ALIMEMAZINE TARTRATE 30 MG / 5 ML ORAL SOLUTION SUGAR-FREE - patient leaflet, side effects, dosage

Patient leaflet - ALIMEMAZINE TARTRATE 30 MG / 5 ML ORAL SOLUTION SUGAR-FREE

5. how to store alimemazine oral solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of the month.
Do not use after the bottle has been opened for more than a month.
Do not used if the product appears to have deteriorated, such as if there are changes in colour of the solution or if the solution becomes cloudy or hazy.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

|6. Contents of the pack and other information

What Alimemazine contains

– Alimemazine tartrate 7.5mg/5ml Oral Solution: Each 5ml contains alimemazine tartrate 7.5mg
– Alimemazine tartrate 30mg/5ml Oral Solution: Each 5ml contains alimemazine tartrate 30mg
– The other ingredients are sucralose, saccharine sodium, citric acid monohydrate (E330), sodium benzoate (E211), sodium sulphite anhydrous (E221), sodium metabisulphite (E223), ascorbic acid (E300), sodium citrate (E331) and artificial apricot flavour (contains propylene glycol E1520). Alimemazine tartrate 7.5mg/5ml Oral Solution also contains artificial caramel flavour (contains propylene glycol E1520).

What Alimemazine Oral Solution looks like and contents of the pack

Alimemazine tartrate (7.5mg/5ml and 30mg/5ml) Oral Solution is a clear colourless to pale yellow solution. It is available in glass bottles of 100ml packaged into a carton with 5ml dosing syringe.

Marketing Authorisation Holder and Manufacturer:

F NOUMED LIFE SCIENCES LIMITED

Noumed House, Shoppenhangers Road Maidenhead, Berkshire, SL6 2RB. UK

This leaflet was last revised in October 2021

Other sources of information:

To listen to or request a copy of this leaflet in braille, large print or audio please call, 020 33998960 (UK only) Please be ready to give the following information:

Product name: Alimemazine tartrate 7.5mg/5ml Oral Solution, Sugar-Free Reference number: PL 44041/0123

Product name: Alimemazine tartrate 30mg/5ml Oral Solution, Sugar-Free Reference number: PL 44041/0124

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Alimemazine tartrate 7.5mg/5ml Oral Solution, Sugar-Free Alimemazine tartrate 30mg/5ml Oral Solution, Sugar-Free

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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.

What is in this leaflet

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

1. what alimemazine oral solution is and what it is used for

The name of your medicine is Alimemazine tartrate 7.5mg/5ml or 30mg/5ml Oral Solution (called Alimemazine Oral Solution throughout this 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.

What Alimemazine is used for:

to treat itching (pruritus) or an itchy, lumpy rash (urticaria) as a sedative before anaesthesia for children aged between 2 and 7 years. This medicine is given to reduce awareness or make the child feel relaxed and at ease before an operation. (Alimemazine tartrate 30mg/5ml Oral Solution only).

2. what you need to know before you take alimemazine oral solution

Do not take Alimemazine and tell your doctor if you: – are allergic (hypersensitive) 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.

– have liver or kidney problems
– have epilepsy
– have Parkinson’s disease (see “Other medicines and Alimemazine”)
– have thyroid problems (hypothyroidism)
– have a tumour on the adrenal gland (called phaeochromocytoma).
– have myasthenia gravis (a form of muscle weakness)
– have an enlarged prostate gland
– have increased pressure in the eye (called narrow angle glaucoma).
– have a history of a blood or bone marrow disorder called agranulocytosis.

Children

– Alimemazine must NOT be used in children less than 2 years old
– Alimemazine Tartrate 30mg/5ml Oral Solution should NOT be used in children unless it is used as a sedative before anaesthesia for children aged between 2 and 7 years, to reduce awareness or make them feel relaxed and at ease before an operation.

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.

Warnings and Precautions

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

– have heart problems
– have fits (epilepsy).
– are elderly and are dehydrated or have been told you have a low blood volume
– are elderly and have had constipation for some time
– are an elderly male and have problems when passing water (urinating)

– are elderly and it is very hot or cold. Your body may find it harder to control its temperature when taking this medicine.

