin, primidone, progabide, valproic acid, brivaracetam.
• medicines to fight fungal infections: itraconazole, ketoconazole, fluconazole, voriconazole
• medicines for allergies: loratadine, terfenadine
• medicines used in severe psychiatric disorders (antipsychotics): olanzapine, loxapine, quetiapine
• medicines for tuberculosis: isoniazid
• medicines to fight viral infections: ritonavir
• medicines to reduce blood pressure: acetazolamide
• medicines for the heart: verapamil, diltiazem
• medicines for the stomach: cimetidine, omeprazole
• medicines that relax muscles: oxybutynin, dantrolene
• medicines that reduce blood clotting: ticlopidine
• nicotinamide (in adults only at high doses), used in vitamin B3 deficiency states
• sedative medicines: valnoctamide
• valpromide (medicine used for epilepsy and manic episodes in bipolar disorders).

These medicines increase the levels of the medicine in the blood and can therefore cause adverse effects
(e.g. dizziness, drowsiness, loss of coordination of movements, double vision), so your doctor
will have blood tests done to check the levels of Carbamazepina EG and these medicines in the
blood and will assess whether to reduce the doses.
Tell your doctor if you are using one or more of the medicines listed below, because these reduce the effects
of Carbamazepina EG:

• medicines for epilepsy: felbamate, mesuximide, oxcarbazepine, phenobarbital, fensuximide, phenytoin and phosphophenytoin, primidone, clonazepam
• medicines against cancer: cisplatin, doxorubicin
• medicines for tuberculosis: rifampicin
• medicines for asthma: theophylline, aminophylline
• medicines for skin problems such as acne: isotretinoin
• St. John's Wort (Hypericum perforatum), herbal medicine used for depression

These medicines reduce the levels of carbamazepine which may therefore be less effective. Your doctor will
have blood tests done to check the levels of Carbamazepina EG and assess whether to change the dose.
Tell your doctor if you are using one or more of the medicines listed below, because Carbamazepina EG can
modify their effect:

• medicines to reduce pain and inflammation: buprenorphine, methadone, paracetamol (acetaminophen), phenazone (antipyrine), tramadol
• antibiotics: doxycycline, rifabutin
• medicines that reduce blood clotting taken orally e.g.: warfarin, phenprocoumon, dicoumarol, acenocoumarol, rivaroxaban, dabigatran, apixaban, edoxaban
• medicines against depression: bupropion, citalopram, mianserin, nefazodone, sertraline, trazodone, imipramine, amitriptyline, nortriptyline, clomipramine
• medicines against nausea: aprepitant
• medicines for epilepsy: clobazam, clonazepam, ethosuximide, felbamate, lamotrigine, eslicarbazepine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide, mephenytoin
• medicines to fight fungal infections: itraconazole, voriconazole
• medicines against parasites: praziquantel, albendazole
• medicines against cancer: imatinib, cyclophosphamide, lapatinib, temsirolimus
• medicines used in severe psychiatric disorders (antipsychotics): clozapine, haloperidol and bromperidol, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, paliperidone.
• medicines to fight viral infections: indinavir, ritonavir, saquinavir
• medicines against anxiety: alprazolam, midazolam.
• medicines for asthma: theophylline
• contraceptive hormones (used to avoid pregnancy), for example pills, patches, injections or implants (see section “Pregnancy, breastfeeding and fertility”). Carbamazepina EG may affect the action of hormonal contraceptives and make them less effective in preventing pregnancy. Talk to your doctor, who will discuss with you the type of contraception most suitable for use during taking Carbamazepina EG.
• medicines for the treatment of high blood pressure (dihydropyridine calcium antagonists) e.g.: felodipine, ivabradine, digoxin
• medicines to reduce cholesterol: simvastatin, atorvastatin, lovastatin, cerivastatin
• hormonal medicines (corticosteroids) e.g.: prednisolone, dexamethasone
• medicines for erectile dysfunction: tadalafil
• medicines that suppress the immune system (immunosuppressants): cyclosporine, everolimus, tacrolimus, sirolimus
• medicines for the thyroid: levothyroxine
• medicines containing estrogens and/or progesterone

Carbamazepine may decrease the levels in the blood of some medicines causing a decrease or
even cancellation of their activity. The doctor will assess whether to change the dose of these medicines.

