25 mg, 50 mg, 100 mg and 200 mg lamotrigine tablets
What Lamotrigine Teva is and what it is used for
Lamotrigine Teva belongs to a group of medicines called antiepileptics. It is used to treat two conditions – epilepsy and bipolar disorder.
Lamotrigine Teva 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 Teva can be used alone or in combination with other medicines to treat epilepsy . Lamotrigine Teva can also be used in combination 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 Teva 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 Teva 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 Teva 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 Teva works in the brain to have this effect.
Lamotrigine contained in Lamotrigine Teva 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 Teva
Do not use Lamotrigine Teva
- if you are allergic (hypersensitive) 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 Teva.
Warnings and cautions
Talk to your doctor or pharmacist before using Lamotrigine Teva:
- if you have any kidney problems
- if you have ever had a rash after taking lamotrigine or any other medicine for bipolar disorder or epilepsy , or if you get a rash or get burnt while taking 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 you’ve taken lamotrigine ( read the description of the symptoms in Section 4 of this leaflet: Rare side effect s )
- if you are already taking any medicine that contains lamotrigine.
- if you have a condition called 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.
If any of this applies to you:
- Tell your doctor who may decide that your dose needs to be lowered or that lamotrigine is not suitable for you.
Important information about potentially life-threatening reactions
A small number of people taking Lamotrigine Teva have an allergic reaction or a skin reaction that can be potentially 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 Teva.
- Read the description of these symptoms in section 4 of this leaflet under “Potentially 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 get any of the following symptoms: fever, rash, neurological symptoms (eg tremors or tremor , confused state, disturbances in brain function).
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 of age.
If you have worrying thoughts or experiences or if you notice that you feel worse or develop new symptoms while taking Lamotrigine Teva:
- 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 Teva have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
If you take Lamotrigine Teva for epilepsy
Seizures with certain types of epilepsy can sometimes get worse or occur more often while you are taking Lamotrigine Teva. 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 Teva:
- Contact a doctor as soon as possible.
Children and young people
Lamotrigine Teva should not be given to people under 18 years of age 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 Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter ones 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 Teva. These medicines 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 or are affected by Lamotrigine Teva or increase the risk of side effects. These medicines 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
- drugs used to treat HIV – infection (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 any of these or if you are starting or stopping any of these medicines.
Hormonal contraceptives (such as birth control pills ) may affect the effect of Lamotrigine Teva.
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 contraceptive pill, your doctor may take blood samples to check your lamotrigine levels. If you are using or planning to start using hormonal contraceptives:
- Tell your doctor who can discuss appropriate contraceptive methods with you.
Lamotrigine Teva may affect the effectiveness of hormonal contraceptives, but there is probably no reduction in the effect. 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 Lamotrigin Teva 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 stop treatment without discussing this with your doctor. This is especially important if you have epilepsy .
- Pregnancy may change the effectiveness of Lamotrigin Teva, so you may need to take blood samples and your dose of Lamotrigin Teva may need to be changed.
- There may be a slight increased risk of malformation in the fetus, including cleft lip or palate , if Lamotrigine Teva 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 breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine. The active substance in Lamotrigine Teva tablets is excreted in human milk and may affect the baby. Your doctor will discuss the risks and benefits of breast-feeding during treatment with Lamotrigin Teva. If you choose to breast-feed, the doctor will check the baby from time to time to see if the baby is drowsy, rash or poor weight gain. Tell your doctor if you notice any of these symptoms in your child.
Driving and using machines
Lamotrigine Teva may cause dizziness and double vision.
- Do not drive or use machines if you do not feel 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 Teva contains
Lamotrigine Teva 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 Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.
Lamotrigine Teva 100 mg tablets contain para-orange (E110)
May cause allergic reactions.
How to use Lamotrigine Teva
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much Lamotrigine Teva to use
It may take a while to find the dose of lamotrigine that is best for you. The dose you take depends on:
- your age
- if you are taking Lamotrigin Teva with other medicines
- if you have any kidney or liver problems.
At the start of treatment, your doctor will prescribe a low dose that will gradually increase over the next few weeks until you reach the dose that works for you ( called the effective dose of one ). Never use Lamotrigine Teva more than your doctor advised.
The usual effective dose of Lamotrigine Teva for adults and children 13 years or older is between 100 mg and 400 mg daily.
For children between 2 and 12 years of age, the effective dose of Lamotrigine Teva depends on the child’s body weight, but normally between 1 mg and 15 mg per kilogram body weight, up to a maximum maintenance dose of 200 mg daily.
Lamotrigine Teva is not recommended for children under 2 years of age.
Method of administration
Take your dose of Lamotrigine Teva once or twice a day according to your doctor’s instructions. It 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.
25 mg, 100 mg, and 200 mg tablets:
The breaker is not there to divide the tablet into equal doses, but only to facilitate swallowing. The tablets must not be chewed or crushed.
50 mg tablets:
The tablets should be swallowed whole and must not be divided, chewed, or crushed.
Always take the full dose of one that your doctor has prescribed. Never take only a portion of the dose prescribed by your doctor.
If you use more Lamotrigine Teva than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) by mistake for assessment of the risk and advice. Show them the Lamotrigine Teva package if possible.
If you take too much Lamotrigine Teva, you are more likely to get serious side effects that can be fatal.
A person who has taken too much lamotrigine may experience any of these symptoms:
- rapid, uncontrolled eye movements ( nystagmus )
- clumsiness, lack of coordination ability that affects balance ( ataxia )
- altered heart rhythm (usually detected on ECG )
- loss of consciousness, seizures or coma .
