Mylan-Venlafaxine XR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MYLAN-VENLAFAXINE XR has been prescribed to you by your doctor to relieve your symptoms of depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)

What it does:

MYLAN-VENLAFAXINE XR belongs to a group of medicines called antidepressants. MYLAN-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 MYLAN-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 MYLAN-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:

Acetone, Ammonio Methacrylate Copolymer, Basic Butylated Methacrylate Copolymer, Gelatin USP*, Hypromellose Ph.Eur, Iron Oxide Black NF**, Iron Oxide Red NF*, Iron Oxide Yellow NF***, Isopropyl Alcohol, Magnesium Stearate Ph.Eur, Sodium Lauryl Sulphate Ph.Eur, Titanium Dioxide Ph.Eur* * Present in Capsule shell all strengths

** Present in Capsule shell 37.5 and 150 mg strengths

*** Present in Capsule shell 150 mg strength only

What dosage forms it comes in:

MYLAN-VENLAFAXINE XR is available in extended release capsules of:

37.5 mg: Hard gelatine size 0 capsule with a flesh opaque body and a light gray opaque cap, imprinted in red ink “G” on the body and “VEN XR” over “37.5” on the cap, the capsule contains one white round biconvex tablet with approximate diameter of 6.0 mm;

75 mg: Hard gelatine size 0 capsule with a flesh opaque body and a flesh opaque cap, imprinted in red ink “G” on the body and “VEN XR” over “75” on the cap, the capsule contains two white round biconvex tablet with approximate diameter of 6.0 mm; 150 mg: Hard gelatine size 00 capsule with a swedish orange opaque body and a swedish orange opaque cap, imprinted in white ink “G” on the body and “VEN XR” over “150” on the cap, the capsule contains three white round biconvex tablet with approximate diameter of 6.8 mm.

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.

MYLAN-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 agitation, hostility or anxiety, impulsive 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 and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Taking MYLAN-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 MYLAN-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 MYLAN-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 MYLAN-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 antidepressant 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.

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 stop taking these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.

Angle-closure Glaucoma

MYLAN-VENLAFAXINE XR can cause an acute attack of glaucoma. Having your eyes examined before you take MYLAN-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 MYLAN-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 MYLAN-VENLAFAXINE XR.

Certain laboratory results may be affected by use of MYLAN-VENLAFAXINE, 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 MYLAN-VENLAFAXINE XR.
• Ketoconazole

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take MYLAN-VENLAFAXINE

  XR exactly as your doctor has instructed.

• Never increase or decrease the amount of MYLAN-

  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 MYLAN-

  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.

• MYLAN-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:

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, MYLAN-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 MYLAN-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.

MYLAN-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.

MYLAN-VENLAFAXINE XR may increase blood pressure in some people. You should have your blood pressure measured prior to starting MYLAN-VENLAFAXINE XR and during treatment. High blood pressure should be controlled before starting MYLAN-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.

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

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of MYLAN-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 MYLAN-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 MYLAN-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 MYLAN-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 MYLAN-VENLAFAXINE XR, contact your doctor or pharmacist.

HOW TO STORE IT

• Store MYLAN-VENLAFAXINE XR at room temperature

  (15°C - 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 MYLAN-

  VENLAFAXINE XR please return any left over medicine to your pharmacist.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC, Etobicoke, Ontario M8Z 2S6

Revised on: May 17, 2018

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-800-575-1379

www.mylan.ca