Diagnostic tests
Carbamazepina may alter some tests used to determine the concentrations of perphenazine and antidepressant medicines (tricyclic antidepressants).

CARBAMAZEPINA EG with food, drinks and alcohol
Do not use Carbamazepina EG together with grapefruit juice, because this increases the effect of
Carbamazepina EG.
Do not drink alcohol together with Carbamazepina EG, because this reduces tolerance to alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Carbamazepina EG can cause major birth defects. If you take Carbamazepina EG during pregnancy, the baby has a risk up to 3 times higher of having a birth defect compared to women who do not take antiepileptic drug treatment. Significant birth defects have been reported, including neural tube defects (opening of the spine), congenital facial defects such as “cleft lip” (split in the upper lip) and cleft palate (split in the palate), congenital head defects, heart defects, congenital penile defects involving the urinary opening (hypospadias) and finger defects. The fetus should be carefully monitored if you have taken Carbamazepina EG during pregnancy.
Problems with neurological development (brain development) have been reported in children born to mothers who used Carbamazepina EG during pregnancy. Some studies have shown that carbamazepine negatively affects the neurological development of children exposed to carbamazepine in the womb, while other studies have not found this effect. The possibility of an effect on neurological development cannot be excluded.
If you are a woman of childbearing potential and are not planning a pregnancy, you should use effective contraception during treatment with Carbamazepina EG. Carbamazepina EG can affect the action of hormonal contraceptives, such as the contraceptive pill, making them less effective in preventing pregnancy. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while taking Carbamazepina EG. If treatment with Carbamazepina EG is stopped, you should continue to use effective contraception for another two weeks after stopping.
If you are a woman of childbearing potential and are planning a pregnancy, consult your doctor before stopping contraception and starting a pregnancy, so that you can switch to other appropriate treatments, in order to avoid exposing the fetus to carbamazepine.
If you are pregnant or suspect you are pregnant, tell your doctor immediately. You should not stop taking the medicine until you have spoken to your doctor. Stopping treatment without consulting your doctor could cause seizures that could be potentially dangerous for you and the fetus. Your doctor may decide to change the treatment.
If you take Carbamazepina EG during pregnancy, the baby will also be at risk of bleeding problems immediately after birth. Your doctor may give you and your baby a medicine to prevent this from happening.
If you are planning a pregnancy or are pregnant, your doctor will recommend that you take folic acid supplements.
In addition, your doctor will recommend taking vitamin K1, both to you during the last weeks of pregnancy and to your baby.

Breastfeeding
Carbamazepine passes into breast milk. Talk to your doctor if you need to breastfeed to reassess with him the need for treatment with Carbamazepina EG

Fertility
In rare cases, impaired fertility in males and sperm production have been reported.

Driving and operating machinery
The ability to drive vehicles and use machinery may be altered by the underlying condition (seizures) and by side effects following treatment with Carbamazepina EG such as, for example, drowsiness, dizziness, loss of coordination (ataxia), visual disturbances (double vision, blurred vision).
These effects are more frequent at the beginning of treatment and when the doses of Carbamazepina EG are changed.
Be particularly careful if you need to drive vehicles or use machinery.
Carbamazepina EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take CARBAMAZEPINA EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
You must use Carbamazepina EG regularly and at the doses prescribed by your doctor. Do not exceed the doses and
frequency of administration recommended by your doctor.
The tablets can be taken before, during or after meals, with some liquid.

Treatment of epilepsy

Use in adults
The doctor will assess the most suitable dose for you and may gradually increase the dose over time.
The recommended initial dose is 100 - 200 mg 1 or 2 times a day. Your doctor will then tell you to
gradually increase the dose to 400 mg 2 or 3 times a day.

Treatment of trigeminal neuralgia

Use in adults
The recommended initial dose is 200 - 400 mg per day, which is then slowly increased
until the pain disappears (usually at a dose of 200 mg 3-4 times a day).
Subsequently, your doctor will gradually reduce the dose until the minimum effective maintenance dose is reached. The maximum recommended dose is 1200 mg per day. Once the pain has disappeared, your
doctor will gradually discontinue treatment until a new attack occurs.

Use in elderly patients and sensitive patients
In elderly people and particularly sensitive patients, the recommended initial dose is 100 mg 2
times a day.

