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You should take SORIATANE as told by your doctor.

Usual dose:

For Severe psoriasis: starting dose of 25 mg once daily; maintenance daily dose from 25 mg to 50 mg; maximum daily dose of 75 mg.

For Other disorders of keratinization: 10 mg once daily; maximum daily dose of 50 mg.

Take SORIATANE once daily with food or after a meal.

Overdose:

In case of drug overdose, contact your doctor, or a Poison Control Centre, or go to Emergency room of the hospital near you immediately.

Missed dose:

If you miss a dose, take it as soon as you remember on the same day. Skip that dose if you do not remember until the next day.

The first few weeks before you begin to see any healing, you may begin to have some side effects.

Side effects of SORIATANE include the following:

Very common:

Dry eyes, particularly if you wear contact lenses;

Dry mouth, chapped lips, runny or dry nose;

Dry skin, peeling of fingertips and/or palms and soles, itchiness, rash, sticky skin, brittle nails;

Chills, joint pain, increased sensitivity to touch.

Most patients experience some degree of hair loss or abnormal hair texture but the condition varies among patients. The extent of hair loss that you may experience and whether or not all your hair will return to normal after treatment cannot be predicted.

Common:

Nosebleeds;

Ear problems such as pain, wax build-up, or buzzing in the ear;

Eye problems such as blurred vision, light sensitivity, pain, impaired vision;

Inflammation along the edge of the eyelid (blepharitis), inflammation or infection of the membrane lining the eyelids (conjunctivitis);

Tiredness, pain, thirst;

Swelling of leg, foot, ankle (oedema);

Bleeding or inflammation of the gums, or inflammation of the mucous lining of the mouth;

Nausea or abdominal pain;

Infections, including skin around the fingernail;

Decreased or increased appetite;

Back pain, bone pain or muscle pain;

Headache, trouble sleeping;

Skin problems such as cold sweat, excessive sweating, sensitivity to sunlight, inflamed, ulcerated, and oily or cracked skin.

Uncommon:

Decrease in night vision, or other eye problems, impaired hearing.

These are not all the possible side effects of SORIATANE. For more information, ask your prescriber or pharmacist.

Serious Side Effects:

Seek emergency treatment, if you experience any of the following symptoms:

• Shortness of breath, dizziness, nausea, chest pain, weakness or trouble speaking as these can be signs of a heart attack, or stroke.
• Swelling of a leg, foot, ankle or arm as these can be signs of a blood clot.
• Worsening depression, suicidal thoughts or thoughts of self-harm.

Other Serious Side Effects:

• Headaches, abdominal pain, diarrhea, rectal bleeding, nausea, vomiting, blurred vision, other visual problems.
• Decrease in night vision.
• Persistent feeling of dry eyes.
• Yellowing of the skin or eyes and/or dark urine, flu-like symptoms.

Aches or pains in bones or joints, or difficulty in moving. Bone changes have been detected by X-ray examination in patients taking SORIATANE. The extent of any harm from these changes is not presently known.

Serious Warnings and Precautions

You must avoid becoming pregnant while you are taking SORIATANE and until at least 3 years after you stop taking SORIATANE (discuss this with your doctor).

You must discuss effective birth control with your doctor before beginning treatment and you must use effective birth control without interruption as follows:

• for at least one month before you start SORIATANE;
• while you are taking SORIATANE; and
• for at least 3 years after you stop taking SORIATANE (discuss this with your doctor); and
• bearing in mind that any method of birth control can fail,
• it is recommended that you either abstain from sexual intercourse or use two effective methods of birth control at the same time (discuss this with your doctor);
• Low dose progesterone-only (Micronor 28) may not be an effective method to prevent pregnancy during treatment with SORIATANE and is not recommended for use.

