250 mg / 100 mg film-coated tablets 
atovaquone / proguanil hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Atovaquone / Proguanil Glenmark is and what it is used for 
2. What you need to know before you take Atovaquone / Proguanil Glenmark 
3. How to take Atovaquone / Proguanil Glenmark 
4. Possible side effects 
5. How Atovaquone / Proguanil Glenmark should be stored 
6. Contents of the packaging and other information 

1. What Atovaquone / Proguanil Glenmark is and what it is used for

Atovaquone / Proguanil Glenmark belongs to a group of medicines called antimalarial drugs. They contain two active ingredients, atovaquone, and proguanil hydrochloride.

Atovaquone / Proguanil Glenmark has two uses:

  • to prevent malaria in adults and children weighing more than 40 kg
  • to treat malaria in adults and children weighing more than 11 kg

Malaria is spread by the bite of an infected mosquito that transmits the malaria parasite (Plasmodium falciparum) to the bloodstream. Atovaquone / Proguanil Glenmark prevents malaria by killing this parasite. In people who are already infected with malaria, Atovaquone / Proguanil Glenmark also kills these parasites.

Protect yourself from getting malaria

People of all ages can get malaria. It is a serious disease, but it can be prevented. In addition to taking Atovaquone / Proguanil Glenmark, it is very important that you also avoid getting stung by mosquitoes.

  • Use insect repellent on exposed skin areas.
  • 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 that is impregnated with insect repellent.
  • Close windows and doors at sunset, if they are not equipped with mosquito nets.
  • Consider using insect repellent (substrate, spray, electric mosquito coil) to empty the room of insects or discourage mosquitoes from entering the room.

If you need further advice, talk to your doctor or pharmacist.

It is still possible to get malaria even though the necessary precautions have been taken. With some types of malaria infections, it takes a long time for symptoms to appear, so the disease may not be noticed until several days, weeks, or months after you have returned from abroad.

See a doctor immediately if you experience symptoms such as high fever, headache, chills, and fatigue after returning home.

Atovaquone / Proguanil Hydrochloride contained in Atovaquone / Proguanil Glenmark 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.

2. What you need to know before taking Atovaquone / Proguanil Glenmark

Do not take Atovaquone / Proguanil Glenmark

  • if you are allergic to atovaquone, Proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
  • to prevent malaria, if you have severe kidney disease

Warnings and cautions

In the prevention of malaria:

  • if you experience nausea (vomiting) within 1 hour of taking your Atovaquone / Proguanil Glenmark tablet, take a new dose immediately
  • it is important to take the full course of Atovaquone / Proguanil Glenmark. If you are forced to take extra tablets due to illness, you may need another prescription.
  • if you have vomiting, it is especially important to use extra protection, such as insect repellent and mosquito nets around the bed. Atovaquone / Proguanil Glenmark may not be as effective as the amount taken up will be less.

In the treatment of malaria:

  • If you have vomiting and diarrhea, tell your doctor, to get regular blood tests. Atovaquone / Proguanil Glenmark will not be as effective as the amount taken up will decrease. The tests show if the malaria parasite has disappeared from your blood.
  • If you have severe kidney disease, your doctor may choose to prescribe another medicine
  • if you get a certain type of infection during treatment with Atovaquone / Proguanil Glenmark, your doctor may prescribe a different type of medicine instead of Atovaquone / Proguanil Glenmark
  • if malaria is treated but then comes back repeatedly or if malaria is caused by a certain type of parasite, your doctor may prescribe another medicine to be taken with Atovaquone / Proguanil Glenmark

Other medicines and Atovaquone / Proguanil Glenmark

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Some medicines may affect the way Atovaquone / Proguanil Glenmark works, and Atovaquone / Proguanil Glenmark may increase or decrease the effect of other medicines taken at the same time. These include:

  • metoclopramide, which is used to treat nausea and vomiting
  • the antibiotics tetracycline, rifampicin, and rifabutin
  • efavirenz or some very active protease inhibitors (used to treat HIV )
  • indinavir, which is used to treat HIV
  • warfarin and other medicines that prevent blood clots
  • etoposide (used to treat cancer).

Tell your doctor if you are taking any of these medicines. Your doctor may decide that Atovaquone / Proguanil Glenmark is not suitable for you, or that you need extra checks while you are taking it.

Remember to tell your doctor if you start taking any other medicine while you are taking Atovaquone / Proguanil Glenmark.

Atovaquone / Proguanil Glenmark with food and drink

Take atovaquone/proguanil Glenmark with food or milk, when possible. It increases the amount of Atovaquone / Proguanil Glenmark that the body can absorb and makes the treatment more effective.

The tablets should preferably not be crushed.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, do not take Atovaquone / Proguanil Glenmark unless your doctor tells you to.

Ask your doctor or pharmacist for advice before taking Atovaquone / Proguanil Glenmark.

Do not breast-feed while taking Atovaquone / Proguanil Glenmark, as the ingredients in Atovaquone / Proguanil Glenmark may pass into breast milk and may harm your baby.

Driving and using machines

Do not drive if you feel dizzy. Atovaquone / Proguanil Glenmark causes some people to experience dizziness. If this happens to you, do not drive, use machines, or participate in activities where you may expose yourself or others to risks.

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.

How to take Atovaquone / Proguanil Glenmark

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Take Atovaquone / Proguanil Glenmark with food or milk whenever possible.

It is best to take Atovaquone / Proguanil Glenmark at the same time each day.

To prevent malaria

The usual dose for adults and adolescents weighing more than 40 kg is 1 tablet once a day, as shown below.

