Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Chloroquine phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
e 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 doctor or pharmacist before taking Malarivon Syrup if: You have any disease of the liver You suffer from any blood disorders (including porphyria, an inherited disease resulting in abnormalities in the normal production of healthy blood) You suffer from kidney problems You suffer from epilepsy, convulsions or diseases of the nervous system You suffer from psoriasis (a skin condition) You suffer from a severe disease of the digestive system You have an inherited condition of glucose-6 phosphate dehydrogenase deficiency such as favism. Some people being treated with Malarivon Syrup can experience mental health problems such as irrational thoughts, hallucinations, feeling confused, aggressiveness, paranoia, feeling depressed or have thoughts of self-harm or suicide, even those who have never had similar problems before. If you or others around you notice any of these side effects (see section 4) seek medical advice straight away. Long term treatment with Malarivon Syrup should be under medical supervision and your doctor will monitor your eyesight and perform blood tests for you. If you experience any visual disturbances other than a temporary inability to focus at the start of treatment then stop taking the medicine immediately and seek the advice of your doctor. Taking Malarivon Syrup can result in severe reductions of blood sugar levels. In extreme cases this may result in loss of consciousness. If you notice symptoms that may be related to low blood sugar levels such as shakiness, heart palpitations, poor muscle coordination, pins & needles, slurred speech, dizziness and/or light headedness then consult your doctor. Other medicines and Malarivon Syrup? Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor or pharmacist if you are taking any of the following medicines. This is because Malarivon Syrup 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 treat epilepsy to prevent convulsions or fits) Digoxin (used to treat heart problems). Azithromycin, clarithromycin, or erythromycin (antibiotics used for treating infections). Taking these medicines at the same time as chloroquine may increase the chance of you getting side effects that affect your heart.
H0090-4
Malarivon Syrup 50mg in 5ml (as base) Oral Solution
Also tell your doctor or pharmacist if you are taking any of the following medicines: Treatments for irregular heart beat Medicines which may cause irregular heart beat as a side effects such as moxifloxacin and droperidol Other medicines used to prevent malaria, such as mefloquine. There is a risk of convulsions or fits when these medicines are taken at the same time as Malarivon Syrup Medicines that may prevent the kidneys from clearing chloroquine from the blood at the normal rate and as a consequence can cause an overdose. The main examples are ciprofloxacin (an antibiotic), cimetidine and omeprazole (used to treat excess stomach acid), and pyrimethamine (used to treat protozoal infections including malaria) 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). Antacids and adsorbents used to treat heartburn or indigestion can interfere with the absorption of chloroquine so they should not be taken within four hours before or after taking Malarivon Syrup. Malarivon Syrup can make the symptoms of 'myasthenia gravis' (which causes muscle weakness) more severe and as a consequence reduce the effectiveness of drugs such as neostigmine and pyridostigmine used to treat the condition. When Malarivon Syrup is taken at the same time as rabies vaccination it may affect the protection provided by the vaccine. Malarivon Syrup inactivates oral typhoid vaccine, so the vaccine should be taken at least three days before starting a course of Malarivon Syrup. Pregnancy and breast-feeding? If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are risks to both the mother and the foetus associated with travelling to countries with malaria when pregnant. Always consult a doctor or pharmacist before travelling. Breast feeding while taking Malarivon Syrup is safe but the small amount of the active ingredient expressed in the milk is not enough to protect the infant 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. Driving and using machines When starting treatment with Malarivon Syrup it is possible that you may have blurred or double vision which will make driving and operating machinery unsafe. If you experience such effects then do not drive or operate machinery. Important information about some of the ingredients in Malarivon Syrup In addition to the active ingredient, some of the other ingredients in Malarivon Syrup may affect some individuals: Malarivon Syrup contains 2.2g of sucrose in 5ml (13.2g in 30ml); which should be taken into account in patients with diabetes mellitus Para-hydroxybenzoates may cause allergic reactions (possibly delayed) The colouring ponceau 4R (E124) may cause allergic reactions. This medicine contains 695mg propylene glycol in each 5ml. If your child or baby is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, particularly if they use other medicines that contain propylene glycol or alcohol. If you are pregnant or breast-feeding, or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
