Revised: 11 June 2015

Information for Consumers

Consumer Medicine Information

DOZILE^®

Doxylamine succinate 25mg capsules

What is in this leaflet

Please read this leaflet carefully before you start taking DOZILE. This leaflet answers some common questions about DOZILE. It does not contain all the available information.

It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking DOZILE against the benefits they expect it will have for you.

Use DOZILE as instructed and follow the advice given in this leaflet.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine. You may need to read it again.

What DOZILE is used for

DOZILE is used to help in the temporary relief of sleeplessness. If you have trouble falling asleep, your doctor or pharmacist will advise you if DOZILE may help.

Ask your doctor or pharmacist if you have any questions about why DOZILE has been recommended for you.

How DOZILE works

DOZILE capsules contain doxylamine succinate. Doxylamine succinate is a type of antihistamine called an ethanolamine derivative antihistamine. It has a sedating effect.

Before taking DOZILE

When you must not take it

Do not take DOZILE if:

• you have an allergy to doxylamine succinate, other ethanolamine derivative antihistamines or any of the ingredients listed at the end of this leaflet. If you are not sure if you have such an allergy to DOZILE, check with your pharmacist or doctor.
• the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.
• the packaging is torn or shows signs of tampering.
• you are having an acute asthma attack.

Do not take DOZILE to treat any other complaint unless your pharmacist or doctor tells you to.

Before you start to take it

Tell your pharmacist or doctor if you have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes.

Tell your pharmacist or doctor if you are pregnant or are planning to become pregnant, or you are breastfeeding or plan to breastfeed. DOZILE should be avoided during pregnancy or lactation.

Tell your pharmacist or doctor if you have or have had any medical conditions, especially the following:

• narrow angle glaucoma
• difficulty passing urine
• prostate problems
• a blockage in your stomach (pyloroduodenal obstruction)
• epilepsy
• a problem with your heart or blood vessels.

If you have not told your pharmacist or doctor about any of these things, tell them before you start taking DOZILE.

Do not give this medicine to anyone else even if they have the same condition as you.

Taking other medicines

Tell your pharmacist or doctor about any other medicines you are taking including medicines that you buy without a prescription, in a pharmacy, supermarket or health food shop.

These medicines may affect the way DOZILE works.

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

• Some medicines for treating depression
• Some medicines that treat loss of bladder control
• Tranquillisers or medicines used to treat anxiety
• Alcohol
• Sleeping tablets
• Some antihistamines.

Other medicines that may affect the way DOZILE works include medicines for stomach spasms or cramps.

Ask your pharmacist or doctor if you are not sure if you are taking any of these medicines.

Your pharmacist or doctor may have more information on medicines to be careful with or to avoid while taking DOZILE.

Using DOZILE

How to take it

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

They may differ from the information contained in this leaflet.

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

Swallow 1 capsule whole with a glass of water 30 minutes before bedtime.

Do not exceed the recommended dosage.

Elderly people may be more sensitive to the effects of DOZILE. If you have any doubts about the dose you should take, discuss this with your pharmacist or doctor.

DOZILE is not recommended for children under 12 years of age.

If you forget to take it

If you forget to take DOZILE before you go to bed and you wake up late in the night or early in the morning, do not take a dose then as you may have trouble waking in the morning.

If you have any questions about this, ask your pharmacist or doctor.

Do not try to make up for missed doses by taking more than one dose at a time because 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 take too much (overdose)

Immediately telephone your doctor or the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) or go to Accident & Emergency at your nearest hospital if you think you or anyone else has taken too much DOZILE, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take too much DOZILE you may have the following symptoms:

• dry mouth
• dilated and fixed pupils
• flushing
• stomach upsets
• sleeplessness
• nervousness
• over excitement
• irritability
• tremors
• nightmares
• hallucinations
• fits
• fast heartbeat
• coma
• heart attack
• stopping breathing.

While you are taking DOZILE

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are taking DOZILE.

If you are about to start on any new medicine, tell your doctor, dentist or pharmacist that you are taking DOZILE.

See your doctor if you are still suffering from sleeplessness after taking DOZILE for 2 weeks. You may have a more serious problem that needs medical attention.

Things you must not do

If you feel tired, drowsy, dizzy or light-headed, do not drive or operate machinery. As with some other antihistamine medicines, DOZILE may cause tiredness, drowsiness, dizziness or light-headedness in some people. If you drink alcohol, the drowsiness, dizziness or light-headedness may be worse.

Things to be careful of

Be careful drinking alcohol while taking DOZILE. The effects of alcohol can be increased by some antihistamine medicines, including DOZILE.

Be careful driving or operating machinery if you have taken DOZILE the night before. You may still be drowsy the next morning.

Things you should do to help you sleep

• Go to bed and arise at the same time daily
• Engage in relaxing activities before bedtime
• Exercise regularly but not in the late evening
• Avoid eating meals or large snacks just before bedtime
• Eliminate daytime naps
• Avoid caffeine-containing drinks after midday
• Avoid alcohol or the use of nicotine late in the evening
• Minimise external disruption (eg light and noise)
• If you are unable to sleep, do not become anxious. Leave the bedroom and participate in relaxing activities such as reading or listening to music until you are tired.

Side effects

All medicines can have 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 pharmacist or doctor to answer any questions you may have.

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

• dizziness
• clumsiness
• over-excitement.

These are the most common side effects of DOZILE. Mostly these side effects are mild and short-lived.

Less common side effects of DOZILE are:

• nausea
• vomiting
• diarrhoea
• stomach problems
• headache
• dry mouth
• difficulty passing urine
• blurred vision
• thick mucous from your lungs.

Tell your pharmacist or doctor immediately if you notice the following:

• fast or irregular heartbeats.

This is a serious side effect. Serious side effects are rare.

Other side effects not listed above may occur in some patients.

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking DOZILE or are concerned about any side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using DOZILE

Storage

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store DOZILE or any other medicine in the bathroom or near a sink.

Do not leave the medicine in the car on hot days or on a window sill. Heat and dampness can destroy some medicines.

Keep DOZILE 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 pharmacist or doctor tells you to stop taking DOZILE or the medicine has passed the expiry date, ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

DOZILE is a purple, oval, soft gel capsule.

Ingredients

The active ingredient in DOZILE is doxylamine succinate. Each capsule contains 25 mg of doxylamine succinate.

The inactive ingredients are:

• butylated hydroxyanisole
• propylene glycol
• macrogol 400
• gelatin
• amaranth
• patent blue V
• sorbitol special - glycerin blend
• water - purified.

Pack sizes

DOZILE is available in blister packs of 10 capsules.

Supplier

DOZILE is supplied in New Zealand by:

Wilson Consumer Products
AUCKLAND

Ph: 09 379 5390
Fax: 09 379 5356

This leaflet was updated in July 2008