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

Other medicines and Alimemazine

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 can affect the way in which some other medicines work. Also, some medicines can affect the way Alimemazine works.

Tell your doctor if you are taking any of the following: – medicines to help you sleep or lower your anxiety – lithium (to treat some types of mental illness) – amphetamine (for Attention Deficit Hyperactivity Disorder (ADHD).

– phenobarbital (to treat epilepsy)
– adrenaline (to treat life-threatening allergic reactions)

– medicines for Parkinson’s disease, such as levodopa (see “Do not take Alimemazine”)
– medicines for depression
– medicines for severe pain, such as codeine or morphine
– 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).

Alimemazine with alcohol

Do NOT drink alcohol or take any medicines containing alcohol while you are taking

Alimemazine. This is because alcohol can increase the chances of you getting side effects. It can also cause serious breathing difficulties.

Pregnancy and breast-feeding

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 if you are breast-feeding. This is because small amounts may pass into the mother’s milk. This can be harmful to your baby.

Driving and using machines

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

Important information about some of the ingredients of Alimemazine

This medicine contains:

- Sucrose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to 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).
- Sodium. Alimemazine Oral Solution contains approximately 24.35mg of sodium per 5ml dose. Take this into account if you are on a controlled sodium diet.
- Propylene glycol: 12 mg Propylene glycol per 5ml dose

3. how to take alimemazine oral solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Alimemazine tartrate 30mg/5ml Oral Solution

For itching or an itchy, lumpy rash

- Adults:

10mg (approx. 1.6ml) two or three times each day.
Your doctor may increase your dose in some cases.

- Elderly:

10mg (approx. 1.6ml) once or twice each day.

Children less than 12 years:

Children less than 12 years of age should be prescribed alimemazine in a lower strength (7.5 mg/5 ml) Oral Solution formulation for itching or an itchy, lumpy rash.

As a sedative before an operation

- Children aged between 3 and 7 years:
Your child’s doctor will decide the amount to give
The maximum dose is up to 2mg (approx. 1.3ml) per kg of bodyweight
Alimemazine is given 1–2 hours before the operation.

Alimemazine tartrate 7.5mg/5ml Oral Solution

For itching or an itchy, lumpy rash

- Children over 3 years of age:
Aged 3 to 5: 2.5mg (1.7ml) of Alimemazine should be used three to four times per day
Aged 5 to 12: 5mg (3.3ml) of Alimemazine should be used three to four times per day.

As a sedative before general anaesthesia

- Children aged between 3 and 7 years:

Alimemazine Tartrate 7.5mg/5ml Oral Solution should be used:

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

Taking this medicine

– Swallow this medicine. A 5 ml graduated dosing syringe is also provided for accurate dosing
– Avoid the oral solution 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

Instructions for use

– The pack contains a 5 ml oral dosing syringe graduated at every 0.1 ml and an adapter for the oral syringe.
– Opening of the bottle: Turn the screw cap anti-clockwise.
– Insert the adapter in the bottle neck (Fig. 1). Make sure that the adapter is tightly fitted.
– Insert the oral syringe in the opening of the adapter (Fig. 1).

– Turn the bottle upside down (Fig. 2).

– Transfer a small amount of the solution into the syringe by pulling out the piston a short distance (Fig. 3A). Push the piston back to remove any air bubbles (Fig. 3B). Now pull the piston as far as to the millilitre (ml) level corresponding to the dose prescribed by your doc-tor (Fig. 3C).

– Place the bottle in upright position. Remove the syringe from the adapter.
– The patient should sit upright and the syringe piston should slowly be pressed into the syringe so that the patient can swallow well (Fig. 4). After having taken the medicine, the patient should drink half a glass of water.
– Rinse the syringe using water only (Fig. 5).
– Close the bottle with the screw cap (adapter can remain on the bottle).

Exposure to sunlight

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

If you take more Alimemazine than you should

If you take more Alimemazine 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 consciousness, 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 to take Alimemazine

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Alimemazine can cause side effects, although not everybody gets them.

Stop taking Alimemazine 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, 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.

Tell your doctor straight away if you have any of the following side effects:

– 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 stiff muscles, trembling or shaking or difficulty moving

LALIS00/01