SOLIAN 400 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. What Solian is and what it is used for

2. What you need to know before you take Solian

B Do not take Solian and tell your doctor if:

x You are allergic (hypersensitive) to amisulpride or any of the other ingredients of , Solian (listed in Section 6).Signs of an allergic | reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

x You have breast cancer or something called ‘a prolactin dependent tumour’.

x You have a tumour on the adrenal gland (called phaeochromocytoma).

x You are taking levodopa, a medicine to treat Parkinson’s disease (see ‘Taking other medicines’ section).

x You have been diagnosed with a pituitary tumour.

x 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 Solian.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Solian 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 heart beat (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 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 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 Solian. 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 Solian.

Other medicines and Solian

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 Solian can affect the way some other medicines work. Also some medicines can affect the way Solian 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 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.
• Medicines for high blood pressure and heart problems such as diltiazem, verapamil, guanfacine and digitalis.
• Clonidine used for migraines, flushing or high blood pressure.
• Mefloquine used to treat malaria.
• Medicines which help you sleep such as barbiturates and benzodiazepines.
• Pain-killers such as tramadol and 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 Solian.

Solian with food and drink

• Swallow Solian tablets with plenty of water before a meal.
• Do not drink alcohol while you are taking Solian. 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

Solian Tablets are not recommended during pregnancy and in women of childbearing potential not using effective contraception. If you use Solian Tablets 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 Solian Tablets. Talk to your doctor about the best way to feed your baby if you are taking Solian Tablets.

^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 Solian

Solian contains lactose, a type of sugar. If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking this medicinal product.

Solian contains sodium

This medicine contains less than 1 mmol sodium per tablet, that is to say essentially ‚sodium-free‘

3. how to take solian

Always take Solian 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.
• Swallow the tablets whole with a drink of water. Do not chew your tablets.
• Take before a meal.
• 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 Solian you take will depend on your illness. Follow your doctor’s instruc­tions carefully.

Adults

• The usual dose is between 50mg and 800mg each day.
• s Your doctor may start you on a lower dose if

I necessary. 2

• If necessary your doctor can prescribe up to 1200mg each day.
• Doses up to 300mg each day can be taken as a single dose. Take the dose at the same time each day.
• Doses above 300mg 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

Solian should not be given to children under 18 years of age.

If you take more Solian than you should If you take more tablets 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 Solian

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 Solian

Keep taking Solian until your doctor tells you to stop. Do not stop taking Solian just because you feel better. If you stop, your illness may get worse or come back. Unless your doctor tells you otherwise, Solian 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 Solian 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 Solian.

0If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Solian can cause side effects, although not everybody gets them.

Stop taking Solian 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 Solian 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.

Other side effects include:

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 s Breast enlargement in men s 3
• 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 in 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.
• Falls due to reduced body balance, sometimes leading to fractures.

0 Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

5. how to store solian

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Solian after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not use Solian if you notice that the tablets become discoloured.

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.

6. contents of the pack and other information

What Solian contains

The tablets contain 100mg, 200mg or 400mg of the active substance, amisulpride.

• The other ingredients in Solian are sodium starch glycolate, lactose monohydrate, microcrystalline cellulose, hypromellose and magnesium stearate. Solian 400mg tablets also contain polyoxyl 40 stearate and titanium dioxide (E171).

What Solian looks like and contents of the pack

• Solian 100mg tablets are white to off-white, flat-faced tablets engraved AMI 100 on one side and a breakable bar on the other. They are supplied in blister packs of 60.
• Solian 200mg tablets are white to off-white, flatfaced tablets engraved AMI 200 on one side and a breakable bar on the other. They are supplied in blister packs of 30, 60, 90, 120 or 150.
• Solian 400mg tablets are white, film-coated, oblong scored tablets engraved AMI 400. They are supplied in blister packs of 30, 60 or 90.