37.5 mg, 75 mg, 150 mg prolonged-release capsule , hard 
venlafaxine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

• Save this information, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Efexor Depot is and what it is used for 
2. What you need to know before you use Efexor Depot 
3. How to take Efexor Depot 
4. Possible side effects 
5. How to store Efexor Depot 
6. Contents of the packaging and other information 

1. What Efexor Depot is and what it is used for

Efexor Depot contains the active substance venlafaxine.

Efexor Depot is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social phobia (fear of or avoidance of social situations), and panic disorder (panic attacks). It is important to treat depression or anxiety disorders properly to help you feel better. If the condition is not treated, it may not go away but become more serious and more difficult to treat.

Efexor Depot is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors ( SNRIs ). This group of drugs is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or have anxiety have lower levels of serotonin and norepinephrine in the brain. It is not completely clear how antidepressants work, but they can help by increasing the levels of serotonin and norepinephrine in the brain.

2. What you need to know before using Efexor Depot

Do not take Efexor Depot

  • if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
  • if you are also taking or at any time within the last 14 days have taken any medicine called irreversible monoamine oxidase inhibitor ( MAOI ) which is used to treat depression or Parkinson’s disease. Taking an irreversible MAOI with Efexor Depot can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Efexor Depot before taking an MAOI(see also the section entitled “Other medicines and Efexor Depot” and the information in this section on “serotonergic syndrome”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Efexor Depot:

  • Using other medicines as if they were taken with Efexor Depot may increase the risk of developing serotonergic syndrome (see section “Other medicines and Efexor Depot”).
  • If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
  • If you have had high blood pressure before.
  • If you have had heart problems in the past.
  • If you have been told that you have an abnormal heart rhythm.
  • If you have previously had seizures (epileptic seizures).
  • If you have previously had low levels of sodium in your blood ( hyponatremia ).
  • If you are prone to bruising or if you bleed easily (if you have had bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding (eg warfarin, which is used to prevent blood clots).
  • If you or someone in your family has had mania or bipolar disorder (feeling of excessive excitement or euphoria ).
  • If you have previously had aggressive behavior.

Efexor depot may cause a feeling of restlessness or inability to stand or sit still during the first weeks of treatment. Tell your doctor if this happens to you.

If you start to feel worse and have thoughts of harming yourself

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These thoughts can get worse when you start using antidepressants, as it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer. These thoughts may also occur when dose one is reduced or when treatment with Exefor Depot is stopped.

These thoughts may be common:

  • If you have previously had thoughts of harming yourself or committing suicide.
  • If you are a young adult. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of caries (holes in the teeth). You should therefore be extra careful with dental hygiene.

Diabetes

Efexor Depot can change your blood sugar levels. Does one of your drugs for diabetes may need to be adjusted.

Sexual problems

Drugs such as Efexor Depot (so-called SNRIs ) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Children and young people

Efexor Depot should not normally be used for the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking drugs of this type. Nevertheless, this medicine can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you were given this medicine, consult your doctor again. You should also inform your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Efexor Depot.

The long-term effects of this drug on growth, maturation, and cognitive and behavioral development have not yet been established for this age group.

Other medicines and Efexor Depot

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Your doctor will decide if you can take Efexor Depot with other medicines.

You should not start or stop taking any medicines, including those that you have bought without a prescription, natural and herbal medicines, before asking your doctor or pharmacist.

  • Monoamine oxidase inhibitors which are used to treat depression or Parkinson’s disease, must not be used with Efexor Depot. Tell your doctor if you have taken any such medicine in the last 14 days. (MAO inhibitors: see section “What you need to know before taking Efexor Depot”).
  • Serotonergic syndrome: A potentially life-threatening condition or reaction such as neuroleptic malignant syndrome (NMS) (see section “Possible side effects”) may occur during treatment with venlafaxine, especially when taken with other medicines.

Examples of such drugs include:

  • triptans (used for migraines )
  • other drugs to treat depression, e.g. SNRIs, SSRIs, tricyclic antidepressants, or lithium-containing medicines
  • medicines containing amphetamines (used to treat ADHD, narcolepsy, and obesity)
  • medicines containing linezolid, an antibiotic (used to treat infections )
  • medicines containing moclobemide, an MAOI (used to treat depression)
  • medicines containing sibutramine (used for weight loss)
  • medicines containing tramadol, fentanyl, tapentadol, pethidine, and pentazocine (used to treat severe pain)
  • medicines containing dextromethorphan (used to treat cough)
  • medicines containing methadone (used to treat opioid abuse or severe pain)
  • medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
  • products containing St. John’s wort ( Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
  • products containing tryptophan (used for sleep problems and depression)
  • antipsychotic drugs (used to treat symptoms when you hear, see or feel things that do not exist, delusions, abnormal suspicion, confusion, and withdrawal).

