Patient Leaflet Updated 04-Jun-2026 | Aurobindo Pharma - Milpharm Ltd.
Carbamazepine Prolonged-release Tablets
Carbamazepine Milpharm 200 mg Prolonged-release Tablets
Carbamazepine Milpharm 400 mg Prolonged-release Tablets
carbamazepine
1. What Carbamazepine Milpharm Prolonged-release is and what it is used for
2. What you need to know before you take Carbamazepine Milpharm Prolonged-release
3. How to take Carbamazepine Milpharm Prolonged-release
4. Possible side effects
5. How to store Carbamazepine Milpharm Prolonged-release
6. Contents of the pack and other information
Carbamazepine Milpharm Prolonged-release are specially formulated to release the active ingredient gradually. Carbamazepine, the active ingredient, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders.
Carbamazepine Milpharm Prolonged-release is used to
A small number of people being treated with anti-epileptics such as carbamazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
If an allergic reaction happens, such as swelling of lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with lymph nodes swelling, rash or skin blistering, tell your doctor immediately or go to the emergency department at your nearest hospital (see “Possible side effects”).
Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of carbamazepine. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first months of treatment.
These serious skin reactions can be more common in people from some Asian countries. The risk of these reactions in patients of Han Chinese or Thai origin may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking Carbamazepine Milpharm Prolonged-release.
If you develop a rash or these skin symptoms, stop taking Carbamazepine Milpharm Prolonged-release and contact your doctor immediately.
If you experience dizziness, drowsiness, decrease in blood pressure, confusion, due to Carbamazepine Milpharm Prolonged-release treatment, this may lead to falls.
You should also ask yourself these questions before taking Carbamazepine Milpharm Prolonged-release. If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Carbamazepine Milpharm Prolonged-release might not be the right medicine for you.
Because of the way that Carbamazepine Milpharm Prolonged-release works, it can affect, and be affected by, lots of other things that you might be eating or medicines that you are taking. It is very important to make sure that your doctor knows all about what else you are taking, including anything that you have bought from a chemist or health food shop. It may be necessary to change the dose of some medicines, or stop taking something altogether.
There is a risk of harm to the unborn child if Carbamazepine Milpharm Prolonged-release is used during pregnancy. Women of childbearing age should use effective contraception during treatment with Carbamazepine Milpharm Prolonged-release and for at least two weeks after the last dose (see the information in Section 2 on pregnancy and breast-feeding).
It is important to tell your doctor or pharmacist if you are taking any other medicines for epilepsy at the same time as Carbamazepine Milpharm Prolonged-release and you are pregnant, think you may be pregnant, or are planning to have a baby (see also the information in Section 2 on pregnancy and breast- feeding).
Tell the doctor if you are taking:
Pregnancy
If you are a woman who is able to have a baby and are not planning a pregnancy, you should use effective contraception during treatment with Carbamazepine Milpharm Prolonged-release. Carbamazepine Milpharm Prolonged-release may affect how hormonal contraceptives, such as the contraceptive (birth control) pill, work and make them less effective at preventing pregnancy. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Carbamazepine Milpharm Prolonged-release. If treatment with Carbamazepine Milpharm Prolonged-release is discontinued, you should continue using effective contraception for at least two more weeks following discontinuation.
If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby.
If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.
You should not stop your treatment without discussing this with your doctor. Suddenly stopping may lead to breakthrough seizures which may harm you and your unborn baby. It is important that your epilepsy remains well controlled.
Taking Carbamazepine Milpharm Prolonged-release during pregnancy increases the chance that the baby may have a physical birth abnormality (major congenital malformations). Studies with women treated with carbamazepine for epilepsy have shown that on average 4-5 babies in every 100 will have serious physical birth abnormalities. This is compared with 2 to 3 babies in every 100 born to women who do not have epilepsy.
These abnormalities can develop early in pregnancy, even before you know you are pregnant. The most common types of major congenital malformations reported for carbamazepine include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations including cleft lip/palate; skeletal, heart, urinary tract and sexual organ malformations.
Studies have found that the risk of physical birth abnormalities increases with increasing doses of carbamazepine. Therefore, it is important that where possible you are prescribed the lowest dose to control your epilepsy.
