Falcimon Artesunate and Amodiaquine Hydrochloride Tablets Patient Info

Falcimon 100/270 B/L

Artesunate/Amodiaquine (as hydrochloride) 100mg/270mg tablets

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

 

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 any further questions, ask your doctor, health care provider or pharmacist.

• 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 are the same as yours.

• If you get any side effects, talk to your doctor, health care provider or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet

1 What Falcimon 100/270 B/L is and what it is used for.

2 What you need to know before you take Falcimon 100/270 B/L.

3 How to take Falcimon 100/270 B/L.

4 Possible side effects.

5 How to store Falcimon 100/270 B/L.

6 Contents of this pack and other information.

 

1 WHAT FALCIMON 100/270 B/L IS AND WHAT IT IS USED FOR

This medicine is an antimalarial, i.e. a drug used to treat a certain type of malaria infection.

Falcimon 100/270 B/L contains two antimalarial medicines, artesunate and amodiaquine, which work together to kill the malaria parasite (tiny organism that is found inside the red blood cells).

Your doctor has found that you have malaria and so has prescribed Falcimon 100/270 B/L.

It is indicated only, for the treatment of so called uncomplicated malarial attacks due to Plasmodium falciparum (a particular type of malaria parasite) against which the medicine is active. For complete cure it is important that you complete the prescribed dose as advised by your doctor, pharmacist or health care provider.

 

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE Falcimon 100/270 B/L

Do not take Falcimon 100/270 B/L

– If you are allergic to amodiaquine, artesunate, or any of the other ingredients of Falcimon 100/270 B/L (see section 6, “What Falcimon 100/270 B/L 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 suggestive of harm to white blood cells) during treatment with amodiaquine.

– If you have an eye disease with damage to your retina.

If you have any doubt, it is essential to ask the advice of your doctor, pharmacist or health care provider.

 

Warnings and precautions

This medicine may cause damage to the liver and/or blood that can sometimes be fatal.

In case of marked asthenia (fatigue), gastrointestinal disturbances, (nausea, vomiting, abdominal pain), jaundice (dark urine, pale bowel motions), sore throat or mouth ulcers, stop the treatment and consult a doctor immediately; your doctor may need to take a blood sample.

Tell your doctor, pharmacist or health care provider, if you have used this or another amodiaquine-containing medicine very recently. Since you might then be more likely to experience side effects, special caution is warranted.

This medicine may cause abnormal movements of the head, tongue or neck (see section 4, Possible side effects). If these symptoms occur, stop the treatment and consult a doctor immediately. These symptoms are usually reversed by discontinuation of the treatment; however medical treatment of the symptoms may be necessary. Your doctor may recommend another antimalarial treatment.

Because caution should be exercised In some patients, it is important to inform your doctor if you have, or have ever had, any of the following:

– A problem with your heart rhythm or any other heart problem.

– A family history of heart rhythm problem or sudden death.

– Low levels of potassium or magnesium in your blood.

– Problems with your liver or kidneys.

If in doubt, do not hesitate to ask the advice of your doctor, pharmacist or health care provider.

 

Falcimon 100/270 B/L contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

Other medicines and Falcimon 100/270 B/L

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines and Falcimon 100/270 B/L interfere with each other. 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 or mental illnesses, and some antibiotic medicines.

– Medicines used to treat HIV/AIDS.

 

Pregnancy and breast-feeding

Do not use this drug during pregnancy without medical advice particularly during the first 3 months of pregnancy.

If you learn that you are pregnant during the treatment, take medical advice: your doctor is the only one to know if you can continue the treatment. Breastfeeding can be considered after medical advice. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

Driving and using machines

If you are experiencing dizziness or fatigue after having taken this medicine, you should not drive vehicles or operate machinery.

 

3 HOW TO TAKE FALCIMON 100/270 B/L

Always take Falcimon 100/270 B/L exactly as your doctor has told you. You should check with your doctor, pharmacist or health care provider if you are not sure. The dosage should be adjusted in accordance with the patient’s weight/age as listed in the following table:

Weight range
(approximate age range)
On three consecutive days
≥18kg to <36kg (6 to 13 years)* 100 mg artesunate + 270 mg amodiaquine/day
(1 tablet of Falcimon 100/270 B/L in one intake
per day)
≥36kg (14 years and above)* 200 mg artesunate + 540 mg amodiaquine/day
(2 tablets of Falcimon 100/270 B/L in one intake
per day)

*If a weight-age mismatch occurs, dosing should be weight-based.

