AMISULPRIDE 50 mg Coated Tablet

Зміст інструкції

1. Amisulpride Mylan 50 mg and 200 mg tablets, 400 mg film-coated tablets
   1. What is Amisulpride Mylan and what is it used for
   2. What you need to know before taking Amisulpride Mylan
2. Amisulpride Mylan contains lactose. If your doctor has diagnosed you with an intolerance to
   1. How to take Amisulpride Mylan
   2. Possible side effects
   3. How to store Amisulpride Mylan
   4. Contents of the pack and other information

Amisulpride Mylan 50 mg and 200 mg tablets, 400 mg film-coated tablets

amisulpride

Generic medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Amisulpride Mylan is and what it is used for
• 2. What you need to know before you take Amisulpride Mylan
• 3. How to take Amisulpride Mylan
• 4. Possible side effects
• 5. How to store Amisulpride Mylan
• 6. Contents of the pack and other information

1. What is Amisulpride Mylan and what is it used for

Amisulpride Mylan contains amisulpride which belongs to a group of medicines called
antipsychotics that help to control the symptoms of a mental illness called schizophrenia.
The symptoms include:
manias (having strange or unusual thoughts)
hallucinations (seeing or hearing things that do not exist)
suspicious or aggressive behaviour without any apparent reason (these are the
so-called “positive symptoms”)
becoming isolated and submissive (these are the so-called “negative symptoms”).
Amisulpride Mylan can be used as initial and long-term treatment of
schizophrenia.

2. What you need to know before taking Amisulpride Mylan

Do not take Amisulpride Mylan if:

• you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction can include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• you have breast cancer or a “prolactin-dependent tumour”
• you have a tumour of the adrenal glands called a pheochromocytoma
• you are taking levodopa (used to treat Parkinson's disease) or medicines to treat heart rhythm disorders or medicines that can cause an abnormal heart rhythm if used at the same time as amisulpride (see below “Other medicines and Amisulpride Mylan”)
• you are under 15 years of age.

Do not take this medicine if any of the above conditions apply to you.
If you have any doubts, ask your doctor or pharmacist before taking Amisulpride
Mylan.

Warnings and precautions
Serious liver problems have been reported with Amisulpride Mylan. Contact your
doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting,
abdominal pain or yellowing of the eyes or skin.
Neuroleptic Malignant Syndrome (NMS) has been reported with the use of antipsychotics.
Contact a doctor or go to hospital immediately if you notice the following effects
undesirable: high unexplained fever, muscle rigidity, blurred vision, muscle pain,
sweating, rapid heartbeat, rapid breathing, feeling confused,
drowsiness or agitation.
Elevated blood levels of creatine phosphokinase (CPK) also occur with NMS.
Talk to your doctor or pharmacist before taking this medicine if:
you have kidney problems
you suffer from Parkinson's disease
you have had epileptic seizures
you have diabetes or have been told that you have an increased risk of developing diabetes
you have an unusual heart rhythm
you have heart disease or a family history of heart problems or sudden death
you have a prolonged QT interval or a family history of it (this is a measure of how the
heart works and can be identified by a doctor using an electrocardiogram)
you have had a stroke or your doctor has told you that you are at risk of stroke
you or someone in your family has a history of blood clots, because
medicines similar to this one have been associated with the formation of blood clots
you or someone in your family has a history of breast cancer, as amisulpride
may affect the risk of developing breast cancer. Therefore, you should be kept under
close medical supervision during treatment with Amisulpride Mylan
you have a slow heart rate (less than 55 beats per minute)
you are taking other medicines that can affect heart function: check
with your doctor before taking any other medicine. See also the section
“Do not take Amisulpride Mylan” and “Other medicines and Amisulpride Mylan”
you have been found to have low levels of potassium or magnesium in your blood
you are elderly, because elderly people are more likely to have a drop in
blood pressure or become drowsy. A small increase in deaths of elderly people with
dementia has been reported in patients taking antipsychotics compared to those who
were not taking them.
If you are not sure if any of these conditions apply to you, talk to your doctor or
pharmacist before taking Amisulpride Mylan.

Other medicines and Amisulpride Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
This is because amisulpride can affect the way some medicines work. Also
some medicines can affect the way amisulpride works.
In particular, do not take this medicine and talk to 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 heart rhythm disturbances)
sultopride or thioridazine (for schizophrenia)
methadone (for pain and drug abuse)
halofantrine (to prevent malaria)
pentamidine (to treat patients with HIV infection)
erythromycin for injection or sparfloxacin (antibiotics)
medicines for fungal infections, such as clotrimazole
vincamine for injection (used for various brain disorders).

