Patient leaflet - Phenergan 25 mg tablets
1. What Phenergan Tablets are and what they are used for
Phenergan 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 body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed.
What Phenergan Tablets are used for
Phenergan 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 6 years and
above
2. What you need to know before you take Phenergan Tablets
Do not take Phenergan Tablets if:
X The person taking the medicine is under 6 years of age. X You are allergic (hypersensitive) 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. X You are taking a medicine for depression called a monoamine
oxidase inhibitor (MAOI). Also do not take Phenergan 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 Phenergan Tablets’)
X 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 Phenergan Tablets.
Warnings and precautions
Check with your doctor or pharmacist before taking Phenergan Tablets if:
You have difficulty breathing, wheezing, tightness in the chest
(asthma) or an infection in your lungs (bronchitis).
- You have seizure disorders such as epilepsy.
You experience an allergic reaction (see section Side Effects),
seek medical help right away.
- You have any serious heart problems.
- You have any personal or family history of heart disease
- You have an irregular heartbeat
You develop a fever or an infection. Talk to your doctor
immediately as laboratory tests to check your blood count may be required.
- 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 sick and confused following a viral illness.
Exposure to sunlight
Phenergan Tablets can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine.
Tests
Taking Phenergan Tablets may affect the results of certain tests. These include some pregnancy tests and skin tests. Phenergan 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 Phenergan Tablets.
Children and adolescents
Do not use in children less than 6 years of age. Because of the risk of choking, the tablets should be avoided in children who have difficulty swallowing tablets.
Other medicines and Phenergan Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Phenergan Tablets can affect the way some medicines work. Also some medicines can affect the way Phenergan Tablets work.
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:
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 mental health problems (antipsychotics such as
haloperidol and quetiapine) or depression (antidepressants such as amitriptyline 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).
Phenergan Tablets may hide the side effects of these medicines
Medicines for the treatment of irregular heartbeats (antiarrhythmics
such as quinidine and amiodarone).
- Medicines for the treatment of epilepsy or seizures
Antimicrobials (such as erythromycin and levofloxacin) for the
treatment of infections.
Phenergan Tablets with alcohol
Do not drink alcohol while you are taking Phenergan Tablets. This is because it can affect the way the medicine works.
Pregnancy and breast-feeding
Use of Phenergan Tablets is not recommended during pregnancy. Talk to your doctor or pharmacist before taking this medicine if you are a woman of childbearing age and not using effective contraception, or if you are pregnant, might become pregnant, or think you may be pregnant. Phenergan Tablets should not be taken 2 weeks before birth.
You should not take Phenergan Tablets if you are breast-feeding. This is because small amounts may pass into mothers’ milk. This can 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, dizzy or sleepy or have blurred vision after taking this medicine or the morning after taking this medicine. If this happens, do not drive or use any tools or machines. You should not drive a vehicle or operate machinery until you know how Phenergan Tablets affect you.
Phenergan Tablets contains lactose:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Phenergan Tablets
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 Phenergan Tablets. 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.
How much to take
The recommended dose is:
For allergies (such as hay fever, rashes and hives) Children 6-10 years:
- A single tablet (25mg) given at night
- DO NOT give more than 25mg each day
Children over 10 years and adults (including the elderly):
- Start with one tablet (25mg) taken at night
This may be increased to a maximum of one tablet (25mg) twice
a day if necessary
For treatment and prevention of feeling sick or being sick (such as travel sickness)
Children 6-10 years:
- Phenergan Elixir should be given in this age group Children over 10 years and adults (including the elderly):
- A single tablet (25 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 6-10 years:
- A single tablet (25mg) given at night
Children over 10 years and adults (including the elderly):
- One or two tablets (25-50mg) taken at night
If you take more Phenergan Tablets than you should
If you or your child takes more Phenergan 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 symptoms of an overdose may occur: fits (seizures), impaired consciousness, coma, uneven heart beat and depressed breathing.
Children may experience excitation, unsteady or uncontrollable movements especially of the hands or feet, hallucinations, limited ability to learn and impairments in thinking, learning, or memory.
If you forget to take Phenergan Tablets
Do not take a double dose to make up for a forgotten dose
If you are taking Phenergan Tablets for an allergic condition - take
your medicine as soon as you remember, then carry on as before
If you are taking Phenergan Tablets 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Phenergan Tablets can cause side effects, although not everybody gets them.
Stop taking Phenergan Tablets and see a doctor or go to a hospital straight away if you notice any of the following side effects:
Allergic reactions (that can occur either immediately or within
several days of drug administration) that may be life-threatening. Symptoms may include rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold, clammy skin, palpitations, dizziness, weakness or fainting
Liver problems that may cause the eyes or skin to go yellow
(jaundice) and darkening of urine
- Muscle stiffness or shaking
Unusual movements of the tongue, facial muscle spasms or being
unable to control some muscles in your face, rolling eyes and trembling
- Very fast, irregular, uneven or forceful heartbeat (palpitations)
General weakness, more frequent infections (particularly throat
infection) and fever due to changes in the blood (agranulocytosis)
Eosinophilia which is an increase in the number of eosinophils (a
type of white blood cell). Eosinophilia will be detected by a blood test.
Thrombocytopenia which is a decrease in the number of platelets
(cells in the blood that help with clotting) found in a blood test, which can lead to bleeding and bruising (thrombocytopenic purpura).
- Tiredness which lasts for a long time. This may be due to a blood problem called anaemia.
- A feeling of aggression, hallucinations and hyperactivity in children
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days.
- 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 or irritated stomach
- 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
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, 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 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 Phenergan Tablets
- KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
- Do not use after the expiry date on the carton and blister pack after EXP. The expiry refers to the last day of that month.
- Do not store above 30°C. Store in the original package in order to protect from light.
- If you notice any signs of deterioration, you should return your medicine to your pharmacist who will tell you what to do.
- Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.
6. Contents of the pack and other information
What Phenergan Tablets contain
Each tablet contains 25mg of the active substance, promethazine hydrochloride
The other ingredients are lactose monohydrate, maize starch, povidone K30, magnesium stearate, macrogol 200, titanium dioxide (E171), indigo carmine (E132) and hypromellose.
What Phenergan Tablets looks like and contents of the pack
Phenergan Tablets are a pale blue, circular tablet marked ‘PN 25’ on one side and the other side is plain, they are supplied in a blister pack of 56 tablets.
Manufacturer
Manufactured by FAMAR HEALTH CARE SERVICES MADRID S.A.U., Avenida de Leganes 62, 28923 Alcoron, Spain.
Procured from within the EU and repackaged by the Product Licence Holder: G-Pharma Limited, Unit 1-4 Dakota Avenue, Salford, M50 2PU.
PL 16369/2222
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Leaflet revision: 08/10/2024
Phenergan® is a registered trademark of Sanofi.
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