Carbamazepine EG: detailed information

Package leaflet: Information for the patient

CARBAMAZEPINE EG 200 mg Tablets, 400 mg Tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CARBAMAZEPINE EG is and what it is used for
What you need to know before taking CARBAMAZEPINE EG
How to take CARBAMAZEPINE EG
Possible side effects
How to store CARBAMAZEPINE EG
Contents of the pack and other information

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

CARBAMAZEPINE EG contains the active substance carbamazepine. CARBAMAZEPINE EG belongs to
a group of medicines known as anti-epileptics.
CARBAMAZEPINE EG is indicated in adults for the treatment of:

certain types of epilepsy, such as psychomotor or temporal lobe epilepsy, generalized tonic-clonic seizures, mixed forms, and focal seizures;
a painful facial condition known as trigeminal neuralgia (essential trigeminal neuralgia);
manic states.

Your doctor may prescribe CARBAMAZEPINE EG alone or in combination with other medicines.
CARBAMAZEPINE EG does not work for certain types of epilepsy such as "absence seizures" (petit mal) and myoclonic seizures.

2. What you need to know before taking CARBAMAZEPINE EG

Do not take CARBAMAZEPINE 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 reduced bone marrow activity leading to a decrease in blood cells;
if you have a blood disease called hepatic porphyria, e.g. acute intermittent porphyria, variegate porphyria, or late cutaneous porphyria;
if you are taking medicines for depression and Parkinson’s disease (monoamine oxidase inhibitors); see section “Other medicines and Carbamazepine EG”;
if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking CARBAMAZEPINE EG.
Inform your doctor before taking CARBAMAZEPINE EG if:

you have or have had liver problems: your doctor will carry out checks 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 sodium levels in the blood, or if you are taking medicines that reduce sodium levels in the blood, e.g. diuretics to lower blood pressure, or medicines that counteract the activity of a hormone called aldosterone. Your doctor will check your blood sodium levels before starting treatment with Carbamazepine EG, then about two weeks later, and subsequently once a month during the first three months of treatment, or as needed.
you have previously experienced adverse effects affecting the blood after treatment with other medicines or previous courses of carbamazepine therapy;
you are of Chinese, Thai, Japanese, or other Asian descent, as serious skin-related adverse reactions have been reported in these populations. If you belong to one of the populations listed above, the risk of such adverse reactions may be predicted by a blood test;
you have had or have had severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) during previous treatment with Carbamazepine EG, as you must not use Carbamazepine EG again;
you are allergic to phenytoin, primidone, or phenobarbital (medicines for epilepsy), as you may also be allergic to carbamazepine contained in Carbamazepine EG;
you suffer from hypothyroidism (underactive thyroid gland), as your doctor will monitor you and may consider adjusting your dose of Carbamazepine EG;
you have high pressure inside the eye;
you suffer from urinary retention.

Stop treatment with Carbamazepine EG and contact your doctor immediately if:

you develop signs and symptoms of serious skin reactions, such as red, round spots or circular patches, often with blisters in the central trunk area, mouth ulcers, ulcers in the throat, nose, genitals, and conjunctivitis (red, swollen eyes), often accompanied by flu-like symptoms, as these may indicate serious, potentially fatal skin reactions. These reactions are more likely during the first months of treatment.
you develop signs and symptoms of a severe allergic reaction to Carbamazepine EG, such as fever, rash, blood vessel inflammation, swollen lymph nodes, joint pain, changes in certain blood parameters, liver problems, spleen problems, lung problems, or other organ issues.

Contact your doctor immediately if, during treatment:

