Artisafe L 40/240mg Tablet 6'S

Introduction About ARTISAFE L 40/240MG TABLET

ARTISAFE L 40/240MG TABLET is a combination of Artemether and Lumefantrine which
belongs to the group of medicines called Antimalarials. It is used in infants,
children and adults for the management of acute uncomplicated malaria (mosquito
borne disease with symptoms of fever with chills, tiredness, nausea, vomiting,
stomach pain) caused by a parasite called plasmodium falciparum.

ARTISAFE L 40/240MG TABLET should be used with caution in patients with severe
liver or kidney problems or if the patient feels worse or unwell to eat and
drink.

ARTISAFE L 40/240MG TABLET is not recommended for use in patients having severe
type of malarial infection affecting the lungs, kidney or brain, heart condition
such as changes in the heart rhythm, slow heartbeat or severe heart disease and
low levels of electrolytes such as potassium or magnesium in the blood.

ARTISAFE L 40/240MG TABLET is generally not recommended for use during the first
trimester of pregnancy and it should be used with caution during the second and
third trimester of pregnancy and breast-feeding women only if advised by the
doctor.

ARTISAFE L 40/240MG TABLET should be used with caution in children and your
child’s doctor may adjust the dose depending upon child’s age and body weight.

The most common side effects of taking ARTISAFE L 40/240MG TABLET are headache,
dizziness, vomiting, stomach pain, nausea, muscle pain and loss of appetite.
Consult your doctor if any of the side effects worsen.

Uses Of ARTISAFE L 40/240MG TABLET

• Manage acute uncomplicated malarial infections (caused by plasmodium falciparum) in infants, children and adults

How ARTISAFE L 40/240MG TABLET Works

ARTISAFE L 40/240MG TABLET effectively manages malarial infections,
whereartemether effectively kills the malarial parasites by binding to haem
(part of molecules that contains iron which is toxic to malarial parasites)
which is produced during the breakdown of haemoglobin. Lumefantrine works by
binding to hemin where it manages the formation of a toxic malarial pigment
called hemozoin, thereby it manages malarial infection. In addition to this
artemether and lumefantrine blocks nucleic acid and protein synthesis in
parasite that damages the parasitic cell membrane of plasmodium falciparum which
leads to the death of parasite. Thus, it helps in managing the malarial
infection.

How to use ARTISAFE L 40/240MG TABLET

Take ARTISAFE L 40/240MG TABLET exactly as advised by your doctor.

For Tablet, Capsule: Swallow ARTISAFE L 40/240MG TABLET with a glass of
water. This medicine should be taken with food or drinks rich in fat such as
milk. Crush the medicine into powder if your child is unable to swallow the
whole medicine.

For Dispersible Tablet: Disperse ARTISAFE L 40/240MG TABLET in the specified
quantity of water as mentioned in the label. Consume the mixture immediately
after reconstitution.

Your doctor will decide the correct dose and duration for you depending upon
your age, body weight and severity of the disease condition.

Side Effects Of ARTISAFE L 40/240MG TABLET

Common

• headache, dizziness
• nausea, vomiting
• stomach pain
• diarrhea
• muscle or joint pain
• difficulty to sleep
• loss of appetite
• cough
• fast heartbeat
• general weakness, tiredness
• involuntary muscle spasms
• abnormal walking (in children above 12 years)
• tingling sensation or numbness of hand and feet
• rashes or itching in the skin
• disturbance in heart rhythm (prolonged QTc interval)

Uncommon

• sleepiness
• decreased skin sensitivity
• inability to coordinate movements

Rare

• allergic reactions

Stop taking ARTISAFE L 40/240MG TABLET and contact your doctor immediately if
you experience any of the following side effects:

• swelling of the face, lips, tongue or throat with difficulty in breathing and swallowing
• skin condition with large fluid filled blisters (bullous eru

How To Manage Side Effects

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a
pain-relieving balm on the forehead if required. Do not consume too much of
alcohol. Consult your doctor if the symptom does not improve.

Nausea and vomiting:

Stick to simple meals while taking this medicine. Avoid eating oily, fried or
spicy foods. Do not lie down or sleep immediately after eating. Consult your
doctor if the symptom does not improve.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals.
Keep a heat pad on your stomach. Do not self-manage on your own and consult your
doctor if the symptom does not improve.

Diarrhea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated.
Avoid taking any medicine on your own for managing diarrhea. Consult your doctor
if the symptom does not improve.

Tiredness:

Drink plenty of fluid and eat balanced diet and frequent meals. Do regular
minimal exercise and follow regular sleep schedule. Consult your doctor if the
symptom does not improve.

Warning & Precautions

!### Pregnancy

ARTISAFE L 40/240MG TABLET is generally not recommended for use during the first
trimester of pregnancy. It should be used with caution during second and third
trimester of pregnancy only if considered clearly necessary. Consult your doctor
before taking ARTISAFE L 40/240MG TABLET.

!### Breastfeeding

ARTISAFE L 40/240MG TABLET should be taken with caution in breast feeding women
only if considered clearly necessary. Consult your doctor before taking ARTISAFE
L 40/240MG TABLET.

!### Driving and Using Machines

Do not drive or operate any machines if you experience dizziness, sleepiness or
weakness after taking ARTISAFE L 40/240MG TABLET.

!### Kidney

ARTISAFE L 40/240MG TABLET is not recommended for use in patients having severe
type of malarial infection affecting the kidneys. It should be taken with
caution in patients with severe kidney problems. Consult your doctor before
taking ARTISAFE L 40/240MG TABLET.

