Sulpiride 200mg/5ml Oral Solution

• 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.

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

• you are allergic to sulpiride or any of the other ingredients of this medicine (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 are taking levodopa or ropinirole used for Parkinson’s disease (see section ‘Other medicines and Sulpiride’).
• 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.

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.

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.
• you have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual.
• you have or have had in the past narrow angle glaucoma (this is abnormal pressure in the eye accompanied by pain and blurred vision).
• you have Parkinson’s Disease.
• you have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these.
• you have an enlarged prostate gland.
• you have had a stroke.
• you are an older person as you may be more sensitive to the effects of the medicine.
• you have problems with your kidneys.
• you have dementia.
• you are 65 years of age or older.
• you are consuming alcohol beverages.
• you have diabetes.
• you have a type of bowel obstruction (ileus).
• you have difficulty passing water (urine).
• you have a digestive problem called congenital digestive stenosis.
• you or someone else in your family has a history of breast cancer.

Sulpiride can make you more sensitive to sunlight. You should avoid being in the sun for long periods and use appropriate protection against the sun.

Medicines of this type (antipsychotics) can cause a combination of fever, muscle rigidity and vegetative symptoms, such as sweating or faster breathing (called “neuroleptic malignant syndrome”). If this happens, treatment must be stopped and you should talk to a doctor immediately.

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

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 Sulpiride can affect the way some other medicines work. Also, some medicines can affect the way Sulpiride works.

In particular, do not take this medicine and tell your doctor if you are taking:

• levodopa (sometimes this is called L-dopa) or ropinirole used to treat Parkinson’s Disease.

Tell your doctor if you are taking any of the following:

• other medicines to treat Parkinson’s Disease including ropinirole and pramipexole.
• medicines to treat high blood pressure or migraine such as beta-blockers, clonidine or diuretics which lower potassium levels (water tablets).
• 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 used to treat abnormal heart rhythms (quinidine, disopyramide, amiodarone, sotalol) or angina (diltiazem, verapamil) and other heart problems (digoxin).
• sucralfate, cisapride and antacids used to treat stomach problems or laxatives.
• lithium used to treat depression.
• medicines used to treat epilepsy.
• some medicines used for allergies (antihistamines that make you sleepy) such as chlorphenamine, promethazine, ketotifen.
• medicines used to help you sleep or lower your anxiety.
• steroids such as prednisolone, dexamethasone and tetracosactide.
• medicines to treat infections such as erythromycin or amphotericin B (that are injected into a vein) or pentamidine (that is breathed in or given by injection)
• medicines used to treat mental or emotional problems such as pimozide, thioridazine, haloperidol or imipramine.
• methadone used for addiction and pain relief.
• halofantrine used to treat malaria.

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

Do not drink alcohol while taking Sulpiride. This is because Sulpiride can make you drowsy and alcohol will make you even drowsier.

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

Sulpiride is not recommended during pregnancy and in women of child-bearing potential not using effective contraception.

The following symptoms may occur in newborn babies, of mothers that have used sulpiride 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.

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

Talk to your doctor about the best way to feed your baby if you are taking Sulpiride.

Sulpiride may make you drowsy or less alert to your surroundings. If this happens to you, do not drive or use machinery.

• methyl (E218) and propyl (E216) parahydroxybenzoates: May cause allergic reactions (possibly delayed).
• liquid maltitol (E965) (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 medicinal product. May have a mild laxative effect. Calorific value 2.3 kcal/g.
• propylene glycol (E1520): This medicine contains 109 mg propylene glycol in each 5ml dose.
• glycerine: This medicine contains 0.19 mg glycerine in each 5 ml dose.
• benzyl alcohol: This medicine contains 0.002 mg benzyl alcohol in each 5 ml dose.
  Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant, breast-feeding, have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

• this medicine contains 200 mg of sulpiride in each 5 ml .
• take this medicine by mouth.

