SUMMARY CMI

Catapres^® Ampoules

Consumer Medicine Information (CMI) summary

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

1. Why am I using Catapres?

Catapres contains the active ingredient clonidine hydrochloride. Catapres is used to lower high blood pressure, also called hypertension. Catapres works by relaxing and widening blood vessels and so helps to lower your blood pressure.

For more information, see Section 1. Why am I using Catapres? in the full CMI.

2. What should I know before I am given Catapres Ampoules?

You should not be given Catapres if you have ever had an allergic reaction to clonidine hydrochloride or any of the ingredients listed at the end of the CMI.

Catapres should not be given to you if you have certain heart problems, such as irregular/slow heartbeat. 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.

This medicine should not be given to a child under the age of 18 years.

For more information, see Section 2. What should I know before I am given Catapres Ampoules? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Catapres 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 am I given Catapres Ampoules?

• Your doctor will tell you what dose of Catapres Ampoules you will receive. Catapres Ampoules can be given as an injection into a muscle or as a slow injection into a vein.

More instructions can be found in Section 4. How are Catapres Ampoules given? in the full CMI.

5. What should I know while I am being given Catapres Ampoules?

For more information, see Section 5. What should I know while I am being given Catapres Ampoule? in the full CMI.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Catapres.
The more frequently reported side effects of Catapres are light-headedness when you stand up suddenly, drowsiness, dryness of the mouth, nausea and vomiting.

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

Catapres^® Ampoules

Active ingredient: clonidine hydrochloride

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I using Catapres Ampoules?
2. What should I know before I am given Catapres Ampoules?
3. What if I am taking other medicines?
4. How are Catapres Ampoules given?
5. What should I know while I am being given Catapres Ampoule?
6. Are there any side effects?
7. Product details

1. Why am I using Catapres Ampoules?

Catapres contains the active ingredient clonidine hydrochloride. Catapres works by relaxing and widening blood vessels and so helps to lower your blood pressure.

Catapres is used to lower high blood pressure, also called hypertension.

2. What should I know before I am given Catapres Ampoules?

Warnings

You should not be given Catapres if:

• you are allergic to clonidine hydrochloride, or any of the ingredients listed at the end of this leaflet.
  - Always check the ingredients to make sure you can use this medicine.
• if you have certain heart problems, such as irregular/slow heartbeat.

Check with your doctor if you:

have or have had any of the following medical conditions:

• heart failure or any heart or circulation problem
• stroke, or transient ischaemic attack (TIA)
• mental depression
• sugar diabetes
• nerve damage, which may lead to weakness in the arms and legs
• constipation
• phaeochromocytoma (a rare tumour of the adrenal gland)
• any problems with your kidneys.

If you are uncertain as to whether you have, or have had, any of these conditions you should raise those concerns with your doctor.

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

You should not be given this medicine if you are pregnant.

It may affect your developing baby if you are given it during pregnancy.

Do not breast-feed if you are given this medicine.

The active ingredient in Catapres passes into breast milk and there is a possibility that your baby may be affected.

Children and adolescents

This medicine should not be given to a child under the age of 18 years.

Serious side effects have been observed when clonidine, the active ingredient in Catapres, is used with methylphenidate in children with ADHD. Therefore, Catapres in this combination is not recommended.

3. What if I am taking other medicines?

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 and Catapres may interfere with each other. These include:

• other medicines for high blood pressure
• medicines for heart problems
• alcohol
• medicines used to control mood swings and some types of depression
• medicines used to relieve pain, swelling or other symptoms of inflammation

These medicines may interfere with Catapres and affect how it works.

You may need different amounts of your medicine, or you may need to take different medicines.

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

4. How are Catapres Ampoules given?

How it is given

• Catapres Ampoules can be given as an injection into a muscle or as a slow injection into a vein.
• Catapres Ampoules must only be given by a doctor or nurse in a setting where appropriate equipment is readily available for diagnosis and patient monitoring.
• Catapres Ampoules should only be given to patients in a lying position.
• Your doctor will decide what dose of Catapres Ampoules you will receive.

