Haloperidol 10mg5ml oral solution sugar free

Main information

  • Trade name:
  • Haloperidol 10mg5ml oral solution sugar free
  • Dosage:
  • 2mg/1ml
  • Pharmaceutical form:
  • Oral solution
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Haloperidol 10mg5ml oral solution sugar free
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 04090300

Other information

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 0427/0070
  • Last update:
  • 19-02-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Continued overleaf

Haloperidol 10mg/5ml Oral Solution

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 your 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.

What is in this leaflet:

1. What Haloperidol Oral Solution is and what it is used for

2. What you need to know before you take Haloperidol Oral Solution

3. How to take Haloperidol Oral Solution

4. Possible side effects

5. How to store Haloperidol Oral Solution

6. Contents of the pack and other information

1. What Haloperidol Oral Solution is and what it is used for

The full name of your medicine is Haloperidol 10mg/5ml Oral Solution. In this leaflet the shorter name Haloperidol is

used. Haloperidol belongs to a group of medicines called neuroleptics.

Haloperidol acts on the brain to calm your emotions.

Haloperidol can be used to treat:

schizophrenia

feeling and being sick

problems with behaviour in adults and children

persistent hiccups or severe tics

Gilles de la Tourette syndrome in adults and children

or to calm your emotions particularly if you feel agitated and restless if you are an older person, over-excited or

aggressive.

2. What you need to know before you take Haloperidol Oral Solution

Do not take Haloperidol and tell your doctor if:

you are allergic (hypersensitive) to haloperidol or any other ingredients in this liquid (listed in section 6). The signs of

allergic reaction can include a rash, itching or shortness of breath

you have a history of blood problems

you have or are at the risk of having an irregular or unusually slow heart beat, heart block or other heart problems

you are taking medicines that affect the beating of your heart such as verapamil and sotalol

you have dulled senses

you have Parkinson’s Disease

you have damage to the part of the brain known as the basal ganglia

you have been told by your doctor that you have low potassium levels in your blood (hypokalaemia).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before

taking Haloperidol.

Warnings and precautions

Talk to your doctor before taking Haloperidol if:

you have a heart problem or anyone in your close family has died suddenly from heart problems

you are pregnant or breast-feeding

you have kidney or liver problems

you have epilepsy or other problems that may cause fits such as brain damage or alcohol withdrawal

you have thyroid problems

you have a tumour of your adrenal gland that causes high blood pressure (phaeochromocytoma)

you are feeling depressed

you have been told by your doctor that you metabolise some drugs slower than other people

you have had a stroke or brain haemorrhage

you have been told you have low levels of potassium, calcium or magnesium in your blood

you or someone else in your family has a history of blood clots, as medicines like these have been associated with

formation of blood clots

you are an elderly patient with dementia

you suffer from a disorder with related memory loss

you have not been eating properly for a long time.

Available safety data in the paediatric population indicate a risk of extrapyramidal symptoms, including tardive

dyskinesia (involuntary, repetitive body movements), and sedation. No long-term safety data are available.

Other important information to take into account before you take this medicine:

if you or members of your family have heart problems (including heart failure, heart attack or uneven heart beats) or

you have low potassium or magnesium in your blood, your doctor may do some tests on your heart (ECG)

your doctor may also want to give you regular blood tests to check the levels of minerals (electrolytes) in your

blood. This is particularly true for patients taking water tablets (diuretics) or who have other related illnesses.

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

Other medicines and Haloperidol:

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 haloperidol can affect the way

some other medicines work. Also some medicines can affect the way haloperidol works.

Special monitoring may be needed if you are taking lithium and haloperidol liquid at the same time. Tell your doctor

straight away and stop taking both medicines if you get:

fever you can’t explain or movements you can’t control

confused, disorientated, a headache, balance problems and feel sleepy. These are signs of a serious condition.

Tell your doctor if you are taking any of these medicines:

medicines to treat high blood pressure such as guanethidine, methyldopa and water tablets (diuretics)

heart medicines to control the heart beat such as quinidine, amiodarone, disopyramide, procainamide, sotalol,

dofetilide and bretylium

medicines that control your emotions such as thioridazine, lithium, sertindole, pimozide and chlorpromazine

medicines for depression and anxiety such as amitriptyline, fluvoxamine, maprotiline, fluoxetine, buspirone,

venlafaxine, sertraline and paroxetine

medicines that help you sleep such as sedatives or hypnotics such as temazepam and alprazolam

medicines to treat epilepsy such as phenobarbital and carbamazepine

medicines used to treat malaria such as quinine, mefloquine and halofantrine

antibiotics such as moxifloxacin, sparfloxacin and erythromycin IV

medicines used to treat fungal infections such as itraconazole and ketoconazole

medicines used to treat Parkinson’s Disease such as levodopa

adrenaline, used for severe allergies and other medicines that mimic the actions of natural substances in the body.

