SUMMARY CMI

Aldomet^®

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 ALDOMET?

ALDOMET contains the active ingredient methyldopa. ALDOMET is used to lower high blood pressure, which doctors call hypertension.

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

2. What should I know before I use ALDOMET?

Do not use if you have ever had an allergic reaction to ALDOMET 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 use ALDOMET? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ALDOMET 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 do I use ALDOMET?

• The dose of ALDOMET varies from patient to patient.
• Swallow the tablets whole with a glass of water or other liquid.

More instructions can be found in Section 4. How do I use ALDOMET? in the full CMI.

5. What should I know while using ALDOMET?

For more information, see Section 5. What should I know while using ALDOMET? in the full CMI.

6. Are there any side effects?

Mild side effects of ALDOMET include dizziness, weakness, light‐headedness, drowsiness, and headache. Taking ALDOMET may also result in serious side effects. These include fever (within the first 3 months of starting), yellowing of the skin and eyes, darker urine than normal, pale stools, swelling of limbs, nightmares or feeling strange or depressed, signs of frequent or worrying infections (e.g. fever, severe chills, sore throat, or mouth ulcers), bruising more easily than normal, signs of anemia (e.g. tiredness, shortness of breath, and looking pale), numbness/tingling/pain or weakness in your hands or feet, itchy skin rash or other skin problems, a slow heart beat or pulse, worsening of angina (chest pain), or larger breasts than normal (especially in men).

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

Aldomet^®

Active ingredient(s): Methyldopa

Consumer Medicine Information (CMI)

This leaflet provides important information about using ALDOMET. 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 ALDOMET.

Where to find information in this leaflet:

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

1. Why am I using ALDOMET?

ALDOOMET contains the active ingredient methyldopa.

ALDOMET is used to lower high blood pressure, which doctors call hypertension.

Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.

There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure.

ALDOMET works by controlling impulses along certain nerve pathways. As a result, it relaxes and widens blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

Your doctor may have prescribed it for another purpose. If you are not sure why you are taking this medicine, ask your doctor.

2. What should I know before I use ALDOMET?

Warnings

Do not use ALDOMET if:

• You are allergic to methyldopa, or any of the ingredients listed at the end of this leaflet.
  - Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue, or any other parts of the body; rash, itching or hives on the skin.
  - Always check the ingredients to make sure you can use this medicine.
• You have taken ALDOMET in the past and developed liver problems.
• You have certain liver diseases, such as hepatitis or cirrhosis.
• You are being treated for depression with medicines called monoamine oxidase inhibitors (MAOIs)
  MAOIs include moclobemide, phenelzine, and tranylcypromine.
• The expiry date on the pack has passed.
  If you take this medicine after the expiry date has passed, it may not work.
• The package shows signs of tampering.

Check with your doctor if you:

• have any other medical conditions, especially the following:
  - angina
  - liver disease
  - phaeochromocytoma or paraganglioma (a rare tumour of the adrenal gland, which sits near the kidney), or if you are suspected of having this.
  - are undergoing dialysis
  - porphyria (a rare blood pigment disorder)
• take any medicines for any other condition
• have had any allergy to any other medicines, or any other substances, such as foods, preservatives, or dyes.

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 if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the possible risks and benefits of using ALDOMET during pregnancy and breastfeeding. ALDOMET passes into breast milk.

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 should NOT be taken with ALDOMET. These include:

• medicines used to treat depression such as moclobemide, phenelzine and tranylcypromine.

Some medicines and ALDOMET may interfere with each other. These include:

• other medicines for high blood pressure
• lithium, a medicine used to treat mood swings and some types of depressions
• iron supplements and multivitamins containing iron.

These medicines may be affected by ALDOMET or may affect how well 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 ALDOMET.

4. How do I use ALDOMET?

How much to take

• Your doctor will tell you how many tablets you need to take each day. This depends on your condition and whether you are taking any other medicines.
• Follow the instructions provided and use ALDOMET until your doctor tells you to stop.

When to take ALDOMET

• ALDOMET should be taken at the same time each day unless your doctor tells you otherwise.
• If you are taking it twice a day, take the tablets at breakfast time and dinner time – that is, about 12 hours apart.
• If you are taking it three times a day, take the tablets about 8 hours apart.
• Taking your tablets at the same time each day will have the best effect on your blood pressure. It will also help you remember when to take the tablets.
• It does not matter if you take ALDOMET before or after food.

How to take ALDOMET

• Swallow the tablets whole with a glass of water or other liquid.

How long to take it

• Continue taking ALDOMET for as long as your doctor tells you.
  This medicine helps to control your high blood pressure but does not cure it. Therefore it must be taken every day.

If you forget to use ALDOMET

ALDOMET should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablets as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

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

If you use too much ALDOMET

If you think that you have used too much ALDOMET, 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.

5. What should I know while using ALDOMET?

Things you should do

• Have your blood pressure checked when your doctor says to make sure ALDOMET is working.
• If you feel light‐headed, dizzy or faint, get up slowly when getting out of bed or standing up.
  You may feel light‐headed or dizzy when you begin to take ALDOMET or if the dose is increased. This is because your blood pressure is falling suddenly. 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. The problem usually goes away after the first few days.
• If you are about to be started on any new medicine remind your doctor and pharmacist that you are taking ALDOMET.
• If you plan to have surgery (even at the dentist) that needs a general anaesthetic, tell your doctor or dentist that you are taking ALDOMET.
  You blood pressure may drop suddenly.
• If you are having blood and urine tests, tell your doctor you are taking ALDOMET
  ALDOMET may interfere with some of these tests giving incorrect results.
• If you develop fever, tell your doctor.
  Your doctor may need to do some blood tests to make sure ALDOMET is not affecting your liver or blood.
• Tell your doctor if you are to have a blood transfusion, that you are taking ALDOMET or have taken it in the past few months.
  ALDOMET may interfere with the tests used to decide which blood group you receive.
• Make sure you drink enough water during exercise and hot weather when you are taking ALDOMET, especially if you sweat a lot.
  If you do not drink enough water while taking it, you may faint or feel light‐headed or sick. This is because your body doesn't have enough fluid and your blood pressure is low. If you continue to feel unwell, tell your doctor.

