AMANTAMED

AMANTAMED

Active ingredient(s): amantadine hydrochloride

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Consumer Medicine Information (CMI)

This leaflet provides important information about using AMANTAMED. 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 AMANTAMED.

Where to find information in this leaflet:

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

1. Why am I using AMANTAMED?

AMANTAMED contains the active ingredient amantadine hydrochloride. AMANTAMED is in a class of medications called adamantanes.

AMANTAMED is used to:

1. To treat the symptoms of Parkinson’s disease

Parkinson’s Disease

Parkinson’s Disease is caused by a disturbance in the balance of two substances, dopamine and acetylcholine, that the brain uses to send signals to other parts of the body.

AMANTAMED helps to fix the imbalance of too little dopamine and/or too much acetylcholine; and to relieve the symptoms, such as shaking of the limbs, stiffness and slowness of movement which make it difficult to perform usual tasks. AMANTAMED can be used alone or with other medicines to treat this condition.

2. To prevent a type of influenza (“the flu”) caused by Type A influenza virus.

AMANTAMED is usually used for people who could become very ill if they get the flu infections (for example, people who have a serious illness such as lung disease or diabetes). Usually these people will have been vaccinated (had a flu shot). But if, for some reason, they have not been vaccinated, AMANTAMED can be given.

AMANTAMED is only used to prevent Type A influenza. It will not help once you have the flu. This medicine cannot prevent or treat colds, other types of flu not caused by Type A virus, or other viral infections.

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 purpose. This medicine is only available with a doctor’s prescription.

It is not habit-forming.

There is not enough information to recommend this medicine for children under five years of age.

2. What should I know before I use AMANTAMED?

Warnings

Do not use AMANTAMED if:

you are allergic to amantadine 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.

Check with your doctor if you:

have any of the following health problems or medical conditions:

• kidney or liver disease
• seizures (fits)
• a mental health condition
• heart disease or circulation problems
• stomach ulcers
• low blood pressure
• increased pressure in the eyes (glaucoma)
• prostate trouble
• recurring skin problems (eczema)

You may need to take different amounts of your medicines or to take different medicines while you are taking AMANTAMED.

Your doctor will want to know if you are prone to allergies.

Ask your doctor for advice if you think you may be allergic, if you have ever had any unusual sensitivity, rash or other possible signs of allergy.

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

Do not take AMANTAMED if you are pregnant.

It may affect your unborn baby if you take it while you are pregnant.

Tell your doctor if you are breastfeeding.

The active ingredient in AMANTAMED passes into the breast milk and could affect your baby. Your doctor can discuss with you the risks and benefits of breast-feeding while you are taking this medicine.

Women of child-bearing potential should use an efficient contraceptive method during treatment and for 5 days after taking their last dose of AMANTAMED. If you become pregnant while taking AMANTAMED, tell your doctor immediately.

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 may interfere with AMANTAMED and affect how it works. These include:

• other medicines for Parkinson’s disease
• medicines for depression or other mental disorders
• other medicines that affect the nervous system (e.g. medicines to help you sleep or calm you down, pain relievers, alcohol)
• medicines for abdominal or stomach cramps or spasms.
• some combination diuretics (water or fluid pills) used to treat high blood pressure (hydrochlorothiazide and triamterene)

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

4. How do I use AMANTAMED?

Take the capsule after a meal or snack.

Swallow the whole capsule with a full glass of water. Do not chew, break, or crush the capsule.

Follow all directions given to you by your doctor and pharmacist carefully.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take AMANTAMED

Follow your doctor’s instructions on how many AMANTAMED capsules to take.

This is important as there are two different ways to take this medicine, depending on whether you are being treated for Parkinson’s disease or for Type-A influenza.

1. For Parkinson’s disease

Start treatment with one capsule taken daily and gradually increase to one capsule taken twice a day. Occasionally, higher doses are needed.

2. For Type A influenza

Children aged 5 to 9 years: Take only one capsule each day.

Children aged 10 or older: Take one capsule twice daily.

Adolescents and adults up to age 65 years: Take one capsule twice daily.

Adults over 65 years: Take one capsule each day. In elderly patients without impaired kidney function: Do not take more than 100 mg daily unless prescribed by your doctor.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions that they give you. For people who are elderly or have reduced kidney function, the dose may need to be reduced or taken less frequently.

Do not change the dose or dosing interval yourself, without your doctor’s advice, regardless of how well you may feel.

When to take AMANTAMED

AMANTAMED capsules should be taken at about the same times each day, as directed by your doctor or pharmacist.

Taking your medicine at the same times each day will have the best effect. It will also help you remember when to take your capsules.

To treat Parkinson’s disease

Adults up to 65 years old: For the first week, take your medicine once daily. After the first week, take one capsule twice daily.

Adults over 65 years old: Take only one capsule daily.

To treat Type A influenza

Children aged 5 to 9, and adults over 65 years old: Take only one capsule daily.

Children aged 10 and older & adults to 65 years: Take one capsule twice each day, starting as soon as possible after exposure to the flu virus.

