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Pil 2306

Malarivon Syrup is an oral solution containing chloroquine phosphate, used for the prevention and treatment of malaria. It is important to follow dosage instructions based on age and to be aware of potential interactions with other medications and side effects, including serious allergic reactions and mental health issues. Patients should consult their doctor before use, especially if they have underlying health conditions or are pregnant or breastfeeding.

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0% found this document useful (0 votes)
35 views2 pages

Pil 2306

Malarivon Syrup is an oral solution containing chloroquine phosphate, used for the prevention and treatment of malaria. It is important to follow dosage instructions based on age and to be aware of potential interactions with other medications and side effects, including serious allergic reactions and mental health issues. Patients should consult their doctor before use, especially if they have underlying health conditions or are pregnant or breastfeeding.

Uploaded by

RanganathBabu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Malarivon Syrup 50mg in 5ml (as base) Oral Solution

H0090-4
Chloroquine Phosphate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Š Keep this leaflet. You may need to read it again
Š If you have any further questions, ask your doctor or pharmacist
Š 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 or
risk of contracting malaria are the same as yours
Š 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.

In this leaflet Also tell your doctor or pharmacist if you are taking
1. What is Malarivon Syrup and what is it used for? any of the following medicines:
2. What you need to know before you use Malarivon Š Treatments for irregular heart beat
Syrup? Š Medicines which may cause irregular heart beat as
3. How to use Malarivon Syrup? a side effects such as moxifloxacin and droperidol
4. Possible side effects? Š Other medicines used to prevent malaria, such as
5. How to store Malarivon Syrup? mefloquine. There is a risk of convulsions or fits
6. Contents of the pack and other information. when these medicines are taken at the same time
as Malarivon Syrup
1. What is Malarivon Syrup and what is it used for? Š Medicines that may prevent the kidneys from
Malarivon Syrup contains chloroquine phosphate and clearing chloroquine from the blood at the normal
belongs to a group of medicines called ‘anti-malarials’. rate and as a consequence can cause an overdose.
It acts on the malarial parasite in the blood stream, and The main examples are ciprofloxacin (an antibiotic),
may prevent, suppress or treat the disease depending cimetidine and omeprazole (used to treat excess
upon the strain of parasite contracted and the stomach acid), and pyrimethamine (used to treat
progression of the disease. protozoal infections including malaria)
You must get medical advice on which anti-malarial Š Medicines like kaolin (used for diarrhoea) which are
medicine to take. called ‘adsorbents’
When travelling to an area where there is a risk of Š Antacid medicines (aluminium, calcium and
contracting malaria always consult official guidelines magnesium salts that are used to treat heartburn or
and local information before deciding on which indigestion).
preventative treatment to take. No treatment to Antacids and adsorbents used to treat heartburn
prevent malaria is 100% effective. or indigestion can interfere with the absorption of
2. What you need to know before you use chloroquine so they should not be taken within four
Malarivon Syrup? hours before or after taking Malarivon Syrup.
Do not use: Malarivon Syrup can make the symptoms of
Š If you are allergic (hypersensitive) to chloroquine ‘myasthenia gravis’ (which causes muscle weakness)
phosphate or any of the ingredients listed in more severe and as a consequence reduce the
section 6 of this leaflet effectiveness of drugs such as neostigmine and
Š If you are taking a medicine called amiodarone pyridostigmine used to treat the condition.
(used to control the heart rate). Malarivon Syrup When Malarivon Syrup is taken at the same time
may increase the risk of uneven heart beats (cardiac as rabies vaccination it may affect the protection
arrhythmias) when it is taken at the same time as provided by the vaccine.
amiodarone. Malarivon Syrup inactivates oral typhoid vaccine, so
Warnings and precautions the vaccine should be taken at least three days before
Talk to your doctor or pharmacist before taking starting a course of Malarivon Syrup.
Malarivon Syrup if: Pregnancy and breast-feeding?
Š You have any disease of the liver If you are pregnant or breast-feeding, think you may
Š You suffer from any blood disorders (including be pregnant or are planning to have a baby, ask your
porphyria, an inherited disease resulting in doctor or pharmacist for advice before taking this
abnormalities in the normal production of healthy medicine.
blood) There are risks to both the mother and the foetus
Š You suffer from kidney problems associated with travelling to countries with malaria
Š You suffer from epilepsy, convulsions or diseases of when pregnant. Always consult a doctor or pharmacist
the nervous system before travelling.
