Lamotrigine Bluefish - Lamotrigine uses, dose and side effects

For adults and children 13 years of age and older, Lamotrigine Bluefish can be used alone or in combination with other medicines to treat epilepsy . Lamotrigine Bluefish can also be used with other medicines to treat the seizures that occur in a condition called Lennox-Gastaut syndrome.
For children between the ages of 2 and 12, Lamotrigine Bluefish can be used with other medicines to treat these conditions. It can be used as the sole treatment to treat a type of epilepsy called typical absences.

Lamotrigine Bluefish also treats bipolar disorder

People with bipolar disorder (sometimes referred to as manic depression ) experience very sharp mood swings with periods of mania (excitement or rush of happiness) alternating with periods of depression (deep sadness or despair). For adults 18 years of age and older, Lamotrigine Bluefish can be used alone or in combination with other medicines to prevent the depressive episodes that occur in bipolar disorder. It is not yet known how Lamotrigine Bluefish works in the brain to have this effect.

What you need to know before you take Lamotrigine Bluefish

Do not take Lamotrigine Bluefish

if you are allergic 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 Lamotrigine Bluefish.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Lamotrigine Bluefish

if you have liver or kidney problems.
if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy , or if you get a rash or get burnt when you take lamotrigine and have been in the sun or artificial light (eg solarium). Your doctor will monitor your treatment and may recommend that you avoid sunlight or protect your skin from the sun’s rays (eg with sunscreen and / or protective clothing).
if you have ever developed meningitis ( meningitis ) after you’ve taken lamotrigine ( read the description of the symptoms in Section 4 of this leaflet: Rare side effect s )
if you are already taking medicines containing lamotrigine.

If any of this applies to you:

Tell your doctor who may decide that your dose needs to be reduced or that Lamotrigine Bluefish is not suitable for you.

Important information about possible life-threatening reactions

A small number of people taking Lamotrigine Bluefish have an allergic reaction or a skin reaction that can be life-threatening and develop into more serious problems if left untreated. These may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to know the symptoms that you should be aware of while taking Lamotrigine Bluefish.

Read the description of these symptoms in section 4 of this leaflet under “Possible life-threatening reactions: contact a doctor immediately”.

Thoughts of harming yourself or suicide

Antiepileptic drugs are used to treat various 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 such thoughts:

when you start treatment
if you have previously had thoughts of harming yourself or committing suicide
if you are under 25 years of age.

If you have worrying thoughts or experiences or if you notice that you feel worse or develop new symptoms while taking Lamotrigine Bluefish:

Contact a doctor as soon as possible or see your nearest hospital for help.It may be helpful to tell a family member, caregiver, or close friend that you may be depressed or have noticeable changes in your mood, and ask them to read this leaflet. You can ask them to tell you if they are worried about your depression or other changes in your behavior.

A small number of people treated with antiepileptic drugs such as lamotrigine have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.

If you are taking Lamotrigine Bluefish for epilepsy

Seizures in certain types of epilepsy can sometimes get worse or occur more often while you are taking Lamotrigine Bluefish. Some patients may experience severe seizures that can cause serious health problems. If your seizures occur more often or if you experience a severe seizure while taking Lamotrigine Bluefish:

Contact a doctor as soon as possible.

Lamotrigine Bluefish should not be given to people under 18 years of age for the treatment of a bipolar disorder.

Drugs for the treatment of depression and other mental health problems increase the risk of suicidal thoughts and suicidal behavior in children and adolescents under 18 years of age.

Brugada syndrome

Brugada’s syndrome is a genetic disease that leads to abnormal electrical activity in the heart. ECG abnormalities that can lead to arrhythmias (abnormal heart rhythms) can be triggered by lamotrigine. Talk to your doctor if you have this disease.

Hemophagocytic syndrome (HLH)

There have been reports of a rare but very severe reaction in the immune system in patients taking lamotrigine. Contact a doctor or pharmacist immediately if you experience any of the following symptoms: fever, rash, neurological symptoms (eg tremors or tremors, confused state, disorders of brain function).

Other medicines and Lamotrigine Bluefish

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.

Your doctor needs to know if you are taking any other medicines to treat epilepsy or mental health problems. This is to ensure that you take the correct dose of Lamotrigine Bluefish. 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.
Tell your doctor if you are taking any of these.

Some medicines affect Lamotrigine Bluefish or make you more likely to get side effects. 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 which is an antibiotic
medicines used to treat HIV (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
hormonal contraceptives such as birth control pills (see below).
Tell your doctor if you are taking or are starting or stopping any of these.

Hormonal contraceptives (eg birth control pills ) can affect the way Lamotrigine Bluefish works

Your doctor may recommend that you use a special type of hormonal contraceptive or another method of contraception such as a condom, diaphragm, or IUD. If you are using a hormonal contraceptive such as a contraceptive pill, your doctor may take a blood test to check the level of Lamotrigine Bluefish. If you are using or planning to start using hormonal contraceptives:

Tell your doctor who discusses appropriate contraceptive methods with you.

