Malarivon 80mg/5ml syrup

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloroquine phosphate

Available from:

Wallace Manufacturing Chemists Ltd

ATC code:

P01BA01

INN (International Name):

Chloroquine phosphate

Dosage:

16mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05040100; GTIN: 05034593034406

Patient Information leaflet

Malarivon Syrup
50mg in 5ml (as base) Oral Solution
Chloroquine Phosphate
_Read all of this leaflet carefully before you start using this
medicine because it contains important information for you._
_ _
✧_ Keep this leaflet. You may need to read it again_
_ _
✧_ If you have any further questions, ask your doctor or pharmacist_
_ _
✧_ 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_
_ _
✧_ 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
1.
What is Malarivon Syrup and what is it used for?
2.
What you need to know before you use Malarivon Syrup?
3.
How to use Malarivon Syrup?
4.
Possible side effects?
5.
How to store Malarivon Syrup?
6.
Contents of the pack and other information.
1.
What is Malarivon Syrup and what is it used for?
Malarivon Syrup contains chloroquine phosphate
and belongs to a group of medicines called ‘anti-
malarials’. It acts on the malarial parasite in the
blood stream, and may prevent, suppress or treat
the disease depending upon the strain of parasite
contracted and the progression of the disease.
You must get medical advice on which anti-malarial
medicine to take.
When travelling to an area where there is a risk of
contracting malaria always consult official guidelines
and local information before deciding on which
preventative treatment to take. No treatment to
prevent malaria is 100% effective.
2.
What you need to know before you use
Malarivon Syrup?
DO NOT USE:
✦ If you are allergic (hypersensitive) to chloroquine
phosphate or any of the ingredients listed in
section 6 of this leaflet
✦ If you are taking a medicine called amiodarone
(used to control the heart rate). Malarivon Syrup
may increase the risk of uneven heart beats
(cardiac arrhythmias) when it is taken at the
same time as amiodarone.
WARNINGS AND PRECAUTIONS
Talk to your

Summary of Product characteristics

OBJECT 1
MALARIVON SYRUP
Summary of Product Characteristics Updated 06-Jan-2017 | Wallace
Manufacturing Chemists Ltd
1. Name of the medicinal product
Malarivon Syrup
2. Qualitative and quantitative composition
Each 5ml contains:
Chloroquine Phosphate 80.0mg
equivalent to
Chloroquine base 50.0mg
Excipient(s) with known effect:
Sucrose
Methyl, Ethyl, Propyl and Butyl Hydroxybenzoic Acid Esters
Propylene Glycol
Colouring (Ponceau 4R) E124
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution
4. Clinical particulars
4.1 Therapeutic indications
For the prophylaxis, suppression and treatment of malaria.
4.2 Posology and method of administration
Method of administration
Oral
Posology
TABLE 1
Age Group Dose
Children up to 1 year: 2.5-5ml
1 to 3 years: 7.5-10ml
3 to 6 years: 10-15ml
6 to 9 years: 15-22.5ml
9 to 12 years: 22.5-30ml
Adults: 30ml
PROPHYLAXIS OR SUPPRESSION OF MALARIA, NON-IMMUNE
A single weekly dose, as shown in Table 1, beginning two weeks before
and continuing four weeks after
exposure to infection
PROPHYLAXIS OR SUPPRESSION OF MALARIA, PARTIALLY-IMMUNE
Half the dose in table 1 every two weeks will afford a high degree of
protection.
TREATMENT OF MALARIA, NON-IMMUNE
Give twice the dose in Table 1, then give the same dose as in table 1
six hours later and then once a day
for two days.
TREATMENT OF MALARIA, PARTIALLY IMMUNE
Give twice the dose in table 1 once only
No distinction is made between the dose for adults and the elderly.
4.3 Contraindications
Hypersensitivity to chloroquine or to any of the excipients listed in
section 6.1
Concomitent use with amiodarone. (See section 4.5)
4.4 Special warnings and precautions for use
When used as malaria prophylaxis official guidelines and local
information on prevalence of resistance to
anti-malarial drugs should be taken into consideration.
Irreversible retinal damage and corneal changes may develop during
long term therapy and after the drug
has been discontinued. Ophthalmic examination prior to, and at 3-6
monthly intervals during us