SUMMARY CMI

PHYSIOTENS^®

Consumer Medicine Information (CMI) summary

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

1. Why am I taking PHYSIOTENS?

PHYSIOTENS contains the active ingredient moxonidine. PHYSIOTENS is used to lower high blood pressure. For more information, see Section 1. Why am I taking PHYSIOTENS? in the full CMI.

2. What should I know before I take PHYSIOTENS?

Do not use 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 other medical conditions, take 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 PHYSIOTENS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PHYSIOTENS and affect how it works or may be affected by PHYSIOTENS.
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 PHYSIOTENS?

• 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 PHYSIOTENS? in the full CMI.

5. What should I know while taking PHYSIOTENS?

For more information, see Section 5. What should I know while taking PHYSIOTENS? 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 symptoms: 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 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

PHYSIOTENS^®

Active ingredient: moxonidine

Consumer Medicine Information (CMI)

This leaflet provides important information about using PHYSIOTENS. 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 PHYSIOTENS.

Where to find information in this leaflet:

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

1. Why am I taking PHYSIOTENS?

PHYSIOTENS contains the active ingredient moxonidine.

PHYSIOTENS 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 it has been prescribed for you.

Your doctor may have prescribed PHYSIOTENS for another use.

2. What should I know before I take PHYSIOTENS?

Warnings

Do not take PHYSIOTENS 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 this medicine.

• you are pregnant or think you may be pregnant.
• you are breastfeeding. PHYSIOTENS passes into breast milk. Your doctor will discuss the possible risks and benefits of taking PHYSIOTENS 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 PHYSIOTENS 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 for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant, 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 PHYSIOTENS 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 PHYSIOTENS and affect how it works or may be affected by PHYSIOTENS. 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 use different amounts of your medicine, or take different medicines.

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

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

4. How do I take PHYSIOTENS?

How much to take

• Your doctor or pharmacist will tell you how many tablets to take each day.
• The usual starting dose of PHYSIOTENS 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 use PHYSIOTENS until your doctor tells you to stop.
• The medicine 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 PHYSIOTENS

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

When to take PHYSIOTENS

• Take PHYSIOTENS 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 with or without food.

If you forget to take PHYSIOTENS

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 PHYSIOTENS

If you think that you have taken too much PHYSIOTENS, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, 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 PHYSIOTENS?

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 this medicine.

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

If you do not drink enough water while taking PHYSIOTENS, 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 this medicine
• that you are taking this medicine if you are about to have any blood tests
• if you have excessive vomiting and/or diarrhoea while taking PHYSIOTENS. 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 PHYSIOTENS.

Things you should not do

• Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not stop taking PHYSIOTENS 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 PHYSIOTENS affects you.

PHYSIOTENS 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 PHYSIOTENS.

The effect of taking alcohol with PHYSIOTENS 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 away from moisture, heat or sunlight.

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 this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not take this medicine after the expiry date.

6. Are there any side effects?

PHYSIOTENS 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

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

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

What PHYSIOTENS contains

Do not take this medicine if you are allergic to any of these ingredients.

What PHYSIOTENS looks like

PHYSIOTENS 200 micrograms tablets are pale pink, round, biconvex, film-coated tablets, imprinted 0.2 on one side (AUST R 114119). Packs of 30 tablets.

PHYSIOTENS 400 micrograms tablets are dull red, round, biconvex, film-coated tablets, imprinted 0.4 on one side (AUST R 114121). Packs of 30 tablets.

Who distributes PHYSIOTENS

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

PHYSIOTENS is made in France.

PHYSIOTENS^® is a Viatris company trade mark

This leaflet was prepared in February 2022.

PHYSIOTENS_cmi\Feb22/00

Published by MIMS March 2022

1 Name of Medicine

Moxonidine.

2 Qualitative and Quantitative Composition

Physiotens tablets are immediate release film coated tablets for oral use containing 200 microgram, 300 microgram or 400 microgram moxonidine.

Excipients with known effect.

3 Pharmaceutical Form

Physiotens 200 microgram tablets.

Physiotens 300 microgram tablets.

Physiotens 400 microgram tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Physiotens is indicated for the treatment of hypertension.

4.2 Dose and Method of Administration

Treatment should be started with 200 microgram Physiotens 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 Physiotens should not be exceeded.
Physiotens may be taken with or without food.

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 coadministered 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 200 microgram to 800 microgram 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 Physiotens by a 2 year old child has been reported. The child ingested an unknown quantity of Physiotens. 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, somnolence, headache, dizziness, asthenia, fatigue and upper abdominal pain. In rare cases emesis, tachycardia, hyperglycaemia 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

The tablets also contain the following excipients: lactose monohydrate, povidone, crospovidone, magnesium stearate, hypromellose, ethylcellulose, macrogol 6000, purified talc, iron oxide red and titanium dioxide.

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

Physiotens tablets should be stored at or below 25°C.

6.5 Nature and Contents of Container

Physiotens 200 microgram tablets: PVC/PVDC/Al blister packs of 7 (sample), 10, 14, 28, 30, 56, 84, and 98 tablets.
Physiotens 300 microgram tablets: PVC/PVDC/Al blister packs of 7, 10, 14, 28, 30, 56, 84, and 98 tablets.
Physiotens 400 microgram tablets: PVC/PVDC/Al blister packs of 7, 10, 14, 28, 30, 56, 84, and 98 tablets.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG).

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

Moxonidine is a white to almost white powder with a melting point of 197-205°C.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes