Product Description:

1. What this product is and what it is used for

Tablets contain amisulpride and belongs to a group of medicines called antipsychotics which help to control the symptoms of a mental illness called schizophrenia.

Symptoms include:
delusions (having strange or unusual thoughts)
hallucinations (seeing or hearing things that are not there)
being suspicious or aggressive for no apparent reason (these are so called “positive symptoms”)
becoming withdrawn and subdued (these are so called “negative symptoms”).

Silomes can be used at the start of and for the long term treatment of schizophrenia

2. What you need to know before you use this product

a. Do not take Silomes
Never take Silomes in the following situations:
If you have a pheochromocytoma (growth of the adrenal medullary gland secreting substances that induce sever hypertension),
Children under 15 years of age,
Breast-feeding.
Known allergy to Amisulpride or to any of the other ingredients,
Known prolactin-dependent tumor
In combination with levodopa (medicine used for Parkinson’s disease)
If you are unsure of anything, it is essential that you ask your doctor or pharmacist for advice.

b. Take special care with Silomes
Talk to your doctor or pharmacist before taking your medicine if:
you have kidney problems
you have Parkinson’s disease
you have ever had fits (epileptic seizures)
you are diabetic or have been told you have an increased risk of developing diabetes
you have an unusual heart rate (rhythm)
you have heart disease or family history of heart problems or sudden death
you have a long QT interval or a history of this in the family (this is a measure of the way your heart is working and can be detected by a doctor using an electrocardiogram)
you had a stroke previously or your doctor has told you that you are at risk of 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 or someone else in your family has a history of breast cancer, as amisulpride can affect the risk of developing breast cancer. You should therefore be closely monitored during treatment with Amisulpride
you have a slow heart beat (less than 55 beats per minute)
you are taking other medicines that could affect your heart’s function: check with your doctor before taking any other medicine. See also
the following section.
you have been told you have a low amount of potassium or magnesium 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 in patients taking antipsychotics compared to those not receiving antipsychotics.

If you are unsure of anything, do not hesitate to ask your doctor or pharmacist for advice.

c. Taking other medicines, herbal or dietary
supplements
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.
This is because amisulpride can affect the way some other medicines work. Also some medicines can affect the way amisulpride works. In particular, do not take this medicine and tell your doctor if you are taking:
bromocriptine or ropinirole (medicines used to treat Parkinson’s disease)
levodopa, a medicine to treat Parkinson’s disease
medicines to treat heart rhythm problems (such as quinidine, disopyramide, procainamide, amiodarone, sotalol)
cisapride (used to treat stomach problems)
bepridil (used to treat angina/chest pain and changes in heart rhythm)
sultopride and thioridazine (for schizophrenia)

methadone (for pain and drug abuse)
halofantrine (to prevent malaria)
pentamidine (to treat infections in HIV patients)
erythromycin by injection or sparfloxacin (antibiotics)
medicines for fungal infections, such as clotrimazole
vincamine by injection (used for various brain disorders)

Tell your doctor if you are taking any of the following medicines:
medicines used to treat high blood pressure or other heart problems, that could slow your heart rate down. These include beta-blockers (such as nebivolol or bisoprolol, diltiazem, verapamil, clonidine, guanfacine, digoxin or digoxin-like medicines
medicines which can cause low potassium levels including diuretics (“water tablets”), some laxatives, amphotericin B (by injection), glucocorticoids (used for conditions such as asthma or rheumatoid arthritis) and tetracosactide (may be used in clinical investigations)
medicines used to treat schizophrenia such as pimozide or haloperidol
imipramine or lithium (used to treat depression)
some antihistamines such as astemizole and terfenadine (for allergies)
other anti-psychotic medicines used for mental health problems
medicines for severe pain called opiates such as morphine or pethidine
medicines which help you sleep such as barbiturates and benzodiazepines
pain-killers such as tramadol and indomethacin
anaesthetics
antihistamines (for allergies) which make you sleepy, such as promethazine.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a
prescription.

d. Taking Silomes with Food and drinks
Do not drink alcohol while you are taking this medicine. This is because it can increase the effects of alcohol.

e. Pregnancy and lactation:
Pregnancy:
Use of this medicine is not recommended during pregnancy. If you discover that you are pregnant, consult your doctor immediately, So that you may follow her recommendations regarding your treatment. Ask your doctor or pharmacist for advice before taking any medicine.

Lactation:
You must not breast-feed if you are taking this medicinal product Ask your doctor or pharmacist for advice before taking any medicine.

f. Effects on ability to drive and use machines:
Be aware, especially if you drive or use machines of the risk of Drowsiness associated with the use of this medicine.

g. Important information about some of the ingredients of Silomes
This medicine contains lactose. You should not use this medicine if you have galactose intolerance, Lapp lactase deficiency or glucose and galactose malabsorption syndrome (rare hereditary diseases).

