LAMOTRIGINE SANDOZ

Package leaflet: Information for the patient

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

lamotrigine
Generic medicine
Please 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 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• In adults and children aged 13 years and older, Lamotrigina Sandoz can be used alone or in combination with other medicines to treat epilepsy. Lamotrigina Sandoz can 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, Lamotrigina Sandoz can be used in combination with other medicines to treat these conditions. It may also 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 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, Lamotrigina Sandoz can be used alone or in combination with other medicines to prevent depressive episodes associated with bipolar disorder. It is not yet known how Lamotrigina Sandoz works in the brain to produce this effect.

2. What you need to know before taking Lamotrigina Sandoz

Do not take Lamotrigina Sandoz:

• 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:
 Tell your doctor and do not take Lamotrigina Sandoz.
Warnings and precautions
Be especially careful with Lamotrigina Sandoz
Talk to your doctor or pharmacist before taking Lamotrigina Sandoz:

• if you have any kidney problems;
• if you have ever developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy;
• if you develop a skin rash or sunburn (sunburn) 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: Rare undesirable 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 cases apply to you:
 Inform your doctor, who may decide to reduce the dose or determine that Lamotrigina Sandoz is not suitable for you.
Important information regarding potentially life-threatening reactions
A small number of people taking Lamotrigina Sandoz have experienced an allergic reaction or a potentially life-threatening skin reaction, which, if untreated, 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 so you can remain vigilant while taking Lamotrigina Sandoz. The risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese or 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 Lamotrigina Sandoz.
 Read the description of these symptoms in section 4 of this leaflet “ Potentially life-threatening reactions ” and 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, skin rash, neurological symptoms (e.g. jerks or tremors, confusion, impaired brain function).
Thoughts of harming yourself or of 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 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 developing new symptoms while taking Lamotrigina Sandoz:
   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 Lamotrigina Sandoz, have also had thoughts of harming themselves or of suicide. If you ever experience such thoughts, 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 experience severe seizures, which can cause serious health problems. If your seizures become more frequent or if you experience a severe seizure while taking Lamotrigina Sandoz:
 Contact your doctor as soon as possible.
Lamotrigina Sandoz 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 Lamotrigina Sandoz
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 are receiving the correct dose of Lamotrigina Sandoz.
These medicines include:

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

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

• valproate, used to treat epilepsy and mental health problems
• carbamazepine, used to treat epilepsy and 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 (combination of lopinavir and ritonavir or atazanavir and ritonavir)
• medicines containing oestrogens, including hormonal contraceptives , such as the pill (see below) and hormone replacement therapy (HRT).

 Tell your doctor if you are taking, or starting or stopping any of these medicines.
Hormonal contraceptives (such as the pill) can alter 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 condoms, diaphragm, or intrauterine device (IUD). If you are using hormonal contraceptives such as the pill, your doctor may take blood samples to monitor levels of Lamotrigina Sandoz.
If you are using or considering starting a hormonal contraceptive:
 Tell your doctor, who will discuss suitable contraceptive methods with you.
Lamotrigina Sandoz 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:
 Tell your doctor. These may be signs that Lamotrigina Sandoz is affecting how the contraceptive works.
Hormone replacement therapies may alter the way Lamotrigina Sandoz works
If you are using a hormone replacement therapy containing oestrogens, your doctor may take blood samples to monitor the level of Lamotrigina Sandoz.
Pregnancy and breastfeeding
 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 also alter the effectiveness of Lamotrigina Sandoz, so blood tests and dose adjustments of Lamotrigina Sandoz may be necessary.
• There may be a small increased risk of birth defects, including cleft lip (cleft lip) or cleft palate (cleft palate), if Lamotrigina Sandoz is taken during the first 3 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 considering doing so, consult your doctor or pharmacist
before taking this medicine. The active substance in Lamotrigina Sandoz passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamotrigina Sandoz and will monitor your baby from time to time for symptoms such as drowsiness, skin 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
Lamotrigina Sandoz may cause dizziness and double vision.
 Do not drive or operate machinery unless you are certain you do not experience these symptoms.
If you have epilepsy, talk to your doctor about driving and using machinery.
Information on excipients in Lamotrigina Sandoz
Lamotrigina Sandoz 5 mg dispersible tablets contain 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 contain 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 contain 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 contain 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 contain 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

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, consult 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 need will depend on:

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

Your doctor will prescribe a low starting dose, which will be gradually increased over several
weeks until the dose that works for you (called the effective dose) is reached. Do not take more
Lamotrigina Sandoz than your doctor has prescribed.
The usual effective dose of Lamotrigina Sandoz in adults and children aged 13 years and older 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 is
between 1 mg and 15 mg per kilogram of the child's body weight, up to a maximum maintenance dose of
200 mg per day.
Lamotrigina Sandoz is not recommended for children under 2 years of age.
How to take your dose of Lamotrigina Sandoz
Take your dose of Lamotrigina Sandoz 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.
Lamotrigina Sandoz dispersible tablets may 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 more water to ensure that all of the medicine has been swallowed.
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 more water to the glass and drink it, to ensure that no medicine remains in the glass.