If side effects occur, the dose can be reduced to one capsule daily.

People with reduced kidney function due to increasing age or kidney disease: Take as directed by your doctor, as you may be reduced to one capsule every 2 to 7 days to help prevent side effects.

How long to take AMANTAMED

To treat Parkinson’s disease

You may need to take AMANTAMED for a long time to control your symptoms.

Do not stop taking this medicine or lower the dose without first checking with your doctor. If it is necessary to stop your medicine, your doctor will gradually reduce the amount you take each day before stopping it completely.

Some people find that this medicine loses some of its effect after several weeks. In this case, your doctor may gradually reduce the dose and stop it for a few weeks, and then start it again to see if the benefit can be regained.

Do not let yourself run out of medicine over the weekend or on holidays. Stopping your medicine may make your condition worse or cause severe side effects.

To treat Type A influenza virus

Keep taking AMANTAMED for at least 10 days.

Sometimes it may be necessary to keep taking it until the outbreak of influenza is over.

If you forget to use AMANTAMED

AMANTAMED should be used regularly at the same time each day. If you miss your dose at the usual time, take the dose as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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

This may increase the chance of you getting an unwanted side effect.

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

If you use too much AMANTAMED

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

Some of the symptoms of an overdose may include stiffness or unusual muscle movements, seizures (fits), vomiting, difficulty breathing, fast or irregular heartbeat.

5. What should I know while using AMANTAMED?

Things you should do

Continue taking AMANTAMED as your doctor tells you.

Call your doctor straight away if you:

• skin does appear to be burning. When you are outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sunlamp or tanning bed or booth. This medicine may cause your skin to be much more sensitive to sunlight than it normally is. Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn.
• you develop blurred vision or other visual problems. Your doctor can refer you to an ophthalmologist who will evaluate and may advise you to stop your treatment with AMANTAMED.
• you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

Before having any surgery or emergency treatment, tell the doctor or dentist that you are using AMANTAMED.

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

Things you should not do

• Do not exceed the recommended dosage.
• Do not give this medicine to anyone else, even if their condition seems similar to yours.
• Do not use it to treat any other complaints unless your doctor tells you to.

Driving or using machines

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

AMANTAMED may cause dizziness, confusion, difficulty concentrating, impair your reactions, or cause blurred vision in some people.

Children should avoid doing things like riding bicycles or climbing trees.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may make you more dizzy or lightheaded than usual.

Looking after your medicine

Keep your medicine in the original container until it is time to take it.

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-anda-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?

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

Less serious side effects

What to do

strong impulse to gamble excessively increased sexual drive or interest uncontrollable excessive shopping or spending binge eating or compulsive eating dizziness or lightheadedness, especially when you get up too quickly from a sitting or lying position purplish-red blotchy spots on the skin, especially of the legs or feet and sometimes in a fish-net pattern. These may appear after taking AMANTAMED for a few months and usually go away gradually within a few weeks after stopping the medicine. symptoms of sunburn (such as redness, itching, swelling or blistering of the skin) that happen more quickly than normal indigestion, loss of appetite, nausea (feeling sick) or vomiting constipation or diarrhoea blurred vision dry mouth swelling of feet or lower legs due to fluid buildup feeling of fast or irregular heartbeat tiredness or listlessness difficulty concentrating nervousness, anxiety or depression disturbed sleep or nightmares weakness, shakiness or trembling difficulty urinating (passing water) or inability to hold your urine (incontinence) excessive sweating headache hair loss

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing, accelerated or troubled breathing stiff, rigid muscles accompanied by a sudden increase in body temperature, sweating, fast heartbeat and feeling disoriented movement disorders constant “flu-like” symptoms such as chills, fever, sore throat, aching joints, sores in mouth, swollen glands fainting spells or seizures (fits) difficulty in speaking or slurred speech confusion, disorientation or hallucinations (seeing, hearing or feeling things that are not there) abnormally high energy or level of activity (mania) sudden loss of vision or trouble focussing your eyes properly yellow colour to the skin and eyes abnormally low body temperatures (below 35°C) in children treated for influenza

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.

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 AMANTAMED contains

Active ingredient (main ingredient)	100 mg of amantadine hydrochloride
Other ingredients (inactive ingredients)	lactose Monohydrate povidone magnesium stearate iron oxide red titanium dioxide gelatin purified water may contain traces of sulfites. The ink contains: shellac ethanol absolute isopropyl alcohol butan-1-ol propylene glycol strong ammonia solution black iron oxide potassium hydroxide iron oxide black purified water
Potential allergens	AMANTAMED contains lactose monohydrate and may contain traces of sulfites.

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

What AMANTAMED looks like

AMANTAMED capsules are size “4” plain hard gelatin capsules with brownish-red colored cap and body.

AUST R 398492

Who distributes AMANTAMED

Medsurge Healthcare Pty Limited
Unit 1& 2, 6-7 Gilda Court
MULGRAVE VICTORIA 3170
Tel: 1300 788 261

http://www.medsurge.com.au

This leaflet was prepared in September 2023.