Š You suffer from psoriasis (a skin condition) Breast feeding while taking Malarivon Syrup is safe but
Š You suffer from a severe disease of the digestive the small amount of the active ingredient expressed
system in the milk is not enough to protect the infant from
Š You have an inherited condition of glucose-6 malaria. Therefore, your baby will still need to be given
phosphate dehydrogenase deficiency such as anti-malarial medicines. Ask your doctor or pharmacist
favism. who will be able to give you advice.
Some people being treated with Malarivon Syrup Driving and using machines
can experience mental health problems such as When starting treatment with Malarivon Syrup it is
irrational thoughts, hallucinations, feeling confused, possible that you may have blurred or double vision
aggressiveness, paranoia, feeling depressed or have which will make driving and operating machinery
thoughts of self-harm or suicide, even those who have unsafe. If you experience such effects then do not drive
never had similar problems before. If you or others or operate machinery.
around you notice any of these side effects (see section Important information about some of the
4) seek medical advice straight away. ingredients in Malarivon Syrup
Long term treatment with Malarivon Syrup should In addition to the active ingredient, some of the
be under medical supervision and your doctor will other ingredients in Malarivon Syrup may affect some
monitor your eyesight and perform blood tests for you. individuals:
If you experience any visual disturbances other than a Š Malarivon Syrup contains 2.2g of sucrose in 5ml
temporary inability to focus at the start of treatment (13.2g in 30ml); which should be taken into account
then stop taking the medicine immediately and seek in patients with diabetes mellitus
the advice of your doctor. Š Para-hydroxybenzoates may cause allergic
Taking Malarivon Syrup can result in severe reductions reactions (possibly delayed)
of blood sugar levels. In extreme cases this may result Š The colouring ponceau 4R (E124) may cause
in loss of consciousness. If you notice symptoms allergic reactions.
that may be related to low blood sugar levels Š This medicine contains 695mg propylene glycol in
such as shakiness, heart palpitations, poor muscle each 5ml. If your child or baby is less than 5 years
coordination, pins & needles, slurred speech, dizziness old, talk to your doctor or pharmacist before giving
and/or light headedness then consult your doctor. them this medicine, particularly if they use other
Other medicines and Malarivon Syrup? medicines that contain propylene glycol or alcohol.
Tell your doctor or pharmacist if you are taking, have If you are pregnant or breast-feeding, or if you
recently taken or might take any other medicines. suffer from a liver or kidney disease, do not take
Tell your doctor or pharmacist if you are taking any this medicine unless recommended by your doctor.
of the following medicines. This is because Malarivon Your doctor may carry out extra checks while you
Syrup may affect the amount of these medicines in are taking this medicine.
your blood: 3. How to use Malarivon Syrup?
Š Praziquantel (used to treat infections of the bowel Always use this medicine exactly as described in
and bladder caused by parasites) this leaflet or as your doctor or pharmacist has told
Š Ciclosporin (mainly used by transplant patients you. Check with your doctor or pharmacist if you are
but also used to treat rheumatoid arthritis and not sure. Read these instructions carefully because
psoriasis) the dose depends both on age and the reason for
Š Anti-convulsant medicines (used to treat epilepsy treatment.
to prevent convulsions or fits) Table 1
Š Digoxin (used to treat heart problems). Age Group Dose
Š Azithromycin, clarithromycin, or erythromycin Children up to 1 year 2.5ml to 5.0ml
(antibiotics used for treating infections). Taking 1 to 3 years 7.5ml to 10ml
these medicines at the same time as chloroquine 3 to 6 years 10ml to 15ml
may increase the chance of you getting side effects 6 to 9 years 15ml to 22.5ml
that affect your heart. 9 to 12 years 22.5ml to 30ml
Over 12 years including adults 30ml
and sounds
In the following directions, unless you have been told Š Yellow colouring of the skin and whites of eyes
by a doctor that you are partially immune to malaria, (jaundice), stomach pain or tenderness. These may
assume that you are non-immune and select the be signs of problems with your liver. Tests may
appropriate dose. reveal changes in the way your liver is working
Š Your psoriasis gets worse.
Suppression or prevention of malaria in Frequency unknown:
non-immune users Š Lowering of the blood glucose level
Take one dose a week as shown in Table 1. Begin two (hypoglycaemia), frequency unknown. You may
weeks before entering the malaria area and continue feel a sense of nervousness, shaky or sweaty.
for four weeks after leaving the malaria area. Changes in your eyesight including double vision,
eye colour changes, difficulty in focusing, changes
Suppression or prevention of malaria in partially to the colours you see or worsening eyesight. In
immune users some cases, blindness can happen
Once every two weeks take half the dose shown in Š Stomach cramps
Table 1. This will afford a high degree of protection Š Feeling dizzy, light-headed and faint. This could be
