25 mg, 50 mg, 100 mg, 200 mg tablets
lamotrigine
What Lamotrigine Aurobindo is and what it is used for
Lamotrigine Aurobindo belongs to a group of medicines called antiepileptics. It is used to treat two conditions – epilepsy and bipolar disorder.
Lamotrigine Aurobindo treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (attacks).
- For adults and children 13 years of age and older, Lamotrigine Aurobindo can be used alone or in combination with other medicines to treat epilepsy . Lamotrigine Aurobindo can also be used with other medicines to treat the seizures that occur in a condition known as Lennox-Gastaut syndrome.
- For children between the ages of 2 and 12, Lamotrigine Aurobindo can be used with other medicines to treat these conditions. It can be used as the sole treatment to treat a type of epilepsy called typical absences.
Lamotrigine Aurobindo also treats bipolar disorder.
People with bipolar disorder (sometimes referred to as manic depression ) experience very sharp mood swings with periods of mania (excitement or rush of happiness) alternating with periods of depression (deep sadness or despair). For adults 18 years of age and older, Lamotrigine Aurobindo can be used alone or in combination with other medicines to prevent periods of depression in bipolar disorder. It is not yet known how Lamotrigine Aurobindo works in the brain to have this effect.
Lamotrigine contained in Lamotrigine Aurobindo may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Lamotrigine Aurobindo
Do not take Lamotrigine Aurobindo:
Lamotrigine Aurobindo 25/50/200 mg tablets
- if you are allergic to lamotrigine or any of the other ingredients of this medicine (listed in section 6).
Lamotrigine Aurobindo 100 mg tablets
- if you are allergic to lamotrigine, para-orange aluminum lacquer or any of the other ingredients of Lamotrigine Aurobindo (listed in section 6).
If this applies to you:
→ Tell your doctor and do not take Lamotrigine Aurobindo.
Warnings and cautions
Warnings and cautions
Talk to your doctor or pharmacist before taking Lamotrigine Aurobindo:
- if you have any kidney problems
- if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy or if you get a rash or get burnt when you take lamotrigine and have been in the sun or artificial light (eg solarium). Your doctor will monitor your treatment and may recommend that you avoid sunlight or protect your skin from the sun’s rays (eg with sunscreen and / or protective clothing).
- if you have ever developed meningitis ( meningitis ) after that you have taken lamotrigine (read the description of its symptoms in section 4 of this leaflet: Rare side effects)
- if you are already taking medicines containing lamotrigine
If any of this applies to you:
→ Tell your doctor who may decide that your dose needs to be reduced or that Lamotrigine Aurobindo is not suitable for you.
Brugada syndrome
Brugada’s syndrome is a genetic disease that leads to abnormal electrical activity in the heart. ECG abnormalities that can lead to arrhythmias (abnormal heart rhythms) can be triggered by lamotrigine. Talk to your doctor if you have this disease.
Hemophagocytic syndrome (HLH)
There have been reports of a rare but very severe reaction in the immune system in patients taking lamotrigine. Contact a doctor or pharmacist immediately if you experience any of the following symptoms: fever, rash, neurological symptoms (eg tremors or tremors, confused state, disorders of brain function).
Important information about possible serious reactions
A small number of people taking lamotrigine get an allergic reaction or skin reaction such as
can be life-threatening and develop into more serious problems if left untreated. This may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with
eosinophilia and systemic symptoms (DRESS). You need to know the symptoms that you should be aware of while taking lamotrigine.
→ Read the description of these symptoms in section 4 of this leaflet. Possible life-threatening reactions: contact a doctor immediately ”.
Thoughts of harming yourself or suicide
Medicines for epilepsy are used to treat several conditions, including epilepsy and bipolar disorder. People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide. If you have bipolar disorder, you are more likely to have such thoughts:
- When you start treatment.
- If you have previously had thoughts of harming yourself or committing suicide.
- If you are under 25 years old.
