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AVAPROP 160 RETARD

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PATIENT INFORMATION LEAFLET

AVAPROP 160 RETARD
(Propranolol Hydrochloride 160mg modified release capsules)
Please read this entire 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1
2
3

What this medicine is and what it is used for
Before you take
How to take

1 What this medicine is and what it is
used for
Avaprop Capsules belong to a group of medicines called
beta−blockers, which help slow the heart beat and relax the
blood vessels. This reduces blood pressure and the heart’s
demand for oxygen.
This medicine is used to treat the following:
 high blood pressure
 chest pain (angina)

2 Before you take
Do not take Avaprop Capsules if:
 you have a history of breathing difficulties, wheezing
or asthma. Consult your doctor or pharmacist first
 you are allergic (hypersensitive) to propranolol
hydrochloride, or any of the other ingredients in this
medicine (see Further information, section 6)
 you sometimes suffer from low blood sugar levels e.g.
due to not having eaten for a long time
 you are known to have increased acids in your blood
(metabolic acidosis), which may cause rapid breathing
 you suffer from the following heart problems:
− second or third degree heart block, which may cause
missed or slower heart beats than normal and
dizziness
− uncontrolled heart failure, which may cause shortness
of breath or ankle swelling
− weakened heart (cardiogenic shock), usually caused
by a heart attack
− chest pains when at rest (Prinzmetal’s angina)
− you have a very slow or irregular heart beat
 you have low blood pressure
 you have high blood pressure due to an untreated
tumour (phaeochromocytoma), which is usually near
the kidney and may cause high blood pressure
 you have severe circulation problems
Take special care with Avaprop Capsules if:
 your heart has difficulty pumping blood around your
body (low cardiac reserve)
 you have a slow heart beat. The dose may need to be
reduced
 you have kidney problems. The dose may need to be
reduced
 you have liver disease. The dose may need to be reduced
 you have a poor flow of blood to your heart (ischaemic
heart disease). Treatment with Avaprop Capsules
should not be stopped suddenly
 you are being treated for diabetes (see Taking other
medicines, section 2)
 you have first degree heart block, which may cause an
irregular heart beat
 you have high blood pressure in the vein taking blood
from the gut to the liver (portal hypertension)
 you have a history of severe allergic reaction which can
cause difficulty in breathing or dizziness (anaphylactic
reaction)
 you have circulation problems, as they may become
worse
 you are elderly as you might need to start on a lower
dose (see How to take, section 3)
 you have or think you may have thyrotoxicosis (a
condition caused by an overactive thyroid gland)
If any of the conditions listed under ‘Do not take’ or
‘Take special care’ apply to you, please contact your
doctor or pharmacist.
Taking other medicines
Please inform your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.

4
5
6

Possible side effects
How to store
Further information

In particular you should tell your doctor or pharmacist if you
are taking the following:
 Disopyramide, lidocaine, quinidine, amiodarone or
propafenone, used to treat irregular heart beat
 Rizatriptan, ergotamine or dihydroergotamine, used to
treat migraine
 Medicines for heart failure such as digoxin (digitalis
glycosides)
 Medicines for high blood pressure or chest pain
(calcium channel blockers) e.g. verapamil, diltiazem,
nifedipine, nisoldipine, nicardipine, isradipine and
lacidipine
 Cimetidine for stomach ulcers
 Ibuprofen and indometacin for pain and inflammation
 Chlorpromazine and thioridazine for mental illness
 Warfarin, used to thin the blood
 Rifampicin for tuberculosis
 Theophylline for asthma
 Adrenaline, for emergency treatment of allergic
reaction (anaphylaxis) or if the heart stops (cardiac
arrest)
 Clonidine, for high blood pressure and migraine.
If Avaprop Capsules and clonidine are used together,
clonidine should not be stopped for several days after
stopping treatment with Avaprop Capsules.
If you are to take Avaprop Capsules instead of
clonidine, you should stop taking clonidine several
days before you start to take Avaprop Capsules.
 Medicines for the treatment of diabetes, such as insulin
and metformin.
One of the actions of this medicine is to slow the heart.
This could mask an increase in the heart rate which
may be a warning sign of low blood sugar levels
(hypoglycaemia).
In addition, it may delay the recovery of blood glucose
to normal levels after taking insulin.
Having an anaesthetic
If you are going to have an operation, or any procedure
needing an anaesthetic, please tell the doctor or dentist
you are taking Avaprop Capsules beforehand. When
medicines such as Avaprop Capsules are used with
anaesthetic drugs, they may increase the risk of you
having low blood pressure and a faster heart beat.
If it has been decided that you should stop your treatment
with Avaprop Capsules before surgery, this should be done
at least 24 hours prior to the operation.
Taking with alcohol
If you frequently drink a lot of alcohol, talk to your doctor
before taking this medicine. This is because alcohol may
affect how the medicine works.
Pregnancy and breast−feeding
If you are pregnant or think you may be pregnant, you
should not take this medicine, unless your doctor thinks it
is absolutely necessary.
You should not take this medicine whilst breast−feeding as
it passes into breast milk.
Ask your doctor or pharmacist for advice before taking any
medicine’
Driving or using machinery
This medicine should not affect your ability to drive or
operate machinery. However, if you feel dizzy or tired when
taking this medicine, do not drive or operate machinery.
Important Information about the ingredients
These capsules contain sucrose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
continued....

