Alimemazine tartrate 7.5mg/5ml Syrup

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

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

• to treat itching (pruritus) or an itchy, lumpy rash (urticaria)
• as a sedative for children aged between 3 and 7 years. This medicine is given to reduce awareness or make the child feel relaxed and at ease before an operation.

• You are allergic (hypersensitivity) to:
  • alimemazine tartrate or any of the other ingredients of this medicine (listed in section 6)
  • any other similar medicines (phenothiazines) such as chlorpromazine.
    The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have liver or kidney problems
• You have epilepsy
• You have Parkinson’s disease
• You have thyroid problems (hypothyroidism)
• You have a tumour on the adrenal gland (called phaeochromocytoma)
• You have myasthenia gravis (a form of muscle weakness)
• You have an enlarged prostate gland
• You have increased pressure in the eye (called narrow angle glaucoma).
• You have a history of a blood or bone marrow disorder called agranulocytosis.

Alimemazine should not be used in children less than 3 years old. 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 Alimemazine syrup.

Talk to your doctor or pharmacist before taking Alimemazine syrup if:

• You are diabetic. This medicine contains sucrose, a type of sugar.
• You have heart problems
• You are elderly and are dehydrated or have been told you have a low blood volume
• You are elderly and have had constipation for some time
• You are an elderly male and have problems when passing water (urinating)
• You are elderly and it is very hot or cold. Your body may find it harder to control its temperature when taking this medicine.
• You have fits (seizures).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Alimemazine syrup.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Alimemazine syrup can affect the way in which some other medicines work. Also some medicines can affect the way Alimemazine syrup works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• medicines to help you sleep or lower your anxiety
• lithium used to treat some types of mental illness
• amphetamine used for Attention Deficit Hyperactivity Disorder (ADHD)
• phenobarbital used for epilepsy
• adrenaline used for life-threatening allergic reactions
• medicines for Parkinson’s disease, such as levodopa
• medicines for depression
• medicines for severe pain (such as codeine or morphine)
• medicines for diabetes. Your doctor may need to change your dose of your medicine.
• medicines for high blood pressure, such as doxazosin, terazosin, guanethidine or clonidine
• medicines for indigestion and heartburn (antacids)
• anticholinergic medicines (includes some medicines used for irritable bowel syndrome, asthma or incontinence).

Do NOT drink alcohol or take any medicines containing alcohol while you are taking Alimemazine syrup. This is because alcohol can increase the chances of you getting side effects. It can also cause serious breathing difficulties.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should NOT take Alimemazine syrup if you are breast-feeding. This is because small amounts may pass into the mother’s 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.

You may feel drowsy or sleepy while taking this medicine. If this happens, do NOT drive or use any tools or machines.

This medicine contains :

• Sucrose. This is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
• Sodium sulphite (E221) and sodium metabisulphite (E223). These may rarely cause severe allergic (hypersensitivity) reactions and difficulty breathing, wheezing and tightness in the chest (bronchospasm)
• Ethanol. Alimemazine Syrup contains 81mg of alcohol (ethanol) in each 2ml which is equivalent to 40.5mg/ml (4% w/v). The amount in 2ml of this medicine is equivalent to less than 2ml beer and 1ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
• Sodium. This medicine contains 24.36 mg sodium (main component of cooking/table salt) in each 5ml. This is equivalent to 1.17% of the recommended maximum daily dietary intake of sodium for an adult.

• Take this medicine by mouth.
• Avoid the syrup touching any part of your skin. This can cause skin redness, swelling and itching (contact skin sensitisation).
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
• Do not take more than the recommended dose.

For itching or an itchy, lumpy rash

• Adults:
  • 10mg two or three times each day.
  • Your doctor may increase your dose depending on your illness.
• Elderly:
  • 10mg once or twice each day.
• Children over 3 years of age:
  Alimemazine Tartrate 7.5mg/5ml Syrup should be used:
  • 2.5 to 5 mg three or four times each day.

Alimemazine Tartrate 7.5mg/5ml Syrup should be used:

• Your child’s doctor will decide the amount to give.
• The maximum dose is up to 2mg per kg of bodyweight.
• Alimemazine syrup is given 1-2 hours before the operation.

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

If you take more Alimemazine syrup than you should, tell a doctor or go to a hospital casualty department immediately. Take the medicine pack with you. This is so the doctor knows what you have taken. Also do this if a child under 3 years of age swallows some of this medicine.

The following effects may happen:

Feeling drowsy, loss of conciousness, increased or rapid heartbeat, changes in heartbeat, uneven heartbeats and feeling very cold. You may also feel dizzy, light-headed or faint (due to low blood pressure) and you may notice you cannot control your movements (for example of the eyes, neck, arms and legs).

If you forget a dose, take it as soon as you remember it. However , if it is nearly time for the next dose, skip the missed dose.

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

• an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• liver problems that may cause the eyes or skin to go yellow (jaundice)
• high temperature, sweating, rigid or stiff muscles, fast heartbeat, fast breathing and feeling confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’.
• very fast, uneven or forceful heartbeat (palpitations). You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain.
• convulsions/fits and movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs
• you may get infections more easily than normal such as fever, severe chills, sore throat or mouth ulcers. These could be a sign of blood problems.

• breathing more slowly or less deeply than normal
• feeling restless and not being able to keep still (akathisia)
• changes in skin or eye colour
• problems with your eyesight
• rigid or stiffed muscles, trembling or shaking or difficulty moving
• feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)
• unexpected excitement or hyperactivity.
• difficulty in passing urine

• constipation
• dry mouth
• stuffy nose
• difficulty sleeping (insomnia)
• feeling agitated
• dizziness
• headache
• drowsiness
• being more sensitive to the sun than usual
• unusual production of breast milk in men and women
• breast enlargement in men
• loss of menstrual periods
• difficulty in getting or maintaing an erection or in ejaculating (impotence)
• skin redness, swelling and itching (contact skin sensitisation)
• skin rashes

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 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 1ml of Alimemazine 7.5mg/5ml syrup contains 1.5mg of the active substance, Alimemazine tartrate.
• Each 1ml of Alimemazine 30mg/5ml syrup contains 6mg of the active substance, Alimemazine tartrate.
• The other ingredients are sucrose, ethanol, citric acid monhydrate anhydrous (E330), sodium benzoate (E211), sodium sulphite anhydrous (E221), sodium metabisulphite (E223), ascorbic acid (E300), apricot flavour, caramel flavour and sodium citrate (E331).

Alimemazine tartrate 7.5mg/5ml syrup is a clear colourless to pale yellow syrupy liquid. It is available in glass bottles of 100ml.

Alimemazine tartrate 30mg/5ml syrup is a clear colourless to pale yellow syrupy liquid. It is available in amber glass bottles of 100ml.

A 2 ml graduated dosing syringe and syringe adapter are also provided.