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Package leaflet: Information for the user

Lamotrigin Amneal 25 mg tablets

Lamotrigin Amneal 50 mg tablets

Lamotrigin Amneal 100 mg tablets

Lamotrigin Amneal 200 mg tablets

Lamotrigine

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 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 Lamotrigin Amneal is and what it is used for

2. What you need to know before you take Lamotrigin Amneal

3. How to take Lamotrigin Amneal

4. Possible side effects

5. How to store Lamotrigin Amneal

6. Contents of the pack and other information

1. What Lamotrigin Amneal is and what it is used for

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat two conditions – epilepsyand bipolar disorder.

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

Lamotrigin Amneal also treats bipolar disorder.

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, Lamotrigin Amneal 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 Lamotrigin Amneal works in the brain to have this effect.

2. What you need to know before you takeLamotrigine Amneal

DO NOT take Lamotrigin Amneal

If this applies to you:

 Tell your doctor, and don’t take Lamotrigin Amneal

Warnings and precautions

Important information about potentially life-threateningreactions:

A small number of people taking lamotrigine get an allergic reaction or potentially life-threateningskin 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 Lamotrigin Amneal

Readthe descriptionof these symptomsin Section 4 of this leaflet under ‘Potentially life-threateningreactions: get a doctor’s help straight away’.

Talk to your doctor or pharmacist before taking Lamotrigin Amneal:

• 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 are already taking medicine that contains lamotrigine.

If any of these applies to you:

 Tell your doctor, who may decide to lower the dose, or that Lamotrigin Amneal is not suitable for you.

Thoughts of harming yourself or suicide

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 Lamotrigin Amneal:

 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 also had thoughts of harming or killing themselves. If any time you have these thoughts, immediately contact your doctor.

If you’re taking Lamotrigin Amneal for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking Lamotrigin Amneal. 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 Lamotrigin Amneal:

 See a doctor as soon as possible.

Lamotrigin Amneal 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.

Other medicines and Lamotrigin Amneal

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines — these include herbal medicines or other medicines you 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. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy

• lithium or olanzapine, used to treat mental health problems

• bupropion, used to treat mental health problems or to stop smoking

 Tell your doctor if you are taking any of these.

Some medicines interact with Lamotrigin Amneal 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 Lamotrigin Amneal 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 Lamotrigin Amneal. 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.

Lamotrigin Amneal 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 Lamotrigin Amneal is affecting the way your contraceptive is working.

Pregnancy and breast-feeding

PregnancyThere may be an increased risk of birth defects in babies whose mothers took Lamotrigin Amneal 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 Lamotrigin Amneal, so you may need blood tests and your dose of Lamotrigin Amneal may be adjusted.

 Talk to your doctor if you’re pregnant, if you might be pregnant, or if you’re planning to become pregnant. You should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy.

Breast-feeding

The active ingredient of Lamotrigin Amneal passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while you’re taking Lamotrigin Amneal, and will check your baby from time to time if you decide to breast-feed.

 Talk to your doctor if you are breast feeding or planning to breast-feed.

Driving and using machines

Lamotrigin Amneal 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.

Lamotrigin Amneal contains lactose

Lamotrigin Amneal tablets contain small amounts of a sugar called lactose. If you have intolerance to lactose or any other sugars:

 Tell your doctor, and don’t take Lamotrigin Amneal.

Lamotrigin Amneal 100 mg tablets contain sunset yellow aluminium lake(E110)

This may cause allergic reactions.

3. How to take Lamotrigin Amneal

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

How much Lamotrigin Amneal to take

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

• your age

• whether you are taking Lamotrigin Amneal 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 Lamotrigin Amneal than your doctor tells you to.

Use in children and adolescents

The usual effective dose of Lamotrigin Amneal 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 of 400 mg daily.

Lamotrigin Amneal is not recommended for children aged under 2 years.

How to take your dose of Lamotrigin Amneal

Take your dose of Lamotrigin Amneal 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. Don’t chew or crush them.

• Always take the full dose that your doctor has prescribed.

If you take more Lamotrigin Amneal than you should

 Contact a doctor or pharmacist immediately. If possible, show them the Lamotrigin Amneal packet.

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

• rapid, uncontrollable eye movements (nystagmus)

• clumsiness and lack of co-ordination, affecting their balance (ataxia)

• loss of consciousness or coma.

If you forget to take Lamotrigin Amneal

Don’t take extra tablets or a double dose to make up for a forgotten dose.

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

Don’t stop taking Lamotrigin Amneal without advice

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

If you are taking Lamotrigin Amnealfor epilepsy

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

If you are taking Lamotrigin Amnealfor bipolar disorder

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

A small number of people taking Lamotrigin Amneal get an allergic reaction or potentially life-threateningskin 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 Lamotrigin Amneal, especially if the starting dose is too high or if the dose increased too quickly, or if Lamotrigin Amneal 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 (DRESS - drug reaction with eosinophilia and systemic symptoms).

• 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 serious 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 Lamotrigin Amneal.

Very common side effects: may affect more than 1 in 10 people

• headache

• feeling dizzy

• feeling sleepy or drowsy

• clumsiness and lack of co-ordination (ataxia)

• double vision or blurred vision

• feeling sick (nausea) or being sick (vomiting)

• skin rash.

Common side effects: may affect up to 1 in 10 people

• aggression or irritability

• rapid, uncontrollable eye movements (nystagmus)

• shaking or tremors

• difficulty in sleeping

• diarrhoea

• dry mouth

• feeling tired

• pain in your back or joints, or elsewhere.

Rare side effects: may affect up to 1 in 1,000 people

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

• Potentially life-threatening skin rashes (Stevens–Johnson syndrome:) have been reported (see section 2 and at the beginning of section 4).

Very rare side effects:may affect up to 1 in 10,000 people

• Potentially life-threatening skin rashes (toxic epidermal necrolysis) have been reported (see section 2 and at the beginning of section 4).

• hallucinations (‘seeing’ or ‘hearing’ things that aren’t really there)

• confusion or agitation

• 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

• changes in liver function, which will show up in blood tests, or liver failure

• changes which may show up in blood tests — including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulo-cytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia

• a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation)

• a high temperature (fever)

• swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy)

• in people who already have Parkinson’s disease, worsening of the symptoms.

Possible risk of bone disorders

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.

Other side effects

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

This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis).

• 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.

• Drug reaction with eosinophilia and systemic symptoms (DRESS)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includesany possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lamotrigin Amneal

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/label of the bottle and the carton after the EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

What Lamotrigin Amneal contains

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 100 mg tablet also contains sunset yellow aluminium lake (E110) and the 200 mg tablet contains indigo carmine aluminium lake (E132).

What Lamotrigin Amneal looks like and contents of the pack

Tablet.

Lamotrigin Amneal 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 halves.

Lamotrigin Amneal 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.

Lamotrigin Amneal 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 halves.

Lamotrigin Amneal 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.

Lamotrigin Amneal tablets are available in:

- Clear PVC/Aluminium foil blisters

Pack sizes: 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.

Marketing Authorisation Holder

Amneal Pharma Europe Limited

70 Sir John Rogerson’s Quay

Dublin 2

Ireland

Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark Lamotrigin Amneal

Sweden Lamotrigin Amneal

United Kingdom Lamotrigine Amneal25 mg/ 50 mg/ 100 mg/ 200 mg Tablets

This leaflet was last revised in 2014-12-04