Lamotrix 100 mg. 30 tablets

What LAMOTRIX is and what it is used for

LAMOTRIX belongs to a group of medicines called antiepileptics. It is used to treat two diseases - epilepsy and bipolar disorder.

LAMOTRIX treats epilepsy by blocking the brain signals that cause epileptic seizures.

• In adults and children 13 years and older. LAMOTRIX can be used alone or in combination with other antiepileptic medicines. LAMOTRIX can be used to treat seizures associated with Lenox-Gastaut syndrome.
• In children aged 2 to 12 years, LAMOTRIX can be used with other medicines to treat the diseases described. It can be used on its own to treat a type of epilepsy called typical absences.

LAMOTRIX is used to treat bipolar disorder
People with bipolar disorder (sometimes called manic-depressive) have extreme mood swings with periods of mania (excitement or euphoria), replaced by periods of depression (deep sadness or despair). In adults 18 years of age and older, LAMOTRIX can be used alone or in combination with other medicines to prevent periods of depression that occur in bipolar disorder. The mechanism of action of lamotrigine in the brain to achieve this effect is not yet clear.

2. What you need to know before you take LAMOTRIX

Do not take LAMOTRIX
- if you are allergic to lamotrigine or any of the other ingredients of this medicine (listed in section 6.1).
If this applies to you, tell your doctor and do not take LAMOTRIX. Warnings and precautions

Talk to your doctor or pharmacist before taking LAMOTRIX:

if you have any kidney problems
if you have ever had a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
if you have ever developed meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare side effects) if you are already taking medicines containing lamotrigine.
Brugada syndrome
Brugada syndrome is a genetic disease that causes a disturbance in the electrical activity of the heart. These ECG abnormalities, which can lead to arrhythmia (irregular heartbeat), can be triggered by lamotrigine. Talk to your doctor if you have this condition.

Haemophagocytic lymphohistiocytosis (HLH)
There have been reports of a rare but very serious immune system reaction in patients taking lamotrigine. Contact your doctor or pharmacist immediately if any of the following symptoms occur while you are taking lamotrigine: fever, rash, neurological symptoms (eg tremor or tremor, confusion, impaired brain function).

Pregnancy and lactation
If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine. The active ingredient in Lamotrix passes into breast milk and may affect your baby. If you decide to breast-feed, your doctor will discuss the risks and benefits of breast-feeding while you are being treated with lamotrigine and will periodically check your baby's condition for drowsiness, rash or low weight gain. Tell your doctor if you notice any of these symptoms in your baby.
If any of the above apply to you, tell your doctor, who may decide to reduce the dose or decide that LAMOTRIX is not suitable for you.

Important information about potentially life-threatening reactions
A small number of patients taking LAMOTRIX develop an allergic reaction or a potentially life-threatening skin reaction that can develop into more serious problems if left untreated. These may include Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). You should be aware of the symptoms to watch for them while you are taking LAMOTRIX.
Read the description of these symptoms in section 4 of this leaflet in “Potentially life-threatening reactions: seek medical advice immediately.

Thoughts of self-harm or suicide
Antiepileptic drugs are used to treat several diseases, including epilepsy and bipolar disorder. People who suffer from bipolar disorder can sometimes have thoughts of self-harm or suicide. If you suffer from bipolar disorder, you are more likely to think this way:
• when you start treatment for the first time
• if you have had thoughts of harming or killing yourself in the past
• if you are under 25 years of age.

If you have depressive thoughts or experiences, or if you notice that you feel worse or develop new symptoms while taking LAMOTRIX, tell your doctor immediately or go to the nearest hospital for help.

You may find it helpful to tell a family member, a person who cares for you, or a close friend
Other medicines and LAMOTRIX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor should know if you are taking other medicines to treat epilepsy or mental health problems. This is to make sure that your doctor is sure that you are taking the right dose. These medicines include:
• oxcarbamazepine, felbamate, gabapentin, levetiracetam, pregabalin, topnramate or zonisamide used to treat epilepsy
• lithium, olanzapine or aripiprazole used to treat mental problems
• bupropion, used to treat mental health problems or to stop smoking.

