Lamotrigine 200 mg tablets

• 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 same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Lamotrigine Milpharm is and what it is used for
2. What you need to know before you take Lamotrigine Milpharm
3. How to take Lamotrigine Milpharm
4. Possible side effects
5. How to store Lamotrigine Milpharm
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 Milpharm 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 Milpharm works in the brain to have this effect.

Lamotrigine 25/50/200 mg tablets

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

Lamotrigine 100 mg tablets

• if you are allergic (hypersensitive) to lamotrigine, sunset yellow aluminium lake 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 Milpharm

Take special care with Lamotrigine

Talk to your doctor or pharmacist before taking Lamotrigine

• 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 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 Milpharm is not suitable for you.

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).

A small number of people taking Lamotrigine 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. 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.

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

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:

• 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 Milpharm 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 Milpharm. 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 Milpharm:

• See a doctor as soon as possible.

Lamotrigine Milpharm should not be given to people aged under 18 years to treat bipolar disorder. 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. It is important to tell your doctor or pharmacist if you are taking any other medicines for epilepsy at the same time as lamotrigine if you are pregnant, think you may be pregnant, or are planning to have a baby (see also the information in Section 2 on pregnancy and breast-feeding).

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. 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 Milpharm 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.

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 Milpharm. 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 Milpharm 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 Milpharm is affecting the way your contraceptive is working.

• If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby.
• If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.
  • 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, so you may need blood tests and your dose of Lamotrigine may be adjusted.
  • Studies of women who took lamotrigine at usual doses while they were pregnant have not shown an increased risk of physical birth abnormalities.
  • The risk of physical birth abnormalities may increase when higher doses of epilepsy medicines are taken or more than one epilepsy medicine is used at the same time. Where possible, your doctor will consider using one epilepsy medicine at the lowest effective dose to control your epilepsy
  • There may be a small increased risk of birth defects, including a cleft lip or cleft palate, if Lamotrigine is taken during the first 3 months of pregnancy.
  • Your doctor may advise you to take folic acid supplements 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 Milpharm 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 Milpharm, 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 Milpharm can cause dizziness and double vision.

• Don’t 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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Lamotrigine Milpharm 100 mg tablets contain sunset yellow aluminium lake, which may cause allergic reactions.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

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

• your age
• whether you are taking Lamotrigine Milpharm 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 Milpharm than your doctor tells you to.

The recommended effective dose of Lamotrigine Milpharm 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 200 mg daily.

Lamotrigine is not recommended for children aged under 2 years.

Take your dose of Lamotrigine Milpharm 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.

• Swallow your tablets whole. If you need to halve your tablets ( to take half the dose for the 25 and 100mg strengths or for ease of swallowing for the 25, 100 and 200mg strengths), then swallow tablet halves whole. Remember not to chew or crush them.See diagrams below.
• Always take the full dose that your doctor has prescribed. Never take only part of a tablet.

Use a tablet cutter to halve tablets. Alternatively, keeping the score-line side facing upwards, hold both the upper and lower sides of the tablet, on either side of the score-line, using the thumb and index finger of both hands [fig. A] and halve the tablet by pressing down and away from the score-line so that the tablet opens at the score-line side [fig. B]. Do not hold on to the shoulder (end) of the tablet, on either side of the score-line [fig. C], when halving since this may cause the tablet to crumble.

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

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

Someone who has taken too much Lamotrigine Milpharm 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 tablets 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

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

Don’t stop taking Lamotrigine Milpharm without advice

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

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

Lamotrigine Milpharm may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine Milpharm, 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 Milpharm.

A small number of people taking Lamotrigine Milpharm 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, 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 serious or sometimes life-threatening skin reactions including rash with target lesions (Erythema multiforme), 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 Milpharm. 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)

Very common (may affect more than 1 in 10 people):

• headache
• skin rash.

Common (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 (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 (may affect up to 1 in 1,000 people):

• skin reaction that causes red spots or patches on the skin, that may look like a target or “bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)
• 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( 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)
• 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.

• red nodules or patches on the skin (pseudolymphoma)
• 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.
• 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme 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 tablet contains 25 mg lamotrigine.
  Each tablet contains 50 mg lamotrigine.
  Each tablet contains 100 mg lamotrigine.
  Each tablet contains 200 mg lamotrigine.
• The other ingredients are Cellulose microcrystalline, lactose monohydrate, indigo carmine aluminium lake (E132) (For 200 mg only), sunset yellow aluminium lake (E110) (For 100 mg only), sodium starch glycolate (Type A), magnesium stearate, povidone (K30).

Tablet.

Lamotrigine Milpharm 25 mg tablets are white to off white coloured, shield shaped uncoated tablets debossed with ‘D’ and ‘93’on one side and scoreline on the other side.

The tablet can be divided into equal doses.

Lamotrigine Milpharm 50 mg tablets are white to off white coloured, rounded square uncoated tablets debossed with ‘D’ on multifaceted side and ‘97’ on the flat side.

Lamotrigine Milpharm 100 mg tablets are peach coloured, mottled, shield shaped uncoated tablets debossed with ‘D’ and ‘94’on one side and scoreline on the other side.

The tablet can be divided into equal doses.

Lamotrigine Milpharm 200 mg tablets are blue coloured, mottled, shield shaped uncoated tablets debossed with ‘D’ and ‘96’on one side and scoreline on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Lamotrigine Milpharm tablets are available in:

• Clear PVC/Aluminium foil blisters
  Pack sizes: 1, 7, 10, 14, 20, 21, 28, 30, 40, 42, 46, 50, 56, 60, 90, 98, 100, 200, 250, 500 tablets.
• HDPE bottles with polypropylene cap and cotton coil
  Pack sizes: 60, 90, 100, 250, 500, 1000 tablets.

Not all pack sizes may be marketed.

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