For children, talk to your doctor.

Atovaquone / Proguanil Glenmark is not recommended for the prevention of malaria in children or in adults or adolescents weighing less than 40 kg.

There may be another type of Atovaquone / Proguanil Glenmark tablets for children available in your country.

To prevent malaria in adults:

  • start taking Atovaquone / Proguanil Glenmark 1 to 2 days before traveling to an area where there is malaria
  •  continue to take it every day during your stay and then continue to take it for another 7 days after returning to a malaria-free area.
  • Take the entire course of Atovaquone / Proguanil Glenmark for maximum protection. Stopping earlier puts you at risk of getting malaria, as it takes 7 days to ensure that any parasites that may be in the blood after a sting from an infected mosquito are killed.

To treat malaria:

The usual dose for adults is 4 tablets once a day for 3 days.

For children weighing 11 kg or more:

  • From 11 to 20 kg: 1 tablet once a day for 3 days
  • From 21 to 30 kg: 2 tablets once a day for 3 days
  • From 31 to 40 kg: 3 tablets once a day for 3 days
  • over 40 kg – dose as for adults

Atovaquone / Proguanil Glenmark is not recommended for the treatment of malaria children weighing less than 11 kg.

For children weighing less than 11 kg, talk to your doctor. There may be another type of Atovaquone / Proguanil Glenmark tablets available in your country.

Consult a doctor or pharmacist. If possible, show them the package with Atovaquone / Proguanil Glenmark.

If you forget to take Atovaquone / Proguanil Glenmark

It is very important that you take the full course of Atovaquone / Proguanil Glenmark. If you forget to take a dose, you do not need to worry. Just take your next dose as soon as you remember. Then continue with the treatment as before. Do not take a double dose to make up for a missed dose.

Do not discontinue your treatment with Atovaquone / Proguanil Glenmark without the advice

Continue taking Atovaquone / Proguanil Glenmark for 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 make sure that all the parasites in the blood have died.

Talk to your doctor or pharmacist if you need any advice.

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

4. 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 small number of people, but their exact occurrence is unknown.

Severe allergic reactions – signs include:

  • rash and itching
  • sudden wheezing, pressure over the chest or throat, difficulty breathing
  • swollen eyelids, face, lips, tongue, or another part of the body

Contact a doctor immediately if you get any of these symptoms. Stop taking Atovakvon / Proguanil Glenmark.

Severe skin reactions:

  • rash, which can form blisters and look like small targets (dark center spots surrounded by a lighter area with a dark ring around the edge) (erythema multiforme)
  • widespread skin rash with blisters and flaky skin occurs especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ).

If you notice any of these symptoms, contact your doctor immediately.

Most of the other reported side effects have been mild and have not lasted that long.

Very common: affects more than 1 user in 10

  • headache
  • nausea (nausea and/or vomiting)
  • abdominal pain
  • diarrhea

Common: affects 1 to 10 people in 100

  • dizziness
  • sleep problems (insomnia)
  • strange dreams
  • Depression
  • loss of appetite
  • fever
  • rash
  • cough
  • allergic reactions
  • itching ( pruritus

Common side effects that can show up in blood tests are:

  • decreased number of red blood cells ( anemia ) that can cause fatigue, headaches, and shortness of breath
  • decreased number of white blood cells ( neutropenia ) which may increase the risk to suffer from infection s
  • low levels of sodium in the blood ( hyponatremia )
  • an increase in liver enzymes. 

Uncommon: affects 1 to 10 people in 1,000

These can affect up to 1 in 100 people:

  • anxiety
  • an unusual awareness of abnormal heartbeats (palpitations) 
  • swelling and redness in the mouth
  • red swollen spots on the skin ( hives )
  • hair loss

Uncommon side effects that may show up in blood tests:

  • an increase in amylase (an enzyme formed 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: Other side effects have occurred in a few individuals, but the exact occurrence is unknown.

  • inflammation of the liver ( hepatitis )
  • blockage of the bile ducts (cholestatic)
  • increased heart rate ( tachycardia )
  • inflammation of the blood vessels ( vasculitis ) which can be visible as red or purple raised dots on the skin, but can affect other parts of the body
  • seizures
  • panic attacks, crying
  • nightmares
  • severe mental problems where the person loses touch with reality and is unable to think and act clearly
  • cold sores
  • blisters
  • flaky skin
  • increased sun sensitivity of the skin
  • effects on the stomach (gastric intolerance)

Other side effects that may show up in blood tests:

  • reduction of all types of blood cells (pancytopenia)

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Atovaquon / Proguanil Glenmark

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 or 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.

6. Contents of the packaging 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:

Core

Poloxamer 188, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, povidone K30, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate

Dragging

Hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 400, macrogol 8000

What the medicine looks like and the contents of the pack

The Atovaquone / Proguanil Glenmark tablet is pinkish-brown to brown, round, film-coated with biconvex beveled edges and “404” embossed on one side and “G” embossed on the other side.

Atovaquone / Proguanil Glenmark is supplied in blister packs of PVC / PVDC (transparent) and hard-cured PVC / PVDC aluminum foil containing 12 tablets

Pack size: 12, 24, 36, 60

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

Glenmark Pharmaceuticals Europe Limited.

Building 2, Croxley Green Business Park Croxley Green, Hertfordshire, WD 18 8YA

UK

Glenmark Pharmaceuticals sro

Hvězdova 1716 / 2b, 140 78 Prague 4,

Czech Republic

Muhammad Nadeem

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