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PERIACTIN 4MG TABLETS

Active substance(s): CYPROHEPTADINE HYDROCHLORIDE

PDF Transcript

ARTWORK INFORMATION:
PRODUCT:

Periactin (Cyproheptadine HCl) 4 mg Tablets

LICENCE:

PL 17507/0199

APPROVED FOR
SUBMISSION:

ITEM / SIZE: Generic package leaflet / 150 mm (w) x 520 mm (h) [flat]
ID CODE:

A1000338/2

VERSION:

1; 06/05/2015

INK:

Black

Note: this document will print at
approx. 69% actual size
when printed on A3 paper.

APPROVED BY
HEALTH AUTHORITY:

PACKAGE LEAFLET: INFORMATION FOR THE USER

PERIACTIN® 4MG TABLETS
(Cyproheptadine Hydrochloride)

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Periactin carefully
to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Periactin is and what it is used for
2. Before you take Periactin
3. How to take Periactin
4. Possible side effects
5. How to store Periactin
6. Further Information
1. What Periactin is and what it is used for
Periactin contains a medicine called cyproheptadine. This belongs to a group of medicines called
‘antihistamines’. In some illnesses too much ‘histamine’ and ‘serotonin’ are produced in the body.
These occur naturally in your body. Periactin helps in these illnesses by stopping the unwanted
effects of histamine and serotonin.
Periactin is used for:
• skin allergies with itchiness, swelling, or red skin, eczema or nettle rash
• itchiness of chicken pox and reactions to insect bites and stings
• sneezing, watery eyes and blocked or runny nose caused by an allergy (allergic rhinitis)
• conjunctivis caused by an allergy- with red, watery, inflamed eyes
• migraine and other similar headaches.
2. Before you take Periactin
Do not take Periactin if:
• you are allergic (hypersensitive) to cyproheptadine or any of the other ingredients of
Periactin (listed in section 6 below)
• you are taking a type of medicine called a monoamine oxidase inhibitor (MAOI) for
depression, such as meclobemide, phenelzine, tranylcypramine, linezolid or pargyline.
• you have a narrowing of the opening from the stomach (‘stricture’)
• you have an eye problem called ‘glaucoma’
• you are being treated for an asthmatic attack
• you are elderly and not very mobile
• you have problems passing urine
• you have a stomach ulcer.
Do not take Periactin if any of the above apply to you. If you are not sure talk to your doctor or
pharmacist before taking Periactin .
Take special care with Periactin
Check with your doctor before taking your medicine if:
• you have ever been told that you have high pressure inside your eye (high intra-ocular
pressure)
• you have an over-active thyroid gland
• you have high blood pressure
• you have heart problems
• you have asthma.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Periactin .
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This includes herbal medicines.
This is because Periactin can affect the way some other medicines work.
Also some medicines can affect the way Periactin works.
Do not take Periactin if you are taking a type of medicine called a ‘monoamine oxidase inhibitor’
(MAO inhibitor) such as meclobemide, phenelzine, tranylcypramine, linezolid or pargyline.
Also, it is important to tell your doctor or pharmacist if you take:
• sleeping pills - such as temazepam, nitrazepam, zopiclone, zaleplon or zolpidem
• medicines for worry or anxiety - such as diazepam, alprazolam, chlordiazepoxide, clorazepate
• medicines for depression- such as fluoxetine, paroxetine, amitriptyline or imipramine
• any medicines that make you sleepy - such as sedatives or tranquillisers.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Periactin .
Taking Periactin with food and drink
Do not drink alcohol while you are taking Periactin. This is because Periactin can make you sleepy
and drinking alcohol at the same time can make you even more sleepy.
Pregnancy and breast-feeding
Do not take Periactin if you are or think you may be pregnant. Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Do not drive or use any tools or machines while taking this medicine. This is because Periactin
can make you sleepy.
Important information about some of the ingredients of Periactin
Periactin contains lactose, which is a type of sugar. If you have been told by your doctor that you
can not tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor
before taking this medicine.
3. How to take Periactin
If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise
follow the instructions below.
Taking this medicine
• Take this medicine by mouth.
• If you do not understand the instructions, or you are not sure, ask your doctor or pharmacist.
The usual doses of Periactin are
For allergies
Adults and children over 14 years
• Start with 1 tablet three times a day.
• Most patients need 3-4 tablets a day.
• Do not take more than 8 tablets a day.
Children aged 7-14 years
• The usual dose is 1 tablet two or three times a day as needed.
• If you need to give an extra dose, give it at bedtime.
• Do not give more than 4 tablets a day.
Children aged 2-6 years
• The usual dose is half a tablet two or three times a day.
• If you need to give an extra dose, give it at bedtime.
• Do not give more than 3 tablets a day.
For migraine
• Take 1 tablet when you are getting the migraine
• Take another one, if needed, after 30 minutes.
• Then take 1 tablet every 4-6 hours to maintain relief.
• Do not take more than 2 tablets in any 4-6 hour period.
Children under 2 years
• Do not give Periactin to children under 2 years of age.
If you take more Periactin than you should
If you take too much Periactin by mistake, contact your doctor immediately or seek medical help
as soon as possible.

