Daraprim 25 mg tablets – patient leaflet, side effects, dosage

1 What Daraprim is and what it is used for

Read all of this leaflet carefully before you start taking this medicine because it contains important

one end of the tablet through the foil layer.

Very common (may affect more than 1 in 10 people)

No studies on the effects on the ability to drive and use machines have been performed. Dizziness and seizures have been reported by patients taking Daraprim. If you experience these, caution should be exercised in driving and using machinery.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• To treat infections caused by Toxoplasma, the usual dose is based on body weight:

• you have ever had fits (seizures). Daraprim should always be given with a folic acid (vitamin)

  • decrease in the number of red blood cells (anaemia). You may feel tired or weak

Daraprim contains a medicine called pyrimethamine. This belongs to a group of medicines called

information for you.

• 2 mg/kg bodyweight (maximum of two tablets) on the first day

supplement.

• Keep this leaflet. You may need to read it again.

  antiprotozoals. They treat infections of the blood caused by parasites. Daraprim is used:

  • headache

Other medicines and Daraprim

• then 1 mg/kg bodyweight (maximum of one tablet) each day for the rest of the course. Children under 5 years should not take Daraprim.

• vomiting, feeling sick and diarrhoea

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular tell your doctor if you are taking any of the following medicines:

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

Toxoplasmosis

• rash

Daraprim contains lactose

• to treat infections, caused by a parasite called Toxoplasma, together with antibiotics called sulphonamides. These infections can affect the:

  Daraprim should always be given with another antibiotic, for example a sulphonamide, and a folic acid (vitamin) supplement.

Common (may affect less than 1 in 10 people but more than 1 in 100 people)

Daraprim contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before using this medicine.

• 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 take more Daraprim than you should

• decrease in the number of blood platelets (cells that help blood to clot). The blood may take longer to clot than normal. You may notice this if you have a nosebleed or cut yourself

5 How to store Daraprim

Adults and children over 6 years.

• trimethoprim or cotrimoxazole – used as antibiotics

  If you take more Daraprim than you should, talk to a doctor or go to hospital straight away. Take this medicine pack with you.

• brain (encephalitis) and other parts of the body if your immune system is poor. This can be due to AIDS

• To treat infections caused by Toxoplasma, the usual dose is:

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

  • Keep this medicine out of the sight and reach of children.
• proguanil or quinine sulfate – used for malaria/night cramps

Daraprim contains sodium

• four tablets each day for the first 1 or 2 days

• Do not use Daraprim after the ‘use by’ date which is stated on the pack. The date refers to the last day of the month.
• dizziness

If you forget to take Daraprim

Daraprim contains less than 1mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

• zidovudine – used to treat HIV infection/AIDS
• eyes, infection can lead to problems with your eyesight

• decrease in the number of white blood cells. This may affect your ability to fight infections
• If you forget to take a dose, take it as soon as you remember it.

• then one or two tablets each day for the rest of the course. In the unborn baby Daraprim may stop toxoplasmosis from the mother damaging the unborn baby.

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• medicines for cancer – such as methotrexate, daunorubicin, or cytosine
• unborn baby, when an infection is passed on from the mother during pregnancy.

In this leaflet:

• However, if it is time for the next dose, skip the missed dose.

  • Store these tablets below 30°C and inside the original packaging to protect them from light.

3 How to take Daraprim

Uncommon (may affect less than 1 in 100 people but more than 1 in 1000 people)

1 What Daraprim is and what it is used for

IMPORTANT

• lorazepam – used to help you sleep or relax

Ask your doctor if you need to have these conditions explained to you.

• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

GSK LOC is responsible to approve the change

2 What you need to know before you take Daraprim

• From week 13 of your pregnancy onwards, the usual dose is:

  • 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 protect the environment.
  • fever

• warfarin – used to thin your blood

• abnormal skin pigmentation Very Rare (may affect less than 1 in 10,000 people)

2 What you need to know before you take Daraprim

that it is accurate, consistent and complete.

3 How to take Daraprim

• two tablets, twice a day, for the first 2 days
• antacids – used for heart-burn or indigestion

4 Possible side effects

• Swallow your tablets with a glass of water.

4 Possible side effects

GSK SDC is responsible for site technical requirements and pre-press suitability.

• then two tablets each day for the rest of the course.

  Like all medicines, Daraprim can cause side effects, although not everybody gets them.

