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PROPRANOLOL 40MG TABLETS

Active substance: PROPRANOLOL HYDROCHLORIDE

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TEVA UK Ref:

Version:

231-30-67683-Z LEA PROPRANOLOL A/S TABS TUK

6

03 June 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

• calcium channel blockers e.g. nifedipine,
nisoldipine, nicardipine, isradipine or
lacidipine
• drugs used to treat diabetes including insulin.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms 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.
IN THIS LEAFLET:

1. What Propranolol is and what it is used for
2. Before you take Propranolol
3. How to take Propranolol
4. Possible side effects
5. How to store Propranolol
6. Further information
Pharma code 165 (0100110)
First bar is 105mm from the top edge of the leaflet.

1

Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Important information about some of the
ingredients of Propranolol
• Patients who are intolerant to lactose should
note that Propranolol tablets contain a small
amount of lactose. If your doctor has told
you that you have an intolerance to some
sugars, contact your doctor before taking
this medicine.
Taking Propranolol with food and drink
• DO NOT take alcohol whilst taking these
tablets, as it may interfere with the action of
Propranolol.

WHAT PROPRANOLOL IS AND WHAT Pregnancy and breast-feeding
IT IS USED FOR
• Propranolol is not recommended if you are

• Propranolol is a type of drug called a
beta-blocker
• Propranolol is used for:
• high blood pressure
• angina pectoris (chest pain)
• long term prevention of further heart
attacks, if you have already had one
• heart rhythm problems or a racing
heartbeat
• anxiety
• migraine (as a preventative treatment)
• involuntary muscle movements
• an over-active thyroid gland.

2

You should warn your doctor or dentist that
you are using Propranolol if you are going to
receive an anaesthetic. Some anaesthetics (e.g.
ether, trichloroethylene) should not be used
with Propranolol. Propranolol may also
increase the effects of lidocaine.

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
• have a history of wheezing or asthma
• suffer from poor circulation
• suffer from Prinzmetal’s angina (angina due
to coronary artery spasm)
• have a slow heart rate
• suffer from other heart problems such as
heart failure, cardiogenic shock, heart block
or sick sinus syndrome
• suffer from uncontrolled heart failure
• have low blood pressure
• have an adrenal tumour
(phaeochromocytoma) resulting in high
blood pressure, flushing, and diarrhoea
• suffer from metabolic acidosis (an imbalance
of the body’s acid-base balance)
• undertake or have recently undertaken
prolonged periods of fasting.

pregnant, planning to become pregnant or
are breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
• Propranolol may cause drowsiness and
dizziness. If affected, DO NOT drive or
operate machinery.

3

HOW TO TAKE PROPRANOLOL

Always take Propranolol exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably
with a glass of water. Propranolol can be taken
with or without food. The usual dose is:

Adults including the Elderly
• High Blood Pressure:
80 mg twice daily. This may subsequently be
increased by your doctor to a maintenance
dose of between 160 - 320 mg daily.
• Angina Pectoris:
40 mg two or three times daily. This may
then be adjusted by your doctor to a usual
maintenance dose of between 120 - 240 mg
per day.
• Long term prevention of further Heart Attack:
Treatment should begin 5 – 21 days after the
initial heart attack with 40 mg taken four
times daily for two or three days.
The dose should then be increased to 80 mg
taken twice daily. In some cases, your doctor
may adjust this dose according to your
response to treatment.
• Heart Rhythm Problems: Overactive Thyroid
Gland:
Take special care with Propranolol
The dose for adults is 10 - 40 mg three or
Tell your doctor before you start to take this
four times daily.
medicine if you:
• Anxiety:
• suffer from liver or kidney problems
• 40 mg daily, for immediate relief of acute
• are undergoing treatment for diabetes
situational anxiety (fear triggered by a
• have thyroid problems.
specific situation such as being in or on
If you are to have surgery, propranolol should
public transportation, tunnels, bridges,
be withdrawn 24 hours before as it may
lifts, planes, cars, or enclosed spaces)
interfere with response to stress.
• 40 mg two or three times per day, for
Propranolol may increase reactions to a
longer term treatment of generalised
number of allergens.
anxiety disorder (also known as GAD, a
condition characterised by persistent and
Taking other medicines
excessive anxiety and worry that lasts for
Talk to your doctor if you are taking any of the
at least six months). Your doctor will
following:
review your dosage after 6 to 12 months.
• sympathomimetic drugs such as adrenaline
• Prevention of Migraine:
• ergotamine (for migraine)
The dose for adults is 40 mg two or three
• prostaglandin synthetase inhibitors used to
times daily. This may then be increased by
treat inflammatory conditions
your doctor to between 80 - 160 mg per day.
• other drugs for other heart conditions such
as flecainide, diltiazem, nifedipine or digoxin • Involuntary Muscle Movements:
40 mg two or three times daily. This may
• cimetidine, hydralazine or chlorpromazine
then be increased by your doctor to between
• quinidine, propafenone, rifampicin,
80 - 160 mg per day.
theophylline, warfarin, thioridazine or
dihydropyridine

REG0069838

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PROPRANOLOL 10 mg, 40 mg,
80 mg AND 160 mg TABLETS

TEVA UK Ref:

