Dozic 5mg / 5ml Oral Solution

Dozic 5mg/5ml Oral Solution

haloperidol

Read all of this leaflet carefully before you start taking this medicine.

• 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 only for you. Do not pass it on to others.
  
  It may harm them, even if their symptoms are the same as yours.


• If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1. What Dozic is and what it is used for


• 2. Before you take Dozic


• 3. How to take Dozic


• 4. Possible side effects


• 5. How to store Dozic


• 6. Further information

What Dozic is and what it is used for

The name of your medicine is Dozic 5mg/5ml Oral Solution (referred to as Dozic in this leaflet).

It contains haloperidol. This belongs to a group of medicines called neuroleptics.

Haloperidol acts on the brain to calm your emotions.

Dozic 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.

Before you take Dozic

Do not take Dozic 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 heart beat 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 Dozic.

Take special care with Dozic.

Before you take Dozic, tell your doctor if:

• 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.

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.

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

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken 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.

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

• medicines to treat high blood pressure such as guanethidine and methyldopa


• heart medicines to control the heart beat such as quinidine and amiodarone


• medicines that control your emotions such as thioridazine, lithium, sertindole, pimozide, buspirone and antidepressants such as amitriptyline, fluvoxamine and fluoxetine


• medicines that help you sleep such as sedatives or hypnotics such as temazepam


• medicines to treat epilepsy such as phenobarbital and carbamazepine


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


• antibiotics such as moxifloxacin


• 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.


• 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.

Taking Dozic with food and drink

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

Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

You should not use this medicine if you are pregnant or breast-feeding unless your doctor feels it is absolutely necessary.

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 Dozic, it may further affect your ability to drive and use machinery.

Important information about what is in this medicine:

This medicine contains:

• methyl and propyl parahydroxybenzoates. These may cause an allergic reaction.
  This allergy may happen some time after starting the medicine.

How to take Dozic

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

• this medicine contains 5mg 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.

If you take more Dozic 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 Dozic

• 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 Dozic

• Keep taking Dozic 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.

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 Dozic
  

An allergic reaction may include any kind of skin rash, flaking skin, boils or sore lips and mouth, sudden wheezing, fluttering or tightness of the chest or collapse.

• 
  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, muscle stiffness or a change in consciousness leading to coma
  
  
  • yellowing of the skin and whites of your eyes (jaundice) with fever and changes in liver function
  
  

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


• feeling depressed, agitated, confused or excited


• fits


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


• 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


• low blood pressure. You may feel dizzy when standing up. Also high blood pressure


• unusual movements, often of the mouth, lips, eyes and tongue. These movements can also include trembling and shaking of the hands and feet, twisting of the body, shuffling walk and stiffness of the arms and legs and unable to sit still


• blurred vision


• hypoglycaemia (low levels of glucose in the blood). The symptoms of this are hunger, shakiness, sweating, confusion, anxiety and weakness


• water retention or difficulty in passing water (urine).

Tell your doctor if you get any of these side effects:

• unable to sleep, feeling drowsy


• headache, feeling dizzy


• feeling sick, loss of appetite, constipation, upset stomach or indigestion


• dry mouth or more saliva in the mouth than normal


• skin rashes, skin reaction to direct sunlight


• swelling of the breasts (particularly in men) and breast milk production


• light periods or absence of periods


• decrease in sexual performance


• weight gain


• excessive sweating


• changes in your level of alertness.

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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

How to store Dozic

• Keep out of the reach and sight of children


• Store below 25°C. Protect from light


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


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.

Further information

What Dozic 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 Dozic looks like and contents of the pack

A colourless solution

It comes in a brown glass bottle holding 100ml or 500ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

This leaflet was last approved in January 2010

P0504