LEVOTHYROXINE TABLETS 25 MICROGRAMS

Active substance: THYROXINE SODIUM

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Patient Information Leaflet

LEVOTHYROXINE TABLETS BP
25, 50 &100 MICROGRAMS

(Levothyroxine Sodium)
WHAT YOU NEED TO KNOW ABOUT
LEVOTHYROXINE TABLETS
Please read this leaflet carefully before you start to take
your tablets. It contains important information. If you are
not sure about anything, or you want to know more, ask
your doctor or a pharmacist. Keep this leaflet safe, as you
may want to read it again. Your tablets are called
Levothyroxine Tablets BP and they are part of a group of
drugs known as thyroid hormones. Normally the thyroid
gland in the body makes enough thyroid hormone but, if
it does not, Levothyroxine Tablets provide the balance.
This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them
even if their symptoms seem to be 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.

3. HOW TO TAKE LEVOTHYROXINE TABLETS

Please tell your doctor before you start to take
Levothyroxine Tablets if you:
• think you may be allergic to Levothyroxine Sodium or to
any of the other ingredients of Levothyroxine Tablets
(these are listed in Section 6.)
• are pregnant, may become pregnant or are
breast-feeding
• have heart disease
• have problems with your circulation
• have high blood pressure
1. WHAT LEVOTHYROXINE TABLETS ARE AND
• are suffering from an overactive thyroid gland
WHAT THEY ARE USED FOR
(hyperthyroidism)
The active ingredient in Levothyroxine Tablets is
• are suffering from an underactive adrenal gland
Levothyroxine Sodium. Levothyroxine Tablets are available in • are suffering from diabetes
three different strengths. Levothyroxine Tablets are used to • have had an underactive thyroid gland for some time.
treat hypothyroidism, a condition in which the thyroid gland
is underactive and so does not make enough thyroxine for
Are you taking other medicines ? Some medicines can
the body's needs. Levothyroxine Tablets are also used to treat interfere with your treatment. Tell your doctor if you re
thyroid cancer and diffuse non-toxic goiter or Hashimoto's
taking any of the following:
thyroiditis, conditions in which the thyroid gland becomes
• medicines to stop your blood clotting (for example
enlarged causing a swelling in the front of the neck.
Warfarin)
• medicines for depression (for example Imipramine,
2. BEFORE YOU TAKE LEVOTHYROXINE TABLETS
Amitriptyline)
• medicines for epilepsy (for example Phenytoin,
Do not take Levothyroxine Tablets if you:
Phenobarbital, Carbamazepine, Primadone)
• think you may be allergic to Levothyroxine or to any of • medicines for diabetes
the other ingredients of Levothyroxine Tablets.
(These are listed in section 6).
In this leaflet:
1. What Levothyroxine Tablets are and what they are
used for
2. Before you take Levothyroxine Tablets
3. How to take Levothyroxine Tablets
4. Possible side effects
5. How to store Levothyroxine Tablets
6. Further Information.

the correct dose is obtained. The usual final dose is
between 50 and 200 mcg daily. This dose also applies to
The doctor will decide what dose of Levothyroxine Tablets
patients with severe hypothyroidism, and to those with
you should take. Always take the tablets exactly as your doctor
heart disease.
has told you to. The dose will be on the pharmacist's label.
Check the label carefully. It should tell you how many tablets Children under 12 years: The dose for children depends
to take and how often. If you are not sure, ask your doctor on their age, weight and the condition being treated. Your
or pharmacist. Your doctor will take regular blood samples child will be monitored to make sure he/she gets the right
at regular intervals to monitor your response to treatment. dose. Give your child this medicine at least half an hour
before the first meal of the day.
Swallow the tablets whole with water. You should take your
tablets as single dose on an empty stomach, usually before
Congenital hypothyroidism in infants: Initially 10 to 50
breakfast.
micrograms/kg body weight a day for the first 3 months.
The dose will then be adjusted depending on response to
For children, the tablets can be crushed in 10 to 15 ml of
treatment.
water (two to three 5 ml spoonfuls) and must then be
swallowed immediately with another 5 to 10 ml of liquid Acquired hypothyroidism in children: Initially 12.5 to 50
(one or two 5 ml spoonfuls). They must be taken as a
micrograms a day. The dose should be increased gradually
single dose on an empty stomach, at least half an hour
every 2 to 4 weeks depending on response to treatment. If
before the first meal of the day.
required the tablets can be crushed in 10 to 15 ml of
drinkable water and given freshly prepared with some
The following doses are intended as a guide:
more liquid (5 to 10 ml).
Adults and children over 12 years: The starting dose is 50
to 100 micrograms (mcg) a day, increasing by 25 to 50 mcg If you forget to take a dose at the right time, take it as
every 3-4 weeks, until you are taking the right amount for soon as you remember. Do not take two doses together. If
your condition. The usual maintenance dose is 100 to
it is almost time to take the next dose, wait until then and
200 mcg daily.
then carry on as before. If you have forgotten several
doses tell your doctor when you have your next check-up
Older patients (over 50 years of age): The starting dose is
or blood test. It can be dangerous to stop taking your
25 mcg a day, increasing by 25 mcg every 4 weeks until
tablets without your doctor's advice.

