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PALUDRINE 100MG TABLETS

Active substance(s): PROGUANIL HYDROCHLORIDE / PROGUANIL HYDROCHLORIDE

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Artwork Information
Product Title:

Paludrine 100mg tabs leaflet

Date:

18-05-15

Label Number:

15-073

Fonts Used:

N. Helvetica, N. Helvetica bold

Font size:

10.5pt

Version 5

Product Size:

340mm x 296mm

Colours Used:

Black

Other
• High temperature (fever).
• Inflammation of blood vessels, which can cause tiredness, weakness, loss of appetite,
rash, ulcers, blood shot eyes, pain in the joints, breathlessness and weight loss.
Do not be concerned by this list of possible side effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the internet at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store Paludrine







Keep your medicine in a safe place where children cannot see or reach it. Your
medicine could harm them.
Do not store your medicine above 30oC.
Protect the tablets from light and moisture.
Keep the tablets in the container they came in.
Do not take Paludrine after the expiry date stated on the carton. The expiry date
refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are no longer required. This will help to
protect the environment.

6. Contents of the pack and other information
What Paludrine Tablets contain
• The active substance in Paludrine Tablets is proguanil hydrochloride. Each tablet
contains 100 mg of proguanil hydrochloride.
• The other ingredients are calcium carbonate, gelatin, magnesium stearate (E572)
and maize starch.
What Paludrine Tablets look like and contents of the pack
Paludrine Tablets are white and round. They have a break line on one side with the letter
‘P’ either side of the line. Paludrine Tablets come in packs of 98 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Paludrine Tablets is held by Alliance Pharmaceuticals
Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.
Paludrine Tablets are manufactured by AndersonBrecon (UK) Limited, Wye Valley
Business Park, Brecon Road, Hay-on-Wye, Hereford HR3 5PG UK.

16853/0144
This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised March 2015
© Alliance Pharmaceuticals Limited 2015
Paludrine, Alliance and Devices are registered trademarks of Alliance Pharmaceuticals Limited

XXXXX

Paludrine®
100 mg tablets
proguanil hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, or
pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
What is in this leaflet:
1. What Paludrine is and what it is used for
2. What you need to know before you take Paludrine
3. How to take Paludrine
4. Possible side effects
5. How to store Paludrine
6. Contents of the pack and other information

2. What you need to know before you take Paludrine
Do not take Paludrine if:
• You are allergic (hypersensitive) to proguanil hydrochloride or any of the other
ingredients of this medicine (see Section 6: Contents of the pack and other information).
Warnings and precautions
Check with your doctor or pharmacist before taking your medicine if:
• You have ever had problems with your kidneys. This is because your doctor may
give you a lower dose of Paludrine.
If you live in a country where malaria occurs, you may already be slightly immune to the
disease. You must ask a doctor or pharmacist for advice before you take anti-malarial
medicines.
Other medicines and Paludrine
Please tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines that you buy without a prescription and
herbal medicines.

Adults and children over 14 years
• Take two tablets daily.
Children
• Under 1 year (including babies who are being breast-fed): Take a quarter of a
Paludrine tablet daily.
• Ages 1 to 4 years: Take half a Paludrine tablet daily.
• Ages 5 to 8 years: Take one Paludrine tablet daily.
• Ages 9 to 14 years: Take one and a half Paludrine tablets daily.
How to take your tablets
• Take the tablet(s) at the same time each day.
• Take the tablet(s) after food.
• Swallow the tablet(s), or part tablets, whole with a drink of water.
• For a young child, the tablet(s) may be given crushed in milk, honey or jam.
If you take more Paludrine tablets than you should
If you take more Paludrine tablets than you should, talk to a doctor or go to a hospital
straight away. Show any left-over medicines or the empty packet to the doctor.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Warfarin or other medicines used to prevent blood clots. Paludrine may increase the
effect of these medicines.
• Antacids (aluminium, calcium and magnesium salts that are used to treat heartburn
or indigestion). Antacids may reduce the amount of Paludrine absorbed from your
gut. This may mean that the full dose of Paludrine is not absorbed into your body
and it will not work properly. Therefore, you should take your antacid dose at least
two hours before or after taking your Paludrine dose.
• Boosted protease-inhibitors (medicines used in the treatment of viral infections, such
as HIV/AIDS), as these may alter the levels of Paludrine in your body.

If you forget to take your Paludrine tablets
• If you forget to take a dose of Paludrine, take it as soon as you remember. However,
if it is nearly time for the next dose of Paludrine, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you know you are to have a live oral typhoid vaccination, you must tell your doctor
beforehand as your treatment with Paludrine might need to be adjusted.

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

Pregnancy
If you are pregnant or may become pregnant, talk to a doctor or pharmacist:
• before you take Paludrine,
• before you take any medicine to prevent malaria,
• and before you go to a country where there is malaria.

Allergic reactions
If you have an allergic reaction, stop taking Paludrine and get medical help or
contact your doctor straight away. The signs may include:
• Difficulty in breathing.
• Swelling of the face, lips, tongue or throat which may cause difficulty in swallowing.
• An itchy rash (similar to nettle rash or hives).

Paludrine can affect the levels of folic acid in the body, therefore pregnant women taking
Paludrine should be given supplements that contain folic acid.
Breast-feeding
• If you are breast-feeding, talk to a doctor or pharmacist before taking Paludrine.
• Although Paludrine passes into the breast milk, the amount is not enough to protect
your baby from malaria. Therefore, your baby will still need to be given anti-malarial
medicines. Ask your doctor or pharmacist who will be able to give you advice.
Driving and using machines
Paludrine is not likely to affect you being able to drive or use any tools or machines.

3. How to take Paludrine
If this medicine is from your doctor or pharmacist, take it exactly as they have told you.
Otherwise, follow the instructions below. If you do not understand the instructions, or you
are not sure, ask your doctor or pharmacist.
When to start taking your medicine
• Start taking this medicine one week before you enter the malaria area. If this is not
possible, start taking this medicine at least two days before you enter the malaria area.




You must continue to take it during your stay.
You must keep taking this medicine for 4 weeks after leaving the malaria area.

Stopping Paludrine
Only stop taking Paludrine four weeks after leaving the malaria area or if your doctor tells
you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Other possible side effects
Stomach and gut
• Stomach upsets, diarrhoea, constipation. These usually improve as treatment continues.
Mouth
• Mouth ulcers.
• Inflamed mouth.
Skin
• Skin reactions, including itching, peeling and rash, sometimes with swelling of the
affected area.
Hair
• Hair loss (sometimes reversible).
Blood
• If you have kidney problems, Paludrine may cause changes to your blood.
• A reduced number of blood cells. This can lead to easy or unexplained bruising,
bleeding, serious infections, or feeling very tired, weak or breathless.
Liver
• Liver problems which may cause yellowing of your skin or the whites of your eyes.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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