Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about APO-Moxonidine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking APO-Moxonidine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What APO-Moxonidine is used for

APO-Moxonidine is used to lower high blood pressure, which is sometimes called hypertension.

Everyone has blood pressure. This pressure helps to move your blood around your body. Your blood pressure may change at different times of the day. You have hypertension when your blood pressure stays higher than normal, even when you are calm or relaxed.

There are usually no symptoms of hypertension. The only way of knowing if you have hypertension is to have your blood pressure checked regularly. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

This medicine is available only with a doctor's prescription.

There is not enough information to recommend the use of this medicine for children under the age of 16 years.

Before you take APO-Moxonidine

When you must not take it

Do not take APO-Moxonidine if you have an allergy to:

• any medicine containing moxonidine
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

Do not give this medicine to a child under the age of 16 years. Safety and effectiveness in children younger than 16 years have not been established.

Do not take APO-Moxonidine if you:

• are aged 75 years or more
• have heart problems such as heart failure or abnormal rhythm
• have severe kidney disease

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• kidney problems
• heart problems including blockages in the electrical signals in the heart
• angio-oedema, which is unusual swelling of the face, lips or tongue
• leg pains or cramps caused by poor blood circulation
• Raynaud's disease, where your fingers go pale and blue and are painful in the cold
• Parkinson's disease, a disease of the nerves which causes uncontrolled shaking and stiffness
• epilepsy
• glaucoma, a disease of increased pressure in the eye
• depression
• galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Use of APO-Moxonidine is not recommended during pregnancy or when breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start taking APO-Moxonidine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor if you are already taking medicines to lower your blood pressure, including beta blockers (such as propanolol and atenolol).

These medicines can have a combined effect when used with APO-Moxonidine to reduce blood pressure and your doctor may need to adjust the dose you have to take.

Some medicines and APO-Moxonidine may interfere with each other. These include:

• some medicines used to treat depression called "tricyclic" medicines (such as imipramine and amitriptyline)
• sleeping tablets or other medicines which make you feel drowsy, including tranquilisers and sedatives (such as lorazepam)
• hypnotics (such as triazolam)
• benzodiazepines (such as Valium)
• other dugs excreted through the kidney tubules (such as frusemide)

These medicines may be affected by APO-Moxonidine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take APO-Moxonidine

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell you how many tablets to take each day.

The usual starting dose of APO-Moxonidine is one 0.2 mg (200 microgram) tablet once per day.

Depending on how your blood pressure responds your dosage may be increased by your doctor to 0.4 mg (400 micrograms) after 2 weeks. After a further 2 weeks your doctor may increase your dosage to 0.6 mg per day (600 micrograms). You should not take 0.6 mg as one dose, it should be taken as a divided dose in the morning and evening.

Ask your doctor how to divide your daily dose.

How to take it

Swallow the tablets whole with a full glass of water.

Do not chew the tablets.

When to take it

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you take this medicine before or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

If there is still a long time to go before your next dose, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take two doses within 6 hours of each other. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much APO-Moxonidine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If possible, show the doctor the pack of tablets.

While you are using APO-Moxonidine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking APO-Moxonidine.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

Keep all of your doctor's appointments so that your progress can be checked.

Patients with kidney disease may need to be carefully monitored.

Make sure you drink enough water during exercise and hot weather when you are taking APO-Moxonidine, especially if you sweat a lot. If you do not drink enough water while taking APO-Moxonidine, you may faint or feel light-headed or sick. This is because your body does not have enough fluid and your blood pressure is too low.

Tell your doctor if you have excessive vomiting and/or diarrhoea while taking APO-Moxonidine. This can also mean that you are losing too much water and your blood pressure may become too low.

Things you must not do

Do not take APO-Moxonidine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how APO-Moxonidine affects you. This medicine may cause dizziness, light-headedness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

You should avoid drinking alcohol while you are taking this medicine. The effect of taking alcohol with APO-Moxonidine has not been studied. Ask your doctor for advice

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking APO-Moxonidine.

This medicine helps most people with high blood pressure, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• dry mouth
• sore throat
• nasal stuffiness or discharge
• coughing
• headache
• lack of energy
• dizziness
• drowsiness
• feeling sick, nausea
• diarrhoea
• back pain
• abdominal pain
• problems sleeping
• skin flushing
• anxiety
• muscle cramps
• palpitations

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

• severe allergic skin reactions (rash, itching, inflamed or reddened skin, hives)
• swelling of the limbs

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• angio-oedema (unusual swelling of the face, eyes, lips, inside the nose, mouth or throat)
• shortness of breath, breathing or swallowing difficulties.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After using APO-Moxonidine

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store APO-Moxonidine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

APO-Moxonidine 0.2 mg (200 micrograms) tablets - pink round biconvex film coated tablets 5 mm in diameter. Packs of 30 tablets.

APO-Moxonidine 0.4 mg (400 micrograms) tablets - pink round biconvex film coated tablets 7 mm in diameter. Packs of 30 tablets.

Ingredients

APO-Moxonidine contains either 0.2 mg (200 micrograms) or 0.4 mg (400 micrograms) of moxonidine as the active ingredient.

The 200 microgram and 400 microgram tablets also contain the following inactive ingredients:

• lactose monohydrate
• povidone
• crospovidone
• magnesium stearate
• OPADRY complete film coating system 03B28796 White
• OPADRY complete film coating system 02F23883 Brown.