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3 How to take
You should always take this medicine as prescribed by
your doctor. Do not take more than the doctor told you
to. Read and follow the instructions on the
pharmacist’s label.



These capsules are for oral administration
Place the capsule on your tongue and swallow it whole
with a little liquid

Normal starting doses
The doses stated below are guidelines only. You should
always take this medicine as prescribed by your doctor.
Adults
High blood pressure: The usual dose is one capsule
daily, taken in the morning or evening. If necessary, your
doctor may increase the dose to two capsules daily.
Angina: The usual dose is one capsule daily, taken in the
morning or evening.
Elderly patients
If you are already taking 160 mg of propranolol hydrochloride
daily, one Avaprop Capsule daily may be given. However,
if you are new to propranolol hydrochloride treatment you
may need smaller starting doses or it might be preferable
to take an alternative medicine.
Patients with kidney or liver problems
A reduced initial dose or an alternative medicine may be
given.
Children
Avaprop Capsules are not recommended for children.
If you forget to take your Avaprop Capsules
If you forget to take a dose at the correct time, take it as
soon as you remember. If your next dose is due within 12
hours, take a single dose now and skip the next. Do not
take a double dose.
If you have taken more Avaprop Capsules than
recommended
If you or someone else has taken more capsules than you
should, contact your doctor or go to your nearest hospital
accident and emergency department straight away. Take
with you any remaining medicine, the original carton and
the label so that the medicine can be identified.
Symptoms of an overdose may include a slower heart
beat, low blood pressure, acute heart problems and
difficulty in breathing or wheezing.
Do not stop taking Avaprop Capsules without your
doctor’s advice
Consult your doctor if you want to discontinue treatment
with Avaprop Capsules as your original symptoms may
recur when you stop taking the capsules. Your doctor will
gradually reduce your dose before you stop taking this
medicine.

4 Possible side effects
As with all medicines, Avaprop Capsules may cause
unwanted effects in some people.
See your doctor immediately if you have the following
side effects. Although rare, treatment may need to be
stopped
 Excessive slowing of the heartbeat, which may make
you feel dizzy, light−headed, faint, tired or short of
breath
 Low blood pressure, which may make you feel faint or
light−headed
 Difficulty breathing or wheezing, especially if you have
a history asthma
Common side effects (affect less than 1 in 10 people)
 Cold fingers and toes
 Difficulty sleeping or disturbed sleep
 Nightmares
 Tiredness
 Slower heart beat
 Poor blood circulation which makes the toes and
fingers numb and pale
Uncommon side effects (affect less than 1 in 100 people)



Feeling or being sick
Diarrhoea

Rare side effects (affect less than 1 in 1,000 people)




Dizziness
Reduction in blood platelets, which increases risk of
bleeding or bruising
Blood disorder

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Worsening of heart failure, which can cause shortness
of breath or ankle swelling
Heart block which may cause an abnormal heart beat,
dizziness, tiredness or fainting
Light−headedness, fainting or dizziness especially
when going from sitting or lying position to standing up
Worsening of pain and/or cramping in the lower leg
Seeing or hearing things that are not real
(hallucinations or psychosis)
Mood changes
Confusion
Memory loss
Skin rashes
Purplish marks on the skin
Hair loss
Scaly pink patches on the skin (psoriasis type reaction)
or worsening of existing psoriasis
Tingling or numbness in the hands or feet
Dry eyes
Visual disturbances
















Very rare side effects (affect less than 1 in 10,000
people)


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
Increase in ANA (Antinuclear Antibodies − detected
through blood test)
Severe muscle weakness or worsening of the condition
(myasthenia gravis)




If any of the side effects get serious or if you notice
any not listed, please contact your doctor or
pharmacist.

5 How to store
This medicine should be kept out of the reach and sight of
children.
Store at or below 25°C in a dry place, protected from light.
Store in the original package.
Do not use your medicine if the pack is damaged or after
the expiry date, which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of 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
What Avaprop Capsules contain:
 Active substance: Each capsule contains 160 mg
propranolol hydrochloride in a modified release
formulation
 Other ingredients: sucrose, corn starch, shellac and
talc.
The capsules contain gelatin and the colourings
erythrosine (E127) and titanium dioxide (E171).
What Avaprop Capsules look like and the contents of
the pack:
Avaprop 160 Retard Capsules are hard gelatin capsules
with a transparent pink body and opaque white cap
containing white to off−white modified release beads.
The capsules have 160 on one side and are plain on the
other.
Avaprop 160 Retard Capsules are available in containers
of 28, 30, 56, 60 or 100 capsules.
Not all sizes may be marketed
Marketing Authorisation Holder
Tillomed Laboratories Ltd
3 Howard Road, Eaton Socon, St Neots,
Cambridgeshire,
PE19 8ET
United Kingdom.
Manufacturer
Valpharma International S.p.A.
Via G. Morgagni, 2
61016 Pennabilli (PU),
Italy
Product Licence Number:
PL 11311/0459
Date of last revision: April 2011

Phone

Avaprop
160mg Caps
PIL
175 x 340 mm
Font SansSerif − Min. Text 8pt
Till−Ver.3.4s
15/04/11
Pantone Black CVC

0800 970 6115

for help
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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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