Skip to Content

NIVAQUINE 68MG/5ML SYRUP

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Interim Version - Not for Marketing

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Nivaquine 68 mg/ 5 ml Syrup
Chloroquine sulphate

Is this leaflet hard to see or read?
Phone 01483 505515 for help
sanofi-aventis
Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Nivaquine Syrup
carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice.
• 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.
In this leaflet:
1. What Nivaquine is and what it is used for
2. Before you take Nivaquine
3. How to take Nivaquine
4. Possible side effects
5. How to store Nivaquine
6. Further information
1. What Nivaquine is and what it is used for
Nivaquine Syrup (called Nivaquine in this leaflet) contains
a medicine called chloroquine sulphate. This belongs to a
group of medicines called anti-malarials. It works by
slowing down the growth and killing malaria parasites in
red blood cells.
Nivaquine is used to help stop you getting malaria. Only
take this medicine if you have been advised by a
healthcare professional that it is suitable for the country
and area that you are visiting.
2. Before you take Nivaquine
Do not take this medicine and tell your
doctor if:
! You are allergic (hypersensitive) to chloroquine or
similar medicines or any of the other ingredients of
Nivaquine (listed in Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
! You are pregnant (see Pregnancy and breast-feeding
below)
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Nivaquine.
Take special care with Nivaquine
Check with your doctor or pharmacist before taking
your medicine if:
▲ You have or have ever had fits (epilepsy)
▲ You have a rare illness called porphyria. This is
especially true if you also drink large quantities of
alcohol
▲ You have liver problems
▲ You have kidney problems
▲ You have severe stomach and bowel (gut) problems
▲ You have problems with your nervous system
▲ You have been told by a doctor that you have
problems with your blood
▲ You have psoriasis (itchy red, raised patches of skin
with silvery scales)
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking Nivaquine.
▲ 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
▲You have heart muscle disease (cardiomyopathy). This can
lead to heart failure with fatal outcome

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including
herbal medicines. This is because Nivaquine can affect
the way some other medicines work. Also some
medicines can affect the way Nivaquine works.
Nivaquine may increase the effect of the following
medicines:
• Ciclosporin - used to help stop rejection of transplants
• Digoxin - used for heart problems. If you feel sick, you
should tell your doctor straight away
• As Nivaquine causes decrease in sugar levels, decrease in
doses of insulin or antidiabetic drugs may be required.
Nivaquine can make the following medicines work
less well:
• Medicines for muscle weakness (myasthenia gravis)
such as neostigmine and pyridostigmine
• Medicines used to treat fits (epilepsy)
• Rabies vaccine - used to protect against rabies
• Agalsidase - used to treat a rare condition called Fabry's
disease
• Praziquantel - used to treat worm infections
The following medicines can make Nivaquine work less
well:
• Medicines for indigestion and heartburn (antacids)
that contain magnesium
• Kaolin - used to treat loose bowel motions
You should make sure that there is a 2 hour gap
between taking Nivaquine and taking these medicines.
The following medicines can increase the chance of
you getting side effects, when taken with Nivaquine:
• Mefloquine - used for malaria
• Cimetidine - used for excess stomach acid or stomach
ulcers
• Medicines for thinning the blood (anticoagulants) such
as warfarin
• Medicines which have an uneven heartbeat as a side
effect (such as amiodarone and moxifloxacin). Nivaquine can
increase the chance of this happening
Pregnancy and breast-feeding
Do not take this medicine and talk to your doctor if you
are pregnant, might become pregnant or think you may
be pregnant.
If you are breast-feeding or planning to breast-feed,
talk to your doctor or pharmacist before taking this
medicine.
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel dizzy or have blurred vision while taking
this medicine. If this happens, do not drive or use any
tools or machines. Also a rare side effect of taking this
medicine is fits (seizures and convulsions). If you suffer
from these you should not drive or use any tools or
machines.
Important information about some of the ingredients
of Nivaquine
This medicine contains:
• Sodium: This medicine contains 57 mg sodium per 30 ml
dose which should be taken into consideration by
people on a controlled sodium diet
• Sucrose: This medicine contains 20 g of sucrose per 30 ml
dose which should be taken into consideration if you
have diabetes
• Methyl parahydroxybenzoate and propyl
parahydroxybenzoate:
These may cause allergic reactions which may not
happen straight away. If you have been told by your
doctor that you cannot tolerate some preservatives
speak to them before taking Nivaquine
3. How to take Nivaquine
Always take Nivaquine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.

Reference: 94420 1.3.1.3 - Leaflet Text - PIL - 68mg/5ml - 2014-03-06 - CCDSv6 - annotated 0.3

Interim Version - Not for Marketing

Taking this medicine
• Take this medicine by mouth
• Take this medicine on the same day each week
• Start to take this medicine one week before you leave
for the area where malaria is present and continue
taking it for four weeks after you have left this area
How much to take
Adults and children 12 years and over
• Take a dose of 30 ml syrup once a week
Infants and children up to 12 years
• Give a dose of 0.5 ml per kilogram of the child’s body
weight once a week
• Please ask your doctor, nurse or pharmacist to work
out how much Nivaquine to give your child
If you take more Nivaquine than you should
If you take more Nivaquine than you should, tell a doctor
or go to a hospital casualty department straight away. Take
the medicine pack with you. This is so the doctor knows
what you have taken.
The following effects may happen: headache, drowsiness,
changes to your eyesight, feeling sick or being sick, shallow
breathing or being unable to breathe, unusual heartbeat
and possibly death.
If you forget to take Nivaquine
If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the
missed dose. Do not take a double dose to make up for a
forgotten dose.
If you forget to take a dose, you are more at risk of getting
malaria. Look out for signs of malaria on your return and
talk to your doctor immediately if you develop fever or flu
like illness within 12 months of returning from an area
with malaria.
If you stop taking Nivaquine
If you stop taking Nivaquine before the end of your course,
you are more at risk of getting malaria. Look out for signs
of malaria on your return and talk to your doctor
immediately if you develop fever or flu like illness within
12 months of returning from an area with malaria.
Tests that you will need if you are taking Nivaquine for
long time
• Blood tests: If you are taking Nivaquine for a long period of
time, your doctor may do regular blood tests.
This is to check the number of red blood cells in your blood
• Eye tests: Your doctor may do eye checks before starting
treatment and every 3-6 months while you are taking Nivaquine.
This is to check that your eyesight is normal. Nivaquine can have
a permanent effect on your
eyes if taken for a long period of time
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nivaquine can cause side effects, although not
everybody gets them.
Stop taking Nivaquine and see a doctor or go to a
hospital straight away if:
Common (affects 1 to 10 people in a 100 people)
• You have an allergic reaction. The signs may include:
red and lumpy skin rash, swollen eyelids, face, lips, mouth
or tongue, itching, difficulty breathing or swallowing
Rare (affects less than 1 in 1000 people)
• You have severe blistering rash where layers of the skin may
peel off to leave large areas of raw exposed skin over the body.
Also a feeling of being generally unwell, fever, chills and aching
muscles. These could be signs of a serious skin problem
Stop taking Nivaquine and see a doctor straight away if
you notice any of the following serious side effects - you
may need urgent medical treatment:
Common (affects 1 to 10 people in a 100 people)
• Fits (convulsions). These could be a sign of malaria in
the brain
Uncommon (affects 1 to 10 people in a 1,000)
• Uneven heartbeats with or without breathlessness, swollen feet,
ankles or legs and tiredness. These could be signs of your heart
not beating or working properly. It can further result in heart
failure and in some cases with fatal outcome during long term
therapy at high doses.
Rare (affects less than 1 in a 1000 people)
• You may get infections more easily than usual or feel tired, faint,
dizzy or have pale skin. These could be signs of a serious blood
problem

