NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
APO-MOXONIDINE TABLETS
moxonidine
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
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