• medicines for diarrhoea which contain an ingredient called kaolin. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Daraprim. Pregnancy and breast-feeding

• decrease in the number of all types of blood cells. Symptoms can include: tiredness, weakness, rashes or bruising easily, pale skin, rapid heart rate, shortness of breath, bleeding problems such as bleeding of the gums or nosebleeds, infections

Do not take Daraprim:

5 How to store Daraprim

Taking out a tablet

GSK Market is responsible

• if you are allergic (hypersensitive) to pyrimethamine or any of the other ingredients of Daraprim (see Section 6: Contents of the pack & other information)

6 Contents of the pack & other information

These tablets come in special packaging to prevent children removing them.

• Daraprim may cause harm to the baby in the first 12 weeks of your pregnancy. A different medicine should be used until the 13^th week of pregnancy. Adults and adolescents who have a poor immune system or AIDS.

6 Contents of the pack and other information

to advise SDC when changes required impact the following:

If you have any of the following side effects or symptoms, talk to your doctor immediately:

Formulation

What Daraprim contains

Tablet embossing

1. 1.

   Separate one tablet: tear along

   the cutting lines to separate one “pocket” from the blister.

   • sore throat, an unexpected illness or skin reaction such as a rash or irritation or breathlessness.

     Storage conditions

     • The active substance is
2. •

   if you are a woman in the first trimester of pregnancy

   Do not take Daraprim if you are 12 weeks pregnant or less. It can harm your baby.

   • contractions of body muscles

     pyrimethamine. Each tablet contains 25 mg of the active substance.

     Shelf Life

   • sudden onset of high fever, rapid shallow breathing, chills and sweating

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3. •

   if you are a woman who is breast-feeding. Ask your doctor or midwife for advice.

   • To treat infections caused by Toxoplasma, the usual dose is based on body weight:

     • abnormal bruising, tiredness, weakness or dizziness

If you are more than 12 weeks pregnant, or might become pregnant, talk to your doctor before taking Daraprim.

• The other ingredients are lactose monohydrate, maize starch, hydrolysed starch, docusate sodium and magnesium stearate.

  NOTE TO MARKET Local approvers must ensure that trade mark and copyright statements included in the brief

These symptoms may mean that you are suffering from a drop in the number of your blood cells. This increases your risk of bleeding, bruising and makes you less able to fight infections. Your doctor will be able to confirm this by carrying out a blood test, and if necessary, will give you appropriate treatment. Daraprim may bring on fits (seizures) in patients who are prone to epilepsy. If you have epilepsy talk to your doctor or pharmacist before taking this medicine.

• abdominal pain
• if you are a child under 5 years of age.
• Less than 60 kg:
• mouth ulcers on the inside of the cheek

• eight tablets on the first day

  comply with guidance provided by Legal: Global Trade Marks.

• Peel back the outer layer:

Do not breast-feed if you are taking Daraprim. Ask your doctor or midwife for advice.

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Daraprim.

What Daraprim looks like and contents of the pack

starting at the corner, lift and peel over the pocket.

• then two tablets each day for the rest of the course.

  • red inflamed dry skin

If you have been prescribed Daraprim for toxoplasmosis please check the leaflet for the sulphonamide antibiotic you should also have been prescribed.

Daraprim tablets are white and round with the marking ‘GS A3A’. They are packaged in blister packs enclosed in a carton. Available in packs of 30 tablets.

• 60 kg or more:

Warnings and Precautions

• eight tablets on the first day

Talk to your doctor before taking Daraprim if:

• then three tablets each day for the rest of the course.

  Production Site:

  GSK_MISSISSAUGA_CANADA

• you have kidney or liver problems

  Specification Reference No: (Do NOT include version number)

  GSLFLT002

  N/A

  Component Dimensions:

  311.15 x 628.65mm

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Marketing Authorisation Holder: The Wellcome Foundation Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Manufacturer:

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom. Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only). Please be ready to give the following information:

Product name: Daraprim 25 mg tablets

Reference number: 00003/5026R This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in: August 2020.

Trade marks are owned by or licensed to the GSK group of companies ©2020 GSK group of companies or its licensor.

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IMPORTANT

GSK LOC is responsible to approve the change

that it is accurate, consistent and complete.

GSK SDC is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise SDC when changes required impact the following:

Formulation

Tablet embossing

Storage conditions

Shelf Life

AIP_Template_V_INDD - 04_2017 - Harmony - Version 2

NOTE TO MARKET Local approvers must ensure that trade mark and copyright statements included in the brief comply with guidance provided by Legal: Global Trade Marks.

Production Site:

GSK_MISSISSAUGA_CANADA

Specification Reference No: (Do NOT include version number)

GSLFLT002

DFT-02812-5634254

N/A

Component Dimensions:

311.15 x 628.65mm

DRAFT REGULATORY – for text and graphics regulatory submission