Invega Sustenna 75mg Injection 1'S

Introduction About INVEGA SUSTENNA 75MG INJECTION

INVEGA SUSTENNA 75MG INJECTION contains Paliperidone which belongs to the group
of medicines called Antipsychotics. INVEGA SUSTENNA 75MG INJECTION is used as a
maintenance management for the symptoms of schizophrenia in adults stabilized on
paliperidone or risperidone.

Schizophrenia is a serious mental disorder characterised by hearing voices or
seeing things that are not there (hallucinations), believe things that are not
true (delusions) or feel unusually suspicious of others, lack of feelings,
trouble speaking, depression, anxious, guilty or tense.

INVEGA SUSTENNA 75MG INJECTION is not recommended for use in patients with
moderate or severe kidney disease. INVEGA SUSTENNA 75MG INJECTION should be used
with caution in patients with liver disease, mild kidney disease, heart disease,
Parkinson’s disease or dementia, breast or brain cancer, fits. Consult your
doctor before receiving it.

INVEGA SUSTENNA 75MG INJECTION is not recommended for use in pregnant and
breastfeeding women, in children and adolescents under 18 years of age. Consult
your doctor before receiving it.

INVEGA SUSTENNA 75MG INJECTION should be used with caution in elderly patients
with dementia. Consult your doctor before receiving it. The most common side
effects of receiving INVEGA SUSTENNA 75MG INJECTION are difficulty falling or
staying asleep. Contact your physician if any of the symptoms worsen.

Uses Of INVEGA SUSTENNA 75MG INJECTION

• Maintenance management for the symptoms of schizophrenia in adults

How INVEGA SUSTENNA 75MG INJECTION Works

INVEGA SUSTENNA 75MG INJECTION acts in the brain by blocking the receptors for
the chemicals called dopamine and 5-hydroxytryptamine (also called serotonin),
which are involved in schizophrenia. By blocking these receptors, INVEGA
SUSTENNA 75MG INJECTION helps to normalize the activity of the brain and reduce
symptoms and stop your symptoms from coming back.

How to use INVEGA SUSTENNA 75MG INJECTION

INVEGA SUSTENNA 75MG INJECTION will be given to you only by a doctor or a nurse
as an intramuscular injection (into the upper arm or buttocks).

Your doctor will decide the correct dose and duration of INVEGA SUSTENNA 75MG
INJECTION for you depending upon your age, body weight and disease condition. Do
not stop receiving INVEGA SUSTENNA 75MG INJECTION unless told to do so by your
doctor. Otherwise, your symptoms may return.

Side Effects Of INVEGA SUSTENNA 75MG INJECTION

Common

• difficulty falling or staying asleep
• common cold symptoms, urinary tract infection, flu like symptoms
• symptoms of high prolactin in men includes breast swelling, difficulty in getting or maintaining erections or other sexual dysfunction and in women symptoms include breast discomfort, leakage of milk from the breasts, missed menstrual periods or other problems with your cycle)
• weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (jerky movements), a sensation of movement "freezing up" and then restarting
• restlessness, feeling sleepy or less alert
• dystonia (slow or sustained involuntary contraction of muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw)
• dizziness
• dyskinesia (involuntary muscle movements and can include repetitive, spastic or writhing movements or twitching)
• tremor (shaking)
• headache
• rapid heart rate
• high blood pressure
• cough, stuffy nose
• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache
• bone or muscle ache, back pain, joint pain
• loss of menstrual periods
• leakage of milk from the breasts
• fever, weakness, fatigue
• a reaction at the injection site, including itching, pain or swelling

Uncommon

• pneumonia, infection of the chest (bronchitis), infection of the breathing passages, sinus infection, bladder infection, ear infection, fungal infection of the nails, tonsillitis, infection of the skin
• diabetes or worsening of diabetes
• increased appetite
• loss of appetite resulting in malnutrition and low body weight
• sleep disorder, elated mood (m
• fainting, a restless urge to move parts of your body, dizziness upon standing, disturbance inattention, problems with speech, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking or numbness of skin
• blurry vision, eye infection or "pink eye", dry eye
• sensation of spinning (vertigo), ringing in the ears, ear pain
• rapid heartbeat upon standing, slow heart rate, a fluttering or pounding feeling in your chest (palpitations)
• low blood pressure, low blood pressure upon standing (may feel faint, dizzy or may pass out when they stand up or sit up suddenly)
• shortness of breath, congestion of breathing passages, wheezing, sore throat, nosebleeds
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth, excessive passing of gas or wind
• hives (or "nettle rash"), itching, rash, hair loss, eczema, dry skin, skin redness, acne
• muscle spasms, joint stiffness, muscle weakness, neck pain
• incontinence (lack of control) of urine, frequent passing of urine, pain when passing urine
• erectile dysfunction, ejaculation disorder
• missed menstrual periods or other problems with your cycle (females), development of breasts in men, sexual dysfunction, breast pain
• swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
• an increase in body temperature
• a change in the way you walk
• chest pain, chest discomfort, feeling unwell
• hardening of the skin
• fall