!### Liver

ARTISAFE L 40/240MG TABLET should be taken with caution in patients with severe
liver problems. Consult your doctor before taking ARTISAFE L 40/240MG TABLET.

!### Allergy

Do not take ARTISAFE L 40/240MG TABLET if you are allergic to Artemether,
Lumefantrine or any other ingredients of this medicine.

!### Lungs

ARTISAFE L 40/240MG TABLET is not recommended for use in patients having malaria
with pulmonary edema or severe type of malarial infection affecting the lungs.
Consult your doctor before taking it.

!### Heart Disease

ARTISAFE L 40/240MG TABLET is not recommended for use in patients with severe
heart disease or with heart diseases such as slow heartbeat, changes in the
rhythm or rate of the heartbeat or family history of death due to heart problems
or born with heart problems. ARTISAFE L 40/240MG TABLET should be taken with
caution in patients with variations in ECG (prolongation of QTc interval).
Consult doctor before taking ARTISAFE L 40/240MG TABLET.

Others

ARTISAFE L 40/240MG TABLET is not recommended for use if you have:

• severe type of malarial infection that has affected the brain
• low levels of electrolytes such as potassium or magnesium in blood

Before taking ARTISAFE L 40/240MG TABLET, inform your doctor if you:

• infected with both the plasmodium falciparum and plasmodium vivax parasites
• feeling worse or if you feel too unwell to eat and drink

Use in pediatrics

ARTISAFE L 40/240MG TABLET should be given with caution in children as the
dosages of ARTISAFE L 40/240MG TABLET vary in children according to their body
weight. So, consult a paediatrician before you give this medicine to your child.

Use in geriatrics

ARTISAFE L 40/240MG TABLET can be used in elderly patients. However, consult
your doctor before taking this medicine.

Interactions

A. Drug – drug interactions:

Before taking ARTISAFE L 40/240MG TABLET, inform your doctor if you are taking
any of the following medicines:

• medicines used to manage heart rhythm problems (Ex. Flecainide, metoprolol)
• medicines used to manage depression (Ex. imipramine, amitriptyline, clomipramine, St. John’s wort)
• medicine used to manage leprosy or tuberculosis (Ex. rifampicin)
• medicines used to manage bacterial infections (EX.  fluroquinolones such as ciprofloxacin, levofloxacin, macrolide antibiotics like azithromycin, erythromycin)
• medicines used to manage fungal infection (Ex. ketoconazole, fluconazole, itraconazole)
• medicines used to manage allergy (Ex. terfenadine, astemizole)
• medicine used to manage stomach disturbance (Ex. cisapride)
• medicines used to manage fits (Ex. carbamazepine, phenytoin)
• medicines used to manage malaria (Ex.  atovaquone/progu
• medicines used to manage HIV infection (Ex. indinavir, ritonavir)
• medicine used to manage pregnancy (Ex. Ethinyl estradiol)

B. Drug – Food interactions

Drink grapefruit juice with caution while taking ARTISAFE L 40/240MG TABLET as
it may interact with this medicine.

Overdosage:

If you or anyone else accidentally take too much of ARTISAFE L 40/240MG TABLET,
consult your doctor immediately or visit a nearby hospital.

Synopsis

Drug	:	Artemether, Lumefantrine
Pharmacological Category	:	Antimalarials
Therapeutic Indication	:	Manages acute uncomplicated malaria
Dosage Forms	:	Tablet, Dispersible tablet, Injection, Syrup, Oral suspension, Dry Syrup

More Information

• Keep ARTISAFE L 40/240MG TABLET out of reach of children
• Store ARTISAFE L 40/240MG TABLET at room temperature

FAQs About ARTISAFE L 40/240MG TABLET

What is ARTISAFE L 40/240MG TABLET used for?

ARTISAFE L 40/240MG TABLET is used in infants, children and adults for the
management of acute uncomplicated malaria (mosquito born disease with symptoms
of fever with chills, tiredness, nausea, vomiting, stomach pain) caused by a
parasite called plasmodium falciparum.

Does ARTISAFE L 40/240MG TABLET helps to manage malaria?

ARTISAFE L 40/240MG TABLET is not used to manage malaria. It is only used to
manage malarial infection caused by a parasite called plasmodium falciparum.
Consult your doctor for advice before taking this medicine.

Is ARTISAFE L 40/240MG TABLET safe to use in pregnant women?

ARTISAFE L 40/240MG TABLET is generally not recommended for use during the first
trimester of pregnancy. It should be used with caution during second and third
trimester of pregnancy only if considered clearly necessary. Consult your doctor
before taking ARTISAFE L 40/240MG TABLET.

Can ARTISAFE L 40/240MG TABLET be used in patients with kidney problems?

ARTISAFE L 40/240MG TABLET is not recommended for use in patients having severe
type of malarial infection affecting the kidneys. It should be taken with
caution in patients with severe kidney problems. Consult your doctor before
taking ARTISAFE L 40/240MG TABLET.

Does ARTISAFE L 40/240MG TABLET cause diarrhea?

Yes, ARTISAFE L 40/240MG TABLET may cause diarrhea in some individuals. To
manage this effect, drink lot of fluids such as water or fruit juices to keep
yourself hydrated. Avoid taking any medicine on your own for managing diarrhea.
Consult your doctor if the symptom does not improve.

Useful Diagnostic Tests

• Peripheral Smear for Malaria