Do not take SORIATANE until you are sure that you are not pregnant:

• You must have 2 negative pregnancy tests before you start SORIATANE. The first test (with a negative result) is obtained at screening when SORIATANE treatment is under consideration. A second (confirmatory) test (with a negative result) must be obtained not older than 3 days before the first dose.
• You must wait until the second or third day of your next menstrual period before you start SORIATANE.
• During treatment, you must have a pregnancy test at 28-day intervals. A negative pregnancy test, from a licensed laboratory, not older than 3 days is mandatory before you can receive another prescription for SORIATANE.
• After stopping treatment, you must have pregnancy tests every 1-3 months for at least 3 years after your last dose.

Every time you start a new course of treatment with SORIATANE, however long the intervening period may have been, you must use effective and uninterrupted birth control, during treatment and for at least 3 years after you stop taking SORIATANE.

Contact your doctor immediately if you do become pregnant while taking SORIATANE or after treatment has stopped. You should discuss the serious risk of having a baby with severe birth deformities because you are taking or have taken SORIATANE, as well as available options, with your doctor.

Do not breastfeed while taking SORIATANE and until at least 3 years after the treatment has stopped.

Male and female patients should avoid consuming alcohol while taking SORIATANE and until least 2 months after the treatment has stopped.

Male and female patients should not donate blood while taking SORIATANE and until at least 3 years after the treatment has stopped.

Before taking SORIATANE, talk to your doctor if you have any of the following conditions:

• high cholesterol or triglycerides
• high blood sugar
• liver or kidney problems
• mood changes
• skin problems
• high pressure in the brain (intracranial hypertension)
• eye problems or wear contact lenses. SORIATANE may cause dry eyes, light sensitivity, or other eyes problems.

While taking SORIATANE you should avoid prolonged exposure to sunlight or sun lamps. Use protective clothing or hat or sunscreen with SPF 30 or more.

SORIATANE is not recommended for use in children.

Before taking SORIATANE tell your doctor or pharmacist about all other medications you take including medications that you bought without prescription, vitamins, and natural products. Particularly if you are taking the following:

• Vitamin A
• Methotrexate
• Tetracyclines, phenytoin
• Glyburide, or a sulfonylurea
• St. John's wort
• Alcohol because it can convert SORIATANE to etretinate, a chemical that also causes birth defects and stays in the body longer.
• Low dose of progesterone-only contraceptive (Micronor 28)

Usual dose:

The usual dose for chronic phase CML is 100 mg once a day, either in the morning or in the evening.

The usual dose for accelerated or blast crisis CML or Ph+ALL is 140 mg once daily, either in the morning or in the evening.

The tablets should be swallowed whole, not crushed. They can be taken with or without food. Try to take SPRYCEL at the same time each day.

Avoid taking grapefruit juice since it may increase the blood levels of SPRYCEL.

Overdose:

In case of drug overdosage, contact a healthcare practitioner (e.g. doctor) hospital emergency department or regional poison control centre, even if there are no symptoms.

Missed dose:

If you miss a dose of SPRYCEL, take your next scheduled dose at its regular time. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.

Most patients taking SPRYCEL will experience some mild to moderate side effects. Most side effects can be managed by your doctor through additional medications, dose adjustments, or other measures.

The following information describes the most important side effects of which you must be aware. It is not a comprehensive list of all side effects recorded in clinical trials with SPRYCEL. You should report any unusual symptoms to your doctor.

Common side effects of SPRYCEL therapy include diarrhea, fever, headache, fatigue, nausea, skin rash, shortness of breath, cough, vomiting, pain, stomach pain, infection, upper respiratory tract infection, muscle aches, joint aches, and bone and extremity pain.

Other important common side effects include:

• Low Blood Counts: As with many leukemia drugs, therapy with SPRYCEL can be associated with low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your doctor will monitor your blood counts frequently after you start SPRYCEL, and may adjust your dose of SPRYCEL or withhold the drug temporarily in the event your blood counts drop too low, or administer additional supportive medicines to help your body regain normal blood levels. In the most severe cases, you may need to receive transfusions of red blood cells or platelets. If you develop a fever while your blood counts are depressed, you should notify your doctor immediately.
• Bleeding: Therapy with SPRYCEL may be associated with bleeding from a variety of sources. The most serious bleeding events observed in clinical studies included bleeding from the gastrointestinal tract and, bleeding into the brain. Bleeding into the brain resulted in the death of nine patients (less than 1% of all patients in clinical trials). The serious bleeding events were associated with very low platelet counts. Less severe bleeding events included bleeding from the nose, the gums, bruising of the skin and excessive menstrual bleeding. Your doctor will monitor your blood counts regularly, but you should notify your physician immediately should you experience bleeding or easy bruising, no matter how mild.
• Fluid Retention: Therapy with SPRYCEL may be associated with fluid building up under the skin of your lower extremities and around your eyes. In more severe cases, fluid may accumulate in the lining of your lungs, the sac around your heart, or your abdominal cavity. If you experience swelling, weight gain, or increasing shortness of breath it could be the result of fluid retention and you should report these events immediately to your doctor. Your doctor can manage fluid retention in a variety of ways while you are receiving SPRYCEL.
• Heart Rhythm Change: SPRYCEL has the potential to induce changes in heart rhythm in susceptible individuals who have certain inherited cardiac syndromes, take medication to control heart rhythm, or are prone to low levels of potassium or magnesium in their blood. Your doctor can assess your risk by reviewing the complete list of medications that you are taking and by monitoring the potassium and magnesium levels in your blood and electrocardiogram.

Other important uncommon side effects include:

• Liver Toxicity: Liver problems such as liver inflammation and increased liver enzyme levels

Other important rare side effects include:

• Pulmonary Arterial Hypertension (increase in blood pressure in the arteries supplying the lungs): SPRYCEL has been associated with an increase in blood pressure in the arteries supplying the lungs. Your doctor will assess your lung and heart function before and during the treatment of SPRYCEL.
• Severe Reaction Involving Skin and Other Organs: A serious skin reaction known as Stevens-Johnson syndrome has been reported with SPRYCEL. Very rarely, severe forms of this reaction may lead to death. Serious cases of another skin reaction known as erythema multiforme have also been reported with SPRYCEL. Stop taking the drug and seek immediate medical attention if you develop any combination of fever, sore mouth or throat, and blistering and/or peeling of your skin or mucous membranes (Stevens-Johnson syndrome) or raised red or purple skin patches with itching, burning pustular eruption (erythema multiforme).

BEFORE you use SPRYCEL talk to your doctor or pharmacist if you:

• are pregnant or planning to become pregnant. SPRYCEL can harm the fetus when given to a pregnant woman. Women should not become pregnant while undergoing treatment with SPRYCEL.

• are breast-feeding. Do not breast-feed if you are taking SPRYCEL.

• are a sexually active male or female. Men and women who take SPRYCEL are advised to use highly effective contraception.

• have a liver problem.

• have a heart problem, such as arrhythmia, long QT syndrome (a hereditary disorder of the heart electrical rhythm).

• have ever had or might now have a hepatitis B infection (an infection of the liver). This is because SPRYCEL could cause the hepatitis B virus to become active again, which can be fatal in some cases. Your doctor will check for signs of this infection before treatment with SPRYCEL is started. If the hepatitis B virus is found, you will be monitored closely during and for several months after treatment with SPRYCEL.

• are lactose intolerant or have been diagnosed with an intolerance to some sugars.

• are taking medicines to thin the blood or prevent clots. SPRYCEL may cause bleeding.

Talk to you doctor or pharmacist if you have:

• muscle aches/pains or weakness, or dark-colored urine

SPRYCEL may interact with other drugs, including those you take without a prescription. You must tell your doctor or pharmacist about all drugs, including prescription and non-prescription drugs, herbal products (e.g. St. John's Wort) and supplements you are taking or planning to take before you take SPRYCEL.

