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PRIADEL 520MG/5ML LIQUID

Active substance(s): LITHIUM CITRATE

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LIQUID MANUFACTURING

Packaging code : 302234
Old packaging code : 301800

Format : 157x315-PL4P10V
Plant barcode : 234

Update : 15/06/2015 - V4

Colors :
Pantone Reflex Blue

Product : PRIADEL LIQUID
15,6G/150ML GB
Packaging type :

Fonts : Ocean Sans Pro SAN

Country : UK
Languages : EN

Min font size used : 8 pt

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Priadel 520mg/5ml Liquid
Lithium Citrate
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
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 the
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 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 effects
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 affect 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
✕ You have severe kidney problems
✕ You have an under-active thyroid gland that is not being
treated
✕ You have low levels of sodium in your body. This can happen if
you are dehydrated or on a low sodium diet
✕ You have an illness called ‘Addison’s disease’. This happens
when your body does not produce enough hormones. This
makes you feel tired, weak, light-headed and makes areas of
your skin go darker
✕ You have a rare condition called Brugada syndrome, or if
anyone in your family has had Brugada syndrome. This is
an abnormal condition of the heart that can make it stop
beating.
Do not take this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking Priadel.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Priadel if:
You have a cold or flu
You have gastroenteritis. This is when you have a problem
with your stomach or gut. Signs include diarrhoea, stomach
pain, being sick, headache, fever and chills
You have any urinary problems such as infections
You are elderly
You are not eating or drinking properly
You have kidney problems
You are taking medicines to treat epilepsy
You have heart problems
You are about to receive anaesthetics
Kidney tumours: Patients with severe kidney impairment who
received lithium for more than 10 years may have a risk of
developing a benign or malignant kidney tumour (microcysts,
oncocytoma or collecting duct renal carcinoma).
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Priadel.
Other medicines and Priadel
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines you
buy without a prescription, including herbal medicines. This is
because Priadel can affect the way some other medicines work.
Also, some medicines can affect the way Priadel works as this can
affect the levels of lithium in your blood.
In particular, check with your doctor if you are taking any of the
following:
• Any other medicines containing lithium
• Medicines used for infections (antibiotics) - such as metronidazole,
erythromycin, doxycycline or oxytetracycline

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• Steroids - used for inflammation and allergies (such as
prednisolone, betamethasone or hydrocortisone)
• Theophylline - used for wheezing or difficulty in breathing
• Caffeine found in some medicines for pain relief that you buy
without a prescription
• Water tablets (diuretics) - such as furosemide, chlortalidone,
indapamide, spironolactone or xipamide
• Urea - used in some creams that soften and moisturise the skin
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used to treat
pain relief and swelling (such as aspirin, ibuprofen, indomethacin
or diclofenac)
• Medicines used for heart problems or high blood pressure - such
as enalapril, lisinopril or ramipril (ACE inhibitors)
• Medicines used to control your heart beat – such as qunidine,
disopyramide, procainamide, amiodarone and sotalol
• Losartan candesartan, irbesartan (called ‘angiotensin II receptor
antagonists’)
• Some medicines for indigestion and heartburn (antacids) - such as
sodium bicarbonate and cisapride
• Calcitonin – used for hypercalcaemia and Paget’s disease/acute
bone loss
The following medicines can increase the chance of side
effects when taken with Priadel. Tell your doctor if you are
taking any of the following before taking Priadel:
• Some medicines used for depression (SSRIs), tricyclics and triptans
derivatives - such as fluvoxamine, paroxetine or fluoxetine
• Medicines used to calm emotional and mental illnesses - such as
haloperidol, flupentixol, diazepam, thioridazine , amisulpride,
fluphenazine, chlorpromazine or clozapine. Coadministration
with Priadel may increase the risk of a serious but rare side effect
called 'neuroleptic malignant syndrome', which may be fatal
• Methyldopa used for high blood pressure
• Some medicines used for fits (epilepsy) - such as carbamazepine
or phenytoin
• Medicines used for chest pain (angina) or high blood
pressure - such as diltiazem or verapamil
Priadel with food and drink
Your diet and the amount of fluid you drink while taking Priadel
is very important (see section 3 below ‘Diet, food and drink while
taking Priadel).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Information for women who could become pregnant
• Talk to your doctor before taking this medicine if you plan
to get pregnant, or think you may be pregnant. It is very
important that you talk to your doctor about your treatment
well before you become pregnant
• You should use an effective method of contraception while
taking Priadel
Information for women who are pregnant
• If you find out you are pregnant while taking Priadel, tell your
doctor straight away
• Do not take Priadel if you are pregnant, especially in the first
3 months of your pregnancy
If your doctor decides that you should have Priadel while you
are pregnant, he or she will:
• Keep a close eye on the level of lithium in your blood.
This is because your kidneys work differently while you are
pregnant
• Arrange for appropriate tests before your baby is born
If it is decided you should have Priadel during late pregnancy
or during labour, your baby may appear ‘floppy’. This returns to
normal without any treatment.
Breast-feeding
• Do not breast-feed if you are taking Priadel. This is because
small amounts may pass into the mother’s milk
Driving and using machines
Do not drive or use any tools or machines if you feel sleepy, tired
or dizzy. Priadel may also cause other effects that can make it
dangerous to drive or use tools and machines such as numbness,
paralysis, weakness or fits (seizures).
Important information about some of the ingredients of
Priadel
Priadel contains 5% ethanol (alcohol) by volume. A 30 ml dose
of this medicine contains 1266mg of ethanol, this is about the
same amount of alcohol as 30ml of beer or 12.5ml of wine. This
can be harmful for those suffering from alcoholism. It should
also be taken into account in pregnant or breast-feeding women
and high risk-groups such as patients with liver disease or fits
(epilepsy).
3. How to take Priadel
Always take Priadel exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Diet, food and drink while taking Priadel
The amount you eat and drink is very important as it can affect the
levels of Priadel in your blood.
• Drink the same amount of fluids every day while taking Priadel.
In hot environments or if you are dehydrated, you may need to
drink extra fluids
• Have a normal balanced diet while taking Priadel. Do not
change your diet without talking to your doctor first
How to take your medicine
• Take this medicine by mouth
• Take your medicine at the same times every day
• Take in two separate doses – half in the morning and half in
the evening
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your
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doctor
Over
1