Tell your doctorif you are taking any of the following medicines:
medicines used to treat high blood pressure and other heart problems that
can slow down the heart rate. These include beta-blockers (such as
nebivolol or bisoprolol), diltiazem, verapamil, clonidine, guanfacine, digoxin or
medicines similar to digoxin
medicines that can lower the level of potassium in the blood, including diuretics,
some laxatives, amphotericin B (for injection), glucocorticoids (used for diseases such as
asthma or rheumatoid arthritis) and tetracosactide (can be used in diagnostic research)
medicines used to treat schizophrenia, such as pimozide, clozapine or haloperidol
imipramine or lithium (used to treat depression)
some antihistamines such as astemizole and terfenadine (for allergies)
mefloquine, used to treat malaria
other antipsychotic medicines, used for mental health problems
medicines to treat severe pain, called opioids such as morphine and pethidine
medicines that promote sleep, such as barbiturates and benzodiazepines
pain relievers such as tramadol and indometacin
anaesthetics
antihistamines (for allergies) that can cause drowsiness, such as promethazine.

Amisulpride Mylan with alcohol
Do not drink alcohol while taking Amisulpride Mylan, because Amisulpride Mylan can
increase the effects of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you
are breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
Amisulpride Mylan is not recommended during pregnancy and in women of childbearing potential who
are not using effective contraceptive measures.
The following symptoms may occur in newborns from mothers who have used Amisulpride
Mylan during the last trimester (last three months of pregnancy): tremors, muscle rigidity
and/or muscle weakness, drowsiness, agitation, breathing problems and feeding disorders. If your baby develops any of these symptoms, you may need to
contact your doctor.
Breastfeeding
You should not breastfeed while taking Amisulpride Mylan. Discuss with your
doctor the best way to feed your baby if you are taking Amisulpride Mylan.

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

Amisulpride Mylan contains lactose. If your doctor has diagnosed you with an intolerance to

certain sugars, consult him/her before taking this medicine.

3. How to take Amisulpride Mylan

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Adults:
If you suffer from positive symptoms, the recommended dose is between 400 mg and 800 mg per day and will be adjusted by your doctor according to the nature and severity of the illness and renal function. The maximum daily dose is 1200 mg.
If you suffer from both positive and negative symptoms, your doctor will adjust the dose so that there is adequate control of the positive symptoms. For maintenance treatment, your doctor will use the lowest possible dose that proves effective for you.
If you suffer from predominantly negative symptoms, the recommended dose is between 50 mg and 300 mg per day and will be adjusted by your doctor according to the nature and severity of the illness and renal function.

Patients over 65 years:
Amisulpride may cause sedation (drowsiness) or a decrease in blood pressure and is generally not recommended in this age group because experience is limited.

Use in children and adolescents:
The efficacy and safety of amisulpride in children and adolescents under 18 years of age have not been established. If absolutely necessary, treatment of adolescents from 15 to 18 years of age must be initiated and conducted by a doctor specializing in the treatment of schizophrenia in this age group.
Children and adolescents under the age of 15 should not take these tablets (see paragraph 2 “Do not take Amisulpride Mylan”).

Patients with kidney problems:
Normally your doctor will give you a lower dose. This may be half or one-third of the usual dose, depending on how your kidneys are functioning.

How to take this medicine:
Swallow the tablets with a glass of water.
You can take the tablets during meals or between meals.
Doses up to 300 mg per day can be taken as a single dose, preferably at the same time each day.
Doses over 300 mg must be taken half in the morning and half in the evening.
The 100 mg, 200 mg and 400 mg tablets can be divided into two equal doses.

If you take more Amisulpride Mylan than you should
Contact your doctor or hospital immediately. Bring the tablets, package leaflet and/or box with you, so that the doctor knows what you have ingested. The following effects may appear: feeling of restlessness or agitation, muscle rigidity, hypotension, drowsiness that may lead to loss of consciousness.

If you forget to take Amisulpride Mylan
Take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Amisulpride Mylan
Continue taking the tablets until your doctor tells you to stop. Do not stop taking them just because you feel better. If you stop, your illness may worsen or return to its original state. Unless your doctor tells you to do so, abrupt discontinuation of treatment may cause withdrawal symptoms such as nausea, vomiting, sweating, difficulty sleeping, extreme restlessness, muscle rigidity or abnormal movements, or your condition may return to its original state. To avoid this, it is important to reduce the dose gradually according to your doctor's instructions.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Contact a doctor or go to the hospital immediatelyif any of the following side effects occur:

Uncommon(may affect up to 1 in 100 people)
A severe allergic reaction. Symptoms may include a skin rash with bumps and itching, difficulty swallowing or breathing, swelling of the lips, face, throat or
tongue.
Epileptic seizures.
You have more infections than usual, causing fever, sore throat and mouth ulcers. This happens
because of a decrease in the number or absence of white blood cells.

