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PALUDRINE/AVLOCLOR ANTI-MALARIAL TRAVEL PACK

Active substance(s): CHLOROQUINE PHOSPHATE / PROGUANIL HYDROCHLORIDE / CHLOROQUINE PHOSPHATE / PROGUANIL HYDROCHLORIDE / CHLOROQUINE PHOSPHATE / PROGUANIL HYDROCHLORIDE

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Artwork Information
Product Title:

Travel Pack (Alliance) PIL

Date:

08-07-2016

Label Number:

16-122

Fonts Used:

Helvetica/ Helvetica condensed

Font size:

11pt 18pt

Version 3

Product Size:

420mm x 297mm

Colours Used:

Black.

Blue dotted and solid lines do not print
Edge code area

Area for text

household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. This will help to
protect the environment.

• Changes to the retina of your eye(s) leading to
‘patchy’ eyesight (retinopathy).
If you are using your Anti-malarial Travel Pack for a long
time, your doctor may suggest that you have eye tests.

6.

Ears
• Hearing loss.
• Ringing in the ears (tinnitus).

Paludrine tablets:
• The active substance in Paludrine tablets is proguanil
hydrochloride. Each tablet contains 100mg of proguanil
hydrochloride.
• The other ingredients are calcium carbonate, gelatin,
magnesium stearate (E572) and maize starch.

If you are using your Anti-malarial Travel Pack for a long
time, your doctor may suggest that you have blood tests.
Liver
• Liver problems which may cause yellowing of your skin or
the whites of your eyes.

Avloclor tablets:
• The active substance in Avloclor tablets is chloroquine
phosphate. Each tablet contains 250 mg of chloroquine
phosphate (equivalent to 155 mg of chloroquine base).
• The other ingredients are magnesium stearate (E572)
and maize starch.

If you are using your Anti-malarial Travel Pack for a long
time, your doctor may suggest that you have blood tests to
check how well your liver is working.
Stomach and gut
• Stomach upsets, feeling sick (nausea), being sick
(vomiting), diarrhoea, constipation, stomach cramps.

What Paludrine/Avloclor Anti-malarial Travel Pack looks
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.
Avloclor tablets are white and round. They have a break line
on one side and the letter ‘A’ either side of the line.
Paludrine/Avloclor Anti-malarial Travel Pack contains 112
tablets (98 Paludrine tablets and 14 Avloclor tablets).

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.
• Weakening of your muscles (neuromyopathy and
myopathy).
• A rash caused by the medicine associated with an
increase in the number of white blood cells (that may
show up in blood tests) and symptoms involving the
whole body. You may notice some or all of the following
symptoms: a skin rash and fever, swelling of the face,
tender generalized swollen or enlarged lymph nodes, or
other symptoms suggesting involvement of other body
organs including the liver, kidney or lung (such as
yellowing of the skin or eyes, urinary problems,
breathlessness).
• Lowering of the blood glucose level.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Paludrine/Avloclor
Anti-malarial Travel Pack is held by Alliance
Pharmaceuticals Limited, Avonbridge House, Bath Road,
Chippenham, Wiltshire, SN15 2BB, UK.
Paludrine/Avloclor Anti-malarial Travel Pack is manufactured
by AndersonBrecon (UK) Limited, Wye Valley Business
Park, Brecon Road, Hay-on-Wye, Hereford HR3 5PG UK

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)

Reporting of side effects
If you get any side effects, talk to your doctor 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.

Please be ready to give the following information:
Product name:

Paludrine/Avloclor
Anti-malarial Travel Pack

Reference number: 16853/0145

How to store your Anti-malarial Travel Pack

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

• Keep this medicine out of the sight and reach of
children. 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 use your Anti-malarial Travel Pack 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

4

XXXXX

Paludrine ® /Avloclor ® Anti-malarial Travel Pack
proguanil hydrochloride tablets (100 mg) and
chloroquine phosphate tablets (250 mg)

Contents of the pack and other information

What Paludrine/Avloclor Anti-malarial Travel Pack
contains
Paludrine/Avloclor Anti-malarial Travel Pack contains two
types of tablets, Paludrine tablets and Avloclor tablets.

Blood
• A reduced number of blood cells. This can lead to easy or
unexplained bruising, serious infections, sudden bleeding
or feeling very tired, weak or breathless.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Avoiding mosquito bites
When you are taking this medicine to prevent malaria, you
should also reduce the chances of being bitten by
mosquitoes.
• Wear light-coloured, long-sleeved clothing and long
trousers when you are outside after sunset.
• Use insect repellent creams or sprays on parts of your
body not covered by clothing.
• Sleep in a properly screened room or under a mosquito
net.
• Spray to kill any mosquitoes that may have entered
rooms in spite of screening.

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.

If you have a high temperature
No medicine can be guaranteed to protect against malaria in
every case. If you have a high temperature (fever) during
your visit to a malaria area, or up to a year after
returning home, you should suspect malaria. Contact a
doctor straight away and let him or her know that you have
visited a malaria area.

