Information for the Patient

NIVAQUINE™ SYRUP 100 ml

(Each 5 ml contains 68 mg Chloroquine Sulphate BP

equivalent to 50 mg chloroquine base)

WHAT YOU SHOULD KNOW ABOUT NIVAQUINE SYRUP

This leaflet should be read carefully before you start to take the syrup as it is a summary of important information about the medicine. This leaflet also gives additional advice on how to avoid being bitten by mosquitos. If you have any questions, or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.

 

ABOUT THIS MEDICINE

  • This medicine is called NIVAQUINE (chloroquine) Syrup.
  • Each 5 ml of syrup contains 68 mg of chloroquine sulphate and the following inactive ingredients: sugar, sodium L-glutamate, saccharin sodium, propylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, peppermint oil pineapple flavour and caramel. It does not contain any dyes.
  • Chloroquine is one of a group of medicines called anti-malarials but it is sometimes useful for other conditions also.
  • This package contains 100 ml of NIVAQUINE Syrup.
  • The product licence of NIVAQUINE Syrup is held by: May & Baker Limited, Eastbourne, England BN21 3YG and the product authorisation by May & Baker Limited, Dagenham, England, RM10 7B. NIVAQUINE IS manufactured by: Rhône-Poulenc Rorer Pharma, St Genis Laval France.

Why has my child been given NIVAQUINE Syrup?

NIVAQUINE is usually given to help prevent your child getting malaria. Malaria is spread by mosquitos. Some mosquitos carry the malaria parasites and can infect your child with them if they bite your child - it can take up to a week or more to develop malaria after an infected bite . NIVAQUINE can help prevent your child getting malaria when your child has been bitten by a mosquito. Like other similar medicines, in some cases NIVAQUINE will not give complete protection against malaria. It is, therefore, important you follow all other medical advice.

Make sure that you have told your doctor or pharmacist which countries you are visiting. In some parts of the world the malaria parasites are not affected by chloroquine. If your child has been given another anti-malarial medicine to take with NIVAQUINE, then you must follow the separate directions for it.

Sometimes your doctor may have prescribed NIVAQUINE for treating other conditions. Please contact your doctor if this is the case.

If your child is already taking NIVAQUINE or medicines called "Avloclor" or "PIaquenil" for another condition consult your doctor.

Keep this leaflet for reference until your child has finished taking the medicine.

Before your child takes NIVAQUINE Syrup

If the answer is YES to any of the following questions you should discuss the matter with your doctor or pharmacist before your child takes any of the syrup.

  • Is your child taking any other medicine?
  • Does your child have any of the following illnesses - liver or kidney illness, epilepsy, psoriasis, blood disorders or neurological disorder?
  • Has your child ever had a severe or allergic reaction to NIVAQUINE or chloroquine on taking it before?

Even if you are breast feeding and taking NIVAQUINE this will not protect your baby against malaria. It is important that you discuss this with your doctor.

How should my child take NIVAQUINE Syrup?

It is very important that your child takes NIVAQUINE syrup properly. If your child does not take enough, he/she has a greater risk of developing malaria.

 

 

NIVAQUINE is a trade mark 56/69/28

If your child takes too much, he/she may develop side effects

  • The dose for children depends on their weight
  • Weigh your child, preferably, in kilograms.
  • Use the table below to show the correct dose.
  • For example, if your child weighs 20 kg (about 3st 2lbs) the dose of NIVAQUINE Syrup is two x 5 ml spoonfuls ( 10 mls).
  • When the weight of your child lies between two weights on the table use the lower dose. For example, if your child weighs 25kg the correct dose is two x 5ml spoonfuls ( 10 mls) of NIVAQUINE syrup.
  • For doses less than 5ml your pharmacist can supply you with a syringe to measure out the NIVAQUINE syrup.
  • When you have worked out the dose, do it again to make sure you have done it properly.

  • Your child should take one full dose at one time. So. if the dose is three x 5ml spoonfuls, this should be taken all at once.
  • If possible. your child should start by taking the dose of syrup above, 1 week before entering a country where malaria may be present.
  • If your child cannot take NIVAQUINE Syrup before entering the country the dose should be taken on arrival.
  • The next dose of syrup is taken one week after the first dose. Don't worry if that seems a long time between doses. NIVAQUINE remains in the body for a long time.

Do not be tempted to give your child the syrup more often unless your Doctor or Pharmacist tells you to.

  • Your child should take the dose on the same day each week
  • If you will have a problem remembering to give the syrup to your child, ask a friend or a relative to remind you. Writing the day your child should take the dose in your diary or on a calendar may help jog your memory.
  • When your child arrives home he/she should continue to take the dose of syrup once a week for 4 weeks. You must remember to be sure that your child keeps taking the syrup when you are at home-even if your child feels perfectly well. Malaria can develop some time after being bitten by a mosquito. If your child stops taking the syrup this will increase the risk of developing malaria when you are at home.
  • If your child forgets to take the syrup, it must be taken immediately you remember and then continued as before.
  • If your doctor has prescribed another medicine to help prevent malaria your child may need to take this medicine more often than NIVAQUINE. Follow the instructions carefully.
  • If your child has to take NIVAQUINE for a long period of time, for example a year or more, consult your doctor who may decide to carry out a few simple test on your child.

