Consumer medicine information

1. Why am I using METROL-XL?

METROL-XL contains the active ingredient metoprolol succinate. It belongs to a group of medicines called beta-blockers, which used to treat heart failure.
For more information, see Section 1. Why am I using METROL-XL? in the full CMI.

2. What should I know before I use METROL-XL?

Do not use if you have ever had an allergic reaction to METROL-XL 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 METROL-XL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with METROL-XL 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 METROL-XL?

Take METROL-XL exactly as your doctor has prescribed. Your doctor will tell you how much METROL-XL tablets to take each day.
More instructions can be found in Section 4. How do I use METROL-XL? in the full CMI.

5. What should I know while using METROL-XL?

6. Are there any side effects?

• Mild side effects: headache, tiredness, drowsiness, weakness, or lack of energy, aches and pains, painful joints, nausea (feeling sick), vomiting, stomach upset, diarrhoea or constipation, weight gain, dry mouth, changes in taste sensation, difficulty sleeping, nightmares, mood changes, confusion, short-term memory loss, inability to concentrate, increased sweating, runny or blocked nose, hair loss.

• Serious side effects: dizziness, light headedness or fainting especially on standing up, which may be a sign of low blood pressure, tingling or pins and needles, coldness, burning, numbness or pain in the arms and/or legs, skin rash or worsening of psoriasis, sunburn happening more quickly than usual, abnormal thinking or hallucinations, buzzing or ringing in the ears, deafness, irritated eyes or blurred vision, problems with sexual function, constant flu-like symptoms with tiredness or lack of energy, unusual bleeding or bruising.

1 Name of Medicine

Metoprolol succinate.

2 Qualitative and Quantitative Composition

Metrol-XL 23.75 mg. Each modified release tablet contains 23.75 mg metoprolol succinate.
Metrol-XL 47.5 mg. Each modified release tablet contains 47.5 mg metoprolol succinate.
Metrol-XL 95 mg. Each modified release tablet contains 95 mg metoprolol succinate.
Metrol-XL 190 mg. Each modified release tablet contains 190 mg metoprolol succinate.
Excipient with known effect. None.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Metrol-XL 23.75 mg. White to off white, oval shape, biconvex film coated tablet with breakline on one side and debossed with 'A' and '3' on each side of breakline on other side.
Metrol-XL 47.5 mg. White to off white, round shape, biconvex film coated tablet with breakline on one side and debossed with 'A50' on other side.
Metrol-XL 95 mg. White to off white, round shape, biconvex film coated tablet with breakline on one side and debossed with 'A100' on other side.
Metrol-XL 190 mg. White to off white, oval shape, biconvex film coated tablet with breakline on one side and debossed with 'A200' on other side.

4 Clinical Particulars

4.9 Overdose

Symptoms. Symptoms of overdosage may include severe hypotension, cardiac insufficiency, bradycardia and bradyarrhythmia, cardiac conduction disturbances, cardiogenic shock, cardiac arrest, impairment of consciousness/coma, convulsions and bronchospasm. The main clinical signs of overdosage are cardiovascular and in some cases decompensation may be rapid. Overdosage with Metrol-XL can lead to death.
Cases of overdosage in paediatric patients need to be given extra attention even if the patient appears well on presentation and even if only a small number of tablets have apparently been taken.
Management. For information on management of overdose, contact the Poisons Information Centre on 131126 (Australia).
Care should be provided at a facility that can provide appropriate supporting measures, monitoring, and supervision.
Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
Syrup of ipecac and gastric lavage are no longer considered to be standard therapy for gut decontamination.
Atropine, adreno stimulating drugs or pacemaker to treat bradycardia and conduction disorders.
Hypotension, acute cardiac failure, and shock to be treated with suitable volume expansion, injection of glucagon (if necessary, followed by an intravenous infusion of glucagon), intravenous administration of adreno stimulating drugs such as dobutamine, with α₁ receptor agonistic drugs added in presence of vasodilation. Intravenous use of calcium salts (Ca²⁺) can also be considered.
Bronchospasm can usually be reversed by bronchodilators.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Metoprolol succinate was not mutagenic in a bacterial assay, nor did it induce chromosomal damage in Chinese hamsters (bone marrow micronucleus and chromosome aberration assays) or in mice (dominant lethal assay).
Carcinogenicity. Long-term studies in animals have been conducted to evaluate the carcinogenic potential of metoprolol succinate. In rats at dietary doses of up to 800 mg/kg/day (36 times the maximum recommended clinical dose (MRCD) on a mg/m² basis) for 18 months, there was no increase in the incidence of neoplasms. The only histologic changes that appeared to be drug related were an increased incidence of focal accumulation of foamy macrophages in pulmonary alveoli and an increased incidence of biliary hyperplasia.
In a 21-month study in CD-1 mice at dietary doses of up to 750 mg/kg/day (17 times the MRCD on a mg/m² basis), benign lung tumours (small adenomas) occurred more frequently in female mice receiving the highest dose than in untreated control animals. There was no increase in malignant or total (benign plus malignant) lung tumours, nor in the overall incidence of tumours.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Metoprolol succinate is a white, crystalline powder with a melting point of approximately 138°C. It is freely soluble in water, soluble in methanol, sparingly soluble in ethanol, slightly soluble in dichloromethane and 2-propanol, and practically insoluble in ethyl acetate, acetone, diethyl ether and heptane.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETSUC.gif Chemical name: di-(±)-1-(isopropylamine)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate.
CAS number. 98418-47-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

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