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PROPRANOLOL 10 MG FILM-COATED TABLETS

Active substance(s): PROPRANOLOL HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Propranolol 10 mg
film-coated tablets
Propranolol 40 mg
film-coated tablets
Propranolol 80 mg
film-coated tablets
Propranolol hydrochloride
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 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. 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 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 unever 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
• 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)
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Propranolol.
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. 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 :
• 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 80-160mg a day.
• Liver disease due to high blood pressure initially 40mg twice a day, maximum
recommended dose 160 mg twice a day
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.

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.

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

For UK - You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
For Malta- ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Propranolol
• Keep this medicine 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.
• 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
10 mg, 40 mg or 80 mg propranolol
hydrochloride.

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

The other ingredients are:

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

maize starch
lactose monohydrate
cellulose microcrystalline (E460)
magnesium stearate

• 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):
• 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.
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

Composition of the tablet coating,
hypromellose (E464)
cellulose microcrystalline (E460)
acetylated monoglycerides and diglycerides
titanium dioxide (E171)
What Propranolol looks like and contents of
the pack
10 mg: White to off-white, round, biconvex
(rounded on both sides) film-coated tablets with
the inscription ‘AI’ on one side and a scoreline on
the other side.
40 mg: White to off-white, round, biconvex
(rounded on both sides) film-coated tablets with
the inscription ‘AL’ on one side and a scoreline on
the other side.
80 mg: White to off-white, round, biconvex
(rounded on both sides) film-coated tablets with
the inscription ‘AM’ on one side and a scoreline
on the other side.
The scoreline is only to facilitate breaking for
ease of swallowing and not to divide into equal
doses.
PVC-PVdC/ ALU Blister in Pack sizes of 25, 28,
30, 50, 56, 60, 100 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited.
Sage House,
319 Pinner road,
North Harrow, HA1 4HF
United Kingdom
This leaflet was last revised in 05/2014

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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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