Rare

• eye infection
• skin inflammation caused by mites, abscess under the skin
• life threatening complications of uncontrolled diabetes
• excessive drinking of water
• not moving or responding while awake (catatonia)
• confusion
• sleep walking
• lack of emotion
• inability to reach orgasm
• blood vessel problems in the brain, including sudden loss of blood supply to brain (stroke or "mini" stroke), unresponsive to stimuli, loss of consciousness, low level of consciousness, convulsion (fits), balance disorder
• abnormal coordination
• glaucoma (increased pressure within the eyeball)
• problems with movement of your eyes, eye rolling, oversensitivity of the eyes to light, increased tears, redness of the eyes
• atrial fibrillation (an abnormal heart rhythm), irregular heartbeat
• flushing
• trouble breathing during sleep (sleep apnea)
• lung congestion
• crackly lung sounds
• inflammation of the pancreas, swollen tongue, stool incontinence, very hard stool
• chapped lips
• rash on skin related to drug, thickening of skin, dandruff
• breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
• joint swelling
• inability to pass urine
• breast discomfort, enlargement of the glands in your breasts, breast enlargement
• vaginal discharge
• very low body temperature, chills, feeling thirsty
• accumulation of pus caused by infection at injection site, deep skin infection, a cyst at injection site, bruising at injection site

Stop receiving INVEGA SUSTENNA 75MG INJECTION and contact your doctor
immediately if you experience any of the following side effects:

• symptoms of blood clots in the veins, especially in the legs such as swelling, pain and redness in the leg, which may travel through blood vessels to the lungs causing chest pain and difficulty breathing
• dementia and a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side or slurred speech, even for a short period of time. These may be signs of a stroke
• fever, muscle stiffness, confusion, sweating or a lowered level of consciousness (a disorder called Neurole
• prolonged or painful erection(priapism)
• tardive dyskinesia (involuntary rhythmic movements of the tongue, mouth and face)
• severe allergic reaction characterized by fever, swollen mouth, face, lip or tongue, throat, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an anaphylactic reaction)

How To Manage Side Effects

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating
Solution) and apply a pain-relieving balm on the head if necessary. Contact your
doctor if the headache did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines
while you are feeling dizzy. Do not drink alcohol, as it can aggravate your
dizziness. Contact your doctor if your dizziness did not improve.

Skin rash:

Avoid hot bath because hot water can irritate your skin further. Do not scratch
the affected area. Use sunscreen and wear protective clothing while going
outside. Use unscented moisturizers to soothe and hydrate the affected area.
Contact your doctor if the rashes worsen.

Nausea, vomiting:

Receive INVEGA SUSTENNA 75MG INJECTION, with or just after a meal. Stick to
simple meals. Avoid eating oily or spicy food. Contact your doctor if nausea and
vomiting did not improve.

Stomach pain:

Try to rest and relax. Eat small meals but take frequently. Keep a heating pad
on your stomach. Contact your doctor if the stomach pain worsens.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated.
Do not take any medicine on your own for managing diarrhoea. Contact your doctor
if your diarrhoea did not improve.

Constipation:

Eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals and
drink plenty of water. Exercise more regularly. Contact your doctor if
constipation persist.

Warning & Precautions

!### Pregnancy

INVEGA SUSTENNA 75MG INJECTION is not recommended for use in pregnant women. If
INVEGA SUSTENNA 75MG INJECTION is used in last trimester (last three months of
pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation,
breathing problems and difficulty in feeding can occur in a newborn baby.
Consult your doctor before receiving INVEGA SUSTENNA 75MG INJECTION.

!### Breastfeeding

INVEGA SUSTENNA 75MG INJECTION is not recommended for use in breastfeeding women
as it may pass through the breast milk. Consult your doctor before receiving
INVEGA SUSTENNA 75MG INJECTION.

!### Driving and Using Machines

Do not drive or use machines while receiving INVEGA SUSTENNA 75MG INJECTION as
dizziness, extreme tiredness and vision problems may occur.

!### Alcohol

Avoid consum

!### Kidney

INVEGA SUSTENNA 75MG INJECTION should be used with caution in patients with mild
kidney disease and requires dose adjustment. INVEGA SUSTENNA 75MG INJECTION is
not recommended for use in patients with moderate or severe kidney disease.
Consult your doctor before receiving INVEGA SUSTENNA 75MG INJECTION.

!### Liver

INVEGA SUSTENNA 75MG INJECTION should be used with caution in patients with
liver disease. Consult your doctor before receiving INVEGA SUSTENNA 75MG
INJECTION.

!### Allergy

Do not receive INVEGA SUSTENNA 75MG INJECTION if you are allergic to
paliperidone or risperidone or any of the other ingredients of INVEGA SUSTENNA
75MG INJECTION.

!### Heart Disease

INVEGA SUSTENNA 75MG INJECTION should be used with caution in patients with
heart disease, low blood pressure upon stands up or sit up suddenly. Consult
your doctor before receiving INVEGA SUSTENNA 75MG INJECTION.

