Dolmatil Tablets

How do I take it?

• Sulpiride tablets can be taken either with or without food.
• Sulpiride is usually taken twice a day (morning and early evening). The dose that is prescribed will vary from person to person. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.
• If you forget to take a dose take it as soon as you remember, unless it is nearly time for your next dose. In this case just leave out the forgotten dose and take the next dose as usual. Don't take a double dose to make up for a missed dose.
• If you have been taking this medicine for a long time you should not suddenly stop taking it unless your doctor tells you to, even if you feel better and think you don't need it any more. This is because the medicine controls the symptoms of the illness but doesn't actually cure it. This means that if you suddenly stop treatment your symptoms could come back. Stopping the medicine suddenly may also rarely cause withdrawal symptoms such as nausea, vomiting, difficulty sleeping or tremor. When long-term treatment with this medicine is stopped, this should be done gradually, following the instructions given by your doctor.

Use with caution in

• Elderly people.
• People with decreased kidney function.
• People who are in excited, agitated or aggressive states (hypomania).
• People with heart disease, such as heart failure, recent heart attack, very slow heart rate (bradycardia), or irregular heartbeats (arrhythmias).
• People with a personal or family history of an abnormal heartbeat, seen on a heart monitoring trace (ECG) as a 'prolonged QT interval', and people taking other medicines that can could increase the risk of this (your doctor will know, but see the end of this factsheet for some examples).
• People with low levels of potassium or magnesium in their blood (hypokalaemia or hypomagnesaemia).
• Elderly people with dementia. (Antipsychotic medicines have been shown to increase the risk of stroke in this group of people. Sulpiride is not licensed or recommended for treating behavioural disturbances in elderly people with dementia).
• People with risk factors for having a stroke, for example a history of stroke or mini-stroke (TIA), smoking, diabetes, high blood pressure, or a type of irregular heartbeat called atrial fibrillation.
• People with a personal or family history of blood clots (venous thromboembolism), for example in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• People with other risk factors for getting a blood clot, for example smoking, being overweight, taking the contraceptive pill, being over 40, recent major surgery or being immobile for prolonged periods.
• People with a history of epilepsy.
• People with conditions that increase the risk of epilepsy or convulsions, eg brain damage or withdrawal from alcohol.
• Parkinson's disease.

Not to be used in

• Children under 14 years of age.
• Severe liver disease.
• Severe kidney disease.
• People with disturbances in the normal numbers of blood cells in the blood.
• Hereditary blood disorders called acute porphyrias.
• People with a tumour of the adrenal glands (phaeochromocytoma).
• People with tumours whose growth is stimulated by the hormone prolactin, for example pituitary gland tumours (pituitary prolactinoma) or breast cancer.
• People with reduced awareness, slow reactions or drowsiness due to illnesses or drugs that reduce activity in the central nervous system.
• People with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption (Dolmatil tablets contain lactose).
• This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine during pregnancy has not been established. It is not recommended for use during pregnancy, particularly in the first and third trimesters, unless considered essential by your doctor. If the medicine is used during the third trimester it could cause side effects or withdrawal symptoms in the baby after birth and the baby may need extra monitoring because of this. Ask your doctor for further information and advice.
• If you think you could be pregnant while taking this medicine it is important to consult your doctor straight away for advice. If you have been taking the medicine for long periods of time you should not suddenly stop taking it unless your doctor tells you to, as this could cause your symptoms to come back.
• This medicine may pass into breast milk. As it could cause drowsiness and potentially other side effects in a nursing infant, it is recommended that women who need to take this medicine should not breastfeed while they are taking it. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Restlessness and agitation.
• Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).
• Increased salivation.
• Rhythmical involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia - see warning section above).
• Difficulty sleeping (insomnia).
• Drowsiness.
• A drop in blood pressure (hypotension) that may cause dizziness.
• Interference with the body's temperature regulation (this is more common in elderly people and may cause heat stroke in very hot weather or hypothermia in very cold weather).
• Skin rashes.
• Weight gain.
• High blood prolactin (milk producing hormone) level - sometimes this can lead to symptoms such as breast enlargement, production of milk and stopping of menstrual periods.
• Sexual problems, such as problems getting an erection.
• Convulsions.
• Irregular heartbeats (arrhythmias).
• High temperature combined with falling levels of consciousness, paleness, sweating and a fast heart beat (neuroleptic malignant syndrome). Requires stopping the medicine and immediate medical treatment - see warning section above.
• Decreased numbers of white blood cells in the blood. Tell your doctor if you get a fever, sore throat, mouth ulcers or other signs of infections while taking this medicine, as these symptoms could suggest a problem with your white blood cells. Your doctor may want you to have a blood test to check the numbers of blood cells in your blood.
• Jaundice or liver problems (tell your doctor straight away if you notice any yellowing of your eyes or skin while taking this medicine).
• Abnormal blood clot in the blood vessels.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Antacids (to treat indigestion or heartburn) and sucralfate can reduce the absorption of sulpiride from the gut. As this could make the sulpiride less effective, you should not take antacids or sucralfate at the same time of day as sulpiride. If you need to take these medicines, you should wait at least two hours after taking your dose of sulpiride.

