Patient Information Leaflet

Avloclor™ Tablets

chloroquine phosphate

What you should know about Avloclor

The information in this leaflet applies only to your medicine, Avloclor. Please read it carefully.

It gives you important information but it can't tell you everything. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

What is your medicine?

Avloclor comes in tablets and each tablet contains 250 mg of chloroquine phosphate.

The tablet contains a number of inactive ingredients which allow it to be made. These are maize starch and magnesium stearate.

Avloclor comes in packs of 20 tablets.

Avloclor belongs to a group of medicines called antimalarials.

This means that it can be used to help prevent malaria.

What is your medicine for?

Avloclor is used to prevent malaria.

When should Avloclor not be used?

• Before taking your medicine, you should ask your doctor or pharmacist if Avloclor is the correct antimalarial medicine for the part of the world that you are visiting.
• The tablets are only for you and must never be given to anyone else.

What precautions should be taken with Avloclor?

Before taking your medicine, tell your doctor or pharmacist if:

• you are allergic to chloroquine phosphate or any other ingredients of Avloclor;
• you have epilepsy or a history of convulsions or fits;
• you have ever had problems with your liver or kidneys;
• you have ever been told you have porphyria (a rare disease of blood pigments) or anyone in your family has, because Avloclor may cause severe symptoms, in particular if you drink alcohol;
• you have psoriasis (a scaly condition of the skin);
• you are pregnant or suspect you may be pregnant or are trying to become pregnant;
• you are breast-feeding (your baby will still need to be given antimalarial treatment and you should consult your doctor or pharmacist for appropriate advice);
• you have myasthenia gravis (a disease of the muscles), because Avloclor can increase the symptoms and reduce the effect of treatment with neostigmine and pyridostigmine;
• you have glucose-6-phosphate dehydrogenase deficiency (a liver disorder), because it is possible that Avloclor may damage blood cells in people with this disorder;
• you are taking or have recently taken any other medicines, including over the counter ones, especially:
  • praziquantel (a drug used to treat parasitic infections of the bowel and bladder), cyclosporin (a drug used mainly in transplant patients but also less commonly in rheumatoid arthritis and psoriasis), anticonvulsant drugs (used mainly to prevent convulsions (fits)) or digoxin (used to control the heart rate), because Avloclor may affect the amount of these drugs in your blood;
  • other antimalarial drugs, such as mefloquine, because there is a risk of convulsions (fits) when these are taken at the same time as Avloclor;
  • cimetidine (used to treat stomach problems), because it inhibits the metabolism of Avloclor and may affect the amount of Avloclor in your blood;
  • antacids (aluminium, calcium and magnesium salts, used to treat heartburn or indigestion), because these drugs may reduce the absorption of Avloclor and so should be taken at least two hours before or after Avloclor.

Your doctor should not prescribe you Avloclor at the same time as amiodarone (used to control the heart rate), because Avloclor may increase the risk of cardiac arrhythmias (abnormal heart rhythms) when taken at the same time as amiodarone.

If you need a vaccination against rabies, make sure you have it before you start on your antimalarial treatment. If you have them at the same time, your rabies vaccine might not work so well.

If you suffer from any fever (high temperature) during or after visiting a country where malaria occurs, you should contact your doctor immediately.

Taking Avloclor for a long period of time may cause changes to parts of the retina and cornea of your eye, which may lead to patchy vision. Your doctor may advise you to have blood or eye tests if you are taking Avloclor for a long time. Your doctor may also monitor you for signs of cardiomyopathy (weakening or change in the heart muscle).

Avloclor may affect your ability to drive a car or to operate machinery (you may experience blurring of vision or difficulty in focusing your eyes while taking Avloclor).

If you go into hospital let the medical staff know you are taking Avloclor.

Only stop taking your Avloclor 4 weeks after leaving the malarious area.

 

How should I take my Avloclor?

