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EVOTROX 100 MICROGRAMS/5ML ORAL SOLUTION

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3077/4/AL

Patient Information Leaflet
Almus Levothyroxine sodium 25mcg/5ml Oral Solution
Almus Levothyroxine sodium 50mcg/5ml Oral Solution
Almus Levothyroxine sodium 100mcg/5ml Oral Solution
Levothyroxine sodium
This leaflet contains important information about Almus Levothyroxine Oral Solution (now
called Levothyroxine sodium Oral Solution throughout the leaflet). 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 further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should 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 get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What this medicine is for
2. Before taking this medicine
3. How to take this medicine
4. Possible side effects
5. Storing your medicine
6. Further information

1. What this medicine is for
Levothyroxine sodium Oral Solution contains
Levothyroxine sodium. Levothyroxine belongs
to a group of medicines called thyroid
hormones, which are used to treat
hypothyroidism (under active thyroid gland).

2. Before using this medicine
This medicine is suitable for most people but a
few people should not use it. If you are in any
doubt, talk to your doctor or pharmacist.

Do not take this medicine and tell your
doctor if you...
• have ever had a bad reaction to any of the
ingredients (see section 6).
• are suffering from a condition that
produces excessive quantities of thyroid
hormone (thyrotoxicosis).
• you are suffering from untreated adrenal
problems.

Talk to your doctor or pharmacist before
taking this medicine if you …
• have any heart problems or have had a
heart attack
• suffer from high blood pressure

• are elderly or have severe long term
hypothyroidism (under active thyroid gland)
• are suffering from a condition caused by an
under active adrenal gland such as
panhypopituitarism.
• have diabetes

Taking other medicines
Levothyroxine sodium Oral Solution can affect
some of the medicines you or your child may
be taking. Make sure your doctor or
pharmacist knows if you are taking any of the
following:
▪ medicines to treat diabetes (eg insulin,
metformin)
▪ medicines to control your heart rate such
as digoxin
▪ tricyclic antidepressants (eg amitriptyline,
dosulepin)
▪ medicines that stimulate the sympathetic
nervous system such as adrenaline
(epinephrine)
▪ anticoagulants (used to thin the blood)
such as warfarin, dicoumarol,
acenocoumarol, phenindione
▪ sodium polystyrene sulphonate (used to
treat kidney disease)

▪ colestyramine (used to treat diarrhoea)
▪ medicines to treat stomach ulcers such
as sucralfate, cimetidine
▪ aluminium hydroxide (used to treat
heartburn)
▪ medicines containing calcium carbonate
▪ “iron” tablets (containing ferrous sulphate)
▪ medicines to treat epilepsy such as
carbamazepine, phenytoin, phenobarbital,
primidone
▪ rifampicin (used to treat serious infections)
▪ aspirin and phenylbutazone (medicines to
reduce inflammation)
▪ propranolol (a beta-blocker)
▪ medicines containing oestrogen (eg HRT,
oral contraceptives – “the pill”)
▪ amiodarone (used to treat some heart
conditions)
▪ lovastatin (used to reduce cholesterol)
▪ corticosteroids (eg hydrocortisone,
prednisolone)
▪ medicines containing testosterone and
mesterolone.
Always tell your doctor or pharmacist about all
the medicines you are taking including
medicines bought without a prescription.

Operations while taking Levothyroxine
sodium Oral Solution

Make sure you tell your doctor or dentist that
you are taking Levothyroxine sodium if you are
due to have an operation or dental procedure
requiring an anaesthetic.

Pregnancy and breast-feeding

If you are pregnant particularly in the first
three months, planning to become pregnant or
are breast-feeding tell your doctor or
pharmacist before taking this medicine.

Important information about some of
the ingredients of Levothyroxine sodium
Oral Solution

▪ Sodium methyl parahydroxybenzoate (E219):
May cause allergic reactions (possibly delayed).

