КАРБАМАЗЕПИНА 200 mg Extended-release tablet

Содержание инструкции

1. Carbamazepine Aurobindo 200 mg prolonged-release tablets, 400 mg prolonged-release tablets
   1. What is Carbamazepina Aurobindo and what is it used for
   2. What you need to know before taking Carbamazepina Aurobindo
   3. How to take Carbamazepina Aurobindo
   4. Possible side effects
   5. How to store Carbamazepina Aurobindo
   6. Package contents and other information

Carbamazepine Aurobindo 200 mg prolonged-release tablets, 400 mg prolonged-release 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 they have the same symptoms as you, as it may 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 Carbamazepine Aurobindo is and what it is used for
• 2. What you need to know before you take Carbamazepine Aurobindo
• 3. How to take Carbamazepine Aurobindo
• 4. Possible side effects
• 5. How to store Carbamazepine Aurobindo
• 6. Contents of the pack and other information

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

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

• treating some forms of epilepsy;
• treating a painful condition of the face called trigeminal neuralgia;
• helping to control severe mood disorders, when other medicines do not work.

2. What you need to know before taking Carbamazepina Aurobindo

Do not take Carbamazepina Aurobindo if

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

Treatment with MAOIs must be stopped at least 14 days before you can take Carbamazepina
Aurobindo.

Warnings and precautions

• A small number of people being treated with antiepileptic medicines like carbamazepine have had thoughts about self-harm or suicide. If you develop these thoughts at any time, contact your doctor immediately.
• Contact your doctor immediately if you develop severe skin reactions while taking this medicine. Rash, with blisters or peeling, ulcers in the mouth or genitals, often with flu-like symptoms or a decrease in blood cells leading to unexplained bruising or bleeding, as these 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 in the first months of treatment and are more common in certain groups of people. The risk of these reactions in patients of Chinese Han, Thai, Japanese or European origin can be predicted by a blood test. Your doctor will decide whether a blood test is necessary before you take carbamazepine. If you develop a rash or any of the other skin symptoms listed, consult a doctor immediately. Tell them that you are taking carbamazepine.
• There is a risk of harm to the fetus if Carbamazepina Aurobindo is used during pregnancy. Women of childbearing potential must use effective contraception during treatment with Carbamazepina Aurobindo and for up to two weeks after the last dose (see Pregnancy and breastfeeding).

Talk to your doctor or pharmacist before taking Carbamazepina Aurobindo:

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

You may be required to provide regular blood and/or urine samples before and during
treatment to check the levels of carbamazepine in your blood and identify any problems before
they become serious.

Other medicines and Carbamazepina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including herbal medicines. Carbamazepina Aurobindo can
influence and be influenced by other medicines.
Do not use Carbamazepina Aurobindo together with MAO inhibitors (see ‘Do not take Carbamazepina
Aurobindo if’).
Other medicines

• Hormonal contraceptives, e.g. pills, patches, injections or implants. Carbamazepina Aurobindo can affect the functioning 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 Carbamazepina Aurobindo.
• Hormone replacement therapy (HRT) such as tibolone. Carbamazepina Aurobindo can 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. You may be taking them to treat inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pain.
• Anticoagulants to stop blood clotting such as acenocoumarol, rivaroxaban, dabigatran, etexilate, apixaban, edoxaban dicumarol, ticlopidine, fenprocoumone or warfarin.
• Antibiotics for the treatment of infections, including skin infections and tuberculosis, such as ciprofloxacin, clarithromycin, doxycycline, erythromycin, isoniazid, josamycin, rifampicin, rifabutin or troleandomycin.
• Antifungals for the treatment of fungal infections such as fluconazole, itraconazole, ketoconazole or voriconazole.
• Pain relievers containing paracetamol (long-term use of carbamazepine and paracetamol can cause hepatotoxicity), dextropropoxyphene, ibuprofen, phenazone, tramadol, methadone or buprenorphine.
• Other medicines for the treatment of epilepsy such as clobazam, clonazepam, felbamate, fosphenytoin, lamotrigine, levetiracetam, mesuximide, phensuccimide, ethosuccimide, 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 drug).
• Lithium (a medicine for bipolar disorder).
• Medicines against nausea or vomiting (antiemetics) 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 activity of the body's defenses (immunosuppressants) such as cyclosporine (used after transplant operations, 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 the treatment of 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 the treatment of worm infections such as albendazole or praziquantel.
• Tadalafil - a medicine used by men with erectile dysfunction.
• Products containing St John's Wort

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

Carbamazepina 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 of Carbamazepina Aurobindo.
• Do not drink alcohol while being treated with this medicine. Drinking alcohol may have more serious effects than usual.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Carbamazepina Aurobindo can cause serious birth defects. If you take Carbamazepina Aurobindo
during pregnancy, your baby has a risk up to 3 times higher of having a birth defect
compared to women who do not take antiepileptic medicines. Major birth defects have been reported
including neural tube defects (opening in the spine), congenital facial defects,
such as cleft lip and palate, congenital head defects, heart defects, congenital defects of the penis involving the urinary opening (hypospadias) and finger defects. The fetus must be
carefully monitored if you have taken Carbamazepina Aurobindo during pregnancy.
Neurodevelopmental problems (brain development) have been reported in children born to mothers who have
used Carbamazepina Aurobindo 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 such an 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 must use effective
contraception during treatment with Carbamazepina Aurobindo. Carbamazepina Aurobindo can
affect the functioning of hormonal contraceptives, such as the contraceptive pill
(contraceptive), 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 Carbamazepina
Aurobindo. If treatment with Carbamazepina Aurobindo is stopped, you should continue to
use effective contraception for another two weeks after stopping treatment.
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, tell your doctor immediately. You should not stop taking
the medicine until you have discussed this with your doctor. Stopping the medicine without
consulting your doctor could cause seizures, which could be dangerous for you and the fetus. The
doctor may decide to change the treatment.
If you take Carbamazepina Aurobindo during pregnancy, your baby will also be at risk of
bleeding problems shortly after birth. Your doctor may give you and your
baby a medicine to prevent this from happening.
Newborns
The newborn must be monitored for adverse drug events 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 infant. Breastfed infants of mothers treated with
carbamazepine should be carefully monitored for any side effects such as poor weight gain,
excessive drowsiness or allergic skin reactions.

Fertility
Taking this medicine may impair male fertility and affect sperm development in the body. If you have any questions, talk to your doctor.

Driving and using machines
Carbamazepina Aurobindo can cause dizziness or drowsiness, or blurred or double vision, or
a lack of muscle coordination, especially at the beginning of treatment or when the dose is
changed. You should therefore be careful when driving a vehicle or using machinery.

Carbamazepina Aurobindo contains hydroxy stearic acid macrogolglycerides
It can cause stomach upset and diarrhoea.

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

3. How to take Carbamazepina Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

• The doctor will usually start treatment with Carbamazepina Aurobindo with a low dose, which may then be increased according to individual needs.
• The required dose varies from patient to patient.
• You will be asked to take your dose 1-2 times a day.
• Since the dosage is individual, always take this medicine as prescribed by your doctor.

Epilepsy
Adolescents over 15 years of age and adults:
The recommended starting dose is 200 mg, to be taken in the evening. The dose may then be increased
slowly to be taken twice a day, in the morning and in the evening. The morning dose is
generally lower. The maximum daily dose is 1200 mg per day.
Children and adolescents:

Age from 6 to 10 years:
The recommended starting dose is 200 mg to be taken in the evening. The dose may then be increased
slowly to be taken twice a day, in the morning and in the evening. The morning dose is
generally lower than that of the evening. 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 of body
weight/day.

Age from 11 to 15 years:
The recommended starting dose is 200 mg to be taken in the evening. The dose may then be increased
slowly to be taken twice a day, in the morning and in the evening. The morning dose is
generally lower than that of the evening. The maximum daily dose is 1000 mg per day.

