Package leaflet: Information for the patient
Lamotrigin BMM Pharma 25 mg tablets
Lamotrigin BMM Pharma 50 mg tablets
Lamotrigin BMM Pharma 100 mg tablets
Lamotrigin BMM Pharma 200 mg tablets
Lamotrigine
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Read 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 further questions, ask your doctor or pharmacist
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any of the side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet, See section 4.
What is in this leaflet:
1. What Lamotrigin BMM Pharma is and what it is used for
2. What you need to know before you take Lamotrigin BMM Pharma
3. How to take Lamotrigin BMM Pharma
4. Possible side effects
5. How to store Lamotrigin BMM Pharma
6. Contents of the pack and other information
1. What Lamotrigin BMM Pharma is and what it is used for
Lamotrigin BMM Pharma is used to treat two different diseases: epilepsy and manic-depressive
(bipolar) disease.
Epilepsy
An epileptic seizure is a sudden, strong and short-lasting increase in the impulses between the brain’s nerve cells. Lamotrigin BMM Pharma works primarily by suppressing rapid repeated nerve discharges, so preventing epileptic seizures.
Manic-depressive (bipolar) disease
This disease is characterised by recurring episodes of depression, mania or hypomania, with long or short symptom-free periods. Lamotrigin BMM Pharma is used as a preventive therapy, against episodes of depression.
2. What you need to know before you take Lamotrigin BMM Pharma
Do not take Lamotrigin BMM Pharma:
- if you are allergic to lamotrigine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
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Talk to your doctor or pharmacist or nurse before taking Lamotrigin BMM Pharma
- if you are taking any other medication for epilepsy or manic-depressive (bipolar) disease, as the dose of Lamotrigin BMM Pharma is dependent on which other medicines you are using
(see “Using of other medicines”). if you have liver or kidney disease if you are allergic to or have experienced rash when taken other antiepileptic medicines.
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Important information about potentially life-threatening reactions
A small number of people taking Lamotrigin BMM Pharma get an allergic reaction or potentially lifethreatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking Lamotrigin BMM Pharma.
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Read the description of these symptoms in Section 4 of this leaflet under ‘Potentially lifethreatening reactions: get a doctor’s help straight away’.
Thoughts of harming yourself or suicide
A small number of people being treated with anti-epileptics such as lamotrigine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Discontinuation of treatment
In the case of epilepsy, sudden discontinuation of treatment can entail a risk of an increased number of seizures. Always therefore consult your doctor before making any changes to the dosage or discontinuing treatment.
Other medicines and Lamotrigin BMM Pharma:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because the dose of Lamotrigin BMM Pharma needs to be adjusted if you are taking certain other medicines, e.g. those containing valproate, carbamazepine, phenytoin, phenobarbital, primidone or rifampicin.
If you are being treated simultaneously with lamotrigine and medicines containing carbamazepine or oxcarbazepine, this may mean a higher incidence of some side-effects (see “Possible side-effects”).
Women who start or stop using contraceptive pills while undergoing treatment with Lamotrigin BMM
Pharma must tell their doctor about this, as the dose of Lamotrigin BMM Pharma may need to be adjusted.
Women who are being treated with Lamotrigin BMM Pharma and taking contraceptive pills at the same time should immediately report any changes in their menstrual bleeding pattern to their doctor.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine. One of the reasons for this is that an increased risk of cleft lip or palate correlated to the treatment of lamotrigine during the first months of the pregnancy has been reported in a study. Do not stop the treatment without talking to your doctor, since a sudden discontinuation of the treatment could lead to breakthrough seizures, which could be a risk for you and your child.
It is possible that breast-feeding infants may be affected. Therefore, do not use Lamotrigin BMM
Pharma while breast-feeding unless specifically prescribed by a doctor.
Driving and using machines:
Lamotrigin BMM Pharma can slow the reactions of some people, especially in combination with other medicines or following a change of dose. This should be borne in mind, e.g. when driving a car or operating machinery.