This medicine does not contain tartrazine or any other azo dyes.

Distributor

APO-Moxonidine is distributed in Australia by:

Southern Cross Pharma Pty Ltd
Suite 5/118 Church Street
Hawthorn VIC 312

This leaflet was prepared in August 2020.

0.2 mg tablets: AUST R 285640

0.4 mg tablets: AUST R 285632

APO-Moxonidine_cmi\0820/27

Published by MIMS September 2020

1 Name of Medicine

Moxonidine.

2 Qualitative and Quantitative Composition

APO-Moxonidine tablets are immediate release film-coated tablets for oral use containing 0.2 mg or 0.4 mg moxonidine.

Excipient with known effect.

3 Pharmaceutical Form

APO-Moxonidine 0.2 mg tablets: pink round biconvex film coated tablets 5 mm in diameter.
APO-Moxonidine 0.4 mg tablets: pink round biconvex film coated tablets 7 mm in diameter.

4 Clinical Particulars

4.1 Therapeutic Indications

APO-Moxonidine is indicated for the treatment of hypertension.

4.2 Dose and Method of Administration

Treatment should be started with 0.2 mg APO-Moxonidine in the morning. The dose may be titrated after two weeks to 0.4 mg given as one dose or as divided doses (morning and evening) until a satisfactory response is achieved. If the response is still unsatisfactory after a further 2 weeks treatment, the dosage can be increased up to a maximum of 0.6 mg in divided doses (morning and evening).
A single daily dose of 0.4 mg and a divided daily dose of 0.6 mg of APO-Moxonidine should not be exceeded.
APO-Moxonidine may be taken with or without food.

Renal impairment.

Use in elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients (see Section 6.1 List of Excipients).
Heart failure (NYHA Class I - IV).
Patients aged 75 years or older (see Section 5.2 Pharmacokinetic Properties, Pharmacokinetics in the elderly).
Bradycardia (HR < 50 beats/minute) or severe bradyarrhythmia, including sick sinus syndrome, or second or third degree atrioventricular (A-V) block.
Malignant arrhythmias.
Severe renal impairment (GFR < 30 mL/min, serum creatinine concentration > 160 micromol/L).

4.4 Special Warnings and Precautions for Use

Cessation of combination therapy with beta-blockers.

Atrioventricular block.

Other.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent administration of other antihypertensive agents enhances the hypotensive effect of moxonidine.
The sedative effect of tricyclic antidepressants, tranquilizers, alcohol, sedatives, hypnotics and benzodiazepines can be potentiated by moxonidine.
Moxonidine moderately augmented the impaired performance in cognitive functions in subjects receiving lorazepam.
Since tricyclic antidepressants may reduce the effectiveness of centrally acting antihypertensive agents, it is not recommended that tricyclic antidepressants be co-administered with moxonidine.
In healthy volunteers, no pharmacokinetic interactions have been observed with glibenclamide or digoxin.
Moxonidine is excreted through tubular excretion. Interaction with other agents that are excreted through tubular excretion cannot be excluded.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Based on its pharmacodynamic properties, moxonidine is unlikely to affect the ability to drive or operate machinery. However, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.

4.8 Adverse Effects (Undesirable Effects)

Moxonidine has been evaluated for safety in over 4000 subjects worldwide, including more than 1200 patients treated for more than 6 months and over 800 patients treated for 1 year or longer. Most adverse events were of mild or moderate severity and did not require discontinuation of therapy.
In placebo-controlled clinical trials, 4.7% of patients treated with moxonidine discontinued therapy due to clinical adverse experiences, compared to 2.5% discontinuations among placebo-treated patients. Table 1 lists adverse events that occurred at an incidence of 1% or more among moxonidine-treated patients who participated in placebo-controlled trials of 6 to 8 weeks' duration, using doses of 0.2 mg to 0.8 mg daily.

Post-marketing adverse events.

Reporting suspected adverse effects.

4.9 Overdose

Oral dosages up to 2.0 mg/day have been tolerated without the occurrence of serious adverse events. The following case of accidental overdose with moxonidine by a 2 year old child has been reported: The child ingested an unknown quantity of moxonidine. The maximum dosage possibly ingested was 14 mg. The child had the following symptoms: sedation, coma, hypotension, miosis and dyspnoea. Gastric lavage, glucose infusion, mechanically assisted ventilation and rest resulted in the complete disappearance of the symptoms in 11 hours.
Because of the pharmacodynamic properties of moxonidine, the following symptoms can be expected in adults: sedation, hypotension, orthostatic dysregulation, bradycardia, dry mouth, somnolescence, headache, dizziness, asthenia, fatigue and upper abdominal pain. In rare cases emesis and paradoxical hypertension may occur. No specific treatment is known. Phentolamine (Regitine) may, depending on the dose, reverse part of the symptoms of moxonidine overdose. Measures to support blood circulation are recommended.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Pharmacokinetics in the elderly.

Pharmacokinetics in renal impairment.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

APO-Moxonidine tablets also contain the following excipients: lactose monohydrate, povidone, crospovidone, magnesium stearate, and Opadry complete film coating system 03B28796 White and Opadry complete film coating system 02F23883 Brown.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

APO-Moxonidine tablets should be stored below 25°C. Store in original container.

6.5 Nature and Contents of Container

Container type.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes