Serious Warnings and Precautions

Diabetic ketoacidosis (DKA), is a serious and life-threatening condition that requires urgent hospitalization. DKA has been reported in patients with type 2 diabetes mellitus (T2DM) with normal or high blood sugar levels who are treated with FORXIGA and other sodium-glucose co-transporter 2 (SGLT2) inhibitors. Some cases of DKA have led to death.

Seek medical attention right away and stop taking FORXIGA immediately if you have any of the following symptoms (even if your blood sugar levels are normal): difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, feeling very thirsty, feeling unusually tired, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.

Do not use FORXIGA if you have:

• DKA or a history of DKA.
• type 1 diabetes.

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

• have type 1 diabetes (your body does not produce any insulin). FORXIGA should not be used in patients with type 1 diabetes.
• have an increased chance of developing DKA, including if you:
  • are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
  • are on a very low carbohydrate diet;
  • drink a lot of alcohol;
  • have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas;
  • are hospitalized for major surgery, serious infection or serious medical illness;
  • have a history of diabetic ketoacidosis (DKA).
• are older than 65 years of age
• have or have had any kidney problems
• have or have had any cases of liver disease
• have heart disease or low blood pressure
• are taking a medicine for high blood pressure or taking a water pill (used to remove excess water from the body)
• are taking medicines to lower your blood sugar such as glyburide, gliclazide or glimepiride (sulfonylureas) or insulin. Taking FORXIGA with any of these medicines can increase the risk of having low blood sugar (hypoglycemia)
• have a history of bladder cancer
• have intolerance to some milk sugars. FORXIGA tablets contain lactose
• often get urinary tract infections

FORXIGA is not recommended for use in patients under 18 years of age.

FORXIGA will cause your urine to test positive for sugar (glucose).

FORXIGA may cause changes in the amount of cholesterol or fats in your blood.

FORXIGA increases the chance of getting a yeast infection of the penis or vagina. This is more likely in people who have had yeast infections in the past.

FORXIGA may cause abnormal kidney function. Your doctor will do blood tests to monitor how well your kidneys are working while you are taking FORXIGA.

Driving and using machines:

FORXIGA may cause dizziness or lightheadedness. Do not drive or use machines until you know how the medicine affects you.

These are not all the possible side effects you may feel when taking FORXIGA. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• sore throat
• influenza
• constipation
• diarrhea
• nausea
• back pain
• pain in the arms, legs, hands or feet
• headache

If any of these affects you severely, tell your doctor or pharmacist.

FORXIGA can cause abnormal blood test results. Your doctor will decide when to perform blood tests. They may check kidney function, blood fat levels (Low Density Lipoprotein cholesterol or LDL-C) and amount of red blood cells in your blood (hematocrit).

Diabetic Ketoacidosis (DKA) is a serious medical condition normally seen at high blood sugar levels; however, it has also been seen at near normal blood sugar levels. Get medical help right away if you have any of the symptoms in the table below under DKA, even if your blood sugar levels are normal.

Talk to your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Drugs that may interact with FORXIGA include

• medicines you take for diabetes, especially sulfonylurea medications or insulin. Low blood sugar (hypoglycemia) may occur if you already take another medication to treat diabetes. Discuss with doctor how much of each medicine to take.

Recommended adult starting dose: one 5 mg tablet a day. Your doctor may increase your dose to one 10mg tablet, if needed to further control your blood sugar level.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose of FORXIGA, take it as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose.

Serious Warnings and Precautions

Neuroleptic malignant syndrome (NMS) is a rare, but life-threatening, disorder of the nervous system that has been linked with drugs such as FLUANXOL. It is characterized by high fever, unusual stiffness of the muscles, disorder of your consciousness, sweating and fast heart rate.

Like all medications FLUANXOL can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor if you experience these or other side effects.

At the beginning of treatment, FLUANXOL may make you feel drowsy and dizzy, so you should not drive a car or use any tools or machines until you are sure FLUANXOL does not affect your mental alertness.

Side effects that have been reported by patients taking FLUANXOL include:

• an allergic reaction (symptoms include skin rash, hives, swelling, difficulty breathing).

• if you experience fever (increased temperature) or soreness of the mouth, gums, or throat that happens while you are taking FLUANXOL, contact your doctor IMMEDIATELY.

• muscle spasm, stiffness, shaking or uncontrolled body movements; this may indicate that you have a syndrome called Tardive Dyskinesia. These can happen in different parts of the body, such as the tongue, face, mouth, jaw, eyes, hands, arms and legs. Small uncontrollable movements of the tongue may be an early sign of the syndrome. If FLUANXOL is stopped when these symptoms are noticed, the syndrome may not develop further. Tardive Dyskinesia can sometimes be permanent, even if you stop taking FLUANXOL. Contact your doctor immediately if this happens to you.

• dry mouth, dizziness, blurred or altered vision, constipation, excessive salivation or sweating, trouble passing urine, decreases in blood pressure, increases in heart rate, weight changes, skin rash, decreased sexual interest or function, and changes in your monthly cycle (if you are female). Tell your doctor or pharmacist if you think you have any of these or other effects while taking FLUANXOL.

