Propranolol hydrochloride 5mg/5ml Oral Solution

• 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 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Propranolol hydrochloride 5mg/5ml, 10mg/5ml, 40mg/5ml and 50mg/5ml Oral Solution but it will be referred to as ‘Propranolol’ throughout 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

• You are allergic to propranolol or any of the other ingredients listed in section 6.

Talk to your doctor, pharmacist or nurse before taking Propranolol.

Propranolol should also not be taken by people with heart failure which is not under control or people with certain other conditions such as heart block, very slow or very irregular heartbeats, very low blood pressure or very poor circulation. It should also not be taken by people who are fasting or have been fasting recently, people who have phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) which is not being treated or by people who have metabolic acidosis or a particular type of chest pain called Prinzmetal's angina. Your doctor will know about these conditions. If you have one of these conditions, make sure your doctor knows about it before you take Propranolol.

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

• Get allergic reactions to such things as insect stings
• Have diabetes as Propranolol may change your normal response to low blood sugar, which usually involves an increase in heart rate. Propranolol may cause low blood sugar levels even in patients who are not diabetic
• Suffer from unstable angina (non exercise-induced sharp chest pain)
• Have thyrotoxicosis as Propranolol may hide the symptoms of thyrotoxicosis
• Have kidney or liver problems (including cirrhosis of the liver) talk to your doctor because you may need to have some check-ups during your treatment
• Have any other health problems such as circulation disorders, heart problems, breathlessness or swollen ankles.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Propranolol works or Propranolol can affect how other medicines work. These medicines include the following:

• Verapamil
• Diltiazem
• Nifedipine
• Nisoldipine
• Nicardipine
• Isradipine
• Lacidipine (which are used to treat hypertension or angina)
• Disopyramide
• Lidocaine
• Quinidine
• Amiodarone or propafenone (for irregular heartbeats)
• Digoxin (for heart failure)
• Adrenaline (a heart stimulant)
• Ibuprofen and indometacin (for pain and inflammation)
• Ergotamine, dihydroergotamine or rizatriptan (for migraine)
• Chlorpromazine and thioridazine (for certain psychiatric disorders)
• Cimetidine (for stomach problems)
• Rifampicin (for the treatment of tuberculosis)
• Theophylline (for asthma)
• Warfarin (to thin the blood) and Hydralazine (for hypertension).

If you are taking clonidine (for hypertension or migraine) and Propranolol together, you must not stop taking clonidine unless your doctor tells you to do so. If it becomes necessary for you to stop taking clonidine, your doctor will give you careful instructions on how to do it.

Alcohol may affect how this medicine works.

If you go into hospital to have an operation, tell the anaesthetist or the medical staff that you are taking Propranolol.

Your medicine is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel dizzy or tired when taking Propranolol. If this happens to you, ask your doctor for advice.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Methyl parahydroxybenzoate (E218): May cause allergic reactions (possibly delayed).

Liquid Maltitol (E965): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This product contains 6.3mg/5ml propylene glycol (E1520) as an ingredient necessary for the medicine to work properly. Talk to your doctor or pharmacist before giving this medicine to your baby if he/she is less than 4 weeks old.

This medicinal product must be taken orally.

Use the measuring syringe or cup provided in the pack to deliver the required dose.

Propranolol is severely toxic if used in overdose. If you have accidently taken more than the prescribed dose or are experiencing symptoms of overdose, you should urgently seek medical attention.

Contact your doctor or pharmacist straight away or go to your nearest hospital casualty department. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified.

If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Do not take two doses at the same time. If you are worried, ask your doctor or pharmacist for advice.

Do not stop taking your medicine without talking to your doctor first. In some cases, it may be necessary to stop taking the medicine gradually.

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 Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting adverse reactions you can help provide more information on the safety of this medicine.

Each 5ml of oral solution contains 5mg propranolol hydrochloride.

Each 5ml of oral solution contains 10mg propranolol hydrochloride.

Each 5ml of oral solution contains 40mg propranolol hydrochloride.

Each 5ml of oral solution contains 50mg propranolol hydrochloride.

The other ingredients are methyl parahydroxybenzoate (E218), citric acid monohydrate (E330), liquid maltitol (E965), orange flavour (containing propylene glycol (E1520)) and purified water.

Propranolol is a clear, colourless oral solution with an orange flavour supplied in an amber glass bottle with tamper-evident child resistant plastic cap with a 5ml oral syringe with 0.1ml graduation marks and a 30ml cup with 5ml graduation with intermediate graduation at 2.5ml and 7.5ml for measuring and administering the dose and a bottle adaptor.

Propranolol is supplied in bottles containing 150ml solution.

POM