AMALESS 5 mg Dispersible Tablets

Зміст інструкції

1. Amaless 5 mg dispersible tablets, 25 mg dispersible tablets, 50mg dispersible tablets
   1. What is Amaless and what is it used for
   2. What you need to know before taking Amaless
   3. How to take Amaless
   4. POSSIBLE SIDE EFFECTS
   5. How to store Amaless
   6. Package Contents and Other Information

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

Amaless 100 mg dispersible tablets
Amaless 200 mg dispersible tablets
Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Amaless and what is it used for

Lamotrigine belongs to a group of medicines called antiepileptics. It is used for the treatment of two
conditions – epilepsyand bipolar disorder.

Amaless treats epilepsyby blocking the signals in the brain that trigger epileptic seizures
(convulsions).

• In adults and children 13 years of age and older, Amaless can be used, alone or with other medicines, for the treatment of epilepsy. Amaless can also be used with other medicines to treat convulsive seizures that occur in a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Amaless can be used with other medicines, for the treatment of these conditions. It can be used alone for the treatment of a type of epilepsy called typical absence seizures.

Amaless also treats bipolar disorder.
People with bipolar disorder (also called manic-depressive illness) have extreme mood swings, with
periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or
despair). In adults 18 years of age and older, Amaless can be used alone or with other
medicines, to prevent the depressive episodes that occur in bipolar disorder. It is not yet known
how Amaless works in the brain to have this effect.

2. What you need to know before taking Amaless

Do not take Amaless

• If you are allergicto lamotrigine or any of the other ingredients 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 rashafter 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 that contain lamotrigine.

If any of these cases applies to you:

Tell your doctor, who may decide to reduce the dose, or that Amaless is not suitable for you.

Important information about potentially serious reactions
A small number of people taking Amaless have developed an allergic reaction or a potentially life-threatening skin reaction, which can develop into more serious problems if 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
watch out for during treatment with Amaless.

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

Thoughts of harming yourself or suicide
Antiepileptic medicines are used to treat serious 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 are more likely to have these thoughts:

• when you first start treatment,
• if you have had thoughts of harming yourself or suicide before
• if you are under 25 years old. If you have thoughts or experiences that disturb you or if you notice that you feel 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 antiepileptics such as Amaless have also had thoughts of harming themselves or
committing suicide. If you have occasionally had 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 have severe seizures, which can cause serious
health problems. If your seizures become more frequent or if you have a severe seizure while taking
Amaless:

Contact a doctor as soon as possible.

Amaless must not be given to people under the age of 18 for the treatment of bipolar
disorder.Medicines that treat depression and other mental health problems increase the risk of
thoughts and behaviors of suicide in children and adolescents under the age of 18.

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines,including herbal remedies or other medicines without a prescription.
Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health problems,
to make sure you are taking the correct dose of Amaless.
These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide,used to treat epilepsy
• lithiumor olanzapine or aripiprazole, used to treat mental health problems
• bupropion, used to treat mental health problemsor to stop smoking

Tell your doctorif you are taking any of these medicines
Some medicines interact with Amaless or make side effects more likely.
These include:

• valproate, used to treat epilepsyand mental health problems
• carbamazepine, used to treat epilepsyand mental health problems
• phenytoin, primidone or phenobarbital, used to treat epilepsy
• risperidone, used to treat mental health problems
• 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 doctorif you are taking, or starting or stopping any of these medicines.

Hormonal contraceptives (such as the pill) can change the way Amaless works
Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method
of contraception, such as a condom, diaphragm or coil. If you are using hormonal contraceptives
such as the pill, your doctor may take blood samples to check your Amaless levels. If you are
using a hormonal contraceptive or are thinking about starting one:

Talk to your doctor, who will discuss suitable contraceptive methods with you.
Amaless can also change the way 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 periods, such as breakthrough bleeding or bleeding between periods:

Tell your doctor. These may be signs that Amaless is changing the way your contraceptive is working.

