Lamotrigine 100mg dispersible tablets sugar free

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
12-06-2018
Tabia za bidhaa Tabia za bidhaa (SPC)
12-06-2018

Viambatanisho vya kazi:

Lamotrigine

Inapatikana kutoka:

Actavis UK Ltd

ATC kanuni:

N03AX09

INN (Jina la Kimataifa):

Lamotrigine

Kipimo:

100mg

Dawa fomu:

Dispersible tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04080100; GTIN: 5012617015600

Taarifa za kipeperushi

                                AAAH7370
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Lamotrigine 5mg, 25mg & 100mg tablet leaflet - UK
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TECHNICAL APPROVAL
AAAH7370
2
05.03.15
jh
10.03.15
jh
Iceland
170 x 320
7
05.03.15
06.03.15
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• 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. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1 WHAT LAMOTRIGINE TABLETS IS AND WHAT IT IS USED FOR
2 BEFORE YOU TAKE LAMOTRIGINE TABLETS
3 HOW TO TAKE LAMOTRIGINE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE LAMOTRIGINE TABLETS
6
FURTHER INFORMATION
1 WHAT LAMOTRIGINE TABLETS IS AND WHAT IT IS USED FOR
Lamotrigine tablets belong to a group of medicines called
anti-epileptics. It is
used to treat two conditions - EPILEPSY and BIPOLAR DISORDER.
Lamotrigine tablets TREATS EPILEPSY by blocking the signals in the
brain that
trigger epileptic seizures (fits).
• For adults and children aged 13 years and over, Lamotrigine
tablets can be
used on its own or with other medicines, to treat epilepsy.
Lamotrigine tablets
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 tablets 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 tablets also TREATS BIPOLAR DISORDER.
People with bipolar disorder (sometimes called
                                
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Tabia za bidhaa

                                OBJECT 1
LAMOTRIGINE ACTAVIS 100MG DISPERSIBLE TABLETS
Summary of Product Characteristics Updated 04-Aug-2015 | Accord-UK Ltd
1. Name of the medicinal product
Lamotrigine Actavis 100mg Dispersible Tablets
2. Qualitative and quantitative composition
Each tablet contains lamotrigine 100mg
For excipients, see 6.1.
3. Pharmaceutical form
“Dispersible Tablet“
White or almost white, round, flat-faced, uncoated tablets with
“100“ marked on one side.
4. Clinical particulars
4.1 Therapeutic indications
Epilepsy
_Adults and adolescents aged 13 years and above_
− Adjunctive or monotherapy treatment of partial seizures and
generalised seizures, including tonic-clonic
seizures.
− Seizures associated with Lennox-Gastaut syndrome. Lamotrigine
Dispersible Tablets is given as
adjunctive therapy but may be the initial antiepileptic drug (AED) to
start with in Lennox-Gastaut
syndrome.
_Children and adolescents aged 2 to 12 years_
− Adjunctive treatment of partial seizures and generalised seizures,
including tonic-clonic seizures and
the seizures associated with Lennox-Gastaut syndrome.
− Monotherapy of typical absence seizures.
Bipolar disorder
_Adults aged 18 years and above_
− Prevention of depressive episodes in patients with bipolar I
disorder who experience predominantly
depressive episodes (see section 5.1).
Lamotrigine Dispersible Tablets is not indicated for the acute
treatment of manic or depressive episodes.
4.2 Posology and method of administration
Administration
Lamotrigine Dispersible Tablets may be chewed, dispersed in a small
volume of water (at least enough to
cover the tablet) or swallowed whole with a little water.
If the calculated dose of lamotrigine (for example for treatment of
children with epilepsy or patients with
hepatic impairment) does not equate to whole tablets, the dose to be
administered is that equal to the
lower number of whole tablets.
Restarting therapy
Prescribers should assess the need for escalation to maintenance dose
when restarting Lamotrigine
Dispersible Tablets in patients w
                                
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