INFORMATION FOR CONSUMERS

Consumer Medicine Information

PERIACTIN^®

cyproheptadine hydrochloride

4 mg tablet

What is in this leaflet

This leaflet answers some common questions about PERIACTIN. It does not contain all 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 you taking PERIACTIN against the benefits they expect it will 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 need to read it again.

What PERIACTIN is used for

Periactin is used to relieve the symptoms of allergy, such as hayfever, runny nose, sneezing, and itchy and watery eyes.

It also relieves the itchiness associated with some skin problems, such as rash, hives, dermatitis, eczema, mild reactions to insect bites, and chickenpox.

Periactin is also used to treat migraines and other similar headaches, in people whose symptoms have not been relieved by other medicines.

Migraine is an intense, throbbing headache, often affecting one side of the head. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound.

Periactin belongs to a group of medicines called antihistamines. It works by blocking the action of histamine and other substances produced by the body, which are causing your allergy or itchiness.

Your doctor may have prescribed PERIACTIN for another reason. Ask your doctor if you have any questions about why PERIACTIN has been prescribed for you.

PERIACTIN is not addictive.

Before you take PERIACTIN

When you must not take it

Do not take PERIACTIN if:

you have an allergy to PERIACTIN or any of the ingredients listed at the end of this leaflet.

Do not take PERIACTIN to treat an acute attack of asthma.

Do not take PERIACTIN if you have the following medical conditions:

a type of glaucoma called angle-closure glaucoma
a narrowing or blockage between the stomach and the small intestine which causes the vomiting of undigested food, such as in some stomach ulcers
prostate problems
difficulty passing urine

Check with your doctor if you are not sure whether you have any of these conditions.

Do not take PERIACTIN if:

you are breast-feeding or plan to breast-feed.
Like most antihistamine medicines, PERIACTIN is not recommended for use while breast-feeding.
you are being treated for depression with medicines called monoamine oxidase inhibitors (MAOIs).
MAOIs include moclobemide, phenelzine and tranylcypromine.
you are elderly and frail or weak.

Your doctor will advise you if this applies to you.

If you are not sure whether you should start taking PERIACTIN, talk to your doctor.

Do not give PERIACTIN to newborn or premature babies or children under 2 years of age.
The safety and effectiveness in children below the age of 2 years have not been established. Some infants using this medicine have been reported to have difficulty breathing or stop breathing.

Before you start to take it

Tell your doctor if:

you are pregnant or intend to become pregnant

Your doctor will discuss the possible risks and benefits of using PERIACTIN during pregnancy.

you are breast-feeding or plan to breast-feed
PERIACTIN is not recommended for use while breast-feeding.
you have or have had any medical conditions, especially the following:
lung problems, such as asthma or bronchitis
an overactive thyroid gland
raised eye pressure
heart disease
high blood pressure
if you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any PERIACTIN.

Taking other medicines

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

Some medicines should not be taken with PERIACTIN. These include:

moclobemide, phenelzine and tranylcypromine, medicines used to treat depression

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

alcohol
medicines used to treat anxiety and to help you sleep
antidepressants

These medicines may be affected by PERIACTIN, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

If you take medicines used to treat anxiety or to help you sleep while you are taking PERIACTIN, you are likely to experience greater drowsiness, sleepiness, tiredness or dizziness. These are also likely to occur more quickly.

If you drink alcohol while you are taking PERIACTIN, you are likely to become more drowsy, sleepy, tired or dizzy. These effects are also likely to occur more quickly.

Your doctor or pharmacist has more information on medicines to avoid or be careful with while taking PERIACTIN.

How to take PERIACTIN

How much to take

Take PERIACTIN only when prescribed by your doctor.
Your doctor will tell you how many tablets you need to take each day.

For allergies and itching:

For adults and children over 14 years, the usual starting dose is one tablet three times a day. The dose may need to be adjusted depending on your response. Do not take more than 8 tablets a day.

For children 7 to 14 years old, the usual starting dose is one tablet two to three times a day. The dose may need to be adjusted depending on the response to Periactin. If an extra dose is needed, it should be given at bedtime. Do not give more than 4 tablets a day.