Pregnancy, breastfeeding and fertility
There may be an increased risk of birth defects in babies whose mothers take Amaless during
pregnancy. These defects include cleft lip or palate. Your doctor may advise you to take a supplement of folic acid, if you are planning a pregnancy or are already pregnant.
Pregnancy can also alter the effectiveness of Amaless, so you may need blood tests and
your dose of Lamotrigine may be changed.

If you are pregnant, suspect you are 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 of
Amaless passes into breast milk and can have effects on the baby. Your doctor will discuss the risks and
benefits of breastfeeding while taking Amaless, and will check your baby from time to time, if you
decide to breastfeed.

Driving and using machines
Amaless can cause dizziness and double vision.

Do not drive or use machines unless you are sure these symptoms do not affect you.
If you have epilepsy, talk to your doctor about driving and using machines.

3. How to take Amaless

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts
you should consult your doctor or pharmacist.

How much Amaless you need to take
It may take time to find the optimal dose of Amaless for you. The dose you need to take
will depend on:

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

The usual effective dose of Amaless in adults and children over 13 years of age is between 100 mg and 400 mg each
day.
In children between 2 and 12 years of age, the effective dose depends on body weight – generally, it is
between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum of 400 mg per
day.
Amaless is not recommended in children under 2 years of age.

How to take the dose of Amaless
Take the dose of Amaless once or twice a day, as your doctor has told you. You can take it with or
without food.

• Always take the full dosethat your doctor has prescribed. Never take only part of the tablet.

Your doctor may also advise you to start or stop taking other medicines, depending on the type of
conditions for which they are taken and your response to treatment.
The dispersible tablets of Amaless can be swallowed whole with a little water, chewed or dissolved
in water to make the medicine liquid.

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 some more water to be sure you have swallowed all the medicine.

To make the medicine liquid:

• Place the tablet in a glass with enough water to at least cover the entire tablet.
• Stir to dissolve the tablet or wait until the tablet has completely dissolved.
• Drink all of the liquid.
• Add a little more water to the glass and drink it, to be sure 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 room immediately. If possible, show them the
Amaless packaging.

If you take too much Amaless you are more likely to have serious side effects that can be fatal.
People who have taken too much Amaless may experience one of the following symptoms:

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of coordination, which changes their 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 doseto make up for a missed dose.

Ask your doctor for advice on how to start taking it again. It is important that you do so.

Do not stop taking Amaless without your doctor's advice
Amaless must be taken until you have been recommended by your doctor. Do not stop unless
your doctor tells you to do so.

If you are taking Amaless for epilepsy
To stop taking Amaless, it is important to reduce the dose gradually, over about 2
weeks. If you suddenly stop taking Amaless, epilepsy may return or
worsen.

If you are taking Amaless for bipolar disorder
Amaless may take some time to work, so you are unlikely to feel better
immediately. If you stop taking Amaless, you will not need to reduce the dose gradually. But if you
want to stop taking Amaless, you should always talk to your doctor first.

4. POSSIBLE SIDE EFFECTS

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

Serious allergic reactions or skin reactions: seek medical help immediately

A small number of people taking Amaless experience an allergic reaction or a skin reaction
potentially serious, which can develop into more serious problems if not treated.
These symptoms are more likely to appear during the first few months of treatment with Amaless,
especially if you started with a dose that was too high or if the dose was increased too quickly, or
if you are taking Amaless with another medicine called valproate. Some of these symptoms are more
common in children, so parents should be particularly careful to monitor them.
The 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, especially around the mouth, nose, eyes and genitals (Stevens-Johnsons syndrome), extensive skin peeling (more than 30% of the body surface area - toxic epidermal necrolysis) or rash involving the liver, blood and other organs (drug reaction with eosinophilia and systemic symptoms also known as hypersensitivity syndrome)
• ulcers in the mouth, throat, nose or genitals
• sore mouth or red and swollen eyes( conjunctivitis)
• high temperature(fever), flu-like symptoms or drowsiness
• swelling of the face,or swelling of the glandsin the neck, armpits or groin
• unexpected bleeding or bruising, or fingers turning blue
• sore throat, or more infections (like colds) than usual
• increased levels of liver enzymes observed in blood tests
• an increase in a type of white blood cells (eosinophils)
• enlarged lymph nodes
• involvement of body organs including liver and kidneys.