3. How to use this product.

Always take your medicine exactly as your doctor has told you. This will help you to get the best results and lower the risk of side effects.
You should check with your doctor or pharmacist if you are not sure.

Method and route of administration:Oral use.

For acute psychotic episodes:
Oral doses between 400 mg/day and 800 mg/ day are recommended. In individual cases, the daily dose may be increased up to 1200 mg/ day. Doses above 1200 mg/day have not been extensively evaluated for safety and therefore should not be used. No specific titration is required when initiating the treatment with Silomes. Doses should be adjusted according to individual response. For patients with mixed positive and negative symptoms:
Doses should be adjusted to obtain optimal control of positive symptoms.

Maintenance treatment:
Should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms, oral doses between 50 mg/day and 300 mg/day are recommended.
Doses should be adjusted individually.

Silomes can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid. The minimum effective dose should be used.

Elderly:
Amisulpride should be used with particular caution because of a possible risk of hypotension and sedation. Reduction in dosage may also be required because of renal insufficiency.

Children:
The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established. There are limited data available on the use of amisulpride in adolescents in schizophrenia.
Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended;

in children up to puberty amisulpride is contraindicated, as its safety has not yet been established.

Renal insufficiency:
Silomes is eliminated by the renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 ml/min and to a third in patients with CRCL between 10-30 ml/min. As there is no experience in patients with severe renal impairment (CRCL < 10 ml/min) particular care is recommended in these patients.

Hepatic insufficiency:

since the drug is weakly metabolised a dosage reduction should not be necessary.

Duration of treatment: In all cases, strictly follow your doctor’s prescription. Do not stop the treatment of your own accord.

a.If you take more Silomes than you should
Contact your doctor or hospital immediately.
Take the tablets, leaflet and/or carton with you so the doctor knows what you have taken. The following effects may happen: feeling restless or
shaky, rigid muscles, low blood pressure, feeling drowsy or sleepy which could lead to a loss of consciousness.

b.If you forget to take Silomes Tablets:
Take the next dose at the usual time. Do not take a double dose. If you have forgotten several doses, consult your doctor.

c.If you stop taking Silomes Tablets
In all cases, strictly follow your doctor’s prescription. Do not stop the treatment of your own accord.

4. Possible side effects

Like all medicines. Silomes can cause side effects, although not everybody gets them. Stop taking Amisulpride and see a doctor or go to a hospital immediately if you notice any of the following side effects:

Uncommon (may affect up to 1 in 100 people)
A serious allergic reaction. The signs may include an itchy, lumpy rash, difficulty swallowing or breathing, swelling of your lips, face, throat or tongue
· A fit (seizure)

Not known (frequency cannot be estimated from the available data)
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’
An unusual heart rate, very fast heart rate or chest pain which could result in a heart attack or life-threatening heart disorder.
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 signs, seek medical advice immediately.
You get more infections than usual, causing fever, sore throat or mouth ulcers. This could be because of a decrease in the number, or lack of white blood cells.
Benign (non-cancerous) pituitary tumour such as prolactinoma.
Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be signs of an illness called syndrome of inappropriate antidiuretic hormone secretion (SIADH).

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 head, neck, jaw or eyes.

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
Low blood pressure, which may cause you to feel dizzy
Increased blood levels of prolactin (a protein), which would be seen in a test and may cause:
- Breast pain or enlargement, unusual production of breast milk (these can occur in women and men)
- Menstrual problems such as missed periods
- Sexual effects such as problems reaching orgasm or difficulty in getting or maintaining an erection
- Unusual growth in the pituitary gland

Uncommon (may affect up to 1 in 100 people)
Slowing of the heart beat
High blood sugar (hyperglycaemia)
Increase in liver enzymes, which would be seen in a blood test

Rare (may affect up to 1 in 1,000 people)
Withdrawal symptoms after stopping treatment of high doses of amisulpride. These may include feeling or being sick difficulty sleeping,
extreme restlessness, muscle stiffness or abnormal movements, or your original illness may come back.

Not known (frequency cannot be estimatedfrom the available data)
Withdrawal symptoms seen in newborn babies where the mother has taken this medicine.
Raised levels of certain fats (triglycerides) and cholesterol in the blood
Confusion
Low levels of sodium in your blood which may be seen in blood tests (hyponatraemia).

If you notice any side effects not mentioned in this leaflet, or if any of the side effects gets serious.

Please inform your doctor or pharmacist.

Product Description:

-Keep this medicine out of the sight and reach of children.
-Do not store above 30°C.
-Do not use Silomes Tablets after the expirydate which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last
day of that month.
-Do not use Silomes Tablets if you notice description of the visible signs of deterioration.
-Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.