If you have worrying thoughts or experiences or if you notice that you feel worse or develop new symptoms while taking Lamotrigine Aurobindo:
→ Contact a doctor as soon as possible or see your nearest hospital for help.
It may be helpful to tell a family member, caregiver, or close friend that you are
may become depressed or have noticeable changes in your mood, and ask them to read this leaflet. You
can ask them to tell you if they are worried about your depression or others
changes in your behavior.
A small number of people being treated with antiepileptic drugs, such as Lamotrigine Aurobindo, have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
If you take Lamotrigine Aurobindo for epilepsy
Seizures with certain types of epilepsy can sometimes get worse or occur more often while you are taking Lamotrigine Aurobindo. Some patients may experience severe seizures that can cause serious health problems. If your seizures occur more often or if you experience a severe seizure while taking Lamotrigine Aurobindo:
→ Contact a doctor as soon as possible.
Lamotrigine Aurobindo should not be given to people under the age of 18 for the treatment of bipolar disorder.
Drugs for the treatment of depression and other mental health problems increase the risk of suicidal thoughts and suicidal behavior in children and adolescents under 18 years of age.
Other medicines and Lamotrigine Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal remedies.
Your doctor needs to know if you are taking any other medicines to treat epilepsy or mental health problems. This is to ensure that you take the correct dose of Lamotrigine Aurobindo. These drugs include:
- oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or
zonisamide used to treat epilepsy
- lithium, olanzapine or aripiprazole used to treat mental health problems
- bupropion used to treat mental health problems or to quit smoking
→ Tell your doctor if you are taking any of these.
Some medicines affect Lamotrigine Aurobindo or make you more likely to get side effects. These include:
- valproate used to treat epilepsy and mental health problems
- carbamazepine used to treat epilepsy and mental health problems
- phenytoin , primidone or phenobarbital used to treat epilepsy
- risperidone used to treat mental health problems
- rifampicin which is an antibiotic
- medicines used to treat HIV (a 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 or are starting or stopping any of these.
Hormonal contraceptives (eg birth control pills ) can affect the way Lamotrigine Aurobindo works
Your doctor may recommend that you use a special type of hormonal contraceptive or another method of contraception such as a condom, diaphragm, or IUD. If you are using a hormonal contraceptive such as the contraceptive pill, your doctor may take a blood test to check your Lamotrigine Aurobindo levels. If you are taking or are planning to start using hormonal contraceptives:
→ Tell your doctor who is discussing suitable contraceptive methods with you.
Lamotrigine Aurobindo may also affect the way hormonal contraceptives work, although they are unlikely to be less effective. If you are using a hormonal contraceptive and notice any change in your menstrual cycle, such as menstrual-like bleeding or spotting between periods:
→ Tell your doctor. This may be a sign that Lamotrigine Aurobindo is affecting the way your contraceptive works.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby,
Consult your doctor or pharmacist before using this medicine.
You should not end your treatment without discussing it with your doctor. It is
especially important if you have epilepsy.
- Pregnancy may change the effectiveness of Lamotrigine Aurobindo, so you may need to take blood samples and your dose of Lamotrigine Aurobindo may need to be changed.
- There may be a small increased risk of malformation in the fetus, including cleft lip or palate , if Lamotrigine Aurobindo is taken during the first three months of pregnancy.
- Your doctor may advise you to take extra folic acid if you are planning to become pregnant and while you are pregnant.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice if you are taking this medicine. The active substance in Lamotrigine Aurobindo is excreted in human milk and may affect the baby. Your doctor will discuss the risks and benefits of breastfeeding during treatment with Lamotrigine Aurobindo. If you choose to breastfeed, the doctor will check the baby from time to time to see if the baby is drowsy, rash, or has poor weight gain. Tell your doctor if you notice any of these symptoms in your child.
Driving and using machines
Lamotrigine Aurobindo may cause dizziness and double vision.
→ Do not drive a vehicle or use any tools or machines unless you are feeling well.