Treatment of mania
The dose ranges from 400 mg to 1600 mg per day. The recommended dose is 400 - 600 mg per day divided
into 2-3 doses.

Use in elderly patients
The doctor will assess a possible reduction of the doses and establish the appropriate dosage in this population of
patients.

If you take more CARBAMAZEPINA EG than you should
In case of accidental ingestion of an excessive dose of CARBAMAZEPINA EG, immediately
inform your doctor or go to the nearest hospital.
You may experience difficulty breathing, rapid and irregular heartbeat, loss of consciousness, fainting,
tremor, nausea and/or vomiting, feeling unwell, problems with urination, hallucinations, disorientation, blurred
vision, confused speech, uncontrollable eye movements, dilated pupils, uncontrollable
movements such as muscle spasms, loss of coordination.

In these cases, stop treatment with Carbamazepina EG and contact your doctor immediately.

If you forget to take CARBAMAZEPINA EG
Do not take a double dose to make up for a missed dose.

If you stop taking CARBAMAZEPINA EG
Do not abruptly stop treatment with Carbamazepina EG as this may worsen your condition.
If you are taking Carbamazepina EG for the treatment of seizures or epilepsy, therapy must
be discontinued gradually over at least 6 months.
If treatment with Carbamazepina EG has to be stopped abruptly, your doctor will prescribe
another medicine.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

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

• reduction in the number of white blood cells in the blood (leukopenia);
• loss of coordination of movements (ataxia);
• dizziness;
• drowsiness,
• fatigue;
• nausea, vomiting;
• allergic skin rashes, urticaria which can also be severe
• increase in some liver enzymes

Common side effects (may affect up to 1 in 10 people)

• increase in the number of white blood cells in the blood (eosinophilia),
• reduction in the number of platelets in the blood (thrombocytopenia);
• swelling due to fluid accumulation (edema), fluid retention;
• increase in body weight;
• reduction in sodium levels in the blood
• reduction of some substances in the blood (e.g. salts), which can in rare cases lead to vomiting, drowsiness, lethargy, headache, confusion, brain disorders;
• headache;
• double vision, blurred vision;
• dry mouth.
• increase in levels of alkaline phosphatase in the blood.

Uncommon side effects (may affect up to 1 in 100 people)

• abnormal involuntary movements e.g. tremor, tics;
• abnormal eye movements (nystagmus);
• diarrhea, constipation;
• skin inflammation with redness and scaling (exfoliative dermatitis).
• Increase in some liver enzymes (transaminases).

Rare side effects (may affect up to 1 in 1000 people)

• increase in the number of white blood cells in the blood (leucocytosis),
• enlargement of the lymph nodes (lymphadenopathy),
• folic acid deficiency;
• delayed allergic reaction affecting multiple organs with symptoms such as fever, rash, inflammation of blood vessels, enlargement of the lymph nodes (lymphadenopathy), pseudo-lymphoma, joint pain (arthralgia), reduction in the number of white blood cells in the blood (leukopenia), increase in the number of white blood cells in the blood (eosinophilia), enlargement of the liver and/or the

spleen, alteration of liver function tests and destruction and disappearance of the intrahepatic bile ducts
(vanishing bile duct syndrome). Lungs, kidneys, pancreas, myocardium, colon may also be involved;

• hallucinations (visual or auditory), depression, restlessness, agitation, aggression, confusion;
• decreased appetite;
• involuntary movements of tongue, mouth, trunk and limbs (dyskinesia), movement disorders of the eyes, speech disorders (dysarthria, slurred speech), alteration of body movements (choreoathetosis)
• damage to peripheral nerves (peripheral neuropathies), tingling (paresthesia), paresis;
• disorders of the electrical activity of the heart;
• high or low blood pressure;
• abdominal pain;
• liver problems including yellowing of the skin, mucous membranes and eyes (jaundice);
• autoimmune disease called systemic lupus erythematosus,
• itching;
• muscle weakness.

