PRIADEL 400MG TABLETS

Active substance: LITHIUM CARBONATE

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Some medicines for indigestion and heartburn (antacids) such as sodium bicarbonate and cisapride



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.

Losartan, candesartan, irbesartan (called ‘angiotensin II
receptor antagonists’)

Calcitonin – used for hypercalcaemia and Paget’s
disease/acute bone loss

If you have any further questions, ask your doctor or
pharmacist.



Medicines used to control your heart beat - such as
quinidine, disopyramide, procainamide, amiodarone and
sotalol.



Keep this leaflet. You may need to read it again.



Medicines used for heart problems or high blood pressure such as enalapril, lisinopril or ramipril (ACE inhibitors)



The name of your medicine is Priadel 400mg Tablets but will be
referred to as Priadel throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine

Non-steroidal anti-inflammatory drugs (NSAIDs) - used to
treat pain relief and swelling (such as aspirin, ibuprofen,
indomethacin or diclofenac)



PRIADEL 400mg TABLETS
(lithium carbonate)

Urea - used in some creams that soften and moisturise the
skin



PACKAGE LEAFLET: INFORMATION FOR THE USER

Water tablets (diuretics) - such as furosemide,
chlortalidone, indapamide, spironolactone or acetazolamide



249 Priadel Leaflet 20140805



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.
In this leaflet:

The following medicines can increase the chance of side
effects when taken with Priadel.

1. What Priadel is and what it is used for

Tell your doctor if you are taking any of the following
before taking Priadel:

2. Before you take Priadel
3. How to take 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



4. Possible side effects

Some medicines used for fits (epilepsy) – such as
carbamazepine or phenytoin

5. How to store Priadel
6. Further information
1. WHAT PRIADEL IS AND WHAT IT IS USED FOR
The name of your medicine is Priadel 400mg Tablets (called Priadel
in this leaflet). Priadel 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:



Medicines used for chest pain (angina) or high blood
pressure - such as diltiazem or verapamil
Taking Priadel with food and drink



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



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).

Aggressive or self-harming behaviour

Pregnancy and breast-feeding

It is also used to help prevent bipolar depression - where the mood
changes between feeling very high (mania) and very low
(depression).

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



2. BEFORE YOU TAKE PRIADEL

You should use an effective method of contraception while
taking Priadel

Do not take Priadel if:
 You are allergic (hypersensitive) to lithium carbonate or any of
the other ingredients of Priadel (see Section 6: Further
information)

Information for women who are pregnant

Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue



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

 You are breast-feeding
 You have heart disease
 You have severe kidney problems

If your doctor decides that you should have Priadel while you
are pregnant, he or she will:

 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.

Check with your doctor or pharmacist before taking your
medicine if:
 You have a cold or flu

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.

 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

Keep a close eye on the level of lithium in your blood. This
is because your kidneys work differently while you are
pregnant

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

 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

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).

 You have a urinary infection

Important information about some of the ingredients of Priadel

 You are elderly

Your medicine contains mannitol (E421). This may cause mild
diarrhoea.

 You are not eating or drinking properly
 You have kidney problems
 You are taking medicines to treat epilepsy

3. HOW TO TAKE PRIADEL

 You have heart problems

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

 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.
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 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:

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



Swallow the tablets whole. Do not crush or chew them



Any other medicines containing lithium





The tablets can be broken in half

Medicines used for infections (antibiotics) - such as
metronidazole, erythromycin doxycycline or oxytetracycline



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



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

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



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’

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





Headaches, a ‘rushing’ sound in your ears and feeling or being
sick. This could be because of increased pressure in the brain

Your doctor will carry out a blood test every week until the level
of lithium in your blood is steady





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

You will then have your blood tested every 3 months to check
the level remains steady

Tell your doctor or pharmacist if any of the following side
effects gets serious or lasts longer than a few days:

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



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

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.



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

If you forget to take Priadel



Uncontrolled movements of the eye

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.

 Weight gain
Tests

If you stop taking Priadel

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.

If you or someone else has taken more Priadel 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.

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.

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

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



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 SIGHT AND REACH OF CHILDREN.



Store in a cool, dry place below 25C.



Do not take the tablets after the date shown on the pack.



If the tablets become discoloured or show any other signs of
deterioration please return them to the pharmacist.



If the doctor tells you to stop taking the tablets please return
them to the pharmacist for safe disposal.

6. FURTHER INFORMATION
What Priadel contains


Each tablet contains 400mg of the active ingredient lithium
carbonate in a special base which releases the medicine slowly.



This base contains glyceryl palmitostearate, mannitol, acacia
powder, sodium lauryl sulphate, magnesium stearate, maize
starch and sodium starch glycollate.

What Priadel looks like and contents of the pack
Priadel is a round white tablet with PRIADEL engraved on one side
and with a breakline on the other.

Altered mental state due to brain disease, damage or
malfunction (encephalopathy)
Other serious side effects which need urgent medical
attention:

Priadel is available as blister packs of 100 tablets.



Swelling around the feet and ankles, face and stomach and
weight gain due to water retention



Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Cloudy or foamy urine (water)



Feeling confused, dazed, delirious or loss of consciousness



Manufacturer

Memory problems



This product is manufactured by

Fits (seizures)





Irregular or slow heart beats, shortness of breath, chest
pain and fainting

Sanofi-Aventis Produtos Farmaceuticos SA, Empreendimento
Lagoas Park, 2740-244 Porto Salvo, Portugal and



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

 Involuntary eye movements
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

Product Licence holder

POM

PL No: 08747/0249

Leaflet revision date: 05 August 2014
Priadel is a registered trade mark of Sanofi-Synthelabo, France.
249 Priadel Leaflet 20140805

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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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