ACTIQ LOZ. 200mcg(as citrate). 30 x 2 = 60 packs

Description:

Actiq Lozenge contains a medicine called fentanyl citrate. Fetanyl is a strong pain-relieving medicine and belongs to a group of medicine known as opioids.

 

Actiq®

lozenge with integral applicator

fentanyl citrate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions

about Actiq. It does not contain all of 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 your taking

Actiq against the benefits they expect it will

have for you.

If you have any concerns about taking

Actiq, talk to your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What Actiq is used for

Actiq contains a medicine called fentanyl

citrate. Fentanyl is a strong pain-relieving

medicine and belongs to a group of medicine

known as opioids.

Actiq lozenge with integral applicator is a

system for delivering fentanyl directly

through the lining of the mouth. When you

place Actiq in your mouth, it dissolves and

the medicine is absorbed through the lining

of your mouth, into the blood system. Taking

the medicine in this way allows it to be

absorbed very quickly to relieve your

breakthrough pain.

Breakthrough pain is additional sudden pain

that occurs in spite of you having taken your

usual opioid pain-relieving medicines.

Keep using the opioid pain medicine you

take for your persistent (around-the-clock)

cancer pain during your Actiq treatment.

Opioid medicines are those that contain

active ingredients such as morphine, fentanyl

citrate, codeine, methadone, oxycodone,

pethidine or buprenorphine.

The use of Actiq by people who are not

taking prescription opioid medicines on a

regular basis could result in life-threatening

side effects.

Ask your doctor if you have any questions

about why Actiq lozenges have been

prescribed for you.

Your doctor may have prescribed it for

another use.

Medicines like Actiq can lead to addiction.

This is unlikely when Actiq is used correctly.

Actiq is only available on a doctor's

prescription.

Before you take it

Actiq is not suitable for everyone.

When you must not take it

Do not take Actiq if:

• you have short term pain, including pain

from injuries, from doctors or dentists

visits, surgery or headaches/migraines

• you have not been using a prescribed

opioid pain medicine every day on a

regular schedule, for at least one week,

to control your persistent pain. This may

increase the risk that your breathing

could slow down to a dangerous level, or

even stop

• you are allergic to fentanyl, or any of the

other ingredients in the formulation (see

list at the end of this leaflet)

• you are pregnant or breast feeding,

unless your doctor tells you it is safe.

Do not take Actiq after the expiry date

shown on the blister package label and the

carton.

The unit is normally white however, a

slightly mottled appearance may occur on

storage. This is due to slight changes in the

flavouring of the product and does not affect

how the product works in any way.

Do not take Actiq if the packaging seems

to have been opened.

If you become pregnant whilst taking

Actiq, you should stop taking it and see

your doctor immediately.

Young women taking Actiq and who are at

risk of becoming pregnant should make sure

that they are using adequate contraception.

Before you start to take it

Tell your doctor if:

• you have any allergies

• you are pregnant or intend to become

pregnant

• you are breast feeding or planning to

breast feed

• your other opioid pain medicine you

take for your persistent (around-theclock)

cancer pain is not stabilized yet

• you have or have had any of the

following medical conditions:

- chronic diseases of the lung, or other

condition which has an effect on your

breathing

- head injury

- diabetes

- exceptionally slow heart rate

- liver or kidney disease.

These organs have an effect on the way in

which your system breaks down the

medicine.

Taking other medicines

Tell your doctor if you are taking any

other medicines, including any that you

buy without a prescription from your

pharmacy, supermarket or health food

store.

Take special care with Actiq if:

• you are taking any medicines which

might normally have a sedative effect

(make you sleepy), such as:

- sleeping pills

- medicines to treat anxiety

- antihistamines

- tranquillisers.

• you are taking any medicines or other

substances that might have an effect on

the way in which your body breaks

down Actiq, such as:

- drugs used to treat fungal infections

- certain antibiotics

- grapefruit juice.

