Patient leaflet - Ziz
1. WHAT ZIZ IS AND WHAT IT IS USED
FOR
Ziz 10 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 tablets are used to treat the following conditions:
- to treat allergic conditions such as hay fever or rashes (like nettle rash or hives)
- to treat or stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness
- for short term use: to treat adults with difficulty sleeping (insomnia)
- for short term use: as a sedative for children aged 5 years and above.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIZ
Do not take Ziz if:
- the person taking this medicine is under 5 years of age
- you are allergic (hypersensitive) 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.
- you are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Ziz 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 Ziz Tablets’’).
- the person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ziz.
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 a stomach blockage or difficulty passing water (urine)
- have hearing problems
- 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
- have any personal or family history of heart disease
- have an irregular heartbeat.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ziz.
Exposure to sunlight
Ziz Tablets can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine.
Tests
Taking Ziz Tablets may affect the results of certain tests. These include some pregnancy tests and skin tests. Ziz Tablets should not be taken at least 3 days before the start of a skin test.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ziz.
Other medicines and Ziz 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 can affect the way some medicines work. Also some medicines can affect the way Ziz works.
In particular 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.
Also tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following:
- medicines that can affect your heart rhythm
medicines for the treatment of irregular
heartbeats (antiarrhythmics such as quinidine and amiodarone)
- antimicrobials (such as erythromycin and levofloxacin) for the treatment of infections
- medicines for mental health problems (antipsychotics such as haloperidol and quietiapine) or depression (antidepressants such as amitryptyline and citalopram)
- 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). Ziz may hide the side effects of these medicines
- anticholinergic medicines. This includes some medicines used for irritable bowel syndrome, asthma or weak bladder. These can increase the risk of dizziness, dry mouth and blurred eyesight.
Ziz tablets with alcohol
Do not drink alcohol whilst taking Ziz. This is because it can affect the way the medicine works.
Pregnancy and breast-feeding
Talk to your doctor before taking Ziz if you are pregnant, or might become pregnant, or think you may be 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.
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 in the morning after taking this medicine. If this happens, do not drive or use any tools or machines.
Promethazine 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.
3. HOW TO TAKE ZIZ
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 Ziz. The following information will help you to decide how much you need to take.
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. Use this medicine only as recommended. Do not exceed the recommended dose.
- If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
- If you feel burning or pain during or shortly after application, tell your doctor or nurse immediately.
How much to take
The recommended doses are:
For allergies (such as hay fever, rashes and hives) Children 2-5 years:
- A liquid form of this medicine should be used in this age group
Children 5-10 years:
- A single dose of either one or two tablets (10 mg or 20 mg) given at night or one tablet (10 mg) given twice a day
- DO NOT give more than two tablets (20 mg) each day Children over 10 years and adults (including the elderly):
- Start with one tablet (10 mg) twice a day
- This may be increased to a maximum of two tablets (20 mg) 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 5-10 years:
- 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 (20 mg) to be taken the night before the journey
- This may be repeated after 6-8 hours if necessary
As a short term paediatric sedative and for short term treatment of insomnia in adults
Children 2-5 years:
- A liquid form of this medicine should be used in this age group
Children 5-10 years:
- Two tablets (20 mg) given as a single dose at night time
Children over 10 years and adults (including the elderly):
- Two to five tablets (20 mg to 50 mg) as a single dose at night time
Use this medicine only as recommended. Do not exceed the recommended dose.
If you take more Ziz than you should
If you or your child accidentally takes too many Ziz tablets 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 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, 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
Do not take a double dose to make up for a forgotten dose.
- If you are taking Ziz for an allergic condition - take your medicine as soon as you remember, then carry on as before.
If you are taking Ziz 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 can cause side effects, although not everybody gets them.
Frequency “not known (cannot be estimated from the available data)”:
- Abnormal electrical activity of the heart that affects its rhythm, including life-threatening rhythm disturbance
- A serious reaction with fever, rigid muscles, changing blood pressure and coma (neuroleptic malignant syndrome)
- Low levels of blood platelets (which can lead to bleeding and bruising)
- Restlessness
- Hallucinations
Aggression
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, breathing or swallowing problems
- 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
- you notice 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
- tiredness which lasts for a long time. This may be due to a blood problem called anaemia
- general weakness, more frequent infections (particularly throat infection) and fever due to changes in the blood (agranulocytosis).
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 or you cannot pass water (urine)
- feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless
- feeling confused, especially in the elderly people
- loss of appetite (anorexia), indigestion or irritated stomach
- feeling dizzy, lightheaded, faint (hypotension)
- being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sunlamps
- unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ZIZ
Keep out of the sight and reach 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.
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 tablets contain
The active substance is promethazine hydrochloride. Each tablet contains 10 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 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
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 03/2025.
CL0146/P/PIL-Br/CL4