Ask your doctor about taking folic acid when trying for a baby and during pregnancy. Folic acid may lower the general risk of serious physical birth abnormalities that exists with all pregnancies.
Taking more than one epilepsy medicine at the same time may also increase the risk of physical birth abnormalities. This means that where possible, your doctor should consider using one epilepsy medicine to control your epilepsy.
Problems with neurodevelopment (development of the brain) cannot be ruled out in children born to women with epilepsy treated with carbamazepine alone or in combination with other antiepileptic drugs during pregnancy.
Findings from a large, published epidemiology study have shown that the use of carbamazepine may affect the growth of your unborn baby during pregnancy.
If you take Carbamazepine Milpharm Prolonged-release during pregnancy, your baby is also at risk for bleeding problems right after birth. Your doctor may give you and your baby a medicine to prevent this.
Breast-feeding
Mothers taking Carbamazepine Milpharm Prolonged-release can breastfeed their babies, but you must tell the doctor as soon as possible if you think that the baby is suffering side effects such as excessive sleepiness, skin reaction or yellow skin and eyes, dark urine or pale stools.
Fertility
You should use an effective method of contraception throughout your treatment with Carbamazepine Milpharm Prolonged-release and for a period of 28 days, after discontinuation of treatment. Irregularity of the menstrual period may occur in women taking hormonal contraceptives (birth control medicines) and Carbamazepine Milpharm Prolonged-release. The hormonal contraceptive may become less effective and you should consider using a different or additional non-hormonal contraceptive method. Ask your doctor about effective contraception.
Carbamazepine Milpharm Prolonged-release can make you feel dizzy or drowsy, or may cause blurred vision, double vision, or you may have a lack of muscular coordination, especially at the start of treatment or when the dose is changed. If you are affected in this way, or if your eyesight is affected, you should not drive or operate machinery.
This may cause stomach upset and diarrhea
This medicine contains less than 1 mmol sodium (less than 23 mg) per tablet, that is to say Carbamazepine Milpharm Prolonged-release is essentially ‘sodium -free’.
The doctor will tell you how many Carbamazepine Milpharm Prolonged-release to take and when to take them. Always follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label carefully. It is important to take the tablets at the right times. If you are not sure, ask your doctor or pharmacist. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor.
Your doctor will usually start Carbamazepine Milpharm Prolonged-release at a fairly low dose which can then be increased to suit you individually. The dose needed varies between patients. You can take Carbamazepine Milpharm Prolonged-release during, after or between meals. Swallow the tablets with a drink. Do not chew them. You are usually told to take a dose two or three times a day. If necessary you may break the tablets in half along the scored line.
To treat epilepsy the usual doses are:
Adults: 800-1,200 mg a day, although higher doses may be necessary. If you are elderly you might require a lower dose.
Children:
Aged 5-10 years: 400-600 mg a day
Aged 10-15 years: 600-1,000 mg a day.
Carbamazepine Milpharm Prolonged-release are not recommended for children under 5.
To treat trigeminal neuralgia the usual dose is: 600-800 mg a day. The maximum dose is 1200mg a day. If you are elderly you might require a lower dose.
To treat mood swings the usual dose is: 400-600 mg a day
If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, though, just take the next dose and forget about the one you missed.
If you accidentally take too many Carbamazepine Milpharm Prolonged-release, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious
Stop taking Carbamazepine Milpharm Prolonged-release and tell your doctor straight away if you notice:
The side effects listed below have also been reported.
Very common (may affect more than 1 in 10 people):
Leucopenia (a reduced number of the cells which fight infection making it easier to catch infections); dizziness and tiredness; feeling unsteady or finding it difficult to control movements; feeling or being sick; changes in liver enzyme levels (usually without any symptoms); skin reactions which may be severe.
Common (may affect up to 1 in 10 people):
Changes in the blood including an increased tendency to bruise or bleed; fluid retention and swelling; weight increase; low sodium in the blood which might result in confusion; headache; double or blurred vision; dry mouth.
Uncommon (may affect up to 1 in 100 people):
Abnormal involuntary movements including tremor or tics; abnormal eye movements; diarrhoea; constipation.
Rare (may affect up to 1 in 1,000 people):
Disease of the lymph glands; folic acid deficiency; a generalised allergic reaction including rash, joint pain, fever, problems with the kidneys and other organs; hallucinations; depression; loss of appetite; restlessness; aggression; agitation; confusion; speech disorders; numbness or tingling in the hands and feet; muscle weakness; high blood pressure (which may make you feel dizzy, with a flushed face, headache, fatigue and nervousness); low blood pressure (the symptoms of which are feeling faint, light headed, dizzy, confused, having blurred vision); changes to heart beat; stomach pain; liver problems including jaundice; symptoms of lupus.
Very rare (may affect up to 1 in 10,000 people):
Changes to the composition of the blood including anaemia; porphyria; meningitis; swelling of the breasts and discharge of milk which may occur in both male and females; abnormal thyroid function tests; osteomalacia (which may be noticed as pain on walking and bowing of the long bones in the legs); osteoporosis; increased blood fat levels; taste disturbances; conjunctivitis; glaucoma; cataracts; hearing disorders; heart and circulatory problems including deep vein thrombosis (DVT), the symptoms of which could include tenderness, pain, swelling, warmth, skin discoloration and prominent superficial veins; lung or breathing problems; severe skin reactions including Stevens-Johnson syndrome (These reactions may be more frequent in patients of Chinese or Thai origin); sore mouth or tongue; liver failure; increased sensitivity of the skin to sunlight; alterations in skin pigmentation; acne; excessive sweating; hair loss; increased hair growth on the body and face; muscle pain or spasm; sexual difficulties which may include reduced male fertility, loss of libido or impotence; kidney failure; blood spots in the urine; increased or decreased desire to pass urine or difficulty in passing urine.
Not Known (frequency cannot be estimated from the available data):
Severe skin reactions, accompanied by feeling unwell and changes in blood results. Diarrhoea, abdominal pain, and fever (signs of inflammation of the colon), reactivation of herpes virus infection (can be serious when immune system is depressed), complete loss of nails, fracture, decrease in the measure of the bone density, drowsiness, memory loss, purple or reddish-purple bumps that may be itchy, high levels of ammonia in the blood (hyperammonaemia). The symptoms of hyperammonaemia may include irritability, confusion, vomiting, loss of appetite, and sleepiness.
Do not be alarmed by this list. Most people take Carbamazepine Milpharm Prolonged-release without any problems.
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton, bottle and blister after EXP. The expiry date refers to the last day of that month.
Blister pack: Store below 30°C
Bottle pack: This medicine does not require any special storage conditions
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is carbamazepine.
Each prolonged-release tablet contains 200 mg or 400 mg of carbamazepine.
The other ingredients are:
Tablet core: cellulose microcrystalline; silica, colloidal anhydrous; croscarmellose sodium; talc; magnesium stearate; ethyl cellulose; cetyl alcohol; sodium lauryl sulfate; ethyl acrylate-methyl methacrylate copolymer; nonoxynol 100.
Tablet coating: hypromellose (E464); macrogolglycerol hydroxystearate; talc (E553b); titanium dioxide (E171).
Carbamazepine Milpharm 200 mg Prolonged-Release Tablets
White to off-white, oval shaped biconvex film-coated tablets. They are approximately 12.5 x 5.8mm, debossed with ‘C’ and ‘2’ separated by score line on both sides.
The tablet can be divided into equal doses.
Carbamazepine Milpharm 400 mg Prolonged-Release Tablets
White to off-white, oval shaped biconvex film-coated tablets. They are approximately 17.5 x 7mm, debossed with ‘C’ and ‘4’ separated by score line on both sides.
The tablet can be divided into equal doses.
Carbamazepine Milpharm 200 mg & 400 mg prolonged-release tablets are available in blister packs.
Carbamazepine Milpharm 400 mg prolonged-release tablets are also available in a white plastic bottle.
Pack sizes:
Blister:
200 mg and 400 mg: 30, 50, 56, 100, 200 and 500 (hospital pack) prolonged-release tablets
Not all pack sizes may be marketed.
This leaflet was last revised in 10/2025.
P1540699
Milpharm Limited, 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, UK
+ 44 (0)208 845 8811
+44 (0)208 845 8811
http://www.aurobindo.com
+44 (0)208 845 8795
