PACKAGE LEAFLET: INFORMATION FOR THE USER

LAMOTRIGINE DOC 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT LAMOTRIGINE DOC IS AND WHAT IT IS USED FOR

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

In adults and children aged 13 years and older, LAMOTRIGINE DOC may be used alone or in combination with other medicines to treat epilepsy. LAMOTRIGINE DOC may also be used in combination with other medicines to treat seizures occurring in a condition called Lennox-Gastaut syndrome.
In children aged between 2 and 12 years, LAMOTRIGINE DOC 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.

LAMOTRIGINE DOC also treats bipolar disorder.
People with bipolar disorder (also called 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, LAMOTRIGINE DOC may be used alone or in combination with other medicines to prevent depressive episodes associated with bipolar disorder. It is not yet known how LAMOTRIGINE DOC works in the brain to produce this effect.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LAMOTRIGINE DOC

Do not take LAMOTRIGINE DOC:

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

If this applies to you:
→ Inform your doctor and do not take LAMOTRIGINE DOC.
Warnings and precautions
Take special care with LAMOTRIGINE DOC
Talk to your doctor or pharmacist before taking LAMOTRIGINE DOC:

if you have any kidney problems
if you have ever had a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy;
if you develop a skin rash or sunburn (sunburn reaction) after taking medicines containing lamotrigine and exposure to sunlight or artificial light (e.g. a sunbed). Your doctor will review your treatment and may advise you to avoid exposure to sunlight or to protect yourself from the sun (e.g. by using sunscreen and/or wearing protective clothing)
if you have ever had meningitis after taking lamotrigine ( read the description of these symptoms in section 4 of this leaflet: Other unwanted effects)
if you are already taking medicines containing lamotrigine
if you have a condition called Brugada syndrome or other heart problems. Brugada syndrome is a genetic condition causing abnormal electrical activity in the heart. ECG abnormalities that may lead to arrhythmia (abnormal heart rhythm) can be caused by lamotrigine.

If any of these apply to you:
→ Inform your doctor, who may decide to reduce your dose or determine that LAMOTRIGINE DOC is not suitable for you.
Important information about potentially life-threatening reactions
A small number of people taking LAMOTRIGINE DOC have experienced an allergic reaction or a potentially life-threatening skin reaction, which, if not treated, may progress to more serious problems. These may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to be aware of the symptoms while taking LAMOTRIGINE DOC. The risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese and Thai origin). If you are of this origin and previous testing has shown you carry this genetic variant (HLA-B*1502), discuss this with your doctor before taking LAMOTRIGINE DOC.
→ Read the description of these symptoms in section 4 of this leaflet under: “Potentially life-threatening reactions: seek immediate medical help”.
Haemophagocytic Lymphohistiocytosis (HLH)
In patients treated with lamotrigine, there have been reports of a rare but very serious immune system reaction.
→ Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. jerks or tremors, confusion, impaired brain function).
Thoughts of harming yourself or suicide
Antiepileptic medicines are used to treat various 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 have these thoughts:

when starting treatment for the first time
if you have previously had thoughts of self-harm or suicide
if you are under 25 years of age If you have thoughts or experiences that trouble you, or if you notice you are feeling worse or developing new symptoms while taking LAMOTRIGINE DOC: → Contact your 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 may become depressed or experience significant mood changes, and ask them to read this leaflet. You may ask them to inform you if they are concerned about your depression or other changes in your behaviour.

A small number of people being treated with antiepileptic medicines, such as LAMOTRIGINE DOC, have also had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately.
If you are taking LAMOTRIGINE DOC for epilepsy
In some types of epilepsy, seizures may occasionally worsen or occur more frequently during treatment with LAMOTRIGINE DOC.
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 LAMOTRIGINE DOC:
→ Contact your doctor as soon as possible.
LAMOTRIGINE DOC must not be given to people under 18 years of age for the treatment of
bipolar disorder. Medicines that treat depression and other mental health conditions increase the risk of suicidal thoughts and behaviours in children and adolescents under 18 years of age.
Other medicines and LAMOTRIGINE DOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine, including herbal preparations or other medicines without a prescription.
Your doctor needs to know if you are taking other medicines for epilepsy or mental health conditions to ensure you are receiving the correct dose of LAMOTRIGINE DOC. These medicines include:

oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy
lithium, olanzapine or aripiprazole, used to treat mental health conditions
bupropion, used to treat mental health conditions or to quit smoking
paracetamol, used to treat pain and fever → Inform your doctor if you are taking any of these medicines.

Some medicines interact with LAMOTRIGINE DOC or make side effects more likely. These include:

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

Hormonal contraceptives (such as the pill) may alter the way LAMOTRIGINE DOC works
Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, diaphragm, or intrauterine device. If you are using hormonal contraceptives such as the pill, your doctor may take blood samples to monitor LAMOTRIGINE DOC levels. If you are using or considering starting a hormonal contraceptive:
→ Inform your doctor, who will discuss suitable contraceptive methods with you.
LAMOTRIGINE DOC may also alter 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 menstrual cycle, such as unexpected bleeding or spotting between periods:
→ Inform your doctor. These may be signs that LAMOTRIGINE DOC is affecting how the contraceptive works.
Pregnancy, breastfeeding and fertility
→ If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your
doctor or pharmacist before taking this medicine.

Do not stop treatment without speaking to your doctor. This is particularly important if you have epilepsy.
Pregnancy may alter the effectiveness of LAMOTRIGINE DOC, so blood tests and dose adjustments may be necessary.
There may be a small increased risk of birth defects, including cleft lip or cleft palate, if LAMOTRIGINE DOC is taken during the first three months of pregnancy.
Your doctor may advise you to take additional folic acid if you are planning a pregnancy or are already pregnant.

→ If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before
taking this medicine. The active substance in LAMOTRIGINE DOC passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine and will monitor your baby periodically for symptoms such as drowsiness, rash, or poor weight gain if you decide to breastfeed. Inform your doctor if you notice any of these symptoms in your baby.
Driving and using machines
LAMOTRIGINE DOC may cause dizziness and double vision.
→ Do not drive or operate machinery unless you are certain you are not affected by these symptoms.
If you have epilepsy, discuss driving and using machinery with your doctor.
LAMOTRIGINE DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. HOW TO TAKE LAMOTRIGINE DOC

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

your age
whether you are taking LAMOTRIGINE DOC with other medicines
whether you have any kidney or liver problems.

Your doctor will start you on a low dose and gradually increase it over several
weeks until the dose that works for you is reached (called the effective dose). Do not take more
LAMOTRIGINE DOC than your doctor has prescribed.
The recommended effective dose of LAMOTRIGINE DOC in adults and children aged 13 years and older is between 100 mg and 400 mg daily.
Use in children
In children aged between 2 and 12 years, the effective dose depends on body weight and is generally between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum of 200 mg per
day.
LAMOTRIGINE DOC is not recommended in children under 2 years of age.
How to take your dose of LAMOTRIGINE DOC
Take your dose of LAMOTRIGINE DOC once or twice a day, as directed by your doctor. It can be taken 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.
The dispersible tablets of LAMOTRIGINE DOC can be swallowed whole with a little water, chewed, or mixed in water to make a liquid medicine. Never take only part of the liquid.
To chew the tablet:
You may need to drink some water at the same time to help the tablet dissolve in your mouth. Then drink a little more water to ensure you have swallowed all the medicine.
To make the medicine into a liquid:

Place the tablet in a glass with enough water to cover the entire tablet.
To dissolve the tablet, stir 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 you have taken all the medicine.

If you take more LAMOTRIGINE DOC than you should
→ Contact your doctor or the nearest hospital emergency department immediately. If possible, show them the LAMOTRIGINE DOC packaging.
If you take too much LAMOTRIGINE DOC, you are more likely to experience serious adverse effects,
which may be fatal.
Symptoms in people who have taken too much LAMOTRIGINE DOC may include:

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

If you forget to take a single dose of LAMOTRIGINE DOC
→ Do not take extra tablets to make up for the missed dose. Take the next dose at your usual time.
If you forget to take several doses of LAMOTRIGINE DOC
→ Ask your doctor for advice on how to restart treatment. It is important that you do so.
Do not stop taking LAMOTRIGINE DOC without consulting your doctor
LAMOTRIGINE DOC should be taken for as long as your doctor recommends. Do not stop unless your doctor tells you to.
If you are taking LAMOTRIGINE DOC for epilepsy
To stop taking LAMOTRIGINE DOC, it is important to gradually reduce the dose over approximately 2 weeks. If you stop taking LAMOTRIGINE DOC suddenly, your epilepsy may return or worsen.
If you are taking LAMOTRIGINE DOC for bipolar disorder
LAMOTRIGINE DOC may take some time to work, so you are unlikely to feel better immediately. When stopping LAMOTRIGINE DOC, gradual dose reduction may not be necessary. However, if you wish to stop taking LAMOTRIGINE DOC, you must always discuss this with your doctor first.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Potentially life-threatening reactions: seek medical help immediately

A small number of people taking LAMOTRIGINE DOC experience an allergic reaction or a potentially life-threatening skin reaction, which, if untreated, may progress to more serious problems.

These symptoms are more likely to occur during the first few months of treatment with LAMOTRIGINE DOC, especially if the starting dose is too high, if the dose is increased too rapidly, or if LAMOTRIGINE DOC is taken together with another medicine called valproate. Some of these symptoms are more common in children, so parents should pay particular attention to their appearance.