Malarivon Syrup? Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Read these instructions carefully because the dose depends both on age and the reason for treatment. Table 1 Age Group Dose Children up to 1 year 2.5ml to 5.0ml 1 to 3 years 7.5ml to 10ml 3 to 6 years 10ml to 15ml 6 to 9 years 15ml to 22.5ml 9 to 12 years 22.5ml to 30ml Over 12 years including adults 30ml
In the following directions, unless you have been told by a doctor that you are partially immune to malaria, assume that you are non-immune and select the appropriate dose. Suppression or prevention of malaria in non-immune users Take one dose a week as shown in Table 1. Begin two weeks before entering the malaria area and continue for four weeks after leaving the malaria area. Suppression or prevention of malaria in partially immune users Once every two weeks take half the dose shown in Table 1. This will afford a high degree of protection against non-resistant malaria. Treatment of malaria in non-immune users Firstly take twice the dose in Table 1. Then, six hours later, take the dose as stated in Table 1. Then, for the next two days, take the dose as stated in Table 1. Treatment of malaria in partially immune users Once only, take twice the dose in Table 1. If you take more Malarivon Syrup than you should If you have taken a possible overdose then you should seek medical advice immediately. If possible you should take any remaining medicine, packaging and this leaflet with you provided it doesn't cause a delay. If you forget to take Malarivon Syrup Do not take a double dose to make up for a forgotten dose. If a dose is missed then resume the treatment immediately. If the product was being taken for prevention of Malaria then be especially alert for any flu like symptoms in the months following and report them immediately to your doctor. 4. Possible side effects? Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Malarivon Syrup and see a doctor or go to a hospital 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): 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 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 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 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): 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 Malarivon is taken for a long time. 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 Your psoriasis gets worse. 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 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. Feeling depressed or having thoughts of self-harm or suicide, feeling anxious, feeling confused, having irrational thoughts, paranoia, aggressiveness, sleep disorders, agitation, feeling elated or overexcited, lack of concentration. Reporting of side effects. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can report
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Malarivon Syrup? Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle. Store below 30°C. Protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
. What Malarivon Syrup contains: The active substance is chloroquine phosphate. Each 5ml of the syrup contains 80mg of chloroquine phosphate which is equivalent to 50mg of chloroquine base. The other ingredients are sucrose, methyl, ethyl, propyl and butyl parahydroxybenzoates, propylene glycol, buttermint toffee essence, sodium saccharin, glycerol, ponceau 4R (E124) and purified water. What Malarivon Syrup looks like and contents of the pack: Malarivon Syrup is a clear red syrup supplied in glass bottles of 75ml. Marketing Authorisation Holder and Manufacturer: The marketing authorisation owner is: Wallace Manufacturing Chemists Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF, UK. The manufacturer is: Laleham Health and Beauty Ltd., Bradshaw Lane, Greenhalgh, Kirkham, Lancashire PR4 3JA, UK. This leaflet was last revised in December 2021 PL00400/0005R
Malarivon Syrup comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Malarivon Syrup is chloroquine phosphate.
This leaflet reproduces the patient information leaflet approved for Malarivon Syrup, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the prophylaxis, suppression and treatment of malaria.
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.
Hypersensitivity to chloroquine or to any of the excipients listed in section 6.1
Concomitent use with amiodarone. (See section 4.5)
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 use is required if patients are receiving chloroquine:
- At continuous high doses for longer than 12 months
- As weekly treatment for longer than 3 years
- When total consumption exceeds 1.6g/kg (cumulative dose 100g)
Patients should be advised to stop taking the drug immediately and seek the advise of their doctor if any disturbances of vision occur.
Bone marrow suppression may occur rarely so full blood counts should be carried out during extended treatment. Caution is required if drugs known to induce blood disorders are used concurrently.
Use with caution in patients with impaired hepatic function, particularly cirrhosis.
Use with caution in patients with porphyria as the disease may be precipitated. This may be especially apparent in patients with a high alcohol intake.
Use with caution in patients with a renal impairment.
Use with caution in patients with a history of epilepsy, convulsions and other neurological disorders.
