Priadel 520mg/5ml liquid

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lithium citrate

Available from:

Essential Pharma M

ATC code:

N05AN01

INN (International Name):

Lithium citrate

Dosage:

104mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020300; GTIN: 5013003900357

Patient Information leaflet

Découpe
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PRIADEL 520MG/5ML LIQUID
Lithium Citrate
Is this leafl et hard to see or read?
Phone [phone] for help
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
• Keep this leafl et. 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 the
same as yours.
• If you get any side eff ects, talk to your doctor or pharmacist.
This
includes any possible side eff ects not listed in this leafl et. See
section 4.
WHAT IS IN THIS LEAFL ET
1. What Priadel is and what it is used for
2. What you need to know before you take Priadel
3. How to take Priadel
4. Possible side eff ects
5. How to store Priadel
6. Contents of the pack and other information
1. WHAT PRIADEL IS AND WHAT IT IS USED FOR
Priadel Liquid contains a medicine called lithium. This belongs to
a group of medicines called mood stabilisers. It works by stabilising
the levels of chemicals in your brain that aff ect your mood.
Priadel can be used to manage or control:
• Mania (feeling highly excited, being over-active and easily
irritated
or distracted).
• Hypo-mania (similar to mania, but less severe).
• Repeated periods of depression, where treatment with other
medicines has not worked.
• Aggressive or self-harming behaviour.
It is also used to help prevent bipolar depression - where the
mood changes between feeling very high (mania) and very low
(depression).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIADEL
DO NOT TAKE PRIADEL IF:
✕ You are allergic (hypersensitive) to lithium citrate or any
of the other ingredients of Priadel (see Section 6: Further
information).
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
✕ You are breast-feeding.
✕ You have heart disease.
✕ Yo

Summary of Product characteristics

OBJECT 1
PRIADEL 520MG/5ML LIQUID
Summary of Product Characteristics Updated 01-Feb-2018 | SANOFI
1. Name of the medicinal product
Priadel 520mg/5ml Liquid.
2. Qualitative and quantitative composition
Each 5ml contains 520mg of the active substance lithium citrate
equivalent to 204mg lithium carbonate.
Also contains 211mg of ethanol 96%.
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Syrup
Clear, colourless, pineapple flavoured, sugar free syrup.
4. Clinical particulars
4.1 Therapeutic indications
1. In the management of acute manic or hypomanic episodes.
2. In the management of episodes of recurrent depressive disorders
where treatment with other
antidepressants has been unsuccessful.
3. In the prophylaxis against bipolar affective disorders.
4. Control of aggressive behaviour or intentional self-harm.
4.2 Posology and method of administration
Dosage must be individualised depending on serum lithium levels and
clinical response. The dosage
necessary to maintain serum lithium levels within the therapeutic
range varies from patient to patient. The
minimum effective dose should be sought and maintained.
As a general rule, the following dosing schedule is recommended.
Please refer also to the specific
recommendations for the different indications as listed below:
1. In patients of average weight (70kg) an initial daily dose of
10-30ml Priadel Liquid (equivalent to 408-
1224mg lithium carbonate) should be given in divided doses, ideally
twice a day. When changing
between lithium preparations serum lithium levels should first be
checked, then Priadel Liquid therapy
started at a daily dose as close as possible to the dose of the other
form of lithium. As bioavailability
varies from product to product (particularly with regard to slow
release preparations) a change of product
should be regarded as initiation of new treatment.
2. Four to a maximum of seven days after starting treatment, serum
lithium levels should be measured.
Optimal maintenance serum levels may vary from patient to patient.
3. Bl