You yourself are responsible for deciding whether you are in a fit state to drive a motor vehicle or carry out work which requires particular concentration. One of the factors that can affect your ability in these respects is the use of medicines on account of their effects and/or side-effects. These effects and side-effects are described in other sections of this leaflet. You should therefore read all of the information in this leaflet for guidance. Talk to your doctor or pharmacist if you are uncertain.
Lamotrigin BMM Pharma contains lactose monohydrate:
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Lamotrigin BMM Pharma contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Lamotrigin BMM Pharma
The tablets are to be swallowed with water.
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The dose is lower at the start of treatment and is then gradually increased taking into account any other medication taken at the same time.
The usual dose is:
Dosage of Lamotrigin BMM Pharma when used on its own for treatment of epilepsy
Adults and children over 12 years old:
The usual starting dose is 25 mg once daily for 2 weeks, followed by 50 mg once daily for 2 weeks.
Your doctor may then increase the dose over a few weeks. The usual maintenance dose is 100-200 mg daily taken either as a single dose or as 2 divided doses. Some patients may require higher doses.
Dosage of Lamotrigin BMM Pharma when used on its own for treatment of manic-depressive
(bipolar) disease.
Adults from 18 years:
The usual starting dose is 25 mg once daily for 2 weeks, followed by 50 mg once daily or in 2 divided doses for 2 weeks. The dose is then increased to 100 mg once daily or in 2 divided doses for 1 week.
After 5 weeks, the usual maintenance dose is 200 mg daily taken either once daily or as 2 divided doses. Some patients may require higher or lower maintenance doses.
Dosage when used in combination with other medicines
Lamotrigin BMM Pharma is often used in combination with other medicines. In this case, the dose of lamotrigine may need to be adjusted. You should check with your doctor or pharmacist if you use
Lamotrigin BMM Pharma in combination with other medicines.
Children below 12 years of age
Lamotrigin BMM Pharma is not recommended for children below 12 years of age, because the product is not available in the appropriate strengths.
Elderly patients (over 65 years of age):
No dose adjustment from recommended schedule is required.
Patients with liver or kidney disease.
If you have liver or kidney disease, the dose of Lamotrigin BMM Pharma may need to be adjusted.
You should check with your doctor or pharmacist if you have liver or kidney disease.
If you take more Lamotrigin BMM Pharma than you should:
Immediately contact a doctor, the nearest hospital casualty department or the centre for poison information for advice.
Symptoms of overdosage are eye twitching, impaired movement coordination, impaired consciousness and coma.
If you forget to take Lamotrigin BMM Pharma:
Take the next tablet as soon as possible, but do not take double doses to compensate for the doses you have missed.
If you stop taking Lamotrigin BMM Pharma:
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Stopping your treatment with Lamotrigin BMM pharma may provoke seizures. Do not stop treatment with Lamotrigin BMM Pharma unless you have discussed this with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Potentially life-threatening reactions: get a doctor’s help straight away
A small number of people taking Lamotrigin BMM Pharma get an allergic reaction or potentially lifethreatening skin reaction, which may develop into more serious problems if they are not treated.
These symptoms are more likely to happen during the first few months of treatment with Lamotrigin
BMM Pharma, especially if the starting dose is too high or if the dose is increased too quickly, or if
Lamotrigin BMM Pharma is taken with another medicine called valproate. Some of the symptoms are more common in children, so parents should be especially careful to watch out for them.
Symptoms of these reactions include: skin rashes or redness, which may develop into life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals
(Stevens–Johnson syndrome), extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis) or extended rashes with liver, blood and other body organs involvement
(DRESS).
