Patient leaflet - EFEXOR XL 150 MG CAPSULES
1. what efexor xl is and what it is used for
Efexor XL contains the active substance venlafaxine. Efexor XL 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 not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and norepinephrine in the brain.
Efexor XL 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 efexor xl do not take efexor xl
- 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 have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Efexor XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Efexor XL before you take any MAOI (see also the section entitled “Other medicines and Efexor XL” and the information in that section about ‘Serotonin Syndrome’).
Warnings and precautions
Talk to your doctor or pharmacist before taking Efexor XL:
- If you use other medicines that taken together with Efexor XL could increase the risk of developing serotonin syndrome (see the section “Other medicines and Efexor XL”).
- If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
- If you have a history of high blood pressure.
- If you have a history of heart problems.
- If you have been told you have an abnormal heart rhythm.
- If you have a history of fits (seizures).
- If you have a history of low sodium levels in your blood (hyponatraemia).
- If you have a history of bleeding disorders (tendency to develop bruises or a tendency to bleed easily), or if you are taking other medicines that may increase the risk of bleeding e.g., warfarin (used to prevent blood clots), or if you are pregnant (see Pregnancy and breast-feeding).
- If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
- If you have a history of aggressive behaviour.
Efexor XL 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 thoughts may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is decreased or during discontinuation of treatment with Efexor XL.
You may be more likely to think like this:
- If you have previously had thoughts about killing yourself or harming yourself.
- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
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 Efexor XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Sexual problems
Medicines like Efexor XL (so called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
Children and adolescents
Efexor XL 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 Efexor XL. 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 Efexor XL
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 Efexor XL 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. Monoamine oxidase inhibitors which are used to treat depression or Parkinson’s disease must not be taken with Efexor XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “What you need to know before you take Efexor XL”).
- Serotonin syndrome:
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 amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
° 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:
- Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat abnormal heart rhythm)
- Antipsychotics such as thioridazine (See also Serotonin syndrome above)
- Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
- Antihistamines (used to treat allergy)
The following medicines may also interact with Efexor XL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
- Ketoconazole (an antifungal medicine)
- Haloperidol or risperidone (to treat psychiatric conditions)
- Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Efexor XL with food, drink and alcohol
Efexor XL should be taken with food (see section 3 “How to take Efexor XL”).
You should avoid alcohol while you are taking Efexor XL. 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 Efexor XL 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 Efexor XL. 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 take Efexor near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Efexor so they can advise you. 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.
Efexor XL 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.
Efexor XL contains sodium
Efexor XL 150 mg and 225 mg contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. how to take efexor xl
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 Efexor XL 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.
Efexor XL 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 Efexor XL”).
If you take more Efexor XL 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 Efexor XL
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 Efexor XL that has been prescribed for you in one day.
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If you stop taking Efexor XL
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 Efexor XL, 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 suicidal thoughts, aggressiveness, 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, problems with eyesight and increase in blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc).
Your doctor will advise you on how you should gradually discontinue Efexor XL treatment. This can take a period of several weeks or months. In some patients, discontinuation may need to occur very gradually over periods of months or longer. 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 Efexor XL. 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)
- Chest tightness, wheezing, trouble swallowing or breathing
- Severe skin rash, itching or hives (elevated patches of red or pale skin that often itch)
- Signs and symptoms of serotonin syndrome which may include 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)
- Signs of infection, such as high temperature, chills, shivering, headaches, sweating, flu-like symptoms. This may be the result of a blood disorder which leads to an increased risk of infection.
- Severe rash, which may lead to severe blistering and peeling of the skin
- Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.
Frequency not known (cannot be estimated from the available data)
- Signs and symptoms of a condition called “stress cardiomyopathy” which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.
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):
- Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
- Black (tarry) stools or blood in stools
- Itchiness, yellow skin or eyes, or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
- Heart problems, such as fast or irregular heart rate, increased blood pressure
- Eye problems, such as blurred vision, dilated pupils
- Nerve problems, such as dizziness, pins and needles, movement disorder (muscle spasms or stiffness), seizures or fits
- Psychiatric problems, such as hyperactivity and feeling unusually overexcited
- Withdrawal effects (see the section “How to take Efexor XL, if you stop taking Efexor XL”).
