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AVLOCLOR 250 MG TABLETS

Active substance(s): CHLOROQUINE PHOSPHATE / CHLOROQUINE PHOSPHATE

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Artwork Information
Product Title:

Avloclor PIL

Date:

15-09-16

Product Size:

420mm x 297mm

Label Number:

16-121

Colours Used:

Black

Fonts Used:

Helvetica/ Helvetica condensed

Font size (min):

12pt, 14pt

Version:

4

Blue dotted and solid lines do not print

Hair
• Changes in hair colour.
• Hair loss.

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Avloclor Tablets look like and contents of
the pack
Avloclor Tablets are white and round. They have a
break line on one side and the letter ‘A’ either side of
the line. Avloclor Tablets come in packs of 20 tablets.

Eyes
• Blurred eyesight.
• Problems with your colour vision.
• Difficulty in focussing your eyes.
• Double vision.
If you are taking Avloclor for a long time, your doctor
may suggest that you have eye tests.

Marketing Authorisation Holder
and Manufacturer
The Marketing Authorisation for Avloclor Tablets is
held by Alliance Pharmaceuticals Limited,
Avonbridge House, Bath Road, Chippenham,
Wiltshire, SN15 2BB, UK.

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

Avloclor Tablets are manufactured by AndersonBrecon
(UK) Limited, Wye Valley Business Park, Brecon
Road, Hay-on-Wye, Hereford HR3 5PG UK.

Stomach and gut
• Stomach upsets, feeling sick (nausea), being sick
(vomiting), diarrhoea or stomach cramps.

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)

Other
• Weakening of your muscles (neuromyopathy and
myopathy).
• Lowering of the blood glucose level.

Please be ready to give the following information:
Product name
Avloclor Tablets
Reference number
16853/0143
This is a service provided by the Royal National
Institute of blind people.

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.

This leaflet was last revised in September 2016
© Alliance Pharmaceuticals Limited 2016
Avloclor, Alliance and associated Devices are
registered trade marks of Alliance Pharmaceuticals
Limited.

5. How to store Avloclor
• 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 take Avloclor after the expiry date stated
on the carton. The expiry date refers to the last
day of that month.

Avloclor ® 250 mg Tablets
chloroquine phosphate
• 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.

Signs of malaria
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 Avloclor is and what it is used for
2. What you need to know before you take Avloclor
3. How to take Avloclor
4. Possible side effects
5. How to store Avloclor
6. Contents of the pack and other information
1.

2. What you need to know before
you take Avloclor
Do not take Avloclor if:
• You are allergic to chloroquine phosphate or
any of the other ingredients of Avloclor (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.

What Avloclor is and what it is
used for

Avloclor contains a medicine called chloroquine
phosphate. This belongs to a group of medicines
called ‘anti-malarials’.
‘Anti-malarials’ can be taken in certain parts of the
world to help prevent malaria. This is a serious
disease spread by infected mosquitoes. Avloclor will
give some degree of protection (prophylaxis) against
malaria in certain countries.

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.
This is because Avloclor may cause severe
symptoms of porphyria, particularly if you
drink alcohol.
• 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.

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

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.

You must get medical advice on which
anti-malarial medicines to take. You must ask your
doctor or pharmacist if Avloclor is suitable for the part
of the world that you are visiting. In some countries
you may have to take Avloclor with another medicine
for maximum protection.

6. Contents of the pack and other
information
What Avloclor Tablets contain
• 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.

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.
4

XXXXX

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

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 Avloclor”).

• Cimetidine (used to treat stomach problems). This
medicine affects how Avloclor is broken down by
your body and may affect the amount of Avloclor
in your blood.
• Levothyroxine (thyroid medicine).
• Medicines like kaolin (used for diarrhoea) which
are called ‘adsorbents’.
• Antacid medicines (aluminium, calcium and
magnesium salts that are used to treat heartburn
or indigestion).

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.

Adsorbents and antacid medicines 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 these medicines at least
four hours before or after taking your Avloclor dose.

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

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 go into hospital, tell the medical staff that you
are taking Avloclor.
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 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.

Other medicines and Avloclor
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 take Avloclor,
• 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).

Breast-feeding
• If you are breast-feeding, talk to a doctor or
pharmacist before taking Avloclor.
• Although Avloclor 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.

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).

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

Also tell your doctor or pharmacist if you are taking
any of the following 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.
• Medicines used to treat epilepsy, as Avloclor may
reduce their effectiveness.
• Agalsidase (used to treat Fabry Disease), as
Avloclor may reduce its activity.

3. How to take Avloclor
Always take Avloclor exactly as described in this
leaflet or as your doctor or pharmacist has told you.
You should check with your doctor or pharmacist if
you are not sure.
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

See section 2, warnings and precautions (rare).
• Abnormal heart rhythm, life-threatening irregular
heart rhythm (seen on ECG). See section 2,
Warnings and precautions (frequency not known).
• Liver problems which may cause yellowing of your
skin or the whites of your eyes. If you are taking
Avloclor for a long time, your doctor may suggest
that you have blood tests to check how well your
liver is working (rare).
• 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.
• Convulsions or fits.
• Some or complete loss of eyesight.
• Changes to the retina of your eye (retinopathy) or
to the cornea. This can lead to ‘patchy’ eyesight.
• 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).
• A reduced number of blood cells. This can make
you bruise more easily, get serious infections,
have sudden bleeding or feel very tired or
breathless. If you are taking Avloclor for a long
time, your doctor may suggest that you have
blood tests.

Adults and children over 14 years
• Take two Avloclor tablets once a week on the
same day each week.
Elderly people
• If you are an elderly person your doctor may
suggest that you have blood tests. Your doctor
may also decide to give you a different dose.
Children
Do not give Avloclor to 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).
• Ages 5 to 8 years: Take one Avloclor tablet once
a week (on the same day each week).
• Ages 9 to 14 years: Take one and a half Avloclor
tablets once a week (on the same day each week).
How to take your tablets
• Take the tablet(s) after food.
• Swallow the tablet(s), or part tablets, whole with a
drink of water.
If you take more Avloclor tablets than you should
If you accidentally take more Avloclor tablets than
you should, tell a doctor straight away. The following
effects may happen: heart problems – leading to
uneven heart beats.
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.

Other possible side effects (frequency not known)
When Avloclor is used to prevent or suppress
malaria, these are generally not serious. If Avloclor is
used for a long time, they can be more serious.

Stopping Avloclor
Only stop taking Avloclor four weeks after leaving the
malaria area or if your doctor tells you to.

Heart
• Changes in the way your heart works (known as
‘electrocardiographic changes’).
• Low blood pressure. This may make you feel faint
or dizzy.

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

4. Possible side effects

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

Like all medicines, Avloclor can cause side effects,
although not everybody gets them.
Serious side effects
If you experience any of the following side effects,
stop taking Avloclor and get medical help or
contact your doctor straight away.
• Allergic reactions including difficulty breathing,
swelling of the face, lips, tongue or throat which
may cause difficulty in swallowing, and an itchy
rash (similar to nettle rash or hives)
• A severe rash with blisters or peeling of the skin
and possibly blisters in the mouth and nose.
• Seeing, feeling or hearing things that are not there
(hallucinations) (rare).
• Cardiac muscle disease (cardiomyopathy) which
may be fatal in case of high-dose long-term use.

Behaviour
• Insomnia.
• Mood changes or other effects on behaviour.
These include feeling depressed, confused or
anxious.
Skin
• Skin rash, including a scaly rash (psoriasis) or itch.
• Peeling skin.
• 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.
3

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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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