Amalexx: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amaless 5 mg dispersible tablets, 25 mg dispersible tablets, 50 mg dispersible tablets, 100 mg dispersible tablets, 200 mg dispersible tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amaless is and what it is used for
What you need to know before taking Amaless
How to take Amaless
Possible side effects
How to store Amaless
Contents of the pack and other information

1. What Amaless is and what it is used for

Lamotrigine belongs to a group of medicines called antiepileptics. It is used to treat two conditions – epilepsy and bipolar disorder.
Amaless treats epilepsy by blocking signals in the brain that trigger epileptic seizures (convulsions).

In adults and children aged 13 years and older, Amaless may be used alone or in combination with other medicines to treat epilepsy. Amaless may also be used together with other medicines to treat convulsive seizures occurring in a condition called Lennox-Gastaut syndrome.
In children aged between 2 and 12 years, Amaless may be used in combination with other medicines to treat these conditions. It may be used alone to treat a type of epilepsy called typical absence seizures.

Amaless also treats bipolar disorder.
People with bipolar disorder (also known as manic depression) experience extreme mood swings, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Amaless may be used alone or in combination with other medicines to prevent depressive episodes associated with bipolar disorder. It is not yet known how Amaless works in the brain to produce this effect.

2. What you should know before taking Amaless

Do not take Amaless

If you are allergic to lamotrigine or to any of the excipients of this medicine (listed in section 6).

If this applies to you:
Tell your doctor, and do not take Amaless.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amaless

if you have kidney problems
if you have ever had a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy
if you have ever developed meningitis after taking lamotrigine (read the description of these symptoms in section 4 of this leaflet: Other side effects)
if you are already taking medicines containing lamotrigine.

If any of these situations apply to you:
Tell your doctor, who may decide to reduce your dose, or that Amaless is not suitable for you.

Important information about potential serious reactions
A small number of people who take Amaless have developed an allergic reaction or a potentially life-threatening skin reaction, which may become more serious if not treated. These may include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You should be aware of the symptoms so you can recognize them during treatment with Amaless.

Read the description of these symptoms in section 4 of this leaflet “Potentially serious reactions: seek medical help immediately”.

Thoughts of harming yourself or suicide
Antiepileptic medicines are used to treat serious conditions, including epilepsy and bipolar disorder. People with bipolar disorder may sometimes have thoughts of harming themselves or of suicide. If you have bipolar disorder, you may be more likely to have these thoughts:

when starting treatment for the first time,
if you have previously had thoughts of harming yourself or related to suicide,
if you are under 25 years of age. If you have thoughts or experiences that trouble you, or if you notice feeling worse or develop new symptoms while taking Amaless: Contact a doctor as soon as possible or go to the nearest hospital for help.

A small number of people treated with antiepileptic medicines such as Amaless have also had thoughts of harming themselves or of suicide. If you occasionally have such thoughts, contact your doctor immediately.

If you are taking Amaless for epilepsy
In some types of epilepsy, seizures may occasionally worsen or occur more frequently during treatment with Amaless. Some patients may experience severe epileptic seizures, which can lead to serious health problems. If your seizures become more frequent or if you experience a severe seizure while taking Amaless:
Contact a doctor as soon as possible.

Amaless must not be given to people under 18 years of age for the treatment of bipolar disorder. Medicines used to treat depression and other mental health conditions may increase the risk of suicidal thoughts and behaviours in children and adolescents under 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal preparations or other non-prescription medicines.
Your doctor needs to know if you are taking other medicines for epilepsy or mental health conditions to ensure you receive the correct dose of Amaless.
These medicines include:

oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used for the treatment of epilepsy
lithium or olanzapine or aripiprazole, used for the treatment of mental health conditions
bupropion, used for the treatment of mental health conditions or for smoking cessation

Tell your doctor if you are taking any of these medicines.
Some medicines interact with Amaless or increase the likelihood of side effects. These include:

valproate, used for the treatment of epilepsy and mental health conditions
carbamazepine, used for the treatment of epilebye and mental health conditions
phenytoin, primidone or phenobarbital, used for the treatment of epilepsy
risperidone, used for the treatment of mental health conditions
rifampicin, an antibiotic
medicines used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir, or a combination of atazanavir and ritonavir)
hormonal contraceptives, such as the pill (see below)
Tell your doctor if you are taking, starting, or stopping any of these medicines.

Hormonal contraceptives (such as the pill) may alter how Amaless works
Your doctor may recommend that you use a specific type of hormonal contraceptive, or another method of contraception, such as condoms, diaphragm, or intrauterine device (IUD). If you are using hormonal contraceptives such as the pill, your doctor may take blood samples to monitor your Amaless levels. If you are using or considering starting a hormonal contraceptive:
Talk to your doctor, who will discuss suitable contraceptive methods with you.
Amaless may also alter how hormonal contraceptives work, although it is unlikely to make them less effective. If you are using a hormonal contraceptive and notice any changes in your menstrual cycle, such as unexpected bleeding or spotting between periods:
Tell your doctor. These may be signs that Amaless is affecting how the contraceptive works.

