LAMOTRIGINA 5 mg Таблетка

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1. Lamotrigina Sandoz 5 mg dispersible tablets, 25 mg dispersible tablets, 50 mg dispersible tablets, 100 mg dispersible tablets, 200 mg dispersible tablets
   1. What is Lamotrigina Sandoz and what it is used for
   2. What you need to know before taking Lamotrigine Sandoz
   3. How to take Lamotrigina Sandoz
   4. Possible side effects
   5. How to store Lamotrigina Sandoz
   6. Contents of the pack and other information

Lamotrigina Sandoz 5 mg dispersible tablets, 25 mg dispersible tablets, 50 mg dispersible tablets, 100 mg dispersible tablets, 200 mg dispersible tablets

lamotrigina
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 Lamotrigina Sandoz is and what it is used for
• 2. What you need to know before you take Lamotrigina Sandoz
• 3. How to take Lamotrigina Sandoz
• 4. Possible side effects
• 5. How to store Lamotrigina Sandoz
• 6. Contents of the pack and other information

1. What is Lamotrigina Sandoz and what it is used for

Lamotrigina Sandoz belongs to a group of medicines called anticonvulsants. It is used for the
treatment of two conditions - epilepsyand bipolar disorder.

Lamotrigina Sandoz treats epilepsyby blocking the signals in the brain that trigger
seizures
(convulsions).

• In adults and children 13 years of age and older, Lamotrigina Sandoz can be used, alone or with other medicines, to treat epilepsy. Lamotrigina Sandoz 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, Lamotrigina Sandoz can be used with other medicines, to treat these conditions. It can be used alone to treat a type of epilepsy called typical absence seizures.

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

2. What you need to know before taking Lamotrigine Sandoz

Do not take Lamotrigina Sandoz:

• if you are allergic( hypersensitive) to 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 Lamotrigina Sandoz.

Warnings and precautions
Take special care with Lamotrigina Sandoz
Talk to your doctor or pharmacist before taking Lamotrigina Sandoz:

• if you have any problems with your kidneys
• if you have ever developed a skin rashafter taking lamotrigine or other medicines for bipolar disorder or epilepsy; or if you have a skin rash or sunburn (sunburn) after taking medicines containing lamotrigine and exposure to the sun or artificial light (e.g. a solarium). The doctor will check the 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 symptomsin section 4 of this leaflet: Other undesirable effects).
• if you are already taking medicines that contain lamotrigine.

If any of these applies to you:
 Tell your doctor,who may decide to reduce the dose, or that Lamotrigina Sandoz is not suitable for you.

Brugada Syndrome
Brugada syndrome is a genetic condition that causes abnormal electrical activity of the heart. Abnormalities on the ECG that can lead to arrhythmia (irregular heartbeat) can be caused by
lamotrigine. Tell your doctor if you have this condition.

Hemophagocytic Lymphohistiocytosis (HLH)
In patients treated with lamotrigine, there have been reports of a rare but very serious reaction of the
immune system. Contact your doctor or pharmacist immediately if you experience any of the
following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. convulsions
or tremors, confusion, impaired brain function).

Important information about potentially life-threatening reactions
A small number of people taking Lamotrigina Sandoz have an allergic reaction or a skin reaction that is potentially life-threatening, which, if left untreated, can develop into more serious problems.
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 pay
attention while taking Lamotrigina Sandoz.
 Read the description of these symptoms in section 4 of this leaflet “Potentially
life-threatening reactions:seek immediate medical attention”.

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
committing suicide. If you have bipolar disorder, you are more likely to have these thoughts:

• when you start treatment for the first time
• if you have had thoughts of harming yourself or related to suicide in the past
• if you are under 25 years old. If you have thoughts or experiences that disturb you or if you notice that you are feeling worse or developing new symptoms while taking Lamotrigina Sandoz:  Contact your doctor as soon as possible or go to the nearest hospital for help.

A small number of people being treated with antiepileptics, such as Lamotrigina Sandoz, have also
had thoughts of harming themselves or committing suicide. If you have these thoughts at any time, contact
your doctor immediately.

If you are taking Lamotrigina Sandoz for epilepsy
In some types of epilepsy, seizures may occasionally worsen or occur more frequently during
treatment with Lamotrigina Sandoz.
Some patients may have severe seizures, which can cause serious health problems. If seizures
become more frequent or if you have a severe seizure while taking Lamotrigina Sandoz:
 Contact your doctor as soon as possible.
Lamotrigina Sandoz should 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 suicidal thoughts and behaviors in children and adolescents under the age of 18 years.

Other medicines and Lamotrigina Sandoz
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.
The 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 Lamotrigina Sandoz.
These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide,used for the treatment of epilepsy
• lithium, olanzapine or aripiprazoleused for the treatment of mental health problems
• bupropion,used for the treatment of mental health problemsor to quit smoking Tell your doctorif you are taking any of these medicines.

Some medicines interact with Lamotrigina Sandoz or make side effects more likely. These include:

• valproate, used for the treatment of epilepsyand mental health problems
• carbamazepine, used for the treatment of epilepsyand mental health problems
• phenytoin, primidoneor phenobarbital,used for the treatment of epilepsy
• risperidone,used for the treatment of mental health problems
• 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)

 Tell your doctorif you are taking, or are starting or stopping any of these
medicines.

Hormonal contraceptives (such as the pill) can change the way Lamotrigina Sandoz
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 levels of Lamotrigina Sandoz.
If you are using or are thinking of starting to use a hormonal contraceptive:
 Tell your doctor, who will discuss suitable contraceptive methods with you.
Lamotrigina Sandoz 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
change in your periods, such as breakthrough bleeding or bleeding between periods:
 Tell your doctor.These may be signs that Lamotrigina Sandoz is changing the way the
contraceptive is working.

Pregnancy and breastfeeding
There may be an increased risk of birth defects in babies whose mothers took Lamotrigina
Sandoz during pregnancy. These defects include cleft lip (labioschisis) or cleft palate
(palatoschisis). Your doctor may advise you to take a supplement of folic acid, if you are
planning a pregnancy or if you are already pregnant.
Pregnancy can also alter the effectiveness of Lamotrigina Sandoz, so blood tests and dose adjustments of Lamotrigina Sandoz may be necessary.
 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 suffer from epilepsy.
 If you are breastfeeding or are planning to breastfeed, ask your doctor or
pharmacist for advice before taking this medicine.The active ingredient of Lamotrigina Sandoz passes into breast milk
and may have effects on your baby. Your doctor will talk to you about the risks and benefits of breastfeeding
while taking Lamotrigina Sandoz and will check your baby from time to time, in case drowsiness, rash or poor weight gain occur, if you decide to breastfeed

Driving and using machines
Lamotrigina Sandoz can cause dizziness and double vision.
 Do not drive or operate machinery unless you are sure these symptoms do not occur.
If you have epilepsy, talk to your doctor about driving and using machines.
Lamotrigina Sandoz 5 mg dispersible tablets contains sorbitol and sodium
This medicine contains 50.56 mg of calcium carbonate sorbitol per tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Lamotrigina Sandoz 25 mg dispersible tablets contains sorbitol and sodium
This medicine contains 9.725 mg of calcium carbonate sorbitol per tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Lamotrigina Sandoz 50 mg dispersible tablets contains sorbitol and sodium
This medicine contains 19.45 mg of calcium carbonate sorbitol per tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Lamotrigina Sandoz 100 mg dispersible tablets contains sorbitol and sodium
This medicine contains 38.90 mg of calcium carbonate sorbitol per tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Lamotrigina Sandoz 200 mg dispersible tablets contains sorbitol and sodium
This medicine contains 77.80 mg of calcium carbonate sorbitol per tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Lamotrigina Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

How much Lamotrigina Sandoz should you take
It may take some time to find the optimal dose of Lamotrigina Sandoz for you. The dose you
should take will depend on:

• your age
• whether you are taking Lamotrigina Sandoz with other medicines
• if you have any kidney or liver problems.

Your doctor will prescribe a low dose to start with, and will gradually increase the dose over a few
weeks until the dose that works for you is reached (called effective dose). Do not take more
Lamotrigina Sandoz than your doctor has told you to.
The usual effective dose of Lamotrigina Sandoz in adults and children aged 13 years or over is
between 100 mg and 400 mg each day.
In children aged between 2 and 12 years, the effective dose depends on body weight – generally, it is
between 1 mg and 15 mg for each kilogram of the child's weight, up to a maximum maintenance dose of
200 mg per day.
Lamotrigina Sandoz is not recommended in children under 2 years of age.

How to take the dose of Lamotrigina Sandoz
Take the dose of Lamotrigina Sandoz once or twice a day, as your doctor has told you. It can be taken
with or without food.

• Always take the full dosethat your doctor has prescribed. Never take only part of a 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 Lamotrigina Sandoz can be swallowed whole with some water,
chewed, or mixed with water to make a liquid medicine.

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 some more water to make sure all the medicine has been swallowed.

To make the medicine liquid:

• Put the tablet in a glass with enough water to at least 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 make sure no medicine remains in the glass.

If you take more Lamotrigina Sandoz than you should
 Contact your doctor or the nearest hospital emergency room immediately.If possible, show
them the Lamotrigina Sandoz packaging.

If you take too muchLamotrigina Sandoz you are more likely to have serious side effects that
can be fatal.
If you have taken too much Lamotrigina Sandoz you may experience one of these symptoms:

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of coordination, which changes balance (ataxia)
• changes in heart rhythm (usually detected by ECG)
• loss of consciousness or coma.

If you forget to take Lamotrigina Sandoz
Do not take a double dose to make up for a missed dose. Take the next dose
at the usual time.
 Ask your doctor for advice on how to start taking it again.It is important that you do so.

Do not stop taking Lamotrigina Sandoz without your doctor's advice
Lamotrigina Sandoz must be taken for as long as your doctor has recommended. Do not stop unless your doctor tells you to.