you develop fever, sore throat, rash, or any sign of skin reactions, mouth ulcers, capillary fragility, small red spots on the skin (petechiae), or red-purple bleeding, as these may indicate toxicity or blood disorders. See also “Important information”.
you are being treated with Carbamazepine EG for mixed seizures (including typical and atypical absences) and notice worsening of epileptic seizures, as treatment may need to be discontinued.
you experience worsening of liver problems or develop new liver problems, as treatment with Carbamazepine EG may need to be stopped.
you develop low sodium levels in the blood (detectable by blood tests).
you develop thoughts of suicide or suicidal tendencies.
you are using oral contraceptives to prevent pregnancy, as their effectiveness may be reduced or nullified by treatment with Carbamazepine EG. Discuss with your doctor the use of alternative contraceptive methods (see section “Pregnancy, breastfeeding and fertility”).
you experience dizziness, drowsiness, low blood pressure, confusion, sedation, or movement disorders that may 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 Carbamazepine EG, your doctor will periodically perform urine and blood tests.
During treatment with Carbamazepine EG, a decrease in platelet and white blood cell counts may occur. Cases of reduced red blood cell production (aplastic anaemia) and severe reduction in white blood cells (agranulocytosis) have also been reported. Your doctor will closely monitor you and perform a complete blood count before treatment and periodically during treatment.
Treatment with Carbamazepine EG may unmask underlying psychiatric disorders and may cause agitation and confusion in elderly patients.

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

Other medicines and CARBAMAZEPINE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use Carbamazepine EG if you are taking:

medicines for depression and Parkinson’s disease (monoamine oxidase inhibitors). Before using Carbamazepine EG, treatment with monoamine oxidase inhibitors must be discontinued for at least 2 weeks or longer (see section “Do not use Carbamazepine EG”).

Consult your doctor before using Carbamazepine EG if you are taking:

levetiracetam (an antiepileptic medicine)
isoniazid (an antibiotic)
lithium (a mood-stabilizing medicine)
metoclopramide (an antiemetic medicine)
neuroleptics (psychiatric medicines): haloperidol, thioridazine
diuretics (medicines that promote urine elimination): hydrochlorothiazide, furosemide
muscle relaxants, e.g.: pancuronium
direct oral anticoagulants, e.g.: rivaroxaban, dabigatran, apixaban, edoxaban.

Inform your doctor if you are taking one or more of the following medicines, as they increase the effects of Carbamazepine EG:

pain and anti-inflammatory medicines: dextropropoxyphene, ibuprofen
hormonal medicines (androgens): danazol
antibiotics: erythromycin, troleandomycin, josamycin, clarithromycin, ciprofloxacin
antidepressants: desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine
antiepileptic and anticonvulsant medicines: stiripentol, vigabatrin, primidone, progabide, valproic acid, brivaracetam
antifungal medicines: itraconazole, ketoconazole, fluconazole, voriconazole
allergy medicines: loratadine, terfenadine
medicines used in severe psychiatric disorders (antipsychotics): olanzapine, loxapine, quetiapine
tuberculosis medicines: isoniazide
antiviral medicines: ritonavir
blood pressure-lowering medicines: acetazolamide
heart medicines: verapamil, diltiazem
stomach medicines: cimetidine, omeprazole
muscle relaxants: oxybutynin, dantrolene
blood-thinning medicines: ticlopidine
nicotinamide (in adults only at high doses), used in vitamin B3 deficiency states
sedatives: valnoctamide
valpromide (a medicine used for epilepsy and manic episodes in bipolar disorders)

These medicines increase the blood levels of the drug and may therefore cause adverse effects (e.g. dizziness, drowsiness, loss of motor coordination, double vision). Your doctor will perform blood tests to monitor levels of Carbamazepine EG and these medicines and may consider reducing their doses.

Inform your doctor if you are taking one or more of the following medicines, as they reduce the effects of Carbamazepine EG:

antiepileptic medicines: felbamate, methsuximide, oxcarbazepine, phenobarbital, fensuximide, phenytoin and fosphenytoin, primidone, clonazepam
anticancer medicines: cisplatin, doxorubicin
tuberculosis medicines: rifampicin
asthma medicines: theophylline, aminophylline
skin problem medicines such as acne: isotretinoin
St John’s wort (Hypericum perforatum), a herbal remedy used for depression

These medicines reduce carbamazepine levels, which may make it less effective. Your doctor will perform blood tests to monitor levels of Carbamazepine EG and may consider adjusting the dose.

