Avloclor Tablets

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Avloclor is and what it is used for
2. Before you take Avloclor
3. How to take Avloclor
4. Possible side effects
5. How to store Avloclor
6. Further information

Avoiding mosquito bites

When you are taking this medicine to prevent malaria, you should also reduce the chances of being bitten by mosquitoes.

• Wear light-coloured, long-sleeved clothing and long trousers when you are outside after sunset.
• Use insect repellent creams or sprays on parts of your 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.

Signs of malaria

No medicine can be guaranteed to protect against malaria in every case. If you have a high temperature (fever) during your visit to a malaria area, or up to a year after returning home, you should suspect malaria. Contact a doctor straight away and let him or her know that you have visited a malaria area.

Do not take Avloclor if:

• You are allergic (hypersensitive) to chloroquine phosphate or any of the other ingredients of Avloclor (see Section 6: Further information).
• You are taking a medicine called amiodarone (used to control the heart rate). Avloclor may increase the risk of uneven heart beats (cardiac arrhythmias) when it is taken at the same time as amiodarone. Check with your doctor or pharmacist if you are not sure.

Take special care with this medicine

Check with your doctor or pharmacist before taking your medicine if:

• You have ever had epilepsy, convulsions or fits.
• You have ever had problems with your liver or kidneys.
• You have ever been told that you have a rare disease of the blood pigment called ‘porphyria’ or anyone in your family has it. This is because Avloclor may cause severe symptoms of porphyria, particularly if you drink alcohol.
• You have a scaly condition of the skin called psoriasis.
• You have a muscle problem called ‘myasthenia gravis’. Avloclor can increase the symptoms of this condition. It can also reduce the effect of medicines used to treat this condition (neostigmine and pyridostigmine).
• You have a blood problem called ‘glucose-6-phosphate dehydrogenase deficiency’. Avloclor may damage blood cells in people with this blood condition.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Avloclor.

If you go into hospital, tell the medical staff that you are taking Avloclor.

If you live in a country where malaria occurs, you may already be slightly immune to the disease. You must ask a doctor or pharmacist for advice before you take anti-malarial medicines.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines. This is because Avloclor 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 prevent convulsions or fits).
• Digoxin (used to treat heart problems).

Also tell your doctor or pharmacist if you are taking any of the following medicines:

• 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 Avloclor.
• Cimetidine (used to treat stomach problems). This medicine affects how Avloclor is broken down by your body and may affect the amount of Avloclor in your blood.
• 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).

Adsorbents and antacid medicines may reduce the amount of Avloclor absorbed from your gut. This may mean that the full dose of Avloclor is not absorbed into your body and it will not work properly. Therefore, you should take these medicines at least four hours before or after taking your Avloclor dose.

Some medicines (for example, ciprofloxacin, cimetidine, omeprazole, pyrimethamine) may increase the amount of Avloclor in your body and this can cause side effects. It is important that you do not take any additional medicines (either prescribed or non-prescribed) before speaking to your doctor.

If you need a vaccination against rabies, make sure you have it before you start your anti-malarial medicine. If you have your rabies injection at the same time as taking your anti-malarial medicine, your rabies vaccine might not work so well.

Pregnancy

If you are pregnant or may become pregnant, talk to a doctor or pharmacist:

• before you take Avloclor,
• before you take any medicine to prevent malaria,
• and before you go to a country where there is malaria.

Breast-feeding

• If you are breast-feeding, talk to a doctor or pharmacist before taking Avloclor.
• Although Avloclor passes into the breast milk, the amount is not enough to protect your baby 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

Sometimes Avloclor causes blurred eyesight or makes it difficult to focus your eyes. If this happens to you, do not drive or use any tools or machines.

When to start taking your medicine

• Start taking this medicine one week before you enter the malaria area.
• You must continue to take it during your stay.
• You must keep taking this medicine for 4 weeks after leaving the malaria area.

Adults and children over 14 years

• Take two Avloclor tablets once a week on the same day each week.

Elderly people

• If you are an elderly person your doctor may suggest that you have blood tests. Your doctor may also decide to give you a different dose.

Children

Do not give Avloclor to children under 1 year of age. For children over 1 year of age, the dose depends on the child’s age.

