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PROPRANOLOL HYDROCHLORIDE 40MG/5ML ORAL SOLUTION

Active substance(s): PROPRANOLOL HYDROCHLORIDE / PROPRANOLOL HYDROCHLORIDE

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Package leaflet: Information for the user

Propranolol hydrochloride 5mg/5ml Oral Solution
Propranolol hydrochloride 10mg/5ml Oral Solution
Propranolol hydrochloride 40mg/5ml Oral Solution
Propranolol hydrochloride 50mg/5ml Oral Solution
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.
 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.
 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.

Other medicines and Propranolol
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken or might take any other medicines.
This is because some medicines can affect the way
Propranolol works or Propranolol can affect how other
medicines work. These medicines include the following:
 Verapamil
 Diltiazem
 Nifedipine
 Nisoldipine
 Nicardipine
 Isradipine
 Lacidipine (which are used to treat hypertension or
angina)
 Disopyramide
 Lidocaine
 Quinidine
 Amiodarone or propafenone (for irregular heartbeats)
 Digoxin (for heart failure)
 Adrenaline (a heart stimulant)
 Ibuprofen and indometacin (for pain and
inflammation)
 Ergotamine, dihydroergotamine or rizatriptan (for
migraine)
 Chlorpromazine and thioridazine (for certain
psychiatric disorders)
 Cimetidine (for stomach problems)
 Rifampicin (for the treatment of tuberculosis)
 Theophylline (for asthma)
 Warfarin (to thin the blood) and Hydralazine (for
hypertension).




The name of your medicine is Propranolol hydrochloride
5mg/5ml, 10mg/5ml, 40mg/5ml and 50mg/5ml Oral
Solution but it will be referred to as ‘Propranolol’
throughout this leaflet.
What is in this leaflet:
1. What Propranolol is and what it is used for
2. What you need to know before you take Propranolol
3. How to take Propranolol
4. Possible side effects
5. How to store Propranolol
6. Contents of the pack and other information

1. What Propranolol is and what it is used for
Propranolol is one of a group of drugs called betablockers. It has effects on the heart and circulation and
also on other parts of the body.
Propranolol can be used for many conditions including
Hypertension (high blood pressure)
Angina (chest pain)
Some arrythmias (disorders of heart rhythm)
Protection of the heart after a myocardial infarction
(heart attack)
 Prevention of migraine
 Essential tremor, anxiety
 Certain thyroid conditions (such as thyrotoxicosis,
which is caused by an overactive thyroid gland)
 Hypertrophic cardiomyopathy (thickened heart
muscle)
 Phaeochromocytoma (high blood pressure due to a
tumour usually near the kidney)
 Bleeding in the oesophagus caused by high blood
pressure in the liver.





2. What you need to know before you take
Propranolol
If you have ever had asthma or wheezing, do not
take your Propranolol. Go back to your doctor or
pharmacist.
Do not take Propranolol if:
 You are allergic to propranolol or any of the other
ingredients listed in section 6.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Propranolol.
Propranolol should also not be taken by people with heart
failure which is not under control or people with certain
other conditions such as heart block, very slow or very
irregular heartbeats, very low blood pressure or very
poor circulation. It should also not be taken by people
who are fasting or have been fasting recently, people
who have phaeochromocytoma (high blood pressure due
to a tumour usually near the kidney) which is not being
treated or by people who have metabolic acidosis or a
particular type of chest pain called Prinzmetal’s angina.
Your doctor will know about these conditions. If you have
one of these conditions, make sure your doctor knows
about it before you take Propranolol.
Talk to your doctor, pharmacist or nurse before taking
Propranolol if you:
 Get allergic reactions to such things as insect stings
 Have diabetes as Propranolol may change your
normal response to low blood sugar, which usually
involves an increase in heart rate. Propranolol may
cause low blood sugar levels even in patients who are
not diabetic
 Suffer from unstable angina (non exercise-induced
sharp chest pain)
 Have thyrotoxicosis as Propranolol may hide the
symptoms of thyrotoxicosis
 Have kidney or liver problems (including cirrhosis of
the liver) talk to your doctor because you may need
to have some check-ups during your treatment

PIL/UK/MFG032/05-08/v4

Have any other health problems such as circulation
disorders, heart problems, breathlessness or swollen
ankles.

If you are taking clonidine (for hypertension or migraine)
and Propranolol together, you must not stop taking
clonidine unless your doctor tells you to do so. If it
becomes necessary for you to stop taking clonidine, your
doctor will give you careful instructions on how to do it.
Propranolol with food, drinks and alcohol
Alcohol may affect how this medicine works.
Operation
If you go into hospital to have an operation, tell the
anaesthetist or the medical staff that you are taking
Propranolol.
Driving and using machines
Your medicine is unlikely to affect your ability to drive or
to operate machinery. However, some people may
occasionally feel dizzy or tired when taking Propranolol. If
this happens to you, ask your doctor for advice.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Propranolol contains:
Methyl parahydroxybenzoate (E218): May cause
allergic reactions (possibly delayed).
Liquid Maltitol (E965): If you have been told by your
doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
This product contains 6.3mg/5ml propylene glycol
(E1520) as an ingredient necessary for the medicine to
work properly. Talk to your doctor or pharmacist before
giving this medicine to your baby if he/she is less than 4
weeks old.

3. How to take Propranolol
Always take this medicine exactly as your doctor or
pharmacist has told you. Your doctor will have decided
how much Propranolol you need to take each day
depending on your condition. Follow your doctor’s
instructions about when and how to take your medicine.
Ask your doctor or pharmacist if you are not sure.
The following table shows the recommended total daily
dosages for an adult:
Conditions
Dose
Hypertension (high blood
160 mg to 320 mg
pressure)
Angina (chest pains)
120 mg to 240 mg
Arrythmias (disorders of heart
30 mg to 160 mg
rhythm)*
Protection of the heart after a
160 mg
heart attack
Prevention of migraine*
80 mg to 160 mg
Essential tremor
80 mg to 160 mg
Anxiety
40 mg to 120 mg
Certain thyroid conditions (such
30 mg to 160 mg
as thyrotoxicosis)*
TURN OVER

Hypertrophic cardiomyopathy
(thickened heart muscle)
Phaeochromocytoma*
Bleeding in the oesophagus
caused by high blood pressure
in the liver

30 mg to 160 mg
30 mg to 60 mg
80 mg to 160 mg

*Under some circumstances, Propranolol can be used to
treat children with these conditions. The dosage will be
adjusted by the doctor according to the child’s age or weight.

Older people may be started on a lower dose.
It is recommended to use the lower strength (5mg/5ml)
of Propranolol Oral Solution when a lower dose (<5mg)
is required.
Method of administration:
This medicinal product must be taken orally.
Use the measuring syringe or cup provided in the pack to
deliver the required dose.
If you take more Propranolol than you should
Contact your doctor or pharmacist straight away or go to
your nearest hospital casualty department. Always take
any remaining medicine, the container and the label with
you, so that the medicine can be identified.
If you forget to take Propranolol
If you forget to take your medicine, take your dose when
you remember and then take your next dose at the usual
time. Do not take two doses at the same time. If you are
worried, ask your doctor or pharmacist for advice.
If you stop taking Propranolol
Do not stop taking your medicine without talking to your
doctor first. In some cases, it may be necessary to stop
taking the medicine gradually.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Propranolol can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine.
Common (may affect up to 1 in 10 people)
Cold fingers and toes
The heart beating more slowly
Numbness and spasm in the fingers which is followed
by warmth and pain (Raynaud’s phenomenon)
 Disturbed sleep/nightmares
 Fatigue.




Uncommon (may affect up to 1 in 100 people)
Diarrhoea
Nausea
Vomiting.





Rare (may affect up to 1 in 1,000 people)
 Worsening of breathing difficulties, if you have or
have had asthma
 Breathlessness and/or swollen ankles, if you also have
heart failure
 Heart block which may cause an abnormal heart beat,
dizziness, tiredness or fainting
 Dizziness, particularly on standing up
 Worsening of your blood circulation, if you already
suffer from poor circulation
 Hair loss
 Mood changes
 Confusion
 Memory loss
 Psychosis or hallucinations (disturbances of the mind)
 Tingling of the hands
 Disturbances of vision
 Dry eyes
 Skin rash, including worsening of psoriasis
 Bruising more easily (thrombocytopaenia)
 Purple spots on the skin (purpura).
Very rare (may occur less than 1 in 10,000 patients)
Severe muscle weakness (myasthenia gravis)
There may be changes to some of the cells or other
parts of your blood. It is possible that your doctor
may occasionally take blood samples to check
whether Propranolol has had any effect on your blood.




Not known (frequency cannot be estimated from the
available data)
 Low levels of blood sugar may occur in diabetic and
non diabetic patients including the newborn, toddlers
and children, elderly patients, patients on artificial
kidneys (haemodialysis) or patients on medication
for diabetes. It may also occur in patients who are
fasting or have been fasting recently or who have a
long-term liver disease
 Seizure linked to low levels of sugar in the blood.

PIL/UK/MFG032/05-08/v4

Do not be alarmed by this list of possible events. You
may not have any of them.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any side effects not
listed in this leaflet.
Reporting of side effects:
If you get any side effects, talk to your doctor or
pharmacist. 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 adverse
reactions you can help provide more information on the
safety of this medicine.

5. How to store Propranolol









Keep this medicine out of the sight and reach of
children.
Do not use Propranolol after the expiry date which is
stated on the carton or bottle label after ‘Exp’. The
expiry date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Discard 90 days after first opening.
Do not use this medicine if you notice that the
solution becomes discoloured or shows any signs of
deterioration. Seek the advice of your pharmacist.
Do not throw away any medicine via waste water or
household waste. Ask your pharmacist how to dispose
of medicines you no longer use. These measures will
help to protect the environment.

6. Contents of the pack and other information
What Propranolol contains
Each 5ml of oral
hydrochloride.
Each 5ml of oral
hydrochloride.
Each 5ml of oral
hydrochloride.
Each 5ml of oral
hydrochloride.

solution contains 5mg propranolol
solution contains 10mg propranolol
solution contains 40mg propranolol
solution contains 50mg propranolol

The other ingredients are methyl parahydroxybenzoate
(E218), citric acid monohydrate (E330), liquid maltitol
(E965), orange flavour (containing propylene glycol
(E1520)) and purified water.
What Propranolol looks like and contents of the
pack
Propranolol is a clear, colourless oral solution with an
orange flavour supplied in an amber glass bottle with
tamper-evident child resistant plastic cap with a 5ml
oral syringe with 0.1ml graduation marks and a 30ml
cup with 5ml graduation with intermediate graduation
at 2.5ml and 7.5ml for measuring and administering
the dose and a bottle adaptor.
Propranolol is supplied in bottles containing 150ml
solution.
POM
Marketing Authorisation Holder and Manufacturer:
Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
This leaflet was last revised in 11/2016.

Expand Transcript

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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