• Examples of medicines that increase the level of SPRYCEL in your bloodstream include ketoconazole, SPORANOX (itraconazole), erythromycin, BIAXIN (clarithromycin).
• Examples of medicines that decrease the amount of SPRYCEL in your bloodstream include dexamethasone, phenytoin, carbamazepine, rifampicin, and phenobarbital.
• Examples of a medicine whose blood levels might be altered by SPRYCEL include SANDIMMUNE/NEORAL (cyclosporine), simvastatin.

The absorption of SPRYCEL from your stomach into your bloodstream is best accomplished in the presence of stomach acid. You should avoid taking medicines that reduce stomach acid such as cimetidine, famotidine, ranitidine, or omeprazole while taking SPRYCEL. Medicines that neutralize stomach acid, such as aluminium hydroxide/magnesium hydroxide, calcium carbonate or calcium carbonate and magnesia may be taken up to 2 hours before or 2 hours after SPRYCEL.

Since SPRYCEL therapy may be associated with bleeding events, tell your doctor if you are regularly using blood thinners, including medications such as warfarin sodium or aspirin.

Always take STALEVO exactly as your doctor has instructed you to. You should check with your doctor or pharmacist if you are unsure.

Usual dose:

Each STALEVO tablet contains one complete dose of levodopa, carbidopa and entacapone. Each time you take STALEVO, take only one tablet. The tablet is not intended to be split or broken into smaller pieces.

Your doctor will tell you exactly how many tablets of STALEVO to take each day. Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.

Do not take more than 8 tablets a day.

Talk to your doctor or pharmacist if you think the effect of STALEVO is too strong or too weak, or if you detect possible side effects.

When and how to take STALEVO:

Strictly follow your doctor's instructions on when and how to use STALEVO, and any other antiparkinson drugs. Check with your doctor or pharmacist if you are unsure about these instructions or the instructions printed on the packaging.

STALEVO may be taken with or without food.

Taking STALEVO with food and drink:

For some patients, taking STALEVO with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts), may reduce the amount of levodopa available to the body, and STALEVO may be less effective. Tell your doctor if you are on a high protein diet.

Do not take STALEVO and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.

Stopping STALEVO treatment:

DO NOT stop taking STALEVO unless your doctor tells you to. In such case, your doctor may need to re-adjust the dosage of your other antiparkinson medications, especially levodopa, to give sufficient control of your symptoms. Abrupt discontinuation of both STALEVO and other antiparkinsonian medication may result in unwanted side effects, such as severe muscular stiffness, high fever and altered consciousness.

Overdose:

If you have taken more medication than what has been prescribed, contact either a hospital emergency department, the nearest Poison Control Centre or your doctor immediately. You may require medical attention even if there are no symptoms.

Missed dose:

If there is more than an hour until your next dose: take one tablet now, and the next tablet at the normal time.

If there is less than an hour until your next dose: take a tablet now, wait an hour, then take another tablet. After that go back to your normal schedule.

Do not take a double dose to make up for forgotten doses. Always leave at least an hour between STALEVO tablets, to avoid possible side effects.

If you are unsure about what to do, consult your doctor.

As with all medicines, patients treated with STALEVO may experience side effects, although not everybody gets them. If you experience any of these side effects, talk to your doctor as soon as you can. Many of the side effects can be relieved by adjusting the dose.

If any of the side effects get serious, tell your doctor, nurse or pharmacist.

Entacapone enhances the effectiveness and effects of levodopa. If you were not previously taking entacapone tablets with your levodopa/carbidopa tablets, switching to STALEVO may cause an increase in certain side effects of levodopa, such as uncontrolled movements, feeling sick (nausea), being sick (vomiting) or hallucinations.

Very common (affecting more than 1 user in 10):

• Uncontrolled movements (dyskinesia);
• Feeling sick (nausea);
• Harmless reddish-brown discoloration of the urine;
• Diarrhea;
• Muscle and/or joint pain.

