LAMOTRIGINE TEVA 100 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - LAMOTRIGINE TEVA 100 MG TABLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet

1. What Lamotrigine is and what it is used for

2. What you need to know before you take Lamotrigine

3. How to take Lamotrigine

4. Possible side effects

5. How to store Lamotrigine

6. Contents of the pack and other information

1. what lamotrigine is and what it is used for

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat epilepsy.

Lamotrigine treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits).

For adults and children aged 13 years and over, Lamotrigine can be used on its own or with other medicines, to treat epilepsy. Lamotrigine can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome.
For children aged between 2 and 12 years, Lamotrigine can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures.

2. what you need to know before you take lamotriginea small number of people taking lamotrigine have experienced an allergic reaction or potentially lifethreatening skin reaction, which may develop into more serious problems if they are not treated. these can include stevens-johnson syndrome (sjs), toxic epidermal necrolysis (ten) and drug reaction with eosinophilia and systemic symptoms (dress). you need to know the symptoms to look out for while you are taking lamotrigine.

Read the description of these symptoms in Section 4 of this leaflet under ‘Potentially life-threatening reactions: get a doctor‘s help straight away‘.

DO NOT take Lamotrigine:

if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of lamotrigine (listed in section 6).

If this applies to you, tell your doctor , and do not take Lamotrigine.

Warnings and precautions

Talk to your doctor or pharmacist before taking before you take Lamotrigine if you:

have problems with your kidneys
have ever developed a rash when you’ve taken lamotrigine or other medicines for 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)

Watch out for important symptoms

If you develop a rash or these skin symptoms, stop taking Lamotrigine, seek urgent advice from a doctor and tell him that you are taking this medicine

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS) have been reported with the use of Lamotrigine, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. For more information on these reactions, please read section 4 (Possible side effects).
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. The rash may progress to widespread blistering or peeling of the skin.
The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or a drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of Lamotrigine, you must not be restarted on Lamotrigine at any time.
a high temperature (fever)
drowsiness
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 you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. shaking or tremor, confusional state, disturbances of brain function).

These symptoms are more likely to happen during the first few months of treatment with Lamotrigine, especially if you start on too high a dose or if your dose is increased too quickly, or if you‘re taking Lamotrigine with another medicine called valproate. Children are more likely to be affected than adults.

The symptoms listed above can develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated. If you notice any of these symptoms, see a doctor as soon as possible. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine.

Thoughts of harming yourself or suicide

You may find it helpful to tell a family member, caregiver or close friend that you can become depressed or have significant changes in mood, and ask them to read this leaflet. You might ask them to tell you if they are worried about your depression or other changes in your behaviour.

If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you‘re taking Lamotrigine:

See a doctor as soon as possible or go to the nearest hospital for help

A small number of people being treated with anti-epileptics such as Lamotrigine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Risk of increased or severe seizures

The seizures in some types of epilepsy may occasionally become worse or happen more often while you‘re taking Lamotrigine. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often , or if you experience a severe seizure while you‘re taking Lamotrigine, see a doctor as soon as possible.

Other medicines and Lamotrigine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines bought without a prescription.

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 stop smoking

If you start or stop taking certain medicines whilst you are taking Lamotrigine, your doctor may need to check your dose of Lamotrigine. These include:

atazanavir in combination with ritonavir
lopinavir in combination with ritonavir

Tell your doctor if you start or stop taking any of these.

Some medicines interact with Lamotrigine or make it more likely that you‘ll have 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
olanzapine, used to treat mental health problems
risperidone, used to treat mental health problems
rifampicin, which is an antibiotic
a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection
hormonal contraceptives, such as the Pill (see below).

Tell your doctor if you are taking, or if you start or stop taking, any of these.

Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine works

Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil. If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamotrigine. If you plan to start using a hormonal contraceptive, talk to your doctor, who will discuss suitable methods of contraception with you.
Lamotrigine can also affect the way hormonal contraceptives work, although it’s unlikely to make them less effective. If you are using a hormonal contraceptive and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods, tell your doctor. These may be signs that Lamotrigine is affecting the way your contraceptive is working.