If you have epilepsy, talk to your doctor about driving and using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lamotrigine Aurobindo contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Lamotrigine Aurobindo 100 mg tablets contain para-orange aluminum lacquer, which may cause allergic reactions.
Lamotrigine Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.
How to take Lamotrigine Aurobindo
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much Lamotrigine Aurobindo to take
It may take a while to find the Lamotrigine Aurobindo dose that is best for you. The dose you take depends on:
- your age
- whether or not you are taking Lamotrigine Aurobindo with other medicines
- if you have any problems with your kidneys or liver.
Your doctor will start you on a low dose and increase the dose gradually over a few weeks until you reach a dose that works for you (called the effective dose of one ). Never take more Lamotrigine Aurobindo than your doctor has told you to.
The usual effective dose of Lamotrigine Aurobindo for adults and children from 13 years of age is between 100 mg and 400 mg daily.
For children between 2 and 12 years of age, the effective dose depends on one’s body weight – usually between 1 mg and 15 mg for each kilogram of the child’s weight up to a maintenance dose of no more than 200 mg daily.
Lamotrigine Aurobindo is not recommended for children under 2 years of age.
How to take your dose of Lamotrigine Aurobindo
Take your dose of Lamotrigine Aurobindo once or twice daily according to your doctor’s instructions. Dose one can be taken with or without food.
Your doctor may also tell you to start or stop taking other medicines, depending on the condition you are being treated for and how you are reacting to the treatment.
- Swallow the tablets whole. If you need to take half the dose of 25 and 100 mg or To facilitate swallowing of 25 mg, 100 mg & 200 mg tablets, swallow tablet halves whole. You must not chew or crush them. See pictures below.
- Always take the full dose prescribed by your doctor. Never take just one part of a tablet.
How to halve the tablets (only applies to 25 mg, 100 mg, and 200 mg).
Use a table knife to halve the tablets. Alternatively, hold the tablet with the breaker up, grab both the upper and lower sides of the tablet, on each side of the breaker, using your thumb and forefinger on both hands (Fig. A), and halve the tablet by pressing down and away from you. , so that the tablet divides according to the line of the breaker groove (Fig. B). Do not hold your fingers on the end of the tablet, on either side of the breaker slot (Fig. C), as this may cause the tablet to fall into pieces.
If you take more Lamotrigine Aurobindo than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake
→ contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice. Show them the Lamotrigine Aurobindo pack if possible.
If you take too much Lamotrigine Aurobindo you are more likely to get serious side effects that can be life-threatening.
A person who has taken too much Lamotrigine Aurobindo may experience any of these symptoms:
- rapid, uncontrolled eye movements ( nystagmus )
- clumsiness and lack of coordination ability that affects balance ( ataxia )
- changes in heart rate (usually detected on ECG)
- loss of consciousness, seizures (convulsions) or coma.
If you forget to take a dose of Lamotrigine Aurobindo
Do not take extra tablets to compensate for a missed dose. Just take your next dose at the usual time.
If you forget to take multiple doses of Lamotrigine Aurobindo
→ Ask your doctor how to start taking the medicine again. You must ask about this
Do not stop taking Lamotrigine Aurobindo without consulting your doctor.
Lamotrigine Aurobindo must be taken for as long as your doctor recommends it. Do not stop without your doctor telling you to.
If you are taking Lamotrigine Aurobindo for epilepsy
To stop taking Lamotrigine Aurobindo, the dose must be reduced gradually over about 2 weeks. If you suddenly stop taking Lamotrigine Aurobindo, your epilepsy may come back or get worse.
If you are taking Lamotrigine Aurobindo for bipolar disorder
It may take some time before Lamotrigine Aurobindo works and therefore you will probably not feel better right away. If you stop taking Lamotrigine Aurobindo, your dose does not need to be reduced gradually. However, you should still talk to your doctor first, if you want to stop taking Lamotrigine Aurobindo.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible life-threatening reactions: contact a doctor immediately
A small number of people taking Lamotrigine Aurobindo have an allergic reaction or a skin reaction that can be life-threatening and develop into more serious problems if left untreated.
It is most likely that you have these symptoms during the first few months of treatment with Lamotrigine Aurobindo, especially if you start on too high a dose or dose of an increased too quickly, or if you are taking Lamotrigine Aurobindo together with another medicine called valproate. Some symptoms are more common in children so parents should pay extra attention.
Symptoms of such reactions include:
- skin rash or redness , which can develop into a life-threatening skin reaction that includes widespread skin rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), extensive flaking of the skin (more than 30% of body surface area – toxic epidermal necrolysis or extensive skin rash affecting the liver, blood and other body organs (drug reaction with eosinophilia and systemic symptoms (DRESS), also known as hypersensitivity syndrome) .
- sores in the mouth, throat, nose or abdomen
- sore mouth or red, swollen eyes (conjunctivitis)
- fever , flu-like symptoms or drowsiness
- swelling around the face or swollen glands in the neck, armpits or groin
- unexpected bleeding or bruising or that the fingers turn blue
- on t in the throat or more infections (for example, colds) than usual
- elevated liver enzyme levels in blood tests
- an increase in a kind of white blood cell ( eosinophils )
- enlarged lymph nodes
- effects on body organs, extensive liver and kidneys.
In many cases, these symptoms are signs of less serious side effects. But you need to be aware that they can be life-threatening and lead to more serious problems, such as organ failure if left untreated. If you notice any of these symptoms:
→ Contact a doctor immediately. Your doctor may decide to take samples of your liver, kidneys, or blood and may tell you to stop taking Lamotrigine Aurobindo. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you to never use
lamotrigine again.
Haemophagocytic syndrome (HLH) (see section 2: What you need to know before taking Lamotrigine Aurobindo).
Very common side effects are (can occur in more than 1 in 10 people):
- headache
- rash
Common side effects are (may affect up to 1 in 10 people):
- aggression or irritability
- drowsiness or drowsiness
- dizziness
- tremors or tremors
- sleep disorders ( insomnia )
- feelings of upset
- diarrhea
- dry mouth
- nausea, vomiting
- fatigue
- back or joint pain or elsewhere
Uncommon side effects ( may affect up to 1 in 100 people):
- clumsiness and lack of coordination ( ataxia )
- double vision or blurred vision
- abnormal hair loss or thinning ( alopecia )
- skin rash or sun damage after exposure to sun or artificial light ( photosensitivity )
Rare side effects (may affect up to 1 in 1,000 people ):
- a life-threatening skin reaction (Stevens-Johnson syndrome), see also the information at the beginning of section 4
- a group of symptoms that include:
- fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to strong light. This may be due to an inflammation of the membranes that protect the brain and the spine ( meningitis ). These symptoms usually go away when treatment is stopped. Contact your doctor if symptoms persist or worsen.
- rapid, uncontrolled eye movements ( nystagmus )
- itching of the eyes with secretions and crusts on the eyelids ( conjunctivitis ).
Very rare side effects are (may affect up to 1 in 10 000 users):
- a life-threatening skin reaction ( toxic epidermal necrolysis ), see also the information at the beginning of section 4
- drug reaction with eosinophilia and systemic symptoms, see also information at the beginning of section 4
- elevated temperature (fever), see also the information at the beginning of section 4
- swelling around the face ( edema ) or swollen glands in the neck, armpit or groin ( lymphadenopathy ) , see also the information at the beginning of section 4
- changes in liver function, as manifested in blood tests, or liver failure , see also the information at the beginning of section 4
- a severe disorder of blood coagulation that may cause unexpected bleeding or bruising (disseminated intravascular coagulation ), see also the information at the beginning of section 4
- changes that can be seen in blood samples – including decreased red blood cell count ( anemia ) , decreased white blood cell count ( leukopenia , neutropenia , agranulocytosis ) , decreased platelet count ( thrombocytopenia ) , decreased number of all these blood cell types (pancytopenia) and a disease in bone marrow one called aplastic anemia
- hallucinations (to “see” or “hear” things that do not really exist)
- confusion
- feeling of “wobbling” or being unsteady when you move
- uncontrollable body movements ( tics ) , uncontrollable muscle spasms that affect the eyes, head and torso (choreoatetosis) or other unusual body movements such as twitching, shaking or stiffness
- more common seizures in those who already have epilepsy
- worsening symptoms in those who already have Parkinson’s disease
- lupus-like reaction (symptoms may include: back or joint pain which may sometimes be accompanied by fever and / or general illness)
- Haemophagocytic syndrome (HLH) (see section 2 What you need to know before taking Lamotrigine Aurobindo).