Pregnancy, breastfeeding and fertility
There may be an increased risk of birth defects in children whose mothers take Amaless during pregnancy. These defects include cleft lip or cleft palate. Your doctor may advise you to take additional folic acid, especially if you are planning a pregnancy or are already pregnant.
Pregnancy may also alter the effectiveness of Amaless, so you may need blood tests and your dose of lamotrigine may need to be adjusted.
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Do not stop treatment without talking to your doctor. This is particularly important if you have epilepsy.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine. The active ingredient in Amaless passes into breast milk and may affect the baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Amaless and may monitor your baby periodically if you decide to breastfeed.

Driving and using machines
Amaless may cause dizziness and double vision.
Do not drive or operate machinery unless you are sure you are not affected by these symptoms.
If you have epilepsy, talk to your doctor about driving and using machinery.

3. How to take Amaless

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
How much Amaless should you take?
It may take some time to find the optimal dose of Amaless for you. The dose you need will depend on:

your age
whether you are taking Amaless with other medicines
whether you have kidney or liver problems. Your doctor will prescribe a low starting dose and gradually increase it over several weeks until the dose that works for you (called the effective dose) is reached. Never take more Amaless than your doctor has told you to.

The usual effective dose of Amaless in adults and children over 13 years of age is between 100 mg and 400 mg
daily.
In children aged between 2 and 12 years, the effective dose depends on body weight – generally, it ranges from
1 mg to 15 mg per kilogram of body weight, up to a maximum of 400 mg per day.
Amaless is not recommended for children under 2 years of age.
How to take your dose of Amaless
Take your dose of Amaless once or twice a day, as directed by your doctor. You may take it with or
without food.

Always take the full dose prescribed by your doctor. Never take only part of a tablet.

Your doctor may also advise you to start or stop taking other medicines, depending on the conditions being
treated and your response to therapy.
Amaless dispersible tablets can be swallowed whole with a little water, chewed, or dissolved in water to make
a liquid medicine.
If you chew the tablet:
You may need to drink some water at the same time to help the tablet dissolve in your mouth. Then drink more
water to ensure you have swallowed all of the medicine.
To make a liquid medicine:

Place the tablet in a glass with enough water to cover the entire tablet.
Stir to dissolve the tablet or wait until the tablet has completely dissolved.
Drink all the liquid.
Add a little more water to the glass and drink it, to ensure that no part of the medicine remains in the glass.

If you take more Amaless than you should
Contact your doctor or the nearest emergency department immediately. If possible, show them the
pack of Amaless.
Taking too much Amaless increases the risk of serious side effects, which may be fatal.
People who have taken too much Amaless may experience one or more of the following symptoms:

rapid, uncontrolled eye movements ( nystagmus )
clumsiness and lack of coordination affecting balance ( ataxia )
changes in heart rhythm (usually detected by ECG)
loss of consciousness, seizures (convulsions), or coma.

If you forget to take Amaless
Do not take a double dose to make up for a missed dose.
Ask your doctor for advice on how to resume taking it. It is important that you do so.
Do not stop taking Amaless without consulting your doctor.
You should continue taking Amaless for as long as your doctor has recommended. Do not stop unless your
doctor tells you to.
If you are taking Amaless for epilepsy
To stop taking Amaless, it is important to gradually reduce the dose over a period of about 2
weeks. If you stop taking Amaless suddenly, your epilepsy may return or worsen.
If you are taking Amaless for bipolar disorder
Amaless may take some time to work, so it is unlikely that you will feel better immediately. If you stop taking
Amaless, it is not usually necessary to taper the dose gradually. However, if you wish to stop taking Amaless,
you must always discuss this with your doctor first.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions or potentially serious skin reactions: seek medical help immediately
A small number of people taking Amaless have an allergic reaction or a potentially serious skin reaction, which may progress to more severe problems if not treated.
These symptoms are most likely to occur during the first months of treatment with Amaless, especially if you started on too high a dose, if the dose was increased too quickly, or if you are taking Amaless together with another medicine called valproate. Some of these symptoms are more common in children, so parents should be particularly vigilant in monitoring for them.
Symptoms of these reactions include:

skin rash or redness, which may progress to severe skin reactions including widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of body surface area – toxic epidermal necrolysis), or rash with involvement of the liver, blood, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as hypersensitivity syndrome)
mouth, throat, nose, or genital ulcers
mouth pain or red, swollen eyes (conjunctivitis)
elevated temperature (fever), flu-like symptoms, or drowsiness
facial swelling, or swelling of glands in the neck, armpits, or groin
unexpected bleeding or bruising, or fingers turning blue
sore throat, or more frequent infections (such as colds) than usual
increased liver enzyme levels observed in blood tests
an increase in a type of white blood cell (eosinophils)
enlarged lymph nodes
involvement of body organs including liver and kidneys.