Signs and symptoms of serotonergic syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, the serotonergic syndrome can resemble malignant neuroleptic syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, elevated levels of muscle enzymes (determined by blood tests).

Tell your doctor immediately, or go to the nearest emergency department, if you think you have had the serotonergic syndrome.

You must tell your doctor if you are taking medicines that may affect your heart rhythm.

Examples of these drugs are:

  • antiarrhythmics e.g. quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythms)
  • antipsychotic drugs e.g. thioridazine (see also Serotonergic syndrome above)
  • antibiotics e.g. erythromycin and moxifloxacin (used to treat infections caused by bacteria)
  • antihistamines (used to treat allergies ).

The following medicines may also affect or be affected by ( interact with) Efexor Depot and should be used with caution. You must tell your doctor or pharmacist if you are taking medicines that contain:

  • ketoconazole (an antifungal )
  • haloperidol or risperidone (to treat psychiatric conditions)
  • metoprolol (a beta-blocker to treat high blood pressure and heart problems).

Efexor Depot with food, drink, and alcohol

Efexor depot should be taken with a meal (see section 3 “How to take Efexor depot”).

Avoid alcohol while taking Efexor Depot 

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Efexor Depot until you have discussed the potential benefits and risks of your unborn baby with your doctor.

Tell your midwife and/or doctor that you are using Efexor Depot. When similar drugs ( SSRIs ) are used during pregnancy, the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN) may increase. This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact your midwife and/or doctor immediately.

Other symptoms that your baby may have when it is born if you take this medicine during pregnancy are that the baby has difficulty breathing and does not eat properly. If your baby has these symptoms when it is born and you are worried, contact your doctor and/or midwife who can advise you.

Efexor Depot passes into breast milk. There is a risk that the child will be affected. You should therefore talk to your doctor who will decide if you should stop breast-feeding or stop treatment with this medicine.

Driving and using machines

Do not drive or use machines until you know how this medicine affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Efexor Depot

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual recommended starting dose for treating depression, generalized anxiety disorder, and social phobia is 75 mg per day. The dose can be increased gradually by your doctor and, if necessary, up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose(37.5 mg) and then increase the dose one step at a time. The highest dose for generalized anxiety disorder, social phobia, and panic disorder is 225 mg daily.

Take Efexor Depot at about the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Efexor Depot should be taken with a meal.

If you have liver or kidney problems, talk to your doctor as your dose of this medicine may need to be changed.

Do not stop taking this medicine without first consulting your doctor (see section “If you stop taking Efexor Depot”).

If you take more Efexor Depot then you should

If you have taken too much of this medicine or if, for example, If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of a possible overdose may include rapid heartbeat, changes in alertness (from drowsiness to coma ), blurred vision, seizures, and vomiting.

If you forget to take Efexor Depot

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and only take one dose as usual. Do not take a double dose to make up for a forgotten dose  Do not take more than the amount of Efexor Depot you have been prescribed per day.

If you stop taking Efexor Depot

You should not stop taking the treatment or reduce the dose without first consulting your doctor, even if you feel better. If your doctor thinks you no longer need Efexor Depot, he/she may ask you to reduce the dose slowly before stopping treatment completely. It is known that you may experience side effects when you stop taking this medicine, especially if you stop suddenly or if your dose is reduced too quickly. Some patients may experience symptoms such as suicidal ideation, aggression, fatigue, dizziness, intoxication, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, anxiety, confusion, ringing in the ears, and crawling or, in rare cases, feeling of electric shock, weakness, sweating, seizures or flu-like symptoms, vision problems and high blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will tell you how to gradually stop taking Efexor Depot. This may take a few weeks or months. In some patients, it may need to be done gradually over several months or longer. If you get any of these or other symptoms that bother you, consult your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If any of the following occur, do not take more Efexor Depot. Tell your doctor immediately, or go to the nearest emergency room.