• a serious condition called Neuroleptic Malignant Syndrome; symptoms include fever, stiff muscles, confusion, reduced consciousness, irregular heart rate and sweating. Go to the nearest Emergency Room of a hospital if you think this is happening to you.

• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.

As with other medicines that work in a way similar to flupentixol (the active ingredient of FLUANXOL), rare cases of the following side effects have been reported:

• QT prolongation (slow heart rate and changes to the ECG)

• Ventricular arrhythmias (irregular heart beat)

• Torsades de Pointes (a special kind of irregular heart beat)

In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death.

Your doctor should check your body weight before starting FLUANXOL and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting FLUANXOL. They will monitor blood sugar, and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism, you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

You should also tell you doctor if you notice any symptoms that worry you, even if you think the problems are not connected with FLUANXOL or are not listed here.

Drugs that may interact with FLUANXOL include:

• tricyclic antidepressant medicines

• guanethidine and similar medicines (used to lower the blood pressure)

• barbiturates and similar medicines

• levodopa and similar medicines (used to treat Parkinson's disease)

• metoclopramide (used in the treatment of gastro-intestinal disorders)

• other antipsychotic medicines (e.g. thioridazine)

• medicines that change the heartbeat (e.g. quinidine, amiodarone, sotalol, erythromycin, moxifloxacin, lithium)

Fluanxol may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with FLUANXOL.

Consult your doctor before taking other medications, including over-the-counter medicines and herbal remedies. Some drugs can produce additional side effects when they are used in combination with FLUANXOL.

You should continue taking VANCOCIN until the prescription is finished, even if you feel better.

Stopping VANCOCIN too soon or missing a dose may prevent your infection from being completely cured, as bacteria such as VRE can become resistant to antibiotics (see above).

Before taking VANCOCIN, tell your doctor and pharmacist if you have any allergies. The drug may contain inactive ingredients that can cause allergic reactions or other problems.

Also, tell your doctor and pharmacist if you have a medical history of kidney disease, hearing problems, any kind of inflammatory bowel disease (IBD), or stomach/intestinal issues.

Elderly patients may be more sensitive to the side effects of VANCOCIN, which may increase their risk for hearing problems or kidney damage.

VANCOCIN and Pregnancy

VANCOCIN is generally considered safe to use during pregnancy, but it should only be used in pregnant women when absolutely needed. 

The medication does not pass into breast milk and is unlikely to cause harm to a breastfeeding baby, but talk to your doctor before breastfeeding while taking VANCOCIN.

The most common side effect of VANCOCIN is an upset stomach.

You should tell your doctor if this problem becomes severe or does not go away.

Other, less common, side effects may include:

• Flu-like symptoms such as sore throat, fever, or chills
• Rash on the skin
• Hives
• Itching
• Breathing or swallowing difficulties
• Skin redness above the waist
• Muscle tightness or pain in the chest and back
• Bleeding or bruising
• Fainting
• Dizziness
• Ringing in the ears
• Blurred vision

Combining VANCOCIN with certain drugs may increase the risk of side effects and is typically not recommended.

However, in some cases, both drugs are needed and may be the best treatment for you. Your doctor may adjust your dose or how often you take each medication.

The following drugs are usually not recommended to take with VANCOCIN:

• Amikacin (amikacin sulfate)
• Garamycin (gentamicin)
• Tobi (tobramycin)
• Anectine (succinylcholine chloride)
• Coumadin (warfarin sodium)

The drugs Questran (cholestyramine) and Colestid (colestipol) can decrease VANCOCIN's effects when given at the same time. You should take these drugs at least three to four hours apart.

This is not a complete list of drugs that interact with VANCOCIN.

Give your healthcare provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use.

Other Interactions 

There are no restrictions on food, drink, or activities while taking VANCOCIN unless your doctor tells you otherwise.

Your dose of VANCOCIN will depend on the strength of the medicine, the number of doses you take daily, and the amount of time you will use the drug. You should follow your doctor's dosing directions.

Oral Dosage

When taken by mouth, VANCOCIN is usually taken four times a day for seven to 10 days or as directed by your doctor.

The following are typical oral dosages for the treatment of C. difficile:

• Adults: 125 milligrams, four times a day.
• Children: The dose is based on body weight and must be determined by your doctor. The usual dose is 40 milligrams per kilogram of body weight per day, divided into three or four doses and taken for seven to 10 days. The total daily dose usually does not exceed 2000 milligrams.

Intravenous Dosage

Intravenous (IV) treatment with VANCOCIN is highly variable.

For these reasons dosing is individualized based on several patient factors including but not limited to age, weight, site/type of infection, and kidney function.

Pharmacists and other healthcare providers will individualize and adjust doses based on ongoing patient response and monitoring of VANCOCIN concentrations in the blood.

VANCOCIN Overdose

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

You can get in touch with your local poison control center.

Missed Dose of VANCOCIN

If you miss a dose, take it as soon as you remember.

If it is close to the time of the next dose, skip the missed dose and resume your normal schedule.

You should not double up on doses to catch up.