Tell your doctor if you are taking any of these medicines.
Some medicines interact with LAMOTRIX or increase the likelihood of side effects in humans. They include:
• valproate, used to treat epilepsy and mental health problems
• carbamazepine, used to treat epilepsy and mental health problems
• phenytoin, primidone or phenobarbitone used to treat epilepsy
• risperidone, used to treat mental problems
• rifampicin, which is an antibiotic
• medicines used to treat infection caused by the human immunodeficiency virus (HIV) (combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as birth control pills (see below). Tell your doctor * if you are taking, starting or stopping any of these medicines.

Hormonal contraceptives (birth control pills) may affect the way LAMOTRIX works
Your doctor may recommend the use of a certain type of hormonal contraceptive or another method of contraception such as the use of a condom, diaphragm or IUD. If you are using a hormonal contraceptive (birth control pill), your doctor may take a blood sample to check the level of LAMOTRIX. If you are taking a hormonal contraceptive or intend to start taking a hormonal contraceptive, discuss this with your doctor, who may suggest suitable methods of contraception.

LAMOTRIX may also affect the action of hormonal contraceptives, although it is not expected to reduce the effect of their action. If you use a hormonal contraceptive and notice any changes in your menstrual cycle, such as sudden heavy bleeding or spotting between cycles, tell your doctor. This may be a sign that LAMOTRIX is affecting the way your contraceptive works.

Pregnancy, lactation and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• You should not stop treatment without discussing it with your doctor. This is especially important if you suffer from epilepsy.
• Pregnancy may change the effectiveness of LAMOTRIX, so blood tests may need to be done and the dose of LAMOTRIX you are taking may need to be adjusted.
• There may be a slightly higher risk of birth defects, including cleft lip and palate, if LAMOTRIX is taken during the first 3 months of pregnancy.
• Your doctor may advise you to take extra folic acid if you intend to become pregnant during pregnancy.

If you are breast-feeding or intend to breast-feed, talk to your doctor or pharmacist before using this medicine. The active substance in LAMOTRIX passes into breast milk and may affect the baby. Your doctor will discuss with you the risks and benefits of breast-feeding while taking LAMOTRIX. It will periodically monitor your baby's condition if you decide to breast-feed while taking LAMOTRIX.

Driving and using machines
LAMOTRIX may cause dizziness and double vision.
Do not drive or use machines unless you are sure that you do not have such symptoms.
If you have epilepsy, talk to your doctor about driving or using machines.
LAMOTRIX contains lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take LAMOTRIX
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

How much LAMOTRIX to take
It may take some time to determine the optimal dose of LAMOTRIX for you. The dose you take will depend on.
• Your age
• whether you are taking LAMOTRIX with other medicines
• if you have any kidney or liver problems.

Your doctor will prescribe a low dose at the beginning of treatment, which will gradually increase over several weeks until you reach a dose that is optimal for controlling the disease (called an effective dose). Never take more LAMOTRIX than prescribed by your doctor.

The usual effective dose of LAMOTRIX for adults and children 13 and older
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Potentially life-threatening reactions: Get medical attention immediately
A small number of people taking lamotrigine experience an allergic reaction or a potentially life-threatening skin reaction that can worsen into more serious problems if left untreated.
These symptoms are more likely to occur during the first few months of treatment with lamotrigine, especially if the starting dose is too high or if the dose is increased too quickly, or if lamotrigine is taken with another medicine called valproate. Some of these symptoms are more common in children, so parents should be especially careful about them.