If you forget to take a dose of Lamotrigine Teva
- Do not take extra tablets to compensate for a missed dose . Take your next dose at the usual time.
If you forget to take multiple doses of Lamotrigine Teva
- Ask your doctor how to start taking the medicine again. It is important that you ask about this.
Do not stop taking Lamotrigine Teva without consulting your doctor
Lamotrigine 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 Teva for epilepsy
To stop taking Lamotrigine Teva, the dose must be reduced gradually over about 2 weeks. If you suddenly stop taking Lamotrigine Teva, your epilepsy may come back or get worse.
If you are taking Lamotrigine Teva for bipolar disorder
It may take some time before Lamotrigine Teva works and therefore you will probably not feel better right away. If you stop taking Lamotrigine Teva, 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 Teva.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Potential life-threatening reactions: contact a doctor immediately
A small number of people taking Lamotrigine Teva have an allergic reaction or a skin reaction that can be potentially 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 Teva, especially if you start on too high a dose or dose of an increased too quickly, or if you are taking Lamotrigine Teva together with another medicine called valproate. Some symptoms are more common in children so parents should pay extra attention.
Symptoms of these reactions include:
- skin rash and 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, also known as DRESS (hypersensitivity syndrome).
- sores in the mouth, throat, nose or genitals
- sore mouth or red and 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 infection (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 potentially life-threatening and lead to more serious problems, such as organ failure if left untreated. So 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 Teva. 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 you use Lamotrigine Teva).
Very common side effects
These can affect more than 1 in 10 people:
- headache
- rash.
Common side effects are
These can affect up to 1 in 10 people:
- aggression or irritability
- drowsiness or drowsiness
- dizziness
- tremors or tremors
- sleep disorders ( insomnia )
- feeling of upset
- diarrhea
- dry mouth
- nausea or vomiting
- fatigue
- back or joint pain or elsewhere.
Uncommon side effects
These can 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 are
These can affect up to 1 in 1,000 people:
- a life-threatening skin reaction (Stevens-Johnson syndrome: ( see also information at the beginning of section 4).
- a group of symptoms that together include: fever, nausea, vomiting, headache, neck stiffness and extreme sensitivity to bright light. This can be caused by an inflammation of the membrane that covers the brain and spinal cord ( meningitis ). These symptoms usually disappear when treatment is stopped, but if the symptoms persist or worsen , contact your doctor.
- rapid, uncontrolled eye movements ( nystagmus )
- itching of the eyes with secretions and crusts on the eyelids ( conjunctivitis ).
Very rare side effect s
These can affect up to 1 in 10,000 people:
- a life-threatening skin reaction ( toxic epidermal necrolysis ): (see also information at the beginning of section 4)
- drug reaction with eosinophilia and systemic symptoms (DRESS),
- ( see also the information at the beginning of section 4)
- elevated temperature (fever): (see also information at the beginning of section 4)
- swelling around the face ( edema ) or swollen glands in the neck, armpit or groin ( lymphadenopathy ): (see also 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 , which 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 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 Teva.
Additional side effects are
Additional side effects have been reported 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 taking epilepsy medication for a long time, if you know you have osteoporosis or if you are taking medication with steroids you
- Nightmares.
- Impaired immune system due to lower levels of immunoglobulins , a type of blood cell that helps protect against infection .
How to store Lamotrigin Teva
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 or carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any 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. One tablet contains 25, 50, 100 or 200 mg of lamotrigine.
- The other ingredients are lactose monohydrate , microcrystalline cellulose, pregelatinised maize starch, povidone K-30, colloidal anhydrous silica, sodium starch glycolate (type A) and magnesium stearate. In addition, the 100 mg tablets contain the dye para-orange S (E110) and the 200 mg tablets contain the dye indigo carmine (E132).
What the medicine looks like and contents of the pack
- Lamotrigine Teva 25 mg tablets: White to off-white, diamond-shaped tablet, marked with the number “93” on one side with a notch between the numbers, and marked with “39” on the other side of the tablet.
- Lamotrigine Teva 50 mg tablets: White to off-white, round tablet, marked with the number “50” on one side and marked with “LT” on the other side of the tablet.
- Lamotrigine Teva 100 mg tablets: Peach-colored, diamond-shaped tablet, marked with the number “93” on one side with a notch between the numbers, and marked with “463” on the other side of the tablet.
- Lamotrigine Teva 200 mg tablets: Blue, diamond-shaped tablet, marked with the number “93” on one side with a notch between the numbers, and marked with “7248” on the other side of the tablet.
- Lamotrigine Teva 25 mg tablets are available in pack sizes of 14, 21, 30, 42, 50, 56, 60, 90 or 100 tablets. Calendar packs: 21, 42 tablets.
- Lamotrigine Teva 50 mg tablets are available in pack sizes of 14, 21, 30, 42, 50, 56, 60, 90, 100 or 200 tablets. Calendar packs: 21, 42 tablets.
- Lamotrigine Teva 100 and 200 mg tablets are available in pack sizes of 21, 30, 42, 50, 56, 60, 90, 100 or 200 tablets. Calendar packs: 21, 42 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str, Dupnitsa, 2600, Bulgaria
Merckle GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany
Pharmachemie BV, Swensweg 5, PO Box 552, 2003 RN Haarlem, Netherlands
Teva Hungary Ltd, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z oo Mogilska 80, 31-546 Krakow, Poland