If you take more Lamotrigina Sandoz than you should
 Contact your doctor or the nearest hospital emergency department immediately. If possible, show
them the Lamotrigina Sandoz packaging.
Taking too much Lamotrigina Sandoz increases the risk of serious adverse effects,
which may be fatal.
If you have taken too much Lamotrigina Sandoz, you may experience one of the following symptoms:

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of coordination affecting balance (ataxia)
• changes in heart rhythm (usually detected by ECG)
• loss of consciousness, seizures, 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 your usual time.
 Ask your doctor for advice on how to resume taking it. It is important that you do so.
Do not stop taking Lamotrigina Sandoz without consulting your doctor
Lamotrigina Sandoz should be taken for as long as your doctor has recommended. Do not stop unless
your doctor tells you to do so.
If you are taking Lamotrigina Sandoz for epilepsy
To stop taking Lamotrigina Sandoz, it is important to gradually reduce the dose over approximately 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 it is unlikely that you will feel better immediately.
If you stop taking Lamotrigina Sandoz, it may not be necessary to taper the dose gradually. However, if you wish
to stop taking Lamotrigina Sandoz, you must always discuss this with your doctor first.

4. Possible side effects

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

Potentially life-threatening reactions: seek medical help immediately

A small number of people taking Lamotrigine Sandoz experience an allergic reaction or potentially life-threatening skin reactions, 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 Sandoz, especially if the starting dose is too high or increased too quickly, or if Lamotrigine Sandoz 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 of the skin, which may progress to severe or sometimes life-threatening skin reactions including rash with target-like lesions (erythema multiforme), widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), widespread 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 genital area
• mouth pain or red, 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 fingers turning blue
• sore throat or more frequent infections (such as colds) than usual
• increased liver enzyme levels observed in blood tests
• increase in a type of white blood cells (eosinophils)
• swollen lymph nodes
• involvement of organs including liver and kidneys

In many cases, these symptoms may indicate less serious side effects. However, you must be aware that they may be potentially life-threatening and, if left untreated, may progress to 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 your liver, kidneys or blood and may instruct you to stop taking Lamotrigine Sandoz. 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 should know before taking Lamotrigine Sandoz).

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

• headache
• rash

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

• aggression or irritability
• drowsiness
• dizziness
• shaking or tremors
• difficulty sleeping (insomnia)
• restlessness
• diarrhoea
• dry mouth
• nausea or vomiting
• fatigue
• back pain, joint pain, or pain in other areas

Uncommon side effects
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 (sun sensitivity) after exposure to sunlight or artificial light (photosensitivity)

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

• skin reaction causing spots or red 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.
• rapid, uncontrollable eye movements (nystagmus)
• itchy eyes, with discharge and crusts on the eyelids (conjunctivitis)

Very rare side effects
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)
• high temperature (fever) (see also 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 information at the beginning of section 4)
• changes in liver function, shown 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)
• changes that may be shown 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 cell types (pancytopenia), and a bone marrow disorder called aplastic anaemia
• 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 trunk (choreoathetosis), or other unusual body movements such as jerking, tremors or stiffness
• in people who already have epilepsy, seizures 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 malaise)
• Haemophagocytic Lymphohistiocytosis (HLH) (see section 2: What you should know before taking Lamotrigine Sandoz)

Other side effects
Other side effects have been reported in a small number of people, but their frequency is unknown:

• 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, if you have a history of osteoporosis, or if you are taking steroids.
• Kidney inflammation (tubulointerstitial nephritis), or inflammation of both the kidneys and eyes (tubulointerstitial nephritis and uveitis syndrome)
• Nightmares
• 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 side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Lamotrigine Sandoz

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 packaging following the term "Exp". The expiry date refers to the last day of that month.
Store below 25°C.
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. Package contents and other information

What Lamotrigina Sandoz dispersible tablets contain
The active substance is: lamotrigine. Each dispersible tablet contains 5 mg, 25 mg, 50 mg, 100 mg or 200 mg of lamotrigine.
The other components are: Calcium carbonate, Sorbitol, Microcrystalline cellulose, Crospovidone, Maize starch, Talc, Blackcurrant flavour, 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 pack of 28 tablets
25 mg dispersible tablets - blister pack of 28 tablets
25 mg dispersible tablets - starter pack for adjunctive therapy with valproate, blister pack of 21 tablets
25 mg dispersible tablets - starter pack for monotherapy, blister pack of 42 tablets
50 mg dispersible tablets - blister pack of 56 tablets
50 mg dispersible tablets - starter pack for adjunctive therapy without valproate, blister pack of 42 tablets
100 mg dispersible tablets - blister pack of 56 tablets
200 mg dispersible tablets - blister pack of 56 tablets

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
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)