What other measures must I take to reduce the risk of

developing Malaria?

Like other anti-malarial medicines, NIVAQUINE does not give guaranteed complete protection against malaria. Your child should also try to avoid being bitten by mosquitos by doing the following:-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • Remember that the risks of being bitten by a mosquito are much greater in a rural, rather than a built-up area. You can reduce the risk of being bitten in a rural area by visiting only in the day, when mosquitos rarely bite.
  • Make sure your child wears long-sleeved clothing and long trousers after sunset, avoiding dark colours as these attract mosquitos
  • Make sure your child wears repellent-soaked wrist or ankle bands between dusk and dawn
  • If your accommodation is not protected against mosquitos by, for example, screened windows and doors and/or air conditioning then do the following
  • When entering a room at night use a fly killer spray to kill any mosquitos which have entered the room at night
  • Make sure your child always sleeps under a mosquito net Make sure that there are no holes in the net and that it is tucked in under the mattress. You can increase the effect of the net by soaking it in an insecticide such as permethrin
  • If you think mosquitos can enter your child's room at night, use an electric mosquito killer or bum a 'mosquito coil' Mosquito 'buzzers' are not effective

Advice on the above can be obtained from your doctor or pharmacist before you leave home

In the countries you are visiting you should obtain information and supplies from a local pharmacist

In the UK further information and supplies can be obtained by telephoning the Medical Advisory Service for Travellers Abroad (MASTA) on 071 631 4408 The London School of Hygiene and Tropical Medicine has a 24 hour recorded help line on 0891 600 350 and recorded advice on preventing mosquito bites on 0891 600 274 (calls are charged at 48p per minute at peak rate and 36p per minute at other times)

How can I tell if my child has developed Malaria?

If any of the following symptoms develop when you are away or within 1 year of arriving home:

High temperature with chills, shivering or sweating,

Headache, diarrhoea, other 'flu-like' symptoms,

or, if you have any concern about your child's health, you should contact a doctor.

What should I do if I think my child may have developed Malaria?

  • Immediately seek medical attention. Delay can be dangerous.
  • If your child has returned home visit your doctor immediately. It is very important that you tell your doctor that your child has recently returned from abroad. Tell your doctor which countries you have visited and what medicines your child has taken.
  • If you cannot see your usual doctor go immediately to the casualty department of your local hospital and tell them the above information.
  • The early stage of malaria is easily treated but delay in seeking medical attention can make It very difficult to treat and may be fatal.

What should I do if my child accidentally takes too much syrup?

If your child has taken too much syrup accidentally

  • Immediately tell your doctor or visit the nearest hospital casualty department
  • Emergency treatment may be required in such cases, as NIVAQUINE overdosage can be dangerous, especially in children
  • Do not use salt to make your child sick-it may make him worse.

Does NIVAQUINE Syrup have Side Effects?

As well as benefits most medicines may have unwanted effects in some people.

The following minor side effects on NIVAQUINE are well known. You need not worry about them unless they become troublesome:

    • headache
    • mild stomach upset

Shortly after taking NIVAQUINE you childís eyesight may become blurred. If your child is affected in this way, make sure that your child does not take part in unsupervised activities until this effect has disappeared - usually within 24 hours

The following are serious side-effects and you should tell your doctor or pharmacist about them immediately

skin trouble such as rash or itching

psoriasis may worsen

severe stomach upset

blurred eyesight which lasts for more than 2 days

convulsions

loss of hair

If they occur before you leave home your doctor or pharmacist may be able to recommend an alternative medicine

If your child has any problems which you think may be caused by NIVAQUINE see a doctor or pharmacist as soon as possible.

How should I store NIVAQUINE Syrup?

  • NIVAQUINE Syrup can be dangerous when not used correctly, especially to young children, and should be kept in a safe place
  • Keep the syrup in a cool place away from light
  • When your child has finished a course of treatment return any unused syrup to a pharmacist who will arrange for it to be destroyed. Do not give this medicine to others - it may be harmful to them

How can I tell if NIVAQUINE Syrup can still be used?

  • All medicines have an expiry date
  • The expiry date of NIVAQUINE Syrup is printed on the bottle label
  • The expiry date follows an 'EXPí printed on the label. So ĎAPR 95' means that the expiry date is April 1995.
  • You should not use your NIVAQUINE Syrup after the expiry date
  • If you have any problem discuss this with your pharmacist

This Leaflet: Date of last revision: March 1993

© Rhône-Poulenc Rorer 1993

Prepared In conjunction with Dr. D. Warhurst

London School of Hygiene and Tropical Medicine