PATIENT INFORMATION LEAFLET

AVAPROP 160 RETARD

(Propranolol Hydrochloride 160mg modified release capsules)

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)

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.

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.

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.

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

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.

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.

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,

PE198ET 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

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