Artesunate/Amodiaquine 50 mg/135 mg Tablets(Ipca Laboratories Ltd), MA081

WHOPAR part 3

October 2021
Section 6 updated: May 2023

WHO-PQ RECOMMENDED
PATIENT INFORMATION LEAFLET

This patient information leaflet focuses on uses of the medicine covered by WHO’s Prequalification Team Medicines. The recommendations for use are based on WHO guidelines and on information from stringent
regulatory authorities.*
The medicine may be authorised for additional or different uses by national medicines regulatory authorities.

*

https://extranet.who.int/pqweb/sites/default/files/documents/75%20SRA%20clarification_Feb2017_newtempl.pdf
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Artesunate/Amodiaquine 50 mg/135 mg Tablets(Ipca Laboratories Ltd), MA081

WHOPAR part 3

October 2021
Section 6 updated: May 2023

Information for the patient[MA081 trade name]†
Amodiaquine (hydrochloride)/artesunate
Read all of 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 questions about the medicine, ask your health care provider.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness seem to be the same as yours.
If you are concerned about any side effects, talk to your health care provider. This includes unwanted
effects not listed in this leaflet. See section 4.

-

What is in this leaflet
1.
2.
3.
4.
5.
6.

What [MA081 trade name] is and what it is used for
What you need to know before you take [MA081 trade name]How to take [MA081 trade name]
Possible side effects
How to store [MA081 trade name]Contents of the pack and other information1.

What [MA081 trade name] is and what it is used for[MA081 trade name] is used to treat malaria. It contains two antimalarial medicines, artesunate andamodiaquine, which work together to kill the malaria parasite in your body. Your health care provider has
recommended [MA081 trade name] for you because you have malaria.
It is to be used only for treating uncomplicated malaria caused by Plasmodium falciparum (a type of malaria
parasite). Uncomplicated malaria is when the patient is conscious and is not suffering serious symptoms suchsevere anaemia, jaundice, breathing difficulties and kidney failure. For complete cure it is important that you
finish taking all the tablets that your health care provider has prescribed for you.
2.

What you need to know before you take [MA081 trade name]

Do not take [MA081 trade name]-

if you are allergic to artesunate, amodiaquine or to any of the other ingredients of [MA081 trade name](see section 6, What [MA081 trade name] contains);
if you have ever had liver problems during treatment with amodiaquine;
if you have ever suffered from sudden high fevers, shaking, severe sore throat or ulcers in the mouth(symptoms of low white blood cell count) during treatment with amodiaquine;
if you have an eye disease with damage to your retina.

If you have any doubt, check with your health care provider.
Take special care with [MA081 trade name]
This medicine may rarely damage the liver or cause blood problems that can be fatal. If you feel weak, havenausea, vomiting, abdominal pain, jaundice (yellowing of the skin with dark urine, pale bowel motions), sorethroat or mouth ulcers, stop treatment with [MA081 trade name] and see your health care provider
immediately; you may need blood tests.
Tell your health care provider if you have used this or another amodiaquine-containing medicine very
recently. This is because you are more likely to get side effects.
†Trade names are not prequalified by WHO. This is the national medicines regulatory agency’s responsibility.
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Artesunate/Amodiaquine 50 mg/135 mg Tablets(Ipca Laboratories Ltd), MA081

October 2021
Section 6 updated: May 2023

This medicine may cause abnormal movements of the head, tongue or neck (extrapyramidal symptoms, seesection 4, Possible side effects). These symptoms are usually reversed by discontinuation of the treatment. If
these rare effects occur, stop the treatment and speak with your health care provider immediately. You may
need other treatment for these symptoms. Your doctor may recommend another malaria treatment.
Tell your health care provider if:-

you have ever had a problem with your heart rhythm or any other heart problem;
a close relative has had heart rhythm problem or died suddenly;
you have low levels of potassium or magnesium in your blood;
you have problems with your liver or kidneys.

If in doubt, ask your health care provider.
Taking other medicines
Tell your health care provider if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. Some medicines and [MA081 trade name] interfere with eachother. Some of these medicines include:-

other medicines used to treat malaria,
medicines used to treat an abnormal heart rhythm,
medicines that can have side effects on your heart, including some medicines used to treat depression ormental illnesses, and some antibiotic medicines (e.g. Cotrimoxazole)
medicines used to treat HIV/AIDS (e.g. zidovudine)-Pregnancy and breast-feeding
If you are pregnant, you must check with your health care provider before you take this medicine,
particularly during the first 3 months of pregnancy.
If you learn that you are pregnant during the treatment, speak with your health care provider.
You can breast-feed your baby during treatment with this medicine but check with your health care provider
first.
Driving and using machines
If you feel dizzy or tired after taking this medicine, you should not drive or operate machinery.
[MA081 trade name] contains lactose
If you have been told by your health care provider that you have an intolerance to some sugars, contact yourhealth care provider before taking this medicinal product.
3.