Lamotrigine Bluefish can also affect the way hormonal contraceptives work, although they are unlikely to be less effective. If you use a hormonal contraceptive and notice any change in your menstrual cycle such as menstrual-like bleeding or spotting between menstruations:

Tell your doctor. This may be a sign that Lamotrigine Bluefish is affecting the way your contraceptive works.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant or if you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not end your treatment without discussing it with your doctor. This is especially important if you have epilepsy .
Pregnancy may change the effectiveness of Lamotrigine Bluefish, so you may need to take blood samples and your dose of Lamotrigine Bluefish may need to be changed.
There may be a small increased risk of fetal malformations, including cleft lip or palate , if Lamotrigine Bluefish is taken during the first three months of pregnancy.
Your doctor may advise you to take extra folic acid if you are planning to become pregnant and while you are pregnant.
If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine. The active substance in Lamotrigine Bluefish is excreted in human milk and may affect the baby. Your doctor will discuss the risks and benefits of breast-feeding during treatment with lamotrigine. If you choose to breast-feed, the doctor will check the baby from time to time to see if the baby is drowsy, rash or poor weight gain. Tell your doctor if you notice any of these symptoms in your child.

Driving and using machines

Lamotrigine Bluefish may cause dizziness and double vision.

Do not drive or use any tools or machines unless you feel comfortable.

If you have epilepsy, talk to your doctor about driving and using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Lamotrigine Bluefish contains lactose and sodium

Lamotrigine Bluefish contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.

How to take Lamotrigine Bluefish

The tablets should be swallowed with water.

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much Lamotrigine Bluefish to take

It may take a while to find the dose of Lamotrigine Bluefish that is best for you. The dose you take depends on:

your age
whether or not you are taking Lamotrigine Bluefish with other medicines
if you have any problems with your kidneys or liver.

Your doctor will start you on a low dose and increase the dose gradually over a few weeks until you reach a dose that works for you (called the effective dose of one ). Never take more Lamotrigine Bluefish than your doctor has told you to.

The usual effective dose of Lamotrigine Bluefish for adults and children from 13 years of age is between 100 mg and 400 mg daily.

For children between 2 and 12 years of age, the effective dose depends on one’s body weight – usually between 1 mg and 15 mg for each kilogram of the child’s weight up to a maintenance dose of no more than 200 mg daily.

Lamotrigine Bluefish is not recommended for children under 2 years of age.

How to take your dose of Lamotrigine Bluefish

Take your dose of Lamotrigine Bluefish once or twice daily according to your doctor’s instructions. It can be taken with or without food.

Your doctor may also tell you to start or stop taking other medicines, depending on the condition you are being treated for and how you are reacting to the treatment.

Swallow the tablets whole . You must not divide, chew or crush them.
Always take the full dose prescribed by your doctor. Never take just one part of a tablet.

The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.

If you take more Lamotrigine Bluefish than you should

If you have ingested too much medicine or if e.g. a child accidentally ingested the drug:

Contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice. Show them the Lamotrigine Bluefish package if possible.

If you take too much Lamotrigine Bluefish you are more likely to get serious side effects that can be life-threatening.

A person who has taken too much Lamotrigine Bluefish may experience any of these symptoms:

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

If you forget to take Lamotrigine Bluefish

Do not take extra tablets to compensate for a missed dose . Just take your next dose at the usual time.

If you forget to take multiple doses of Lamotrigine Bluefish

Ask your doctor how to start taking the medicine again. It is important that you ask about this.

Do not stop taking Lamotrigine Bluefish without consulting your doctor

Lamotrigine Bluefish must be taken for as long as your doctor recommends it. Do not stop without your doctor telling you to.

If you are taking Lamotrigine Bluefish for epilepsy

To stop taking Lamotrigine Bluefish is important to dose a reduced gradually over about

2 weeks. If you suddenly stop taking Lamotrigine Bluefish, your epilepsy may return or worsen.

If you are taking Lamotrigine Bluefish for bipolar disorder

It may take time for Lamotrigine Bluefish to work and therefore you will probably not feel better right away. If you stop taking Lamotrigine Bluefish, your dose does not need to be reduced gradually. However, you should still talk to your doctor first, if you want to stop taking Lamotrigine Bluefish.

Possible side effects

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

Possible life-threatening reactions: contact a doctor immediately

A small number of people taking Lamotrigine Bluefish have an allergic reaction or a skin reaction that can be serious and develop into more serious life-threatening problems if left untreated.

You are most likely to get these symptoms during the first months of treatment with Lamotrigine Bluefish, especially if you start with too high a dose or if your dose is increased too fast, or if you take Lamotrigine Bluefish with another medicine called valproate. Some symptoms are more common in children, so parents should pay extra attention.

