Ropizuva 7.5mg Injection 1'S

Introduction About ROPIZUVA 7.5MG INJECTION

ROPIZUVA 7.5MG INJECTION contains Ropivacaine which belongs to the group of
medicines called Local Anaesthetics. It is used in adults and children above 12
years of age to numb (anaesthetise) parts of the body during surgery, including
having a baby by caesarean section and to relieve pain during childbirth, after
surgery or after an accident.

ROPIZUVA 7.5MG INJECTION is not recommended for use in patients suffering from
hypovolemia (decrease in blood volume). Consult your doctor before receiving it.

ROPIZUVA 7.5MG INJECTION should be used with caution in patients suffering from
lung, heart diseases, severe liver or kidney disease. Consult your doctor before
receiving it.

ROPIZUVA 7.5MG INJECTION should be used during pregnancy only if clearly
necessary and inform your doctor if you are breast feeding as it is not known
whether this medicine passes into breast milk.

ROPIZUVA 7.5MG INJECTION is not recommended for use in children below 12 years
of age. It should be used with caution in elderly patients above 65 years of
age. Consult your doctor before receiving it.

The most common side effects after receiving ROPIZUVA 7.5MG INJECTION are low
blood pressure causing dizziness or light-headedness and nausea. Contact your
doctor if any of the symptoms worsen.

Uses Of ROPIZUVA 7.5MG INJECTION

• To numb (anaesthetise) parts of the body during surgery
• To relieve pain during childbirth, after surgery or after an accident

How ROPIZUVA 7.5MG INJECTION Works

ROPIZUVA 7.5MG INJECTION works by stopping the nerves from being able to pass
pain messages to the brain. Thus ROPIZUVA 7.5MG INJECTION will stop you feeling
pain, heat or cold in where it is used however you may still have other feelings
like pressure or touch.

How to use ROPIZUVA 7.5MG INJECTION

ROPIZUVA 7.5MG INJECTION will be given to you only by a doctor as an injection
or as an infusion into the region or near to the body part that needs to be
numbed or as an epidural injection (into the area around the spinal cord). Your
doctor will decide the exact dose and duration of management depending upon the
type of pain relief you need, age, body weight and condition.

Side Effects Of ROPIZUVA 7.5MG INJECTION

Common

• low blood pressure causing dizziness, light-headedness
• nausea, vomiting
• difficulty in passing urine
• high blood pressure
• back pain
• fever and chills
• slow or fast heart beat (bradycardia, tachycardia)
• pins and needles
• headache
• muscle stiffness

Uncommon

• anxiety
• fits
• numbness of the lips and around the mouth, tongue
• hearing problems
• problems with your sight (vision), speech (dysarthria)
• muscular twitching and trembling
• fainting
• difficulty breathing
• low body temperature

Rare

• heart attack (cardiac arrest)
• arrhythmias (uneven heartbeat)
• damaged nerves

Stop receiving ROPIZUVA 7.5MG INJECTION and consult your doctor immediately if
you experience any of the following side effects:

• serious allergic reactions (such as anaphylaxis) include sudden onset of rash, itching or hives, swelling of the face, lips, tongue or other parts of the body causing shortness of breath, wheezing or difficulty breathing
• signs and symptoms of methemoglobinemia include pale, grey or blue-coloured skin, headache, rapid heart rate, shortness of breath, light-headedness and fatigue

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 your headache did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines
while you are feeling dizzy. Contact your doctor if your dizziness did not
improve.

Nausea and vomiting:

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

Warning & Precautions

!### Pregnancy

ROPIZUVA 7.5MG INJECTION should be used during pregnancy only if clearly
necessary. Contact your doctor before receiving it.

ROPIZUVA 7.5MG INJECTION is not recommended for use as an injection into the
neck of the womb to relieve pain during childbirth.

!### Breastfeeding

If you are breastfeeding, ask your doctor for advice as it is not known whether
this medicine passes into breast milk.

!### Driving and Using Machines

ROPIZUVA 7.5MG INJECTION can make you feel sleepy and affect your
action-reaction speed. Do not drive or operate machines until the next day after
receiving ROPIZUVA 7.5MG INJECTION.

!### Kidney

ROPIZUVA 7.5MG INJECTION should be used with caution in patients suffering from
severe kidney diseases. Consult your doctor before receiving it.

!### Liver

ROPIZUVA 7.5MG INJECTION should be used with caution in patients suffering from
advanced liver diseases. Consult your doctor before receiving it.

!### Allergy

Do not receive ROPIZUVA 7.5MG INJECTION if you are allergic to ropivacaine or to
other local anaesthetics such as lidocaine, bupivacaine or any of the other
ingredients of this ROPIZUVA 7.5MG INJECTION.

!### Lungs

ROPIZUVA 7.5MG INJECTION should be used with caution in patients suffering from
lung diseases. Consult your doctor before receiving it.

!### Heart Disease

ROPIZUVA 7.5MG INJECTION should be used with caution in patients suffering from
heart disease such as partial or complete heart conduction block. Consult your
doctor before receiving it.

