ALENAMI™

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Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ALENAMI. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. If you need any more information about ALENAMI please ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you taking ALENAMI against the benefits it can 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 want to read it again

What ALENAMI capsules is used for

The name of your medicine is ALENAMI. ALENAMI capsules contain the active ingredient, phentermine. Phentermine is combined with a resin which slowly releases the phentermine so the effect of ALENAMI lasts all day.

ALENAMI is used to reduce body weight in obese or overweight patients. Your doctor will assess whether ALENAMI is suitable for you.

ALENAMI works by directly affecting the area of the brain that controls your appetite making you feel less hungry.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

ALENAMI should be used as a part of an overall weight management plan which should include a medically controlled diet and exercise program.

ALENAMI is available only with a doctor’s prescription.

Your doctor may prescribe ALENAMI for another purpose. If you are not sure why you are taking this medicine ask your doctor.

Before you are given it

When you must not take it

Do not take ALENAMI if you have an allergy to:

• any medicine containing phentermine
• any of the ingredients listed at the end of this leaflet
• any other similar medicines used to reduce weight

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 12 years. Safety and effectiveness in children younger than 12 years have not been established.

Do not take this medicine if you have any of the following medical conditions:

• very high blood pressure
• high blood pressure in the lung
• problems with the valves in your heart
• disease related to blood vessels in the brain
• severe heart disease including changes in the rhythm or rate of the heart beat
• narrowing of the blood vessels due to thickening or hardening of the blood vessel wall
• overactive thyroid gland
• psychiatric illness including anorexia nervosa (loss of appetite) and depression
• glaucoma (high pressure in the eye)

Do not use this medicine:

• if you are currently taking, or have taken within the last 14 days, antidepressant medicines from the mono-amine oxidase inhibitor (MAOI) class such as phenelzine (eg Nardil) or tranylcypromine (eg Parnate).
• if you have previously misused drugs or alcohol

You must not be given 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 be given this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor or pharmacist can discuss with you the risks and benefits involved.

Tell your doctor if you:

• have high blood pressure
• have heart disease such as angina (chest pain)
• have diabetes
• have epilepsy

If you have not told your doctor about any of the above, tell him/ her before you start taking ALENAMI. Your doctor can discuss with you the risks and benefits involved.

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.

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

• any medicines for weight reduction
• any medicines for depression or obsessive compulsive disorder such as fluoxetine (eg Prozac, Erocap, Lovan, Zactin); sertraline (eg, Zoloft); paroxetine (eg Aropax); clomipramine (eg Anafranil, Placil)
• ergot-like medicines for migraine such as ergotamine (eg Cafergot, Ergodryl, Migral)
• any cough and cold remedies containing pseudoephedrine, phenylpropanolamine or phenylephrine
• thyroid hormones
• any medication for mental illness
• medicines for lowering high blood pressure including clonidine, methyldopa or guanethidine.

These medicines may be affected by ALENAMI 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 ALENAMI

Carefully follow all directions given to you by your doctor or pharmacist and never change the dose yourself. 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

In adults and children over 12 years, the usual dose of ALENAMI is one capsule every day. However, your doctor will prescribe the right dose for you.

Increasing the dose may not necessarily make you lose more weight or make you lose weight faster. However you will most likely experience more side effects. Your doctor will tell you how long you are to take ALENAMI for.

How to take it

Swallow the capsules whole with plenty of water. Do not chew or open the capsules.

When to take it

Take ALENAMI first thing in the morning, at breakfast time so that it does not keep you awake at night. 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.

ALENAMI is not recommended for elderly patients or for children younger than twelve years.

How long to take it

Take this medicine as long as your doctor tells you to.

If you forget to take it

If you forget to take your ALENAMI dose at breakfast take it no later than lunch time. Alternatively, skip the dose you missed and take your next dose at the normal time on the next day. If you take ALENAMI any later than lunch-time you may have trouble sleeping at night.

Never take a double dose to make up for a dose you have missed. If you have trouble remembering when 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 (Australia: telephone 13 11 26; New Zealand: 0800 POISON or 0800 764 766) 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 ALENAMI. Do this even if there are no signs of discomfort or poisoning. You may need urgent attention.

While you are using ALENAMI

If you are about to be started on any new medicine remind your doctor and pharmacist that you are taking ALENAMI.

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. It may interfere with the results of some tests.

Keep all of your doctor’s appointments so that your progress can be checked.

Tell your doctor immediately if you experience sudden or rapid weight loss, difficulty breathing, chest pain, fainting, and swelling of the lower limbs and if you cannot exercise as much as you usually can.

Things you must not do

Do not take ALENAMI 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.

Things to be careful of

Be careful driving or operating machinery until you know how ALENAMI affects you.

DO NOT drink alcohol whilst taking ALENAMI.

Check with your doctor or pharmacist before you start to take any cough or cold medication.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking ALENAMI.

This medicine helps most people with a weight problem 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 immediately or go to Accident and Emergency at your nearest hospital if you experience:

• heart attack
• stroke
• angina
• myocardial infarction

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• feeling more awake than usual
• trouble sleeping
• your heart seems to beat faster and harder
• your blood pressure may be raised slightly
• irregular heart beats
• chest pain
• feeling restless
• feelings of extreme happiness followed by depression and tiredness
• nervousness
• tremor (shaking)
• headache
• dizziness
• nausea
• vomiting
• diarrhoea or constipation
• stomach cramps

Tell your doctor as soon as possible if you notice any of the following:

• sudden or rapid weight loss
• difficulty breathing
• chest pain
• fainting
• swelling of the lower limbs
• or if you cannot exercise as much as you usually can
• dry mouth or an unpleasant taste in your mouth
• difficulty passing urine
• skin rashes
• impotence
• changes in sexual drive
• swelling of the face

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 ALENAMI

Storage

Keep your capsules in the blister foil in the carton until it is time to take them. If you take the capsules out of the pack they may not keep well.

Keep ALENAMI in a cool dry place where the temperature stays below 30°C.

Do not store ALENAMI or any other medicine in the bathroom or near a sink. Do not leave them on a windowsill or in the car.

Protect from light.

Heat and dampness can destroy some medicines.

Keep them where children cannot reach them. 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

What ALENAMI looks like

ALENAMI capsules are available in three strengths in packs of 30 capsules:

15 mg – AUST R 319359
Grey and green capsule, marked with “15” in black ink

30 mg – AUST R 319419
Grey and reddish brown capsule, marked with “30” in black ink

40 mg – AUST R 319420
Grey and orange capsule, marked with “40” in black ink

Ingredients

ALENAMI capsules contain:

• phentermine
• lactose
• liquid paraffin
• magnesium stearate
• gelatin
• titanium dioxide
• iron oxide black (CI 77499)

In addition:

ALENAMI 15 mg contains:

• brilliant blue FCF (CI 42090)
• sunset yellow FCF (CI 15985)
• quinolone yellow (CI 47005)

ALENAMI 30 mg contains:

• iron oxide red (CI 77491)

ALENAMI 40 mg contains:

• erythrosine (CI 45430)
• sunset yellow FCF (CI 15985).

ALENAMI capsules are gluten-free.

Sponsor

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

Australian Registration Numbers:

AUSTR 319359 ALENAMI phentermine
15mg sustained release capsules

AUSTR 319419 ALENAMI phentermine
30mg sustained release capsules

AUSTR 319420 ALENAMI phentermine
40mg sustained release capsules

This leaflet was revised in May 2021

Published by MIMS March 2022