Symptoms of such reactions include:

skin rash or redness , which can develop into life-threatening skin reactions that include widespread rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), extensive flaking of the skin (more than 30% of body surface area – toxic epidermal necrolysis ) or extensive skin rash affecting the liver, blood and other body organs (drug reaction with eosinophilia and systemic symptoms, also known as hypersensitivity syndrome [DRESS])
sores in the mouth, throat, nose or abdomen
sore mouth or red swollen eyes ( conjunctivitis )
fever, flu-like symptoms or drowsiness
swelling around the face or swollen glands in the neck, armpits or groin
unexpected bleeding or bruising or that the fingers turn blue
sore throat or more infection (for example, colds) than usual
elevated liver enzyme levels in blood tests
an increase in a kind of white blood cell ( eosinophils )
enlarged lymph nodes
effects on body organs, extensive liver and kidneys

In many cases, these symptoms are signs of less serious side effects. But you need to be aware that they can be potentially life-threatening and lead to more serious problems, such as organ failure if left untreated. So if you notice any of these symptoms:

Contact a doctor immediately. Your doctor may decide to take samples of your liver, kidneys or blood and may tell you to stop taking Lamotrigine Bluefish. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis , your doctor will tell you to never use lamotrigine again.

Very common side effects are

May affect more than 1 user in 10:
headache
rash

Common side effects are

May affect up to 1 in 10 users

aggression or irritability
drowsiness or drowsiness
dizziness
tremors or tremors
sleep disorders ( insomnia )
feelings of upset
diarrhea
dry mouth
nausea, vomiting
fatigue
back or joint pain or elsewhere.

Uncommon side effects are

May affect up to 1 in 100 users

clumsiness and lack of coordination ( ataxia )
double vision or blurred vision
abnormal hair loss or thinning ( alopecia )
skin rash or sun damage after exposure to sun or artificial light ( photosensitivity )

Rare side effects are

May affect up to 1 in 1000 users

a life-threatening skin reaction ( Stevens-Johnson syndrome ): (see also information at the beginning of section 4)
a group of symptoms that include: fever, nausea, vomiting, headache, neck stiffness and extreme sensitivity to bright light. This may be due to an inflammation of the membrane that protects the brain and spine ( meningitis ). These symptoms usually go away when treatment is stopped. Contact your doctor if symptoms persist or worsen.
rapid, uncontrolled eye movements ( nystagmus )
itching of the eyes with secretions and crusts on the eyelids ( conjunctivitis ).

Very rare side effect s

May affect up to 1 in 10,000 users

a life-threatening skin reaction ( toxic epidermal necrolysis ): see also information at the beginning of section 4
drug reaction with eosinophilia and systemic symptoms (DRESS): (see also information at the beginning of section 4)
elevated temperature (fever): (see also information at the beginning of section 4)
swelling around the face ( edema ) or swollen glands in the neck, armpit or groin ( lymphadenopathy ): (see also information at the beginning of section 4)
changes in liver function, as evidenced by blood tests, or liver failure: (see also information at the beginning of section 4)
a severe disorder of blood coagulation that may cause unexpected bleeding or bruising (disseminated intravascular coagulation ): (see also information at the beginning of section 4)
changes that can be seen in blood samples – including decreased red blood cell count ( anemia ), decreased white blood cell count ( leukopenia , neutropenia , agranulocytosis ) , decreased platelet count ( thrombocytopenia ) , decreased number of all these blood cell types (pancytopenia) and a disease in bone marrow one called aplastic anemia
hallucinations (to “see” or “hear” things that do not really exist)
confusion
feeling of “wobbling” or being unsteady when you move
uncontrollable body movements ( tics ) , uncontrollable muscle spasms that affect the eyes, head and torso (choreoatetosis) or other unusual body movements such as twitching, shaking or stiffness
more common seizures in those who already have epilepsy
worsening symptoms in those who already have Parkinson’s disease
lupus-like reaction (symptoms may include: back or joint pain which may sometimes be accompanied by fever and / or general illness).
Haemophagocytic syndrome (HLH) (see section 2 What you need to know before taking lamotrigine).

Additional side effects are

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

There have been reports of skeletal effects including osteopenia and osteoporosis (thinning of the skeletal bone) and bone 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.
Impaired immune system due to lower levels of immunoglobulins , a type of blood cell that helps protect against infection .

How to store Lamotrigine Bluefish

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 carton after EXP. The expiration date is the last day of the specified month.

Lamotrigine Bluefish has no special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of lamotrigine.
The other ingredients are lactose monohydrate , microcrystalline cellulose, sodium starch glycolate , yellow iron oxide (E 172), magnesium stearate and maize starch.

What the medicine looks like and contents of the pack

Lamotrigine Bluefish 25 mg tablets are yellow round tablets marked with “25” on one side and with a notch on the other side. Size: 6 mm.

Lamotrigine Bluefish 50 mg tablets are yellow round tablets marked with “50” on one side and with a notch on the other side. Size: 8 mm.

Lamotrigine Bluefish 100 mg tablets are yellow round tablets marked with “100” on one side and with a notch on the other side. Size: 10 mm.

Lamotrigine Bluefish 200 mg tablets are yellow capsule-shaped biconvex tablets marked with “200” on one side and glossy on the other. Size: 8×18 mm.

Pack sizes for Lamotrigine Bluefish 25 mg, 50 mg, 100 mg and 200 mg:

10, 21, 28, 30, 42, 50, 56, 60, 98, 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

PO Box 49013

100 28 Stockholm

Sweden

Manufacturer