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Venlafaxin Pfizer


Packageleaflet: Information for the user


Venlafaxin Pfizer 37.5 mg prolonged-release capsules, hard

Venlafaxin Pfizer 75 mg prolonged-release capsules, hard

Venlafaxin Pfizer 150 mg prolonged-release capsules, hard


venlafaxine


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet


1. What Venlafaxin Pfizer is and what it is used for


Venlafaxine Pfizer contains the active substance venlafaxine.


Venlafaxin Pfizer is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.


Venlafaxin Pfizer is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.


2. What you need to know before you take Venlafaxin Pfizer


Do not take Venlafaxin Pfizer


known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlafaxin Pfizer, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxin Pfizer before you take any MAOI (see also the section entitled “Other medicines and Venlafaxin Pfizer” and the information in that section about ‘Serotonin Syndrome’).


Warnings and precautions


Talk to your doctor or pharmacist before taking Venlafaxin Pfizer:


Venlafaxin Pfizer may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you.


Thoughts of suicide and worsening of your depression or anxiety disorder


If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.


You may be more likely to think like this:


If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.


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.

Dry mouth


Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take special care in your dental hygiene.


Diabetes


Your blood glucose levels may be altered due to Venlafaxin Pfizer. Therefore, the dosages of your diabetes medicines may need to be adjusted.


Children and adolescents


Venlafaxin Pfizer should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed this medicine for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Venlafaxin Pfizer. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine in this age group has not yet been demonstrated.


Other medicines and Venlafaxin Pfizer


Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


Your doctor should decide whether you can take Venlafaxin Pfizer with other medicines.


Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.


A potentially life‑threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section “Possible side effects”) may occur with venlafaxine treatment, particularly when taken with other medicines.


Examples of these medicines include:

  • Triptans (used for migraine)

  • Other medicines to treat depression, for instance SNRIs, SSRIs, tricyclics, or medicines containing lithium

  • Medicines containing linezolid, an antibiotic (used to treat infections)

  • Medicines containing moclobemide, a MAOI (used to treat depression)

  • Medicines containing sibutramine (used for weight loss)

  • Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)

  • Medicines containing dextromethorphan (used to treat coughing)

  • Medicines containing methadone (used to treat opioid drug addiction or severe pain)

  • Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)

  • Products containing St. John’s Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)

  • Products containing tryptophan (used for problems such as sleep and depression)

  • Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)


Signs and symptoms of serotonin syndrome may include a combination of the following:

restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.


In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).


Tell your doctor immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you.


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


Examples of these medicines include:


The following medicines may also interact with Venlafaxin Pfizer and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:



Venlafaxin Pfizer with food, drink and alcohol


Efexor depot should be taken with food (see section 3 “How to take Venlafaxin Pfizer”).


You should avoid alcohol while you are taking Venlafaxin Pfizer.


Pregnancy and breast-feeding


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.

You should use Venlafaxin Pfizer only after discussing the potential benefits and the potential risks to your unborn child with your doctor.


Make sure your midwife and/or doctor knows you are on Venlafaxin Pfizer. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.


If you are taking this medicine during pregnancy, in addition to having trouble breathing, another symptom your baby might have when it is born is not feeding properly. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.


Venlafaxin Pfizer passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast‑feeding or stop the therapy with this medicine.


Driving and using machines


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


3. How to take Venlafaxin Pfizer


Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


The usual recommended starting dose for treatment of depression, generalised anxiety disorder and social anxiety disorder is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily 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 gradually. The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.


Take Venlafaxin Pfizer at approximately the same time each day, either in the morning or in the evening. Capsules must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.


Venlafaxin Pfizer should be taken with food.


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


Do not stop taking this medicine without talking to your doctor (see the section “If you stop taking Venlafaxin Pfizer”).


If you take more Venlafaxin Pfizer than you should


Call your doctor or pharmacist immediately if you take more of this medicine than the amount prescribed by your doctor.


The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.


If you forget to take Venlafaxin Pfizer


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 take only a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of Venlafaxin Pfizer that has been prescribed for you in one day.


If you stop taking Venlafaxin Pfizer


Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Venlafaxin Pfizer, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using this medicine, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.


Your doctor will advise you on how you should gradually discontinue Venlafaxin Pfizer treatment. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.


If you have any further questions on the use of this medicine, 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 happen, do not take more Venlafaxin Pfizer. Tell your doctor immediately, or go to the casualty department at your nearest hospital:


Uncommon (may affect up to 1 in 100 people)


Swelling of the face, mouth, tongue, throat, hands, or feet, and/or a raised itchy rash (hives), trouble swallowing or breathing


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


In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).