Others

Before receiving INVEGA SUSTENNA 75MG INJECTION, inform your doctor if you:

• have Parkinson’s disease or dementia
• condition with high temperature and muscle stiffness (also known as Neurole
• have abnormal movements of the tongue or face (Tardive Dyskinesia)
• are diabetic or prone to diabetes
• have had breast cancer or a tumour in the brain
• have epilepsy or fits
• have prolonged or painful erection.
• have problems with controlling body temperature or overheating
• have an abnormally high level of the hormone prolactin in blood or possible prolactin-dependent tumor
• or a family history of blood clots
• are planning to have an eye operation

Use in pediatrics:

INVEGA SUSTENNA 75MG INJECTION is not recommended for use in children and
adolescents under 18 years of age. Consult your doctor before receiving INVEGA
SUSTENNA 75MG INJECTION.

Use in geriatrics:

INVEGA SUSTENNA 75MG INJECTION should be used with caution in elderly patients
with dementia. Your doctor may adjust your dose if your kidney function is
reduced. Consult your doctor before receiving INVEGA SUSTENNA 75MG INJECTION.

Interactions

A. Drug - Drug interactions:

Before receiving INVEGA SUSTENNA 75MG INJECTION, inform your doctor if you are
taking any of the following medicine:

• opioids (medicines used to manage severe pain) Ex. codeine, morphine
• medicines help you to sleep Ex. alprazolam
• carbamazepine (used to manage fits and mood disorder)
• medicines used to lower blood pressure Ex. enalapril, metoprolol
• antipsychotics (medicines used to manage schizophrenia and psychoses) Ex. chlorpromazine, haloperidol, risperidone
• antihistamines (medicines used to relive symptoms of allergies) Ex. chlorpheniramine, clemastine, fexofenadine
• levodopa (used to manage Parkinson’s disease and restless legs syndrome)
• medicines used to control heart rhythm Ex. quinidine, disopyramide
• medicines used to manage infections Ex. ciprofloxacin
• psychostimulants (medicines that increase the activity of the brain) Ex. methylphenidate (used to manage attention deficit hyperactivity disorder)
• medicines used to manage depression Ex. amitriptyline

Overdosage:

INVEGA SUSTENNA 75MG INJECTION will be administered to you only by a doctor or a
nurse in a hospital and so it is unlikely to receive an overdose. However,
consult your doctor or nurse if you experience any unusual symptoms like
drowsiness or sedation, fast heart rate, low blood pressure, slow or abnormal
movements of the face, body, arms or legs.

Synopsis

Drug	:	Paliperidone
Pharmacological Category	:	Antipsychotic drugs
Therapeutic Indication	:	Maintenance management of Schizophrenia
Dosage Forms	:	Tablet, Injection

More Information

• Keep INVEGA SUSTENNA 75MG INJECTION out of reach of children
• Store INVEGA SUSTENNA 75MG INJECTION below 30°C

FAQs About INVEGA SUSTENNA 75MG INJECTION

What does INVEGA SUSTENNA 75MG INJECTION do to the brain?

INVEGA SUSTENNA 75MG INJECTION acts in the brain by blocking the receptors for
the chemicals called dopamine and 5-hydroxytryptamine (also called serotonin),
which are involved in schizophrenia. By blocking these receptors, INVEGA
SUSTENNA 75MG INJECTION helps to normalize the activity of the brain and reduce
symptoms and stop your symptoms from coming back.

What is INVEGA SUSTENNA 75MG INJECTION used for?

INVEGA SUSTENNA 75MG INJECTION is an antipsychotic, it is used in adults as a
maintenance management for the symptoms of schizophrenia stabilized on
paliperidone or risperidone. Contact your doctor before receiving INVEGA
SUSTENNA 75MG INJECTION.

Can INVEGA SUSTENNA 75MG INJECTION be used in pregnant women?

No, INVEGA SUSTENNA 75MG INJECTION is not recommended for use in pregnant women.
If INVEGA SUSTENNA 75MG INJECTION is used in last trimester (last three months
of pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation,
breathing problems and difficulty in feeding can occur in newborn baby. Consult
your doctor before receiving INVEGA SUSTENNA 75MG INJECTION.

How does INVEGA SUSTENNA 75MG INJECTION make you feel?

INVEGA SUSTENNA 75MG INJECTION can decrease hallucinations (hearing voices or
seeing things that are not there) and help you to think more clearly and
positively about yourself, feel less agitated and take a more active part in
everyday life. Consult your doctor before receiving INVEGA SUSTENNA 75MG
INJECTION.

Why you should not stop INVEGA SUSTENNA 75MG INJECTION?

If you stop receiving INVEGA SUSTENNA 75MG INJECTION suddenly it can cause
'rebound psychosis'. This means that the symptoms of your illness return
suddenly, and you may become unwell again. Hence, do not stop receiving INVEGA
SUSTENNA 75MG INJECTION unless told to do so by your doctor.