Inform your doctor if you are taking one or more of the following medicines, as Carbamazepine EG may alter their effects:

pain and anti-inflammatory medicines: buprenorphine, methadone, paracetamol (acetaminophen), phenazone (antipyrine), tramadol
antibiotics: doxycycline, rifabutin
oral anticoagulants, e.g.: warfarin, phenprocoumon, dicoumarol, acenocoumarol, rivaroxaban, dabigatran, apixaban, edoxaban
antidepressants: bupropion, citalopram, mianserin, nefazodone, sertraline, trazodone, imipramine, amitriptyline, nortriptyline, clomipramine
anti-nausea medicines: aprepitant
antiepileptic medicines: clobazam, clonazepam, ethosuximide, felbamate, lamotrigine, eslicarbazepine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide, mephenytoin
antifungal medicines: itraconazole, voriconazole
antiparasitic medicines: praziquantel, albendazole
anticancer medicines: imatinib, cyclophosphamide, lapatinib, temsirolimus
antipsychotics: clozapine, haloperidol and bromperidol, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, paliperidone
antiviral medicines: indinavir, ritonavir, saquinavir
anti-anxiety medicines: alprazolam, midazolam
asthma medicines: theophylline
hormonal contraceptives (used to prevent pregnancy), e.g. pills, patches, injections, or implants (see section “Pregnancy, breastfeeding and fertility”). Carbamazepine EG may affect the action of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. Consult your doctor, who will discuss the most appropriate type of contraception to use during treatment with Carbamazepine EG.
medicines for high blood pressure (dihydropyridine calcium antagonists), e.g.: felodipine, ivabradine, digoxin
cholesterol-lowering medicines: simvastatin, atorvastatin, lovastatin, cerivastatin
hormonal medicines (corticosteroids), e.g.: prednisolone, dexamethasone
medicines for erectile dysfunction: tadalafil
immunosuppressants: cyclosporine, everolimus, tacrolimus, sirolimus
thyroid medicines: levothyroxine
medicines containing oestrogen and/or progesterone

Carbamazepine may reduce blood levels of certain medicines, leading to reduced or even abolished activity. Your doctor will evaluate whether the dose of these medicines needs to be adjusted.

Diagnostic tests
Carbamazepine may alter certain tests used to determine levels of perphenazine and antidepressant medicines (tricyclic antidepressants).

CARBAMAZEPINE EG with food, drinks and alcohol
Do not take Carbamazepine EG with grapefruit juice, as this increases the effect of Carbamazepine EG.
Do not consume alcohol with Carbamazepine EG, as this reduces alcohol tolerance.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Carbamazepine EG may cause significant congenital malformations. If you take Carbamazepine EG during pregnancy, your baby has up to a 3 times higher risk of congenital malformations compared to babies born to women not taking antiepileptic medicines. Serious congenital malformations have been reported, including neural tube defects (spinal column opening), facial malformations such as cleft lip (cleft in the upper lip) and cleft palate, head malformations, heart defects, penile defects involving the urinary opening (hypospadias), and finger defects. The fetus should be closely monitored if you have taken Carbamazepine EG during pregnancy.

Neurodevelopmental problems (brain development) have been reported in children born to mothers who used Carbamazepine EG during pregnancy. Some studies have shown that carbamazepine negatively affects neurological development in children exposed in utero, while others have not found such an effect. A possible effect on neurodevelopment cannot be ruled out.

If you are a woman of childbearing potential and not planning a pregnancy, you must use an effective contraceptive method during treatment with Carbamazepine EG. Carbamazepine EG may affect the action of hormonal contraceptives, such as the contraceptive pill, making them less effective in preventing pregnancy. Consult your doctor, who will discuss the most appropriate type of contraception to use during treatment with Carbamazepine EG. If treatment with Carbamazepine EG is stopped, you must continue using an effective contraceptive method for two additional weeks after stopping.

If you are a woman of childbearing potential and planning a pregnancy, consult your doctor before stopping contraception and starting a pregnancy, so that you can switch to appropriate alternative treatments to avoid fetal exposure to carbamazepine.

If you are pregnant or suspect you are pregnant, inform your doctor immediately. Do not stop taking the medicine until you have discussed it with your doctor. Stopping treatment without medical advice could lead to potentially dangerous seizures for you and the fetus. Your doctor may decide to modify your treatment.

If you take Carbamazepine EG during pregnancy, your baby will also be at risk of bleeding problems immediately after birth. Your doctor may administer a medicine to you and your baby to prevent this.

If you are planning a pregnancy or are pregnant, your doctor will recommend taking folic acid supplements.

Additionally, your doctor will recommend vitamin K1, both for you during the last weeks of pregnancy and for your baby.