3. How to take this medicine
Always take Levothyroxine sodium Oral Solution
exactly as your doctor has told you. If you are
not sure, check with your doctor or pharmacist.
You should take your Levothyroxine sodium Oral
Solution on an empty stomach, usually before
breakfast.
The usual daily dosages are:
Adults and children over 12 years:
The starting dose is 50 to 100 micrograms
(mcg) a day, increasing by 25 to 50 mcg every
3-4 weeks, until you are taking the right
amount for your condition. The usual
maintenance dose is 100 to 200 mcg daily.
Older patients (over 50 years of age):
The starting dose is 25 mcg a day, increasing
by 25 mcg every 4 weeks until the correct
dose is obtained. The usual final dose is
between 50 and 200 mcg daily. This dose also
applies to patients with severe hypothyroidism,
and to those with heart disease.
Children under 12 years:
The dose for children depends on their age,
weight and the condition being treated.
Your child will be monitored to make sure
he/she gets the right dose. Give your child
this medicine at least half an hour before the
first meal of the day.
The usual maintenance dose for children is
100 to 150 micrograms per m² body surface
area. This will be worked out by your doctor or
pharmacist using the height and weight of
your child.
Congenital hypothyroidism in infants:
Initially 10 to 15micrograms/kg body weight a
day for the first 3 months. The dose will then
be adjusted depending on response to
treatment.
Acquired hypothyroidism in children:
Initially 12.5 to 50micrograms a day. The dose
should be increased gradually every 2 to 4
weeks depending on response to treatment.

If you take more Levothyroxine sodium
Oral Solution than you should
If you accidentally take an overdose of your
medicine, either call your doctor straight away,
or go to your nearest hospital casualty
department. Symptoms of an overdose include:
• Mild to moderate overdose: fever, angina,
a racing heart, irregular heart beats,
muscle cramps, headache, restlessness,
flushing, sweating, diarrhoea.
• Severe overdose: thyroid crisis including
irregular heart beats, heart failure,
collapse, coma, death.
Signs and symptoms of increased thyroid
hormone levels may not be seen for up to 5
days.
Always take any remaining medicine, the
container and the label with you, so that the
medicine can be identified.

If you forget to take Levothyroxine
sodium Oral Solution
If you forget to take your medicine, take your
dose when you remember and then take your
next dose at the usual time. Don’t take two
doses at the same time. If you have forgotten
several doses tell your doctor when you have
your next check-up or blood test. It can be
dangerous to stop taking your medicine
without your doctor’s advice.
If you are worried, ask your doctor or
pharmacist for advice.

4. Possible side effects
Like all medicines, Levothyroxine sodium Oral
Solution can have side effects although not
everybody gets them.
If any of the following happen, stop taking
Levothyroxine sodium Oral Solution and tell
your doctor immediately or go to the casualty
department at your nearest hospital:
• Swelling of the hands, feet, ankles, face,
lips, mouth or throat which may cause
difficulty in swallowing or breathing
• Hives
• Fainting
• Yellowing of the skin and eyes also called
jaundice

These are all very serious side effects. If you
have them, you may have a serious allergic
reaction to Levothyroxine sodium Oral Solution.
You may need urgent medical attention or
hospitalisation. All of these very serious side
effects are very rare.
The following side effects may be due to high
doses and usually disappear after reducing the
dose or stopping the medicine. Tell your doctor
if you notice:
• Heart: a racing heart, irregular heart beats,
palpitations, anginal pain.
• Central nervous system: headache,
restlessness, excitability, difficulty in
sleeping, flushing, sweating, fever,
involuntary shakiness, heat intolerance.
• Stomach and intestines: diarrhoea, being
sick, excessive weight loss.
• Muscle and bone: muscle cramps, muscular
weakness.
• Other: partial hair loss during first few
months of therapy.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. Storing your medicine
• Keep out of the reach and sight of children
• Do not store above 25ºC. Store the
container in the outer carton.
• Do not use Levothyroxine sodium Oral
Solution after the expiry date which is stated
on the bottle after Exp:. The expiry date
refers to the last day of that month.
• Medicines should not be disposed 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
Levothyroxine sodium Oral Solution is a clear
colourless solution.
Each 5 ml of Levothyroxine sodium Oral
Solution contains Levothyroxine sodium
equivalent to Levothyroxine sodium anhydrous
25 micrograms (mcg) (PL 20249/0004),
50 mcg (PL 20249/0007) or 100 mcg
(PL 20249/0005) (active ingredient).
It also contains the following inactive
ingredients:
Glycerol, citric acid monohydrate, sodium
methyl parahydroxybenzoate (E219) and
purified water.
Each bottle contains 100ml of oral solution.
A double ended 5ml and 2.5ml polypropylene
spoon is also included to help measure the
dose.
The Marketing Authorisations for Levothyroxine
sodium Oral Solution are held by Kappin
Ltd., Cunard Road, Park Royal, London,
NW10 6PN.
Levothyroxine sodium Oral Solution is
manufactured by Orbis Consumer Products
Ltd., Cunard Road, Park Royal, London,
NW10 6PN.
Levothyroxine sodium Oral Solution
is distributed by Almus Pharmaceuticals, East
Street, Epsom, Surrey KT17 1BH.

Contact us at the above
address for information in
large print, audio or braille
This leaflet was updated in June 2010

3077/4/AL

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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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