Consumer medicine information

1. Why am I using Propranolol-WGR?

PROPRANOLOL-WGR contains the active ingredient propranolol hydrochloride. PROPRANOLOL-WGR is used to treat or prevent a number of conditions, most of which are related to the heart. For more information, see Section 1. Why am I using Propranolol-WGR? in the full CMI.

2. What should I know before I use Propranolol-WGR?

Do not use if you have ever had an allergic reaction to propranolol hydrochloride or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Propranolol-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Propranolol-WGR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Propranolol-WGR?

• Your doctor will tell you what dose to take.

• More instructions can be found in Section 4. How do I use Propranolol-WGR? in the full CMI.

5. What should I know while using Propranolol-WGR?

6. Are there any side effects?

Common side effects include: nausea (feeling sick), vomiting, loss of appetite, diarrhoea, stomach pain, flatulence, cold hands or feet, dizziness, tiredness, rash, flushing, hair loss, feeling tired, lethargic or lack of energy. Serious side effects include: depression, disturbed sleep, vivid dreams or nightmares, conjunctivitis, dry eyes, visual disturbances, trouble passing urine, unexplained bruising, mood changes, confusion, sexual problems, loss of hearing or slow heart beats. Very serious side effects include: extreme tiredness or breathlessness on mild exercise, wheezing, difficulty breathing or an asthma attack or fast heart beats (palpitations).
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Propranolol hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains 10 mg or 40 mg propranolol hydrochloride as the active ingredient for oral administration.
Excipients with known effect. Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

10 mg tablets. Orange coloured, round, biconvex tablets, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side.
40 mg tablets. Green coloured, round, biconvex tablets, embossed with "P" and "40" on either side of the breakline on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

Propranolol is known to cause severe toxicity when used in overdose. Patients should be informed of the signs of overdose and advised to seek urgent medical assistance if an overdose of propranolol has been taken.
Clinical features. Cardiac. Bradycardia, hypotension, and cardiogenic shock may develop. QRS complex prolongation, ventricular tachycardia, first to third degree AV block, ventricular fibrillation or asystole may also occur. Development of cardiovascular complications is more likely if other cardioactive drugs, especially calcium channel blockers, digoxin, cyclic antidepressants or neuroleptics have also been ingested.
CNS. Drowsiness, seizures, and in severe cases coma may occur.
Other features. Bronchospasm, hyperkalaemia and occasionally CNS-mediated respiratory depression may occur.
Management. If overdosage occurs, in all cases therapy with propranolol hydrochloride should be discontinued and the patient observed closely. In addition the following therapeutic measures are suggested:
General treatment should include: close supervision in a monitored environment (which may include treatment in an intensive care ward), the use of gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, the use of intravenous fluids to treat hypotension and shock.
Bradycardia. Excessive bradycardia can be countered with atropine 1 to 2 mg intravenously (incrementally in 0.6 mg doses) and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required this may be repeated or followed by an intravenous infusion of glucagon (1 to 10 mg/hour) depending on response. If no response to glucagon occurs or if glucagon is unavailable, a β-adrenoreceptor stimulant such as isoprenaline (25 microgram initially) or orciprenaline (0.5 mg) may be given by slow intravenous injection.
Cardiac failure. Digitalisation and diuretics.
Hypotension. Vasopressors e.g. noradrenaline or adrenaline. There is evidence that adrenaline is the drug of choice.
Bronchospasm. Administer isoprenaline and aminophylline.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Propranolol hydrochloride is an off-white to white crystalline solid with little or no odour. Propranolol hydrochloride dissolves in water to the extent of one part in twenty at 20°C and has a similar solubility in 95% ethanol, but is only slightly soluble in chloroform.
Propranolol is a β-adrenoreceptor blocking agent which is structurally related to other β-blocking agents such as atenolol, pindolol and oxprenolol, differing from these compounds by substitution on the aromatic ring.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPROPRA.gif Chemical name: (2RS)-1-[(1-Methylethyl) amino]-3- (naphthalen-1-yloxy) propan-2-ol hydrochloride.
Molecular formula: C₁₆H₂₁NO₂.HCl.
Molecular weight: 295.8.
CAS number. 318-98-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PROWGRST.gif