SUMMARY CMI

MOXONIDINE-WGR

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about taking MOXONIDINE-WGR, speak to your doctor or pharmacist.

1. Why am I taking MOXONIDINE-WGR?

MOXONIDINE-WGR contains the active ingredient moxonidine. MOXONIDINE-WGR is used to lower high blood pressure.

For more information, see Section 1. Why am I taking MOXONIDINE-WGR? in the full CMI.

2. What should I know before I take MOXONIDINE-WGR?

Do not take if you have ever had an allergic reaction to moxonidine 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 take MOXONIDINE-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MOXONIDINE-WGR and affect how it works or may be affected by MOXONIDINE-WGR.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take MOXONIDINE-WGR?

• The usual starting dose is one 200 micrograms tablet once per day. Depending on how your blood pressure responds, your dosage may be increased by your doctor.
• Swallow the tablets whole with a full glass of water or another liquid. Do not chew the tablets.

More instructions can be found in Section 4. How do I take MOXONIDINE-WGR? in the full CMI.

5. What should I know while taking MOXONIDINE-WGR?

For more information, see Section 5. What should I know while taking MOXONIDINE-WGR? in the full CMI.

6. Are there any side effects?

Speak to your doctor if you have any of these less serious side effects and they worry you: dry mouth, headache, lack of energy, dizziness, drowsiness, feeling sick, nausea, problems sleeping, skin flushing, anxiety. Tell your doctor as soon as possible if you notice any of these serious side effects: severe allergic skin reactions (rash, itching, inflamed or reddened skin), swelling of the limbs. Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects: angioedema (unusual swelling of the face, eyes, lips, inside the nose, mouth or throat), shortness of breath, breathing or swallowing difficulties.

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.

FULL CMI

MOXONIDINE-WGR

Active ingredient: Moxonidine

Consumer Medicine Information (CMI)

This leaflet provides important information about taking MOXONIDINE-WGR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking MOXONIDINE-WGR.

Where to find information in this leaflet:

1. Why am I taking MOXONIDINE-WGR?
2. What should I know before I take MOXONIDINE-WGR?
3. What if I am taking other medicines?
4. How do I take MOXONIDINE-WGR?
5. What should I know while taking MOXONIDINE-WGR?
6. Are there any side effects?
7. Product details

1. Why am I taking MOXONIDINE-WGR?

MOXONIDINE-WGR contains the active ingredient moxonidine. MOXONIDINE-WGR is used to lower high blood pressure, which is sometimes called hypertension.

Everyone has blood pressure. This pressure helps to move 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 MOXONIDINE-WGR has been prescribed for you.

Your doctor may have prescribed MOXONIDINE-WGR for another use.

2. What should I know before I take MOXONIDINE-WGR?

Warnings

Do not take MOXONIDINE-WGR if:

• You are allergic to moxonidine, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can take MOXONIDINE-WGR.
• You are pregnant or think you may be pregnant.
• You are breastfeeding. MOXONIDINE-WGR passes into breast milk. Your doctor will discuss the possible risks and benefits of taking MOXONIDINE-WGR when breastfeeding.
• You are aged 75 years or more.
• Have heart problems such as heart failure or abnormal rhythm.
• Have severe kidney disease.

Do not give MOXONIDINE-WGR 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 it after the expiry date (EXP) 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.

Check with your doctor if you have:

• Any other medical conditions or take any medicines for any other condition.
• Any allergies to any other medicines, foods, dyes or preservatives.
• Angioedema, which is unusual swelling of the face, lips or tongue.
• Depression.
• Epilepsy.
• Glaucoma, a disease of increased pressure in the eye.
• Heart problems.
• Kidney problems.
• Leg pains or cramps caused by poor blood circulation.
• Parkinson's disease, a disease of the nerves which causes uncontrolled shaking and stiffness.
• Raynaud's disease, where your fingers go pale and blue and are painful in the cold

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant, are breastfeeding or intend to breastfeed.

