• 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.

The name of your medicine is Lamotrigine Desitin 10mg/ml Oral Suspension but it will be referred to as 'Lamotrigine Desitin' throughout this leaflet.

1. What Lamotrigine Desitin is and what it is used for
2. What you need to know before you take Lamotrigine Desitin
3. How to take Lamotrigine Desitin
4. Possible side effects
5. How to store Lamotrigine Desitin
6. Contents of the pack and other information

People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). For adults aged 18 years and over, Lamotrigine Desitin can be used on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamotrigine Desitin works in the brain to have this effect.

• 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 don't take Lamotrigine Desitin.

• if you have any kidney problems
• if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
• if you experience a rash or sunburn after taking lamotrigine and having been exposed to sun or artificial light (e.g. solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself against the sun (e.g. use of a sunscreen and/or to wear protective clothing)
• 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 medicine that contains lamotrigine
• if you have a condition called Brugada syndrome, or other heart problems. Brugada syndrome is a genetic disease that results in abnormal electrical activity within the heart. ECG abnormalities which may lead to arrhythmias (abnormal heart rhythm) can be triggered by lamotrigine.

If any of these applies to you:

• Tell your doctor, who may decide to lower the dose or that Lamotrigine Desitin is not suitable for you.

A small number of people taking Lamotrigine Desitin get an allergic reaction or potentially life-threatening 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 Desitin. This risk may be associated with a variant in genes in people from Asian origin (mainly Han Chinese and Thai). If you are of such origin and have been tested previously carrying this genetic variant (HLA-B* 1502), discuss this with your doctor before taking Lamotrigine Desitin.

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

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).

Anti-epileptic medicines 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 may be more likely to think like this:

• when you first start treatment
• if you have previously had thoughts about harming yourself or about suicide
• if you are under 25 years old.

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

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

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.

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

The seizures in some types of epilepsy may occasionally become worse or happen more often while you're taking Lamotrigine Desitin. 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 Desitin:

• See a doctor as soon as possible.

Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years.

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.

Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health problems. This is to make sure you take the correct dose of Lamotrigine Desitin. 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 stop smoking
• paracetamol, used to treat pain and fever

Tell your doctor if you are taking any of these.

Some medicines interact with Lamotrigine Desitin or make it more likely that people will 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 phenobarbitone, used to treat epilepsy
• risperidone, used to treat mental health problems
• rifampicin, which is an antibiotic
• medicines used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such as the Pill (see below).

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

Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine Desitin 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 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 Desitin. If you are using a hormonal contraceptive or if you plan to start using one:

• Talk to your doctor, who will discuss suitable methods of contraception with you.

Lamotrigine Desitin 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 Desitin is affecting the way your contraceptive is working.

• 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 particularly important if you have epilepsy.
  • Pregnancy may alter the effectiveness of Lamotrigine Desitin, so you may need blood tests and your dose of Lamotrigine Desitin may be adjusted.
  • There may be a small increased risk of birth defects, including a cleft lip or cleft palate, if Lamotrigine Desitin is taken during the first 3 months of pregnancy.
  • Your doctor may advise you to take extra folic acid if you're planning to become pregnant and while you're pregnant.
• 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 Desitin 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 Desitin 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.

Lamotrigine Desitin can cause dizziness and double vision.

• Don't drive or use machines unless you are sure you're not affected.

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

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).

Sodium: This medicine contains 0.676 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.03% of the recommended maximum daily dietary intake of sodium for an adult.

Propylene glycol (E1520): This medicine contains 0.940 mg propylene glycol in each ml.

Benzoic acid (E210): This medicine contains 0.0025 mg benzoic acid in each ml.

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

• your age
• whether you are taking Lamotrigine Desitin with other medicines
• whether you have any kidney or liver problems.

Your doctor will prescribe a low dose to start 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 Desitin than your doctor tells you to.

The usual effective dose of Lamotrigine Desitin for adults and children aged 13 years or over is between 100 mg and 400 mg each day.

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 maintenance dose of 200mg daily.

Lamotrigine Desitin is not recommended for children aged under 2 years.