• Antidepressants of the serotonergic type.

Taking Actiq with these may increase

the risk of serotonergic syndrome, a

potentially life threatening condition

• you intend to drink alcohol, drive, or

operate machinery in the few hours after

taking Actiq. Your doctor will be able to

advise you on this.

How to take it

Do not take Actiq to treat any condition

other than that directed by your doctor.

How many to take

Your doctor will advise you on the

appropriate starting dose of Actiq for the

relief of your breakthrough pain.

Ask your doctor if you are not sure about

the right dose or if you have any questions

about taking Actiq.

It is very important that you use this

medicine in the manner as directed by your

doctor.

You should start to feel some pain relief

quickly while you are taking Actiq.

Until the dose that effectively controls your

breakthrough pain has been determined, if

you do not get enough pain relief from just

one Actiq, your doctor may allow you to use

a second dose to treat an episode of

breakthrough pain.

Do not use a second Actiq unit unless your

doctor tells you to do so and never use

more than two Actiq units to treat a single

episode of breakthrough pain.

It is recommended that you wait at least 4

hours before treating another episode of

breakthrough pain with Actiq.

You must tell your doctor immediately if

you are using Actiq more than four times

per day, as the doctor may wish to change

your medicine for your persistent pain.

Once your persistent pain has been

controlled, your doctor may need to change

your dose of Actiq further.

For best results, let your doctor know

about your pain and how Actiq is working

for you so that the dose can be changed if

needed.

Do not change doses of Actiq or your

other pain medicines on your own.

Contact your doctor if your right dose of

Actiq does not relieve your breakthrough

pain. Your doctor will decide if your dose

needs to be changed.

DO NOT TAKE MORE THAN THE

DOSE YOUR DOCTOR HAS

RECOMMENDED.

Change in dosage must be directed and

monitored by your doctor.

How to take it

1. Each Actiq unit is sealed in its own

blister package.

Do not open the package until you are

ready to use it.

Hold the blister package with the printed

side away from you. Grasp the short tab

end of the blister package. Place scissors

close to the end of the Actiq unit and cut

the long tab end completely off (as

shown). Separate the printed backing

from the blister package and pull the

printed backing completely off the

blister package.

Remove the Actiq unit from the blister

package.

2. Place Actiq in your mouth between your

cheeks and gums. Using the handle,

move it around in your mouth especially

along your cheeks. Twirl the handle

often.

You may drink some water before

using Actiq, to help with taking the

product but you should not drink or

eat anything while using Actiq.

3. To get the most effective relief, finish

the Actiq completely in 15 minutes. If

you finish it too quickly, you will

swallow more of the medicine and get

less relief of your breakthrough pain.

It is also most important that you do

not bite or chew Actiq for the same

reason.

4. If you begin to feel dizzy or sick before

you have finished the medicine, remove

the Actiq unit from your mouth and

dispose of it immediately, as instructed

in this leaflet. If for some reason you are

not finishing the entire Actiq unit each

time you have an episode of

breakthrough pain, you should call your

doctor.

5. Once a dose has been arrived at which

effectively controls your pain, you

should not use more than four units of

Actiq per day. If you think you might

need to use more than four Actiq units

per day, you should notify your doctor

immediately.

6. Do not use more than two Actiq units

to treat a single episode of

breakthrough pain.

Taking Actiq with food or drink

Actiq may be used before or after but not

during meals. You may drink some water

before using Actiq to help moisten your

mouth, but you should not drink or eat

anything while taking the medicine.

When to take it

Actiq must only be used for breakthrough

pain. Breakthrough pain is additional sudden

pain that occurs in spite of you having taken

your usual opioid pain-relieving medicines.

How long to take it

You should not normally stop taking Actiq

for breakthrough pain unless your doctor

tells you to.

If you are taking high doses of Actiq and

feel that the pain is getting worse with

time please speak to your doctor.