Symptoms of these reactions include;
• skin rashes or redness that can develop into life-threatening skin reactions, including widespread blistering or flaking of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive exfoliation of the skin (more than 30% of the body surface - toxic epidermal necrolysis) or extensive rash affecting the liver, blood and other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS hypersensitivity syndrome)
• ulcers in the mouth, throat, nose or genitals
• dry mouth or red and swollen eyes {conjunctivitis)
• fever (chills), flu-like symptoms, or drowsiness
• swelling of the face or enlarged lymph nodes in the neck, armpits or groin
• unexplained bleeding or bruising, or bruising of the fingers
• sore throat or infections (such as colds) more common than usual
• elevated levels of liver enzymes seen in blood tests
• increased levels of white blood cells (eosinophils)
• enlarged lymph nodes
• affects organs of the body, including the liver and kidneys.

In many cases, these symptoms are a sign of less serious side effects, but you should be aware that they are potentially life-threatening and can develop into more serious problems, such as organ failure, if left untreated.

If you notice any of these symptoms, contact your doctor immediately. Your doctor may decide to do tests on your liver, kidneys or blood, and may tell you to stop taking lamotrigine. If you develop Stevens-John's Syndrome or toxic epidermal necrolysis, your doctor will tell you that you should never take lamotrigine again.

Very common side effects (may affect more than 1 in 10 people):
• headache
• each rash.

Common side effects (may affect up to 1 in 10 people):
• aggression or irritability
• drowsiness
• dizziness
• tremors or tremors
• sleep problems (insomnia)
• anxiety
• diarrhea
• dry mouth
• nausea or vomiting
• fatigue
• pain in the back, joints or other parts of the body

Uncommon side effects (may affect up to 1 in 100 people)
• clumsiness and lack of coordination (ataxia)
• double vision or blurred vision
• unusual hair loss or thinning hair (alopecia).

Rare side effects (may affect up to 1 in 1,000 people)
• life-threatening skin reactions (Stevens-Johnson syndrome): see also information at the beginning of section 4
• a group of symptoms that occur at the same time, including: fever, nausea, vomiting »headache, stiff neck and extremely strong sensitivity to bright light. This can be caused by inflammation of the lining that covers the brain and spinal cord (meningitis). These symptoms usually disappear after stopping treatment. However, if symptoms persist or worsen, talk to your doctor.
• rapid, uncontrolled eye movements (nystagmus)
• itching in the eyes with discharge and crusting of the eyelids (conjunctivitis).

Very rare side effects (may affect up to 1 in 10,000 people)
• life-threatening skin reactions (toxic epidermal necrolysis) '. see also the information at the beginning of point 4
• drug reaction with eosinophilia and systemic symptoms: see also information at the beginning of section 4
• high fever (chills): see also the information at the beginning of section 4
• swelling of the face (edema) or enlarged lymph nodes in the neck, armpits or groin (lymphadenopathy): see also the information at the beginning of section 4.
• changes in liver function that occur in blood tests or liver failure: see also the information at the beginning of section 4.
• serious blood clotting disorder that may cause unexplained bleeding or bruising (disseminated intravascular coagulation): see also the information at the beginning of section 4.
• changes that may occur in the blood tests - including a reduced number of red blood cells (anemia) ^ a reduced number of white blood cells (leukopenia
How to store LAMOTRIX
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and each blister. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What LAMOTRIX contains
The active substance is lamotrigine.
LAMOTRIX 25 mg: Each tablet contains 25 mg lamotrigine.
LAMOTRIX 50 mg: Each tablet contains 50 mg lamotrigine.
LAMOTRIX 100 mg: Each tablet contains 100 mg lamotrigine.
LAMOTRIX 200 mg: Each tablet contains 200 mg lamotrigine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate and iron oxide (E 172).

What LAMOTRIX looks like and contents of the pack
LAMOTRIX 25 mg are beige, round, flat tablets marked MS on one side and 6 mm in diameter.
LAMOTRIX 50 mg are beige, round, flat tablets with a score line and a diameter of 8 mm.
LAMOTRIX 100 mg are beige, round, flat tablets with a score line and a diameter of 9.5 mm.
LAMOTRIX 200 mg are beige, round, flat tablets with a score line and a diameter of 12.77 mm.

The tablets can be divided into two equal doses, except for the 25 mg tablets, which do not have a score line.
LAMOTRIX is available in packs of 30 tablets.

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