PRIADEL®

400 mg controlled release tablets

Lithium carbonate

What is in this leaflet

This leaflet answers some common questions about PRIADEL. It does not contain
all the available information. It does not take the place of talking to your
doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you
taking PRIADEL against the benefits he/she expects it will have for you. If you
have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What PRIADEL is used for

PRIADEL is used for the treatment of mania and hypomania, recurrent bipolar
depression and prophylactic treatment of recurrent affective disorders. Lithium
carbonate provides a source of lithium ions, which compete with sodium ions at
various sites in the body.

Before you take PRIADEL

Do not take PRIADEL if:

• you have an allergy to PRIADEL or any of the ingredients listed at
  the end of this leaflet
• you have problems passing urine or have an impairment of kidney function
• you have an impairment of heart function
• you have Addison's disease or untreated hypothyroidism.

Tell your doctor if:

• you have any other medical conditions
• you are taking lithium in any other form
• you intend to become pregnant or to breast-feed. Lithium may be harmful to
  the foetus and newborn baby. Hence, it is strongly recommended that lithium be
  discontinued before a planned pregnancy. Lithium is secreted into breast milk,
  therefore bottle feeding is recommended.

Your doctor might arrange for blood tests and other health checks to be
carried out prior to and during treatment with PRIADEL.

Treatment with PRIADEL tablets requires regular monitoring of serum lithium
levels. Your doctor will arrange for the necessary blood tests to be carried
out. Frequent blood tests are required at the start of treatment. The period
between blood tests is then increased gradually up to about three months.
Additional blood tests may be required following alteration of your dosage, a
change in your condition or other illness, or following a significant change in
your sodium (e.g. salt) or fluid intake.

Taking other medicines

It is very important that you tell your doctor if you are taking any other
medicines, including any non-prescription products. The combination of PRIADEL
with other medicines may lead to increased side effects, and your doctor may
have to adjust your dose of PRIADEL if you are taking certain other medicines.

How to take PRIADEL

Take PRIADEL only when prescribed by your doctor. Your doctor will tell you
how many tablets you need to take each day. The dose will vary depending on the
condition being treated.

Carefully follow all the directions given to you by your doctor. They may differ
from the information contained in this leaflet. If you do not understand how to
take the medicine, ask your doctor or pharmacist for help.

PRIADEL tablets are normally taken as a single daily dose, in the morning or on
retiring. Alternatively, the dose may be divided and given morning and evening.

PRIADEL tablets should be taken whole - they should not be crushed, chewed or
swallowed with hot liquids. PRIADEL tablets are scored, so they can be divided
accurately to provide dosages to the nearest 200 mg.

Do not stop taking PRIADEL without consulting your doctor.

During treatment with PRIADEL, you should try to ensure a constant diet and
fluid intake. This will help maintain a stable salt and water balance. This
applies particularly in hot weather and during periods of illness.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take
your next dose when you are meant to. Otherwise, take it as soon as you
remember, and then go back to taking your doses as you would normally. If you
are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not
take a double dose to make up for the dose that you missed.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking PRIADEL. All medicines can have side effects. Sometimes
they are serious but most of the time they are not. You may need medical
treatment if you experience some of the side effects, particularly lithium
intoxication.

The side effects of PRIADEL are usually related to high serum lithium
concentrations. The more common side effects are listed below. Elderly patients
may be more sensitive to these side effects.

• Mild gastrointestinal disturbances, nausea, vertigo, muscle weakness and a
  dazed feeling may occur on commencing treatment with PRIADEL, but frequently
  disappear after stabilisation of dose.
• Fine hand tremors.
• An increase in urine output and mild thirst.
• Weight gain or fluid retention.
• Disturbances of calcium and magnesium metabolism have been reported.
• Skin conditions including acne, psoriasis, rashes and leg ulcers may be
  aggravated by lithium treatment.
• Long term treatment may be associated with disturbances of thyroid
  function and memory impairment.
• Up to one third of patients may develop some impairment of kidney
  function.

Inform your doctor if you experience any of the following:

• infectious diseases, including colds, influenza, gastro-enteritis and
  urinary infections
• excessive urine output or thirst
• episodes of nausea and vomiting, or other conditions that may lead to salt
  or water depletion (including severe dieting)
• swelling of the face, lips, mouth, tongue or throat.

If you experience any of the following symptoms of lithium intoxication, you
should stop taking your PRIADEL tablets and immediately
contact your doctor:

Gastro-intestinal symptoms, e.g.:

• anorexia or loss of appetite
• diarrhoea
• vomiting.

Central nervous system symptoms, e.g.:

• muscle weakness
• lack of co-ordination
• drowsiness or lethargy
• giddiness
• movement disorders
• tinnitus
• blurred vision
• slurred speech
• coarse tremor and muscle twitching
• disorientation
• seizures.

If you become pregnant while taking PRIADEL, tell your doctor immediately.

Overdose

Immediately telephone your doctor or the National Poisons Information Centre
(telephone 0800 POISON or 0800 764 766) for advice if you think
that you or anyone else may have taken too much PRIADEL. Do this even if there
are no signs of discomfort or poisoning. Keep telephone numbers of these places
handy.

Lithium intoxication may occur if your serum lithium level is too high. If you
experience any of the symptoms of lithium intoxication listed above under Side
Effects, you should stop taking your PRIADEL tablets and

immediately contact your doctor.

Storage conditions

Store PRIADEL in a cool, dry place, at or below 25°C.

Keep all medicines out of the reach of children.

Do not use PRIADEL if the product has passed the expiry date on the pack.

Product description

PRIADEL is a white, scored tablet, containing 400 mg lithium carbonate in a
controlled release form.

Packets of PRIADEL contain 100 tablets.

Inactive ingredients

• Mannitol
• Acacia
• Sodium lauryl sulphate
• Glycerol palmito stearate
• Maize starch
• Magnesium stearate
• Sodium carboxymethyl starch

PRIADEL tablets do not contain any sugar, gluten or colouring agent.