Use with caution in patients with psoriasis as chloroquine may precipitate a severe attack.
Use with caution in patients with severe gastro-intestinal disease.
Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency, as there may be risk of haemolysis.
Chloroquine has been shown to cause severe hypoglycaemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications. Patients treated with chloroquine should be warned about the risk of hypoglycaemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycaemia during treatment with chloroquine should have their blood glucose level checked and treatment reviewed as necessary.
A small number of cases of diffuse parenchymal lung disease have been identified in patients taking chloroquine. A response after therapy with steroids has been observed in some of these cases.
Cases of drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been identified in patients taking chloroquine. Recovery after discontinuation of treatment and response after therapy with steroids has been observed.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltese insufficiency should not take this medicine.
If the patient is taking amiodarone then chloroquine may increase the risk of cardiac arrhythmias including ventricular arrhythmias, bradycardias and cardiac conduction defect. Concurrent use is contraindicated. Co-administration with other drugs that have antiarrhythmogenic properties, e.g. moxifloxacin, droperidol, may increase the risk of cardiac arrhythmias.
Antacids and adsorbents (e.g. kaolin) may reduce the absorption of chloroquine, so should be administered at least four hours apart.
Concomitant use of drugs such as multidrug and toxin extrusion protein (MATE1) inhibitors (e.g., ciprofloxacin, cimetidine, omeprazole, pyrimethamine) may impact the renal clearance of chloroquine, which could theoretically lead to increased levels of chloroquine and potentially overdosage (see section 4.9). In addition, care should be taken when alkalinization of urine occurs as this may reduce chloroquine renal excretion.
Chloroquine increases risk of convulsions with mefloquine (anti-malarial drug).
Chloroquine antagonises the anticonvulsant effect of antiepileptics.
Chloroquine may possibly increase the plasma concentration of digoxin.
When co-administered with ciclosporin, chloroquine increases plasma ciclosporin concentration resulting in increased risk of toxicity.
Chloroquine has been reported to reduce the bioavailability of praziquantel. Caution is advised during co-administration.
Chloroquine has the potential to increase symptoms of myasthenia gravis and thus diminish effect of neostigmine and pyridostigmine.
Concomitant administration of chloroquine with rabies vaccine may affect the antibody response.
Concomitant administration of chloroquine inactivates oral typhoid vaccine, so the vaccine should be completed at least three days before the first dose of chloroquine.
Pregnancy
Should not be used during pregnancy unless, in the judgement of the physician, potential benefit outweighs the risk. When given at high doses throughout pregnancy it has been reported to give rise to foetal abnormalities including visual loss, ototoxicity and cochlea-vestibular dysfunction.
Malaria in pregnant women increase the risk of maternal death, miscarriages, still-births and low birth weight infants with the associated risk of neonatal death. Travel to malarious areas should be avoided during pregnancy but if this is not possible women should receive effective prophylaxis.
Breast-feeding
Malarivon Syrup is excreted in breast milk, although amounts are probably too small to be harmful when used for malaria prophylaxis but as a consequence they are insufficient to protect the infant.
At start of treatment chloroquine has a temporary effect on visual accommodation, causing blurred and/or double vision. Therefore patients should be advised that the product may affect their ability to drive or operate machinery.
The following CIOMS frequency rating is used when applicable:
Very common ≥ 10%; Common ≥ 1 and < 10%; Uncommon ≥ 0.1 and < 1%; Rare ≥ 0.01 and < 0.1%; Very rare < 0.01%; Not known (frequency cannot be estimated from available data)
Cardiac disorders
- Uncommon: cardiomyopathy has been reported during long term therapy at high doses, which may result in cardiac failure and in some cases a fatal outcome.
- Rare: cardiac arrhythmias, including QT prolongation, torsade de pointes, ventricular tachycardia and ventricular fibrillation have been reported with therapeutic doses of chloroquine as well as with overdose. The risk is greater if chloroquine is administered at high doses. Fatal cases have been reported.
- Not known - hypotension.
Nervous system disorders
- Very common: headache
- Common: convulsions have been reported rarely (these may result from cerebral malaria).
