Consumer medicine information

CIZINATE®


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 taking CIZINATE?

CIZINATE contains the two active ingredients, cinnarizine and dimenhydrinate. CIZINATE is used for the short term treatment of the symptoms of vertigo.

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

2. What should I know before I take CIZINATE?

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

3. What if I am taking other medicines?

Some medicines may interfere with CIZINATE 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 take CIZINATE?

  • The standard dose for this medicine is one tablet three times a day, although your doctor may have prescribed a different dose.
  • CIZINATE tablets should be swallowed without chewing and with a glass of liquid, following a meal, at the same time each day.
  • Usually you will take CIZINATE for up to 4 weeks. Your doctor will however decide how long you will need to take this medicine.

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

5. What should I know while taking CIZINATE?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using CIZINATE.
  • If you are about to be started on a new medicine, tell your doctor, dentist or pharmacist that you are taking CIZINATE.
  • Tell your doctor if you have kidney or liver problems, suffer from an eye disease, have convulsions, fits or seizures, have increased pressure in the brain, suffer from alcohol abuse or have prostate problems which cause difficulty in urinating, or are under 18 years of age. Tell your doctor if you have other medical conditions.
  • If you plan to have surgery requiring a general anaesthetic, tell your doctor or dentist that you are taking CIZINATE.
  • If you become pregnant while taking CIZINATE, tell your doctor immediately.
Things you should not do
  • Do not give CIZINATE to anyone else, even if they have the same condition as you.
  • Do not take CIZINATE to treat any other complaints unless your doctor tells you to.
  • Do not stop taking CIZINATE, or lower the dosage without checking with your doctor.
Driving or using machines As CIZINATE may cause dizziness in some people, be careful before you drive or use any machines or tools until you know how CIZINATE affects you.
Drinking alcohol Avoid alcoholic drinks while taking CIZINATE.
Looking after your medicine
  • Keep your tablets in a cool, dry place out of the reach of children where the temperature stays below 25°C.
  • Do not store CIZINATE in the bathroom, near a sink, on a windowsill or in the car on hot days.

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

6. Are there any side effects?

Common side effects: drowsiness, dry mouth, headache and stomach pain. Less common side effects: sweating, reddening of the skin, indigestion, feeling sick, diarrhoea, nervousness, cramps, forgetfulness, ringing in the ear, tingling of the hands or feet, shaking, light sensitivity, impaired vision, allergic reactions, difficulty in urinating, weakness, bruising, infections. Weight gain and constipation have been reported.

Serious side effects include skin reactions, difficulty breathing, shortness of breath, severe eye pain, convulsions or fitting, trembling and shaking of the hands and fingers, uncontrollable body or face movements, body twisting movements, muscle stiffness with difficulty walking, arms and legs stiffness, or severe excitement or restlessness and desire to keep moving; swelling of the face, lips, tongue or other body parts; rash, itching or hives on the skin or other skin reactions; tightness of the chest; yellowing of the skin or whites of the eyes.

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.

CIZINATE®

Active ingredient(s): cinnarizine and dimenhydrinate


Consumer Medicine Information (CMI)

This leaflet provides important information about using CIZINATE. 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 CIZINATE.

Where to find information in this leaflet:

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

1. Why am I taking CIZINATE?

CIZINATE contains the two active ingredients cinnarizine and dimenhydrinate. The two substances belong to different groups of medicines. Cinnarizine is part of a group called calcium antagonists and also has anti-dopamine and anti-histamine effects. Dimenhydrinate belongs to a group called antihistamines. Both substances work by reducing symptoms of vertigo (a feeling of dizziness or ‘spinning’) and nausea (feeling sick). When these two substances are used together they are more effective than when each one is used on its own.

CIZINATE is used for short-term symptomatic treatment of vertigo, in adults who have not responded to alternative treatments. Vertigo can have a number of different causes.

2. What should I know before I take CIZINATE?

Warnings

Do not use CIZINATE if:

  • you are allergic to cinnarizine and/or dimenhydrinate or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

  • you are allergic to any other similar medicines such as diphenhydramine or other antihistamines such as chlorpheniramine.

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.

  • have severe kidney problems (renal impairment)
  • have severe liver problems (hepatic impairment)
  • suffer from angle-closure glaucoma (a specific type of eye disease)
  • have convulsions, fits or seizures (epilepsy)
  • have increased pressure in the brain
  • suffer from alcohol abuse
  • have prostate problems which cause difficulty in urinating
  • are under 18 years of age

Safety and effectiveness in children younger than 18 years have not been established.

Check with your doctor if you have:

  • low or high blood pressure
  • severe heart disease
  • raised pressure in the eye
  • obstruction in the bowels
  • an enlarged prostate
  • an overactive thyroid
  • kidney or liver problems
  • movement disorders such as disease of the brain affecting movement (Parkinson’s disease) or tremor
  • depression
  • have allergies to any other medicines, foods, preservatives or dyes
  • take any medicines for any other condition

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.

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 CIZINATE and affect how it works.

CIZINATE may increase the effects of the following medicines:

  • tricyclic antidepressants (used to treat depression and anxiety)
  • atropine (a medicine that relaxes muscles and is often used to examine your eye)
  • ephedrine (can be used to treat cough or blocked nose)
  • procarbazine (a medicine used to treat some kinds of cancer)
  • medicines taken to lower blood pressure

Amino glycosides (a type of antibiotic) can damage the inner ear. If you take CIZINATE you may not notice that this damage is happening.

