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

• are pregnant, think you are, or plan to get pregnant
• are breastfeeding, or planning to breastfeed, as metronidazole is excreted in human breast milk
• have liver problems
• have any allergies to this drug or its ingredients (see What the nonmedicinal ingredients are:) or a known allergy to nitroimidazoles (e.g. tinidazole)
• have an active or chronic severe disease of the nervous system
• have any blood disorder (e.g. leukemia, hemophilia, or other). Your doctor may order periodic blood tests.
• have a thyroid condition or hypoadrenalism (underactive adrenal glands)

Contact your doctor if the following occurs while taking FLAGYL:

• You feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions), have temporary eyesight problems ( e.g. blurred or double vision). If this happens do not drive or use machinery or tools
• You feel tingling, pain, numbness or weakness in the arms or legs ( peripheral neuropathy)

Unnecessary use of FLAGYL should be avoided and prolonged treatment duration should be carefully weighed by your doctor. Its use should be reserved for the conditions described in the “What the medication is used for:” section.

Avoid alcohol during FLAGYL treatment and for at least one day following treatment to avoid an adverse reaction.

If a sexual partner shows signs of infection, the partner should be examined and treated by the doctor too.

If you have liver problems, your doctor may tell you to use a lower dose or to use the medicine less often. FLAGYL may darken your urine and this is not considered a concern.

Like all medicines, FLAGYL can cause side effects, although not everybody gets them.

These side effects may include:

• Unpleasant taste in the mouth
• Furred tongue or tongue discoloration
• Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhea
• Loss of appetite
• Feeling sleepy or dizzy

This is not a complete list of side effects. For any unexpected side effects while taking FLAGYL, contact your doctor or pharmacist.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because FLAGYL can affect the way some other medicines work. Also, some other medicines can affect the way FLAGYL works.

In particular tell your doctor if you are taking any of the following medicines:

• Medicines used to thin the blood such as warfarin (Coumadin);
• Lithium;
• Phenobarbital;
• Phenytoin (Dilantin);
• 5-fluorouracil (or 5-FU);
• Busulfan (Myleran);
• Cyclosporin (Neoral);
• Disulfiram;
• Vecuronium.

If you are not sure, talk to your doctor or pharmacist before taking FLAGYL.

Do not drink any alcohol while you are taking FLAGYL and for at least 1 day after finishing your course. Drinking alcohol while using FLAGYL might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.

Usual adult dose:

Treatment of Trichomoniasis:

Oral Administration:

Single-Dose Treatment:

For both women and men, 2 g (4 capsules) administered as a single dose after a meal.

Standard Ten-day Treatment:

• Women: One 250 mg tablet twice a day, morning and night for 10 consecutive days.
• Men: One 250 mg tablet twice a day for 10 consecutive days.

For both men and women, it may be occasionally necessary to give a second ten-day course after 4 to 6 weeks.

Vaginal Treatment:

Cream—One applicator full of FLAGYL Cream (500 mg) once or twice a day into the vagina for 10 or 20 consecutive days even during menstruation.

The applicator should not be used after the 7th month of pregnancy.

Treatment of Amebiasis:

Adults:

Intestinal Amebiasis—Three 250 mg tablets three times daily for 5 to 7 days.

Amebic abscesses of the liver—Two to three 250 mg tablets three times daily for 5 to 7 days.

Children:

Administer 35 to 50 mg/kg/day in three divided doses for 5 to 7 days.

Treatment of Giardiasis:

Adults:

One 250 mg tablet twice daily for 5 to 7 days.

Children:

Administer 25 to 35 mg/kg/day in two divided doses for 5 to 7 days.

Treatment of Bacterial Vaginosis:

Adults:

500 mg orally twice a day for 7 days.

Concurrent treatment of sexual partners is not usually indicated.

Anaerobic Infections:

Adults:

In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially. This may be followed by oral therapy with FLAGYL capsules.

Oral Administration:

500 mg every 8 hours. Treatment for seven days should be satisfactory for most patients.

Overdose:

Warning:

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 forget to take FLAGYL, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

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

• You have any allergies to this drug or its ingredients.
• You have a history of blood disease or your blood is not normal in some way.
• You are pregnant or nursing.
• You plan to be in the sun. Avoid excessive exposure to sunlight, including sunlamps and tanning beds.
• Irritation occurs during treatment, discuss with your doctor. Your doctor may advise that you discontinue the medication, discontinue the medication temporarily, or take the medication less frequently.

Drugs that may interact with METROCREAM include: coumarin, warfarin, other imidazole preparations such as clotrimazole and tioconazole, and possibly alcohol.

Usual adult dose:

Results should be expected in about three weeks with continuing improvement through nine weeks of treatment.

This medicine is for external use only. Do not use this medicine in or near the eyes. If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Overdose:

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects. Massive ingestion may produce vomiting and slight disorientation. If you or anyone else suspects an overdose, promptly call your doctor or pharmacist.

Missed dose:

If you miss a dose of this medicine, apply 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.

