Vizoden^® contains Vilazodone HCl, is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. It is not known if Vizoden^® is safe and effective for use in children for the treatment of MDD.  

Do not take Vizoden^® if you:  

• Take a Monoamine Oxidase Inhibitor (MAOI)  

• Have stopped taking an MAOI in the last 14 days  

• Are being treated with the antibiotic linezolid or intravenous methylene blue Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you stop treatment with Vizoden^®.  

Before taking Vizoden^®, tell your healthcare provider about all your medical conditions, including if you:  

• Have or have a family history of suicide, depression, bipolar disorder, mania or hypomania.  

• Have or had bleeding problems.  

• Have or had seizures or convulsions.  

• Have high pressure in the eye (glaucoma).  

• Have low sodium levels in your blood.  

• Drink alcohol.  

Pregnancy and Lactation  

If you are pregnant or plan to become pregnant. Taking Vizoden^® late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the risks to your baby if you take Vizoden^® during pregnancy. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Vizoden^®.  

If you are breastfeeding or plan to breastfeed. It is not known if Vizoden^® passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Vizoden^®.  

 Other medicines and Vizoden^®

Tell your healthcare provider about all the medicines you take, including prescription  and over-the-counter medicines, vitamins, and herbal supplements. 

Vizoden^® and some medicines may affect each other causing possible serious side effects. Vizoden^® may affect the way other medicines work and other medicines may affect the way Vizoden^® works.  

 Especially tell your healthcare provider if you take:  

• MAOIs.  

• Medicines used to treat migraine headaches known as triptans.  

• Tricyclic antidepressants.  

• Fentanyl.  

• Lithium.  

• Tramadol.  

• Tryptophan.  

• Buspirone.  

• Amphetamines.  

• St. John’s Wort.  

• Medicines that can affect blood clotting such as aspirin, nonsteroidal antiinflammatory drugs (NSAIDS) and warfarin.  

• Diuretics.  

• Medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIS) and serotonin norepinephrine reuptake inhibitors (SNRIS).  

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Vizoden^® with your other medicines. Do not start or stop any other medicines during treatment with Vizoden^® without talking to your healthcare provider first. Stopping Vizoden^® suddenly may cause you to have serious side effects. See, “What are the possible side effects of Vizoden^®” Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.  

What should I avoid while taking Vizoden^®  

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Vizoden^® affects you. Vizoden^® can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.  

• Avoid drinking alcohol during treatment with Vizoden^®.  

Important information about some of the ingredients of Vizoden^® 

Vizoden^® contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.  

Take Vizoden^® exactly as your healthcare provider tell you to. Do not change your dose or stop taking Vizoden^® without first talking to your healthcare provider.  

Your healthcare provider may need to change the dose of Vizoden^® until it is the right dose for you.  

Take Vizoden^® 1 time each day with food.  

 If you forget to take Vizoden^®

If you miss a dose of Vizoden^®, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Vizoden^® at the same time.  

If you take more Vizoden^® than you should  

If you take too much Vizoden^®, call your healthcare provider or the nearest hospital or get emergency treatment right away. 

Vizoden^® may cause serious side effects, including:  

• See, “What is the most important information I should know about Vizoden^®?”  

• Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when Vizoden^® is taken with certain other medicines. Stop taking Vizoden^® and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:  

- Agitation.  

- Seeing or hearing things that are not real (hallucinations).  

- Confusion.  

- Coma.  

- Fast heartbeat.  

- Blood pressure changes.  

- Dizziness.  

- Sweating.  

- Flushing.  

- High body temperature (hyperthermia).  

- Tremors, stiff muscles, or muscle twitching.  

- Loss of coordination.  

- Seizures.  

- Nausea, vomiting, diarrhea.  

• Increased risk of bleeding. Taking Vizoden^® with aspirin, non-steroidal antiinflammatory drugs (NSAIDs), warfarin or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.  

• Mania or hypomania (manic episodes) in people who have a history of bipolar disorder. Symptoms may include:  

- Greatly increased energy.  

- Severe trouble sleeping.  

- Racing thoughts.  

- Reckless behavior.  

- Unusually grand ideas.  

- Excessive happiness or irritability.  

- Talking more or faster than usual.  

• Discontinuation syndrome. Suddenly stopping Vizoden^® may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:  

- Nausea.  

- Changes in your mood.  

- Sweating.  

- Headache.  

- Irritability and agitation.  

- Tiredness.  

- Dizziness.  

- Problems sleeping.  

- Electric shock sensation (paresthesia).  

- Hypomania.  

- Anxiety.  

- Ringing in your ears (tinnitus).  

- Confusion.  

- Seizures.  

• Seizures (convulsions).  

• Eye problems (angle-closure glaucoma): Vizoden^® may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have changes in your vision or eye pain.  

• Low sodium levels in your blood (hyponatremia). Low sodium levels in your blood may be serious and may cause death. Elderly people may be at greater risk for this. Signs and Symptoms of low sodium levels in your blood may include:

- Headache.  

- Difficulty concentrating.  

- Memory changes.  

- Confusion.  

- Weakness and unsteadiness on your feet which can lead to falls.  

In severe or more sudden cases, signs and symptoms include:  

- Hallucinations (seeing or hearing things that are not real).  

- Fainting.  

- Seizures.  

- Coma.  

- Respiratory arrest.  

- Death.  

The most common side effects of Vizoden^® include diarrhea, nausea or vomiting, trouble sleeping.  

These are not all the possible side effects of Vizoden^®. Call your doctor for medical advice about side effects.  

Keep out of the sight and reach of children.  

- Do not store above 30ºC.  

- Do not use this medicine after the expiry date which is stated on the package after “Exp”. The expiry date refers to the last day of that month.  

- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.