PRIADEL 400MG TABLETS

249 Priadel Leaflet 20170803



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’)

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRIADEL® 400mg TABLETS
(lithium carbonate)
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 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.



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



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.



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



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.

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

1. WHAT PRIADEL IS AND WHAT IT IS USED FOR



Methyldopa used for high blood pressure

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



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 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

Priadel can be used to manage or control:

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)

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').



Repeated periods of depression, where treatment with other
medicines has not worked



Aggressive or self-harming behaviour

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

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

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)

You should use an effective method of contraception while
taking Priadel

Information for women who are pregnant

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIADEL

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



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 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



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

 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.

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.

Breast-feeding


Do not breast-feed if you are taking Priadel. This is because
small amounts may pass into the mother’s milk

Warnings and precautions

Driving and using machines

Talk to your doctor or pharmacist before taking Priadel if:

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 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

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

3. HOW TO TAKE PRIADEL

 You have kidney problems
 You are taking medicines to treat epilepsy

Always take Priadel exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

 You have heart problems

Diet, food and drink while taking Priadel

 You are about to receive anaesthetics

The amount you eat and drink is very important as it can affect the
levels of Priadel in your blood.

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.



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

Other medicines and Priadel

How to take your medicine

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines.



Take this medicine by mouth



Swallow the tablets whole. Do not crush or chew them

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 work as this can affect the levels of lithium in your blood.



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

In particular, check with your doctor if you are taking any
of the following:


Any other medicines containing lithium

Adults weighing about 70kg



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





Steroids - used for inflammation and allergies (such as
prednisolone, betamethasone or hydrocortisone)

Elderly and adults weighing under 50kg



Theophylline - used for wheezing or difficulty in breathing





Caffeine found in some medicines for pain relief that you
buy without a prescription

The usual starting dose is between 200mg to 400mg each
day





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

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



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



The maximum dose will depend on your blood levels and
illness

The usual starting dose is between 400mg to 1,200mg each
day

Use in children



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’

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:


Hair loss or inflamed hair follicles

If you are going to have other types of blood test, tell the doctor or
nurse that you are taking lithium.



Acne, skin spots or rashes, skin ulcers and/or itching

If you take more Priadel than you should



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

If you forget to take Priadel



Weight gain

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.

Tests

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.
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 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.

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 SIGHT AND REACH OF CHILDREN.

Allergic reactions



Do not store above 25C.

If you have an allergic reaction, stop taking Priadel and see a doctor
or go to a hospital straight away.



Store in the original package in a cool, dry place.

The signs may include: rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.



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.

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):

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Priadel contains



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

Priadel is a round white tablet with PRIADEL engraved on one side
and with a breakline on the other.



Difficulty in speaking or slurred speech

Priadel is available as blister packs of 100 tablets.



Altered mental state due to brain disease, damage or
malfunction (encephalopathy)

Product Licence holder



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

Other serious side effects which need urgent medical
attention:

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



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

Manufacturer



Cloudy or foamy urine (water)





Feeling confused, dazed, delirious or loss of consciousness

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



Memory problems





Fits (seizures)

Delpharm Dijon, 6, Boulevard de l’Europe, 21800 Quetigny,
France.



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

This product is manufactured by

POM

PL: 08747/0249

Leaflet revision date: 03 August 2017

Tell a doctor or pharmacist straight away if you notice any of
the following serious side effects:

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



Priadel is a registered trade mark of Sanofi-Synthelabo, France.

Frequency unknown:


Benign/malignant kidney tumours (microcysts, oncocytoma,
or collecting duct renal carcinoma) (in long-term therapy)

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)

249 Priadel Leaflet 20170803