There may be an increased risk of drowsiness and sedation if sulpiride is taken with any of the following (which can also cause drowsiness):

• alcohol
• barbiturates, eg amobarbital, phenobarbital
• benzodiazepines, eg diazepam, temazepam
• MAOI antidepressants, eg phenelzine
• sedating antihistamines, eg chlorphenamine, hydroxyzine
• sleeping tablets, eg zopiclone
• strong opioid painkillers, eg morphine, codeine
• tricyclic antidepressants, eg amitriptyline.

This medicine may enhance the blood pressure-lowering effects of certain medicines used to treat high blood pressure (antihypertensives). If you are taking medicines for high blood pressure you should tell your doctor if you feel dizzy or faint after starting treatment with this medicine, as your blood pressure medicines may need adjusting.

There may be an increased risk of an abnormal heart rhythm if sulpiride is taken in combination with other medicines that can cause a 'prolonged QT interval' on a heart monitoring trace or ECG. These include the following; they should be avoided where possible in people taking this medicine:

• antiarrhythmics (medicines to treat abnormal heart beats), eg amiodarone, procainamide, disopyramide, quinidine, sotalol, dronedarone
• the antihistamines astemizole, mizolastine or terfenadine (no longer available in the UK)
• arsenic trioxide
• atomoxetine
• bosutinib
• certain antidepressants, eg citalopram, escitalopram, clomipramine
• certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine, Riamet
• certain other antipsychotics, eg thioridazine, chlorpromazine, sertindole, pimozide, droperidol
• cisapride
• intravenous erythromycin or pentamidine
• methadone
• moxifloxacin
• ranolazine
• saquinavir
• sildenafil
• tolterodine
• vandetanib
• vardenafil.

There may also be an increased risk of a prolonged QT interval if medicines that can alter the levels of salts such as potassium or magnesium in the blood, eg diuretics such as furosemide, or medicines that can slow down the heart rate, eg beta-blockers, clonidine, diltiazem, verapamil or digoxin are taken in combination with sulpiride.

There may be an increased risk of extrapyramidal-type side effects (abnormal body movements) if this medicine is used in combination with lithium, metoclopramide or tetrabenazine.

Sulpiride may oppose the effect of levodopa and medicines for Parkinson's disease that work by stimulating dopamine receptors in the brain, for example ropinirole, pergolide, bromocriptine.

Sulpiride may oppose the effect of anticonvulsant medicines used to treat epilepsy.

There may be an increased chance of problems with your blood cells if sulpiride is taken in combination with other medicines that can affect your blood cells, for example chemotherapy medicines.

References:

http://patient.info/medicine/sulpiride-dolmatil-sulpor

http://www.medicines.org.uk/emc/medicine/10939/PIL/Dolmatil+Tablets+200mg,+Dolmatil+400mg+Tablets

http://www.netdoctor.co.uk/medicines/brain-and-nervous-system/a6678/dolmatil-sulpiride/

https://www.drugs.com/uk/dolmatil-200mg-tablets-spc-10904.html

https://en.wikipedia.org/wiki/Sulpiride