Other side effects that you should tell your doctor about include (The frequency of these side effects are included in the list “Other side effects that may occur” below):



Do not be concerned if you see small white balls or granules in your stools after taking this medicine. Inside Venlafaxin Pfizer capsules are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule into your stomach. As they travel through your stomach and intestines, venlafaxine is slowly released. The spheroid “shell” does not dissolve and is passed out in your stools. So, even though you may see spheroids in your stools, your dose of medicine has been absorbed.


Other side effects that may occur


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



Common (may affect up to 1 in 10 people)



Uncommon (may affect up to 1 in 100 people)



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



Very rare (may affect up to 1 in 10,000 people)



Frequency not known (cannot be estimated from the available data)



Venlafaxin Pfizer sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, Venlafaxin Pfizer may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Venlafaxin Pfizer for a long time.


Reporting of side effects


If you get any side effects, talk to your doctor orpharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Venlafaxin Pfizer


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 packaging. The expiry date refers to the last day of that month.


Do not store above 30°C.


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.


6. Contents of the pack and other information


What Venlafaxin Pfizer contains


The active substance is venlafaxine.


Venlafaxin Pfizer 37.5 mg:

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


The other ingredients are:

Capsule contents:microcrystalline cellulose, ethylcellulose, hypromellose, talc

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

Capsule printing ink: shellac, red iron oxide (E172), simethicone, propylene glycol


Venlafaxin Pfizer 75 mg:

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


The other ingredients are:

Capsule contents:microcrystalline cellulose, ethylcellulose, hypromellose, talc

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

Capsule printing ink:shellac, red iron oxide (E172), , simethicone, propylene glycol


Venlafaxin Pfizer 150 mg:

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


The other ingredients are:

Capsule contents:microcrystalline cellulose, ethylcellulose, hypromellose, talc

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

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


What Venlafaxin Pfizer looks like and contents of the pack


Venlafaxin Pfizer 37.5 mg is an opaque light grey and opaque peach hard prolonged-release capsule (gelatine) 15.9 mm x 5.82 mm with a ‘W’ and strength ‘37.5’ printed in red.

Venlafaxin Pfizer 37.5 mg is available in:

Blister packs of 7, 10, 14, 20, 21, 28, 30, 35, 50, 60, 100 and hospital packs of 70 (10x7) or 1x70

Blister unit dose packs of 14, 28, 84, 100

Plastic (HDPE) bottles of 7, 14, 20, 21, 35, 50, 100 hospital pack of 70.


Venlafaxin Pfizer 75 mg is an opaque peach hard prolonged-release capsules (gelatine) 19.4 mm x 6.91 mm with a ‘W’ and strength ‘75’ printed in red.

Venlafaxin Pfizer 75 mg is available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 and hospital packs of 500 (10x50); 1000 (10x100)

Blister unit dose packs of 14, 28, 84, 100

Plastic (HDPE) bottles of 14, 20, 50, 100 and hospital packs of 500 and 1000.


Venlafaxin Pfizer 150 mg is an opaque dark orange hard prolonged-release (gelatine) 23.5 mm x 7.65 mm with a ‘W’ and strength ‘150’ printed in white.

Venlafaxin Pfizer 150 mg is available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 hospital packs of 500 (10x50), 1000 (10x100)

Blister packs of 14, 28, 84, 100

Plastic (HDPE) bottles of 14, 20, 50, 100 and hospital packs of 500 and 1000.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


[To be completed nationally]


{Name and address}

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{fax}

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Manufacturers


Pfizer Ireland Pharmaceuticals

Little Connell

Newbridge

County Kildare

Republic of Ireland


Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

D-79090 Freiburg

Germany


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria

Venlafaxin Pfizer 37.5 mg Kapseln

Venlafaxin Pfizer 75 mg Kapseln

Venlafaxin Pfizer 150 mg Kapseln


Cyprus

Venlafaxin Pfizer 37.5 mg

Venlafaxin Pfizer 75 mg

Venlafaxin Pfizer 150 mg


Denmark

Venlafaxin Pfizer 37.5 mg

Venlafaxin Pfizer 75 mg

Venlafaxin Pfizer 150 mg


Finland

Venlafaxin Pfizer 37.5 mg

Venlafaxin Pfizer 75 mg

Venlafaxin Pfizer 150 mg


Greece

Venlafaxin Pfizer 37.5 mg

Venlafaxin Pfizer 75 mg

Venlafaxin Pfizer 150 mg


Sweden

Venlafaxin Pfizer 37.5 mg

Venlafaxin Pfizer 75 mg

Venlafaxin Pfizer 150 mg



*[Please note that not all listed products and strengths may be available.]


This leaflet was last revised in

2016-05-12

11