PRIADEL 400MG TABLETS

Active substance: LITHIUM CARBONATE

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0260/030712/1/F

Priadel ®400mg Tablets
(lithium carbonate)
Patient Information Leaflet

* Non-steroidal anti-inflammatory drugs (NSAIDs) - used to treat pain relief

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.

* Medicines used for heart problems or high blood pressure - such as

and swelling (such as aspirin, ibuprofen, indomethacin or diclofenac)
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

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

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
* 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

What Priadel tablets are and what they are used for

The name of your medicine is 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. Please note that the leaflet also contains information about other
strengths of the medicine. Priadel 200mg.

Taking Priadel tablets 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 breast-feeding.

Priadel Tablets can be used to manage or control:
Information for women who could become pregnant

* 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).

* 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

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
* 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.
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.
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 soften and moisturise the skin

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 diarrohoea.

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

0260/030712/1/B
®

Priadel 400mg Tablets
(lithium carbonate)
Patient Information Leaflet (continued)
Children
Priadel Tablets are 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 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 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.
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. 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
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 or loss of conciousness
* Memory problems
* Fits (seizures)
* Irregular or slow heart beats, shortness of breath, chest pain and fainting
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
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.

5

How to store Priadel tablets

* KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF
CHILDREN.

* Store in a cool, dry place.
* Do not take your tablets out of the blister until it is time to take your dose.
* 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 tablets contain
Each tablet contains 400mg lithium carbonate as the active ingredient in a
controlled release form which means the medicine is slowly released into
your body.
The tablets also contain Maize starch, mannitol, acacia powder, sodium
lauryl sulphate, sodium starch glycolate, magnesium stearate and precirol
ATO/5.
What Priadel Tablets look like and contents of the pack
They are white, circular, bi-convex tablets marked ‘PRIADEL’ on one side
and scored on the other side.
Each blister pack contains 100 tablets (10 blisters of 10).
Maunfaturer and Licence Holder
The tablets are manufactured by Synthelabo Groupe, Quetigny, France and
procured from within the EU and produced and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0260

Priadel is a registered trademark of Sanofi-Aventis.
Revision date: 03/07/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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