Carbamazepine Aurobindo: detailed information

Package leaflet: Information for the user

Carbamazepine Aurobindo 200 mg prolonged-release tablets, 400 mg prolonged-release tablets

Generic 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Carbamazepine Aurobindo is and what it is used for

Carbamazepine Aurobindo contains the active substance carbamazepine, which belongs to a group of
medicines called antiepileptics. Carbamazepine Aurobindo prolonged-release tablets are
specifically formulated to gradually release the active substance. Carbamazepine, the active
ingredient, can act on the body in several ways. It is an anticonvulsant medicine (prevents
seizures), but it can also modify certain types of pain and control mood disorders.
Carbamazepine Aurobindo is used for:

treating certain types of epilepsy;
treating a painful facial condition called trigeminal neuralgia;
helping to control severe mood disorders when other medicines do not work.

2. What you need to know before taking Carbamazepine Aurobindo

Do not take Carbamazepine Aurobindo if

you are allergic to carbamazepine or to any group of structurally related medicines (e.g. tricyclic antidepressants such as amitriptyline or imipramine);
you are allergic to any of the other ingredients of Carbamazepine Aurobindo (listed in section 6);
you have heart disease (atrioventricular block);
you have had bone marrow problems;
you have or have had blood disorders such as acute intermittent porphyria, variegate porphyria, or late cutaneous porphyria;
you are taking a medicine called monoamine oxidase inhibitor (MAOI), used to treat depression.

Treatment with MAOIs must be discontinued at least 14 days before starting Carbamazepine Aurobindo.

Warnings and precautions

A small number of people taking antiepileptic medicines such as carbamazepine have had suicidal thoughts or self-harming thoughts. If you experience such thoughts at any time, contact your doctor immediately.
Contact your doctor immediately if you develop severe skin reactions while taking this medicine. Skin rash, with blisters or peeling, mouth or genital ulcers, often accompanied by flu-like symptoms or reduced blood cells leading to unexplained bruising or bleeding, may be signs of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP). These types of skin reactions are more likely during the first months of treatment and occur more frequently in certain patient groups. The risk of these reactions in patients of Han Chinese, Thai, Japanese, or European origin may be predicted by a blood test. Your doctor will decide whether a blood test is necessary before starting carbamazepine. If you develop a skin rash or any of the other listed skin symptoms, consult a doctor immediately. Inform them that you are taking carbamazepine.
There is a risk of harm to the fetus if Carbamazepine Aurobindo is used during pregnancy. Women of childbearing potential must use an effective contraceptive method during treatment with Carbamazepine Aurobindo and for up to two weeks after the last dose (see Pregnancy and breastfeeding).

Talk to your doctor or pharmacist before taking Carbamazepine Aurobindo:

if you have heart, liver, or kidney disease;
if you have kidney problems associated with low sodium levels in the blood;
if you have glaucoma (increased pressure in the eye). It is important to visit your optician regularly during treatment with Carbamazepine Aurobindo;
if you have a type of epilepsy with mixed seizure types, including absence seizures (clouding of consciousness);
if you are elderly;
if you are allergic to a medicine for epilepsy called phenytoin;
if you have a condition called hypothyroidism and are taking hormone replacement therapy (HRT);
if you have urinary retention or inability to urinate;
if you are pregnant or planning a pregnancy;
if you are breastfeeding;
if you have blood disorders, including those caused by other medicines (haematological disorders);
if you have myotonic dystrophy (degenerative muscle disease and cardiac conduction abnormalities are common in these patients);
if you experience symptoms such as dizziness, lightheadedness, low blood pressure, or confusion due to taking Carbamazepine Aurobindo, which may lead to falls.

You may be asked to provide regular blood and/or urine samples before and during treatment to monitor carbamazepine blood levels and detect any problems early.

Other medicines and Carbamazepine Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal preparations. Carbamazepine Aurobindo may affect, and be affected by, other medicines.