In many cases, these symptoms will be signs of less serious adverse effects. However, you must be aware that they can be potentially serious and may progress to more severe problems, such as organ failure, if not treated. If you notice any of these symptoms:
Contact your doctor immediately. Your doctor may decide to perform tests for liver, kidney, or blood function and may instruct you to stop taking Amaless. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you never to use lamotrigine again.
Very common adverse reactions
May affect more than 1 in 10 people:

headache
rash

Common adverse reactions
May affect up to 1 in 10 people:

aggression or irritability
feeling drowsy
dizziness
jerking movements or tremors
difficulty sleeping (insomnia)
feeling restless
diarrhoea
dry mouth
nausea or vomiting
fatigue
back, joint, or other pain

Uncommon adverse reactions
May affect up to 1 in 100 people:

clumsiness and lack of coordination (ataxia)
double vision or blurred vision

Rare adverse reactions
May 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 including: fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to light. This may be caused by inflammation of the membranes covering the brain and spinal cord (meninges). These symptoms usually resolve once treatment is stopped; however, if symptoms persist or worsen, contact your doctor
rapid, uncontrolled eye movements (nystagmus)
itchy eyes with discharge and crusts on the eyelids (conjunctivitis)

Very rare adverse reactions
May 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 information at the beginning of section 4)
elevated temperature (fever): (see also information at the beginning of section 4)
facial swelling (edema), or swelling of glands in the neck, armpits, or groin (lymphadenopathy): (see also information at the beginning of section 4)
changes in liver function, which may be detected by blood tests, or liver failure: (see also information at the beginning of section 4)
a serious blood clotting disorder, which may cause unexpected bleeding or bruising (disseminated intravascular coagulation): (see also information at the beginning of section 4)
blood test abnormalities – including reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced numbers of all these cell types (pancytopenia), and a bone marrow disorder called aplastic anaemia
hallucinations (“seeing” or “hearing” things that are not actually there)
confusion
feeling “wobbly” or unsteady when moving
uncontrolled body movements (tics), uncontrollable muscle spasms affecting the eyes, head, and torso (choreoathetosis), or other unusual body movements such as jerking, tremors, or stiffness
in people who already have epilepsy, seizures may occur more frequently
in people who already have Parkinson’s disease, worsening of symptoms
lupus-like reactions (symptoms may include back or joint pain, sometimes accompanied by fever and/or general feeling of being unwell)

Other adverse reactions
Other adverse reactions 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 taking antiepileptic medicines long-term, if you have a history of osteoporosis, or if you are taking steroids.

Nightmares.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Amaless

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amaless contains

The active substance is lamotrigine. Each dispersible tablet contains 5 mg, 25 mg, 50 mg, 100 mg, or 200 mg of lamotrigine.
The excipients are: microcrystalline cellulose, heavy magnesium carbonate, polacrilin potassium, sucralose, povidone (K30), magnesium stearate, black currant flavour (maltodextrin, artificial flavours, triacetin, benzyl alcohol, acetic acid, and caramel colour).

Description of the appearance of Amaless and package contents
Dispersible tablet
Amaless 5 mg dispersible tablets:
Tablets from white to off-white, capsule-shaped, uncoated, with “H” engraved on one side and “81” on the other side.
Amaless 25 mg dispersible tablets:
Tablets from white to off-white, rounded, square-shaped, uncoated, with “H” engraved on the multifaceted side and “80” on the flat side.
Amaless 50 mg dispersible tablets:
Tablets from white to off-white, rounded, square-shaped, uncoated, with “H” engraved on the multifaceted side and “79” on the flat side.
Amaless 100 mg dispersible tablets:
Tablets from white to off-white, rounded, square-shaped, uncoated, with “H” engraved on the multifaceted side and “78” on the flat side.
Amaless 200 mg dispersible tablets:
Tablets from white to off-white, rounded, square-shaped, uncoated, with “H” engraved on the multifaceted side and “77” on the flat side.

Packaging:
Pack contents
PVC/Aclar/Aluminum blisters:
7, 10, 14, 20, 21, 28, 30, 40, 42, 50, 56, 60, 90, 98, 100, 200 tablets.
HDPE containers:
Amaless 25 mg, 50 mg, 100 mg and 200 mg: 30, 90, 100 and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Via San Giuseppe, 102 – 21047 Saronno (VA) - Italy

Manufacturer responsible for batch release:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia,
BBG 3000 Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
France Lamotrigine Arrow Lab 25 mg/ 50 mg/ 100 mg/ 200 mg dispersible tablets
Germany Lamotrigin Aurobindo 5 mg tablets for the preparation of an oral suspension
Ireland Lamotrigine Aurobindo 5 mg/ 25 mg/ 50 mg/ 100 mg/ 200 mg dispersible/chewable tablets
Italy Amaless 5 mg/ 25 mg/ 50 mg/ 100 mg/ 200 mg dispersible tablets
Malta Lamotrigine Aurobindo 50 mg/ 100 mg/ 200 mg dispersible tablets
Netherlands Lamotrigine Aurobindo 5 mg/ 25 mg/ 50 mg/ 100 mg/ 200 mg dispergeerbare tabletten