EFFEXOR comes in immediate-release tablets of 25 milligrams (mg), 37.5 mg, 50 mg, 75 mg, and 100 mg, and in extended-release capsules of 37.5 mg, 75 mg, 150 mg, and 225 mg.

If taken as an immediate-release pill, the dose is usually split up and taken two or three times during the day, with food.

If you're taking the extended-release capsules (tablets in the generic form), take your dose at breakfast or dinner, ideally at the same time every day.

You need to swallow the capsule whole: Do not crush, chew, divide, or place it in a liquid.

If you can't ingest the capsule in one take, open it and sprinkle the drug on a soft liquidly food such as pudding or applesauce, swallow the food immediately, and chase it down with a glass of water.

Doctors usually start patients between 37.5 mg to 75 mg a day, gradually increasing dosage to an average maximum of 225 mg a day.

It can take up to two months for EFFEXOR to work.

Do not stop taking the medication without first consulting with your doctor, as stopping EFFEXOR abruptly can bring on anxiety, irritability, fatigue, headaches, vomiting, and tremors.

EFFEXOR Overdose

If you have taken too much EFFEXOR, call your doctor or poison control center immediately, or go straight to an emergency room.

Symptoms of a EFFEXOR overdose include:

• Vomiting
• Rapid heart rate
• Blurry vision
• Extreme fatigue
• Convulsions

Missed Dose of EFFEXOR

Take the missed dose as soon as you remember, unless it's close to the time for your next dose.

In that case, skip the missed dose and take the next dose at the regular time.

Do not take two doses of EFFEXOR together, and do not take more than one dose of the extended-release capsule or tablet in one day.

Common Side Effects of EFFEXOR

Check with your doctor if these side effects persist, or become overly troublesome:

• Unusual dreams
• Insomnia
• Sexual dysfunction
• Drowsiness, weakness, or fatigue
• Dizziness, blurred vision
• Loss of appetite
• Heartburn
• Increased sweating
• Headaches
• Nausea
• Vomiting
• Constipation
• Diarrhea
• Dry mouth
• Chills
• Gas or stomach pain
• Runny nose
• Tremors, shaking, chills
• Tingling sensations
• Heartburn
• Weight loss

Serious Side Effects of EFFEXOR

Call your doctor or get immediate medical help if you experience any of these serious side effects:

• Symptoms of serotonin syndrome, including agitation, hallucinations, coma, muscle twitching, rapid heartbeat, compromised coordination, high or low blood pressure, excessive sweating or fever
• Increased cholesterol levels
• Narrow-angle glaucoma, enlarged pupils
• Low-salt (sodium) levels in the blood
• Seizures or convulsions
• Abnormal bleeding, increased bruising
• Severe allergic reactions
• Chest discomfort, or difficulty breathing

EFFEXOR is generally not recommended for children younger than 18 years old, but if it has been prescribed, be aware that studies have suggested that it might slow growth and weight gain, and contribute to suicidal thoughts.

Low sodium in the blood is more likely to occur in elderly patients and those taking diuretics.

EFFEXOR and Weight Gain

Like many other antidepressants, use of EFFEXOR has been associated with weight gain.

Weight gain caused by EFFEXOR may be due to fluid retention, lack of exercise, increased appetite, or other factors.

Experts recommend physical activity and eating fewer high-calorie foods to manage your weight while taking EFFEXOR or other antidepressants.

Allergic Reaction to EFFEXOR

Seek medical help immediately at any sign of an allergic reaction to EFFEXOR:

• Difficulty breathing
• Swelling of the face, tongue, eyes, or mouth
• Rash, itchy hives, or blisters that can occur alone or accompany fever or joint pain

The FDA has issued a black-box warning for EFFEXOR because studies found an increased risk of suicidal thoughts and behavior in children, teenagers, and young adults taking antidepressants, including Effexor.

EFFEXOR can interact with other prescription or nonprescription medications in ways that hinder its effectiveness or bring on serious side effects.

Tell your doctor if you are taking other antidepressants, including such selective serotonin uptake inhibitors (SSRIs) as Paxil (paroxetine) or Zoloft (sertraline), other SSNRIs such as Cymbalta (duloxetine) or Pristiq (desEFFEXOR), or any monoamine oxidase inhibitors (MAOIs), including Nardil (phenelzine) or Marplan (isocarboxazid), or whether you stopped taking an MAOI within 14 days of beginning EFFEXOR.

You also need to inform your healthcare provider if you take so-called tripan medications such as sumatriptan (Imitrex, Imigran) for migraines, certain painkillers such as Utram (tramadol), the antibiotic linezolid (Zyvox), or intravenous methylene blue, which is used to treat the blood disorder methemoglobinema.

These medications, along with the herbal supplement St. John's wort, raise the level of serotonin in the brain, and when taken in tandem with EFFEXOR can trigger a rare but potentially life-threatening condition called serotonin syndrome.

EFFEXOR might also enhance the anti-blood-clotting effect of such blood thinners as warfarin (Coumadin, Jantoven), as well as aspirin, and non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen (Advil, Motrin).

EFFEXOR Withdrawal

If you stop taking EFFEXOR suddenly, or reduce your dosage, withdrawal symptoms can occur, often within a matter of hours.

EFFEXOR withdrawal symptoms include:

• Anxiety, confusion, or agitation
• Lack of coordination or vertigo
• Nausea, diarrhea, or vomiting
• Sleep disorders or nightmares
• Headache
• Dry mouth
• Fatigue
• Brain zaps (electric-like shocks)

Many of these symptoms can cause severe disorientation, and are especially dangerous to people driving, operating machinery, or engaging in other risky tasks.

Talk to your doctor about any unusual side effects, and follow your doctor's instructions for tapering off or stopping your use of EFFEXOR.

Pregnancy and EFFEXOR

EFFEXOR may cause harm to a developing fetus.

Newborns whose mothers took EFFEXOR in the last three months of pregnancy were reported to experience feeding and breathing problems, and seizures, shakes, jitters, and constant crying immediately following delivery.

For women who take antidepressants in the second and third trimesters of pregnancy, there is a risk that the baby can be born prematurely, according to the National Alliance on Mental Illness.

EFFEXOR does pass into breast milk, but there have been no sufficient studies to determine the risk to the infant, so talk to your doctor if you plan to breastfeed.

EFFEXOR and Alcohol

Do not drink alcohol while taking EFFEXOR, as alcohol can augment the sleepiness effect of the drug.

EFFEXOR and Other Interactions

Since EFFEXOR can induce sleepiness or hinder your ability to think clearly or react quickly, do not drive or operate heavy machinery until you know how Effexor affects you.

Your doctor needs to know about all the medications you take, whether prescription or over-the-counter, vitamins, illegal or recreational drugs, and dietary or herbal supplements, as they can affect how Effexor works, and vice-versa.

EFFEXOR interacts with the following drugs, which should not be taken with Effexor or taken only under close medical supervision:

• Monoamine oxidase inhibitors (MAOIs), including phenelzine sulfate (Nardil), tranylcypromine sulfate (Parnate), isocarboxazid (Marplen), rasagline (Azilect), selegeline (Eldepryl, Emsam)
• Antidepressants, including amitriptyline (Elavil), citalopram (Celexa), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), fluvoxamine (Luvox)
• Tripans (Imitrex, Imigran, Migriptan)
• Linezolid (Zyvox)
• Cimetidine (Tagamet, Tagamet HB)
• Ketoconazole (Nizoral)
• Ibuprofen (Advil, Motrin)
• Naproxen (Aleve, Naprosyn)
• Warfarin (Coumadin)
• Aspirin (Bayer)
• Lithium (Eskalith, LithoBid)
• Tramadol (Ultram, Ultracet)
• Tryptophan
• St. John's wort

BEFORE you use Lotemax Ointment and Gel talk to your doctor or pharmacist:

• If you have an eye disease/infection caused by viruses such as herpes simplex, vaccinia and varicella or caused by bacteria or a fungus or if you think you have any other eye infection.

• If you had or have glaucoma or increased pressure in the eye as Lotemax Ointment and Gel might increase the pressure in the eye. Glaucoma, which occurs when the pressure in the eye increases for a period of time, can cause damage to the optic nerve, vision problems, and sometimes a loss of vision. Your doctor may monitor your intraocular pressure.

• If signs and symptoms fail to improve after two days of using Lotemax Ointment and Gel, consult your doctor

• If you are pregnant or planning to become pregnant. Lotemax Ointment and Gel should not be used in pregnant women unless the doctor determines this is appropriate for you as there might be a risk of harm to the embryo or fetus.

• If you are breastfeeding or planning to breastfeed. Lotemax Ointment and Gel should not be used in breastfeeding women unless the doctor determines that this is appropriate for the infant as there might be a risk of harm to the nursing baby.

• If you are under 18 years of age.

Consult your doctor if the following occurs while taking Lotemax Ointment and Gel:

• If you develop an eye infection or other new or worsening symptoms.

• If you develop a blister on the eye (a bleb).

Eye ointment and gel can cause your vision to be blurred. This usually passes quickly. Do not drive or use machines until your vision is clear. Like all medicines, Lotemax Ointment and Gel can have unwanted effects. The most common side effects in patients treated with Lotemax Ointment and Gel are:

• Increased pressure within the eye

• Blurred or abnormal vision

• Swelling or discharge from the eyes

• Painful, dry or sticky eyes

• Tearing

• Sensation of having an object in your eye

• Itching in the eye or on the eyelid

• Redness in the eye or on the eyelid

• Photophobia (discomfort on exposure to light)

Another unwanted effect might include headache, cold, cough, runny nose, or drug sensitivity.

If you notice these or any other effects, tell your doctor or pharmacist.

For any unexpected effects while taking Lotemax Ointment and Gel, contact your doctor or pharmacist.

Drug interaction studies have not been done for Lotemax Ointment and Gel.

Please inform your doctor or pharmacist if you are taking or have taken recently any other medicines, even those not prescribed.