Breastfeeding
Carbamazepine passes into breast milk. Consult your doctor if you intend to breastfeed, to reassess the need for treatment with Carbamazepine EG.

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

Driving and using machines
Your ability to drive vehicles and operate machinery may be impaired by the underlying condition (seizures) and by adverse effects of treatment with Carbamazepine EG, such as drowsiness, dizziness, loss of motor coordination (ataxia), and visual disturbances (double vision, blurred vision). These effects are more common at the beginning of treatment and when doses of Carbamazepine EG are changed.

Exercise particular caution if you need to drive or operate machinery.

Carbamazepine 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 CARBAMAZEPINE EG

Take this medicine exactly as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
You must take Carbamazepine EG regularly and at the doses prescribed by your doctor. Do not exceed the doses or frequency of administration recommended by your doctor.
The tablets can be taken before, during, or after meals, with a little liquid.

Treatment of epilepsy
Use in adults
Your doctor will determine the most suitable dose for you and may gradually increase it over time.
The recommended starting dose at the beginning of treatment is 100–200 mg once or twice daily. Your doctor will then instruct you to gradually increase the dose up to 400 mg two or three times daily.

Treatment of trigeminal neuralgia
Use in adults
The recommended starting dose at the beginning of treatment is 200–400 mg per day, which is then slowly increased until the pain disappears (usually reaching a dose of 200 mg three to four times daily).
Subsequently, your doctor will gradually reduce the dose until reaching the lowest effective maintenance dose. The maximum recommended dose is 1200 mg per day. Once the pain has disappeared, your doctor will gradually discontinue treatment until a new episode occurs.

Use in elderly patients and sensitive patients
In elderly patients and particularly sensitive individuals, the recommended starting dose is 100 mg twice daily.

Treatment of mania
Dosage 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
Your doctor will assess whether dose reduction is necessary and will establish an appropriate dosage regimen for this patient population.

If you take more CARBAMAZEPINE EG than you should
In case of accidental overdose of CARBAMAZEPINE EG, contact your doctor immediately or go to the nearest hospital.
You may experience breathing difficulties, rapid and irregular heartbeat, loss of consciousness, fainting, tremor, nausea and/or vomiting, feeling unwell, urinary problems, hallucinations, disorientation, blurred vision, slurred speech, uncontrolled eye movements, dilated pupils, uncontrolled movements such as muscle spasms, or loss of coordination.
In such cases, stop treatment with Carbamazepine EG and contact your doctor immediately.

If you forget to take CARBAMAZEPINE EG
Do not take a double dose to make up for the forgotten dose.

If you stop taking CARBAMAZEPINE EG
Do not stop treatment with Carbamazepine EG abruptly, as this may worsen your condition.
If you are taking Carbamazepine EG for the treatment of seizures or epilepsy, therapy should be discontinued gradually over a period of at least six months.
If treatment with Carbamazepine EG must be stopped abruptly, your doctor will prescribe an alternative medicine.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

decrease in the number of white blood cells in the blood (leucopenia);
loss of coordination of movements (ataxia);
dizziness;
drowsiness;
fatigue;
nausea, vomiting;
allergic skin reactions, urticaria which may also be severe;
increase in certain 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);
decrease in the number of platelets in the blood (thrombocytopenia);
swelling due to fluid accumulation (edema), fluid retention;
weight gain;
reduction in sodium levels in the blood;
reduction in certain substances in the blood (e.g. salts), which may rarely lead to vomiting, drowsiness, lethargy, headache, confusion, brain disorders;
headache;
double vision, blurred vision;
dry mouth;
increase in alkaline phosphatase levels in the blood.

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

involuntary abnormal movements, e.g. tremor, tic;
abnormal eye movements (nystagmus);
diarrhoea, constipation;
skin inflammation with redness and peeling (exfoliative dermatitis);
increase in certain liver enzymes (transaminases).

