WHAT YOU SHOULD KNOW

ABOUT NIVAQUINE™ TABLETS

This leaflet should be read carefully before you start to take the tablets as it is a summary of important information about your 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) tablets.
  • Each tablet contains 200 mg of chloroquine sulphate and the following inactive ingredients: cellulose, glucose, acacia, modified starch, magnesium stearate, hydroxypropylmethyl cellulose, polyethylene glycol, yellow Opaspray.
  • Chloroquine is one of a group of medicines called anti-malarials but it is sometimes useful for other conditions also.
  • This package contains 28 tablets of NIVAQUINE.
  • The manufacturer and product licence holder of NIVAQUINE tablets is: May & Baker Limited, Rainham Road South, Dagenham, Essex RM10 7XS

Why have I been given Nivaquine Tablets?

NIVAQUINE is usually given to help prevent you getting malaria. Malaria is spread by mosquitos.

Some mosquitos carry the malaria parasites and can infect you with them if they bite you - it can take a week or more to develop malaria after an infected bite.

NIVAQVINE can help prevent you getting malaria when you have 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 you have 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 you are already taking NIVAQUINE or medicines called "Avloclor" or "PIaquenil" for another condition consult your doctor.

Keep this leaflet for reference until you have finished taking the medicine.

Before taking your Nivaquine Tablets

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

  • Are you taking any other medicine?
  • Are you pregnant or think you may be pregnant or are you trying to become pregnant?

NIVAQUINE is a trade mark 59/69/16

(Smaller than original)

  • Are you breast feeding your baby?
  • Do you have any of the following illnesses - liver or kidney illness, epilepsy, psoriasis, blood disorders or neurological disorder?
  • Have you ever had a severe or allergic reaction to NIVAQUINE or chloroquine on taking it before?
  • Is the user a child under 12 years old?

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 I take my NIVAQUINE Tablets?

It is very important that you take your NIVAQUINE tablets properly.

If you do not take enough, you have a greater risk of developing malaria.

If you take too much, you may develop side effects.

  • Take the tablets with a glass of water
  • Do not chew the tablets
  • If possible, start by taking 2 NIVAQUINE tablets 1 week before entering a country in which malaria may be present.
  • If you cannot take NIVAQUINE TABLETS before entering the country take 2 tablets as soon as you arrive
  • The next dose is 2 tablets 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 take the tablets more often unless your Doctor or Pharmacist tells you to.

  • whilst you are away take 2 tablets on the same day each week
  • If you think you will have a problem remembering to take the tablets ask a friend or relative to remind you. Writing the day you should take the dose in your diary or on a calendar may help jog your memory.
  • When you arrive home continue to take 2 tablets once a week for 4 weeks. You must remember to keep taking the tablets when you are at home - even If you fed perfectly well. Malaria can develop some time after being bitten by a mosquito. If you stop taking the tablets this will increase the risk of developing malaria when you are at home.
  • If you forget to take your tablets take them immediately you remember and then continue as before.
  • If your doctor has prescribed another medicine to help prevent malaria you may need to take this medicine more often than NIVAQUINE. Follow the instructions carefully.
  • If you have 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 tests on you.

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.

 

 

 

 

 

 

You 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.
  • Use insect repellent on exposed skin between dusk and dawn.
  • Wear long-sleeved clothing and long trousers after sunset, avoiding dark colours as these attract mosquitos.
  • Wear 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.
  • Always sleep 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 room at night, use an electric mosquito killer or burn 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 O71 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 6C0 274 (calls are charged at 48p per minute at peak rate and 36p per minute at other times).

How can I tell if I may have 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 health you should contact a doctor.

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

  • Immediately seek medical attention. Delay can be dangerous.
  • If you have returned home visit your doctor immediately. It is very important that you tell your doctor that you have recently returned from abroad. Tell your doctor which countries you have visited and what medicines you have 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 I accidentally take too many tablets or a young child swallows some tablets?

If you have taken too many tablets or you think that a young child has taken some 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.

Do NIVAQUINE Tablets have Side Effects?

As well as benefits most medicines may have unwanted effects in some people. The following minor side effects of NIVAQUINE are well known. You need not worry about them unless they become troublesome:

  • headache l mild stomach upset

Shortly after taking NIVAQUINE your eyesight may become blurred. If you are affected in this way make sure that you do not drive a car or operate machinery 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 you have any problems which you think may be caused by NIVAQVINE see a doctor or pharmacist as soon as possible

How should I store NIVAQUINE Tablets?

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

How can I tell if my NIVAQUINE Tablets can still be used?

  • All medicines have an expiry date.
  • The expiry date of NIVAQUINE tablets is printed on the end flap of the NIVAQUINE tablet carton.
  • The expiry date follows an 'EXP’ printed on the flap. So ‘EXP APR 95' means that the expiry date is April 1995.
  • You should not use your NIVAQUINE tablets after the expiry date.
  • If you have any problem discuss this with your pharmacist.

This Leaflet: Dale of last revision: November 1994

© Rhône-Poulenc Rorer 1993

Prepared in conjunction with Dr. D. Warhurst

London School of Hygiene and Tropical Medicine