Rare(may affect up to 1 in 1000)
A high body temperature, blurred vision, sweating, muscle stiffness,
fast heartbeat, shortness of breath and feeling confused, drowsy or
agitated. These may be symptoms of a serious but rare side effect called
Neuroleptic Malignant Syndrome.
An unusual heartbeat, very rapid heartbeat or chest pain that may
result in a heart attack or life-threatening disturbances.
Formation of blood clots in the veins (thrombosis), especially in the legs (symptoms
include: swelling, pain and redness of the legs), which can move
through the blood vessels to the lungs, causing chest pain and
difficulty breathing. If you notice any of these symptoms, seek immediate medical
attention.
Benign (non-cancerous) pituitary tumor such as a prolactinoma.
Feeling unwell, confusion or weakness, feeling sick (nausea), loss of
appetite, irritability. These may be signs of a condition called inappropriate secretion of the
antidiuretic hormone (SIADH) syndrome.

Inform 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)
Tremor, stiffness or spasms of the muscles, slowness of movement, increased
salivation, feeling restless.

Common(may affect up to 1 in 10 people)
Uncontrollable movements, especially of the head, neck, jaw or eyes.

Uncommon(may affect up to 1 in 100 people)
Uncontrollable movements, especially of the face and tongue.
Osteoporosis (a condition in which bones are more likely to break) or
osteopenia (weakening of the bones).
Aspiration pneumonia (a type of infection that occurs when food, saliva, liquids
or vomit are aspirated into the lungs or airways, ending up in the lungs instead of
being swallowed into the esophagus and stomach).

Other side effects include:
Common(may affect up to 1 in 10 people)
Difficulty falling asleep (insomnia) or feeling anxious or agitated.
Feeling sleepy.
Constipation, nausea, dry mouth.
Weight gain.
Decreased blood pressure which can cause dizziness.
Difficulty reaching orgasm.
Blurred vision.
Increased levels of prolactin (a protein) in the blood, which can be detected in a
laboratory test and may cause:
Pain or enlargement of the breasts, unusual secretion of milk from the breasts (which may
occur in both women and men)
Menstrual problems such as missed periods
Difficulty achieving and maintaining an erection.

Uncommon(may affect up to 1 in 100 people)
Slowed heartbeat.
High blood sugar levels (hyperglycemia).
Increased levels of certain fats (triglycerides) and cholesterol in the blood.
Increases in liver enzymes, which can be observed in blood tests.
Confusion.
Increased blood pressure.
Nasal congestion.
Urinary retention (inability to completely empty the bladder).
Liver tissue damage.

Rare(may affect up to 1 in 1000)
Low levels of sodium in the blood that can be observed with blood tests
(hyponatremia).

Not known(frequency cannot be estimated based on available data)
Restless legs syndrome (feeling of discomfort in the legs temporarily
relieved by movement with symptoms worsening at the end of the day).
Increased sensitivity of the skin to the sun and ultraviolet light.
Withdrawal symptoms observed in newborns when the mother has used this medicine.
Falls due to reduced ability to maintain body balance, sometimes resulting
in fractures.
Rhabdomyolysis (muscle breakdown associated with muscle pain).
Increased levels of creatine phosphokinase (blood test indicating muscle damage).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information about the safety of this
medicine.

5. How to store Amisulpride Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the
packaging after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Amisulpride Mylan contains
The active ingredient is amisulpride
Each 50 mg tablet contains 50 mg of amisulpride.
Each 200 mg tablet contains 200 mg of amisulpride.
Each 400 mg tablet contains 400 mg of amisulpride.
The other ingredients are lactose monohydrate (see section 2 “Amisulpride Mylan
contains lactose”), microcrystalline cellulose, sodium glycolate starch (Type A), hypromellose,
magnesium stearate.
The film coating contains hypromellose, titanium dioxide (E171), macrogol 400 (only in the
400 mg tablets).

Description of the appearance of Amisulpride Mylan and contents of the pack
50 mg: round, white tablet with “AA 50” imprinted on one side and “G” on the other,
diameter of 6 mm.
200 mg: round, white tablet with “AMI” fracture line “200” imprinted on one side and
“G” on the other, diameter of 10 mm.
400 mg: capsule-shaped, film-coated tablet, white with “AS 400” imprinted on one
side and a fracture line on the other, length of 18 mm.
Amisulpride Mylan is available in blister packs containing:
12 tablets (50mg)
20 tablets (50mg, 200mg, 400mg)
30 tablets (50mg, 200mg, 400mg)
30x1 tablets (400mg)
50 tablets (50mg, 200mg, 400mg)
60 tablets (50mg, 200mg, 400mg)
60x1 tablets (200mg)
90 tablets (50mg, 200mg, 400mg)
100 tablets (50mg, 200mg, 400mg
120 tablets (200mg)
150 tablets (200mg)
150 (3 cartons of 50) tablets (200mg)
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer responsible for batch release:
Mylan Hungary Kft./Mylan Hungary Ltd., Mylan utca 1., Komárom, 2900, Hungary