Cipla Lumartem Artemether and Lumefantrine Tablets Patient Info

PATIENT INFORMATION LEAFLET
INFORMATION FOR THE USER

Lumartem

Read all of this leaflet carefully before you start taking this medicine.

– 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 or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

 

In this leaflet

1. What Lumartem is and what it is used for?

2. Before you take Lumartem

3. How to take Lumartem?

4. Possible side effects

5. How to store Lumartem?

6. Further information

 

1. WHAT LUMARTEM IS AND WHAT IT IS USED FOR?

This medicine is an antimalarial. It is used to treat a certain type of malaria infection in adults and children who weigh at least 5 kg.

Lumartem contains two antimalarial drugs, artemether and lumefantrine in fixed dose, which work together to kill the malaria parasite (a tiny organism that is found inside the red blood cells). Your doctor has found that you have malaria and so has prescribed Lumartem.

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 worker.

 

2. BEFORE YOU TAKE LUMARTEM

You should not take Lumartem

If you are hypersensitive (allergic) to artemether lumefantrine or any of the other ingredients of Lumartem (see section 6, What Lumartem contains).

Take special care with Lumartem

If you are pregnant, you must tell your doctor or health care provider. Lumartem should only be used in pregnancy if it is considered absolutely necessary (see below Pregnancy and breast- feeding).

Lumartem can change your electrical recording of the heart (electrocardiogram, ECG,). Therefore, before taking, Lumartem, inform your doctor or health care provider if you have:

Any condition with certain abnormal ECG changes.

A salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment, a very slow heart rate (bradycardia).

A weak heart (heart failure).

A history of abnormal heart rhythms (arrhythmias).

Also, inform your doctir or health care provider:

If you are taking any medicine that lowers your blood potassium levels.

If you are taking other medicines that result in certain abnormal EGG changes (see below, Taking other medicines).

If you experience palpitations or an irregular heartbeat during treatment, you should tell your doctor immediately. He/she may wish to perform an ECG.

The use of Lumartem has not been investigated in patients with kidney or liver disease. If you have any such condition, you should inform your doctor or health care provider before taking Lumartem.

Lumartem should not be used in patients with severe malaria for malaria prophylaxis or in combination with other drugs against malaria, unless your doctor or health care provider considers this appropriate in your particular case.

You should inform your doctor or health care provider about all malaria medicines that you have taken the last months, as the appropriateness of using Lumartem may depend on this. Lumartem may lower the effects of hormonal contraceptives. Therefore a different or an additional method of contraception (e.g. condoms, intra-uterine device, pessary) should be used during treatment with Lumartem.

It is important that your doctor or health care provider knows about all your symptoms, even when you think they are not related to malaria infection.

Taking other medicines

It is important you tell your doctor, health care provider or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. These may affect the action of Lumartem, or Lumartem may affect their action. Side effects of either medicine may become worse and/or the medicines may become less effective.

Especially tell your doctor or health care provider if you take or have recently taken:

• Any other medicines to treat or prevent malaria.

• Medicines for your heart.

• Antipsychotic medicines (for treatment of abnormal condition of the mind).

• Antidepressants (medication to alleviate mood disorders).

• Antibiotics.

• Antihistamines- (for treatment of, e.g., allergies).

• Cisapride (a medicine for improving gastric motility).

• Medicines to treat HIV infection.

• Medicines against fungal infection.

• Hormonal methods of birth control (for example birth control pills or contraceptive patch).

Taking Lumartem with food and drink

Lumartem should be taken with food or a milky drink.

Pregnancy and breast feeding

Pregnancy

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

Breast-feeding

Breast-feeding can be considered after medical advice.

Driving and using machines
Lumartem may cause dizziness and fatigue. If you feel dizzy or fatigued while taking Lumartem, do not drive and do not use any tools or machines.

Important information about some of the ingredients of Lumartem

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

 

3. HOW TO TAKE LUMARTEM?

Lumartem should always be taken exactly as described by the doctor or health care provider. You should check with your doctor, health care provider or pharmacist if you are not sure.

The dose of Lumartem is decided on the basis of your or your child’s bodyweight.

