Phenergan 5mg/5ml Elixir (100ml)

Product Summary

Phenergan Elixir contains 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.

Phenergan Elixir is used to treat the following conditions:

• Sleeping difficulty (insomnia) in adults – short term use
• Allergic conditions such as hay fever or rashes (nettle rash or hives)
• Feeling sick (nausea) or being sick (vomiting) such as in travel sickness

For short-term use, it can be used as a sedative for children aged 5 years and above.

Directions

See the information leaflet for full details regarding dosages for each indication you are treating.

For allergies (such as hay fever, rashes and hives):

• Children 2–5 years: Either a single dose of ONE to THREE 5 ml spoonfuls OR ONE 5 ml spoonful twice a day. DO NOT give more than three 5 ml spoonfuls a day.
• Children 5–10 years: Either a single dose of ONE to FIVE 5 ml spoonfuls OR ONE or TWO 5 ml spoonfuls twice a day. DO NOT give more than five 5ml spoonfuls a day.
• Children over 10 years and adults (including the elderly): Start with TWO 5 ml spoonfuls twice a day. This may be increased to a maximum of FOUR 5 ml spoonfuls three times a day.

For children over 10 years and adults, Phenergan Tablets may be more convenient.

For treatment and prevention of feeling sick or being sick (such as travel sickness):

• Children 2–5 years: ONE 5 ml spoonful the night before the journey. This may be repeated after 6–8 hours if necessary.
• Children 5–10 years: TWO 5 ml spoonfuls the night before the journey. This may be repeated after 6–8 hours if necessary.
• Children over 10 years and adults (including the elderly): FIVE 5 ml spoonfuls the night before the journey. This may be repeated after 6–8 hours if necessary

For children over 10 years and adults, Phenergan Tablets may be more convenient.

As a short-term paediatric sedative and for short-term treatment of insomnia in adults:

• Children 2–5 years: THREE or FOUR 5 ml spoonfuls as a single dose at night time.
• Children 5–10 years: FOUR or FIVE 5 ml spoonfuls as a single dose at night time.
• Children over 10 years and adults (including the elderly): FIVE toTEN 5 ml spoonfuls as a single dose at night time.

Use this medicine only as recommended.

Do not exceed the recommended dose.

Exposure to sunlight:

Phenergan Elixir can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine.

If you take more Phenergan Elixir than you should, seek medical attention straight away.

Ingredients

• Active ingredient: Each 5 ml of solution contains 5 mg of the active substance promethazine hydrochloride.
• Other ingredients: hydrogenated glucose syrup (maltitol liquid), orange juice flavour, caramel (E150), sodium benzoate (E211), sodium sulphite anhydrous (E221), sodium metabisulphite (E223), ascorbic acid (E300), citric acid anhydrous (E330), sodium citrate (E331), acesulfame potassium (E950) and water.

Warnings and Restrictions

If you take too much by accident:

• tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you so the doctor knows what you have taken. Also, do this if a child under 2 years of age swallows some of this medicine.

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 heartbeat and breathing problems.

In adults: feeling sleepy or drowsy, fits, very fast, uneven or forceful heartbeat (palpitations), loss of consciousness and breathing problems.

Do not take this medicine if:

• you are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Phenergan Tablets (listed in the patient information leaflet). 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 Phenergan Tablets if you have stopped taking one of these MAOI medicines within the last 14 days.
• the person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache
• you have diabetes. The elixir contains hydrogenated glucose syrup and is not suitable for diabetics.

Promethazine is not recommended for use in children of less than two years of age because of the potential for fatal respiratory depression.

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.

Speak to your pharmacist or doctor before taking Phenergan if you are taking any other medication.

Check with your doctor or pharmacist before taking your medicine if:

• you have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis)
• you have epilepsy
• you have any serious heart problems
• 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 Reye’s Syndrome or possible Reye’s Syndrome – signs include being sick and confused following a viral illness

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Phenergan Elixir.

Pregnancy and breastfeeding

• Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
• Phenergan Elixir should not be taken 2 weeks before birth.
• You should not take Phenergan Elixir if you are breastfeeding. This is because small amounts may pass into mothers’ milk. This can be harmful to your baby.

Driving and using machines

• You may feel drowsy or sleepy after taking this medicine or the morning after taking this medicine. If this happens, do not drive or use any tools or machines.

Taking other medicines

Speak to your pharmacist or doctor before taking Phenergan if you are taking any other medication.

Storage

• Store below 25°C
• Keep the bottle in the outer carton in order to protect from light
• Keep this medicine out of the sight and reach of children
• Do not use Phenergan Elixir after the expiry date which is stated on the carton and bottle label. The expiry date refers to the last day of that month
• Do not use Phenergan Elixir after the bottle has been opened for more than a 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 protect the environment.