For children 2 to 6 years old, the usual starting dose is half a tablet two to three times a day. The dose may need to be adjusted depending on the response to Periactin. If an extra dose is needed, it should be given at bedtime. Do not give more than 3 tablets a day.

For migraine and vascular types of headaches:

The recommended dose is one tablet initially. This can be repeated in half an hour if necessary. Do not take more than two tablets in a 4 to 6 hour period. Relief from the migraine usually occurs with two doses and is maintained with one tablet every 4 to 6 hours.

Swallow PERIACTIN with a glass of water.

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

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablet(s) as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

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

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

If you take too much (overdose)

Immediately telephone your doctor or National Poisons Centre (0800 POISON or 0800 764 766) for advice, or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much PERIACTIN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too many tablets, you may have a dry mouth, dilated pupils, flushing and stomach upsets. Other more serious symptoms, especially in infants and children, include hallucinations (seeing, feeling or hearing things that are not there), convulsions, central nervous system depression, respiratory and cardiac arrest, and death.

While you are using PERIACTIN

Things you must do

If you become pregnant while taking PERIACTIN, tell your doctor.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking PERIACTIN.

Things you must not do

If you feel drowsy, sleepy, tired or dizzy, do not drive a car or operate machinery.
As with some other antihistamine medicines, PERIACTIN can cause drowsiness, sleepiness, tiredness or dizziness. If you drink alcohol, these symptoms could be worse.

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

Things to be careful of

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

Adverse Effects

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

PERIACTIN helps most people with allergies and migraine, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects. If you are over 65 years of age you may have an increased chance of getting adverse 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:

difficulty thinking or working because of:
drowsiness, sleepiness, tiredness, sedation
dizziness, headache
restlessness, nervousness, irritability
excitation (particularly in children)
buzzing or ringing in the ears
confusion
inability to sleep
stomach or bowel problems
nausea, vomiting
upset stomach
increased or loss of appetite, weight gain
diarrhoea, constipation
changes in your sight or taste such as:
blurred vision
dry mouth, nose and throat
nose bleeds
disturbed co-ordination, tremor or shaking
aggressive behaviour
excessive perspiration or sweating
early periods in women

These are usually mild adverse effects of PERIACTIN. Drowsiness and sleepiness often disappear after the first three or four days of taking PERIACTIN. If you are over 65 years of age you are more likely to feel dizzy, drowsy and light-headed.

Tell your doctor immediately if you notice any of the following:

fast or irregular heart beats, also called palpitations
skin rash, pinkish, itchy swellings on the skin, also called hives or nettlerash
yellowing of the skin and/or eyes also called jaundice
seeing, feeling or hearing things that are not there
frequent and/or severe infections such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal
signs of anaemia, such as tiredness, being short of breath, looking pale
passing urine frequently, difficulty passing urine
spinning sensation, also called vertigo
tingling or numbness of the hands or feet

These are serious adverse effects. You may need urgent medical attention. Serious adverse effects are rare.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

convulsions or fits
wheezing, chest tightness
fainting
swelling of the face, lips, throat and tongue, which may cause difficulty breathing or swallowing

These are very serious adverse effects. You may need urgent medical attention. Serious adverse effects are rare.

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

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

After using PERIACTIN

Storage

Keep your tablets in the container they are dispensed in until it is time to take the medicine.
If you take the tablets out the container they may not keep well.

Keep PERIACTIN 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 or on window sills.
Heat and dampness can destroy some medicines.

Keep it 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 doctor tells you to stop taking the tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

PERIACTIN comes as a white, round tablet with 'MSD62' marked on one side and the other side scored.

Ingredients

Active ingredient:

cyproheptadine hydrochloride 4 mg per tablet

Inactive ingredients:

maize (corn) starch
pregelatinised maize (corn) starch
calcium phosphate
lactose
magnesium stearate

PERIACTIN does not contain gluten, sucrose, tartrazine or any other azo dyes.

Supplier

PERIACTIN is supplied in New Zealand by:-

Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673

This leaflet was prepared in May 2006

CP-PAT-0506(240506)

^®Registered Trademark of Merck & Co Inc., Whitehouse Station, NJ, USA