Do not use Carbamazepine Aurobindo together with MAO inhibitors (see 'Do not take Carbamazepine Aurobindo if').

Other medicines:

Hormonal contraceptives, e.g. pills, patches, injections, or implants. Carbamazepine Aurobindo may affect the effectiveness of hormonal contraceptives and make 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 Carbamazepine Aurobindo.
Hormone replacement therapy (HRT), such as tibolone. Carbamazepine Aurobindo may make HRT less effective.
Any medicine for depression or anxiety such as alprazolam, citalopram, desipramine, fluoxetine, fluvoxamine, mianserin, midazolam, nefazodone, paroxetine, sertraline, trazodone, or viloxazine, tricyclic antidepressants (e.g. imipramine, amitriptyline, nortriptyline, clomipramine).
Corticosteroids (“steroids”) such as dexamethasone or prednisolone. These may be used to treat inflammatory conditions such as asthma, inflammatory bowel disease, or muscle and joint pain.
Anticoagulants to prevent blood clotting such as acenocoumarol, rivaroxaban, dabigatran etexilate, apixaban, edoxaban, dicoumarol, ticlopidine, phenprocoumon, or warfarin.
Antibiotics for treating infections, including skin infections and tuberculosis, such as ciprofloxacin, clarithromycin, doxycycline, erythromycin, isoniazid, josamycin, rifampicin, rifabutin, or troleandomycin.
Antifungals for treating fungal infections such as fluconazole, itraconazole, ketoconazole, or voriconazole.
Painkillers containing paracetamol (long-term use of carbamazepine and paracetamol may cause hepatotoxicity), dextropropoxyphene, ibuprofen, phenazone, tramadol, methadone, or buprenorphine.
Other medicines for treating epilepsy such as clobazam, clonazepam, felbamate, fosphenytoin, lamotrigine, levetiracetam, methsuximide, phensuximide, ethosuximide, oxcarbazepine, eslicarbazepine, phenobarbital, phenytoin, primidone, progabide, stiripentol, tiagabine, topiramate, valproic acid, valpromide, vigabatrin, or zonisamide, brivaracetam.
Medicines for treating high blood pressure or heart problems such as atorvastatin, lovastatin, simvastatin, cerivastatin, digoxin, diltiazem, felodipine, ivabradine, or verapamil.
Antihistamines (medicines for treating allergies such as hay fever, itching, etc.) such as loratadine or fexofenadine.
Diuretics (“water tablets”) such as hydrochlorothiazide or furosemide.
Cimetidine or omeprazole (medicines for treating stomach ulcers).
Isotretinoin (a medicine for treating acne).
Metoclopramide (an anti-nausea medicine).
Lithium (a medicine for bipolar disorder).
Medicines for nausea or vomiting (anti-emetics) such as aprepitant, ondansetron.
Acetazolamide (a medicine for treating glaucoma – increased pressure in the eye).
Danazol (treatments for endometriosis).
Theophylline or aminophylline (used in the treatment of asthma).
Medicines that reduce the body’s natural defences (immunosuppressants) such as cyclosporine (used after organ transplant, but sometimes also in the treatment of arthritis or psoriasis), everolimus, sirolimus, or tacrolimus.
Medicines for treating schizophrenia such as aripiprazole, bromperidol, clozapine, haloperidol, thioridazine, loxapine, valnoctamide, valproic acid, primidone, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone.
Anticancer medicines such as cisplatin, cyclophosphamide, doxorubicin, imatinib, lapatinib, temsirolimus.
Medicines for treating HIV such as indinavir, sofosbuvir, ritonavir, or saquinavir.
Levothyroxine (used to treat hypothyroidism).
Muscle relaxants such as pancuronium, dantrolene, or oxybutynin.
Bupropion (used to help stop smoking).
Medicines or supplements containing vitamin B (nicotinamide).
Medicines for treating parasitic worm infections such as albendazole or praziquantel.
Tadalafil – a medicine used by men with erectile problems.
Products containing St. John’s wort.