Version:

231-30-67683-Z LEA PROPRANOLOL A/S TABS TUK

6

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Children
• Heart Rhythm Problems; Overactive Thyroid
Gland
Your doctor will calculate the appropriate dose
for your child based on the child’s body weight.
The dose should be taken three or four times
daily.
• Prevention of migraine
For children under 12 years old, 20 mg two or
three times daily.
Older children may be given the adult dose.
Patients with kidney problems
A reduced starting dose may be given.
If you take more Propranolol than you should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately. An overdose is likely to
cause low blood pressure, breathlessness,
confusion, low blood sugar levels, slow pulse
rate and heartbeat, unconsciousness. Please
take this leaflet, any remaining tablets and the
container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Propranolol
If you forget to take a tablet, take one as soon
as you remember, unless it is time to take the
next one. DO NOT take a double dose to make
up for a forgotten tablet dose.

doctor may decide to stop your treatment with
Propranolol.
The following side effects have also been
reported. Tell your doctor if you get any of
these and they are troubling you:
• visual disturbances
• confusion, mood changes
• pins-and-needles
• nightmares
• poor circulation, which makes the fingers
and toes pale, cold and numb
• worsening of existing psoriasis (patches of
thickened and sore skin)
• hair loss.
The following are minor side effects. If you get
these, and they last for longer than a few days,
tell your doctor:
• feeling or being sick, diarrhoea
• tiredness, and/or difficulty in sleeping.
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 side effects you can help provide
more information on the safety of this
medicine.

5

HOW TO STORE PROPRANOLOL

Keep out of the reach and sight of children.
Store in a dry place. Protect from light. Do not
store above 25°C.
Do not use Propranolol after the expiry date
that is stated on the outer packaging. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
If you have any further questions on the use of pharmacist how to dispose of medicines no
longer required. These measures will help to
this product, ask your doctor or pharmacist.
protect the environment.
If you stop taking Propranolol
DO NOT stop taking your medicine without
talking to your doctor first, even if you feel
better.
Your treatment with Propranolol must not be
stopped suddenly. If it is necessary to stop
treatment, your doctor should reduce your
dose gradually.

4

POSSIBLE SIDE EFFECTS

6

Like all medicines, Propranolol can cause side
effects, although not everybody gets them.
Stop taking the tablets and tell your doctor
immediately or go to the casualty department
at your nearest hospital if the following
happens:
• an allergic reaction causing swelling of the
lips, face or neck leading to severe difficulty
in breathing or severe skin rash or hives.
This is a very serious but rare side effect. You
may need urgent medical attention or
hospitalisation.
Tell your doctor if you experience any of the
following side effects:
• heart problems such as a very slow heart
rate, heart failure getting worse (symptoms
may include feeling breathless or swollen
ankles) or heart block (symptoms may
include slow or irregular heartbeat,
shortness of breath, dizziness and fainting,
pain or discomfort in your chest)
• low blood pressure, which may make you
feel dizzy or light headed on standing
• breathlessness or wheezing (sometimes with
a fatal outcome in patients with a history of
asthma or hay fever)
• blood disorders (symptoms may include
paleness of skin, fever, unusual bleeding or
unexplained bruising)
• pain in the calf muscles, muscle weakness
• low levels of sugar in the blood
(hypoglycaemia) may occur in children
(frequency is unknown). Symptoms may
include weakness, headache, feeling hungry,
double vision, and mood changes,
aggressive or abnormal behaviour)
• seizure linked to low levels of sugar in the
blood (frequency is unknown)
• being unable to distinguish between reality
and your imagination, hallucinations
(hearing, or seeing, things that are not
there), or delusions (believing things that are
untrue)
• skin troubles such as rashes or itching
• dry eyes.
Not all of these effects are serious, but your

FURTHER INFORMATION

What Propranolol tablets contain:
• The active ingredient is 10, 40, 80 or 160 mg
of propranolol hydrochloride
• The other ingredients are maize starch,
lactose monohydrate, Starch pregelatinised,
sodium starch glycolate, Silica Colloidal
Anhydrous and magnesium stearate (E572)
• The coating contains hypromellose (E464),
macrogol, erythrosine (E127), brilliant blue
(E133), titanium dioxide (E171) and iron
oxide (E172)
• The tablets are polished with carnauba wax.
What Propranolol tablets look like and
contents of the pack:
• Propranolol tablets are dark pink, biconvex,
film coated tablets, engraved on one side
with a breakline on the reverse. The
engraving marks for each tablet strength are:
10 mg: Berk 1Z1 or 1Z1
40 mg: Berk 2Z1 or 2Z1
80 mg: Berk 3Z1 or 3Z1
160 mg: Berk 4Z1 or 4Z1.
• All strengths are available in pack sizes of 7,
10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
120, 150, 160 and 168 tablets
• Other pack sizes are available for each
strength as follows:
10 mg: 50, 500, 1,000 and 40,000 tablets
40 mg: 50, 500, 1,000 and 20,000 tablets
80 mg: 500 and 1,000 tablets
160 mg: 8000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: June 2015
PL 00289/0168-0171

67683-Z

160 x 323

REG0069838

Version 2.6

Approved

Page 2 of 3

03 June 2015

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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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