Under 6 years:
Carbamazepina Aurobindo prolonged-release tablets should 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 state
without pain. The maximum daily dose is 1200 mg. The dose may also be gradually reduced if
pain is not felt.
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 a day.
A lower dosage is indicated in patients with severe cardiovascular disease and in the elderly.
If you feel that the effect of carbamazepine is too strong or too weak, contact your doctor or pharmacist.

Duration of treatment
The duration of taking Carbamazepina Aurobindo depends on its indication and the 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 therapies.
A specialist doctor experienced in the treatment of epilepsy must decide on the setting, duration of
treatment and discontinuation of carbamazepine for individual cases.
In general, a dose reduction and discontinuation of the drug should be considered only after a period of two or three years free from convulsive crises.
Discontinuation must occur with gradual dose reductions over a period of one or two years; children
may exceed the dose per kg of body weight instead of a dose adjustment based on age, in
which the results of the EEG should not worsen.
In the treatment of neuralgias, it has proven useful to carry out the therapy for a few weeks with a maintenance dose just sufficient to relieve the pain. Careful dose reduction should be adopted to determine if, in the meantime, spontaneous remission has occurred. If pain attacks recur, the original maintenance dose must be continued.

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

How to take Carbamazepina Aurobindo

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

If you take more Carbamazepina Aurobindo than you should
If you or your child have accidentally taken too many tablets, contact your doctor immediately
or go to the emergency room of the nearest hospital. Bring the package of the medicine with you
so that the operators can see what you have taken. You may have difficulty breathing, a fast or irregular heartbeat, a feeling of weakness or tremor, a feeling of unwellness or loss of consciousness.

If you forget to take Carbamazepina Aurobindo
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose,
simply take the next dose and forget the one you missed. Do not take a double dose to make up for a missed tablet.

If you stop treatment with Carbamazepina Aurobindo
Do not suddenly stop taking the tablets. Talk to your doctor first. If it is
necessary to reduce the dose, this will be done slowly.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately inform your doctor (or ask someone else to do so) if you notice any of the following serious side effects - you may need urgent medical attention:

• Severe skin reactions such as rash, redness of the skin, blistering on the lips, eyes or mouth, or peeling of the skin, 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 white of the eyes (hepatitis) ( rare).
• Swelling of the ankles, feet or lower legs ( not common).
• Any signs of nervous 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 lupus erythematosus) ( rare).
• Fever, rash, joint pain and abnormalities in blood and liver function tests (these may be signs of a multi-organ sensitivity disorder) ( rare).
• Bronchospasm with wheezing and coughing, 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)

• Leukopenia (a reduced number of cells that fight infections making you more likely to get infections); dizziness, fatigue, drowsiness or sedation.
• Feeling unsteady or having difficulty controlling movements.
• Feeling unwell or sick.
• Rash.
• Skin reactions (with severe itching or hives) that can be serious.

Common(may affect up to 1 in 10 people)

• Changes in the blood including an increased tendency to bruise or bleed (thrombocytopenia).
• Changes in the blood including an increase in the number of white blood cells (eosinophilia).
• Fluid retention and swelling.
• Weight gain.
• Reduction of certain substances in the blood (e.g. salts), which can rarely 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 may cause confusion or behavioral changes.
• Headache.
• Double or blurred vision, eye problems.
• Dry mouth.

Not common(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).
• Increased transaminases.

Rare(may affect up to 1 in 1000 people)

