Physicians should completely familiarize themselves with the contents of this leaflet before prescribing hydroxychloroquine .
Hydroxychloroquine belongs to the family of medicines called antiprotozoals. Protozoa are tiny, one-celled animals. Some are parasites that can cause many different kinds of infections in the body.
This medicine is used to prevent and to treat malaria and to treat some conditions such as liver disease caused by protozoa. It is also used in the treatment of arthritis to help relieve inflammation, swelling, stiffness, and joint pain and to help control the symptoms of lupus erythematosus (lupus; SLE).
This medicine may be given alone or with one or more other medicines. It may also be used for other conditions as determined by your doctor.
Hydroxychloroquine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, hydroxychloroquine is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Children are especially sensitive to the effects of hydroxychloroquine. This may increase the chance of side effects during treatment. Overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-milligrams [mg] strength) of chloroquine has resulted in death in small children. Because hydroxychloroquine is so similar to chloroquine, it is probably just as toxic.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hydroxychloroquine in the elderly with use in other age groups.
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine with meals or milk to lessen possible stomach upset, unless otherwise directed by your doctor.
Keep this medicine out of the reach of children. Children are especially sensitive to the effects of hydroxychloroquine and overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-mg strength) of chloroquine has resulted in death in small children. Hydroxychloroquine is probably just as dangerous.
It is very important that you take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of serious side effects.
If you are taking this medicine to help keep you from getting malaria, keep taking it for the full time of treatment. If you already have malaria, you should still keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return.
Hydroxychloroquine works best when you take it on a regular schedule. For example, if you are to take it once a week to prevent malaria, it is best to take it on the same day each week. Or if you are to take 2 doses a day, 1 dose may be taken with breakfast and the other with the evening meal. Make sure that you do not miss any doses. If you have any questions about this, check with your health care professional.
For patients taking hydroxychloroquine to prevent malaria:
For patients taking hydroxychloroquine for arthritis or lupus:
For patients unable to swallow hydroxychloroquine tablets:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after long-term treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
If your symptoms do not improve within a few days (or a few weeks or months for arthritis), or if they become worse, check with your doctor.
Hydroxychloroquine may cause blurred vision, difficulty in reading, or other change in vision. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.
Malaria is spread by mosquitoes. If you are living in, or will be traveling to, an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. When this medicine is used for short periods of time, side effects usually are rare. However, when it is used for a long time and/or in high doses, side effects are more likely to occur and may be serious.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.