302234 - 234

Graphic designer : CR - CD
Plant : Colomiers

LIQUID MANUFACTURING

Packaging code : 302234
Old packaging code : 301800

Format : 157x315-PL4P10V
Plant barcode : 234

Update : 15/06/2015 - V4

Colors :
Pantone Reflex Blue

Product : PRIADEL LIQUID
15,6G/150ML GB
Packaging type :

Fonts : Ocean Sans Pro SAN

Country : UK
Languages : EN

Min font size used : 8 pt

Adults weighing about 70kg
• The usual starting dose is between 10ml and 30ml (two to six
5ml spoonfuls) each day
Elderly and adults weighing under 50kg
• The usual starting dose is between 5ml and 10ml (one to two
5ml spoonfuls) each day
• Your doctor may decide to increase this dose by another one
or two 5ml spoonfuls every 3 to 5 days. Increasing the dose is
usual, but do not do this unless your doctor tells you to
• In some cases your doctor may increase your dose up to 45ml
(nine 5ml spoonfuls) each day
Use in children
Priadel is not recommended for children and adolescents.
Patients with kidney problems
Your doctor will monitor the level of lithium in your blood and
adjust your dose accordingly. You should not take Priadel if you
have severe kidney problems (see section 2).
Blood tests
• Within the first week of treatment your doctor will give you a
blood test. This is to check the level of lithium in your blood
• Your daily dose will be changed depending on the results of your
blood test
• Your doctor will carry out a blood test every week until the level
of lithium in your blood is steady
• You will then have your blood tested every 3 months to
check that the level remains steady
If you are going to have other types of blood test, tell the doctor or
nurse that you are taking lithium.
If you take more Priadel than you should
If you or someone else has taken more Priadel Liquid than you
should, talk to a doctor or go to your nearest hospital casualty
department straight away. Remember to take the medicine pack
with you. This is so the doctor knows what you have taken.
The following effects may happen: feeling sick or being sick, blurred
vision, increased need to pass water, lack of control over passing
water or stools, feeling lightheaded or drowsy, confusion and
blackouts. You may also experience shaking or muscle weakness,
muscle twitches and jerks or spasms causing unusual movements
of the face, tongue, eyes or neck. In severe cases you may lose
consciousness, have fits, shortness of breath or chest pain.
If you forget to take Priadel
If you forget to take a dose at the right time, take it as soon as you
remember, then go on as before. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Priadel
Keep taking your medicine until your doctor tells you to stop. Do
not stop taking Priadel just because you feel better. If you stop, your
illness may return.
When your doctor says that you can stop taking Priadel, your dose
will be lowered gradually. Your doctor will help you to do this.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Priadel can cause side effects, although not
everybody gets them. Side effects are more likely to happen at the
start of treatment.
Allergic reactions
If you have an allergic reaction, stop taking Priadel and see a doctor
or go to a hospital straight away. The signs may include: rash,
swallowing or breathing problems, swelling of your lips, face, throat
or tongue.
Stop taking Priadel and see your doctor or go to a hospital
straight away if you notice a combination of any of the
following serious side effects:
The following side effects may be signs of lithium toxicity
(too much lithium in your blood):
• Loss of appetite, diarrhoea and vomiting (being sick)
• Muscle weakness, lack of co-ordination, muscle twitching or
sudden jerks and shaking
• Feeling drowsy or very tired, balance problems and feeling
dizzy with a spinning sensation (vertigo)
• Difficulty in walking or unusual involuntary movements, such
as unusual eye movements
• Ringing in the ears (tinnitus) or blurred vision
• Difficulty in speaking or slurred speech
• Altered mental state due to brain disease, damage or
malfunction (encephalopathy)
Other serious side effects which need urgent medical
attention:
• Swelling around the feet and ankles, face and stomach and
weight gain due to water retention
• Cloudy or foamy urine (water)
• Feeling confused, dazed, delirious or loss of consciousness
• Memory problems
• Fits (seizures)
• Irregular or slow heart beats, shortness of breath, chest pain
and fainting
• Involuntary eye movements
• Abnormal muscle breakdown (rhabdomyolysis) which can
lead to kidney problems
Frequency unknown:
• Benign/malignant kidney tumours (microcysts, oncocytoma,
or collecting duct renal carcinoma) (in long-term therapy)
Tell a doctor or pharmacist straight away if you notice any of
the following serious side effects:
• Increased thirst and passing water (urine) more often than
normal. You may also feel tired and hungry. This could be due to
high blood sugar levels or a condition called ‘diabetes insipidus’.
It is important to tell your doctor if you are passing more water
than usual as the amount of Priadel you are taking may need to
be changed
• You have a swelling or a lump on your neck (which may be

