Amisulpride Mylan

Patient Information Leaflet

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

amisulpride
Generic medicine
Please read all of this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 Amisulpride Mylan is and what it is used for

Amisulpride Mylan contains the active substance amisulpride, which belongs to a group of medicines called antipsychotics. These help control the symptoms of a mental illness called schizophrenia.
The symptoms include:
delusions (having strange or unusual thoughts)
hallucinations (seeing or hearing things that do not exist)
suspicious or aggressive behaviour without apparent reason (these are known as "positive symptoms")
becoming withdrawn and subdued (these are known as "negative symptoms").
Amisulpride Mylan can be used as initial and long-term treatment for schizophrenia.

2. What you need to know before taking Amisulpride Mylan

Do not take Amisulpride Mylan if:

• you are allergic to amisulpride or to any of the excipients of this medicine (listed in section 6). Signs of an allergic reaction may include 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 phaeochromocytoma
• you are taking levodopa (used to treat Parkinson's disease) or medicines used to treat heart rhythm disorders, or medicines that may cause an abnormal heart rhythm when used together with amisulpride (see below "Other medicines and Amisulpride Mylan")
• you are under 15 years of age.

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

Warnings and precautions

Severe 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 side effects: unexplained high fever, muscle stiffness, blurred vision, muscle pain, sweating, rapid heartbeat, rapid breathing, confusion, drowsiness, or agitation.

It is known that NMS may also be associated with elevated blood levels of creatine phosphokinase (CPK).

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 are at 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 long QT interval or a family history of it (this is a measure of how the heart functions 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 else in your family has a history of blood clots, as similar medicines have been associated with blood clot formation
• you or someone in your family has a history of breast cancer, since amisulpride may affect the risk of developing breast cancer. Therefore, you must be closely monitored by your doctor during treatment with Amisulpride Mylan
• you have a slow heart rate (less than 55 beats per minute)
• you are taking other medicines that may affect heart function: check with your doctor before taking any other medicine. See also 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, as elderly people are more likely to experience low blood pressure or drowsiness. A small increase in deaths among elderly patients with dementia has been reported in patients taking antipsychotics compared to those who do not take them.

If you are unsure whether any of these conditions apply to you, discuss them with 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 obtained without a prescription.

This is because amisulpride may affect how some medicines work. Some medicines may also affect how 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 used to treat Parkinson's disease
• medicines used to treat heart rhythm disorders (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 addiction)
• halofantrine (to prevent malaria)
• pentamidine (to treat HIV-infected patients)
• injectable erythromycin or sparfloxacin (antibiotics)
• antifungal medicines such as clotrimazole
• injectable vincamine (used for various brain disorders).

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

• medicines used to treat high blood pressure and other heart problems that may slow heart rate. These include beta-blockers (such as nebivolol or bisoprolol), diltiazem, verapamil, clonidine, guanfacine, digoxin, or medicines similar to digoxin
• medicines that may lower potassium levels in the blood, including diuretics, some laxatives, amphotericin B (by injection), glucocorticoids (used for conditions such as asthma or rheumatoid arthritis), and tetracosactide (which may be used in diagnostic testing)
• medicines used to treat schizophrenia, such as pimozide, clozapine, or haloperidol
• imipramine or lithium (used to treat depression)
• certain antihistamines such as astemizole and terfenadine (for allergies)
• mefloquine, used to treat malaria
• other antipsychotic medicines used for mental health conditions
• medicines used to treat severe pain, called opioids such as morphine and pethidine
• medicines that promote sleep, such as barbiturates and benzodiazepines
• analgesics such as tramadol and indometacin
• anaesthetics
• antihistamines (for allergies) that may cause drowsiness, such as promethazine.

Amisulpride Mylan and alcohol

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

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Pregnancy

Amisulpride Mylan is not recommended during pregnancy and in women of childbearing age who are not using effective contraception.

The following symptoms may occur in newborns whose mothers have used Amisulpride Mylan during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you may need to contact your doctor.

Breastfeeding

You must 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, drowsy, or have blurred vision while taking this medicine. If this happens, you must not drive or operate tools or machinery.

Amisulpride Mylan contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Amisulpride Mylan