The recommended dose for adults is:

• the doctor will start you on a dose of 200 mg (5 ml ) to 400 mg (10 ml ) two times a day (usually morning and early evening).
• the doctor may reduce the dose or increase it to a maximum of 1.200 mg (30 ml ) two times a day.
• if you are an older person the dose will be the same as that for adults unless you have a kidney or liver problem. The doctor may lower the dose in this case.

This medicine must not be given to children under 14 years of age.

If you take more Sulpiride 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.

• if you forget a dose, skip the missed dose then go on as before.
• do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Keep taking this medicine until your doctor tells you to stop, as it may be necessary to lower the dose gradually.

Common (may affect up to 1 in 10 people)

• you have tremor, stiffness and shuffling (parkinsonism)
• you have trembling, muscle spasms or slow movements (extrapyramidal disorders)

Uncommon (may affect up to 1 in 100 people)

• you have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs (dystonia)

Rare (may affect up to 1 in 1.000 people)

• you have very fast or very slow, uneven or forceful heartbeats. You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain.

Not known (frequency cannot be estimated from the available data)

• you have a severe allergic reaction (anaphylactic reaction or anaphylactic shock). The signs may include shock such as difficulty in breathing, dizziness, cold clammy skin, pale skin colour and racing heart beat.
• low blood pressure
• alteration of the heart rhythm (called 'Prolongation of QT interval', seen on ECG, electrical activity of the heart)
• you have fits
• you have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called 'neuroleptic malignant syndrome'.
• you have 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 breathing. If you notice any of these symptoms seek medical advice immediately. If left untreated, it is possible that it could lead to a blockage of the main artery of the lung (pulmonary embolism). Symptoms of this include very fast or very slow, uneven forceful heartbeats. You may also have problems breathing such as wheezing, shortness of breath, tightness and or pain in your chest.
• you have a life-threatening irregular heartbeat (Torsade de pointes)
• you have a cardiac arrest
• you get more infections than usual. This could be because of a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia)
• shortness of breath or difficulty breathing
• an infection of the lungs (possibly as a result of inhaling food, liquid or vomit into the lungs)

Common (may affect up to 1 in 10 people)

• feeling restless and not being able to keep still (akathisia)

Uncommon (may affect up to 1 in 100 people)

• feeling dizzy, light-headed or faint when you stand or sit up quickly (due to low blood pressure)
• producing more saliva than usual
• frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called 'leukopenia'.
• abnormal increase in muscle tension and reduced ability to stretch (hypertonia)
• involuntary and uncontrollable movements (dyskinesia)

Rare (may affect up to 1 in 1.000 people)

• rolling of the eyes

Not known (frequency cannot be estimated from the available data)

• your neck becomes twisted to one side
• your jaw is tight and stiff
• decreased body or muscle movement (hypokinesia)
• feeling confused
• high blood pressure
• unusual tiredness, or bruising because of blood disorders
• feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be something called a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
• tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood
• feeling agitated
• blurred vision, eye changes such as clouding of the lens or colour change
• yellowing of your skin and whites of the eyes (jaundice), inflammation of your liver (hepatitis)
• skin reaction to sunlight
• difficulty in passing water

Common (may affect up to 1 in 10 people)

• abnormal production of breast milk in men and women
• weight gain
• painful breasts in men and women
• feeling drowsy or sleepy
• difficulty sleeping (insomnia)
• skin rashes
• constipation

Uncommon (may affect up to 1 in 100 people)

• breast enlargement in women
• loss of menstrual periods
• difficulty in getting or keeping an erection or in ejaculating (impotence) or being unable to have an orgasm

Not known (frequency cannot be estimated from the available data)

• breast enlargement in men
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia)
• feeling depressed
• high blood sugar levels (hyperglycaemia)
• high or low body temperature
• blocked nose
• dry mouth
• muscle breakdown resulting in kidney damage (rhabdomyolysis)
• increased level of creatine phosphokinase in blood (an indicator of muscle damage)

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.

Sulpiride can increase the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.

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 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.

• 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 (containing propylene glycol (E1520), glycerine and benzyl alcohol), aniseed flavour (containing propylene glycol (E1520)) and purified water.

A colourless to slightly yellow liquid with an odour of lemon and aniseed.

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