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caused by an enlarged thyroid gland)
• You have a fast heartbeat, sweating, stress (anxiety),
increased appetite, loss of weight, weakness and are unable
to tolerate heat. This could be due to higher levels of thyroid
hormone in the blood (hyperthyroidism)
• You feel tired, have cold skin and hair becomes dry, thinning
of hair or fingernails, hoarse voice, joint or muscle pain and
gain weight. This could be due to lower levels of thyroid
hormone in the blood (hypothyroidism)
• You have increased thirst, pass more water than usual, feel tired
or depressed, muscle aches or pains, bone or joint pain and
stomach upsets. This could be due to a hormone problem called
‘hyperparathyroidism’
• You have indigestion or heartburn and are feeling sick, being
sick or have abdominal pain. You may also have black tarry
stools (faeces) or blood in your stools or you may notice blood
or dark bits (like coffee grounds) when you are being sick. This
could be due to a stomach problem called ‘gastritis’
• Headaches, a ‘rushing’ sound in your ears and feeling or being
sick. This could be because of increased pressure in the brain
• Numbness, weakness and pain in the arms and legs (peripheral
neuropathy)
Tell your doctor or pharmacist if any of the following
side effects gets serious or lasts longer than a few
days:
• Hair loss or inflamed hair follicles
• Acne, skin spots or rashes, skin ulcers and/or itching
• Slight shaking of the hands
• You have skin irritation and swelling. Skin may appear red, itchy
with silvery scales (psoriasis). If you already have this condition,
you could notice that it is getting worse
• Feeling sick, a watery or dry mouth and/or changes in the way
things taste
• Stomach pain
• Sexual problems including being unable to get an erection,
having delayed ejaculation or being unable to have an orgasm
• Blurred vision or blind spots in your eyesight
• Uncontrolled movements of the eye
• Weight gain
Tests
Blood tests may show an increase in white blood cells (leucocytosis)
or changes in the way the kidney is working. They may also show
changes in the levels of calcium or magnesium in your blood.
A test on your heart may show changes in the way your heart is
working.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Priadel
• Keep out of the reach and sight of children
• Do not use Priadel after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that
month
• Store below 25˚C. Keep in the outer carton in order to protect
from light.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines
no longer required. These measures will help to protect the
environment
6. Contents of the pack and other information
What Priadel contains
• Each 5ml of the syrup contains 520mg of lithium citrate which
is equivalent to 204mg of the active substance, lithium
carbonate
• The other ingredients are: ethanol, xanthan gum, saccharin
sodium, sorbic acid, citric acid, pineapple flavour, water
What Priadel looks like and contents of the pack
• Priadel is a clear, colourless syrup
• Priadel is available in an amber glass bottle fitted with a screw cap
• Priadel is supplied in bottles of 150ml and 300ml. Not all pack
sizes are marketed.
• Priadel Liquid is supplied with a 2.5/5ml double ended spoon
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS , UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Unither Liquid Manufacturing, Zone Industrielle d’En Sigal,
1-3 allee de la Neste, 31770 Colomiers, France
This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in June 2015.
© Sanofi, 1990 - 2015
The MDF The Bipolar Organisation is a charity which can provide
more information about Manic Depression/Bipolar Disorder.
They can be contacted at:
MDF The Bipolar Organisation, Castle Works, 21 St. Georges
Road, London SE1 6ES.
Telephone: 0207 793 2600 Fax: 0207 793 2639
E-mail: mdf@mdf.org.uk
302234 - 234

Graphic designer : CR - CD
Plant : Colomiers

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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