62.5 mg / 25 mg film-coated tablets
atovaquone / proguanil hydrochloride
What Malarone Junior is and what it is used for
Malarone Junior belongs to a group of medicines called malaria medicines. Each tablet contains two active substances, atovaquone, and proguanil hydrochloride.
What Malarone Junior is used for
Malarone Junior has two uses:
- prophylaxis (prevention) against malaria (for children weighing between 11 kg and 40 kg)
- treatment of malaria (for children weighing between 5 kg and under 11 kg).
Dosage instructions for each area of use can be found in section 3, How to give Malarone Junior.
This medicine is usually used in children and adolescents, but can also be prescribed to adults weighing less than 40 kg.
Malaria is spread through the bite of infected mosquitoes that carry the malaria parasite (Plasmodium falciparum) further into the bloodstream. Malarone Junior kills the parasite and can thus prevent malaria from developing ( prophylaxis ). Malarone Junior also kills Plasmodium falciparum parasites in individuals who have already developed malaria.
Advice on how to protect your child from malaria
People of all ages can get malaria. It is a serious disease, but it can be prevented.
In addition to taking Malarone Junior, it is very important that you also make sure to avoid mosquito bites, e.g. by:
- use insect repellent on exposed skin surfaces
- wear light clothing that covers most of the body , especially after sunset because it is the time when mosquitoes are most active
- sleep in a room with mosquito nets or under a mosquito net impregnated with insect repellent
- close windows and doors at sunset if mosquito nets are missing
- consider using insecticides (substrates, sprays, electronic mosquito coils) to remove mosquitoes before nightfall or to prevent mosquitoes from entering.
- If you need further advice, talk to your doctor or pharmacist
However, you can get malaria even though all precautions have been taken. In some types of malaria infection, it takes a long time before symptoms appear and the disease only breaks out after several days, weeks, or even months after you have returned home from your stay abroad.
- Seek medical attention immediately if your child develops symptoms such as fever, headache, chills and fatigue after returning home.
What you need to know before you give Malarone Junior
Do not give Malarone Junior
- if your child is allergic to atovaquone, proguanil hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- as prophylaxis (prevention) against malaria if your child has a serious kidney disease.
- Tell your doctor if any of these apply to your child.
Take special care with Malarone Junior
Talk to your doctor or pharmacist before giving Malarone Junior to your child about:
- your child has a serious kidney disease
- your child is being treated for malaria and weighs less than 5 kg or is receiving Malarone Junior prophylaxis ( prophylaxis ) against malaria and weighs less than 11 kg.
- Tell your doctor or pharmacist if any of these apply to your child.
Other medicines and Malarone Junior
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including without a prescription.
Some medicines may affect the effect of Malarone Junior and Malarone Junior may also increase or decrease the effect of other medicines taken at the same time, eg:
- metoclopramide (antiemetic and antiemetic)
- tetracyclines , rifampicin and rifabutin ( antibiotics )
- efavirenz or some very active protease inhibitors (used to treat HIV )
- warfarin and other blood thinners
- etoposide (used to treat cancer).
- Tell your doctor if your child is taking any of these medicines. Your doctor may decide that Malarone Junior is not suitable for your child or that closer monitoring is needed while your child is taking Malarone Junior.
- Remember to tell your doctor if your child starts taking any other medicine while taking Malarone Junior.
Taking Malarone Junior with food or drink
Whenever possible, give Malarone Junior food or milk. Food increases the body’s uptake of Malarone Junior and makes the treatment more effective.
Pregnancy and breastfeeding
Do not use Malarone Junior if you or your baby are pregnant unless your doctor tells you to.
Do not breastfeed while taking Malarone Junior to breastfeed as the active substances may pass into breast milk and thus harm the baby.
Driving and using machines
If you get dizzy, do not drive.
Some people get dizzy when taking Malarone Junior. If you feel affected, do not drive, operate machinery or engage in risky activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Malarone Junior contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to give Malarone Junior
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Whenever possible, Malarone Junior should be given food or milk. The tablets should preferably be swallowed whole. If the child has difficulty swallowing the tablets whole, they can be crushed and mixed with food or milk drink just before ingestion.
It is best if Malarone Junior is taken at the same time each day.
If your child vomits
Prophylaxis (prevention) against malaria
- If your child vomits within an hour after taking the tablet , give a new dose immediately .
- It is important that your child completes the prescription one of Malarone Junior . If your child has to take additional tablets due to vomiting, he / she may need to get more Malarone Junior prescribed.
- If your child has vomited , it is especially important to use other protective measures such as. insecticides and mosquito nets. The effect of Malarone Junior can be reduced because the amount of drugs taken up in the body then becomes smaller.
