Promethazine Hydrochloride 25mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROMETHAZINE HYDROCHLORIDE 25 MG TABLETS
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 Promethazine is and what it is used for
2. What you need to know before you take Promethazine
3. How to take Promethazine
4. Possible side effects
5. How to store Promethazine
6. Contents of the pack and other information
1. WHAT PROMETHAZINE IS AND WHAT IT IS USED FOR
The name of your medicine is Promethazine Hydrochloride 25 mg Tablets (called Promethazine in the leaflet). 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
Promethazine is used to treat the following conditions:
• for short term use: to treat adults with difficulty in sleeping (insomnia)
• 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.
• for short term use: as a sedative for children
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROMETHAZINE
Do not take Promethazine 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 (See "Taking other medicines" section below).
• 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 Promethazine.
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 in passing 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.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Promethazine.
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 Promethazine Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Promethazine can affect the way some medicines work. Also some medicines can affect the way Promethazine 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.
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 (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, asthma or weak bladder. These can increase the risk of dizziness, dry mouth and blurred vision.
Tests
Taking Promethazine may affect the results of certain tests. These include some pregnancy tests based on urine samples and skin tests. Promethazine should not be taken at least 3 days before the start of a skin test.
Promethazine tablets with food and drink
Do not drink alcohol whilst taking Promethazine. Alcohol may increase the sedative effects of Promethazine and make you feel very sleepy.
Pregnancy and breast-feeding
Talk to your doctor before taking Promethazine if you are pregnant or planning to become pregnant. Promethazine should not be taken 2 weeks before birth.
You should not take Promethazine 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 of 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.
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 Promethazine.
3. HOW TO TAKE PROMETHAZINE
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
• 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, ask your doctor.
How much to take
The usual doses are:
For allergies (such as hay fever or 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.
As a short-term paediatric sedative and 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.
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 Promethazine than you should
If you or your child accidentally takes more Promethazine 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, 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 Promethazine
Do not take a double dose to make up for a forgotten dose.
• If you are taking Promethazine for an allergic condition - take your medicine as soon as you remember, then carry on as before
• If you are taking Promethazine 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, Promethazine 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)
• 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 in passing urine, especially in the elderly and children
• feeling drowsy, sleepy, dizzy or tiredness, headaches, fits
• feeling confused, especially in the elderly
• feeling depressed, restless or disorientated (not knowing where you are), having nightmares or difficulty 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 PROMETHAZINE
Keep out of the sight and reach of children.
Store below 25°C and protect from light. 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 Promethazine 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 Promethazine tablets look like and contents of the pack
Promethazine tablets are blue, sugar-coated tablets which come in blister packs of 10, 14, 28, 30 and 56 tablets and in containers of 100 and 500 tablets. Not all pack sizes may be marketed.
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
CL0092/P/PIL/CL1