Very rare side effects (may affect up to 1 in 10,000 people)

• reduction in the number of white blood cells in the blood (agranulocytosis),
• reduction in the number of red blood cells in the blood due to various causes (anemia, megaloblastic anemia, hemolytic anemia, aplastic anemia);
• reduction in the number of all blood cells (pancytopenia);
• reduction in the production of red blood cells (pure red cell aplasia);
• increase in the levels of red blood cell precursors (reticulocytosis);
• allergic reactions, even severe;
• swelling of the skin or mucous membranes (angioedema);
• reduction in gammaglobulins in the blood (hypogammaglobulinemia);
• swelling of the breasts and secretion of milk which can occur in both men and women;
• blood diseases called acute porphyria (acute intermittent porphyria and variegate porphyria), non-acute porphyria (tardive cutaneous porphyria);
• mental disorders;
• altered mental status and muscle rigidity, increased body temperature, heart rate, blood pressure (neuroleptic malignant syndrome)
• inflammation of the membranes lining the brain and spinal cord (aseptic meningitis)
• alterations in taste;
• eye disorders (conjunctivitis, lens opacity)
• hearing disorders e.g. ringing and buzzing in the ears (tinnitus), hypersensitivity and reduced tolerance to sounds, reduced ability to hear sounds, altered perception of tone;
• alterations in heart rhythm, severe heart failure, worsening of coronary problems, slowing of the heartbeat, blockage of cardiac conduction accompanied by fainting,
• circulatory collapse, formation of a blood clot in a vein e.g. in the lungs (pulmonary embolism);
• inflammation of a vein with subsequent formation of a blood clot in the vein itself (thrombophlebitis)
• pulmonary hypersensitivity characterized e.g. by fever, difficulty breathing and pneumonia;
• inflammation of the pancreas (pancreatitis);
• inflammation of the tongue (glossitis);
• inflammation of the oral mucosa (stomatitis);
• liver problems including liver failure, granulomatous hepatitis;
• rashes on the skin also potentially fatal (erythema multiforme, erythema nodosum, purpura, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• hypersensitivity to light or sunlight (photosensitivity reaction)
• alteration of skin color,
• acne,
• excessive sweating,
• hair loss,
• abnormal hair growth in women (hirsutism);
• bone metabolism disorders (leading to weakening of bones (osteomalacia/osteoporosis), joint pain, muscle pain and spasm;
• kidney problems such as tubulointerstitial nephritis, renal failure;
• kidney impairment (presence of protein in the urine, presence of blood in the urine, increased levels of urea and nitrogen in the blood
• reduced elimination of urine (oliguria), urinary retention, frequent emission of small amounts of urine (pollachiuria)
• sexual dysfunction, erectile dysfunction, abnormalities in sperm formation in males with decreased number and/or motility of sperm
• increased pressure inside the eye
• increased levels of cholesterol in the blood, HDL and triglycerides
• alteration of thyroid function parameters, increased levels of prolactin in the blood

Not known (frequency cannot be estimated from available data)

• recurrence of infections due to the Herpes virus;
• bone marrow depression (decrease in the number of blood cells caused by a malfunction of the system that produces blood cells);
• falls due to dizziness, drowsiness, decreased pressure, confusion, sedation, involuntary movement disorders
• sedation, memory disorders;
• inflammation of the colon (colitis);
• skin rash due to the medicine with increased number of white blood cells in the blood (eosinophilia) and symptoms involving the whole organism;
• severe form of reaction to the drug, characterized by erythema and swelling with formation of pustules (acute generalized exanthematous pustulosis - AGEP),
• alteration of the skin that presents thickened reddish plaques (lichenoid keratosis),
• nail loss (onychodysdysis);
• fractures of the bones, decreased bone density.
• high levels of ammonia in the blood (hyperammonemia). Symptoms of hyperammonemia can include irritability, confusion, vomiting, loss of appetite and drowsiness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store CARBAMAZEPINA EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Store the tablets at room temperature.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CARBAMAZEPINA EG contains

• The active ingredient is carbamazepine. Each tablet contains 200 or 400 mg of carbamazepine.
• The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose, anhydrous colloidal silicon dioxide, magnesium stearate.

Description of the appearance of CARBAMAZEPINA EG and contents of the pack
White, smooth tablets.
CARBAMAZEPINA EG is available in packs of 50 tablets for the 200 mg dosage and in
packs of 30 tablets for the 400 mg dosage.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6 – 20136 Milan

Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno, 48 20089, Quinto de’ Stampi, Rozzano - Milan