Uncommon (may affect up to 1 in 100 people)

  • Swelling of the face, mouth, tongue, neck, hands, or feet and/or a raised itchy rash ( hives ), difficulty swallowing or breathing.

Rare (may affect up to 1 in 1,000 people)

  • Chest tightness, wheezing, difficulty swallowing, or breathing.
  • Severe skin rash, itching, or hives (raised spots of red or pale skin that often itch).
  • Signs and symptoms of serotonergic symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.
  • In its most severe form, the serotonergic syndrome can resemble malignant neuroleptic syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, elevated levels of muscle enzymes (determined by blood tests).
  • Signs of infection, such as fever, chills, tremors, headache, sweating, flu-like symptoms. This may be due to a blood disease that leads to an increased risk of infection.
  • Severe rash, which can lead to severe blisters and scaly skin.
  • Unexplained muscle aches, tenderness, or weakness. This may be a sign of rhabdomyolysis.

Has been reported (occurs in an unknown number of users)

  • Signs and symptoms of a condition called “stress cardiomyopathy” may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Other side effects that you should tell your doctor are (the frequency of these side effects is included in the list of ‘Other side effects that may occur’ below):

  • Cough, wheezing, and shortness of breath, which may occur with fever.
  • Black (tar-like) stool or blood in the stool.
  • Itching, yellowish skin or yellow eyes, or dark urine, which may be symptoms of an inflammation of the liver ( hepatitis ).
  • Heart problems, such as fast or irregular heart rate, high blood pressure.
  • Eye problems, such as blurred vision, dilated pupils.
  • Nerve problems, such as dizziness, tingling, and numbness, movement disorders (muscle spasms or stiffness), seizures.
  • Mental problems, such as hyperactivity and feelings of unusual elation.
  • Withdrawal symptoms (see section 3 “How to take Efexor depot, if you stop taking Efexor depot”).
  • Prolonged bleeding – if you cut or injure yourself, it may take a little longer than. common for bleeding to stop.

Do not worry if you see small white grains in your stool after taking Efexor Depot. Inside the Efexor prolonged-release capsules are small white grains that contain the active substance venlafaxine. These grains are released from the capsule in your stomach. As the grains pass through the gastrointestinal tract, venlafaxine is slowly released. The shell of the grain remains undissolved and disappears along with your feces. Your dose of venlafaxine has been taken up, even if you see barley in your stool.

Other side effects may occur

Very common (may affect more than 1 user in 10)

  • Dizziness, headache, drowsiness.
  • Insomnia.
  • Nausea, dry mouth, constipation.
  • Sweating (even at night).

Common (may affect up to 1 in 10 people)

  • Loss of appetite.
  • Confusion, feeling of being separated from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
  • Tremors, a feeling of restlessness or an inability to sit or stand still, numbness and tingling, altered taste experience, increased muscle tension.
  • Visual disturbances including blurred vision, dilated pupils, the inability of the eye to automatically change focus from distant to near objects.
  • Ringing in the ears ( tinnitus ).
  • Fast heartbeat, palpitations.
  • High blood pressure, redness.
  • Shortness of breath, yawning.
  • Vomiting, diarrhea.
  • Mild skin rash, itching.
  • Need to urinate more often than usual, inability to urinate, difficulty urinating.
  • Irregular periods such as increased bleeding or more irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction ( impotence ).
  • Weakness ( asthenia ), fatigue, chills.
  • Weight gain, weight loss.
  • Elevated cholesterol.

Uncommon (may affect up to 1 in 100 people)

  • Overactivity, thoughtlessness, and reduced need for sleep (mania).
  • Hallucinations, feeling detached from reality, abnormal orgasm, lack of emotion, feeling of excessive arousal, gnashing of teeth.
  • Fainting, involuntary muscle movements, impaired coordination, and balance.
  • Dizziness (especially if you get up too fast), decreased blood pressure.
  • Bloody vomiting, black tar-like stools, or blood in the stools, which may indicate internal bleeding.
  • Sensitivity to sunlight, bruising, abnormal hair loss.
  • Inability to control urine.
  • Stiffness, spasms, and involuntary muscle movements.
  • Some change in liver enzyme levels in the blood.