In many cases these symptoms will be signs of less serious side effects. But you should be informed that
they are potentially serious and can progress to more serious problems, such as organ failure,
if not treated. If you notice any of these symptoms:

Contact your doctor immediately. The doctor may decide to do tests related to the liver, kidneys or
blood and may tell you to stop taking Amaless. If you have developed
Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you that you should never use
lamotrigine again.

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

• headache
• skin rash

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

• aggressiveness or irritability
• feeling sleepy
• feeling dizzy
• jerks or tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhoea
• dry mouth
• nausea or vomiting
• fatigue
• back pain, or joint pain, or elsewhere.

Uncommon side effects
May affect up to 1 in 100people:

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

Rare side effects
May affect up to 1 in 1000people:

• a life-threatening skin reaction (Stevens-Johnson syndrome): (see also the information at the beginning of section 4)
• a group of symptoms that include: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to light. This may be caused by inflammation of the membranes lining the brain and spinal cord (meningitis). These symptoms usually disappear once treatment is stopped, however if the symptoms continue or worsen contact your doctor
• rapid and uncontrollable eye movements ( nystagmus)
• itchy eyes, with discharge and crusting of the eyelids (conjunctivitis)

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

• 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)
• high temperature (fever): (see also the information at the beginning of section 4)
• swelling of the face (edema), or swelling of the glands in the neck, armpits or groin (lymphadenopathy): (see also the information at the beginning of section 4)
• changes in liver function, which can be detected by blood tests, or liver failure: (see also the information at the beginning of section 4)
• a serious blood clotting disorder, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): (see also the information at the beginning of section 4)
• changes that can be demonstrated by blood tests - including a reduction in the number of red blood cells in the blood (anaemia), a reduction in the number of white blood cells in the blood (leucopenia, neutropenia, agranulocytosis), a reduction in the number of platelets (thrombocytopenia), a reduction in the number of all these types of cells (pancytopenia), and a disorder of the bone marrow called aplastic anaemia
• hallucinations (“seeing” or “hearing” things that are not really there)
• confusion
• feeling “wobbly” or unstable in movements
• uncontrollable body movements (tics), uncontrollable muscle spasms affecting eyes, head, and torso (choreoathetosis), or other unusual body movements, such as jerks, tremors or stiffness
• in people who already suffer from epilepsy, seizures occur more frequently
• in people who already suffer from Parkinson’s disease, worsening of symptoms
• lupus-like reactions (symptoms may include back or joint pain sometimes accompanied by fever and/or general ill health).

Other side effects
Other side effects have been reported in a small number of people but their exact frequency is not
known:
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 drugs for a long time,
if you have a history of osteoporosis or if you take steroids.

• Nightmares.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects 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 indicated on the blister or on the box after EXP. The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Medicines should 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 ingredient 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, blackcurrant 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” imprinted 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” imprinted on the
faceted side and “80” on the flat side.
Amaless 50 mg dispersible tablets:
Tablets from white to off-white, rounded, square-shaped, uncoated, with “H” imprinted on the
faceted side and “79” on the flat side.
Amaless 100 mg dispersible tablets:
Tablets from white to off-white, rounded, square-shaped, uncoated, with “H” imprinted on the
faceted side and “78” on the flat side.
Amaless 200 mg dispersible tablets:
Tablets from white to off-white, rounded, square-shaped, uncoated, with “H” imprinted on the
faceted side and “77” on the flat side.

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following
names:
France Lamotrigine Arrow Lab 25 mg/ 50 mg/ 100 mg/ 200 mg dispersible tablet
Germany Lamotrigin Aurobindo 5 mgTabletten zur Herstellung einer Suspension zum
Einnehmen
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