25 mg, 50 mg, 100 mg, 200 mg dispersible tablets
lamotrigine
What Lamotrigine 1A Farma is and what it is used for
Lamotrigine 1A Farma belongs to a group of medicines called antiepileptics. It is used to treat two conditions – epilepsy and bipolar disorder.
Lamotrigine 1A Farma 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 1A Farma can be used alone or in combination with other medicines to treat epilepsy . Lamotrigine 1A Farma can also be used with other medicines to treat the seizures that occur in a condition called Lennox-Gastaut syndrome.
- For children aged between 2 and 12 years, Lamotrigine 1A Farma 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 1A Farma 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 1A Farma 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 1A Farma works in the brain to have this effect.
Lamotrigine contained in Lamotrigine 1A Farma 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 take Lamotrigine 1A Farma
Do not take Lamotrigine 1A Farma:
- if you are allergic to lamotrigine or any of the other ingredients of this medicine (listed in section 6).
If this applies to you:
→ Tell your doctor and do not take Lamotrigine 1A Farma.
Warnings and cautions
Talk to your doctor or pharmacist before taking Lamotrigine 1A Farma :
- if you have any problems with your kidneys or liver
- if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
- if you have ever developed meningitis ( 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
- if you have a condition called Brugada SyndromeBrugada’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.
If any of this applies to you:
→ Tell your doctor who may decide that your dose needs to be reduced or that Lamotrigine 1A Farma is not suitable for you.
Important information about possible life-threatening reactions
A small number of people taking Lamotrigine 1A Farma have an allergic reaction or a skin reaction that can be life-threatening and develop into more serious problems if left untreated. This may include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia, and systemic symptoms. You need to know the symptoms that you should be aware of while taking Lamotrigine 1A Farma.
→ Read the description of these symptoms in section 4 of this leaflet under “Possible life-threatening reactions: contact a doctor immediately”.
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).
Thoughts of harming yourself or suicide
Antiepileptic drugs are used to treat various 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 of age.
If you have worrying thoughts or experiences or if you notice that you feel worse or develop new symptoms while taking Lamotrigine 1A Farma:
→ 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 may be 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 other changes in your behavior.
A small number of people who are treated with anti-epileptic drugs such as Lamotrigine 1A Farma have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
If you are taking Lamotrigine 1A Farma for epilepsy
Seizures in certain types of epilepsy can sometimes get worse or occur more often while you are taking Lamotrigine 1A Farma. 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 1A Farma:
→ Contact a doctor as soon as possible.
Children and young people
Lamotrigine 1A Farma 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 1A Farma
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 medicines.
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 1A Farma. These medicines include:
- oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate , zonisamide, lacosamide or perampanel 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 Lamotrigin 1A Farma 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 1A Farma 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 a pill, your doctor may take blood samples to check your Lamotrigine 1A Farma levels. If you are using or planning to start using hormonal contraceptives:
→ Tell your doctor who discusses appropriate contraceptive methods with you.
Lamotrigine 1A Farma may also affect the way hormonal contraceptives work, although they are unlikely to be less effective. If you use a hormonal contraceptive and notice any change in your menstrual cycle such as menstrual-like bleeding or spotting between menstruations:
→ Tell your doctor. This may be a sign that Lamotrigine 1A Farma 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, ask your doctor or pharmacist for advice before taking this medicine.
- You should not end your treatment without discussing it with your doctor. This is especially important if you have epilepsy .
- Pregnancy may change the effectiveness of Lamotrigin 1A Farma, so you may need to take blood samples and your dose of Lamotrigin 1A Farma may need to be changed.
- There may be a slight increased risk of malformation in the fetus, including cleft lip or palate , if Lamotrigine 1A Farma 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 before taking this medicine.
The active substance in Lamotrigine 1A Farma is excreted in human milk and may affect the baby. Your doctor will discuss the risks and benefits of breastfeeding during treatment with lamotrigine. 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 1A Farma may cause dizziness and double vision.
→ Do not drive or use 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 attention. 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 1A Farma contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet and dose, ie essentially ‘sodium-free.
How to take Lamotrigine 1A Farma
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much Lamotrigine 1A Farma to take
It may take a while to find the Lamotrigine 1A pharmacokinetics, the dose is best for you. The dose you take depends on:
- your age
- if you are taking Lamotrigine 1A Farma with other medicines or not
- 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 Lamotrigine 1A Farma more than your doctor has told you.
The usual effective dose of Lamotrigine 1A Farma 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 the body weight – usually, it is 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 1A Farma is not recommended for children under 2 years of age.
How to take your dose of Lamotrigine 1A Farma
Take your dose of Lamotrigine 1A Farma once or twice daily according to your doctor’s instructions. It can be taken with or without food.
- Always take the full dose prescribed by your doctor. Never take just one part of a tablet.
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.
Lamotrigine 1A Farma dispersible tablets can be either swallowed whole with a little water or mixed with water for liquid medicine.