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

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

4. Possible side effects

Like all medicines, Lamotrigina Sandoz can cause side effects, although not everybody gets them.
manifest.

Potentially life-threatening reactions: seek medical attention immediately
A small number of people taking Lamotrigina Sandoz have an allergic reaction or a potentially life-threatening skin reaction, which, if left untreated, can develop into more serious problems.
These symptoms are more likely to occur during the first few months of treatment with Lamotrigina
Sandoz, especially if the initial dose is too high or if the dose is increased too rapidly, or if
Lamotrigina Sandoz is taken with another medicine called valproate. Some of these symptoms are
more common in children, so parents should pay particular attention to their appearance.
The symptoms of such reactions include:

• skin rash or skin reddening,which can develop into life-threatening skin reactions including widespread rash with blisters and peeling of the skin, which appear particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome), widespread detachment of the skin (more than 30% of the body surface - toxic epidermal necrolysis) or extensive rashes involving the liver, blood and other organs (drug reaction with eosinophilia and systemic symptoms which is also known as hypersensitivity syndrome).
• ulcers in the mouth, throat, nose or genitals
• painful eyes 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 in blood tests
• increase of a type of white blood cells in the blood (eosinophils)
• enlarged lymph nodes
• organ involvement 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 life-threatening and can, if left untreated, develop into more serious problems,
such as organ failure. If you notice any of these symptoms:
 Contact your doctor immediately.Your doctor may decide to perform diagnostic tests on the liver,
kidneys or blood and may tell you to stop taking Lamotrigina Sandoz. 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:

• aggression or irritability
• drowsiness
• dizziness
• shaking or tremors
• difficulty sleeping (insomnia)
• agitation
• diarrhoea
• dry mouth
• nausea or vomiting
• tiredness
• back pain, or joint pain, or pain elsewhere.

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

• clumsiness and lack of coordination ( ataxia)
• double vision or blurred vision
• skin rash (of the skin) or sunburn (sunburn) after exposure to the sun or artificial light (photosensitivity)

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

• a life-threatening skin reaction (Stevens-Johnson syndrome)( see also theinformation at the beginning of paragraph 4).
• a group of symptoms associated with fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by inflammation of the membranes surrounding 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, 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 theinformation at the beginning of paragraph 4).
• drug reaction with eosinophilia and systemic syndrome (DRESS) (see also the informationat the beginning of paragraph 4)
• high temperature ( fever)( see also the information at the beginning of paragraph 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 paragraph 4).
• impaired liver function, demonstrated by blood tests, or liver failure (see also the information at the beginning of paragraph 4).
• a severe blood clotting disorder, which can cause unexpected bleeding or bruising ( disseminated intravascular coagulation) (see also the information at the beginning of paragraph 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 bone marrow disorder called aplastic anaemia.
• hallucinations (“seeing” or “hearing” things that are not really there)
• confusion
• feeling “wobbly” or unstable when moving
• uncontrollable body movements (tics), involuntary 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 which can sometimes be accompanied by fever and/or general malaise).
• Hemophagocytic Lymphohistiocytosis (HLH) (see section 2 What you need to know before taking lamotrigine).

Other side effects
Other side effects have been reported in a small number of people but their frequency is not known:

• There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids.
• Nightmares
• Reduced immunity due to lower levels of antibodies in the blood called immunoglobulins that help protect against infections.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lamotrigina Sandoz

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 or on the packaging after the wording
“Scad”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lamotrigina Sandoz dispersible tablets contain
The active ingredient is: lamotrigine. Each dispersible tablet contains 5 mg, 25 mg, 50 mg, 100 mg or 200
mg of lamotrigine.
The other ingredients are: Calcium Carbonate Sorbitol, Microcrystalline Cellulose, Crospovidone, Corn Starch, Talc, Blackcurrant Aroma, Sodium Saccharin, Sodium Stearyl Fumarate, Anhydrous Colloidal Silica.

Description of the appearance of Lamotrigina Sandoz dispersible tablets and contents of the pack
Dispersible tablets .
5 mg dispersible tablets - blister packs of 28 tablets
25 mg dispersible tablets - blister packs of 28 tablets
25 mg dispersible tablets - starter pack for add-on therapy with valproate, blister packs of 21
tablets
25 mg dispersible tablets - starter pack for monotherapy, blister packs of 42 tablets
50 mg dispersible tablets - blister packs of 56 tablets
50 mg dispersible tablets - starter pack for add-on therapy without valproate, blister packs of 42
tablets
100 mg dispersible tablets - blister packs of 56 tablets
200 mg dispersible tablets - blister packs of 56 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni 1
21040 Origgio (VA) - Italy

Manufacturers:

• Bluepharma Industria Farmaceutica S.A. - Apartado 7003 - S. Martinho Do Bispo Coimbra (Portugal)
• Salutas Pharma Gmbh - Otto Von Guericke-Allee 1-Barleben (Germany)