PRIADEL 400MG PROLONGED RELEASE TABLETS

Active substance: LITHIUM CARBONATE

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Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 8 pt
Code actuel / Current code : 451400
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

×
×
×
×

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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Priadel 200mg and 400mg
prolonged release tablets
lithium carbonate

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
• 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.

Take special care with Priadel Tablets
Check with your doctor or pharmacist before taking
your medicine 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 a urinary infection
▲ 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
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Priadel Tablets.

In this leaflet:
1. What Priadel Tablets are and what they are used for
2. Before you take Priadel Tablets
3. How to take Priadel Tablets
4. Possible side effects
5. How to store Priadel Tablets
6. Further information

1. What Priadel Tablets are and what
they are used for

*531121*

The name of your medicine is Priadel 200mg or
Priadel 400mg Prolonged Release Tablets (called
Priadel Tablets in this leaflet). Priadel Tablets
contain 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 Tablets 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).

Taking other medicines
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 Tablets can affect the way some
other medicines work. Also, some medicines can
affect the way Priadel Tablets work 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
• 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
acetazolamide
• Urea - used in some creams that
Turn
soften and moisturise the skin

2. Before you take Priadel Tablets

Do not take Priadel Tablets if:
× You are allergic (hypersensitive) to lithium
carbonate or any of the other ingredients of
Priadel Tablets (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

sanofi aventis

Code AC / Item : 531121
Description AC : Notice Priadel 200/400 mg
Destination :
Grande Bretagne
Date / Version : 03/12/13 V2
Dimension :
210x148 mm
Type :
Roul. double

Over

1

SENS DE DEROULEMENT
RECTO
(Intérieur bobine)

531121

Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 8 pt
Code actuel / Current code : 451400
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

• 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 quinidine, 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 Tablets.
Tell your doctor if you are taking any of the
following before taking Priadel Tablets:
• 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
Taking Priadel with food and drink
Your diet and the amount of fluid you drink while
taking Priadel Tablets is very important (see section 3
below ‘Diet, food and drink while taking Priadel
Tablets').
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or breastfeeding.
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 Tablets
Information for women who are pregnant
• If you find out you are pregnant while taking
Priadel Tablets, tell your doctor straight away
• Do not take Priadel Tablets if you are
pregnant, especially in the first 3 months of
your pregnancy
If your doctor decides that you should have Priadel
Tablets 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 Tablets
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
Tablets. 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 Tablets 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 Tablets
Your medicine contains mannitol (E421). This may
cause mild diarrhoea.
3. How to take Priadel Tablets
Always take Priadel Tablets 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 Tablets
The amount you eat and drink is very important as
it can affect the levels of Priadel Tablets in your
blood.
• Drink the same amount of fluids every day while
taking Priadel Tablets. In hot environments or if
you are dehydrated, you may need to drink extra
fluids
• Have a normal balanced diet while taking
Priadel Tablets. Do not change your diet without
talking to your doctor first
How to take your medicine
• Take this medicine by mouth
• Swallow the tablets whole. Do not crush or chew
them
• The tablets can be broken in half
• Take your medicine at the same times every day
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
Adults weighing about 70kg
• The usual starting dose is between 400mg to
1,200mg each day
Elderly and adults weighing under 50kg
• The usual starting dose is between 200mg to
400mg each day
• Your doctor may decide to increase this dose
by 200mg to 400mg every 3 to 5 days.
Increasing the dose is usual, but do not do
this unless your doctor tells you to
• The maximum dose will depend on your
blood levels and illness
Children
Priadel Tablets are not recommended for
children and adolescents.
Turn
Over
2

sanofi aventis

Code AC / Item : 531121
Description AC : Notice Priadel 200/400 mg
Destination :
Grande Bretagne
Date / Version : 03/12/13 V2
Dimension :
210x148 mm
Type :
Roul. double

531121

Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 8 pt
Code actuel / Current code : 451400
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

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).

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)

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 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.

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

If you take more Priadel Tablets than you should
If you or someone else has taken more Priadel
Tablets 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.

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 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

If you forget to take Priadel Tablets
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 Tablets
Keep taking your medicine until your doctor tells you
to stop. Do not stop taking Priadel Tablets just because
you feel better. If you stop, your illness may return.
When your doctor says that you can stop taking
Priadel Tablets, 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 Tablets can cause side
effects, although not everybody gets them. Sideeffects 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.

Turn
Over

3

sanofi aventis

Code AC / Item : 531121
Description AC : Notice Priadel 200/400 mg
Destination :
Grande Bretagne
Date / Version : 03/12/13 V2
Dimension :
210x148 mm
Type :
Roul. double

531121

Accord Spécification

Accord CQL

Site de Quetigny

Polices / Fonts : Ocean Sans/ZapfDin.
Texte corps mini / Text size mini : 8 pt
Code actuel / Current code : 451400
Couleur (s) / Color(s) : 2

Noir + Bleu PMS Reflex Blue U
Plan N° : N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

• Numbness, weakness and pain in the arms and
legs (peripheral neuropathy)

What Priadel 400mg prolonged release tablets contain
• Each tablet contains 400mg of the the active
substance, lithium carbonate
• The other ingredients are: Glycerol distearate,
mannitol (E421), acacia spray dried, sodium
laurilsulfate, magnesium stearate, maize starch
and sodium starch glycolate (Type A).

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

What Priadel Tablets look like and contents of the pack
Priadel 200mg prolonged release tablets are white,
scored, capsule-shaped tablets engraved with P200
on one side. They are supplied in blister packs of
100 tablets or securitainers of 100 or 500 tablets.
Not all pack sizes may be marketed.
Priadel 400mg prolonged release tablets are white,
circular, bi-convex tablets engraved PRIADEL on one
side, scored on the other side. They are supplied in
blister packs of 100 tablets or securitainers of 50,
100 or 1000 tablets or hospital packs of 100 tablets.
Not all pack sizes may be marketed.
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

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.

Manufacturer
Sanofi Winthrop Industrie, 6 Boulevard de l’Europe,
21800 Quetigny, France

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.

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 December 2013
© Sanofi, 1985 - 2013
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 7932639
E-mail: mdf@mdf.org.uk

5. How to store Priadel Tablets
• Keep out of the reach and sight of children
• Do not use Priadel Tablets 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 25ºC. Store in the original package
to protect from moisture.
• 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. Further information
What Priadel 200mg prolonged release tablets
contain
• Each tablet contains 200mg of the the active
substance, lithium carbonate
• The other ingredients are: Glycerol
monostearate, glycerol distearate, mannitol
(E421), acacia spray dried, sodium laurilsulfate,
magnesium stearate, maize starch and sodium
starch glycolate (Type A).
4

sanofi aventis

Code AC / Item : 531121
Description AC : Notice Priadel 200/400 mg
Destination :
Grande Bretagne
Date / Version : 03/12/13 V2
Dimension :
210x148 mm
Type :
Roul. double

531121

Expand view ⇕

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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