Common (affecting 1 to 10 users in 100):

• Heart or artery disease events other than a heart attack (e.g. chest pain, swelling or blue coloration of the extremities, shortness of breath on exertion, angina, disease of the heart valves or other conditions identified by your physician), irregular heart rate or rhythm;
• Light-headedness or fainting due to low blood pressure; high blood pressure;
• Worsening of Parkinson's symptoms;
• Dizziness; drowsiness; tingling or numbness;
• Vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation;
• Inability to sleep; hallucinations, confusion; abnormal dreams including nightmares;
• Mental changes, including problems with memory or thinking; anxiety and depression (possibly with thoughts of suicide);
• Tiredness; chest pain;
• More frequent falling; impaired walking; loss of both strength and energy;
• Shortness of breath;
• Increased sweating; rashes;
• Muscle cramps; involuntary muscle contractions; swelling of legs;
• Blurred vision;
• Anemia, decreased appetite; decreased weight;
• Headache;
• Urinary tract infection.

Uncommon (affecting 1 to 10 users in 1000):

• Heart attack (chest pain often associated with left shoulder or jaw pain, feeling of constriction around chest and sweating);
• Bleeding in the gut;
• Abnormal liver function tests;
• Psychotic symptoms; feeling agitated;
• Inflammation of the colon (colitis) which may lead to diarrhea and weight loss;
• Skin, nail, hair and sweat discolorations;
• Inflammation of the veins in the legs;
• Changes in the blood cell count which may result in bleeding;
• Swallowing difficulties;
• Inability to urinate;
• Generally feeling unwell.

Rare or very rare effects:

• Convulsions.

STALEVO may lower your blood pressure and cause a decrease in your blood pressure when standing up rapidly after sitting or lying down), with or without symptoms such as dizziness, nausea, syncope (fainting) and sweating. Decreases in blood pressure may occur more frequently during the start of treatment with STALEVO. Therefore, you should avoid standing rapidly after sitting or lying down, especially after prolonged periods. You should also be careful if you are taking other medicinal products that may decrease blood pressure.

Severe diarrhea while taking STALEVO can cause significant loss of weight for some individuals. In some cases diarrhea and weight loss have been caused by inflammation of the colon, which has occurred during treatment with entacapone. Therefore, it is important to tell your doctor if you have diarrhea so that the cause of your symptoms can be determined. Your weight should also be closely monitored. Your treatment may need to be adjusted to avoid diarrhea and excessive weight loss.

Other:

The exact frequencies of these side effects are not known but are based upon reports received since the product has been on the market:

• hepatitis (inflammation of the liver);
• itching;
• excessive daytime somnolence; sudden sleep onset episodes.

If you notice any other possible side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Some people feel sleepy, drowsy, or, rarely, may suddenly fall asleep without warning (i.e. without feeling sleepy or drowsy) when taking STALEVO. During treatment with STALEVO take special care when you drive or operate a machine. If you experience excessive drowsiness or a sudden sleep onset episode, refrain from driving and operating machines, and contact your physician.

Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the drugs used to treat Parkinson's disease. Therefore, your doctor should perform periodic skin examinations.

In a study of patients with early stage Parkinson's disease, who were treated with levodopa/carbidopa or STALEVO(levodopa/carbidopa/entacapone) for an average of about 3 years, prostate cancer was reported more frequently in the group of patients that received STALEVO. It is not known if treatment with STALEVO affects the risk of having prostate cancer. Therefore, it is important for men to have their regular prostate examinations during treatment with STALEVO. STALEVO should not be used for the treatment of early stage Parkinson's disease.

BEFORE you use STALEVO talk to your doctor or pharmacist if:

• You have ever had a heart attack, asthma or any other diseases of the heart, blood vessels or lungs.
• You have or ever had a liver problem, such as liver disease or abnormal liver function tests.
• You have or ever had a severe kidney problem.
• You have or ever had hormone-related diseases.
• You have ever had inflammatory bowel disease.
• You have problems urinating, or have been told you have an enlarged prostate, prostate cancer, or elevated levels of Prostate Specific Antigen (PSA).
• You have ever had stomach ulcers.
• You have ever had convulsions.
• You have ever suffered from any form of severe mental disorder.
• You feel depressed, have suicidal thoughts, or notice unusual changes in your behavior.
• You have chronic wide-angle glaucoma. Your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
• You are taking other medicines that can cause low blood pressure. You should be aware that STALEVO may make these reactions worse.
• Uncontrolled movements begin or get worse after you start taking STALEVO, your doctor may need to change the dose of your antiparkinson medications.
• You have been told by your doctor that you have a hereditary intolerance to some sugars, contact your doctor before taking this medicinal product.
• You are taking any iron supplements or multivitamins containing iron.
• Tell your doctor if you or your family/caregiver notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviors are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.

If any of the following occurs, tell your doctor immediately:

• If you find yourself suddenly falling asleep, or if you feel very drowsy (see precaution in box above).
• If your muscles get very rigid or jerk violently, or if you suffer from tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure (signs of Neuroleptic Malignant Syndrome, NMS).
• If you experience diarrhea, your doctor may follow-up on your weight in order to prevent potential excessive weight loss.
• If you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time after starting treatment with entacapone, contact your doctor. He/she may decide to do a general medical evaluation, including blood tests to check liver function.

If you are going to have a surgery with a general anaesthesia, inform the doctor that you are taking STALEVO.

If you feel the need to stop using STALEVO, please consult your doctor first. Abruptly stopping treatment or rapidly decreasing the dose can lead to serious side effects in some patients. It may be necessary to reduce the dose of STALEVO gradually, and make changes in your other antiparkinson medication, in order to prevent side effects and keep your Parkinson's symptoms from getting worse.

Driving and using machines:

STALEVO may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, be particularly careful when you drive or when you operate any tools or machines (see precaution in box above).

Older people:

If you are over 65, you can take STALEVO without dose adjustment.

Pregnant women:

If you are pregnant or think you may be pregnant, do not take STALEVO before consulting your doctor. STALEVO is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risk of taking STALEVO during pregnancy.

Breast-feeding mothers:

If you are breast-feeding, tell your doctor. You should not breast-feed while under treatment with STALEVO.

Children and adolescents:

The use of STALEVO has not been established in children and adolescents less than 18 years of age and can therefore not be recommended.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any to lower your blood pressure, non-prescription medicines or herbal products. STALEVO may increase the effects and side effects of certain antidepressants and some other medicines. These include MAO-A inhibitors (e.g. moclobemide), tricyclic antidepressants (e.g. amitryptiline) and noradrenaline re-uptake inhibitors (e.g. desipramine, maprotiline and venlafaxine), as well as paroxetine, rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa and apomorphine.

Watch out for additional effects if you take these medicines while being treated with STALEVO.

The effects of STALEVO may be weakened by certain medicines. It includes medicines:

• used to treat mental disorders (certain antipsychotics, such as chlorpromazine, haloperidol and risperidone),
• used to treat nausea and vomiting (certain antiemetics, such as prochlorperazine and promethazine),
• used to prevent convulsions (such as phenytoin),
• used to relax the muscles (such as papaverine).

Tell your doctor if you are taking these medicines, or if you notice that STALEVO does not work as well when you take them.

Iron supplements or multivitamins containing iron may reduce the amount of levodopa and/or carbidopa available to the body, and may make STALEVO less effective. STALEVO may also make it harder for you to digest iron. Therefore, do not take STALEVO and iron supplements or multivitamins containing iron at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.

Your dosage will be based on your medical condition, the number of meals you consume in a day, and your response to treatment.

Take the medicine before meals. If you skip a meal, skip the dose of STARLIX. If you add a meal, take an extra dose.

