Amisulpride 100mg/ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or 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 Amisulpride Oral Solution is and what it is used for
2. What you need to know before you take Amisulpride Oral Solution
3. How to take Amisulpride Oral Solution
4. Possible side effects
5. How to store Amisulpride Oral Solution
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to amisulpride or any of the other ingredients of Amisulpride Oral Solution (listed in section 6 below); Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• if you have breast cancer or something called ‘a prolactin dependent tumour’
• if you have a tumour on the adrenal gland (called phaeochromocytoma).
• if you are taking levodopa, a medicine used to treat Parkinson’s disease , bromocriptine used in pituitary problems and ropinirole used in restless leg syndrome. (See ‘Taking other medicines’ section)
• if you have been diagnosed with a pituitary tumour.
• if you are under 18 years of age

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 Amisulpride Oral Solution.

Talk to your doctor, pharmacist or nurse before taking Amisulpride Oral Solution if:

• You have kidney problems;
• You have ever had fits (epileptic seizures).
• You have Parkinson’s disease;
• You have heart disease, or a family history of heart problems;
• You have had a stroke or your doctor has told that you might have a stroke
• 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 a diabetic or have been told you have an increased risk of having diabetes;
• You have a slow heart beat (less than 55 beats per minute).
• You have a low amount of potassium in your blood
• You are elderly. This is because elderly people would be more likely to get low blood pressure or feel sleepy. A small increase in the number of deaths of elderly people with dementia has been reported for patients taking antipsychotics compared to those not receiving antipsychotics.
• You have an unusual heart rate (rhythm).
• You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual.
• You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leukopenia’.
• You or someone else in your family has a history of breast cancer.
• You have high levels of prolactin

Severe liver problems have been reported with Amisulpride Oral Solution.

Talk to your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellow discoloration of the eyes or skin.

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

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 Amisulpride Oral Solution can affect the way some other medicines work. Also some medicines can affect the way Amisulpride Oral Solution works.

Do not take Amisulpride Oral Solution.

Please also tell your doctor or pharmacist if you are taking any of the following medicines:

• Levodopa, a medicine to treat Parkinson’s disease
• Drugs called ‘dopamine agonists’ such as ropinirole and bromocriptine

Tell your doctor if you are taking any of the following medicines;

• Medicines used to control your heart beat such as quinidine, disopyramide, amiodarone and sotalol.
• Clozapine used to treat schizophrenia.
• Other anti-psychotic medicines used for mental problems.
• Medicines for severe pain called opiates such as morphine or pethidine.
• Mefloquine used to treat malaria.
• Medicines for high blood pressure and heart problems such as diltiazem, verapamil, guanfacine or digitalis.
• Clonidine used for migraines, flushing or high blood pressure.
• Medicines which help you sleep such as barbiturates and benzodiazepines.
• Pain-killers such as tramadol or indomethacin.
• Anaesthetics. Inform your doctor or dentist that you are taking Amisulpride Oral Solution before you have an anaesthetic
• Antihistamines such as promethazine which make you sleepy.

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

• A carbohydrate rich (starchy/sugary) meal may adversely effect how this medicine works. Therefore you should take Amisulpride Oral Solution before a meal and at about the same time(s) each day.
• Take the solution with a drink that does not contain alcohol.
• Do not drink alcohol while you are taking Amisulpride Oral Solution. This is because it can affect the way the medicine works

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.

Pregnancy

Amisulpride Oral Solution is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

If you use Amisulpride Oral Solution during the last three months of pregnancy, your baby may suffer from agitation, increased muscle tension, involuntary trembling of the body, sleepiness, breathing problems, or difficulty in feeding. Talk to your doctor, if your baby develops any of these symptoms.

Breast-feeding

You should not breast-feed during therapy with Amisulpride Oral Solution. Talk to your doctor about the best way to feed your baby if you are taking Amisulpride Oral Solution.

You may feel less alert, drowsy or sleepy and have blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines.

Amisulpride Oral Solution contains parahydroxybenzoates (E216 propyl parahydroxybenzoate and E218 methyl parahydroxybenzoate). These may cause allergic reactions (possibly delayed).

This medicinal product contains 0.18mmol (4.02mg) sodium (salt) per 1ml of oral solution. To be taken into consideration by patients on a controlled sodium (salt) diet.

This medicinal product also contains small amounts of ethanol (alcohol), less than 0.5mg per 1ml of oral solution.

Your doctor may need to give you a lower dose.

Amisulpride Oral Solution should not be given to children under 18 years of age.

If you take more solution than you should, tell a doctor or go to a hospital casualty department straight away.

Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling restless or shaky, rigid muscles, feeling drowsy or sleepy which could lead to a loss of consciousness.

If you forget to take a dose, take it as soon as you remember it.

However, if it is nearly time for the next dose, skip the missed dose+

Do not take double the amount to make up for a forgotten dose

• Keep taking Amisulpride Oral Solution until your doctor tells you to stop. Do not stop taking Amisulpride Oral Solution just because you feel better. If you stop, your illness may get worse or come back. Unless your doctor tells you otherwise, Amisulpride Oral Solution should not be stopped suddenly. Stopping treatment suddenly can lead to withdrawal effects such as:
  • Feeling or being sick
  • SweatingDifficulty sleeping or feeling very restless Muscle stiffness or unusual body movements your original condition may come back

Uncommon (may affect up to 1 in 100 people)

• You have an allergic reaction. The signs may include: an itchy lumpy rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have a fit (seizure).
• 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 (leukopenia or neutropenia).

Rare (may affect up to 1 in 1000 people)

• You have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be the symptoms of a serious but rare side effect called ‘neuroleptic malignant syndrome’.
• You have a very fast or unusual heart rate or chest pain which could result in a heart attack or life-threatening heart disorder.
• 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 in breathing. If you notice any of these symptoms seek medical advice immediately.

Very common (may affect more than 1 in 10 people)

• Trembling, muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless.

Common (may affect up to 1 in 10 people)

• Movements that you cannot control, mainly of the arms and legs. (These symptoms can be reduced if your doctor lowers your dose of Amisulpride Oral Solution or prescribes an additional medicine)

Uncommon (may affect up to 1 in 100 people)

• Movements that you cannot control, mainly of the face or tongue.

Common (may affect up to 1 in 10 people)

• Difficulty sleeping (insomnia) or feeling anxious or agitated
• Feeling drowsy or sleepy
• Constipation, feeling or being sick, dry mouth
• Putting on weight
• Unusual production of breast milk in women and men, breast pain
• Menstrual period stops
• Breast enlargement in men
• Difficulty in getting or maintaining an erection, or in ejaculating
• Feeling dizzy (which can be due to low blood pressure)
• Blurred vision

Uncommon (may affect up to 1 in 100 people)

• Slowing of the heart beat
• High blood sugar (hyperglycaemia)
• Feeling confused
• Nasal congestion
• A condition called ‘osteoporosis’. This is when your bones are more likely to break
• High levels of fat (triglycerides) or cholesterol in the blood
• Accidental inhalation of food with risk of pneumonia (lung infection)
• Increase in blood pressure
• Difficulty passing water (urine)
• Liver tissue damage

Rare (may affect up to 1 in 1000 people)

• Noncancerous benign tumour (such as prolactinoma).
• Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable.
  This could be an illness called a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• Tired, weak, confused, have muscles that ache, are still or do not work well. This may be due to low sodium levels in your blood

Not known (frequency cannot be estimated from available data)

• Restless legs syndrome (uncomfortable feeling in legs temporarily relieved by movement and symptoms getting worse at the end of the day).
• Increased sensitivity of your skin to sun and ultraviolet light.

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 at: 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 substance is amisulpride. Each 1ml of oral solution contains 100mg amisulpride.
• The other ingredients are saccharin sodium, sodium gluconate, gluconolactone, hydrochloric acid (used to adjust the pH), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate, Toffee Flavour A (containing glycerol (E422) and ethanol) and purified water (see section 2, Before you take Amisulpride Oral Solution).

Amisulpride Oral Solution is a colourless to brown yellowish clear solution. It is available in an amber glass bottle containing 60ml of medicine. The pack also contains a 5ml, plastic oral dosing syringe.

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email [email protected].