Document: leaflet MAH GENERIC_PL 24668-0196 change

• leaflet MAH BRAND_PLPI 20636-2597
• leaflet MAH GENERIC_PL 24668-0196

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•    Tiredness which lasts for a long time. This may be due to a blood problem called anaemia

•    Over-active behaviour in children

•    A combination of symptoms (known as 'neuroleptic malignant syndrome') including high temperature, pale complexion, muscle stiffness or tremor, and changes in your mental state (such as confusion, irritability and extreme agitation). See also section 2 'Warnings and precautions.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.

•    Dry mouth, blurred vision or you cannot pass water (urine)

•    Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless

•    Loss of appetite (anorexia), indigestion

•    Feeling dizzy, lightheaded, faint (hypotension)

•    Feeling confused, especially in elderly people

•    Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/vellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

^1 How to store Promethazine Tablets

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6| Contents of the pack and other information

What Promethazine Tablets contain

•    The active substance is promethazine hydrochloride

•    The other ingredient(s) are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycolate (Type A), stearic acid, magnesium stearate.

Tablet coating: hypromellose (E464), macrogol 8000 (E1521), titanium dioxide (E171), talc.

What Promethazine Tablets look like and contents of the pack

Promethazine 25mg Film-coated Tablets are white oval shaped, 9.8 x 6.2mm biconvex marked with "C25" on one side and plain on the other side.

Pack sizes

Blisters: 56 film-coated tablets.

Marketing Authorisation Holder Caduceus Pharma Ltd.

6^th floor, 94 Wigmore Street

London

W1U 3RF

UK

Manufacturer

Actavis, Barnstaple, EX32 8NS, UK

This leaflet was last revised in May 2016

Caduceus

Caduceus

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

•    The full name of this medicine is Promethazine Hydrochloride 25mg Film-coated Tablets but within

the leaflet it will be referred to as Promethazine Tablets.

What is in this leaflet j What Promethazine Tablets are and what they are used for 4 What you need to know before you take Promethazine Tablets How to take Promethazine Tablets

4| Possible side effects ^1 How to store Promethazine Tablets

6| Contents of the pack and other information

j What Promethazine Tablets are and what they are used for

Promethazine Tablets contain a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your

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Package leaflet: Information for the user

Promethazine Hydrochloride 25mg Film-coated Tablets body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed.

Promethazine Tablets can be given to you either by a doctor or directly by a pharmacist depending on the condition you are being treated for.

Promethazine Tablets may be provided directly by a pharmacist for use in the following situations:

•    To treat allergic conditions such as hay fever or rashes (like nettle rash or hives)

•    To treat adults with difficulty sleeping (insomnia)

•    To treat or stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness.

Promethazine Tablets may also be given to you by a doctor. This can be for use in any of the above situations or for use in the following additional situation:

• As a sedative for children. This is a medicine given to reduce awareness or make you feel relaxed and at ease.

4 What you need to know before you take Promethazine Tablets

Do not take this medicine and tell your doctor if:

•    You are allergic to promethazine hydrochloride or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also, do not take Promethazine Tablets if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure, ask your doctor or pharmacist (see "Other medicines and Promethazine Tablets" section below)

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296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Promethazine Tablets 25mg x 56's (UK)

JDE No.:    50889063

Dimensions: 296x210 (Reel Fed) Component: Leaflet for Blisters

Pharmacode: 6755

Date Sent: 15/02/16 Technologist: R.Wrey <Sf Technically Approved

•    The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache.

Do not give PromethazineTablets to children younger than 5 years.

Other strengths and pharmaceutical forms of promethazine may be available for use in children aged 2 to 5 years.

Warnings and precautions

Talk to your doctor or pharmacist before taking PromethazineTablets if

•    you have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis)

•    you have epilepsy

•    you have any serious heart problems

•    you have liver or kidney problems

•    you have a stomach blockage or difficulty passing water

•    you have hearing problems

•    you have increased pressure in the eye (narrow angle glaucoma)

•    you have had something called Reye's Syndrome or possible Reye's Syndrome - signs include being sickand confused following a viral illness.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking PromethazineTablets.

PromethazineTablets may occasionally cause a condition called neuroleptic malignant syndrome which is potentially life-threatening. If you notice symptoms such as high temperature, pale complexion, muscle stiffness or tremor, and changes in your mental state (such as confusion, irritability and extreme agitation), you should stop taking these tablets and immediately inform your doctor. See also section 4'Possible side effects)

Other medicines and Promethazine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks:

•    Some medicines for depression called monoamine oxidase inhibitors (MAOIs).

If you are not sure, askyour doctor or pharmacist.

Tell your doctor or pharmacist if you are taking any of the following:

•    Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or weak bladder.These can increase the risk of dizziness, dry mouth and blurred eyesight

•    Medicines for depression (such as amitriptyline)

•    Medicines to help you to sleep or feel more relaxed (such as diazepam or zolpidem)

•    Medicines such as aspirin (for arthritis and pain in your joints). Promethazine Tablets may hide the side effects of these medicines.

PromethazineTablets with alcohol

Do notdrinkalcohol while you are taking PromethazineTablets.This is because it can affect the way the medicine works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor for advice before taking this medicine.

PromethazineTablets should not be taken 2 weeks before birth.

You should not take PromethazineTablets ifyou are breast-feeding.This is because small amounts may pass into mothers'milk. This can be harmful to your baby. Ifyou are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel drowsy or sleepy after taking this medicine. If this happens, do not drive or use any tools or machines.

B How to take Promethazine Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.

The amount you need to take depends on the reason you are taking Promethazine Tablets.The following information will help you to decide how much you need to take.

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296x210 Leaflet Reel Fed Bi Fold Profile (BST)

PromethazineTablets 25mg x 56's

(UK)_

JDE No.:    50889063

Dimensions: 296x210 (Reel Fed) Component: Leaflet for Blisters

Pharmacode: 6755

Date Sent: 15/02/16 Technologist: R.Wrey Technically Approved

Taking this medicine

Take this medicine by mouth.

Do not take for longer than 7 days. If your symptoms worsen or do not improve after 7 days, talk to your doctor or pharmacist.

If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but askyour doctor.

The recommended dose is:

For allergies (such as hay fever, rashes and hives)

Children 5-10 years:

-25mg given at night

-    DO NOT give more than 25mg each day. Children over 10 years and adults (including the elderly):

-    Start with 25mg taken at night

-This may be increased to a maximum of 25mg twice a day if necessary.

For treatment and prevention of feeling sick or being sick (such as travel sickness)

Children over 10 years and adults (including the elderly):

-    25mg to be taken the night before the journey

-This may be repeated after 6-8 hours if necessary.

For treatment of adults with difficulty sleeping (insomnia)

Adults (including the elderly):

-    25mg or 50mg taken at night.

As a sedative for children (under the advice of a doctor only)

PromethazineTablets may also be used as a shortterm sedative.This will normally have been prescribed by a doctor.The information below is a guide to the doses recommended.

Children 5-10 years:

-25mg given at night.

Children over 10 years:

-    25mg or 50mg taken at night.

Exposure to sunlight

PromethazineTablets can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine.

If you take more Promethazine Tablets than you should

If you oryour child takes more PromethazineTablets than you should, tell a doctor or go to a hospital casualty department straight away.Take the medicine pack with you. This is so the doctor knows whatyou oryour child has

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taken.The following effects may happen:

In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hallucinations, fits (seizures), loss of consciousness, uneven heartbeat and breathing difficulties.

In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven heartbeat and breathing difficulties.

If you forget to take Promethazine Tablets

Do not take a double dose to make up for a forgotten dose

•    If you are taking PromethazineTablets for an allergic condition - take your medicine as soon as you remember, then carry on as before

•    If you are taking PromethazineTablets for sedation or sleeping problems - miss that dose and take the next evening's dose as usual.

Tests

Taking PromethazineTablets may affect the results of certain tests. These include some pregnancy tests and skin tests. PromethazineTablets should not be taken for at least 3 days before the start of a skin test.

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

□ Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking PromethazineTablets and see a doctor or go to a hospital straight away if you notice any of the following side effects:

•    An allergic reaction.The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    Liver problems that may cause the eyes or skin to go yellow (jaundice)

•    Muscle stiffness or shaking

•    Being unable to control some muscles in your head or face

•    You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling

•    Very fast, uneven orforceful heartbeat (palpitations)

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Promethazine 25mg 56Tablets PIL - UK			colours/plates:
			1. Black |
^actavis creating value In pharmaceuticals t 00441271311400 f 00441271311449	item no: AAAI8125	dimensions: 296x210	2.
	print proof no: 6	pharmacode:	3.
			4.
	origination date: 24.02.16	min pt size: 9	5.
@ artworkstudio@actavis.co.uk	originated by: SAnson		6.
approved for print/date	revision date: 12.05.16	Technical Approval	Non Printing Colours
			1.
	revised by: S.Anson	date sent: ri/a
			2.
	supplier: Actavis UK	technically app. date: n/a	3.