Frequency not known
• Problems controlling certain muscles of the body or you have
muscle spasms or ‘jerks’. The affected muscles may include your
tongue, mouth, jaw, arms and legs. The spasms may cause
unusual movements of the face, tongue, eyes, neck and affect
speech, expression and/or lead to unnatural positioning of the
head and shoulders
Tell your doctor as soon as possible if you have any of
the following side effects:
Very common (affects more than 1 in 10 people)
• Unable to sleep (insomnia)
Common (affects 1 to 10 people in a 100)
• Blurred vision that lasts longer than 48 hours. This
could lead to permanent damage to your eyes
• Feeling depressed (depression)
Uncommon (affects 1 to 10 people in a 1,000)
• Hearing problems and ringing in the ears
Rare (affects less than 1 in a 1000 people)
• Loss of eyesight during long term high dose treatment
• Feeling anxious or confused, being unable to concentrate or
seeing or hearing unusual sights and sounds
• Yellow colouring of the skin and whites of eyes (jaundice),
stomach pain or tenderness. These may be signs of problems
with your liver. Tests may reveal
changes in the way your liver is working
Frequency unknown
• Lowering of the blood glucose level (hypoglycaemia), frequency
unknown. You may feel a sense of nervousness, shaky or
sweaty.
• Changes in your eyesight including double vision, eye
colour changes, difficulty in focusing, changes to the
colours you see or worsening eyesight. In some cases,
blindness can happen
Tell your doctor or pharmacist if any of the following side
effects get serious or lasts longer than a few days:
Very Common (affects more than 1 in 10 people)
• Feeling sick or being sick, diarrhoea
• Headache
• Itching
• Tingling, burning or very sensitive skin, muscle
weakness, cramps or balance problems. These could be
signs of problems with your nerves or muscles
• Hair loss
• Darkening of the nails and mucus membranes (lips,
mouth, genitals, anus and inner lids of eyes) if Nivaquine
is taken for a long time
Rare (affects less than 1 in a 1000 people)
• Your psoriasis gets worse
Frequency unknown
• Thoughts of harming or killing yourself
• Stomach cramps
• Feeling dizzy, light-headed and faint. This could be due to low
blood pressure
• Skin that is itchy, lightens in colour or is more sensitive to
sunlight.
Talk to your doctor or pharmacist if any of the side effects
gets serious or lasts longer than a few days, or if you notice
any side effects not listed in this leaflet.

5. How to store Nivaquine
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Nivaquine after the expiry date which is
stated on the bottle after EXP. The expiry date refers to
the last day of that month.
Store below 25°C. Protect from light.
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. Further information
What Nivaquine contains
• Each 5 ml of syrup contains 68 mg of the active
substance, chloroquine sulphate. This is equivalent to
50 mg of chloroquine
• The other ingredients are sucrose, monosodium
glutamate, saccharin sodium, propylene glycol, methyl
parahydroxybenzoate, propyl parahydroxybenzoate ,
peppermint oil, pineapple flavour, caramel and
purified water
Reference: 94420 1.3.1.3 - Leaflet Text - PIL - 68mg/5ml - 2014-03-06 - CCDSv6 - annotated 0.3

What Nivaquine looks like and contents of the pack
Nivaquine is a straw coloured syrup. It comes in an
amber glass bottle containing 100 ml with a child
resistant cap.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi-aventis
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 01483 505515 ; Fax: 01483 535432
email: uk-medicalinformation@sanofi-aventis.com
Manufacturer
A Nattermann & Cie. GmbH, Nattermannallee 1
D-50829 Cologne, Germany.
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in March 2014
© Sanofi-aventis, 1981-2014

Reference: 94420 1.3.1.3 - Leaflet Text - PIL - 68mg/5ml - 2014-03-06 - CCDSv6 - annotated 0.3

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.

Hide