Rare (may affect up to 1 in 1,000 people)

  • Seizures.
  • Cough, wheezing, shortness of breath, which may occur along with fever.
  • Altered perception of space and confusion, often in combination with hallucinations ( delirium ).
  • Excessive fluid intake (so-called SIADH).
  • Decreased sodium levels in the blood.
  • Severe pain in the eyes and impaired vision or blurred vision.
  • Abnormal, fast, or irregular heartbeat, which can lead to fainting.
  • Severe pain in the abdomen or back (which may indicate a serious illness in the abdomen, liver, or pancreas).
  • Itching, yellow skin or eyes, dark urine, or flu-like symptoms, which are signs of liver inflammation ( hepatitis ).

Very rare (may affect 1 in 10,000 users)

  • Prolonged bleeding, which may be a sign of a decrease in the number of platelets in the blood, leads to an increased risk of bruising or bleeding.
  • Abnormal production of breast milk.
  • Unexpected bleeding, e.g. bleeding gums, blood in the urine or bloody vomiting, or the appearance of unexpected bruising or ruptured blood vessels.

Has been reported (occurs in an unknown number of users)

  • Suicidal ideation and suicidal ideation, cases of suicidal ideation, and suicidal ideation have been reported during treatment with venlafaxine or immediately after stopping treatment (see section 2, What you need to know before taking Efexor Depot ).
  • Aggression.
  • Dizziness.

Efexor Depot sometimes causes side effects that you may not be aware of, such as high blood pressure or abnormal heartbeat, small changes in your blood levels of liver enzymes, sodium, or cholesterol. In more rare cases, the Efexor depot may impair the function of the platelets (platelets) in the blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to take blood samples from time to time, especially if you have been taking Efexor Depot for a long time.

5. How to store Efexor Depot

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is venlafaxine.

Efexor Depot 37.5 mg:

Each prolonged-release capsule contains 42.43 mg venlafaxine hydrochloride, equivalent to 37.5 mg venlafaxine-free bases.

Other ingredients are:

Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc.

Capsule shell: gelatin, black, red, and yellow iron oxide (E172), titanium dioxide (E171)

Capsule label: shellac, red iron oxide (E172), ammonium hydroxide, simethicone, propylene glycol

Efexor Depot 75 mg:

Each prolonged-release capsule contains 84.85 mg venlafaxine hydrochloride, equivalent to 75 mg venlafaxine free base.

Other ingredients are:

Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc

Capsule shell: gelatin, red and yellow iron oxide (E172), titanium dioxide (E171)

Capsule label: shellac, red iron oxide (E172), ammonium hydroxide, simethicone, propylene glycol

Efexor Depot 150 mg:

Each prolonged-release capsule contains 169.7 mg venlafaxine hydrochloride, equivalent to 150 mg venlafaxine free base.

Other ingredients are:

Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc

Capsule shell: gelatin, red and yellow iron oxide (E172), titanium dioxide (E171)

Capsule labeling: shellac, sodium hydroxide, povidone, titanium dioxide (E171), propylene glycol

What the medicine looks like and the contents of the pack

Efexor Depot 37.5 mg is a peach-colored and gray opaque hard prolonged-release capsule (gelatin) 15.9 mm x 5.82 mm marked with ‘W’ and strength ’37 .5 ‘with red ink.

Efexor Depot 37.5 mg is available in:

Blister packs of 7, 10, 14, 20, 21, 28, 30, 35, 50, 60, 84, 100 and hospital packs of 70 (10×7, 1×70) or in cans of 7, 14, 20, 21, 35, 50, 100 and hospital packaging of 70 pieces.

Efexor Depot 75 mg is a peach-colored opaque hard prolonged-release capsule(gelatin) 19.4 mm x 6.91 mm marked with ‘W’ and strength ’75’ with red ink.

Efexor Depot 75 mg is available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100 and hospital packs of 500 (10×50) and 1000 (10×100) or in cans of 14, 20, 50, 100 and hospital packages of 500 and 1000 pieces.

Efexor Depot 150 mg is a brick red opaque hard prolonged-release capsule (gelatin) 23.5 mm x 7.65 mm marked “W” and “150” in white ink.

Efexor Depot 150 mg is available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100 and hospital packs of 500 (10×50) and 1000 (10×100) or in cans of 14, 20, 50, 100 and hospital packages of 500 and 1000 pieces.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Manufacturer:

Pfizer Ireland Pharmaceuticals

Little Connell

Newbridge

County Kildare, Ireland

Pfizer Manufacturing Deutschland GmbH

Company Freiburg

Mooswaldallee 1

D-79090 Freiburg

Germany

Muhammad Nadeem

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