These are normally found in cough and cold medicines.

other medicines to treat allergies (antihistamines) such as terfenadine and promethazine

medicines to treat stomach problems such as cisapride

phenindione, used to treat thrombosis

strong painkillers such as codeine

arsenic mesilate, given for leukaemia

dolasetron, used to treat nausea (feeling sick) and vomiting

rifampicin used to treat serious infections.

Haloperidol with food, drink and alcohol

You must not drink alcohol whilst taking this medicine. This is because this medicine may make you feel drowsy and

drinking alcohol will make you even more drowsy. Drinking alcohol may also affect the condition you are suffering

from.

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 for

advice before taking this medicine. You should not use this medicine unless your doctor feels it is absolutely necessary

if you are pregnant, or if you are breast-feeding as small amounts may pass into the mother’s milk.

The following symptoms may occur in newborn babies, of mothers that have used haloperidol in the last trimester

(last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing

problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your

doctor.

Driving and using machines

Do not drive or use tools or machines if this medicine makes you drowsy or gives you blurred vision.

If you drink alcohol whilst taking Haloperidol, it may further affect your ability to drive and use machinery.

Important information about what is in this medicine:

Haloperidol Oral Solution contains:

methyl and propyl parahydroxybenzoates. These may cause an allergic reaction.

This allergy may happen some time after starting the medicine.

3. How to take Haloperidol Oral Solution

Always take this medicine exactly as your doctor or pharmacist has told you. Look on the label and check with your

doctor or pharmacist if you are not sure.

Taking this medicine

this medicine contains 10mg of haloperidol in each 5ml

take this medicine by mouth

if you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to

your doctor or pharmacist.

Adults

initial dose: 3mg to 15mg daily split into two or three doses

maintenance dose: the dose will be gradually reduced to 5mg to 10mg daily.

The maximum dose for all treatments is 30mg a day.

Children

Your doctor will work out the dose for your child according to their age and weight

The dose should be split into a morning dose and an evening dose.

The maximum dose for children is 10mg a day.

P0665

Package leaflet: Information for the user

Haloperidol 10mg/5ml Oral Solution

10mg/5ml

P0665

P0590

150 x 500mm (folded 150 x 33mm)

ONE

Rosemont

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

TM

Product:

Strength:

New Item Code:

Previous Item Code:

Design Icon:

Cutter Ref:

Dimensions:

Number of

colours used:

Black

New Pharmacode:

Barcode:

Keyline

Sugar-Free

Pack Size

YES

100ml

Date: 05.08.13

Proof Number: ONE

Page: 1 of: 2

Tick

applicable

P0665

Haloperidol 10mg/5ml Oral Solution

10mg/5ml

P0665

P0590

150 x 500mm (folded 150 x 33mm)

ONE

Rosemont

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

TM

Product:

Strength:

New Item Code:

Previous Item Code:

Design Icon:

Cutter Ref:

Dimensions:

Number of

colours used:

Black

New Pharmacode:

Barcode:

Keyline

Sugar-Free

Pack Size

YES

100ml

Date: 05.08.13

Proof Number: ONE

Page: 2 of: 2

Tick

applicable

If you take more Haloperidol than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have

taken. Signs of an overdose may include low or high blood pressure, extreme sleepiness, muscle spasms, fits, quick

and shallow breaths and coma.

If you forget to take Haloperidol

Do not take a double dose (two doses at the same time) to make up for forgotten doses.

Skip the missed dose then go on as before.

If you stop taking Haloperidol

Keep taking Haloperidol until your doctor tells you to stop. The doctor will lower your

dose gradually.

If you stop taking the medicine suddenly you may get

withdrawal symptoms. Signs include:

feeling or being sick, sweating and difficulty sleeping

(insomnia)

your original symptoms becoming worse

movements that you can’t control.

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

pharmacist.

4. Possible side effects

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

Stop taking the medicine straight away and see your doctor if:

you have an allergic reaction to Haloperidol

An allergic reaction may include sudden swelling of the face or throat, sudden wheezing, fluttering or tightness of the

chest or collapse. Any kind of skin rash such as hives (also known as nettle rash or uticaria), itching, severe irritation,

reddening, blistering or flaking of your skin, boils or sore lips and mouth.

you have any of the following symptoms:

unusually fast heart beat, unstable blood pressure (feeling dizzy, light-headed or faint) and sweating. These are early

warning signs of a disorder caused by the type of medicine you are taking

very high body temperature, faster breathing, muscle stiffness or a change in consciousness leading to coma.