You should not take CIZINATE with drugs that are used to correct problems with your heart beat (anti-arrhythmics).

CIZINATE can make you tired or sleepy when taken with the medicines listed below:

  • barbiturates (medicines that are often taken to calm you down)
  • narcotic analgesics (strong painkillers such as morphine and codeine)
  • any antihistamine medications
  • tranquillisers (a type of medicine used to treat depression and anxiety)
  • monoamine oxidase inhibitors (used to treat depression and anxiety)

You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

CIZINATE may also change the way your skin reacts to allergy tests.

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

4. How do I take CIZINATE?

How much to take

The standard dose for this medicine is one tablet three times a day. Your doctor may have prescribed a different dose.

CIZINATE tablets should be swallowed without chewing and with a glass of liquid.

Follow the instructions provided and use CIZINATE until your doctor tells you to stop.

Do not take more than the dose your doctor has prescribed for you.

When to take CIZINATE

CIZINATE should be used regularly at the same time each day. Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.

Take CIZINATE immediately after a meal, at about the same time each day. If you take CIZINATE on an empty stomach, it may cause stomach upsets.

Usually you will take CIZINATE for up to 4 weeks. Your doctor will tell you if you need to take CIZINATE for a different amount of time.

Continue taking your medicine for as long as your doctor tells you.

If you forget to take CIZINATE

If you forget to take a tablet of CIZINATE just miss out that tablet. Take the next tablet of CIZINATE the next time when you would usually take it.

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 are not sure what to do, ask your doctor or pharmacist.

If you take too much CIZINATE

If you think that you have taken too much CIZINATE, you may need urgent medical attention.

If you take too much CIZINATE you may become very tired, dizzy and shaky. Your pupils might dilate and you may not be able to urinate. Your mouth may feel dry, your face flush, you may have a faster heart rate, fever, sweat and have a headache.

If you have taken a massive amount of CIZINATE you could have fits, hallucinations, high blood pressure, feel shaky, get excited, and find it difficult to breathe. Coma could occur.

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 taking CIZINATE?

Things you should do

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

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

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking CIZINATE.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking CIZINATE.

If you become pregnant while taking CIZINATE, tell your doctor immediately.

Things you should not do

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

Do not take CIZINATE to treat any other complaints unless your doctor tells you to.

Do not stop taking CIZINATE, or lower the dosage without checking with your doctor.

Driving or using machines

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

CIZINATE may cause dizziness in some people. If you have these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may alter how this medicine affects you. You should avoid alcoholic drinks while taking CIZINATE.

Looking after your medicine

  • Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they will not keep well.

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

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.

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
Common side effects:

  • drowsiness
  • dry mouth
  • headache
  • stomach pain

Uncommon side effects:
(affect up to 1 in 100 people):

  • sweating
  • reddening of the skin
  • indigestion
  • nausea (feeling sick)
  • diarrhea
  • nervousness
  • cramps
  • forgetfulness
  • tinnitus (ringing in the ear)
  • paraesthesia (tingling of the hands or feet)

Rare side effects:
(affect up to 1 in 1,000 people):

  • tremor (shaking)
  • impaired vision
  • allergic reactions (e.g. skin reactions)
  • light sensitivity
  • difficulty in urinating

Very rare side effects:
(affect fewer than 1 in 10,000 people):

  • weakness
  • bruising
  • infections more likely

The following side effects have also been reported:

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

If CIZINATE causes stomach pain this may be reduced if CIZINATE is taken with food.

Common side effects are usually mild and disappear within a few days even if you keep taking CIZINATE.

If you suffer from infections with fever and serious deterioration of your general health, see your doctor and tell him about your medicine.

Serious side effects

Serious side effects What to do
  • tightness of the chest
  • jaundice (yellowing of the skin or whites of the eyes)
  • increased pressure inside the eye or severe eye pain
  • unusual excitement
  • severe skin reactions
  • skin reactions
  • difficulty breathing

Extrapyramidal symptoms:

  • convulsions or fitting
  • uncontrollable movements of the body or face
  • trembling and shaking of the hands and fingers
  • twisting movement of the body
  • muscle stiffness with difficulty walking
  • stiffness of the arms and legs
  • severe feeling of restlessness and desire to keep moving

Allergic reactions:

  • 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
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. Stop taking CIZINATE immediately.

Extrapyramidal symptoms affect the nervous system. and may be serious. You may need immediate medical attention.

They have been reported more frequently in older people, women and people taking high doses for long periods of time. In rare cases these effects are irreversible.

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 and is not addictive.

What CIZINATE contains

Active ingredient
(main ingredient)
20 mg cinnarizine
40 mg dimenhydrinate
Other ingredients
(inactive ingredients)
microcrystalline cellulose
croscarmellose sodium
maize starch
hypromellose
colloidal anhydrous silica
purified talc
magnesium stearate

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

What CIZINATE looks like

CIZINATE tablets are white to almost white, round, biconvex uncoated tablets.

They are available in packs of 20, 30, 50 and 100 tablets. (AUST R 288566).

Who distributes CIZINATE

Southern XP Pty Ltd
Unit 5/118 Church Street
Hawthorn, VIC, 3122
Australia

Sponsor:

Southern XP IP Pty Ltd
Unit 5/118 Church Street
Hawthorn, 3122, Victoria
Australia

This leaflet was prepared in June 2022.

Published by MIMS August 2022