If you are taking medicines for depression and need a blood test to monitor the medicine levels in your blood, inform your doctor or hospital staff that you are taking carbamazepine, as this may interfere with test results.

Carbamazepine Aurobindo with food, drinks, and alcohol

Do not take the tablets with grapefruit or grapefruit juice, as this may increase the likelihood of side effects from Carbamazepine Aurobindo.
Do not drink alcohol during treatment with this medicine. Drinking alcohol may have more pronounced effects than usual.

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.

Carbamazepine Aurobindo may cause serious birth defects. If you take Carbamazepine Aurobindo during pregnancy, your baby has up to a 3-fold increased risk of having a congenital malformation compared to women who do not take antiepileptic medicines. Major congenital malformations reported include neural tube defects (opening in the spine), facial malformations such as cleft lip and 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 Aurobindo during pregnancy.

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

If you are a woman of childbearing potential and are not planning a pregnancy, you must use an effective contraceptive method during treatment with Carbamazepine Aurobindo. Carbamazepine Aurobindo may affect the effectiveness of hormonal contraceptives, such as the oral contraceptive pill, and make 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 Carbamazepine Aurobindo. If treatment with Carbamazepine Aurobindo is stopped, you should continue using an effective contraceptive method for an additional two weeks after discontinuation.

If you are a woman of childbearing potential and are planning a pregnancy, talk to your doctor about switching to other suitable treatments before stopping contraception and before starting a pregnancy, to avoid exposing the fetus to carbamazepine.

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

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

Newborns

The newborn should be monitored for adverse drug reactions if the mother has used this medicine.

Breastfeeding

Carbamazepine passes into breast milk. The benefits of breastfeeding should be weighed against the risk of adverse effects in the newborn. Infants breastfed by mothers treated with carbamazepine should be closely observed for possible side effects such as poor weight gain, excessive sleepiness, or skin allergic reactions.

Fertility

Taking this medicine may impair male fertility and affect sperm development in the body. If you have any questions, discuss them with your doctor.

Driving and using machines

Carbamazepine Aurobindo may cause dizziness or drowsiness, blurred vision, double vision, or lack of muscle coordination, especially at the beginning of treatment or when the dose is changed. Therefore, you should exercise caution when driving or operating machinery.

Carbamazepine Aurobindo contains macrogol glycerol hydroxystearate

This may cause gastrointestinal disturbances and diarrhoea.

Carbamazepine Aurobindo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. Carbamazepine Aurobindo is essentially “sodium-free”.

3. How to take Carbamazepine Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Your doctor will usually start treatment with Carbamazepine Aurobindo at a low dose, which may then be increased according to individual needs.
The required dose varies from patient to patient.
You will be instructed to take your dose 1–2 times a day.
As dosing is individual, always take this medicine exactly as prescribed by your doctor.

Epilepsy
Adolescents over 15 years of age and adults:
The recommended starting dose is 200 mg taken in the evening. The dose may then be slowly increased to be taken twice daily, in the morning and evening. The morning dose is generally lower. The maximum daily dose is 1200 mg per day.
Children and adolescents:
Age 6 to 10 years:
The recommended starting dose is 200 mg taken in the evening. The dose may then be slowly increased to be taken twice daily, in the morning and evening. The morning dose is generally lower than the evening dose. The maximum daily dose is 1000 mg per day.
In general, the maintenance dose for children is on average 10–20 mg of carbamazepine/kg body weight/day.
Age 11 to 15 years:
The recommended starting dose is 200 mg taken in the evening. The dose may then be slowly increased to be taken twice daily, in the morning and evening. The morning dose is generally lower than the evening dose. The maximum daily dose is 1000 mg per day.
Under 6 years of age:
Carbamazepine Aurobindo prolonged-release tablets must not be used in children under 6 years of age. Other medicines are available for children under 6 years of age.

Trigeminal neuralgia
The recommended starting dose is 200–400 mg per day.
The dose may be increased to 600–800 mg per day, divided into 3–4 doses, to maintain a pain-free state. The maximum daily dose is 1200 mg. The dose may also be gradually reduced if pain is not present.

Mood disorders
The recommended starting dose is 200–400 mg per day. If necessary, the dose may be increased up to 800 mg, taken twice daily.
A lower dose is recommended for patients with severe cardiovascular disease and in elderly patients.
Consult your doctor or pharmacist if you feel the effect of carbamazepine is too strong or too weak for you.

Duration of treatment
The duration of treatment with Carbamazepine Aurobindo depends on your condition and individual response to the medicine. Your doctor will tell you how long to take it.
Antiepileptic therapy and prophylaxis of manic-depressive phases are generally long-term treatments.
An experienced specialist in epilepsy treatment should decide on the initiation, duration, and discontinuation of carbamazepine for each individual case.
In general, consideration should be given to reducing and stopping the drug only after a seizure-free period of two or three years.
Discontinuation should occur gradually, by slowly reducing the dose over a period of one or two years; in children, the dose per kg body weight may be exceeded instead of adjusting the dose according to age, provided EEG results do not worsen.
In the treatment of neuralgias, it has proven useful to continue therapy for several weeks at the lowest effective maintenance dose sufficient to relieve pain. A careful dose reduction should be performed to determine whether spontaneous remission has occurred in the meantime. If pain attacks recur, the original maintenance dose must be continued.

How to stop treatment
This medicine must be gradually reduced to avoid recurrence of disease symptoms. Therefore, do not stop taking this medicine without first talking to your doctor.

How to take Carbamazepine Aurobindo

Swallow the tablets with a glass of water.
Each tablet may be divided into equal doses.
Do not chew or crush the tablet, as this would affect the special "controlled-release" system.
You may take Carbamazepine Aurobindo during or after meals.

If you take more Carbamazepine Aurobindo than you should
If you or your child have accidentally taken too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine pack with you so that medical staff can see what has been taken. You may experience difficulty breathing, rapid or irregular heartbeat, feeling weak or shaky, feeling unwell, or loss of consciousness.

If you forget to take Carbamazepine Aurobindo
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, simply take the next dose at the usual time and skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Carbamazepine Aurobindo
Do not stop taking the tablets suddenly. Discuss this first with your doctor. If it is necessary to reduce the dose, this will be done gradually.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately (or ask someone else to do so) if you notice any of the following
serious side effects – you may need urgent medical treatment:

Severe skin reactions such as rash, redness of the skin, blistering on the lips, eyes or mouth, or skin peeling, accompanied by fever, as these may be symptoms of Stevens-Johnson syndrome, TEN (toxic epidermal necrolysis) ( very rare ), DRESS (drug reaction with eosinophilia and systemic symptoms), AGEP (acute generalized exanthematous pustulosis) ( not known ).
Mouth ulcers, unexplained bruising or bleeding ( common ).
Sore throat or high fever, or both ( very rare ).
Yellowing of the skin or the whites of the eyes (hepatitis) ( rare ).
Swelling of the ankles, feet or lower legs ( uncommon ).
Any signs of nerve disease or confusion ( rare ).
Joint and muscle pain, rash on the nose and cheeks, and breathing problems (these may be signs of a rare reaction known as drug-induced lupus) ( rare ).
Fever, rash, joint pain, and abnormalities in blood and liver function tests (these may be signs of a multi-organ hypersensitivity disorder) ( rare ).
Bronchospasm with wheezing and cough, difficulty breathing, feeling faint, rash, itching or swelling of the face (these may be signs of a severe allergic reaction) ( very rare ).
Pain in the area near the stomach ( very rare ).

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

Leucopenia (reduced number of infection-fighting cells, increasing susceptibility to infections); dizziness, fatigue, drowsiness or numbness.
Feeling unsteady or having difficulty controlling movements.
Feeling unwell or being sick.
Rash.
Skin reactions (with severe itching or hives) which may be severe.

Common (may affect up to 1 in 10 people)

Changes in blood including increased tendency to bruise or bleed (thrombocytopenia).
Changes in blood including increased number of white blood cells (eosinophilia).
Fluid retention and swelling.
Weight gain.
Reduction in certain substances in the blood (e.g. salts), which rarely may lead to water intoxication with lethargy, vomiting, headache, confusion and other neurological disorders.
Low levels of sodium or other salts (electrolytes) in the blood, which could cause confusion or behavioral changes.
Headache.
Double or blurred vision, eye problems.
Dry mouth.

Uncommon (may affect up to 1 in 100 people)

Abnormal involuntary movements including tremor, spasms or tics.
Abnormal eye movements.
Diarrhea, constipation.
Skin inflammation with exfoliation (exfoliative dermatitis).
Increase in transaminases.

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

Temporary increase in white blood cell count (leukocytosis).
Enlargement of lymph nodes (lymphadenopathy).
Lumps in the neck or under the arm (may be signs of lymph gland disease).
Sore mouth or darkening of the skin (may be signs of folate deficiency in the body).
Restlessness.
Involuntary facial movements (similar to grimacing) or twisting or writhing movements of the body.
Speech problems.
Numbness or tingling in hands and feet.
Muscle weakness causing loss of movement.
High or low blood pressure.
Stomach ache.
Blood spots in the urine (haematuria).
Increase in urea or nitrogen-containing compounds in the blood.
Confusion, agitation (these may occur especially in the elderly).
Aggression.
Hallucinations.
Feeling sad or low (also known as depression).
Ringing in the ears (also known as tinnitus).
Conduction disturbances in the heart (AV block).
Joint pain (arthralgia).
Enlargement of the liver and spleen (hepatosplenomegalia).
Liver failure.
Loss of appetite.
Cataract.
Reduction in the number of bile ducts (ductopenia).

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

Changes in blood composition including anaemia.
Latent psychosis (subclinical mental illness).
Disease with sun sensitivity and skin defects (porphyria).
Abnormal thyroid function tests.
Osteomalacia (which may present as pain when walking and bending of the long bones of the legs).
Fragile bones (also known as osteoporosis).
Increased levels of fats in the blood, increased levels of cortisol in the blood or increased prolactin in the blood.
Taste disturbances.
Inflammation in the eyes (conjunctivitis).
Hearing disorders such as changes in sound pitch, hearing loss or increased sensitivity to sound.
Inflammation or swelling of the stomach (pancreatitis), mouth (gums) (gingivitis) or
tongue (glossitis).
Inflammation of the mucous membrane of the mouth (stomatitis).
Increased sensitivity of the skin to sunlight.
Changes in skin colour.
Acne.
Increased growth of body and facial hair.
Sexual difficulties which may include reduced male fertility such as abnormal sperm.
Breast enlargement and milk secretion which may occur in both males and females.
Impotence.
Inflammation of the pancreas (pancreatitis).
Severe acute reaction (hypersensitivity) accompanied by fever and skin blisters/skin detachment (known as toxic epidermal necrolysis or Lyell's syndrome) (see section 2).
Anaphylactic reactions (shock), often as an allergic reaction (angioedema).
Severe illness accompanied by muscle stiffness, strong urge to move, sweating, salivation, reduced consciousness (neuroleptic malignant syndrome).
Inflammation of the meninges and/or spinal cord membranes due to a virus (aseptic meningitis) with sudden muscle contractions (myoclonus) and local blood abnormalities (peripheral eosinophilia).
Some disturbances in heart conduction leading to arrhythmias (atrioventricular block) with sudden loss of consciousness (syncope) lasting from a few seconds to several hours, sometimes preceded by dizziness, sweating and nausea.
Slow heart rate (bradycardia).
Heart failure may occur and pre-existing coronary artery disease may worsen.
Closure of a vein by a blood clot with inflammation of the vessel wall and surrounding tissue (thrombophlebitis).
Blockage of a blood vessel by an enlarged blood clot (embolism).
Sudden loss of consciousness (collapse).
Pulmonary hypersensitivity reactions, characterized among others by fever and/or shortness of breath (dyspnea) and/or pneumonia.
Granulomatous liver disease.
Muscle spasm.
Kidney problems (tubulointerstitial nephritis) or kidney failure.
Increased or decreased need to urinate (pollakiuria) or difficulty urinating (dysuria).
Low levels of antibodies in the blood (hypogammaglobulinemia).

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

Reactivation of herpes virus infection.
Memory problems.
Inflammation of the colon (colitis).
Single small skin lesion (lichenoid keratosis).
Loss of fingernails and toenails.
Bone fractures.
Decreased bone density.
Falls, associated with ataxia, dizziness, drowsiness, hypotension, confusion, sedation which may lead to falls and consequently to fractures or other injuries.
High levels of ammonia in the blood (hyperammonaemia). Symptoms of hyperammonaemia may include irritability, confusion, vomiting, loss of appetite and drowsiness.
Purple or brown spots on the skin.

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported.
Consult your doctor or pharmacist if you are taking antiepileptic medicines long-term, if you have a history of osteoporosis or if you are taking steroids.
Reporting of side effects
If you get any side effects, including ones 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Carbamazepine Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister pack after "EXP". The expiry date refers to the last day of that month.
Blister packs: Store below 30°C.
Bottle containers: This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Return unused medicines to your pharmacist. This will help protect the environment.

6. Package contents and other information

What Carbamazepina Aurobindo contains
The active substance is carbamazepine.
Each prolonged-release tablet contains 200 mg of carbamazepine.
Each prolonged-release tablet contains 400 mg of carbamazepine.
The other components are:
Tablet core: microcrystalline cellulose; anhydrous colloidal silica; croscarmellose sodium; talc;
magnesium stearate; ethylcellulose; cetyl alcohol; sodium lauryl sulfate; ethyl acrylate-methyl methacrylate copolymer; nonoxinol 100.
Tablet coating: hypromellose (E464); macrogol glyceryl hydroxystearate; talc (E553b);
titanium dioxide (E171).

Description of the appearance of Carbamazepina Aurobindo and package contents
Carbamazepina Aurobindo 200 mg prolonged-release tablets
Film-coated tablets, white to off-white in colour, oval-shaped, biconvex. Approximately 12.5 x 5.8 mm in size, marked with "C" and "2" separated by a score line on both sides.
The tablet can be divided into equal doses.

Carbamazepina Aurobindo 400 mg prolonged-release tablets
Film-coated tablets, white to off-white in colour, oval-shaped, biconvex. Approximately 17.5 x 7 mm in size, marked with "C" and "4" separated by a score line on both sides.
The tablet can be divided into equal doses.

Carbamazepina Aurobindo 200 mg and 400 mg prolonged-release tablets are available in blister packs.
Carbamazepina Aurobindo 400 mg prolonged-release tablets are additionally available in plastic bottles.

Pack sizes:
Blister packs:
200 mg and 400 mg: 30, 50, 100, 200 and 500 (hospital pack) prolonged-release tablets.
Bottle:
400 mg: 500 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica S.A.
Rua João de Deus, n. 19, 2700-487 Amadora, Portugal
Arrow Generiques
26 Avenue Tony Garnier, 69007 Lyon, France

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Carbamazépine Arrow LP 200 mg/400 mg, comprimé pelliculé sécable à libération prolongée
Germany: Carbamazepin Puren 200 mg/ 300 mg/ 400 mg/ 600 mg Retardtabletten
Italy: Carbamazepina Aurobindo
Netherlands: Carbamazepine Aurobindo retard 200 mg/400 mg, tablet met verlengde afgifte
Portugal: Carbamazepina Generis Phar