What to do if you take too many tablets - It is important
not to take too many tablets. Contact your nearest
hospital casualty department or a doctor for advice if you
have swallowed too many tablets or if you think a child
has swallowed any. Take this leaflet, and any tablets that
you still have to show the doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levothyroxine Tablets can cause side
effects, although not everybody gets them. These usually
only happen if the dose you are taking is too high.
Tell your doctor if you get: rapid or irregular heart beats,
palpitations, chest pain, muscle cramps or weakness,
headache, restlessness, excitability, flushing, sweating,
diarrhoea, vomiting, fever, tremor, sleeplessness, heat
intolerance and excessive weight loss. Rash, itching and
puffiness may also occur.
Very rarely, if far too many tablets have been taken in one
go or over many years, serious heart problems have been
reported. If you feel unwell in any other way, tell your
doctor as soon as you can. Children may have some hair
loss at the beginning of treatment, however this is usually
temporary and the hair returns.
5. HOW TO STORE LEVOTHYROXINE TABLETS
Store the tablets in their original pack away from direct
light. Store below 25°C. Keep all medicines out of the

• Sucralfate, Cimetidine or aluminium hydroxide for a
stomach ulcer, Colestyramine to lower your cholesterol
levels, calcium carbonate or iron supplements.
Levothyroxine Tablets can be taken with these medicines
but not at the same time. Your doctor or pharmacist will
advise you
• Rifampicin (for infections particularly tuberculosis),
Digoxin or Amiodarone (for your heart), Propranolol
(for high blood pressure), Lovastatin (for high
cholesterol levels) or Phenylbutazone
• Aspirin (anti-inflammatory medicines)
• Estrogen, estrogen containing products
• oral contraceptives
• androgens or corticosteroids
• any other medicines including ones that you have
bought for yourself without a prescription.
These tablets contain lactose and sucrose. If you have
been told by your doctor that you have an intolerance to
some sugars contact your doctor before taking these
tablets.
If you see another doctor or visit a hospital, remember to
tell them what medicines you are already taking.
Levothyroxine Tablets may react with an anaesthetic
(Ketamine) which you may be given before an operation.

reach and sight of children. Do not take the tablets after
the expiry date which is printed on the carton and label.
You should take any tablets that are out of date or which
you no longer need back to your pharmacist.
6. FURTHER INFORMATION
There are three strengths of Levothyroxine Tablets,
25 micrograms (mcg), 50 mcg and 100 mcg. Levothyroxine
Tablets contain the active ingredient Levothyroxine Sodium.
Each tablet contains Levothyroxine Sodium equivalent to
Levothyroxine Sodium Anhydrous 25 mcg, 50 mcg or 100
mcg (active ingredient); and lactose, sucrose, maize starch
and magnesium stearate (other ingredients).
Levothyroxine Tablets are white and come in packs of 28,
500 or 1000 tablets. The 25 mcg tablets are engraved E 902
on one side and plain on the other. The 50 mcg tablets are
engraved E 905 on one side and plain on the other. The
100 mcg tablets are engraved E 907 on one side and plain
on the other.
The Marketing Authorisation Holder is: RPH
Pharmaceuticals AB, Lagervägen 7, 136 50 Jordbro,
Sweden.
The Manufacturer is: Recipharm Limited, Vale of Bardsley,
Ashton-under-Lyne, Lancashire, OL7 9RR, UK.
If you would like any more information please contact
Medical Information on 0800 0329975.
Date of revision: January 2013

MU

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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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