Number of Lumartem tablets for treatment according to weight bands

Weight range Time
Day 1 Day 2 Day 3
Immediately
after diagnosis/
onset of
8 hours
after previous
dose
12 hours
after previous
dose
12 hours
after previous
dose
12 hours
after previous
dose
12 hours
after previous dose
from 5kg up to 15kg 1 tablet 1 tablet 1 tablet 1 tablet 1 tablet 1 tablet
From 15kg up to 25kg 2 tablets 2 tablets 2 tablets 2 tablets 2 tablets 2 tablets
From 25kg up to 35kg 3 tablets 3 tablets 3 tablets 3 tablets 3 tablets 3 tablets
From 35kg (or ≥ 12 years of age) 4 tablets 4 tablets 4 tablets 4 tablets 4 tablets 4 tablets

The first dose should be followed by a second dose after 8 hours. The following two days the doses of Lumartem should be taken 12 hours apart.

Lumartem should be taken with food or a milky drink. If you are unable to tolerate food, Lumartem should still be administered, but your body may take up less of the medicine. If you vomit within 1 hour of taking the medication, you should repeat the dose.

If you take more Lumartem than you should

If you take too many tablets, you may develop an abnormal heartbeat. Immediately contact your doctor, health care provider or the nearest hospital emergency department for further advice.

If you forget to take Lumartem

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. Make sure you take all six doses of this regimen.

It you stop taking Lumartem

You should keep taking the medicine for as long as your doctor has ordered, even if you are feeling better. If you stop the medicine too soon, the infection may not be completely cured.

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

 

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lumartem can cause side effects, although not everybody gets them. When treating malaria, it is not always possible to differentiate between unwanted affects caused by Lumartem, and those caused by any other medicines you may be taking at the same time. For this reason, it is important that you inform the doctor or health care provider of any change in your health.

The following side effects have been reported in patients treated with Lumartem:
The most commonly reported side effects (greater than 1 in every 10 patients treated) include headache, dizziness, feeling sick, vomiting, abdominal pain, loss of appetite, palpitations, pain in muscles and joints, fatigue and disturbed steep.

Commonly (greater than 1 in every 100 patients treated) reported side effects include alterations to the electrocardiogram (ECG), tingling in hands and feet, problems with walking, cough, diarrhoea, itching, rash and insomnia.

Uncommon side effects (greater than 1 in every 1000 patients treated but less than 1 in 100): involuntary muscle jerks, coordination disturbances, altered liver function tests and drowsiness.

The following side effects have been reported in patients treated with Lumartem. However, frequency estimates for these effects are not available: hypersensitivity reaction, hives, rapid swelling of the face and throat (angioedema).

A similar side effect profile was reported for children.

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

 

5. HOW TO STORE LUMARTEM?

Keep out of reach and sight of children.

Do not store above 30oC. Protect from light. Store in the original package.

Do not use Lumartem after the expiry date which is stated on the blister and the outer packaging after EXPIRY. The expiry date refers to the last day of that month.

Do not use Lumartem if you notice any sign of discolouration of tablets.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required.

 

6. FURTHER INFORMATION

What Lumartem contains

The active ingredients are: Artemether and lumefantrine.

The other ingredients are: Croscarmellose sodium, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 80 and purified talc.

What Lumartem look like and contents of the pack

Yellow, circular, flat, bevelled, uncoated tablets with a central break-line on one side and plain on other side.

The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

The primary packs are:

Aluminium-aluminium blister foils. Pack sizes: packs of 1×6 (6), 2×6 (12), 3×6 (18) or 4×6 (24) tablets.

Aluminium blister foil and a clear transparent, well thermoformable PVC/PCTFE film.

Pack size: Packs of 6, 12, 18 or 24 tablets.

 

Suppler

CIPLA LTD.

289, JBB Marg

Mumbal Central

Mumbai 400 008 INDIA

exports@cipla.com

 

Manufacturer

CIPLA LTD.

Plot 9 & 10, Indore SEZ

Pithampur, M.P.-454 775,

INDIA

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

This leaflet was last approved in

September 2010. Sections 5 and 6 updated in March 2012.

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

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