What is in this leaflet:
1. What Paludrine/Avloclor Anti-malarial Travel Pack is and
what it is used for
2. What you need to know before you use your Anti-malarial
Travel Pack
3. How to use your Anti-malarial Travel Pack
4. Possible side effects
5. How to store your Anti-malarial Travel Pack
6. Contents of the pack and other information
1.

2.

What Paludrine/Avloclor Anti-malarial
Travel Pack is and what it is used for

What you need to know before you
use your Anti-malarial Travel Pack

Do not use this Anti-malarial Travel Pack if:
• You are allergic to proguanil hydrochloride, chloroquine
phosphate or any of the other ingredients in the tablets
(see Section 6: Contents of the pack and other
information).
• You are taking a medicine called amiodarone (used to
control the heart rate). Avloclor may increase the risk of
uneven heart beats (cardiac arrhythmias) when it is taken
at the same time as amiodarone. Check with your doctor
or pharmacist if you are not sure.

The name of your medicine is ‘Paludrine/Avloclor
Anti-malarial Travel Pack’. It is referred to as ‘Anti-malarial
Travel Pack’ in the rest of this leaflet.
Your Anti-malarial Travel Pack contains two types of tablets:
• The Paludrine tablets contain a medicine called proguanil
hydrochloride.
• The Avloclor tablets contain a medicine called
chloroquine phosphate.

Warnings and precautions
Check with your doctor or pharmacist before taking your
medicine if:
• You have ever had epilepsy, convulsions or fits.
• You have ever had problems with your liver or kidneys.
• You have ever been told that you have a rare disease of
the blood pigment called ‘porphyria’ or anyone in your
family has it.
• You have a scaly condition of the skin called psoriasis.
• You have a muscle problem called ‘myasthenia gravis’.
Avloclor can increase the symptoms of this condition. It
can also reduce the effect of medicines used to treat this
condition (neostigmine and pyridostigmine).
• You have a blood problem called ‘glucose-6-phosphate
dehydrogenase deficiency’. Avloclor may damage blood
cells in people with this blood condition.

Both medicines belong to a group of medicines called
‘anti-malarials’.
‘Anti-malarials’ can be used in certain parts of the world to
help prevent malaria. This is a serious disease spread by
infected mosquitoes. Your Anti-malarial Travel Pack will give
some degree of protection (prophylaxis) against malaria in
certain countries. It can be used when it is necessary to take
more than one type of medicine at the same time to help
prevent malaria.
Medicines to help prevent malaria (malaria prophylaxis) are
recommended for:
• People travelling to countries where malaria occurs.
• People living in malaria areas who are not immune to
malaria.

This leaflet was last revised June 2016
© Alliance Pharmaceuticals Limited 2016

These people have little or no immunity to malaria, so they
are at risk of severe attacks.

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before using your Anti-malarial
Travel Pack.

Paludrine, Avloclor, Alliance and associated devices are
registered trademarks of Alliance Pharmaceuticals Limited

You must get medical advice on which anti-malarial
medicines to take. You must ask your doctor or pharmacist
if this Anti-malarial Travel Pack is suitable for the part of the
world that you are visiting.

Chloroquine can cause lowering of the blood glucose level.
Please ask your doctor to inform you of signs and symptoms
of low blood glucose levels. A check of the blood glucose
level may be necessary.

1

body and may affect the amount of Avloclor in your blood.
• Medicines like kaolin (used for diarrhoea) which are called
‘adsorbents’.
• Antacids (aluminium, calcium and magnesium salts that
are used to treat heartburn or indigestion).

Chloroquine may cause heart rhythm disorders in some
patients: caution should be taken when using chloroquine,
if you were born with or have family history of prolonged
QT interval, if you have acquired QT prolongation (seen
on ECG, electrical recording of the heart), if you have
heart disorders or have a history of heart attack
(myocardial infarction), if you have salt imbalance in the
blood (especially low level of potassium or magnesium,
see section “Other medicines and your Anti-malarial Travel
Pack”).

Antacids may reduce the amount of Avloclor absorbed from
your gut. This may mean that the full dose of Avloclor is not
absorbed into your body and it will not work properly.
Therefore, you should take your antacid dose at least four
hours before or after taking your Avloclor dose.
Some medicines (for example, ciprofloxacin, cimetidine,
omeprazole, pyrimethamine) may increase the amount of
Avloclor in your body and this can cause side effects. It is
important that you do not take any additional medicines
(either prescribed or non-prescribed) before speaking to
your doctor.

If you experience palpitations or irregular heart beat during
the period of treatment, you should inform your doctor
immediately. The risk of heart problems may increase with
increase of the dose. Therefore, the recommended dosage
should be followed.
If you go into hospital, tell the medical staff that you are
taking both Paludrine and Avloclor.

If you need a vaccination against rabies, make sure you
have it before you start your anti-malarial medicine. If you
have your rabies injection at the same time as taking your
anti-malarial medicine, your rabies vaccine might not work
so well.

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.

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.

Other medicines and your Anti-malarial Travel Pack
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.

Pregnancy
If you are pregnant or may become pregnant, talk to a
doctor or pharmacist:
• before you use this Anti-malarial Travel Pack,
• before you take any medicine to prevent malaria,
• and before you go to a country where there is malaria.