• This medicinal product must be taken orally.
• Shake well before use for at least 10 seconds.
• Use the measuring syringe or cup provided in the pack to deliver the required dose. If your dose is smaller than 20ml, then use syringe. If your dose is larger than 20ml, then use cup. If your dose is larger than 20ml, but is not measurable by cup alone due to limited graduation markings of cup, then use both devices like this: use cup to take as much as portion of dose is measurable by cup and then after use syringe to take remaining portion of dose.
• Take your dose of Lamotrigine Desitin once or twice a day, as your doctor advises. It can be taken 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.
• Always take the full dose that your doctor has prescribed. Never take only part of a dose.

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).
b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of suspension by pulling the piston down (figure 5A) and then push the piston up in order to remove any possible air bubbles (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e) Empty the contents of the syringe into the mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).
b) Fill the cup with a small amount of suspension by tilting the bottle horizontally to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 2).
c) Empty the contents of the cup into the patient's mouth slowly to avoid a choking hazard (figure 3).
d) Close the bottle with the plastic screw cap. Wash the cup with water (figure 4).

• Contact a doctor or nearest hospital emergency department immediately. If possible, show them the Lamotrigine Desitin packet.

If you take too much Lamotrigine Desitin you may be more likely to have serious side effects which may be fatal.

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

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

• Don't take extra dose to make up for a missed dose. Just take your next dose at the usual time.

In case you forget to take multiple doses of Lamotrigine Desitin

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

Lamotrigine Desitin must be taken for as long as your doctor recommends. Don't stop unless your doctor advises you to.

To stop taking Lamotrigine Desitin, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine Desitin, your epilepsy may come back or get worse.

Lamotrigine Desitin may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine Desitin, your dose will not need to be reduced gradually. But you should still talk to your doctor first, if you want to stop taking Lamotrigine Desitin.

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

These symptoms are more likely to happen during the first few months of treatment with Lamotrigine Desitin, especially if the starting dose is too high or if the dose is increased too quickly or if Lamotrigine Desitin 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), 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 the 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.

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 Desitin. 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 Desitin).

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)
• skin rash or sunburn after exposure to sun or artificial light (photosensitivity)

Rare side effects

These 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 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)
• itchy eyes, with discharge and crusty eyelids (conjunctivitis).

Very rare side effects

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

• 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 (DRESS): (see also the information at the beginning of Section 4)
• a high temperature (fever): (see also the information at the beginning of Section 4)
• swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): (see also the information at the beginning of Section 4)
• changes in liver function, which will show up in blood tests, or liver failure: (see also the information at the beginning of Section 4)
• a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): (see also the information at the beginning of Section 4)
• haemophagocytic lymphohistiocytosis (HLH) (see Section 2: What you need to know before you take Lamotrigine Desitin)
• 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 repeated body movements and/or sounds or words (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).

Other side effects have occurred in a small number of people but their exact frequency is unknown:

• 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 anti-epileptic medication, have a history of osteoporosis or take steroids
• Inflammation of the kidney (tubulointerstitial nephritis), or inflammation of both the kidney and the eye (tubulointerstitial nephritis and uveitis syndrome)
• Nightmares
• Lower immunity because of lower levels of antibodies called immunoglobulins in the blood which help protect against infection.
• red nodules or patches on the skin (pseudolymphoma)

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 Website at: www.mhra.gov.uk/yellowcard 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.

The active substance is Lamotrigine.

Each ml of suspension contains 10mg Lamotrigine

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), simethicone emulsion [contains benzoic acid (E210)], carbomer, glycerol, saccharin sodium, sodium hydroxide (for pH adjustment), strawberry flavour [contains propylene glycol (E1520)] and purified water.

Lamotrigine Desitin is a white to off-white colour suspension with odour of strawberry which is supplied in amber glass bottles with a tamper evident, child resistant white plastic screw cap. The pack also contains a 5ml oral syringe with 0.1ml intermediate graduation with an adaptor and a 20ml measuring cup with markings of 2.5/5/10/15/20ml.

Lamotrigine Desitin is supplied in a bottle containing 300ml oral suspension.

Marketing Authorisation Holder:

Manufacturer: