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PROPRANOLOL HYDROCHLORIDE 10MG FILM-COATED TABLETS

Active substance(s): PROPRANOLOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER




Propranolol Hydrochloride
10mg film-coated tablets



have kidney disease or problems with your kidneys. You may
need to have check-ups during your treatment
have liver disease or problems with your liver (such as
cirrhosis of the liver). You may need to have some check-ups
during your treatment
this medicine may mask symptoms of hyperthyroidism
(increased appetite, weight loss, sweating)
have diabetes. Your medicine may lower blood sugar levels
(hypoglycaemia) leading to slow heart rate
have a condition caused by an overactive thyroid gland
(thyrotoxicosis). Your medicine may hide the symptoms of
thyrotoxicosis
suffer from Raynaud’s disease (cold sensations in fingers
and toes) or intermittent claudication (narrowing of
arteries in the legs causing pain on walking)

Your medicine is available using the name
Propranolol Hydrochloride 10mg film-coated tablets but will be
referred to as Propranolol throughout this leaflet.
Other strengths 40mg and 80mg are also available.



Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you






If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Propranolol.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist or nurse.
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 of the side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Propranolol is and what it is used for
What you need to know before you take Propranolol
How to take Propranolol
Possible side effects
How to store Propranolol
Contents of the pack and other information

1. What Propranolol is and what it is used for
Propranolol belongs to the group of beta blockers. It is used to:

treat pain in the chest (due to poor blood flow to the heart
muscle)

treat high blood pressure (hypertension)

help prevent additional heart attacks

treat tremors (shaking with an unknown cause)

control irregular or fast heart beats

control fast heart rate and other symptoms caused by an
overactive thyroid gland (thyrotoxicosis)

treat high blood pressure caused by a tumour near a kidney
(pheochromocytoma)

reduce severe headaches (migraine)

prevent stomach bleeding in patients with high blood
pressure in their liver or swollen blood vessels in their gullet

Under some conditions, propranolol can be used to treat
children with arrhythmias (disorders of the heart rhythm).
The dosage will be adjusted by the doctor according to the
child’s age or weight.
It works by the effects it has on the heart and circulation and also
on other parts of the body.

2. What you need to know before you take
Propranolol
Do not take Propranolol:















if you are allergic (hypersensitive) to propranolol
hydrochloride or any of the other ingredients of this medicine
(listed in section 6).
have untreated/uncontrolled heart failure
shock caused by heart problems
severe heart defects (second or third degree heart blocks) )
a condition which may be treated by a pacemaker
suffer with heart conduction or rhythm problems
have a very slow or very uneven heart rate
increased acidity of the blood (metabolic acidosis)
are on a strict fasting diet
suffer from asthma, wheezing or any other breathing
difficulties
suffer from untreated pheochromocytoma (high blood
pressure due to a tumour near the kidney)
suffer from severe blood circulation problems (which may
cause your fingers and toes to tingle or turn pale or blue)
suffer from a tight, painful feeling in the chest in periods of
rest (Prinzmetal’s angina)
have very low blood pressure

If you think that one of these situations applies to you, or if you
are in any doubt, talk to your doctor before you start using
Propranolol.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking
Propranolol if you:

have a history of allergic reactions, for example to insect
stings

have poor blood circulation or controlled heart failure

sharp chest pain which is not caused by exercise (unstable
angina)

suffer from muscle weakness (myasthenia gravis)

have a weak heart or first degree heart block



Other medicines and Propranolol

Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines. This includes
medicines that you buy without a prescription and herbal
medicines. This is because Propranolol can affect the way some
other medicines work and some medicines can have an effect on
Propranolol.
In particular, tell your doctor if you are taking any of the following
medicines:

barbiturates (to treat severe insomnia).

MAO inhibitors (to treat depression).

Propafenone, disopyramide, lidocaine, quinidine or
amiodarone (used to treat life-threatening heart conduction
or rhythm problems)

Fingolimod (to treat multiple sclerosis)

Verapamil, bepridil, nifedipine, nisoldipine, nicardipine,
isradipine, lacidipine and diltiazem (to treat heart diseases
such as high blood pressure or chest pain)

disopyramide, quinidine and amiodarone, lidocaine or
flecanide (to treat irregular heartbeat and arrhythmias)

indomethacin or ibuprofen (to treat pain and inflammation)

cimetidine (to treat stomach ulcers)

adrenaline (epinephrine, used in anaphylactic shock) a
medicine that stimulates the heart

fluvoxamine (used to treat depression)

clonidine, moxonidine and methyldopa ( used to treat high
blood pressure). If you are taking clonidine and Propranolol
together, do not stop taking clonidine unless your doctor tells
you to do so. If you have to stop taking clonidine, your
doctor will give you careful instructions about how to do it.

Digoxin (for heart problems)

Warfarin (to thin the blood)

chlorpromazine or thioridazine (for mental illness)

medicines to treat diabetes including insulin

medicines to treat migraine, like rizatriptan, ergotamin or
dihydroergotamine

rifampicin (to treat infection/tuberculosis)

theophylline (treating asthma and reversible airways
obstruction)

smoking tobacco

Anaesthetics or tests

If you are going to have an anaesthetic or any blood or urine
tests, please tell your doctor or dentist that you are taking
Propranolol tablets.
If you see another doctor or go into hospital, let them know what
medicines you are taking. This is because you can get low blood
pressure (hypotension) if you are given certain anaesthetics while
you are taking propranolol.

Taking Propranolol with food and drink

If you frequently drink a lot of alcohol, talk to your doctor before
having this medicine. This is because alcohol can affect how the
medicine works.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Propranolol is not recommended during pregnancy or
breastfeeding.

Driving and using machines

Because of the side effects, i.e. tiredness and dizziness, it is
conceivable that the ability to drive and use machines might be
affected.

Important information about some of the
ingredients of Propranolol:

Propranolol contains lactose monohydrate. If you have been told
by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

3. How to take Propranolol
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse has told you. Check with your
doctor or pharmacist or nurse if you are not sure.
Swallow your propranolol tablets with a drink of water before
meals. Swallow whole. Do not chew.
Do not stop taking this medicine unless your doctor tells you to
stop.

Adults :













Pediatric population:


Arrhythmias: Under some conditions, propranolol can be
used to treat children with arrhythmias (disorders of heart
rhythm). The dosage will be adjusted by the doctor according
to the child’s age or weight.

Elderly:

Your dose may be decided based on clinical response.

Liver or kidney failure:

Your dose may be decided based on clinical response.

If you take more Propranolol than you should

If you have accidentally taken more than the prescribed dose,
contact your nearest casualty department or tell your doctor or
pharmacist at once. Overdose causes an excessively slow heart
rate, too low blood pressure, heart failure and breathing difficulty
with symptoms such as fatigue, hallucinations, fine tremor,
confusion, nausea, vomiting, body spasms, fainting or coma, low
blood sugar.

If you forget to take Propranolol

If you forget to take a dose, take it as soon as you remember.
However, if it is almost time for the next dose, skip the missed
dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Propranolol

If you stop taking propranolol tablets suddenly you may
experience unpleasant side effects including sweating, shaking,
worsening of angina, irregular heart beat, heart attack or death.
Withdrawal should be gradual.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Stop treatment and contact a doctor at once if you
have the following symptoms:




intolerance to Propranolol such as slow heart rate and low
blood pressure causing dizziness, light-headedness, fainting
or blurred vision.
allergic reaction such as itching, difficulty breathing or
swelling of the face, lips, throat or tongue.

Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:
Common (may affect up to 1 in 10 people):




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Chest pain (angina): initially 40mg two or three times a day,
maximum recommended dose 120-240mg a day.
High blood pressure (hypertension)- initially 40mg two or
three times daily, which may be increased by 80mg per day,
upto 160-320mg a day is recommended.
Heart attack (post myocardial infarction) - initially 40 mg two
to three times daily, later dose may be increased to 80 mg
twice daily.
Tremor - 40 mg two to three times daily.
Irregular heart rhythms – 10 mg to 40 mg two or three times
a day.
over active thyroid gland - your dose may be decided based
on clinical response.
Pheochromocytoma

before an operation - 60mg a day for 3 days.

non operable treatment dose - 30mg a day.
Migraine: initially 40mg two or three times a day, upto 80160mg a day.
Liver disease due to high blood pressure - initially 40mg
twice a day, maximum recommended dose 160 mg twice a
day

tiredness, cold extremities, difficulty in sleeping (these
symptoms usually disappear)
slow or irregular heartbeat, severely restricted blood flow to
the fingers and toes (Raynaud’s syndrome)
nightmares or disturbed sleep, shortness of breath

Uncommon (may affect up to 1 in 100 people):


feeling sick (nausea) or being sick (vomiting) and diarrhoea
(these symptoms usually disappear)

Rare (may affect up to 1 in 1,000 people):












your medicine may alter the number and types of your blood
cells such as reduce the number of platelets in your blood
which may make you bruise more easily. If you notice
increased bruising, nosebleeds, sore throats or infections,
you should tell your doctor who may want to give you a
blood test
worsening of heart failure or heart block (which may cause
an abnormal heart beat, dizziness, tiredness or fainiting on
standing/ low blood pressure)
skin rash, worsening of psoriasis, hair loss or thinning of hair,
dry flaky skin
seeing, hearing or feeling things that seem real, but do not
happen (hallucinations), mood changes, pins and needles,
severe mental disorder (psychoses), feeling confused,
memory loss
dry eyes, visual disturbances
Being unable to think with clarity
abnormal skin sensations (as tingling or tickling or itching or
burning)
swelling of the blood vessels below the skin, which may be
painful and accompanied by redness.

What Propranolol looks like and contents of the
pack

The tablets are white to off-white, round, biconvex film-coated
tablets imprinted with 'AI' on one side and a score-line on the
other side.
The score-line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Your medicine is available in blister packs of 28 and 50 tablets.

Manufacturer

Manufactured by: Accord Healthcare Limited. Sage House, 319
Pinner road, North Harrow, HA1 4HF, United Kingdom
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0636

POM

Leaflet issue and revision date (Ref): 08.06.15

Very rare (may affect up to 1 in 10,000 people):





sever muscle weakness (myasthenia gravis)
Low levels of sugar in the blood (hypoglycaemia). This can
happen in people with or without diabetes. This includes
elderly people, people on artificial kidneys (haemodialysis) or
people taking medicines for diabetes. It may also happen if
you are fasting or in people with a long-term liver disease
sweating

Not known (frequency cannot be estimated from
the available data):












a pain in the head.
an acute blood disorder
difficulty in breathing
signs of hyperthyroidism may be hidden
changes in blood fats, changes in kidney functions
changes in blood sugar levels
fits (seizures) linked to low blood sugar levels
worsening of chest pain, depression
constipation, dry mouth,eye infections
changes in sex drive or potency
joint pain

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.
By reporting side effects you can help provide more information
on the safety of this medicine.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard

5. How to store Propranolol










Keep out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date stated on the
label after ‘EXP’. The expiry date refers to the last day of
that month.
If your doctor decides to stop the treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you further.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Propranolol contains

The active ingredient is propranolol hydrochloride.
Each film-coated tablet contains 10mg of
propranolol hydrochloride.
The other ingredients are: maize starch, lactose monohydrate,
magnesium stearate, hypromellose E464,
microcrystalline cellulose E460,
acetylated monoglycerides and diglycerides
and titanium dioxide E171.

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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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