Tell your doctor if you feel unwell during

your course of treatment.

On the advice of your doctor, you may stop

taking Actiq if you are no longer

experiencing breakthrough pain. There are

usually no noticeable effects if you stop

taking Actiq. You should continue to take

your usual opioid medicine to treat your

persistent (around-the-clock) pain as

instructed by your doctor.

How to dispose of Actiq after use

Partially used Actiq units may contain

enough medicine to be harmful or lifethreatening

to a child.

Even if there is little or no medicine left on

the handle, the handle itself must be properly

disposed of, as follows:

• If the medicine is totally gone, throw the

handle away in a waste container that is

out of reach of children and pets.

• If any medicine remains on the handle,

place the unit under hot running water to

dissolve the remainder and then throw

the handle away in a waste container that

is out of reach of children and pets.

• If you do not finish the entire Actiq unit

and you cannot immediately dissolve the

remaining medicine, put the Actiq unit

out of reach of children and pets until

such a time as you can dispose of the

partially used Actiq unit as instructed

above.

• Do not flush partially used Actiq units,

Actiq handles, or the blister packaging

down the toilet.

If you take too many Actiq units

(overdose)

Immediately telephone your doctor or the

Poisons Information Centre (telephone 13

11 26) for advice, or go to Accident and

Emergency at your nearest hospital if you

think that you or anyone else may have

taken too many Actiq units.

Do this even if there are no signs of

discomfort or poisoning.

The most common side effects are feeling

sleepy, sick or dizzy. If you begin to feel

very sleepy, remove the Actiq unit from your

mouth and call another person to help you.

A serious side effect of Actiq is slow shallow

breathing. This can occur if your dose of this

medicine is too high or if you take too much

Actiq. You and your carer should discuss this

side effect with your doctor.

Note to carers

If you see that the patient taking Actiq has

slow breathing or if you have a hard time

waking the person up, take the following

steps IMMEDIATELY:

1. Using the handle, remove the Actiq unit

from the person's mouth and keep it out

of reach of children or pets until the

Actiq unit is disposed of.

2. CALL FOR EMERGENCY HELP.

3. See instructions below for what to do if

a child or adult accidentally takes Actiq.

What to do if a child or adult

accidentally takes Actiq

If you think someone has accidentally

taken Actiq follow these steps:

1. If the person is asleep, wake them up by

calling their name and shaking their arm

or shoulder.

2. CALL FOR EMERGENCY HELP.

3. While waiting for emergency help:

- if the person seems to be breathing

slowly, prompt them to breathe every 5-

10 seconds

- if the person has stopped breathing

give mouth to mouth resuscitation until

help arrives.

If someone has accidentally taken Actiq, they

may have the following symptoms:

• very sleepy

• itching, especially around the nose and

eyes

• dizzy

• feeling sick or vomiting

• not breathing or breathing very slowly.

While you are taking it

Things you must do

Make sure that all of your doctors and

pharmacists know about your use of

Actiq. Remind them if any new medicines

are about to be started, including any

medicines that you may purchase without

a prescription.

Things that you must not do

Do not use Actiq to treat any other

complaints unless your doctor tells you to.

It may not be safe to use Actiq for another

complaint.

Do not give Actiq to someone else even if

their symptoms are the same.

Actiq should only be used by the person for

whom it was prescribed. It may not be safe

for another person to use Actiq.

Side Effects

Tell your doctor or pharmacist as soon as

possible if you do not feel well while you

are taking this medicine.

Like all medicines, Actiq can cause side

effects. Sometimes they are serious, most of

the time they are not. You may need medical

treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer

any questions you may have.

Tell your doctor if you notice any of the

following and they worry you:

• headache

• nausea/vomiting

• feeling unwell

• weakness, dizziness

• sleepiness, sedation

• constipation

• anxiety

• anorexia

If you feel excessively dizzy, sleepy or

otherwise ill while taking Actiq, use the

handle to remove the Actiq unit and dispose

of it according to the instructions given in

this leaflet. Then contact your doctor for

further directions on using Actiq.