• Temporary increase in the number of white blood cells (leucocytosis).
• Enlargement of the lymph nodes (lymphadenopathy).
• Nodes in the neck or under the armpit (these may be signs of a disease of the lymphatic glands).
• Painful mouth or dark coloration of the skin (these may be signs of a lack of folic acid in the body).
• Restlessness.
• Involuntary facial movements (similar to grimaces) or twisting or contorting movements of the body.
• Speech problems.
• Numbness or tingling in the hands and feet.
• Muscle weakness causing loss of movement.
• High or low blood pressure.
• Stomach pain.
• Blood in the urine (hematuria).
• Increased compounds containing urea or nitrogen in the blood.
• Confusion, agitation (these may occur especially in the elderly).
• Aggression.
• Hallucinations.
• Feeling sad or down (also known as depression).
• Ringing in the ear (also known as tinnitus).
• Heart conduction disorders (AV block).
• Joint pain (arthralgia).
• Enlargement of the liver and spleen (hepatosplenomegaly).
• 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 anemia.
• Latent psychoses (subliminal mental illnesses).
• Disease with sensitivity to sunlight and skin defects (porphyria).
• Abnormal thyroid function tests.
• Osteomalacia (which may be noticed as pain during walking and bending of the long leg bones).
• Fragile bones (known as osteoporosis).
• Increased levels of fats in the blood, increased levels of cortisol in the blood or prolactin in the blood.
• Taste disorders.
• Inflammation in the eyes (conjunctivitis).
• Hearing disorders such as changes in pitch of sound, 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 color.
• Acne.
• Increased hair growth on the body and face.
• Sexual difficulties that may include reduced male fertility such as abnormal sperm.
• Swelling of the breasts and secretion of milk that can occur in both males and females.
• Impotence.
• Inflammation of the pancreas (pancreatitis).
• Severe, acute reaction (hypersensitivity) accompanied by fever and blisters on the skin/spreading of the skin (called toxic epidermal necrolysis or Lyell's syndrome) (see paragraph 2).
• Anaphylactic reactions (shock), often as an allergic reaction (angioedema).
• Severe illness accompanied by muscle rigidity, a strong need to move, sweating, salivation, reduced consciousness (neuroleptic malignant syndrome).
• Inflammation of the meninges and/or membranes of the spinal cord due to a virus (aseptic meningitis) with sudden muscle contraction (myoclonus) and local blood defects (peripheral eosinophilia.
• Some disorders in heart conduction leading to arrhythmias (atrioventricular block) with sudden loss of consciousness (syncope) that can last from a few seconds to several hours, sometimes preceded by dizziness, sweating and nausea.
• Slow heartbeat (bradycardia).
• Heart failure and worsening of pre-existing coronary heart disease may occur.
• Closure of a vein by a blood clot with inflammation of the vessel wall and surrounding environment (thrombophlebitis).
• Blockage of a blood vessel by an enlarged blood clot (embolism).
• Sudden loss of consciousness (collapse).
• Pulmonary hypersensitivity reactions, characterized among other things 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 (pollachiuria) or difficulty urinating (dysuria).
• Low levels of antibodies in the blood (hypogammaglobulinemia).

Not known(frequency cannot be estimated on the basis of 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 that can lead to falls and, consequently, to fractures or other injuries.
• High levels of ammonia in the blood (hyperammonemia). Symptoms of hyperammonemia 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 drugs for a long time, if you have a history
of osteoporosis or if you are taking steroids.

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 Aurobindo

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 package, bottle and blister
after “EXP”. The expiry date refers to the last day of that month.
Blister packs: Store at a temperature below 30°C.
Bottle packs: This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Return any unused medicine to the
pharmacist. This will help protect the environment. 

6. Package contents and other information

What Carbamazepina Aurobindo contains
The active ingredient is carbamazepine.
Each prolonged-release tablet contains 200 mg of carbamazepine.
Each prolonged-release tablet contains 400 mg of carbamazepine.
The other ingredients are: 

Tablet core:microcrystalline cellulose; anhydrous colloidal silicon dioxide; sodium croscarmellose; talc;
magnesium stearate; ethylcellulose; cetyl alcohol; sodium lauryl sulfate; ethyl acrylate-methyl
methacrylate copolymer; nonoxynol 100.

Tablet coating:hypromellose (E464); macrogolglycerol 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 color, oval in shape, biconvex. Dimensions
approximately 12.5 x 5.8 mm, with “C” and “2” imprinted on both sides, separated by a score line.
The tablet can be divided into equal doses.

Carbamazepina Aurobindo 400 mg prolonged-release tablets
Film-coated tablets, white to off-white in color, oval in shape, biconvex. Dimensions
approximately 17.5 x 7 mm, with “C” and “4” imprinted on both sides, separated by a score line.
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 also available in
plastic bottles.
Packs:
Blister:

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 authorised in the Member States of the European Economic Area under the
following denominations:
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