against non-resistant malaria. due to low blood pressure
Š Skin that is itchy, lightens in colour or is more
Treatment of malaria in non-immune users sensitive to sunlight.
Firstly take twice the dose in Table 1. Then, six hours Š Feeling depressed or having thoughts of self-harm
later, take the dose as stated in Table 1. Then, for the or suicide, feeling anxious, feeling confused, having
next two days, take the dose as stated in Table 1. irrational thoughts, paranoia, aggressiveness, sleep
disorders, agitation, feeling elated or overexcited,
Treatment of malaria in partially immune users lack of concentration.
Once only, take twice the dose in Table 1. Reporting of side effects.
If you get any side effects, talk to your doctor,
If you take more Malarivon Syrup than you should pharmacist or nurse. This includes any possible side
If you have taken a possible overdose then you should effects not listed in the package leaflet. You can report
seek medical advice immediately. If possible you side effects directly via the Yellow Card Scheme at
should take any remaining medicine, packaging and www.mhra.gov.uk/yellowcard or search for MHRA Yellow
this leaflet with you provided it doesn’t cause a delay. Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
If you forget to take Malarivon Syrup information on the safety of this medicine.
Do not take a double dose to make up for a forgotten
dose. If a dose is missed then resume the treatment 5. How to store Malarivon Syrup?
immediately. If the product was being taken for Keep this medicine out of the sight and reach of
prevention of Malaria then be especially alert for any children. Do not use this medicine after the expiry date
flu like symptoms in the months following and report which is stated on the bottle.
them immediately to your doctor. Store below 30°C. Protect from light.
4. Possible side effects? Do not throw away any medicines via wastewater or
Like all medicines, this medicine can cause side effects, household waste. Ask your pharmacist how to throw
although not everybody gets them. away medicines you no longer use. These measures
will help protect the environment.
Stop taking Malarivon Syrup and see a doctor or
go to a hospital straight away if you notice any of 6. Contents of the pack and other information.
the following serious side effects – you may need What Malarivon Syrup contains:
urgent medical treatment: The active substance is chloroquine phosphate.
Common (affects 1 to 10 people in a 100 people): Each 5ml of the syrup contains 80mg of chloroquine
Š You have an allergic reaction. The signs may phosphate which is equivalent to 50mg of chloroquine
include: red and lumpy skin rash, swollen eyelids, base. The other ingredients are sucrose, methyl, ethyl,
face, lips, mouth or tongue, itching, difficulty propyl and butyl parahydroxybenzoates, propylene
breathing or swallowing glycol, buttermint toffee essence, sodium saccharin,
glycerol, ponceau 4R (E124) and purified water.
Š Fits (convulsions). These could be a sign of malaria
in the brain. What Malarivon Syrup looks like and
contents of the pack:
Uncommon (affects 1 to 10 people in a 1,000):
Malarivon Syrup is a clear red syrup supplied in glass
Š Uneven heartbeats with or without breathlessness, bottles of 75ml.
swollen feet, ankles or legs and tiredness. These
could be signs of your heart not beating or working Marketing Authorisation Holder and Manufacturer:
properly. It can further result in heart failure and The marketing authorisation owner is:
in some cases with fatal outcome during long term Wallace Manufacturing Chemists Ltd.,
therapy at high doses. 51-53 Stert Street, Abingdon,
Rare (affects less than 1 in 1000 people): Oxfordshire OX14 3JF, UK.
Š You have severe blistering rash where layers of The manufacturer is:
the skin may peel off to leave large areas of raw Laleham Health and Beauty Ltd.,
exposed skin over the body Bradshaw Lane, Greenhalgh,
Š Also a feeling of being generally unwell, fever, Kirkham, Lancashire PR4 3JA, UK.
chills and aching muscles. These could be signs of a
serious skin problem
Š You may get infections more easily than usual or This leaflet was last revised in December 2021
feel tired, faint, dizzy or have pale skin. These could
be signs of a serious blood problem.
Frequency not known:
PL00400/0005R
Š 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:
Š Very Common (affects more than 1 in 10 people):
Š Feeling sick or being sick, diarrhoea
Š Headache
Š Itching
Š Tingling, burning or very sensitive skin, muscle
weakness, cramps or balance problems. These
could be signs of problems with your nerves or
muscles
Š Hair loss
Š Darkening of the nails and mucus membranes
(lips, mouth, genitals, anus and inner lids of eyes) if
Malarivon is taken for a long time.
Š Unable to sleep (insomnia).
Common (affects 1 to 10 people in a 100):
Š Blurred vision that lasts longer than 48 hours. This
could lead to permanent damage to your eyes
Š Feeling depressed (depression).
Uncommon (affects 1 to 10 people in a 1,000):
Š Hearing problems and ringing in the ears.
Rare (affects less than 1 in a 1000 people):
Š Loss of eyesight during long term high dose
treatment
Š Feeling anxious or confused, being unable to
concentrate or seeing or hearing unusual sights

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