- Uncommon: neuropathy
- Rare: polyneuropathy
- Not known: acute extrapyramidal disorders (such as dystonia, dyskinesia, tongue protrusion, torticollis).
Psychiatric disorders
- Very common: insomnia
- Common: depression
- Rare: psychiatric disorders such as anxiety, agitation, confusion, hallucinations, delirium
- Not known: suicidal behaviour
Eye disorders
- Common: transient blurred vision
- Rare: reversible corneal opacity, cases of retinopathy as well as cases of irreversible retinal damage have been reported during long term, high dose therapy.
- Not known: maculopathy and macular degeneration have been reported and may be irreversible, macular defects of colour vision, optic atrophy, scotomas, field defects, blindness and pigmented deposits, difficult in focusing, diplopia.
Gastro-intestinal disorders
- Very common: gastrointestinal disturbances such as nausea, vomiting, diarrhoea.
- Not known: abdominal cramps
Blood and lymphatic system disorders
- Rare: bone marrow depression, including aplastic anaemia, agranulocytosis, pancytopenia, thrombocytopenia, neutropenia
Hepatobiliary disorders
- Rare: changes in liver function, including hepatitis and abnormal liver function tests
- Immune system disorders
- Common: allergic and anaphylactic reactions, including angioedema
Ear and labyrinth disorders
- Uncommon: ototoxicity such as tinnitus, hypoacusis, nerve deafness.
Musculoskeletal and connective tissue disorders
- Uncommon: myopathy
Skin and subcutaneous tissue disorders
- Very common: pruritis,
- Common: skin eruptions, urticaria
- Uncommon: alopecia, bluish-black pigmentation of the nails and mucosae (long term use).
- Rare: exacerbation of psoriasis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
- Very rare: exfoliative dermatitis and similar desquamation-type events.
- Not known: depigmentation, photosensitivity, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
Metabolism and nutrition disorders
- Not known: hypoglycaemia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard
Chloroquine is highly toxic in overdose and children are particularly susceptible. The chief symptoms of overdosage include circulatory collapse due to a potent cardiotoxic effect, respiratory arrest and coma. Symptoms may progress rapidly after initial headache, drowsiness, visual disturbances, nausea and vomiting. Cardiac complications may occur without progressively deepening coma.
Death may result from circulatory or respiratory failure or cardiac arrhythmia. If there is no demonstrable cardiac output due to arrhythmias, asystole or electromechanical dissociation, external chest compression should be persisted with for as long as necessary, or until adrenaline and diazepam can be given (see below).
Gastric lavage should be carried out urgently (as soon as possible within 2 hours of the overdose), first protecting the airway and instituting artificial ventilation where necessary. There is a risk of cardiac arrest following aspiration of gastric contents in more serious cases. Activated charcoal left in the stomach may reduce absorption of any remaining chloroquine from the gut (minimum 5 times the suspected maximum dose of chloroquine phosphate). Circulatory status (with central venous pressure measurement), respiration, plasma electrolytes and blood gases should be monitored, with correction of hypokalaemia and acidosis if indicated. Cardiac arrhythmias should not be treated unless life threatening; drugs with quinidine-like effects should be avoided. Intravenous sodium bicarbonate 1-2mmol/kg over 15 minutes may be effective in conduction disturbances, and DC shock is indicated for ventricular tachycardia and ventricular fibrillation.
Early administration of the following has been shown to improve survival in cases of serious poisoning:
1. Adrenaline infusion 0.25micrograms/kg/min initially, with increments of 0.25micrograms/kg/min until adequate systolic blood pressure (more than 100mg/Hg) is restored; adrenaline reduces the effects of chloroquine on the heart through its inotropic and vasoconstrictor effects.
2. Diazepam infusion (2mg/kg over 30 minutes as a loading dose, followed by 1-2mg/kg/day for up to 2-4 days). Diazepam may minimise cardiotoxicity.
Acidification of the urine, haemodialysis, peritoneal dialysis or exchange transfusion have not been shown to be of value in treating chloroquine poisoning. Chloroquine is excreted very slowly, therefore cases of overdosage require observation for several days.
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Malarivon Syrup. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.