- ulcers in the mouth, throat, nose or genitals
- a sore mouth or red or swollen eyes (conjunctivitis)
- a high temperature (fever), flu-like symptoms or drowsiness
- swelling around your face, or swollen glands in your neck, armpit or groin
- unexpected bleeding or bruising, or the fingers turning blue
- a sore throat, or more infections (such as colds) than usual
- increased levels of liver enzymes seen in blood tests
- an increase in a type of white blood cell (eosinophils)
- enlarged lymph nodes
- involvement of the organs of the body including liver and kidneys.
In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially life-threatening and can develop into more serious problems, such as organ failure, if they are not treated. If you notice any of these symptoms:
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Contact a doctor immediately. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigin BMM Pharma. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine again.”
The side-effects below are divided up on the basis of reported side-effects in epilepsy and manicdepressive (bipolar) disease respectively.
Epilepsy
Very common : may affect more than 1 in 10 people
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Dizziness, headache
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Rash
Double vision, blurred vision
Common : may affect up to 1 in 10 people
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Drowsiness, weakness sleeplessness
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Unsteady walking, tremor
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Eye twitching
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Irritation
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Nausea, vomiting, diarrhoea
Uncommon : may affect up to 1 in 100 people
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Aggressiveness.
Rare : may affect up to 1 in 1,000 people
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Conjunctivitis
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A life-threatening skin reaction (Stevens–Johnson syndrome): (see also the information at the beginning of Section 4).
Very rare : may affect up to 1 in 10,000 people
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Agitation, unsteadiness, motor disturbances, changed pattern of movement, increased frequency of seizures
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Blood effects
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Liver affects
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Involuntary spasms, hallucinations, confusion
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Hypersensitivity reactionsA life-threatening skin reaction (toxic epidermal necrolysis): (see also the information at the beginning of Section 4)
In patients with Parkinson’s disease, worsening of Parkinson symptoms has been reported in very rare cases.
Manic-depressive (bipolar) disease
Very common : may affect more than 1 in 10 people
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Rash
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Headache
Common : may affect up to 1 in 10 people
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Dizziness, drowsiness, restlessness
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Pain
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Back and joint pain
Very rare : may affect up to 1 in 10,000 people
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A life-threatening skin reaction (Stevens–Johnson syndrome): (see also the information at the beginning of Section 4).
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A life-threatening skin reaction (toxic epidermal necrolysis): (see also the information at the beginning of Section 4)
Other side effects
Other side effects have occurred in a small number of people but their exact frequency is unknown:
A group of symptoms together including:
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Fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light.
This may be caused by an inflammation of the membranes that cover the brain and spinal cord
(meningitis).
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There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication long-term, have a history of osteoporosis, or take steroids.
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Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): (see also the information at the beginning of Section 4)
Reporting of side effects
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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lamotrigin BMM Pharma
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 and carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longeruse. These measures will help to protect the environment.
6. Contents of the pack and other information
What Lamotrigin BMM Pharma contains:
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The active substance is lamotrigine.
The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, yellow iron oxide (E 172), magnesium stearate and maize starch.
What Lamotrigin BMM Pharma looks like and contents of the pack:
Lamotrigin BMM Pharma 25 mg tablets are round yellow tablets marked “25” on one side and scored on the other. Size: 6 mm.
Lamotrigin BMM Pharma 50 mg tablets are round yellow tablets marked “50” on one side and scored on the other. Size: 8 mm.
Lamotrigin BMM Pharma 100 mg tablets are round yellow tablets marked “100” on one side and scored on the other. Size: 10 mm.
Lamotrigin BMM Pharma 200 mg tablets are yellow capsule-shaped biconvex tablets marked “200” on one side and smooth on the other. Size: 8x18 mm.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Pack sizes for Lamotrigin BMM Pharma 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 Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
BMM Pharma AB
Blasieholmsgatan 2
111 48 Stockholm
Sweden
Manufacturer
Bluefish Pharmaceuticals AB
Torsgatan 11
111 23 Stockholm
Sweden
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This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark:
Sweden:
This patient information leaflet was last revised in
2015-10-15
Lamotrigin BMM Pharma
Lamotrigin BMM Pharma
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