Treatment of malaria
- If your child suffers from vomiting and diarrhea , consult your doctor as regular blood tests should be taken. The effect of Malarone Junior is reduced as the amount of drugs absorbed into the body then becomes smaller. Blood samples are taken to show if the malaria parasite has disappeared from the blood.
Prophylaxis (prevention) against malaria
The recommended dose for prophylaxis is based on the weight of the child as follows:
11-20 kg – 1 tablet daily
21-30 kg – 2 tablets once daily
31-40 kg – 3 tablets once daily
- start by giving Malarone Junior 1 to 2 days before arrival in a malaria-infected area
- continue to give Malarone Junior every day throughout your stay
- continue to give Malarone Junior for another 7 days after returning to the malaria-free area.
For maximum protection, your child must complete the entire prescription one.
Treatment of malaria
The recommended dose for the treatment of malaria infection is based on the weight of the child as follows:
5-8 kg – 2 tablets once daily for 3 days
9-10 kg – 3 tablets once daily for 3 days
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Be aware of the following serious reactions. They have occurred in a few individuals, but the exact occurrence is unknown.
Severe allergic reactions – symptoms include:
- skin rash and itching
- wheezing, swelling of the airways or throat and difficulty breathing that occurs suddenly
- swelling of the eyelids, face, lips, tongue or other parts of the body.
- Contact a doctor immediately if your child suffers from any of these symptoms. Stop giving Malarone Junior.
Severe skin reactions
- rash, possibly with blisters that look like small bumps (annular, dark spots, surrounded by a lighter area with a dark ring around the edge) ( erythema multiforme )
- severe, widespread rash with blisters and scaling, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ).
- If you notice any of these symptoms contact your doctor immediately.
Most other side effects reported have been mild and transient.
Very common side effects are
May affect more than 1 in 10 people:
- headache
- nausea and vomiting
- abdominal pain
- diarrhea.
Common side effects are
May affect up to 1 in 10 people:
- dizziness
- insomnia
- strange dreams
- Depression
- loss of appetite
- fever
- skin rash, possibly itchy
- cough.
Common side effects that can be detected with blood tests:
- decreased number of red blood cells ( anemia ), which can cause fatigue, headaches and shortness of breath
- decreased number of white blood cells ( neutropenia ) which may make you more likely to catch the infection you
- low levels of sodium in the blood ( hyponatremia )
- elevated liver enzyme values.
Uncommon side effects are
May affect up to 1 in 100 people:
- anxiety
- palpitations that are experienced as unpleasant ( palpitation )
- swelling and redness in the oral cavity
- hair loss
- itchy, uneven rash (hives).
Uncommon side effects that can be detected by blood tests:
- elevated amylase values ( an enzyme produced in the pancreas ).
Rare side effects are
May affect up to 1 in 1,000 people:
- to see and hear things that do not exist ( hallucinations )
Other side effects ar
Other side effects have occurred in a few individuals, but the exact occurrence is unknown.
- inflammation of the liver ( hepatitis )
- clogging of the bile ducts (bile stasis )
- increased heart rate ( tachycardia )
- inflammation of the blood vessels ( vasculitis ). These can appear as red or dark violet raised spots on the skin, but can also affect other parts of the body
- cramps
- panic attacks, crying
- nightmares
- severe mental problems where the person loses contact with reality and is unable to think and act clearly
- indigestion
- sores in the oral cavity
- blisters
- scaly skin
- increased sun sensitivity of the skin.
Other side effects that can be detected with blood tests:
- decreased number of all blood cells (pancytopenia).
How to store Malarone Junior
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
Active substances: 62.5 mg atovaquone and 25 mg proguanil hydrochloride in each tablet.
Other ingredients:
tablet core: poloxamer 188, microcrystalline cellulose, hydroxypropyl cellulose, povidone K30, sodium starch glycolate (type A), magnesium stearate
film coatings: hypromellose, titanium dioxide (dye E171), red iron oxide (dye E172), macrogol 400, polyethylene glycol 8000 (see section 2).
- Contact your doctor before giving Malarone Junior if your child is allergic to any of the ingredients.
What the medicine looks like and contents of the pack
Malarone Junior tablets are round, pink, and film-coated. They are supplied in blister packs containing 12 tablets.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline AB, Box 516, 169 29 Solna.
Tel: 08 – 638 93 00
Email: info.produkt@gsk.com
Manufacturer:
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
or
Glaxo Wellcome SA, Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
This medicinal product is authorized under the European Economic Area under the names:
| ASK | Malarone Junior |
| THE | Malarone Junior |
| EL | Malarone Pediatric |
| IT | Malarone Pediatric |
| LU | Malarone Junior |
| NL | Malarone Junior |
| NO | Malarone Junior |
| ES | Malarone Junior |
| SEE | Malarone Junior |
| UK | Malarone pediatric |