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If you forget to take Periactin
• If you forget to take a tablet, skip the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Periactin can cause side effects, although not everybody gets them.
Stop taking Periactin and tell your doctor straight away, if you notice any of the following
serious side effects- you may need urgent medical treatment:
• allergic skin rash and hives
• severe allergic reaction which causes difficulty in breathing or dizziness
Other side effects include:
Heart and circulation
• increased heart rate
• low blood pressure
• palpitations
• feeling like you have a missed heart beat
Blood
• nosebleeds
Nervous system
• feeling sleepy, dizzy, problems with co-ordination, or feeling tired
• feeling confused, restless, over excited, nervous, irritable or trembling
• being unable to sleep, pins and needles or feeling numb
• inflammation of your nerves - signs include being more sensitive to pain and feeling that you
can not move (paralysis), fits (convulsions)
• feeling aggressive
• seeing, hearing, or feeling something that is not there (hallucinations)
• feeling faint
• headache
• an exaggerated feeling of well being (euphoria)
• being very upset (hysteria)
• anti-histamine medicines such as this medicine can sometimes make young children over
excited
Eyes or ears
• Inflammation inside the ear, ringing in the ears
• blurred or double vision
• vertigo
Chest
• dry throat and nose
• presence of phlegm
• blocked nose
• feeling wheezy
• tight chest
Stomach and gut
• dry mouth
• stomach ache, loss of appetite
• feeling sick (nausea), being sick (vomiting)
• increase in your appetite and weight gain
• diarrhoea or constipation
Urinary
• passing urine more often
• difficulty passing urine
• being unable to empty your bladder of urine
Skin and hair
• your skin being sensitive to sunlight
• you may sweat more than usual
• severe shivering
• swelling of your skin
Liver
• liver problems, including jaundice, hepatitis and hepatic failure - signs include yellowing of
your skin and eyes, sometimes with a fever, pale stools and dark urine
Sexual
• menstrual problems
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme (Tel: Freephone 0808 100 3352 or Website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Periactin
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package in order to protect from light.
Do not transfer your medicines into another box or container - they might get mixed up.
Do not use Periactin after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to
dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Periactin contains
Active ingredient:
The active substance is cyproheptadine hydrochloride. Each Periactin contains 4 mg anhydrous
cyproheptadine hydrochloride.
Other ingredients:
The other ingredients are calcium hydrogen phosphate E341, lactose, magnesium stearate E572,
potato starch, pregelatinised maize starch.
What Periactin looks like and contents of the pack
Periactin tablets are white round bevel-edged tablets marked ‘MSD 62’ on one side with a single
scoreline on the other.
Periactin are supplied in blister packs of 30 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation is held by Auden Mckenzie (Pharma Division) Ltd, Mckenzie House,
Bury Street, Ruislip, Middlesex, HA4 7TL, UK.
Periactin tablets are made by Tiofarma BV, Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijereland,
Netherlands.

This leaflet was prepared in 05/2015
® denotes registered trademark of Auden Mckenzie (Pharma Division) Ltd, Ruislip, Middlesex, UK.
© Auden Mckenzie (Pharma Division) Ltd. 2010. All rights reserved.

Auden Mckenzie (Pharma Division) Ltd,
Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.