Rare side effects (may affect up to 1 in 1,000 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, skin rash, inflammation of blood vessels, enlargement of the lymph nodes (lymphadenopathy), pseudo-lymphoma, joint pain (arthralgia), decrease in the number of white blood cells in the blood (leucopenia), increase in the number of white blood cells in the blood (eosinophilia), enlargement of the liver and/or spleen, changes in liver function tests and destruction and disappearance of intrahepatic bile ducts (vanishing bile duct syndrome). Lungs, kidneys, pancreas, myocardium, and colon may also be involved;
hallucinations (visual or auditory), depression, restlessness, agitation, aggression, confusion;
decreased appetite;
involuntary movements of the tongue, mouth, trunk and limbs (dyskinesia), eye movement disorders, speech disorders (dysarthria, slurred speech), alteration in body movements (choreoathetosis);
damage to peripheral nerves (peripheral neuropathies), tingling (paraesthesiae), paresis;
disturbances in the heart's electrical activity;
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)

decrease in the number of white blood cells in the blood (agranulocytosis);
reduction in the number of red blood cells due to various causes (anaemia, megaloblastic anaemia, haemolytic anaemia, aplastic anaemia);
reduction in all blood cells (pancytopenia);
reduction in red blood cell production (pure red cell aplasia);
increase in 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 (hypogammaglobulinaemia);
breast enlargement and milk secretion, which may occur in both men and women;
blood disorders called acute porphyria (acute intermittent porphyria and variegate porphyria), non-acute porphyria (porphyria cutanea tarda);
mental disorders;
altered mental state and muscle rigidity, increased body temperature, increased heart rate, increased blood pressure (neuroleptic malignant syndrome);
inflammation of the membranes covering the brain and spinal cord (aseptic meningitis);
taste disturbances;
eye disorders (conjunctivitis, lens opacity);
hearing disorders, e.g. ringing or buzzing in the ears (tinnitus), hypersensitivity and reduced tolerance to sounds, reduced ability to hear sounds, altered perception of tone;
heart rhythm disturbances, severe heart failure, worsening of coronary problems, slowed heartbeat, conduction block 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 consequent formation of a blood clot in the vein itself (thrombophlebitis);
pulmonary hypersensitivity, characterised for example by fever, breathing difficulties and pneumonia;
inflammation of the pancreas (pancreatitis);
inflammation of the tongue (glossitis);
inflammation of the mouth mucosa (stomatitis);
liver problems including liver failure, granulomatous hepatitis;
skin rashes, even potentially fatal (erythema multiforme, nodular erythema, purpura, Stevens-Johnson syndrome, toxic epidermal necrolysis);
hypersensitivity to light or sunlight (photosensitivity reaction);
change in skin colour;
acne;
excessive sweating;
hair loss;
abnormal growth of hair in women (hirsutism);
bone metabolism disorders (leading to weakening of bones (osteomalacia/osteoporosis), joint pain, muscle pain and spasms;
kidney problems such as tubulointerstitial nephritis, renal failure;
kidney impairment (presence of protein in urine, presence of blood in urine, increased levels of urea and nitrogen in blood);
reduced urine excretion (oliguria), urine retention, frequent passage of small amounts of urine (pollakiuria);
sexual dysfunction, erectile dysfunction, abnormalities in sperm formation in males with reduced number of sperm and/or motility;
increased pressure inside the eye;
increased levels of cholesterol in the blood, HDL and triglycerides;
alteration in thyroid function parameters, increased levels of prolactin in the blood.

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

recurrence of infections due to the Herpes virus;
bone marrow depression (decrease in blood cells caused by malfunction of the blood cell production system);
falls due to dizziness, drowsiness, low blood pressure, confusion, sedation, disturbances in voluntary movements;
sedation, memory disturbances;
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 body;
severe form of drug reaction, characterised by erythema and swelling with pustule formation (acute generalised exanthematous pustulosis - AGEP);
skin alteration presenting thickened reddish plaques (lichenoid keratosis);
nail loss (onychomadesis);
bone fractures, decreased bone density;
elevated levels of ammonia in the blood (hyperammonaemia). Symptoms of hyperammonaemia may include irritability, confusion, vomiting, loss of appetite and drowsiness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 CARBAMAZEPINE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What CARBAMAZEPINA EG contains

The active substance is carbamazepine. Each tablet contains 200 or 400 mg of carbamazepine.
The other components are microcrystalline cellulose, sodium carboxymethylcellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of CARBAMAZEPINA EG and package contents
White, smooth tablets.
CARBAMAZEPINA EG is available in packs of 50 tablets for the 200 mg strength and in
packs of 30 tablets for the 400 mg strength.
Marketing Authorization 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