Take this medicine exactly as prescribed by your doctor. 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 your doctor will adjust it according to the nature and severity of your illness and your renal function.
The maximum daily dose is 1200 mg.
If you suffer from both positive and negative symptoms, your doctor will adjust the dose to ensure adequate control of positive symptoms. For maintenance treatment, your doctor will use the lowest possible dose that remains effective for you.
If you suffer mainly from 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 your illness and your renal function.
Patients over 65 years of age:
Amisulpride may cause sedation (drowsiness) or a drop in blood pressure and is generally not recommended in this age group due to limited experience.
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 treatment is absolutely necessary, adolescents aged 15 to 18 years should be treated only under the supervision of a doctor specialized in the treatment of schizophrenia in this age group.
Children and adolescents under 15 years of age must not take these tablets (see section 2 “Do not take Amisulpride Mylan”).
Patients with renal problems:
Your doctor will normally prescribe a lower dose. This may be half or one-third of the usual dose, depending on how well your kidneys are functioning.
How to take this medicine:
Swallow the tablets with a glass of water.
You may take the tablets during meals or between meals.
Doses up to 300 mg per day may be taken as a single dose, preferably at the same time each day.
Doses exceeding 300 mg should be divided, with half taken in the morning and half in the evening.
The 100 mg, 200 mg and 400 mg tablets may be divided into two equal doses.
If you take more Amisulpride Mylan than you should
Contact your doctor or go to the nearest hospital immediately. Take the tablets, the package leaflet and/or the packaging with you so that the doctor knows what you have taken. The following effects may occur: feeling restless or agitated, muscle stiffness, hypotension, drowsiness which 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 your next dose, skip the missed dose. Do not take a double dose to make up for a 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 condition may worsen or return to its original state. Unless your doctor tells you otherwise, abruptly stopping treatment may cause withdrawal symptoms such as nausea, vomiting, sweating, difficulty sleeping, extreme restlessness, muscle stiffness or abnormal movements, or your condition may return to its previous state. To avoid this, it is important to gradually reduce the dose according to your doctor's instructions.
If you have any questions about the use of this medicine, consult 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 hospital immediately if you experience any of the following
side effects:
Uncommon (may affect up to 1 in 100 people)
A severe allergic reaction. Symptoms may include a rash with lumps and itching, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
Epileptic seizures.
You get more infections than usual, causing fever, sore throat and mouth ulcers. This occurs due to a decrease in or lack of white blood cells.
Rare (may affect up to 1 in 1,000 people)
High body temperature, blurred vision, sweating, muscle stiffness, rapid heartbeat, shortness of breath, and feeling confused, drowsy or agitated. These may be symptoms of a rare but serious side effect called Neuroleptic Malignant Syndrome.
An unusual heartbeat, very rapid heartbeat or chest pain which may lead to a heart attack or life-threatening conditions.
Formation of blood clots in the veins (thrombosis), especially in the legs (symptoms include: swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.
Benign (non-cancerous) pituitary tumour such as prolactinoma.
Feeling unwell, confusion or weakness, feeling sick (nausea), loss of appetite, irritability. These could be signs of a condition called Syndrome of Inappropriate Secretion of Antidiuretic Hormone (SIADH).
Inform your doctor as soon as possible if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people)
Tremor, muscle stiffness or spasms, slowness of movement, increased salivation, feeling restless.
Common (may affect up to 1 in 10 people)
Uncontrolled movements, especially of the head, neck, jaw or eyes.
Uncommon (may affect up to 1 in 100 people)
Uncontrolled movements, especially of the face and tongue.
Osteoporosis (a condition in which bones are more likely to break) or osteopenia (weak bones).
Aspiration pneumonia (a type of infection that occurs when food, saliva, liquids or vomit are inhaled into the lungs or airways, ending up in the lungs instead of being swallowed into the oesophagus 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 drowsy.
Constipation, nausea, dry mouth.
Weight gain.
Low blood pressure which may cause dizziness.
Difficulty reaching orgasm.
Blurred vision.
Increased levels of prolactin in the blood (a protein), which may be detected in a laboratory test and may cause:
Breast pain or enlargement, unusual milk discharge from the breasts (which may occur in both women and men)
Menstrual problems such as absence of menstruation
Difficulty achieving and maintaining an erection.
Uncommon (may affect up to 1 in 100 people)
Slowed heartbeat.
High blood sugar levels (hyperglycaemia).
Increased levels of certain fats (triglycerides) and cholesterol in the blood.
Increased liver enzymes, which may be observed in blood tests.
Confusion.
Increased blood pressure.
Stuffy nose.
Urinary retention (inability to completely empty the bladder).
Liver tissue damage.
Rare (may affect up to 1 in 1,000 people)
Low levels of sodium in the blood which may be detected in blood tests (hyponatraemia).
Not known (frequency cannot be estimated from the available data)
Restless legs syndrome (an uncomfortable sensation in the legs temporarily relieved by movement, with symptoms worsening towards the end of the day).
Increased skin sensitivity to sunlight 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 (a blood test indicating muscle damage).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on 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 stated on the blister and packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special 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. Package contents and other information

What Amisulpride Mylan contains
The active substance 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 components are monohydrate lactose (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 400 mg tablets).

Description of the appearance of Amisulpride Mylan and package contents
50 mg: white, round tablet, engraved “AA 50” on one side and “G” on the reverse, 6 mm in diameter.
200 mg: white, round tablet, engraved “AMI” and a break line “200” on one side and “G” on the reverse, 10 mm in diameter.
400 mg: white, film-coated, capsule-shaped tablet, engraved “AS 400” on one side and a break line on the reverse, 18 mm in length.

Amisulpride Mylan is available in blister packs containing:
12 tablets (50 mg)
20 tablets (50 mg, 200 mg, 400 mg)
30 tablets (50 mg, 200 mg, 400 mg)
30x1 tablets (400 mg)
50 tablets (50 mg, 200 mg, 400 mg)
60 tablets (50 mg, 200 mg, 400 mg)
60x1 tablets (200 mg)
90 tablets (50 mg, 200 mg, 400 mg)
100 tablets (50 mg, 200 mg, 400 mg)
120 tablets (200 mg)
150 tablets (200 mg)
150 (3 cartons of 50) tablets (200 mg)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano, Italy

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