AMISULPRIDE 100 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - AMISULPRIDE 100 MG / ML ORAL SOLUTION

5. how to store amisulpride 100 mg/ml oral solution

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Amisulpride 100 mg/ml Oral Solution after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
Amisulpride 100 mg/ml Oral Solution should be disposed of 2 months after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
If your medicine becomes discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.

6. contents of the pack and other information

What Amisulpride 100 mg/ml Oral Solution contains

Each 1 ml of oral solution contains 100 mg amisulpride.
The other ingredients are saccharin sodium, sodium gluconate, hydrochloric acid, methyl parahydroxybenzoate E218, propyl parahydroxybenzoate E216, potassium sorbate, caramel flavour, ethyl alcohol (ethanol) and purified water.

What Amisulpride 100 mg/ml Oral Solution looks like and contents of the pack

Amisulpride 100 mg/ml Oral Solution is a clear yellow liquid, with an odour of caramel. It is available in 60 ml amber glass bottle with a child resistant plastic cap and 5 ml plastic oral syringe graduated in mg.

PLGB: 15814/1220 POM

Manufactured by Unither Liquid Manufacturing, Colomiers, France.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Leaflet revision and issue date (Ref.): 30.11.2021.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER Amisulpride 100 mg/ml Oral Solution

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 pharmacist or nurse.
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 any of the side effects get serious, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Amisulpride 100 mg/ml Oral Solution is and what it is used for

2. What you need to know before you take Amisulpride 100 mg/ml Oral Solution

3. How to take Amisulpride 100 mg/ml Oral Solution 4. Possible side effects

5. How to store Amisulpride 100 mg/ml Oral Solution
6. Contents of the pack and other information

1. what amisulpride 100 mg/ml oral solution is and what it is used for

The name of your medicine is Amisulpride 100 mg/ml Oral Solution. Amisulpride 100 mg/ml Oral Solution contains a medicine called amisulpride. This belongs to a group of medicines called ‘antipsychotics’. It is used to treat an illness called schizophrenia.

Schizophrenia can make you feel, see or hear things which do not exist, have strange and frightening thoughts, change how you act, and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed. Amisulpride 100 mg/ml Oral Solution works by improving disturbed thoughts, feelings and behaviour. It is used to treat schizophrenia when it starts and also over the long term.

2. what you need to know before you take amisulpride 100 mg/ml oral solution

Do not take Amisulpride 100 mg/ml Oral solution and tell your doctor if:

You are allergic (hypersensitive) to amisulpride or any of the other ingredients of Amisulpride 100 mg/ml 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.

You have breast cancer or something called ‘a prolactin dependent tumour’.
You have a tumour on the adrenal gland (called phaeochromocytoma).
You are taking levodopa, a medicine used to treat Parkinson’s disease (See ‘Taking other medicines’ section).
You have been diagnosed with a pituitary tumour
The patient is under 18 years old.

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 100 mg/ml Oral Solution.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Amisulpride 100 mg/ml Oral solution if:

You have kidney problems.
You have Parkinson’s disease.
You have ever had fits (epileptic seizures).
You have an unusual heart rate (rhythm).
You have heart disease or family history of heart problems.
Your doctor has told you that you might have a stroke.
If 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 diabetic or have been told you have an increased risk of having diabetes.
You have a slow heartbeat (less than 55 beats per minute).
You have been told you have a low amount of potassium in your blood.
You are elderly. This is because elderly people are 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 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 100 mg/ml 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 100 mg/ml Oral Solution.

Other medicines and Amisulpride 100 mg/ml Oral solution

Tell your doctor or pharmacist if you are taking or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Amisulpride 100 mg/ml Oral Solution can affect the way some other medicines work. Also some medicines can affect the way Amisulpride 100 mg/ml Oral Solution works.

In particular, do not take this medicine, and tell your doctor 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 heartbeat 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.
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 100 mg/ml Oral Solution.

Amisulpride 100 mg/ml Oral Solution with food and drink

Take the solution with a drink that does not contain alcohol.
Do not drink alcohol while you are taking Amisulpride 100 mg/ml Oral Solution. This is because it can affect the way the medicine works.

Pregnancy, breast-feeding and fertility

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 100 mg/ml Oral Solution is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

If you use Amisulpride 100 mg/ml 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 100 mg/ml Oral Solution. Talk to your doctor about the best way to feed your baby if you are taking Amisulpride 100 mg/ml Oral Solution.

Driving and using machines

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.

Important information about some of the ingredients of Amisulpride 100 mg/ml Oral Solution

Amisulpride 100 mg/ml Oral Solution contains small amounts of ethyl alcohol (ethanol), less than 100mg per ml.
Amisulpride 100 mg/ml Oral solution also contains parahydroxybenzoates (propyl hydroxybenzoate E216 and methyl hydroxybenzoate E218), these may cause allergic reactions (these may be delayed).

3. how to take amisulpride 100 mg/ml oral solution

Always take Amisulpride 100 mg/ml Oral Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

Take this medicine by mouth.
Take the solution with a drink that does not contain alcohol.
Use the graduated syringe to measure your medicine. Each 1ml of solution contains 100mg of your medicine.
If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

How much to take

The amount of Amisulpride 100 mg/ml Oral Solution you take will depend on your illness. Follow your doctor’s instructions carefully.

Adults

The usual dose is between 50mg (0.5ml) and 800mg (8ml) each day.
Your doctor may start you on a lower dose if necessary.
If necessary your doctor can prescribe up to 1200mg (12ml) each day.
Doses up to 300mg (3ml) each day can be taken as a single dose. Take the dose at the same time each day.
Doses above 300mg (3ml) should be taken as half in the morning and half in the evening.

Elderly

Your doctor will need to keep a close check on you as you are more likely to have low blood pressure or sleepiness due to this medicine.

People with kidney problems

Your doctor may need to give you a lower dose.

Children under 18 years of age

Amisulpride 100 mg/ml Oral Solution should not be given to children under 18 years of age.

If you take more Amisulpride 100 mg/ml Oral Solution than you should

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 Amisulpride 100 mg/ml Oral Solution

If you forget 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 a double dose to make up for a forgotten dose.

If you stop taking Amisulpride 100 mg/ml Oral Solution

Keep taking Amisulpride 100 mg/ml Oral Solution until your doctor tells you to stop. Do not stop taking Amisulpride 100 mg/ml 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 100 mg/ml Oral Solution should not be stopped suddenly. Stopping treatment suddenly may cause withdrawal effects such as:

Feeling or being sick
Sweating
Difficulty sleeping or feeling very restless
Muscle stiffness or unusual body movements
Your original condition may come back

Blood Tests

Taking Amisulpride 100 mg/ml Oral Solution may affect the results of some blood tests. These include tests to measure the hormone called ‘prolactin’ and liver tests. If you are going to have a blood test, it is important to tell your doctor you are taking Amisulpride 100 mg/ml Oral Solution.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Amisulpride 100 mg/ml Oral Solution can cause side effects, although not everybody gets them.

Stop taking Amisulpride 100 mg/ml Oral Solution and see a doctor or go to a hospital straight away if:

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.

Tell your doctor as soon as possible if you have any of the following side effects:

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 100 mg/ml Oral Solution or prescribes an additional medicine).