If you are given too much Catapres

As Catapres Ampoules are given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

Symptoms of an overdose may include slow heartbeat, drowsiness, temporarily stopping breathing and coma. Other signs include dizziness, weakness, lethargy, feeling cold, vomiting, looking pale, or having an irregular heartbeat.

You should immediately:

• Tell your doctor or nurse immediately if you experience any signs of overdose, or
• if you are not in hospital, go to the Emergency Department at your nearest hospital.
• phone the Poisons Information Centre
  (in Australia by calling 13 11 26; in New Zealand by calling 0800 764 766)

You may need urgent medical attention.

5. What should I know while I am being given Catapres Ampoule?

Things you should do

Tell any other doctors, dentists, and pharmacists who treat you that you have been given Catapres.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Catapres affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may affect how well your medicine works. You may need different amounts of your medicine, or you may need to take different medicines.

Looking after your medicine

Catapres Ampoules will be stored in the pharmacy or ward below 30°C. Each ampoule can only be used once and unused contents of opened ampoules must be discarded.

When to discard your medicine

Catapres must not be used after the expiry date printed on the pack or ampoule or if the packaging is torn or shows signs of tampering.

6. Are there any side effects?

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.

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

More frequently reported side effects

Less frequently reported side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Catapres Ampoules.

Tell your doctor or nurse if you notice anything unusual, during or after treatment with Catapres Ampoules.

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 Catapres Ampoule contains

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

What Catapres Ampoule looks like

Catapres is the brand name of your medicine.

Catapres Ampoule is a clear, colourless solution. It comes in a glass ampoule. (AUST R 17919).

Who distributes Catapres Ampoule

Clinect Pty Ltd
120-132 Atlantic Drive
Keysborough, VIC 3173
Australia
Telephone: 1800 899 005

Catapres Ampoule are supplied in New Zealand by:

Clinect NZ Pty Limited
C/- Ebos Group Limited
108 Wrights Road
Christchurch 8024
New Zealand
Telephone: 0800 138 803

This leaflet was prepared in August 2023.

Published by MIMS October 2023

1 Name of Medicine

Clonidine hydrochloride.

2 Qualitative and Quantitative Composition

Catapres 150 tablets contain 150 microgram of clonidine hydrochloride.
Catapres ampoules contain 150 microgram of clonidine hydrochloride/1 mL.

Excipients with known effect.

3 Pharmaceutical Form

Catapres 150 tablets.

Catapres ampoules.

4 Clinical Particulars

4.1 Therapeutic Indications

Oral.

Parenteral.

4.2 Dose and Method of Administration

The dosage recommendations are as follows:

Tablets.

Maintenance.

Ampoules.

Renal impairment.

4.3 Contraindications

Catapres should not be used in patients with known hypersensitivity to the active ingredient, clonidine hydrochloride, and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of second or third degree.
In case of rare hereditary conditions that may be incompatible with an excipient of the product (see Section 4.4 Special Warnings and Precautions for Use) the use of the product is contraindicated.

