250/100 mg film-coated tablets
atovaquone / proguanyhydrochloride
What Malastad is and what it is used for
Malastad belongs to a group of medicines called malaria medicines. Each tablet contains two active substances, atovaquone, and proguanil hydrochloride.
Malastad has two uses:
- prophylaxis (prevention) against malaria in adults and children weighing more than 40 kg.
- treatment of malaria in adults and children weighing more than 11 kg.
Malaria is spread through the bite of infected mosquitoes, which carry the malaria parasite ( Plasmodium falciparum ) further into the bloodstream. Malastad kills the parasite and can thus prevent malaria from developing ( prophylaxis ). Malastad also kills Plasmodium falciparum parasites in individuals who have already developed malaria.
Atovaquone and proguanil hydrochloride found in Malastad may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
Protect yourself from malaria
- In addition to taking Malastad, it is very important that you also make sure to avoid mosquito bites. Use insect repellent on exposed skin surfaces .
- Wear light clothing that covers most of the body , especially after sunset because that is when the mosquitoes are most active.
- Sleep in a screened room or under a mosquito net impregnated with insect repellent.
- Close windows and doors at sunset if mosquito nets are missing.
- Consider using insect repellent (substrate, spray, plug) 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 for symptoms to 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 you experience symptoms such as fever, headache, chills, and fatigue after returning home.
What you need to know before using Malastad
Do not use Malastad
- if you are allergic ( hypersensitive ) to atovaquone, proguanil hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- As a prophylaxis (prevention) against malaria if you have a serious kidney disease.
Warnings and cautions
Talk to a doctor or pharmacist before taking Malastad.
Malaria prevention
- if you are sick (vomiting) within an hour after taking the tablet, take a new dose immediately
- it is important that you complete the prescription one of Malastad. If you have to take additional tablets due to vomiting, you may need to get more Malastad prescribed
- if you have vomited, it is especially important to use other protective measures such as insecticides and mosquito nets. The effect of Malastad can be reduced because the amount of drugs taken up in the body then becomes smaller.
Treatment of malaria
- If you experience vomiting and diarrhea, consult your doctor as regular blood tests should be taken. The effect of Malastad decreases because the amount of drug taken up in the body then becomes smaller. Blood samples are taken to show if the malaria parasite has disappeared from the blood
- If you have severe kidney disease, your doctor may decide to prescribe another medicine
- if you get a certain type of infection during treatment with Malastad, your doctor may prescribe another type of medicine instead of Malastad
- for malaria treatment, but then comes back repeatedly or if malaria is caused by a certain type of parasite, your doctor may decide that a different drug is taken simultaneously with Mala City.
Other medicines and Malastad
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect the effect of Malastad and Malastad can also increase or decrease the effect of other medicines taken at the same time, eg:
- metoclopramide, antiemetic and antiemetic
- antibiotics , tetracyclines , rifampicin and rifabutin
- 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 you are taking any of these medicines. Your doctor may decide that Malastad is not suitable for you or that closer monitoring is needed while you are taking Malastad.
Malastad with food, drink and alcohol
Whenever possible, take Malastad with food (preferably a high-fat meal) or milk. Food increases the body’s uptake of Malastad and makes the treatment more effective.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking Malastad.
Do not breastfeed while taking Malastad as the active substances may pass into breast milk and thus harm your baby.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
If you get dizzy, do not drive. Some people get dizzy when they take Malastad. 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.
Malastad contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet.
i.e. is next to “sodium-free”.
3. How to use Malastad
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Whenever possible, take Malastad with food or milk.
It is best if Malastad is taken at the same time each day.
Prophylaxis (prevention)
The usual dose for adults and adolescents weighing more than 40 kg is 1 tablet daily as shown below.
For children, consult your doctor.
Malastad is not recommended as a prophylaxis against malaria infection in children or adults weighing less than 40 kg.
There may be another anti-malarial drug for children weighing less than 40 kg in your country.
For prophylaxis in adults, one should
- start treatment with Malastad 1 to 2 days before arrival in a malaria-infected area
- continue to take Malastad every day throughout the stay and then continue to take Malastad for another 7 days after returning to the malaria-free area. For maximum protection, a prescription must be completed. If treatment is stopped earlier, you risk getting malaria because it must be 7 days since the mosquito bite to be sure that all the parasites in the blood have died.
Treatment of malaria
The usual dose for the treatment of adults is 4 tablets once daily for 3 days.
Use for children and adolescents
Prophylaxis (prevention)
For children, consult your doctor.
Malastad is not recommended as a prophylaxis against malaria infection in children or adults weighing less than 40 kg.
There may be another anti-malarial drug for children weighing less than 40 kg in your country.
Treatment of malaria
For children weighing more than 11 kg:
- 11 to 20 kg – 1 tablet daily for 3 days
- 21 to 30 kg – 2 tablets once daily for 3 days
- 31 to 40 kg – 3 tablets once daily for 3 days
- more than 40 kg – adult dosage.
Malastad is not recommended for the treatment of malaria in children weighing less than 11 kg.
For children weighing less than 11 kg talk to your doctor. There may be another anti-malarial drug for children weighing less than 11 kg in your country.
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 you experience any of these symptoms. Stop taking Malastad.
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: may affect more than 1 in 10 people:
- headache
- nausea and vomiting
- abdominal pain
- diarrhea.
Common side effects: may affect up to 1 in 10 people:
- dizziness
- sleep problems ( insomnia )
- strange dreams
- Depression
- loss of appetite
- fever
- rash
- itching
- cough
- allergic reactions.
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: may affect up to 1 in 100 people:
- anxiety
- palpitations experienced uncomfortable ( palpitation s )
- swelling and redness in the oral cavity
- red swollen spots on the skin ( hives )
- hair loss.
Uncommon side effects that can be detected by blood tests:
- elevated amylase values ( an enzyme produced in the pancreas ).
Has been reported (occurs in an unknown number of users)
- 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
- to see and hear things that do not exist ( hallucinations )
- nightmares
- sores in the oral cavity
- blisters
- scaly skin
- increased sensitivity of the skin to sunlight ( photosensitivity reactions ).
Other side effects that can be detected with blood tests:
- in people with severe kidney disease, decrease in all types of blood cells ( pancytopenia )
How to store Malastad
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 and blister. 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
The active substances are atovaquone and proguanil hydrochloride.
Each tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride.
Other ingredients are:
Tablet core:
Poloxamer 188, microcrystalline cellulose, hydroxypropyl cellulose, povidone K30, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate
Movie cover:
Hypromellose, titanium dioxide (dye E171), red iron oxide (dye E172), macrogol 400, polyethylene glycol 8000.
What the medicine looks like and contents of the pack
Malastad film-coated tablets are pink-brown to brown, round, biconvex with beveled edges, with “404” engraved on one side and “G” engraved on the other side.
Malastad is supplied in PVC / PVDC (clear) and hard PVC / PVDC-aluminum blisters containing 12 tablets.
Pack sizes: 12, 24, 36, 48, 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark