Ziz
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Chatfield
Pharmaceuticals Ltd
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIZ 10 mg TABLETS
PROMETHAZINE 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 Ziz 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.
- This medicine may not work as well if you take it for more than 7 days.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Ziz is for
2. Before you take Ziz
3. How to take Ziz
4. Possible side effects
5. How to store Ziz
6. Further information
1. WHAT ZIZ IS FOR
Ziz 10 mg Tablets contain a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works directly on the brain to help you feel more relaxed.
Ziz Tablets can be given to you either by a doctor or directly by a pharmacist depending on the condition you are being treated for.
Ziz 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
Ziz 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 situations:
• To help you feel more relaxed before an operation
• If you are having difficulty sleeping
• As a sedative for both adults and children.
This is a medicine given to reduce awareness or make you feel relaxed and at ease.
2. BEFORE YOU TAKE ZIZ
Do not take Ziz and tell your doctor if:
• you are allergic to promethazine hydrochloride or any of the other ingredients in the tablets (see section 6 of this leaflet)
• you are allergic to any other phenothiazine drugs (used to treat mental health problems, nausea and vomiting or vertigo), such as chlorpromazine, prochlorperazine or pericyazine
• 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.
Take special care with Ziz
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 difficulty in passing urine
• have an enlarged prostate gland
• have a stomach blockage
• have increased pressure in the eye (narrow angle glaucoma)
• have suffered from 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription. This is because Ziz can affect the way some medicines work. Also some medicines can affect the way Ziz works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• medicines for depression called monoamine oxidase inhibitors (MAOIs), such as moclobemide or you have stopped taking one of these MAOI medicines within the last 14 days
• 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, reduce fever or treat arthritis, 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 dry mouth, blurred vision, constipation and difficulty in passing urine.
Tests
Taking Ziz may affect the results of certain tests. These include some pregnancy tests based on urine samples and skin tests. Ziz should not be taken at least 3 days before the start of a skin test.
Taking Ziz with food and drink
Do not drink alcohol whilst taking Ziz. Alcohol may increase the sedative effects of Ziz and make you feel very sleepy.
Pregnancy and breast-feeding
Talk to your doctor before taking Ziz if you are pregnant or planning to become pregnant. Ziz should not be taken 2 weeks before birth.
You should not take Ziz if you are breast-feeding. This is because small amounts may pass into the mothers' milk. This could be harmful to your baby.
Follow the advice from 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.
Important information about some of the ingredients of Ziz tablets
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.
3. HOW TO TAKE ZIZ
If your doctor has prescribed this medicine, always take Ziz exactly as your doctor has told you to. Otherwise, follow the instructions provided in this leaflet. If you are not sure how much you need to take talk to your doctor or pharmacist.
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 dose is:
For allergies (such as hay fever, rashes and hives) Children 2-5years: A liquid form of this medicine should be used in this age group Children 5-10years: A single dose of either one or two tablets (10mg or 20mg) given at night or one tablet (10mg) given twice a day. DO NOT give more than two tablets (20mg) each day.
Children over 10 years and adults (including the elderly): Start with one tablet (10mg) twice a day. This may be increased to a maximum of two tablets (20mg) three times a day.
For treatment and prevention of feeling sick or being sick (such as travel sickness)
Children 2-5 years: A liquid form of this medicine should be used in this age group Children 5-10years: A single tablet to be taken the night before the journey. This may be repeated after 6-8 hours if necessary.
Children over 10 years and adults (including the elderly): Two tablets (20mg) to be taken the night before the journey. This may be repeated after 6-8 hours if necessary.
As a sedative (only under the advice of a doctor)
Ziz Tablets may also be used as a short term sedative. This will normally have been prescribed by a doctor. The information below is a guide to the doses recommended.
Children 2-5 years: A liquid form of this medicine should be used in this age group.
Children 5-10years: Two tablets (20mg) given as a single dose at night time.
Children over 10 years and adults (including the elderly): Two to five tablets (20mg to 50mg) as a single dose at night time.
Children under 2 years: DO NOT give this medicine to children under 2 years old.
If you take more Ziz 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: Feeling excited, moving unsteadily or stumbling, uncontrolled movements especially of the hands or feet, hearing or seeing things that are not there (hallucinations), fits, 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
If you forget to take Ziz don't worry,just miss that dose and take the next evening's 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 medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ziz 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, trembling
• over-active behaviour in children
• very fast, uneven or forceful heart beat (palpitations)
• 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.
Tell your doctor or pharmacist if any of the following side effects become serious or last longer than a few days:
• dry mouth, blurred vision, constipation and difficulty in 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, 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.
Also tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.
5. HOW TO STORE ZIZ
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original packaging. Keep the blister packs in the outer carton.
Do not use the tablets after the expiry date, which is stated on the carton and blister packs. 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 how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Ziz tablets contain
The active substance (the ingredient that makes the tablets work) is promethazine hydrochloride.
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 tablets look like and contents of the pack
Ziz tablets are round, blue, sugar-coated tablets which come in blister packs of 16 tablets.
Marketing Authorisation Holder
Chatfield Pharmaceuticals Limited,
Kramer Mews, London SW5 9JL
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 approved in 11/2011
ZIZ0026/10S/LEA005