Riva-Venlafaxine XR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RIVA-VENLAFAXINE XR has been prescribed to you by your doctor to relieve your symptoms of the following conditions:

• Depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)
• Generalized anxiety or nervousness
• Social phobia (social anxiety disorder) – avoidance and/or fear of social situations
• Panic disorder (repeated, unexpected panic attacks)

What it does:

RIVA-VENLAFAXINE XR belongs to a group of medicines called anti-depressants. RIVA-VENLAFAXINE XR is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine.

When it should not be used:

• Do not use RIVA-VENLAFAXINE XR if you are allergic to it or to any of the components of its formulation (see list of components at the end of this section). Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
• Do not use RIVA-VENLAFAXINE XR if you are currently taking or have recently taken monoamine oxidase inhibitor antidepressants (e.g. phenelzine sulphate, moclobemide).

What the medicinal ingredient is:

Venlafaxine Hydrochloride

What the nonmedicinal ingredients are:

37.5 mg

Black iron oxide, D&C yellow 10, dibutyl sebacate, ethylcellulose, FD&C yellow 6, gelatine, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, red iron oxide, shellac, starch, strong ammonia solution, sucrose, talc, and titanium dioxide.

75 mg

Dibutyl sebacate, D&C yellow 10, ethylcellulose, FD&C yellow 6, gelatin, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, red iron oxide, shellac, starch, strong ammonia solution, sucrose, talc, and titanium dioxide.

150 mg

Dibutyl sebacate, ethylcellulose, FD&C yellow 6, gelatin, polyethylene glycol, povidone, propylene glycol, Shellac Glaze ~ 45% (20% esterified) in Ethanol, starch, sucrose, talc, and titanium dioxide.

What dosage forms it comes in:

RIVA-VENLAFAXINE XR 37.5 mg is supplied as a hard gelatin capsule, with a grey cap and peach body, filled with white to off-white pellets. Imprinting on Body: 37.5 Cap: N.

RIVA-VENLAFAXINE XR 75 mg is supplied as a hard gelatin capsule, with a peach cap and peach body, filled with white to off-white pellets. Imprinting on Body: 75 Cap: N

RIVA-VENLAFAXINE XR 150 mg is supplied as a hard gelatin capsule, with a dark orange cap and dark orange body, filled with white to off-white pellets. Imprinting on Body: 150 Cap: N

WARNINGS AND PRECAUTIONS

During treatment with these types of medication it is important that you and your doctor have good ongoing communication about how you are feeling.

RIVA-VENLAFAXINE XR is not for use in children under 18 years of age.

New or Worsened Emotional or Behavioural Problems

Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better. They may experience new or worsened feelings of aggression, agitation, hostility, anxiety, impulsivity or thoughts about suicide, self-harm or harm to others. Suicidal thoughts and actions can occur in any age group but may be more likely in patients 18 to 24 years old. Should this happen to you, or to those in your care, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

You may be more likely to think like this if you have previously had thoughts about harming yourself.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Taking RIVA-VENLAFAXINE XR may increase your risk of experiencing sexual problems, which may continue after RIVA-VENLAFAXINE XR has been discontinued. Tell your doctor if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.

Taking RIVA-VENLAFAXINE XR may increase your risk of breaking a bone if you are elderly or have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to avoid falls especially if you get dizzy or have low blood pressure.

Before taking RIVA-VENLAFAXINE XR tell your doctor or pharmacist:

• if you have ever had any allergic reaction to medications, food, etc;
• all your medical conditions, including a history of seizures, liver disease, kidney disease, heart problems or high cholesterol;
• if you have a bleeding disorder or have been told that you have low platelets;
• if you have blood pressure problems;
• any medications (prescription or non-prescription) which you are taking, especially monoamine oxidase (MAO) inhibitors (e.g. phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegeline) or any other antidepressants, weight-loss medication, sleeping pills, antianxiety drugs, or medication to control blood pressure;
• if you are pregnant or thinking about becoming pregnant, or if you are breast feeding;
• your habits of alcohol and/or street drug consumption;
• any natural or herbal products you are taking (e.g., St. John’s Wort);
• if you had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis;

• if you drive a vehicle or perform hazardous tasks during your work;

Discontinuing RIVA-VENLAFAXINE XR

It is very important that you do NOT stop taking these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.

Effects on Pregnancy and Newborns

Post-marketing reports indicate that some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressants, such as RIVA-VENLAFAXINE XR, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.

In most cases, the SSRI or other newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

Taking RIVA-VENLAFAXINE XR in mid to late pregnancy may increase the risk for preeclampsia (high blood pressure and protein in the urine) and taking it near delivery may increase the risk of heavy bleeding after giving birth.

If you are pregnant and taking an SSRI, or other newer anti-depressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT change your dosage of these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.

Angle-closure Glaucoma

Venlafaxine can cause an acute attack of glaucoma. Having your eyes examined before you take RIVA-VENLAFAXINE XR could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

• eye pain
• changes in vision
• swelling or redness in or around the eye

INTERACTIONS WITH THIS MEDICATION

Do not use RIVA-VENLAFAXINE XR if you are taking or have recently taken monoamine oxidase inhibitors.