Follow your doctor's instructions about when and how to take your tablets. Please read the label on the container. Ask your doctor or pharmacist in case of uncertainty. Your doctor will give you more specific guidance when Avloclor is used for other conditions other than treatment or prevention of malaria.

Adults: Two tablets taken once a week, on the same day each week.

Children: The following single dose taken once a week on the same day each week:

• 1-4 years: half a tablet
• 5-8 years: one tablet
• 9-14 years: one and a half tablets

Adults and Children: Start 1 week before exposure to risk and continue until 4 weeks after leaving the malarious area.

• Swallow the tablet (or part tablet) whole with a drink of water.
• Take your Avloclor tablets on the same day each week.
• If you miss a dose, take the dose as soon as you remember. Do not take two doses at the same time.
• The dosage for children is as described above. If you need additional advice please consult your doctor.
• If you are elderly it may be advisable for your doctor to do some blood tests and possibly prescribe a different dose.
• If you take more than your normal dose, contact your doctor or nearest hospital urgently.
• Only stop taking Avloclor if your doctor tells you or if you develop a side effect as explained later on. For the prevention of malaria, only stop taking your Avloclor four weeks after leaving the malarious area.

What undesirable events may be experienced with Avloclor?

As with all medicines, undesirable events are sometimes experienced. When Avloclor is used in the prevention of malaria these are generally not serious. If used for a long time they can be more serious. For Avloclor these include:

• headache
• stomach upsets, feeling sick, vomiting, diarrhoea or stomach cramps
• skin rash, including psoriasis, or itch, peeling skin or sensitivity to sunlight that requires medical treatment
• hair discolouration or hair loss
• discolouration of the skin and mucous membranes, such as the inside of the mouth
• blurring or partial or complete loss of vision, difficulty in focusing your eyes or double vision
• convulsions or fits
• mood changes or other effects on behaviour including feeling anxious or rarely hallucinations (seeing, feeling or hearing things that are not there)
• dizziness or light-headedness
• changes in your blood which may make you bruise easily, get serious infections, feel very tired or breathless or may give your skin and eyes a yellow colour (due to a liver problem)
• hearing loss and tinnitus (ringing in the ears)
• severe rash with peeling or blistering skin sometimes with ulceration of mucous membranes (for example, the inside of your mouth and nose).

If you take Avloclor for a long time you may experience electrocardiographic changes (changes in the normal electrical signals of your heart), cardiomyopathy (weakening or change in the heart muscle leading to tiredness or breathlessness), retinopathy (changes to the retina of your eye leading to 'patchy' vision) or sensitivity to light, or neuromyopathy (weakening of muscles).

Do not be alarmed by this list of possible events. You may not have any of them.

Stop taking Avloclor and seek local medical advice, or contact your doctor immediately, in any of the following situations:

• If you develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.
• If you develop swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing.
• If you develop urticaria (itchy skin rash, nettle rash or hives).

Tell your doctor or pharmacist if you think you have any of these or any other problems with the tablets.

How should I store Avloclor?

• Your tablets should not be kept above 30°C, protected from light and moisture.
• Keep your tablets in the container they came in.
• Do not take your tablets after the expiry date on the container. Return any remaining tablets to your pharmacist for disposal.
• Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.
• If your doctor decides to stop treatment return any unused tablets to your pharmacist.

Important additional information

Malaria can be fatal. It is essential to take medical advice on which antimalarial drugs are appropriate. For some countries, chloroquine may not be suitable or may have to be taken with another drug to give maximum protection.

No medication can be guaranteed to protect against malaria in every case. Any traveller becoming ill either when visiting a malarious region or after returning home should suspect malaria and seek medical advice as soon as possible.

In addition to taking antimalarial drugs it is advisable to take other measures. Protect against mosquito bites by wearing light-coloured long-sleeved clothing and long trousers, when out of doors after sunset. Use insect repellent creams on parts of the body not covered by clothing. Sleep in a properly screened room or under a mosquito net. Spray to kill any mosquitoes that may have entered rooms in spite of screening.