Symptoms of such reactions include:

Skin rash or redness, which may progress to severe or sometimes life-threatening skin reactions including rash with target-like lesions (erythema multiforme), widespread rash with blistering and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin detachment (more than 30% of body surface area – toxic epidermal necrolysis), or widespread rashes involving the liver, blood, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome)
Ulcers in the mouth, throat, nose, or genitals
Pain in the mouth or red or swollen eyes (conjunctivitis)
High temperature (fever), flu-like symptoms, or drowsiness
Swelling of the face, or swelling of the glands in the neck, armpits, or groin
Unexpected bleeding or bruising, or if fingers turn blue
Sore throat, or more frequent infections (such as colds) than usual
Increased levels of liver enzymes observed in blood tests
Increase in a type of white blood cells (eosinophils)
Swollen lymph nodes
Organ involvement including liver and kidneys

In many cases, these symptoms may indicate less serious adverse effects. However, you must be aware that they are potentially life-threatening and, if left untreated, may progress to more serious conditions, such as organ failure. If you notice any of these symptoms:
→ Contact your doctor immediately. Your doctor may decide to perform diagnostic tests on your liver, kidneys, or blood and may instruct you to stop taking LAMOTRIGINE DOC. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you never to take lamotrigine again.

Haemophagocytic Lymphohistiocytosis (HLH) (see section 2: What you need to know before taking LAMOTRIGINE DOC).

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
Drowsiness
Dizziness
Shakes or tremors
Difficulty sleeping (insomnia)
Restlessness
Diarrhoea
Dry mouth
Nausea and vomiting
Fatigue
Back or joint pain, or pain in other areas

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

Clumsiness and lack of coordination (ataxia)
Double vision or blurred vision
Unusual hair loss or thinning (alopecia)
Skin rash or sunburn (sunburn-like reaction) after exposure to sunlight or artificial light (photosensitivity)

Rare adverse reactions
May affect up to 1 in 1,000 people:

Skin reaction causing red spots or patches on the skin, which may resemble a target or "bull's eye" with a dark red center surrounded by paler red rings (erythema multiforme)
A life-threatening skin reaction (Stevens-Johnson syndrome): see also information at the beginning of section 4.
A group of associated symptoms including: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light. This may be caused by inflammation of the membranes covering the brain and spinal cord (meningitis). These symptoms usually disappear once treatment is stopped; however, if symptoms persist or worsen, contact your doctor.
Itchy eyes, with discharge and crusts on the eyelids (conjunctivitis)
Rapid, uncontrollable eye movements (nystagmus)

Very rare adverse reactions
May affect up to 1 in 10,000 people:

Hallucinations ("seeing" or "hearing" things that are not really there)
Confusion
Feeling "wobbly" or unsteady in movement
Uncontrollable, repetitive 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 jerks, tremors, or stiffness
A severe, 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)
In people who already have epilepsy, seizures occur more frequently
Changes in liver function, shown by blood tests, or liver failure (see also information at the beginning of section 4)
Changes that may be shown by blood tests – including reduced number of red blood cells in the blood (anaemia), reduced number of white blood cells in the blood (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all these types of cells (pancytopenia), and a bone marrow disorder called aplastic anaemia
A serious blood clotting disorder, which may cause unexpected bleeding or bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4)
High temperature (fever)
Swelling of the face (oedema), or swelling of the glands in the neck, armpits, or groin (lymphadenopathy) (see also information at the beginning of section 4)
In people who already have Parkinson's disease, worsening of symptoms
Haemophagocytic lymphohistiocytosis (HLH) (see section 2 What you need to know before taking LAMOTRIGINE DOC)
Lupus-like reactions (symptoms may include: back or joint pain, sometimes accompanied by fever and/or general malaise)
High temperature (fever) (see also information at the beginning of section 4)

Other adverse reactions
Other adverse reactions have occurred in a small number of people, but their frequency is unknown:

Cases of bone disease including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported. Contact your doctor or pharmacist if you are on long-term treatment with an antiepileptic medicine, if you have a history of osteoporosis, or if you are taking steroids.
Kidney inflammation (tubulointerstitial nephritis), or inflammation of both the kidneys and the eyes (tubulointerstitial nephritis and uveitis syndrome)
Nightmares
Drug reaction with eosinophilia and systemic symptoms (DRESS)
Reduced immunity due to lower levels of antibodies in the blood called immunoglobulins, which help protect against infections
Red skin nodules or patches (pseudolymphoma)

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

5. HOW TO STORE LAMOTRIGINE DOC

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

6. PACK CONTENTS AND OTHER INFORMATION

What LAMOTRIGINE DOC contains
The active substance is lamotrigine. Each dispersible tablet contains 25 mg, 50 mg, 100 mg or 200 mg of
lamotrigine.
The other ingredients are: crospovidone, potassium acesulfame (E 950), orange flavour, mannitol (E 421),
anhydrous colloidal silica, sodium stearoyl fumarate.

Description of the appearance of LAMOTRIGINE DOC and pack contents
Dispersible tablets.
25 mg:
White, round, biconvex tablets.
Pack: 21, 28, 42 tablets.
50 mg:
White, round, biconvex tablets.
Pack: 42, 56 tablets.
100 mg:
White, round, biconvex tablets.
Pack: 56 tablets.
200 mg:
White, round, biconvex tablets.
Pack: 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.
Manufacturer:
Special Product’s line S.p.A. - Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (Frosinone) – Italy.

Lamotrigine Doc Generici