- Prolonged bleeding – if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Do not be concerned if you see small white balls or granules in your stools after taking this medicine. Inside Efexor XL 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)
- Dizziness; headache; drowsiness
- Insomnia
- Nausea; dry mouth; constipation
- Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
- Appetite decreased
- Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido; agitation; nervousness; abnormal dreams
- Tremor; a sensation of restlessness or an inability to sit or stand still; pins and needles; altered taste sensation; increased muscle tonus
- Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
- Ringing in the ears (tinnitus)
- Fast heartbeat; palpitations
- Increase in blood pressure; flushing
- Shortness of breath; yawning
- Vomiting; diarrhoea
- Mild rash; itching
- Increased frequency in urination; inability to pass urine; difficulties passing urine
- Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/ orgasm (males); erectile dysfunction (impotence)
- Weakness (asthenia); fatigue; chills
- Weight gain; weight loss
- Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
- Over activity, racing thoughts and decreased need for sleep (mania)
- Hallucinations; feeling separated (or detached) from reality; abnormal orgasm; lack of feeling or emotion; feeling over-excited; grinding of the teeth
- Fainting; involuntary movements of the muscles; impaired coordination and balance
- Feeling dizzy (particularly when standing up too quickly); decrease in blood pressure
- Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
- Sensitivity to sunlight; bruising; abnormal hair loss
- Inability to control urination
- Stiffness, spasms and involuntary movements of the muscles
- Slight changes in blood levels of liver enzymes
Rare (may affect up to 1 in 1,000 people)
- Seizures or fits
- Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
- Disorientation and confusion often accompanied by hallucination (delirium)
- Excessive water intake (known as SIADH)
- Decrease in blood sodium levels
- Severe eye pain and decreased or blurred vision
- Abnormal, rapid or irregular heartbeat, which could lead to fainting
- Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
- Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis)
Very rare (may affect up to 1 in 10,000 people)
- Prolonged bleeding, which may be a sign of reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding
- Abnormal breast milk production
- Unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
Frequency not known (cannot be estimated from the available data)
- Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, What you need to know before you take Efexor XL)
- Aggression
- Vertigo
- Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy and breast-feeding in section 2 for more information.
5. how to store efexor xl
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 efexor xl contains
The active substance is venlafaxine.
Efexor XL 75 mg:
Each prolonged-release capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine free base.
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), ammonium hydroxide, simethicone, propylene glycol.
Efexor XL 150 mg:
Each prolonged-release capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine free base.
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 (see section 2 “Efexor XL contains sodium”), povidone, titanium dioxide (E171), propylene glycol.
Efexor XL 225 mg:
Each prolonged-release capsule contains 254.52 mg of venlafaxine hydrochloride, equivalent to 225 mg of venlafaxine free base.
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, sodium hydroxide (see section 2 “Efexor XL contains sodium”), povidone, titanium dioxide (E171), propylene glycol.
What Efexor XL looks like and contents of the pack Efexor 75 mg is an opaque peach hard prolonged-release capsule (gelatine) 19.4 mm x 6.91 mm with a ‘W’ and strength ‘75’ printed in red.
Efexor 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 as bottles of 14, 20, 50, 100 and hospital packs of 500 and 1000.
Efexor 150 mg is an opaque dark orange hard prolonged-release capsule (gelatine) 23.5 mm x 7.65 mm with a ‘W’ and ‘150’ printed in white.
Efexor 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 as bottles of 14, 20, 50, 100 and hospital packs of 500 and 1000.
Efexor 225 mg are light grey cap and opaque dark orange body capsules with a ‘W’ and ‘225’ printed in white.
Efexor 225 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).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Upjohn UK Limited
Ramsgate Road Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer:
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge
County Kildare
Republic of Ireland
Pfizer Manufacturing Deutschland GmbH Betriebsstatte Freiburg Mooswaldallee 1
D-79090 Freiburg
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
| Austria | Efectin ER 37.5 mg Kapseln Efectin ER 75 mg Kapseln Efectin ER 150 mg Kapseln |
| Belgium, Luxembourg | Efexor-Exel 37.5 Efexor-Exel 75 Efexor-Exel 150 Efexor-Exel 225 |
| Bulgaria | Efectin ER 75 mg Efectin ER 150 mg |
| Czech Republic | Efectin ER 37.5 mg Efectin ER 75 mg Efectin ER 150 mg |
| Cyprus, Greece, Estonia, Lithuania, Portugal | Efexor XR |
| Latvia | Efexor XR Efexor XR 75 Efexor XR 150 |
| Denmark, Finland, Iceland, Norway, Sweden | Efexor Depot |
| France | Effexor L.P. |
| Germany | Trevilor retard 37.5 mg Trevilor retard 75 mg Trevilor retard 150 mg |
| Ireland, Malta, United Kingdom | Efexor XL |
| The Netherlands | Efexor XR 37.5 Efexor XR 75 Efexor XR 150 |
| Italy | Efexor Faxine |
| Poland | Efectin ER 37.5 Efectin ER 75 Efectin ER 150 |
| Romania | Efectin EP 37.5 mg Efectin EP 75 mg Efectin EP 150 mg |
| Slovenia | Efectin ER 37.5 mg trde kapsule s podaljsanim sproscanjem Efectin ER 75 mg trde kapsule s podaljsanim sproscanjem Efectin ER 150 mg trde kapsule s podaljsanim sproscanjem |
| Spain | Vandral Retard 75 mg capsulas de liberacion prologada Vandral Retard 150 mg capsulas de liberacion prologada Vandral Retard 225 mg capsulas de liberacion prologada |
*[Please note that not all listed products and strengths may be available.]
This leaflet was last revised in 05/2021.
Ref: EF 19_0
This leaflet can be made available in large print, audio or Braille on request. Contact 0800 198 5000 to request this, quoting the following numbers: 00057/1280 or 00057/1281 or 00057/1512. mock up 7684
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