Your doctor or pharmacist can discuss the risks and benefits involved.

3. What if I am taking other medicines?

Tell your doctor if you are already taking medicines to lower your blood pressure.

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

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

Some medicines may interfere with MOXONIDINE-WGR and affect how it works or may be affected by MOXONIDINE-WGR. These include:

• Some medicines used to treat depression called "tricyclic" medicines (such as amitriptyline and imipramine).
• Sleeping tablets or other medicines which make you feel drowsy.

You may need to take different amounts of MOXONIDINE-WGR or take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking MOXONIDINE-WGR.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MOXONIDINE-WGR.

4. How do I take MOXONIDINE-WGR?

How much to take

• Your doctor or pharmacist will tell you how many tablets to take each day.
• The usual starting dose of MOXONIDINE-WGR is one 200 micrograms tablet once per day.
• Depending on how your blood pressure responds, your dosage may be increased by your doctor to 400 micrograms after 2 weeks. After a further 2 weeks, your doctor may increase your dosage to 600 micrograms per day. You should not take 600 micrograms as one dose, it should be taken as a divided dose.
• Ask your doctor how to divide your daily dose.
• Follow the instructions provided and take MOXONIDINE-WGR until your doctor tells you to stop.
• MOXONIDINE-WGR helps control your condition, but it does not cure it. It is important to keep taking your medicine even if you feel well.

How to take MOXONIDINE-WGR

• Swallow the tablets whole with a full glass of water or another liquid.
• Do not chew the tablets.

When to take MOXONIDINE-WGR

• Take MOXONIDINE-WGR 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 MOXONIDINE-WGR with or without food.

If you forget to take MOXONIDINE-WGR

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 it 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 getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for advice.

If you take too much MOXONIDINE-WGR

If you think that you have taken too much MOXONIDINE-WGR, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If possible, show the doctor the pack of tablets.

5. What should I know while taking MOXONIDINE-WGR?

Things you should do

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

If you are going to have surgery, tell the surgeon that you are taking MOXONIDINE-WGR.

Make sure you drink enough water during exercise and hot weather when you are taking MOXONIDINE-WGR, especially if you sweat a lot.

If you do not drink enough water while taking MOXONIDINE-WGR, 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.

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.

Tell your doctor:

• If you become pregnant while you are taking MOXONIDINE-WGR.
• That you are taking MOXONIDINE-WGR if you are about to have any blood tests.
• If you have excessive vomiting and/or diarrhoea while taking MOXONIDINE-WGR. This can also mean that you are losing too much water and your blood pressure may become too low.

Remind any doctor, dentist or pharmacist you visit that you are taking MOXONIDINE-WGR.

Things you should not do

• Do not take MOXONIDINE-WGR to treat any other complaints unless your doctor or pharmacist tells you to.
• Do not give MOXONIDINE-WGR to anyone else, even if they have the same condition as you.
• Do not stop taking MOXONIDINE-WGR suddenly, or change the dosage, without checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how MOXONIDINE-WGR affects you.

MOXONIDINE-WGR may cause drowsiness, dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

You should avoid drinking alcohol when taking MOXONIDINE-WGR.

The effect of taking alcohol with MOXONIDINE-WGR has not been studied. Ask your doctor for advice.

Looking after your medicine

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

Store it in a cool dry place below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half-metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to take MOXONIDINE-WGR or it is out of date, take it to any pharmacy for safe disposal.

Do not take MOXONIDINE-WGR after the expiry date.

6. Are there any side effects?

MOXONIDINE-WGR helps most people with high blood pressure, but it may have unwanted side effects in a few people.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.

However, some side effects may need medical attention. Do not be alarmed by this list of possible side effects. You may not experience any of them.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

MOXONIDINE-WGR is only available with a doctor's prescription.

What MOXONIDINE-WGR contains

MOXONIDINE-WGR does not contain tartrazine or any other azo dyes.

Do not take MOXONIDINE-WGR if you are allergic to any of these ingredients.

What MOXONIDINE-WGR looks like

MOXONIDINE-WGR 0.2 mg (200 micrograms) Film-Coated Tablet*

Pale pink, coloured round shaped tablet debossed with MX2 on one side and plain on another side.

Pack sizes of 98, 84, 56, 30, 28, 14 and 10 film-coated tablets*.

AUST R 300130.

MOXONIDINE-WGR 0.4mg (400 micrograms) Film-Coated Tablet*

Dull brick red coloured round shaped tablets debossed with MX4 on one side and plan on another side.

Pack sizes of 98, 84, 56, 30, 28, 14 and 10 film-coated tablets*.

AUST R 300127.

*Not all strengths and pack sizes may be available.

Who distributes MOXONIDINE-WGR

Wagner Pharmaceuticals Pty Ltd
6 Albert Street
Preston VIC 3072
Tel: 1800 936 140

This leaflet was prepared in October 2024.

Published by MIMS January 2025

1 Name of Medicine

Moxonidine.

2 Qualitative and Quantitative Composition

Moxonidine is a white to almost white powder with a melting point of 197-205°C. Moxonidine is very slightly soluble in water, sparingly soluble in methanol.

200 microgram.

400 microgram.

List of excipients with known effect.

3 Pharmaceutical Form

Tablet, film coated.

Moxonidine-WGR 200 microgram tablets.

Moxonidine-WGR 400 microgram tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Moxonidine-WGR is indicated for the treatment of hypertension.

4.2 Dose and Method of Administration

Treatment should be started with 200 microgram Moxonidine-WGR in the morning. The dose may be titrated after two weeks to 400 microgram 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 600 microgram in divided doses (morning and evening).
A single daily dose of 400 microgram and a divided daily dose of 600 microgram of Moxonidine-WGR should not be exceeded.
Moxonidine-WGR may be taken with or without food.

4.3 Contraindications

Hypersensitivity to any of the ingredients of this product.
Heart failure (NYHA Class I - IV).
Patients aged 75 years or older.
Bradycardia (HR < 50 beats/minute) or severe bradyarrhythmia, including sick sinus syndrome, or second or third degree atrioventricular (AV) block.
Malignant arrhythmias.
Severe renal impairment (GFR < 30 mL/min, serum creatinine concentration > 160 micromol/L).

4.4 Special Warnings and Precautions for Use

Renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Cessation of combination therapy with beta-blockers.

Angioneurotic oedema.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent administration of other antihypertensive agents enhances the hypotensive effect of Moxonidine-WGR.
The effect of sedatives and hypnotics may be intensified by Moxonidine-WGR. The sedative effect of benzodiazepines can be enhanced by concurrent administration of Moxonidine-WGR. 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.

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 200 microgram to 0.8 mg daily.

Laboratory test finding.

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. 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 Poisons Information Centre on 13 11 26 (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

Each tablet includes the following excipients: lactose monohydrate, crospovidone, povidone, magnesium stearate, Opadry complete film coating system 03F540200 Pink (PI 111786) for 200 microgram strength and Opadry complete film coating system 03F540201 Pink (PI 111784) for 400 microgram strength.

6.2 Incompatibilities

Concurrent administration of other antihypertensive agents enhances the hypotensive effect of Moxonidine-WGR.
The effect of sedatives and hypnotics may be intensified by Moxonidine-WGR. The sedative effect of benzodiazepines can be enhanced by concurrent administration of Moxonidine-WGR. 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.

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

Moxonidine-WGR tablets should be stored below 25°C. Protect from light. Protect from moisture.

6.5 Nature and Contents of Container

Supplied in blister pack as follows:

Moxonidine-WGR 200 microgram tablets.

Moxonidine-WGR 400 microgram tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4: Prescription Only Medicine.

Summary Table of Changes