4.4 Special Warnings and Precautions for Use

Special care should be exercised in treating patients who have a history of depression or who have advanced cerebrovascular disease. Reduction of blood pressure in the latter circumstances may itself cause mental changes. Concurrent administration of tricyclic antidepressants may require adjustment of Catapres dosage.
Although a transient rise in blood sugar has been noted occasionally in humans treated with Catapres, which may be due to a pharmacologic alpha-adrenomimetic effect of the drug, no case of induced diabetes mellitus due to Catapres has been reported. Patients with clinical diabetes mellitus should be watched for a possible increase in their requirements of anti-diabetic therapy.
Catapres should be used with caution in patients with mild to moderate bradyarrhythmia such as low sinus rhythm, with disorders of cerebral or peripheral perfusion, polyneuropathy, and constipation.
No therapeutic effect of Catapres can be expected in the treatment of hypertension caused by phaeochromocytoma.
Since Catapres and its metabolites are extensively excreted in the urine, careful adjustment of dosage is required in patients with renal insufficiency (see Section 4.2 Dose and Method of Administration, Renal impairment).
As with other anti-hypertensives, treatment with Catapres should be monitored particularly carefully in patients with heart failure or severe coronary heart disease.
Termination of oral therapy should be gradual (e.g. over more than 7 days).
Sudden cessation of antihypertensive therapy is known to be associated in some instances with rebound hypertension which in some cases may be severe. This may occur with Catapres particularly in patients receiving more than the maximum recommended dose of 900 microgram per day.
Following sudden discontinuation of Catapres after prolonged treatment with high doses, restlessness, palpitations, rapid rise in blood pressure, nervousness, tremor, headache or nausea have been reported.
An excessive rise in blood pressure following discontinuation of Catapres therapy can be reversed by intravenous phentolamine (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
If long-term treatment with a β-blocker needs to be interrupted, the β-blocker should be gradually phased out first, then clonidine.
Patients who wear contact lenses should be warned that treatment with Catapres may cause decreased lacrimation.
Catapres 150 tablets contain 205.5 mg of lactose monohydrate per maximum recommended daily dose. Patients with the rare hereditary conditions of galactose intolerance, e.g. galactosaemia should not take this medicine.

Anaesthesia.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

If the patient is on antihypertensive therapy, care should be taken as even a small dose of clonidine may further lower blood pressure and necessitate adjustment of the antihypertensive regimen.
When Catapres is used as an antihypertensive agent additional clonidine for the prophylaxis of migraine or the alleviation of symptoms in menopausal flushing should not be prescribed. Catapres may potentiate the effects of alcohol, sedatives, hypnotics or other centrally active substances.
Although retinal, lens or corneal damage have not been detected with clonidine therapy, follow-up procedures, such as ophthalmoscopy, are recommended.
Substances which raise blood pressure or induce a sodium and water retaining effect such as nonsteroidal anti-inflammatory drugs can reduce the therapeutic effect of clonidine.
Substances with α₂-adrenergic receptor blocking properties, such as phentolamine, may abolish the α₂-adrenergic receptor mediated effects of clonidine in a dose dependent way.
Concomitant administration of drugs with a negative chronotropic or dromotropic effect such as β-blockers or digitalis glycosides can cause or potentiate bradycardic rhythm disturbances.
It cannot be ruled out that concomitant administration of a β-blocker will cause or potentiate peripheral vascular disorders.
The antihypertensive effect of clonidine may be reduced or abolished and orthostatic regulation disturbances may be provoked or aggravated by concomitant administration of tricyclic antidepressants or neuroleptics with α-receptor blocking effects.
Based on observations in patients in a state of delirium alcoholicum, it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT prolongation, ventricular fibrillation) of high intravenous doses of haloperidol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that they may experience undesirable effects such as dizziness, sedation and accommodation disorder during treatment with Catapres. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

The following adverse events (regardless of causality) and incidences are based on a review of 22 clinical studies comprising 640 patients treated with clonidine hydrochloride.
The corresponding frequency category estimation for each adverse drug reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). See Table 1.
Most adverse effects are mild and tend to diminish with continued therapy.
Occasional reports of abnormal liver function tests and cases of hepatitis have also been reported.

Reporting of suspected adverse reactions.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

Management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Catapres 150 tablets contain the excipients maize starch, lactose monohydrate, calcium hydrogen phosphate, colloidal anhydrous silica, povidone and stearic acid.
Catapres ampoules contain the excipients sodium chloride, hydrochloric acid and water for injections.

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

Catapres 150 tablets should be stored below 25°C
Catapres ampoules should be stored below 30°C.

6.5 Nature and Contents of Container

Catapres 150 tablets.

Catapres ampoules.

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)

S4 - Prescription Only Medicine.

Summary Table of Changes