You should avoid taking St. John’s Wort if you are taking RIVA-VENLAFAXINE XR.

Certain laboratory results may be affected by use of RIVA-VENLAFAXINE XR, discuss with your doctor if you receive any unusual lab reports.

You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:

• other antidepressants, such as SSRIs and certain tricyclics
• other drugs that affect serotonin such as, amphetamines, lithium, linezolid, sibutramine, tryptophan, triptans used to treat migraines
• certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
• certain medicines used to treat cough, such as dextromethorphan
• certain medicines used to treat schizophrenia
• certain medicines used to treat bipolar depression, such as lithium
• metoprolol or other medications used to treat high blood pressure and angina
• certain medicines which may affect blood clotting and increase bleeding, such as oral anti-coagulants (e.g. warfarin, dabigatran), acetylsalicylic acid (e.g. Aspirin) and other non-steroidal anti-inflammatory drugs (e.g. ibuprofen)
• certain medicines used to treat epilepsy
• cimetidine
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking RIVA-VENLAFAXINE XR
• Ketoconazole

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take RIVA-VENLAFAXINE XR exactly as your doctor has instructed.
• Never increase or decrease the amount of RIVA-VENLAFAXINE XR you, or those in your care if you are a caregiver or guardian, are taking unless your doctor tells you to and do not stop taking this medication without consulting your doctor.
• As with all antidepressants improvement with RIVA-VENLAFAXINE XR is gradual. You may not have noticeable effect in the first few days of treatment. Some symptoms may begin to improve within about 2 weeks but significant improvement can take several weeks.

• RIVA-VENLAFAXINE XR should be taken once a day with food, as prescribed; do not divide, crush or chew the capsules.

REMEMBER: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further questions, please ask your doctor or pharmacist.

Overdose:

In case of overdose, contact your doctor or the nearest hospital emergency department, even though you may not feel sick.

Missed Dose:

If you happen to miss a dose, do not try to make up for it by doubling up on the dose next time. Just take your next regularly scheduled dose and try not to miss any more.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, RIVA-VENLAFAXINE XR 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. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

If you experience an allergic reaction (including red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

Some side effects of RIVA-VENLAFAXINE XR are:

• headache
• nausea
• dry mouth
• constipation
• loss of appetite
• vomiting
• sleepiness
• dizziness
• insomnia
• sexual problems
• weakness
• sweating
• nervousness
• abnormal vision
• abnormal dreams

Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately; do not discontinue your medication on your own.

RIVA-VENLAFAXINE XR does not usually affect people’s normal activities. However, some people feel sleepy while taking it, in which case they should not drive or operate machinery.

Although psychiatric disorders may be associated with decreases in sexual desire, performance and satisfaction, treatment with this medication may also affect sexual functioning.

RIVA-VENLAFAXINE XR may increase blood pressure in some people. You should have your blood pressure measured prior to starting RIVA-VENLAFAXINE XR and during treatment. High blood pressure should be controlled before starting RIVA-VENLAFAXINE XR. Blood pressure changes may sometimes be sudden and without warning. Consult your doctor if you have symptoms that may indicate a sudden rise in your blood pressure, such as headache (particularly in the back of head/neck when waking up); stronger, possibly more rapid, or irregular heart beat; chest pain; dizziness; excessive tiredness; or blurred vision.

RIVA-VENLAFAXINE XR may raise cholesterol levels in some patients. Blood cholesterol tests may be required by your doctor during treatment with RIVA-VENLAFAXINE XR.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of RIVA-VENLAFAXINE XR Capsules. Your doctor may lower your dosage gradually depending on your dose and how long you have been taking RIVA-VENLAFAXINE XR.Symptoms such as anorexia (loss of appetite, loss of weight), anxiety, agitation (restlessness), aggression, confusion, convulsions, coordination problems, diarrhea, dizziness, dry mouth, fatigue, headache, hypomania (rapid mood swings), insomnia, nausea, nervousness, nightmares, paresthesia (sensation of tingling, burning or crawling of the skin), electric shock sensations, sleep disturbances, somnolence (drowsiness), sweating, tinnitus (ringing in the ears), vertigo (sensation that the world is spinning), vomiting and other symptoms have been reported after stopping treatment, reducing the dosage of RIVA-VENLAFAXINE XR, or when a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of RIVA-VENLAFAXINE XR to alleviate the symptoms.

Effects on Newborns

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressant, such as RIVA-VENLAFAXINE XR, during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can. See WARNINGS AND PRECAUTIONS section for more information.

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

HOW TO STORE IT

• Store RIVA-VENLAFAXINE XR at room temperature (15-30˚C), in a dry place.
• Keep container tightly closed.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop taking RIVA-VENLAFAXINE XR please return any left over medicine to your pharmacist.

Reporting Side Effects

MORE INFORMATION

Last revised: July 8, 2020

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Inc. at: 1-800-363-7988. health professionals can be found by contacting Laboratoire Riva

This document plus the full product monograph, prepared for