If you get any of the following side effects, see your doctor as soon as possible:

blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may

travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these

symptoms seek medical advice immediately

heart changes including fast heart beats, unusual heart beats, heart attack. Symptoms of a heart attack are chest

pain which may spread to the shoulders, neck or arms and shortness of breath. If you get these see a doctor straight

away. Unexplained deaths have been reported but it is not proven that they were caused by haloperidol

blood problems. You may notice signs such as high temperature or chills, sore throat, ulcers in your mouth or throat

and unusual tiredness.

Very Common side effects (affects more than 1 in 10 people)

feeling agitated

difficulty sleeping

headache

repetitive, involuntary muscle movements.

Common side effects (affects fewer than 1 in 10 people)

twitching often of the mouth, jaws, lips, eyes, tongue and throat

vision disturbance rapid eye movements and rolling of the eyes

feeling depressed or sleepy

symptoms of psychosis such as abnormal thoughts or visions, or hearing abnormal sounds

repetitive body movements and the presence of involuntary movements

sustained muscle contractions causing twisting of the body or a rigid or abnormal posture

decreased body movements, slow ability to start and continue movements

unable to sit still

increased tone of muscles and tremors. This can include trembling and shaking of the hands and feet

mask-like face

low blood pressure. You may feel dizzy when standing up

problems with erection

increase or decrease in weight

abnormal test results for liver function.

Uncommon side effects (affects fewer than 1 in 100 people)

jerky movements and muscle problems such as spasms, stiffness and involuntary contractions

enlarged liver, yellowing of the skin and whites of your eyes (jaundice) with fever

feeling confused

feeling restless

increased heart rate

abnormal neck movements

fits or seizures (convulsions)

parkinsonism (characterised by tremor, rigidity, or instability when standing)

difficulty breathing or wheezing

blurred vision

frequent infections. This can be caused by a fall in the number of white blood cells

decrease or loss of sexual drive

irregular, painful or no monthly period

women unexpectedly producing breast milk, breast discomfort or pain.

Rare side effects (affects fewer than 1 in 1000 people)

raised prolactin (hormone) levels in the blood

being unable to open mouth

muscle twitching, movement disorder, involuntary eye movements

spasm of the airways

heavy periods, menstrual disorder, sexual dysfunction

abnormal heart traces (electrocardiogram, ‘ECG’).

The following side effects have also been reported (frequency unknown)

high blood pressure

fluid retention affecting the brain, resulting in weakness, tiredness or confusion

bleeding or bruising more easily than normal. This can be caused by a fall in the number of small blood cells called

platelets.

Other side effects:

Common side effects (affects fewer than 1 in 10 people)

feeling dizzy

feeling sick (nausea) or being sick (vomiting)

dry mouth or more saliva in the mouth than normal

skin rashes

constipation

water retention or difficulty in passing water (urine).

Uncommon side effects (affects fewer than 1 in 100 people)

skin reaction to direct sunlight

excessive sweating, itching or skin rash causing red patches

fever

difficulty walking, shuffling

build up of fluid (oedema).

The following side effects have also been reported (frequency unknown)

loss of appetite, upset stomach or indigestion

swelling of the breasts (particularly in men)

build up of fluid in the throat or spasm in the throat

low blood sugar levels (hypoglycaemia). The symptoms of this are hunger, shakiness, sweating, dizziness, confusion,

anxiety and weakness

liver failure or biliary disorders

a severe skin rash that causes blistering, particularly the mouth and tongue. These may be signs of a condition

known as Stevens-Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN). If this happens seek medical advice

immediately. Your doctor may have to stop your treatment

men experiencing painful or prolonged erection

inappropriate antidiuretic hormone secretion (where the body produces too much antidiuretic hormone)

feeling of dizziness or spinning (vertigo)

rapid or irregular heart beats

swelling of the face

flaking or peeling of the skin

inflamed skin (red, hot to the touch and tender) or inflammation of the blood vessels characterised by fever, pain in

the joints and muscles

low body temperature

feeling drowsy

in newborn babies, of mothers that have used haloperidol in the last trimester (last three months of their pregnancy),

side effects can occur. See section 2: Pregnancy and breast feeding.

In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking

antipsychotics compared with those not receiving antipsychotics.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Haloperidol Oral Solution

Keep this medicine out of the sight and reach of children

Store below 25°C. Protect from light

Do not use this medicine after the expiry date which is stated on the label and carton (exp: month, year)

The expiry date refers to the last day of that month

Do not use this medicine if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist

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.

6. Contents of the pack and other information

What Haloperidol Oral Solution contains

The active ingredient is haloperidol

The other ingredients are propylene glycol (E1520), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216),

lactic acid (E270) and purified water.

What Haloperidol Oral Solution looks like and contents of the pack

A colourless solution.

It comes in a brown glass bottle holding 100ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd,

Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This leaflet was last revised in 07/2013.

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18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Europe - EMA - European Medicines Agency