Other side effects are
other side effects is has occurred in a small number of people but their exact frequency is unknown:
- There have been reports of bone diseases e.g. decreased bone density in the skeleton, osteoporosis and bone fractures. Contact your doctor or pharmacist if you are being treated with epilepsy medication for a long time, if you know you have osteoporosis or if you are on medication with steroids .
- renal inflammation ( tubulointerstitial nephritis ), or inflammation of both kidney and eye ( tubulointerstitial nephritis and uveitis )
- Nightmares
- Impaired immune system due to lower levels of immunoglobulins , a type of blood cell that helps protect against infection .
You can also report side effects directly via
The Medical Products Agency,
Box 26,
751 03 Uppsala
By reporting side effects, you can help increase the safety of medicines.
How to store Lamotrigine 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 blister/label on the bottle and carton after EXP.
The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
– The active substance is lamotrigine.
Each tablet contains 25 mg of lamotrigine.
Each tablet contains 50 mg lamotrigine
Each tablet contains 100 mg lamotrigine
Each tablet contains 200 mg lamotrigine
The other ingredients are microcrystalline cellulose, lactose monohydrate, indigo carmine
aluminum lacquer (E132), (For 200 mg only), Para-orange aluminum lacquer (E110) (For 100 mg only),
sodium starch glycolate (type A), magnesium stearate, povidone (K30).
What the medicine looks like and contents of the pack
Tablet
Lamotrigine Aurobindo 25 mg tablets are white to off-white, shield-shaped, uncoated tablets debossed with “D” and “93” on one side and the scoreline on the other.
The tablet can be divided into two equal doses.
Lamotrigine Aurobindo 50 mg tablets are white to off-white, square with rounded corners, uncoated tablets imprinted with “D” on the polygonal side, and ’97 ‘on the flat side.
Lamotrigine Aurobindo 100 mg tablets are peach-colored, flaming, shield-shaped, uncoated tablets debossed with “D” and “94” on one side and the scoreline on the other.
The tablet can be divided into two equal doses.
Lamotrigine Aurobindo 200 mg tablets are blue, flaming, shield-shaped uncoated tablets debossed with “D” and 96 “on one side and the scoreline on the other side.
The breaker is not for dividing the tablet into equal doses, but only for easier swallowing.
Lamotrigine tablets are available in:
– Clear PVC / Aluminum foil blister Pack sizes
: 1, 7, 10, 14, 20, 21, 28, 30, 40, 42, 46, 50, 56, 60, 90, 98, 100, 200, 250, 500 tablets.
– HDPE jars with polypropylene lids and cotton spool
Pack sizes: 60, 90, 100, 250, 500, 1000 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta
Manufacturer:
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
UK
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Generis Pharmacêutica, SA,
Rua João de Deus, 19,
2700-487
Amadora, Portugal
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
This medicinal product is authorized under the European Economic Area under the names:
| Czech Republic | Lamotrigine Aurovitas |
| Denmark | Lamotrigine “Aurobindo” |
| Germany | Lamotrigine Aurobindo 25 mg / 50 mg / 100 mg / 200 mg tablets |
| Portugal | Lamotrigina Aurobindo |
| Sweden | Lamotrigine Aurobindo 25 mg / 50 mg / 100 mg / 200 mg tablets |
| UK | Lamotrigine Milpharm 25 mg / 50 mg / 100 mg / 200 mg tablets |