Do not drive or operate machinery if you

are feeling sleepy, dizzy or have difficulty

in concentrating.

Tell your doctor immediately, or get

someone to take you to Accident and

Emergency at your nearest hospital if you

notice any of the following:

• becoming very sleepy

• having slow or shallow breathing

• sudden signs of allergy such as rash,

itching or hives on the skin, swelling of

the lips, tongue or throat, shortness of

breath, wheezing or trouble breathing.

• if you have some or all of the following

symptoms you may have something

called serotonin syndrome: feeling

confused, feeling restless, sweating,

shaking, shivering, hallucinations,

sudden jerks in your muscles or a fast

heart beat

Whilst using the Actiq lozenge you may

experience irritation, pain, gum bleeding or

an ulcer at the site of application.

Tell your doctor if you notice anything else

that is making you feel unwell.

Other side effects not listed in this leaflet

may also occur in some patients.

Do not be alarmed by this list of possible

side effects.

You may not experience any of them.

After using it

Storage

Keep Actiq lozenges in their individual

blister package and carton box until it is

time to take the dose.

If you take Actiq out of its blister package, it

may not keep as well.

Do not use it if the blister package has

been damaged or opened before you are

ready to use it.

Keep Actiq in a cool dry place where the

temperature stays below 30°C.

Do not store it or any other medicine in

the bathroom or near a sink. Do not leave

it in the car on hot or cold days.

Heat, cold and dampness can destroy some

medicines.

Actiq lozenges must be kept out of the

reach of children.

The pain-relieving medicine in Actiq is very

strong and could be life-threatening if taken

accidentally by a child.

A locked cupboard at least one-and-a-half

metres above the ground is a good place to

store medicines.

Disposal

Return all unused units to the pharmacist

or doctor if you are no longer using Actiq

or if you have unwanted units.

Product description

What Actiq looks like

The Actiq unit consists of a white to offwhite

solid medication attached to a handle

(applicator).

Each unit contains either 200 micrograms,

400 micrograms, 600 micrograms, 800

micrograms, 1200 micrograms or 1600

micrograms of the active ingredient fentanyl.

The dosage strength is marked on the

medication, on the handle and on the blister

package to ensure that you are taking the

right medicine.

Each blister package contains one individual

Actiq unit.

Ingredients

Active ingredient:

The active ingredient is fentanyl, present in

the product as fentanyl citrate.

Inactive ingredients:

Dextrates, citric acid, dibasic sodium

phosphate, artificial berry flavour

(maltodextrin, propylene glycol, artificial

flavours, and triethyl citrate), magnesium

stearate, confectioner's sugar (as sucrose and

maize starch), purified water, and starch

sodium octenyl succinate (E1450). The

imprinting ink used contains de-waxed white

shellac and brilliant blue FCF CI42090.

Each unit of Actiq provides approximately 2

grams of glucose load from the dextrates.

Actiq is supplied in Australia by:

Teva Pharma Australia Pty Ltd

37 Epping Rd.

Macquarie Park

NSW 2113

Telephone: 1800 288 382

Australian Registration Numbers:

Actiq 200 micrograms: AUST R 91598

Actiq 400 micrograms: AUST R 91600

Actiq 600 micrograms: AUST R 91601

Actiq 800 micrograms: AUST R 91602

Actiq 1200 micrograms: AUST R 91603

Actiq 1600 micrograms: AUST R 91604.

ACTIQ is a registered trademark of Teva

Pharmaceutical Industries Limited

This leaflet was revised in August 2017.

 

While all efforts have been made to ensure that ingredient listings are accurate, up to date and complete for products on the Superpharmacy website, suppliers may change formulations on short notice. Please check ingredient listings on the actual product before use. 
www.superpharmacy.com.au Australia's best source for prescriptions online.