What is promethazine?

These tablets contain 10mg of promethazine hydrochloride, a type of medicine known as a phenothiazine. Promethazine hydrochloride has a variety of medical uses:

• Treatment of allergic conditions such as hay fever or rashes

• Prevention or treatment of nausea and vomiting (i.e. travel sickness)

• Short term relief of insomnia (difficulty sleeping) in adults

• Short term use as a sedative for children over 5 years old

What is the recommended dosage?

The recommended dosage for promethazine will depend on your age and what you’re planning to use the tablets for. Always follow your doctor or pharmacist’s specific advice on how to take this medicine for your condition.

For allergies:

Children 5-10 years: 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) in one day.

Adults and children over 10 years old: start with one tablet (10mg) twice a day. This can be increased to a maximum of two tablets (20mg) three times a day.

For travel sickness:

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.

Adults and children over 10 years old: two tablets to be taken the night before the journey. This may be repeated after 6-8 hours if necessary.

Short term sedative for children or insomnia treatment for adults:

Children 5-10 years: two tablets (20mg) given as a single dose at night time.

Adults and children over 10 years old: two to five tablets (20mg to 50mg) as a single dose at night time.

How does promethazine hydrochloride work?

Promethazine hydrochloride is a type of medicine called a phenothiazine, which works by blocking a chemical called histamine that your body produces during an allergic reaction. This medicine also works directly on the brain to help you feel more relaxed.

Will these tablets make me feel drowsy?

Promethazine hydrochloride is a drowsy medicine. That means you may feel sleepy after taking this medicine in the evening and the following morning too. If you feel drowsy after taking promethazine, do not drive or operate machinery until this side effect has subsided.

Can I drink alcohol while taking this medicine?

Do not drink any alcoholic drinks while taking promethazine tablets. This is because alcohol can affect the way promethazine works and may worsen some side effects.

Are these tablets suitable for pregnant or breastfeeding women?

If you are pregnant, think you may be pregnant or are trying to become pregnant, speak to a doctor or pharmacist for advice before taking promethazine tablets. You must not take this medicine two weeks before birth or if you are breastfeeding. This is because small amounts of the medicine may pass into your milk and harm your baby.

When should promethazine not be used?

Promethazine tablets are not suitable for some groups of people. You must avoid this medicine if:

• You are allergic to promethazine hydrochloride or any of the other ingredients

• You are currently, or have recently been taking a medicine for depression called a monoamine oxidase inhibitor (MAOI) in the last 14 days

• The person taking this medicine is under 5 years old

• The person taking this medicine is unconscious or suffers from severe dizziness, drowsiness or headache

Some people will need to take extra caution before taking promethazine tablets. Speak to your doctor or pharmacist before taking this medicine if you currently have, or have ever had:

• Asthma, bronchitis or any other breathing difficulties

• Epilepsy

• Any serious heart problems

• Liver or kidney problems

• A stomach blockage or difficulty passing urine

• Hearing problems

• Increased pressure in the eye (narrow-angle glaucoma)

• Reye’s Syndrome (symptoms include being sick and confused after a viral illness)

Speak to your doctor or pharmacist before taking this medicine if you are taking any other medicines or herbal remedies, including those obtained without a prescription. This is particularly important if you are taking:

• Some medicines for depression called monoamine oxidase inhibitors (MAOIs)

• Anticholinergic medicines (used for asthma, irritable bowel syndrome or a weak bladder)

• Medicines for depression such as amitriptyline

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

• Medicines for arthritis and pain in your joints such as aspirin

Are there any side effects?

Like all medicines, promethazine hydrochloride tablets can cause some side effects, but not everyone will get them. Stop taking these tablets straight away and seek emergency medical attention if you notice any of the following serious side effects:

• An allergic reaction (rash, difficulty breathing, swelling of the face, lips tongue or throat, sudden wheezing or collapse)

• Liver problems (yellowing of the skin or the whites of the eyes)

• Muscle stiffness or shaking

• Being unable to control some muscles in your head or face

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

• Very fast, uneven or forceful heartbeat

• Irregular heartbeat

• Tiredness which lasts for a long time

• Changes in the numbers and types of your blood cells (increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness or abnormal paleness of the skin)

• Overactive behaviour in children

Speak to your doctor if you find that any of the following side effects become serious or last longer than a few days:

• Dry mouth, blurred vision, difficulty passing urine, constipation, difficulty shedding tears (especially in children and the elderly)

• Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless

• Feeling depressed, having nightmares or problems sleeping, headaches

• Loss of appetite, indigestion, stomach upsets

• Feeling dizzy, lightheaded or faint

• Feeling confused (especially in elderly people)

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

• Being more sensitive to the sun than usual

If you experience any side effects, including those that are not listed in the patient information leaflet, you can report them using the MHRA Yellow Card Scheme.

Why do I need to answer questions to buy this product?

You do not need a prescription for promethazine, however, you will be asked to complete a short medical questionnaire by your pharmacist before we can take your order. This includes some simple questions that all pharmacies legally are required to ask before supplying this kind of product. This helps our pharmacy team to be sure that promethazine is the best choice for you.

Storage information

Store below 25°C, out of sight and reach of children. Do not use this medication after the expiry date, referring to the last day of the month stated on the packaging. Keep this medication in its original packaging.