How to take [MA081 trade name]

Always take [MA081 trade name] exactly as your health care provider has told you. You should check withyour health care provider if you are not sure.
The dose depends on the patient’s weight as follows:
Weight(approximate age)
9 kg to 18 kg(1 to 5 years)
18 kg to 36 kg(6 to 13 years)
more than 36 kg(over 14 years)

Dose
1 tablet [MA081 trade name] daily for 3 days
(50 mg artesunate + 135 mg amodiaquine daily for 3 days)
2 tablets [MA081 trade name] daily for 3 days
(100 mg artesunate + 270 mg amodiaquine daily for 3 days)
4 tablets [MA081 trade name] daily for 3 days
(200 mg artesunate + 540 mg amodiaquine daily for 3 days)

Do not take [MA081 trade name] with a meal that contains a high amount of fat.
Swallow the tablet with a drink of water.
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Artesunate/Amodiaquine 50 mg/135 mg Tablets(Ipca Laboratories Ltd), MA081

WHOPAR part 3

October 2021
Section 6 updated: May 2023

For very young children or patients who cannot swallow the tablets whole, the tablets can be crushed andswallowed with water, or mixed with water and swallowing the mixture.
If you vomit within half-an-hour of taking the tablets, take another dose as soon as you can. Then contact
your health care provider for more tablets to finish the course. Tell your health care provider if you keepvomiting.
If you take more [MA081 trade name]
If you accidentally take a lot more tablets, then you or somebody else should immediately contact a healthcare provider or the nearest hospital emergency department. An overdose of this medicine can cause
headaches, dizziness, visual disturbances, a drop in blood pressure, convulsions (fits), or abnormal
movements of the head, tongue or neck. If any of these symptoms occur, see a health care provider
immediately.
If you forget to take [MA081 trade name]
Make sure that you do not miss a dose of this medicine. However, if you forget a dose, take the missed doseas soon as you remember. Take the next dose as usual. Do not take a double dose to make up for a forgotten
tablet.
If you stop taking [MA081 trade name]For this medicine to work properly you must take it regularly until you finish the course. Even if you feelbetter, it does not mean that your malaria has been completely cured. Tiredness, nausea and vomiting may becaused by the infection and not by the medicine so you should not stop your medicine if you get theseeffects.
If you have any further questions on the use of this medicine, ask your health care provider.
4.

Possible side effects

Like all medicines, [MA081 trade name] can cause side effects, although not everybody gets them.
Common side effects (affects 1 to 10 users in 100): loss of appetite, difficulty sleeping, sleepiness, cough,nausea, abdominal pain, weakness, tiredness.
Uncommon side effects (affects 1 to 10 users in 1,000):acute bronchitis, gastroenteritis, oral thrush, decrease
in red blood cell count (anaemia), hypoglycaemia (low blood sugar), hallucination, tingling and numbness of
the limbs, yellowing of the eye, dizziness, heart rhythm disorders, diarrhoea, vomiting, itching, rashes,swelling of the face, skin disorders, joint pain, swelling of the limbs (oedema), fever.
During post-marketing experience the following additional side effects have been reported: Common sideeffects (affects 1 to 10 users in 100): alteration of the heart rhythm (called ‘prolongation of QT interval’).
Frequency not known: low number of white blood cells (which can make you more prone to infections),
potentially severe disturbances of liver function, eye disorders, slate-grey pigmentation, especially of thefingers and mucous membranes (lining of body cavities), nervous system problems and muscle impairment.
Headache, cold, flu, rhinitis (runny nose), shivering, sore throat, swelling of the spleen, convulsion (fits),yellowing of the skin, allergic reaction. Some of these effects may be caused by the malaria.
Also, side effects called extrapyramidal symptoms can occur. These symptoms include abnormal movementsof the head, tongue or neck (e.g. facial spasms, tongue protrusion, difficulties in speaking) and rigidity in thebody, even after a single dose.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, tell your healthcare provider.
Reporting of side effects
If you get any side effects,talk to your health care provider. This includes unwanted effects not listed in thisleaflet. If available, you can also report side effects directly through the national reporting system. By
reporting side effects you can help improve understanding about the safety of this medicine.
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WHOPAR part 3

Artesunate/Amodiaquine 50 mg/135 mg Tablets(Ipca Laboratories Ltd), MA081

5.

October 2021
Section 6 updated: May 2023

How to store [MA081 trade name]

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use [MA081 trade name] after the expiry date which is stated on the blister and the outer packaging
after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines in wastewater or household waste. Ask your health care provider how tothrow away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What [MA081 trade name] contains-The active ingredients are amodiaquine (as hydrochloride) and artesunate.
The other ingredients of [MA081 trade name] are colloidal silicon dioxide, croscarmellose sodium,hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch, mannitol andpregelatinised starch.

What [MA081 trade name] looks like and contents of the pack
[MA081 trade name] is a round bilayered tablet. One layer is yellow coloured and the other one is white toslightly yellow with a breakline.
The break-line is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal
doses.
[MA081 trade name] is presented in:- Alu/Alu blister of 3 tablets in a printed show box along with a leaflet. Ten of these boxes are packed in acarton box.
- 25 Alu/Alu blisters of 3 tablets packed in a carton box along with a leaflet.
Supplier and Manufacturer
Supplier

Manufacturer

Ipca Laboratories Ltd
48 Kandivli Ind. Estate
Kandivli (West)400 067 Mumbai
India
Tel: +91-22-6210 5100/6210 5000
Fax: +91-22-6210 5105/+91-22-6210 5005
E-mail; ipca@ipca.com

Ipca Laboratories Ltd
Plot No. 255/1
Village Athal
396 230 Silvassa
U.T. of Dadra and Nagar
Haveli and Daman and Diu,
India
Tel: 0260 6164200/6164203
E-mail: ipca@ipca.com

For any information about this medicine, contact the local representative of the supplier.
This leaflet was last revised in October 2021
Section 6 updated in May 2023

Detailed information on this medicine is available on the World Health Organization (WHO) website:
https://extranet.who.int/pqweb/medicines

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