Call your doctor straight away if you:

• Are experiencing any of the serious side effects listed under Section 6. Are there any side effects?

Remind any doctor, dentist, pharmacist, or anaesthetist you visit that you are using ALDOMET.

Things you should not do

• Do not give your medicines to anyone else, even if they have the same condition as you.
• Do not stop using ALDOMET unless advised by your doctor.

Driving or using machines

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

ALDOMET may cause dizziness, light headedness, drowsiness or sleepiness, especially after the first few doses and if the dose is increased. Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or drowsy.

Drinking alcohol

Tell your doctor if you drink alcohol.

If you drink alcohol, dizziness or drowsiness from ALDOMET can be worse.

Looking after your medicine

• Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle, they may not keep well.
• Keep ALDOMET in a cool dry place, away from moisture, heat, or sunlight where the temperature stays below 30°C. For example, do not store it:
  - In the bathroom or near a sink, or
  - In the car or on window sills
  Heat and dampness can destroy some medicines.

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

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

Do not use this medicine after the expiry date.

6. Are there any side effects?

ALDOMET 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.

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 ALDOMET contains

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

What ALDOMET looks like

ALDOMET is a yellow, round tablet with '250' marked on one side and 'ALDOMET' on the other side. A bottle contains 100 tablets.

(AUST R 34361)

Who distributes ALDOMET

Aspen Pharmacare Australia Pty Ltd
34‐36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was revised in August 2024

Published by MIMS November 2024

1 Name of Medicine

Methyldopa (as sesquihydrate).

2 Qualitative and Quantitative Composition

Aldomet 250 mg, yellow, biconvex, circular shaped tablet, film coated "250" on one side and "ALDOMET" on the other.
Each Aldomet tablet contains 250 mg of the active methyldopa (as sesquihydrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.1 Therapeutic Indications

Hypertension (mild, moderate to severe).

4.2 Dose and Method of Administration

General.

Adults.

Children.

4.3 Contraindications

Aldomet is contraindicated in patients:
with active hepatic disease, such as acute hepatitis and active cirrhosis;
with hypersensitivity (including hepatic disorders associated with previous methyldopa therapy) to any component of these products (see Section 4.4 Special Warnings and Precautions for Use);
on therapy with monoamine oxidase (MAO) inhibitors;
with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma;
with porphyria.

4.4 Special Warnings and Precautions for Use

Anaemia.

Coombs test.

Fever and hepatic function.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Lithium.

Other antihypertensive drugs.

Iron.

Monoamine oxidase (MAO) inhibitors.

4.6 Fertility, Pregnancy and Lactation

(Category A)
Category A of Australian Categorisation Risk of Drug Use in Pregnancy: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Aldomet has been used under close medical and obstetric supervision for the treatment of hypertension during pregnancy. There was no clinical evidence that Aldomet caused foetal abnormalities or affected the neonate.
Methyldopa does cross the placental barrier and appears in cord blood.
Although no obvious teratogenic effects have been reported, the possibility of foetal injury cannot be excluded and the use of the drug in women who are or may become pregnant requires that anticipated benefits be weighed against possible risks.
Methyldopa appears in breast milk. Therefore, caution should be exercised if Aldomet is given to a breastfeeding mother.

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medication on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. Headache, asthenia, or weakness may be noted as early and transient symptoms.
Significant adverse effects due to Aldomet have been infrequent and this agent is usually well tolerated.
The following reactions have been reported:

Central nervous system.

Cardiovascular.

Gastrointestinal.

Hepatic.

Haematological.

Allergic.

Dermatological.

Other.

Reporting suspected adverse events.

4.9 Overdose

Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distention, flatus, diarrhea, nausea, vomiting).
In the event of overdosage, symptomatic and supportive measures should be employed. When ingestion is recent, gastric lavage or emesis may reduce absorption. When ingestion has been earlier, infusions may be helpful to promote urinary excretion. Otherwise, management includes special attention to cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function, and cerebral activity.
Sympathomimetic drugs (e.g. levarterenol, noradrenaline, metaraminol bitartrate) may be indicated. Methyldopa is dialyzable.
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

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Carnauba wax, citric acid, citric acid monohydrate, colloidal anhydrous silica, ethylcellulose, guar gum, hypromellose, iron oxide red, magnesium stearate, powdered cellulose, propylene glycol, purified talc, quinoline, yellow aluminium lake, sodium calcium edetate, 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

3 years.

6.4 Special Precautions for Storage

Store below 30 degrees Celsius.

6.5 Nature and Contents of Container

White HDPE bottles containing 100 tablets.

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

Methyldopa is a white to yellowish white crystalline powder or almost colourless crystals. It is odourless and almost tasteless. It is slightly soluble in water and in ethanol (96%), and is practically insoluble in ether and in chloroform. It dissolves in dilute mineral acids.
Methyldopa is the l-isomer of alpha-methyldopa. Chemical name: (-)-3-(3, 4-dihydroxyphenyl)- 2-methyl-l- alanine sesquihydrate. Molecular formula: C₁₀H₁₃NO₄.1½ H₂O. MW: 238.2.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes