Ziz Extra Strength Product: (p;ome'hazil,e| 25 mg Tablets MA Holder: Chelonia	Printing Colours: | Black	Non-Printing Colours: | Profile	Chelonia HEALTHCARE Final Preparation Date For Submission: 19/05/2016
PL No.: 33414/0147			Packing Site Technical Approval: 00/00/0000 Authority Approval Date: 00/00/0000 Latest Implementation Deadline: 00/00/0000
Pack Size: All Packs	Dimensions: 148 x 297 mm
Livery: Chelonia	Created By: DTawde
Manufacturer: -Market: UK Component: Leaflet	Artwork Code: CL0147/P/PIL-Br/CL2		Print Proof Approval: 00/00/0000
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PACKAGE LEAFLET: INFORMATION FOR THE USER

ZIZ EXTRA STRENGTH 25 mg TABLETS

PROMETHAZINE HYDROCHLORIDE

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.

What is in this leaflet

1.    What Ziz Extra Strength is and what it is used for

2.    What you need to know before you take Ziz Extra Strength

3.    How to take Ziz Extra Strength

4.    Possible side effects

5.    How to store Ziz Extra Strength

6.    Contents of the pack and other information

1. WHAT ZIZ EXTRA STRENGTH IS AND WHAT IT IS USED FOR

Ziz Extra Strength 25 mg Tablets contain a medicine called promethazine hydrochloride. It belongs to a group of medicines called phenothiazines, and works by blocking a substance called histamine that your body makes during an allergic reaction. It works directly on the brain to help you feel more relaxed.

Ziz Extra Strength is used to treat the following conditions:

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

•    to treat and prevent you feeling sick (nausea) or being sick (vomiting), such as travel sickness.

•    to treat adults with difficulty sleeping (insomnia)

•    for short term use: as a sedative for children

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIZ EXTRA STRENGTH

Do not take Ziz Extra Strength if:

•    you are allergic to promethazine hydrochloride or any of the other ingredients in the tablets (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.

•    the person taking this medicine is under 2 years old

•    you are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI) or you have stopped taking one of these MAOI medicines within the last 14 days

•    the person taking this medicine is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache.

Do not take this medicine if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist

before taking Ziz Extra Strength.

Warnings and precautions

Tell your doctor or pharmacist before you take this

medicine if you:

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

•    have epilepsy

•    have any serious heart problems

•    have liver or kidney problems

•    have an enlarged prostate gland

•    have a stomach blockage or difficulty passing water (urine)

•    have hearing problems

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

•    have had something called Reye's Syndrome or you have signs of Reye's Syndrome, such as being sick and confused after a viral illness.

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

You may get high fever, muscle cramps or stiffness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot. This may be signs of a very serious and sometimes deadly health problem called neuroleptic malignant syndrome. Stop taking your medicine and tell your doctor immediately. There have been some cases of abuse with this medicine. This risk of abuse is greater in those with a history of drug abuse.

Other medicines and Ziz Extra Strength Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription, including herbal medicines. This is because Ziz Extra Strength can affect the way some medicines work. Also some medicines can affect the way Ziz Extra Strength works.

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 ask your doctor or pharmacist.

In particular, tell your doctor or pharmacist if you are taking any of the following:

•    other medicines for depression called tricyclic antidepressants, such as amitriptyline or dosulepin

•    medicines to help you to sleep or feel more relaxed, such as diazepam or zolpidem

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

•    anticholinergic medicines. This includes some medicines used for irritable bowel syndrome or weak bladder, such as atropine or oxybutynin. These can increase the risk of dizziness, dry mouth and blurred vision.

Tests

Taking Ziz Extra Strength may affect the results of certain tests. These include some pregnancy tests based on urine samples and skin tests. Ziz Extra Strength should not be taken at least 3 days before the start of a skin test.

Ziz Extra Strength tablets with food and drink

Do not drink alcohol whilst taking Ziz. Alcohol may increase the sedative effects of Ziz Extra Strength and make you feel very sleepy.

Pregnancy and breast-feeding

Talk to your doctor before taking Ziz Extra Strength if you are pregnant or planning to become pregnant or think you may be pregnant. Ziz Extra Strength should not be taken 2 weeks before birth.

You should not take Ziz Extra Strength if you are breast-feeding. This is because small amounts may pass into the mothers' milk. This could be harmful to your baby.

If you 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 or the day after you have taken this medicine. If this happens, do not drive or operate machinery.

Ziz Extra Strength Tablet contains lactose and sucrose

This medicine contains lactose and sucrose (types of sugars). If you know you have an intolerance to some sugars contact your doctor or pharmacist before taking Ziz Extra Strength.

3. HOW TO TAKE ZIZ EXTRA STRENGTH

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

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

Taking this medicine

•    Swallow the tablets whole with a glass of water.

•    This medicine may not work as well if you take it for more than 7 days. If your symptoms worsen or do not improve after 7 days talk to your doctor or pharmacist.

How much to take

The usual doses are:

As a short-term paediatric sedative for short term

treatment of insomnia in adults

Adults (including the elderly) and children over 10

years: 1 or 2 tablets (25 mg to 50 mg) taken at night.

Children 5-10 years: A single tablet (25 mg) given at

night.

Children 2-5 years: A liquid form of this medicine should be used.

For allergies (such as hay fever, rashes and hives) Adults (including the elderly) and children over 10 years: Start with 1 tablet (25 mg) taken at night. This may be increased to a maximum of 1 tablet (25 mg) twice a day if necessary.

Children 5-10 years: A single tablet (25 mg) given at night.

DO NOT give more than 25 mg per day.

Children 2-5 years: A liquid form of this medicine should be used.

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

Adults (including the elderly) and children over 10 years: A single tablet (25 mg) taken the night before the journey. This may be repeated after 6 to 8 hours if necessary.

Children 5-10 years: A liquid form of this medicine or Promethazine 10 mg tablets should be used.

Children 2-5 years: A liquid form of this medicine should be used.

Children under 2 years

DO NOT give this medicine to children under 2 years old. Use this medicine only as recommended. Do not exceed the recommended dose.

Exposure to sunlight

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

If you take more Ziz Extra Strength than you should

If you or your child accidentally takes too many tablets, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you or your child has taken.

The following effects may occur:

•    In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hearing or seeing things that are not there (hallucinations), fits (seizures), loss of consciousness, uneven heart beat and breathing difficulties

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

If you forget to take Ziz Extra Strength

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

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

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

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ziz Extra Strength can cause side

effects, although not everybody gets them.

STOP TAKING this medicine 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, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, sudden wheezing or collapse

•    liver problems which may cause yellowing of the skin or whites of the eyes (jaundice)

•    muscle stiffness or shaking

•    being unable to control some muscles in the head or face

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

•    over-active behaviour in children

•    very fast, uneven or forceful heart beat (palpitations)

•    irregular heartbeat

•    changes in the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

Not Known: frequency cannot be estimated from the available data

•    You have high fever, muscle cramps or stiffness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot. This may be signs of a very serious and sometimes deadly health problem called neuroleptic malignant syndrome.

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

•    dry mouth, blurred vision, constipation and difficulty shedding tears or passing urine, especially in the elderly and children

•    feeling drowsy, sleepy, dizzy or tired, headaches, fits

•    feeling confused, especially in the elderly

•    feeling depressed, restless or disorientated (not knowing where you are), having nightmares or problems sleeping

•    loss of appetite (anorexia), feeling or being sick, diarrhoea, indigestion, stomach upsets

•    feeling dizzy, lightheaded or faint (hypotension)

•    skin rash, itching, red and raised lumps (hives)

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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 ZIZ EXTRA STRENGTH

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use the tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ziz Extra Strength tablets contain

The active substance is promethazine hydrochloride. Each tablet contains 25 mg of the active substance.

The other ingredients in the tablets are lactose, maize starch, pregelatinised maize starch, magnesium stearate, talc, bleached shellac, titanium dioxide (E171), povidone, sucrose, beeswax, carnauba wax and opalux blue which contains patent blue (E131), indigo carmine (E132), titanium dioxide (E171) and sodium benzoate (E211).

What Ziz Extra Strength tablets look like and contents of the pack

Ziz Extra Strength tablets are blue, sugar-coated tablets which come in blister packs of 10 and 30 tablets and in containers of 100, 500 and 1000 tablets.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

11 Boumpoulinas, Nicosia,

P.C. 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London, SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 05/2016

CL0146/P/PIL-Br/CL2