With this product appropriate dose adjustments cannot be achieved for children weighing less than 18 kg. For these patients tablets containing less artesunate and amodiaquine are available. Falcimon 100/270 B/L should not be taken with a high-fat meal. Swallow the tablet with a drink of water. For very young children or patients not able to swallow the tablets whole, the tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately, If you vomit within half an hour of taking the tablets, take another dose as soon as you can. Then, contact your doctor for a prescription for more tablets. Tell your doctor if you keep vomiting.

 

If you take more Falcimon 100/270 B/L than you should

If you accidentally take a lot more tablets than the doctor prescribed, contact a doctor or the nearest hospital emergency department immediately, or make sure that someone else contacts them for you. Headaches, dizziness, visual disturbances, circulatory collapse, convulsions, or abnormal movements of the head, tongue or neck, usually indicate an overdosage. If any of these symptoms occur, stop the treatment and consult a doctor immediately.

 

If you forget to take Falcimon 100/270 B/L

Try to make sure that you do not miss any dose. However, if you do forget a dose, take the missed dose as soon as you realise that you have forgotten it. Then take the next dose after the prescribed interval. Do not take a double dose to make up for a forgotten tablet.

 

If you stop taking Falcimon 100/270 B/L

To be effective the medicine must be taken regularly at the dose prescribed and for as long as your doctor has advised. The disappearance of fever or any other symptoms does not mean that you are completely cured. Any sensations of fatigue, nausea, vomiting might not be due to the drug but to the infection itself. Reducing or suspending your treatment would have no effect on these sensations or symptoms and would only delay your recovery.

If you have any further questions on the use of this product, ask your doctor, pharmacist or health care provider.

 

4 POSSIBLE SIDE EFFECTS

Like all medicines, Falcimon 100/270 B/L 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 Ito 10 users in 1,000): acute bronchitis, gastroenteritis, oral thrush, decrease in red blood cell count (anaemia), hypeglycaemia (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.

Side effects that may be linked to amodiaquine, one of the active ingredients of Falcimon 100/270 B/L: 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 the fingers and mucous membranes, nervous system and muscle impairment.

During post-marketing experience the following additional side effects have been reported (frequency not known): headache, cold, flu, rhinitis, shivering, sore throat, enlargement of the spleen, convulsion, yellowing of the skin, allergic reaction. For some of these events it is unclear whether they are related to amodiaquine/artesunate or to the underlying malaria disease.

Also, side effects known as extrapyramidal symptoms have been reported. These symptoms may include: abnormal movements of the head, tongue or neck (e.g. facial spasms, tongue protrusion, difficulties in speaking) and generalized rigidity, even after administration of a single dose.

If any of the side effects gets serious, or if you notice any side effect not fisted in this leaflet, please tell your doctor, pharmacist or health care provider.

 

5 HOW TO STORE Falcimon 100/270 B/L

Keep out of reach of children. Do not store above 30oC.

Do not use Falcimon 100/270 B/L after the expiry date which is stated after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

 

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Falcimon 100/270 B/L contains

The active ingredients are 100 mg artesunate and 270 mg amodiaquine (as hydrochloride).

The other ingredients are: lactose anhydrous, lactose monohydrate, croscarmellose sodium, magnesium stearate, calcium carbonate DC 95S with 5% corn starch and colloidal anhydrous silica.

 

What Falcimon 100/270 B/L looks like and contents of the pack

Falcimon 100/270 B/L is a circular uncoated bilayered flat bevelled tablet with one white to light yellowish layer and the other yellow layer debossed with ‘100’ on one side and with central break-line on the white to light yellowish layer.

The break-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. The break-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. The tablets are provided in an Alu/Alu blister pack containing 3 tablets, One blister pack is contained in a carton.

The tablets are provided in an Alu/Alu blister pack containing 6 tablets.

One blister pack is contained in a carton.

The tablets are provided in an Alu/Alu blister pack containing 3 tablets.

25 blister pack are contained in a carton.

The tablets are provided in an Alu/Alu blister pack containing 6 tablets.

25 blister pack are contained in a carton

 

Supplier and Manufacturer

Supplier

Cipla Limited

Cipla House,

Peninsula Business Park,

Ganpatrao Kadam Marg,

Lower Parel, Mumbai-400013,

India

 

Manufacturer

Cipla Limited

Unit II, A-42, MIDC Patalganga,

District: Raigad Maharashtra state

India.

 

For any information about this medicinal product, please contact the supplier.

This leaflet was last approved in September 2014, Section 6 updated in July 2015.

Detailed information on this medicine is available on the World Health Organization (WHO) website: http://www.who.int/prequal

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