Amiodarone (used to control heart rate) must not be taken at
the same time as Avloclor (see section 2: What you need to
know before you take Avloclor).
Tell your doctor or pharmacist if you are taking any of the
following medicines. This is because Avloclor may affect the
amount of these medicines in your blood.
• Praziquantel (used to treat infections of the bowel and
bladder caused by parasites).
• Ciclosporin (mainly used by transplant patients but also
used to treat rheumatoid arthritis and psoriasis).
• Anti-convulsant medicines (used to prevent convulsions
or fits).
• Digoxin (used to treat heart problems).

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 using your Anti-malarial Travel Pack.
• Although Paludrine and Avloclor pass 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.

Also 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.
• Medicines known to affect the rhythm of your heart. This
includes medicines used for abnormal heart rhythm
(antiarrhythmics), for depression (tricyclic antidepressants)
for psychiatric disorders (antipsychotics), for bacterial
infections or against malaria (e.g. halofantrine).
• Mefloquine, taken to prevent malaria may increase the
risk of convulsions or fits when taken at the same time as
Avloclor.
• Levothyroxine (thyroid medicine).
• Medicines used to treat epilepsy, as Avloclor may reduce
their effectiveness.
• Agalsidase (used to treat Fabry Disease), as Avloclor
may reduce its activity.
• 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.
• Cimetidine (used to treat stomach problems). This
medicine affects how Avloclor is broken down by your

Driving and using machines
Sometimes Avloclor tablets cause blurred eyesight or make
it difficult to focus your eyes. If this happens to you, do not
drive or use any tools or machines.
3.

How to use your Anti-malarial Travel Pack

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

2

4.

Adults and children over 14 years
• Take two Avloclor tablets once a week on the same day
each week.
• And take two Paludrine tablets daily, at the same time
each day.
Two tablets
weekly

Possible side effects

Like all medicines, your Anti-malarial Travel Pack can
cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, stop using your Antimalarial Travel Pack 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).

Two tablets
Daily

Other possible side effects
Heart
• Changes in the way your heart works (known as
‘electrocardiographic changes’).
• Low blood pressure. This may make you feel faint or dizzy.
• Cardiac muscle disease (cardiomyopathy) which may be
fatal in case of high-dose long-term use (rare). See
section 2, Warnings and precautions.
• Abnormal heart rhythm, life-threatening irregular heart
rhythm (seen on ECG). See section 2, Warnings and
precautions.

Children
Do not use this Anti-malarial Travel Pack in children under 1
year of age. For children over 1 year of age, the dose
depends on the child’s age.
• Ages 1 to 4 years: Take half an Avloclor tablet once a
week (on the same day each week) and take half a
Paludrine tablet daily (at the same time each day).
• Ages 5 to 8 years: Take one Avloclor tablet once a week
(on the same day each week) and take one Paludrine
tablet daily (at the same time each day).
• Ages 9 to 14 years: Take one and a half Avloclor tablets
once a week (on the same day each week) and take one
and a half Paludrine tablets daily (at the same time each
day).

Lungs
• Inflammation of the lungs causing a condition known as
diffuse parenchymal lung disease.
If you develop serious breathlessness or worsening of
breathlessness seek prompt medical advice.
Mouth
• Mouth ulcers.
• Inflamed mouth.

How to take your tablets
• 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.

Nervous system
• Headache.
• Feeling dizzy or light-headed.
• Convulsions or fits.
• Involuntary muscle movements or spasms.

If you take more Paludrine or Avloclor tablets than you
should
If you accidentally take more Paludrine or Avloclor tablets
than you should, tell a doctor straight away. Show any
left-over medicines or the empty packet to the doctor. The
following effects may happen if you take more Avloclor
tablets than you should: heart problems – leading to uneven
heart beats.

Behaviour
• Insomnia.
• Mood changes or other effects on behaviour. These include
feeling: depressed, confused, anxious, or rarely, seeing,
feeling or hearing things that are not there (hallucinations).
Skin
• Skin rash, including a scaly rash (psoriasis) or itch, which
sometimes causes swelling of the affected area.
• Peeling or scaly skin.
• A severe rash with blisters or peeling of the skin and
possibly blisters in the mouth and nose.
• Discolouration of the skin or mucous membranes (such
as the inside of your mouth).
• Being sensitive to sun light which may require medical
treatment.
• The appearance of small fluid filled bumps on the skin.

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 forget to take your Avloclor tablets
• If you forget to take a dose of Avloclor, take it as
soon as you remember.
• Then wait for 7 days before you take the next dose
of Avloclor.
• Carry on taking your Avloclor tablets each week, on
this new day of the week.

Hair
• Changes in hair colour.
• Hair loss (sometimes reversible).

Stopping your Anti-malarial Travel Pack
Only stop using your Anti-malarial Travel Pack 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.

Eyes
• Blurred eyesight.
• Some or complete loss of eyesight.
• Problems with your colour vision.
• Difficulty in focussing your eyes.
• Double vision.

3

Expand Transcript

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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