Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lamotrigine
Milpharm Ltd
N03AX09
Lamotrigine
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 8901175005963
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 Read the complete document
OBJECT 1 Lamotrigine 50 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 • 4.2 Posology and method of administration • 4.3 Contraindications • 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 • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Lamotrigine Milpharm 50 mg tablets 2. Qualitative and quantitative composition Each tablet contains 50 mg lamotrigine. Excipient with known effect: Lactose: 38mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. White to off white coloured, rounded square uncoated tablets debossed with 'D' on multifaceted side and '97' on the flat 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 generalized seizures, including tonic-clonic seizures. • Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given as an adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaout syndrome. Children and adolescent Read the complete document