Pregnancy, breast-feeding 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 for your epilepsy while you‘re pregnant. However, there is an increased risk of birth defects in babies whose mothers took Lamotrigine during pregnancy. These defects include cleft lip or cleft palate. Your doctor may advise you to take extra folic acid if you‘re planning to become pregnant and while you‘re pregnant.
Pregnancy may also alter the effectiveness of Lamotrigine, so your doctor may take samples of your blood to check the level of Lamotrigine, and may adjust your dose.
If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice

before taking this medicine. The active ingredient of Lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast feeding while you‘re taking Lamotrigine, and will check your baby from time to time whether drowsiness, rash or poor weight gain occurs, if you decide to breast-feed. Inform your doctor if you observe any of these symptoms in your baby.

Driving and using machines

Lamotrigine can cause dizziness and double vision. Do not drive or operate machines unless you are sure you’re not affected.

If you have epilepsy, talk to your doctor about driving and using machines

Lamotrigine tablets contain small amounts of a sugar called lactose. If you have intolerance to lactose or any other sugars, tell your doctor, and do not take Lamotrigine.

Lamotrigine 100 mg tablets also contain E110 (sunset yellow FCF), which may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. how to take lamotrigine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much Lamotrigine to take

It may take a while to find the best dose of Lamotrigine for you. The dose you take will depend on:

your age
whether you are taking Lamotrigine with other medicines
whether you have problems with your kidneys or liver.

Your doctor will start you on a low dose, and gradually increase the dose over a few weeks until you reach a dose that works for you (called the effective dose ). Never take more Lamotrigine than your doctor tells you to.

The recommended effective dose of Lamotrigine for adults and children aged over 12 years

For children aged 2 to 12 years , the effective dose depends on their body weight — usually, it‘s between 1 mg and 15 mg for each kilogram of the child‘s weight, up to a maximum of 400 mg daily.

Lamotrigine is not recommended for children aged under 2 years.

How to take your dose of Lamotrigine

Take your dose of Lamotrigine once or twice a day, as your doctor advises. You can take it with or without food.

Your doctor may also advise you to start or stop taking other medicines, depending on what condition you‘re being treated for and the way you respond to treatment.

Swallow your tablets whole. Do not break, chew or crush them.
Always take the full dose that your doctor has prescribed. Never take only part of a tablet.

If you take more Lamotrigine than you should

If anyone takes too much Lamotrigine, contact a doctor or pharmacist or go to the nearest emergency department immediately. If possible, show them the Lamotrigine packet.

Someone who has taken too much Lamotrigine may have any of these symptoms:

rapid, uncontrollable eye movements (nystagmus)
heart rhythm changes (detected usually on ECG)
clumsiness and lack of co-ordination, affecting their balance (ataxia)
loss of consciousness, fits (convulsions) or coma.

If you forget to take Lamotrigine

Do not take extra tablets or a double dose to make up for a forgotten dose. If you have missed taking a dose of this medicine, just take your next dose at the usual time.

Ask your doctor for advice on how to start taking it again. It‘s important that you do this.

Do not stop taking Lamotrigine without advice

Take Lamotrigine for as long as your doctor recommends. Do not stop unless your doctor advises you to. To stop taking Lamotrigine, it is important that your dose is reduced gradually , over about 2 weeks. If you suddenly stop taking Lamotrigine, your epilepsy may come back or get worse.

4. possible side effects

Like all medicines, this medicine can cause side effects, but not everyone gets them.

Potentially life-threatening reactions: get a doctor’s help straight away

A small number of people taking Lamotrigine get an allergic reaction or potentially serious skin reaction , which may develop into more serious, and even life-threatening, problems if they are not treated.

These symptoms are more likely to happen 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 the symptoms are more common in children, so parents should be especially careful to watch out for them.

Symptoms of these reactions include:

skin rashes or redness which may develop into life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome (SJS)), extensive peeling of the skin (more than 30% of the body surface -toxic epidermal necrolysis) or extended rashes with liver, blood and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS hypersensitivity syndrome).
ulcers in the mouth, throat, nose or genitals
a sore mouth or red or swollen eyes (conjunctivitis)
a high temperature (fever), flu-like symptoms or drowsiness
swelling around your face, or swollen glands in your neck, armpit or groin
unexpected bleeding or bruising, or your fingers turning blue
a sore throat, or more infections (such as colds) than usual
increased levels of liver enzymes seen in blood tests
an increase in a type of white blood cell (eosinophils)
enlarged lymph nodes
involvement of the organs of the body including liver and kidneys.

These are very serious but rare or very rare side effects. You may need urgent medical attention or hospitalisation. In many cases, these symptoms will be signs of less serious side effects but you must be aware that they are potentially life-threatening and can develop into more serious problems, such as organ failure, if they are not treated. If you notice any of these symptoms:

Contact a doctor immediately. Your doctor may decide to carry out tests on your liver, kidneys or blood and may tell you to stop taking Lamotrigine. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine again

Haemophagocytic lymphohistiocytosis (HLH) (see section 2 What you need to know before you take lamotrigine) has been reported very rarely.

Very common side effects

These may affect more than 1 in 10 people:

headache
skin rash.

Common side effects

These may affect up to 1 in 10 people:

aggression or irritability
feeling sleepy or drowsy
feeling dizzy
shaking or tremors
difficulty in sleeping (insomnia)
feeling agitated
diarrhoea
dry mouth
feeling sick (nausea) or being sick (vomiting)
feeling tired
pain in your back or joints, or elsewhere.

Uncommon side effects

These may affect up to 1 in 100 people

clumsiness and lack of co-ordination (ataxia)
double vision or blurred vision
unusual hair loss or thinning (alopecia).

Rare side effects

These may affect up to 1 in 1,000 people:

a group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis). These symptoms usually disappear once treatment is stopped however if the symptoms continue or get worse contact your doctor
rapid, uncontrollable eye movements (nystagmus).

Very rare side effects

These may affect up to 1 in 10,000 people:

changes which may show up in blood tests – including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulocytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia) and a disorder of the bone marrow called aplastic anaemia
hallucinations (‘seeing’ or ‘hearing’ things that aren’t really there)
confusion
feeling ‘wobbly’ or unsteady when you move about
uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness
in people who already have epilepsy, seizures happening more often
in people who already have Parkinson’s disease, worsening of the symptoms
lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).

Frequency not known

The frequency of these side effects cannot be estimated from the currently available data:

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.
Nightmares
Lower immunity because of lower levels of antibodies called immunoglobulins in the blood which help protect against infection.

Reporting of side effects:

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: 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

5. how to store lamotriginedo not store above 30oc. store in the original blister pack to protect from moisture.

Do not use this medicine after the expiry date which is stated on the outer packaging. 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 throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information the active ingredient is lamotrigine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, povidone K-30, colloidal anhydrous silica, sodium starch glycolate (Type A) and magnesium stearate. In addition, the 100 mg tablets contain sunset yellow FCF (E110) and the 200 mg tablets contain indigo carmine (E132).

What Lamotrigine Teva Tablets look like and contents of the pack:

Lamotrigine 25 mg tablets are white to off white, diamond shaped tablets, debossed with the number —93” on one side and scored between the two numbers, debossed —39” on the other side.
Lamotrigine 50 mg Tablets are white to off white, round shaped tablet, debossed with the number —50” on one side and debossed —LT” on the other side.
Lamotrigine 100 mg tablets are peach, diamond shaped tablets, debossed with the number —93” on one side and scored between the two numbers, debossed —463” on the other side.
Lamotrigine 200 mg tablets are blue, diamond shaped tablets, debossed with the number —93” on one side and scored between the two numbers, debossed —7248” on the other side.
Lamotrigine packs are blister packs of transparent or white opaque PVC/PVDC-aluminium lidded with

aluminium foil for 21, 21 calendar, 30, 42, 42 calendar, 56, 60, 90, or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom.

Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in October 2020.

PL00289/0496–0499