Others

ROPIZUVA 7.5MG INJECTION is not recommended for use if you have:

• hypovolemia (decrease in blood volume)

Before receiving ROPIZUVA 7.5MG INJECTION inform your doctor if you have:

• acute porphyria (rare blood disorder) or family history of porphyria
• poor general health due to age or other reasons
• glucose-6phosphate dehydrogenase deficiency (hereditary disorder that affects red blood cells)
• congenital or idiopathic methemoglobinemia (condition affects red blood cells)

Use in paediatrics:

ROPIZUVA 7.5MG INJECTION is not recommended for use in children below 12 years
of age. Consult your doctor before receiving it.

Use in geriatrics:

ROPIZUVA 7.5MG INJECTION should be used with caution in elderly patients above
65 years of age. Consult your doctor before receiving it.

Interactions

A. Drug-Drug interactions:

Before receiving ROPIZUVA 7.5MG INJECTION, inform your doctor if you are taking
any of the following medicine:

• morphine, codeine (medicines used to manage severe pain)
• local anaesthetics such as bupivacaine, articaine, benzocaine, prilocaine, procaine, mepivacaine, tetracaine (medicines which induce numbness in a specific part of the body)
• mexiletine, amiodarone, lidocaine (medicines used for management of irregular heartbeat)
• fluvoxamine, imipramine (medicine used for management of depression)
• ketoconazole (used for management fungal infections)
• nitric oxide, nitro-glycerine, nitroprusside (medicines used to manage high blood pressure and heart diseases)
• nitrous oxide (a medicine used in general anaesthesia or to manage severe pain)
• phenobarbital, phenytoin, sodium valproate (medicines used to manage fits)
• acetaminophen (a medicine used to manage fever and pain)
• metoclopramide (used for management nausea and vomiting)
• sulfasalazine (used for management inflammatory bowel disease)
• antineoplastic agents Ex. cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase (medicines used to manage cancer)
• chloroquine, primaquine, quinine (medicines used to manage malaria)
• enoxacin, sulphonamides like silver sulphadiazine (used to manage bacterial infections)
• dapsone (used to manage leprosy)
• nitrofurantoin (used to manage urinary tract infections)
• para-amino salicylic acid (used to manage tuberculosis)
• theophylline (used to manage asthma)

Overdosage:

ROPIZUVA 7.5MG INJECTION will be administered to you only by a doctor in a
hospital and so it is unlikely to receive an overdose. However, consult your
doctor or nurse if you experience any unusual symptoms such as dizziness or
light headedness, numbness of lips, tongue, around mouth, hearing problems,
visual problems, tingling sensations, muscle stiffness, muscle twitching, speech
problems, tremors, trembling, fits, loss of consciousness low blood pressure,
slow or irregular heartbeat. These symptoms might worsen to cardiac arrest,
breathing arrest or severe fits.

Synopsis

Drug	:	Ropivacaine
Pharmacological Category	:	Local Anaesthetics
Therapeutic Indication	:	To numb part of the body during surgery and to relieve pain
Dosage Forms	:	Injection

More Information

• Keep ROPIZUVA 7.5MG INJECTION out of reach of children
• Store ROPIZUVA 7.5MG INJECTION below 30°C
• Do not freeze

FAQs About ROPIZUVA 7.5MG INJECTION

What is ROPIZUVA 7.5MG INJECTION used for?

ROPIZUVA 7.5MG INJECTION is used in adults and children above 12 years of age to
numb (anaesthetise) parts of the body during surgery, including having a baby by
caesarean section and to relieve pain during childbirth, after surgery or after
an accident. Contact your doctor before receiving it.

What does ROPIZUVA 7.5MG INJECTION do to the brain?

ROPIZUVA 7.5MG INJECTION works by stopping the nerves from being able to pass
pain messages to the brain. Thus ROPIZUVA 7.5MG INJECTION will stop you feeling
pain, heat or cold in where it is used however you may still have other feelings
like pressure or touch.

What if I receive too much of ROPIZUVA 7.5MG INJECTION?

ROPIZUVA 7.5MG INJECTION will be administered to you only by a doctor in a
hospital and so it is unlikely to receive an overdose. However, consult your
doctor or nurse if you experience any unusual symptoms such as dizziness or
light headedness, numbness of lips, tongue, around mouth, hearing problems,
visual problems, tingling sensations, muscle stiffness, muscle twitching, speech
problems, tremors, trembling, fits, loss of consciousness low blood pressure,
slow or irregular heartbeat. These symptoms might worsen to cardiac arrest,
breathing arrest or severe fits.

Who should not use ROPIZUVA 7.5MG INJECTION?

ROPIZUVA 7.5MG INJECTION is not recommended for use in patients with hypovolemia
(low blood volume), allergic history to ropivacaine or to other local
anaesthetics such as lidocaine, bupivacaine and in children under 12 years of
age. Contact your doctor before receiving it.

Does ROPIZUVA 7.5MG INJECTION make you sleepy?

ROPIZUVA 7.5MG INJECTION can make you feel sleepy. Try to rest and relax. Get
enough sleep. Do not drive or operate machines until the next day after
receiving ROPIZUVA 7.5MG INJECTION. Contact your doctor if your sleepiness did
not improve.

Useful Diagnostic Tests

• Electrocardiogram (ECG)
• Kidney function test