• Ages 1 to 4 years: Take half an Avloclor tablet once a week (on the same day each week).
• Ages 5 to 8 years: Take one Avloclor tablet once a week (on the same day each week).
• Ages 9 to 14 years: Take one and a half Avloclor tablets once a week (on the same day each week).

How to take your tablets

• Take the tablet(s) after food.
• Swallow the tablet(s), or part tablets, whole with a drink of water.

If you take more Avloclor tablets than you should

If you take more Avloclor tablets than you should, talk to a doctor or go to a hospital straight away.

If you forget to take your Avloclor tablets

• If you forget to take a dose of Avloclor, take it as soon as you remember.
• Then wait for 7 days before you take the next dose of Avloclor.
• Carry on taking your Avloclor tablets each week, on this new day of the week.

Stopping Avloclor

Only stop taking Avloclor four weeks after leaving the malaria area or if your doctor tells you to.

Allergic reactions

If you have an allergic reaction, stop taking Avloclor and get medical help or contact your doctor straight away. The signs may include:

• Difficulty in breathing.
• Swelling of the face, lips, tongue or throat which may cause difficulty in swallowing.
• An itchy rash (similar to nettle rash or hives).

Other possible side effects

When Avloclor is used to prevent or suppress malaria, these are generally not serious. If Avloclor is used for a long time, they can be more serious.

Stomach and gut

• Stomach upsets, feeling sick (nausea), being sick (vomiting), diarrhoea or stomach cramps.

Nervous system

• Headache.
• Feeling dizzy or light-headed.
• Convulsions or fits.
• Mood changes or other effects on behaviour. These include feeling anxious or, rarely, seeing, feeling or hearing things that are not there (hallucinations).

Skin

• Skin rash, including a scaly rash (psoriasis) or itch.
• Peeling skin.
• A severe rash with blisters or peeling of the skin and possibly blisters in the mouth and nose.
• Discolouration of the skin or mucous membranes (such as the inside of your mouth).
• Being sensitive to sun light which may require medical treatment.

Hair

• Changes in hair colour.
• Hair loss.

Eyes

• Blurred eyesight.
• Some or complete loss of eyesight.
• Difficulty in focussing your eyes.
• Double vision.
• Changes to the retina of your eye (retinopathy) or to the cornea. This can lead to ‘patchy’ eyesight.

If you are taking Avloclor for a long time, your doctor may suggest that you have eye tests.

Ears

• Hearing loss.
• Ringing in the ears (tinnitus).

Blood

• A reduced number of blood cells. This can make you bruise more easily, get serious infections, or feel very tired or breathless.

If you are taking Avloclor for a long time, your doctor may suggest that you have blood tests.

Heart

• Changes in the way your heart works (known as ‘electrocardiographic changes’).
• Low blood pressure. This may make you feel faint or dizzy.
• Weakening or change in the heart muscle (cardiomyopathy). This may make you feel tired or short of breath.

Liver

• Liver problems which may cause yellowing of your skin or the whites of your eyes.

If you are taking Avloclor for a long time, your doctor may suggest that you have blood tests to check how well your liver is working.

Lungs

• Inflammation of the lungs causing a condition known as diffuse parenchymal lung disease.

If you develop serious breathlessness or worsening of breathlessness seek prompt medical advice.

Other

• Weakening of your muscles (neuromyopathy).
• A rash caused by the medicine associated with an increase in the number of white blood cells (that may show up in blood tests) and symptoms involving the whole body. You may notice some or all of the following symptoms: a skin rash and fever, swelling of the face, tender generalized swollen or enlarged lymph nodes, or other symptoms suggesting involvement of other body organs including the liver, kidney or lung (such as yellowing of the skin or eyes, urinary problems, breathlessness).

Do not be concerned by this list of possible side effects. You may not get any of them.

What Avloclor Tablets contain

• The active substance in Avloclor Tablets is chloroquine phosphate. Each tablet contains 250 mg of chloroquine phosphate (equivalent to 155 mg of chloroquine base).
• The other ingredients are magnesium stearate and maize starch.

What Avloclor Tablets look like and contents of the pack

Avloclor Tablets are white and round. They have a break line on one side and the letter ‘A’ either side of the line. Avloclor Tablets come in packs of 20 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Avloclor Tablets is held by

Avloclor Tablets are manufactured by