To swallow the tablet whole:
You may need to drink some water at the same time so that the tablet dissolves in your mouth. Then drink a little more water so that you can safely swallow all the medicine.
To make a liquid medicine:
- Put the tablet in a glass with at least enough water to cover the whole tablet.
- Stir to dissolve the tablet or wait until the tablet is completely dissolved.
- Drink all the liquid.
- Add a little more water to the glass and drink it to ensure that no medicine is left in the glass.
If you take more Lamotrigine 1A Farma than you should
If you have ingested too much medicine or if e.g. a child accidentally ingested the drug:
→Contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice. Show them the Lamotrigine 1A Farma package if possible.
If you take too much Lamotrigine 1A Farma you are more likely to get serious side effects that can be life-threatening.
A person who has taken too much Lamotrigine 1A Farma 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 1A Farma
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 1A Farma
→ Ask your doctor how to start taking the medicine again. You must ask about this.
If you stop using Lamotrigine 1A Farma
Do not stop taking Lamotrigine 1A Farma without consulting your doctor
Lamotrigine 1A Farma 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 1A Farma for epilepsy
To stop taking Lamotrigine 1A Farma, the dose must be reduced gradually over about 2 weeks. If you suddenly stop taking Lamotrigine 1A Farma, your epilepsy may come back or get worse.
If you are taking Lamotrigine 1A Farma for bipolar disorder
It may take some time before Lamotrigine 1A Farma works and therefore you will probably not feel better right away.
If you stop taking Lamotrigine 1A Farma, the dose does not need to be reduced gradually. However, you should still talk to your doctor first, if you want to stop taking Lamotrigine 1A Farma.
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 1A Farma have an allergic reaction or a skin reaction that can be life-threatening and develop into more serious problems if left untreated.
You are most likely to get these symptoms during the first few months of treatment with Lamotrigine 1A Farma, especially if you start with too high a dose or if your dose is increased too fast, or if you take Lamotrigine 1A Farma with another medicine containing 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 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, also known as hypersensitivity syndrome).
- sores in the mouth, throat, nose or genitals
- sore mouth or red or 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
- sore throat or more infections (such as colds) than usual
- elevated liver enzyme levels in blood samples
- increased number of a certain type of white blood cell ( eosinophils )
- enlarged lymph nodes
- effects on organs such as the 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 1A Farma. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you never to use lamotrigine again.
Haemophagocytic syndrome (HLH) (see section 2 What you need to know before taking Lamotrigine 1A Farma).
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 or vomiting
- fatigue
- back or joint pain or elsewhere.
Less common side effects are (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 ).
Rare side effects are (may affect up to 1 in 1000 users)
- a life-threatening skin reaction ( Stevens-Johnson syndrome ): see also information at the beginning of section 4
- a group of symptoms that include:
- fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be due to an inflammation of the membrane that protects the brain and 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)
- Haemophagocytic Syndrome (HLH) (see section 2 What you need to know before you use Lamotrigine 1A Farma)
- a life-threatening skin reaction ( toxic epidermal necrolysis ): see also 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 evidenced by blood tests, or liver failure: see also 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 information at the beginning of section 4
- changes that can be seen in blood tests – 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).
Other side effects are
Other side effects have been reported in a small number of people but the exact frequency is unknown:
- There have been reports of skeletal effects including osteopenia and osteoporosis (thinning of the skeletal bone) and bone fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis or are taking steroids .
- Nightmares.
- Impaired immune system due to lower levels of immunoglobulins , a type of blood cell that helps protect against infection .
How to store Lamotrigine 1A Farma
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 or blister / can 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 dispersible tablet contains 25 mg, 50 mg, 100 mg and 200 mg lamotrigine.
Other ingredients are microcrystalline cellulose (E460), povidone K30 (E1201), sodium (Type A), hydroxypropyl cellulose (E463), saccharin sodium (E954), black currant flavor (one of the ingredients is maltodextrin), magnesium stearate (E470b), colloidal anhydrous silica (E551 ).
What the medicine looks like and contents of the pack
Lamotrigine 1A Farma dispersible tablets are white to off-white, round, and flat with beveled edges.
Lamotrigine 1A Farma dispersible tablets are packaged in PVC / PE / PVDC / Al blisters of 14, 28, 30, 50, 56, 60, 90, 100 or 200 dispersible tablets in cartons.
Lamotrigine 1A Farma dispersible tablets are packaged in perforated PVC / PE / PVDC / Al unit dose blisters of 100 x 1 dispersible tablet
Lamotrigine 1A Farma dispersible tablets are packaged in a PP can with an LDPE cap containing 90, 100, or 200 dispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
1A Farma A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
SC Sandoz SRL, Str. Livezeni 7A, 540472, Targu-Mures, Romania
or
Salutas Pharma GmbH, Otto-von-Guericke- Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Trimline 2d, 9220 Lendava, Slovenia