Your doctor may start you on a lower dose of STARLIX and gradually increase it.

If you consume liquid meals, you may need a higher dose of STARLIX. Talk to your doctor about this.

Follow the instructions on your prescription label carefully. Don't take more or less of the drug than is prescribed.

STARLIX Overdose

If you suspect an overdose, you should contact a poison-control center or emergency room immediately.

Missed Dose of STARLIX

If you miss a dose of STARLIX, take it as soon as you remember, but only if you're getting ready to eat a meal.

Skip the missed dose if it's almost time for your next scheduled dose.

Don't take extra medicine to make up for a missed dose.

Common Side Effects of STARLIX

Tell your doctor if any of the following side effects become severe or don't go away:

• Headache
• Runny nose or nasal congestion
• Joint pain or stiffness
• Back pain
• Constipation
• Flu-like symptoms
• Cough
• Weight gain

Serious Side Effects of STARLIX

Call your doctor immediately if you experience any of the following serious side effects:

• Seizures
• Yellowing of the skin or eyes (jaundice)
• Signs of an allergic reaction, which may include hives; difficulty breathing; or swelling of the face, lips, tongue, or throat.

STARLIX shouldn't be used in people with type 1 diabetes (the body doesn't produce any insulin) or diabetic ketoacidosis (a dangerous condition that can occur if high blood sugar is untreated).

Before taking this medicine, tell your doctor if you have or have ever had:

• Liver disease
• Kidney disease
• Pituitary disease
• Neuropathy
• Adrenal problems
• Gout

Tell your healthcare providers that you're taking STARLIX before having any type of surgery, including a dental procedure.

This drug may cause changes in your blood sugar.

You should know the symptoms of high and low blood sugar episodes and be prepared to treat them.

Talk to your physician if you experience an illness, fever, injury, or unusual stress, because these events can affect your blood-sugar levels and how much STARLIX you need.

STARLIX helps control diabetes but does not cure it. Continue to take it even if you feel well, and don't stop taking it without talking with your doctor.

Your doctor will probably want to check your glucose levels often while you are taking STARLIX.

Always wear a diabetic ID bracelet to be sure you get proper treatment in case of an emergency.

Pregnancy and STARLIX

STARLIX should not be used during pregnancy.

Tell your doctor if you're pregnant or plan to become pregnant before taking STARLIX.

You shouldn't breastfeed while taking STARLIX. The drug can pass into breast milk and may harm a breastfeeding baby.

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Albuterol (Proventil, Ventolin, ProAir)
• Allergy medications
• Aspirin and nonsteroidal anti-inflammatory drugs ,such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn)
• Beta-blockers, such as propranolol (Inderal)
• Chloramphenicol (Chloromycetin)
• Chlorpromazine (Thorazine)
• Cold medicine
• Corticosteroids, such as dexamethasone (Decadron), methylprednisolone (Medrol), or prednisone (Deltasone, Orasone)
• Diuretics (water pills)
• Epinephrine
• Estrogens
• Fluphenazine (Prolixin)
• Isoniazid (Nydrazid, in Rifamate)
• Medications that contain alcohol or sugar
• Mesoridazine (Serentil)
• Niacin
• Oral contraceptives (birth control pills)
• Perphenazine (Trilafon)
• Phenelzine (Nardil)
• Probenecid (Benemid)
• Prochlorperazine (Compazine)
• Promazine (Sparine)
• Promethazine (Phenergan)
• St. John's wort
• Terbutaline (Brethine, Bricanyl)
• Thioridazine (Mellaril)
• Thyroid medication
• Tranylcypromine (Parnate)
• Trifluoperazine (Stelazine)
• Triflupromazine (Vesprin)
• Trimeprazine (Temaril)

STARLIX and Alcohol

Alcohol can affect your blood sugar.

Talk to your doctor about whether consuming alcohol is safe while taking STARLIX.