Lamotrigine 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lamotrigine

Available from:

Milpharm Ltd

ATC code:

N03AX09

INN (International Name):

Lamotrigine

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 8901175005970

Patient Information leaflet

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 further questions, ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
same as yours.
-
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4..
WHAT IS IN THIS LEAFLET:
1.
What Lamotrigine Milpharm is and what it is used for
2.
What you need to know before you take Lamotrigine Milpharm
3.
How to take Lamotrigine Milpharm
4.
Possible side effects
5.
How to store Lamotrigine Milpharm
6.
Contents of the pack and other information
1.
WHAT LAMOTRIGINE MILPHARM IS AND WHAT IT IS USED FOR
Lamotrigine Milpharm belongs to a group of medicines called anti-
epileptics. It is used to treat two conditions – EPILEPSY and
BIPOLAR
DISORDER.
LAMOTRIGINE MILPHARM TREATS EPILEPSY by blocking the signals in
the brain that trigger epileptic seizures (fits).
•
For adults and children aged 13 years and over, Lamotrigine
Milpharm can be used on its own or with other medicines, to
treat epilepsy. Lamotrigine Milpharm can also be used with
other medicines to treat the seizures that occur with a condition
called Lennox-Gastaut syndrome.
•
For children aged between 2 and 12 years, Lamotrigine
Milpharm can be used with other medicines, to treat those
conditions. It can be used on its own to treat a type of epilepsy
called typical absence seizures.
LAMOTRIGINE MILPHARM ALSO TREATS BIPOLAR DISORDER.
People with bipolar disorder (sometimes called _manic depression_)
have extreme mood swings, with periods of mania (excitement or
euphoria) alternating with periods of depression (deep sadness or
despair). For adults aged 18 years and over, Lamotrigine Milpharm
can be used on its own or with other medicines, to prevent the
periods of depression that occ

Summary of Product characteristics

OBJECT 1
Lamotrigine 100 mg tablets
Summary of Product Characteristics Updated 11-Oct-2021 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Lamotrigine Milpharm 100 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 100 mg lamotrigine.
Excipients with known effect:
Lactose: 76mg
Sunset yellow aluminium lake: 0.2mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet.
Peach coloured, mottled, shield shaped uncoated tablets debossed with
'D' and '94'on one side and
scoreline on the other side.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Epilepsy:
Adults and adolescents aged 13 years and above
• Adjunctive or monotherapy treatment of partial seizures and
generalized seizures, including tonic-clonic
seizures.
• Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is
given as an adjunctive therapy but
may be the initial antiepil