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

■    feeling sleepy or drowsy

■    unable to sleep

■    feeling depressed

■    breast swelling and pain (men or women) and secretion of breast milk in women

■    irregular or absent periods

■    changes in sexual function

■    diarrhoea that may be caused by the liquid maltitol in the medicine

■    weight gain

■    blocked nose

■    dry mouth

■    constipation

■    skin rashes, skin reaction to direct sunlight.

There have been reports of unexplained deaths, but it is not proven that they were due to sulpiride.

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/Yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

RoEemoni^ Package leaflet: Information for the user

Sulpiride Rosemont 200mg/5ml Oral Solution

5. How to store Sulpiride Rosemont

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. See section 4.

What is in this leaflet:

1.    What Sulpiride Rosemont is and what it is used for

2.    What you need to know before you take Sulpiride Rosemont

3.    How to take Sulpiride Rosemont

4.    Possible side effects

5.    How to store Sulpiride Rosemont

6.    Contents of the pack and other information

■    keep this medicine out of the sight and reach of children

■    do not store above 25°C

■    get rid of the medicine 3 months after opening

■    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.

1. What Sulpiride Rosemont is and what it is used for

The name of your medicine is Sulpiride Rosemont 200mg/5ml Oral Solution (called Sulpiride in this leaflet).

It contains sulpiride. This belongs to a group of medicines called benzamides. These act on the brain to reduce abnormal behaviour.

Sulpiride is used for treating schizophrenia.

2. What you need to know before you take Sulpiride Rosemont

6. Contents of the pack and other information

What Sulpiride Rosemont contains

■    the active ingredient is sulpiride.

■    the other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), citric acid monohydrate (E330), liquid maltitol (E965), lemon flavour, aniseed flavour and purified water.

What Sulpiride Rosemont looks like and contents of the pack A colourless to slightly yellow liquid with an odour of lemon and aniseed.

It comes in a brown glass bottle holding 150ml of liquid.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was last revised in 11/2015.

Do not take Sulpiride and tell your doctor if:

■    you are allergic (hypersensitive) to sulpiride or any other ingredients in this liquid (listed in Section 6).

The signs of an allergic reaction include a rash, itching or shortness of breath

■    you have high blood pressure particularly due to a growth on your adrenal glands (phaeochromocytoma)

■    you have porphyria, a problem with your metabolism that can cause skin blisters, pain in and around your stomach (abdomen) and brain or nervous system problems

■    severe kidney, blood or liver problems

■    you have an alcohol-related illness or any other problems that affect your nervous system

■    you have ever had breast cancer or a type of brain tumour called 'pituitary prolactinoma'

■    you have low numbers of some blood cells in your body due to "bone marrow suppression". You may feel tired, get more infections or bruise more easily than usual

■    you are taking levodopa (see section 'Taking other medicines').

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 this medicine.

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Warnings and precautions

Talk to your doctor before taking Sulpiride if:

■    you have 'hypomania'. These are mood swings that may show as excitability, anger, irritability and a lower need for sleep

■    you have heart problems including unusual heart beats, heart disease or heart failure. If you or members of your family suffer from heart problems, your doctor may give you some tests on your heart and blood before giving you Sulpiride

■    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 have high blood pressure

■    you have ever had liver problems or a history of jaundice (yellowing of the skin and whites of the eyes)

■    you have lung and breathing problems

■    you have a condition that causes muscle weakness with tiredness, called myasthenia gravis

■    you have epilepsy    „    ,    ,    ,

Continued overleaf

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