Phenergan Elixir

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 after 7 days.

1. What Phenergan Elixir is and what it is used for
2. What you need to know before you take Phenergan Elixir
3. How to take Phenergan Elixir
4. Possible side effects
5. How to store Phenergan Elixir
6. Contents of the pack and other information

Phenergan Elixir is used to treat the following conditions:

• To treat allergic conditions such as hay fever or rashes (like nettle rash or hives)
• To 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.

• The person taking the medicine is under 6 years of age
• 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
• You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Phenergan Elixir 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 Elixir’)
• 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 Elixir.

Check with your doctor or pharmacist before taking Phenergan Elixir if:

• You have difficulty breathing, wheezing,tightness in the chest (asthma) or an infection in your lungs (bronchitis).
• You have a seizure disorder 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.
• You have diabetes. This medicine contains hydrogenated glucose syrup (see ‘Phenergan Elixir contains’).

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

Taking Phenergan Elixir may affect the results of certain tests. These include some pregnancy tests and skin tests. Phenergan Elixir 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 Elixir.

Do not use in children less than 6 years of age.

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 Elixir can affect the way some medicines work. Also some medicines can affect the way Phenergan Elixir 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:

• 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 Elixir 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.

Do not drink alcohol while you are taking Phenergan Elixir. This is because it can affect the way the medicine works.

Use of Phenergan Elixir 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 Elixir should not be taken in the 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.

If you are breastfeeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

You may feel drowsy, dizzy, or sleepy or have blurred vision while taking this medicine or in 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 Elixir affects you.

• Hydrogenated glucose syrup (maltitol liquid): This is a type of carbohydrate which the body will convert into small amounts of sugar. This medicine contains 1g of sugar in each 5ml dose. Taking this amount of Phenergan Elixir is unlikely to affect the control of your diabetes or require you to increase your diabetes medication. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Hydrogenated glucose syrup may have a mild laxative effect. The calorific value of hydrogenated glucose syrup is 2.3kcal/g. A 5ml dose (one teaspoon) contains approximately 10kcal.
• Sodium sulphite and sodium metabisulphite: These may rarely cause severe allergic (hypersensitivity) reactions and difficulty breathing, wheezing and tightness in the chest (bronchospasm)
• Sodium: This medicine contains 37mg sodium (main component of cooking/table salt) in each 5ml dose. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult. Take this into account if you are on a controlled sodium diet
• Sodium benzoate: This medicine contains 5mg sodium benzoate in each 5ml dose, which is equivalent to 1mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

• 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.
• After use, wipe the neck of the bottle with a clean damp cloth. This will remove any liquid that is left, before putting the cap back on
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

The recommended dose is:

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

Children 6-10 years:

• Either a single dose of one to five 5ml spoonfuls OR one or two 5ml 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 5ml spoonfuls twice a day
• This may be increased to a maximum of four 5ml 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 6-10 years:

• Two 5ml 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 5ml 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 6-10 years:

• Four or five 5ml spoonfuls as a single dose at night time

Children over 10 years and adults (including the elderly):

• Use of Phenergan Tablets is recommended

If you or your child have taken more Phenergan Elixir 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 have taken. Also do this if a child under 6 years of age swallows some of this medicine.

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

Do not take a double dose to make up for a forgotten dose

• If you are taking Phenergan Elixir for an allergic condition - take your medicine as soon as you remember, then carry on as before
• If you are taking Phenergan Elixir for sedation or sleeping problems - miss that dose and take the next evening’s dose as usual

• 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 heartbeat 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

• 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)

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.

Each 5ml of solution contains 5mg of the active substance, promethazine hydrochloride.

The other ingredients are 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), acesulphame potassium (E950) and water.

A clear, golden, syrupy liquid with an odour of oranges contained in an amber glass bottle with a child resistant cap and tamper-evident ring. Your elixir is available in glass bottles of 100ml.

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