Venlalic (venlafaxine) XL 75 mg prolonged-release tablets

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Venlafaxine XL is and what it is used for
2. What you need to know before you take Venlafaxine XL
3. How to take Venlafaxine XL
4. Possible side effects
5. How to store Venlafaxine XL
6. Contents of the pack and other information

• 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 Venlafaxine XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine XL before you take any MAOI (see also the section entitled “Other medicines and Venlafaxine XL” and the information in that section about “Serotonin Syndrome”).

Talk to your doctor or pharmacist before taking Venlafaxine XL:

• If you use other medicines that taken together with Venlafaxine XL could increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxine XL ”).
• if you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements
• 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.

Venlafaxine 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.

Do not drink alcohol while being treated with Venlafaxine XL as it can lead to extreme tiredness and unconsciousness. Concomitant use with alcohol and/or certain medicines can make your symptoms of depression and other conditions, such as anxiety disorders worse.

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. These thoughts may also occur when your dose is decreased or during discontinuation of treatment with Venlafaxine 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 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.

Your blood glucose levels may be altered due to Venlafaxine XL. Therefore, the dosages of our diabetes medicines may need to be adjusted.

Medicines like Venlafaxine XL (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Venlafaxine 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 Venlafaxine 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.

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 Venlafaxine 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 Venlafaxine 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 Venlafaxine 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 SNRI, 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, an MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing opioids (e.g., buprenorphine, 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 heartbeat, 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 heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

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 ab-normal 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 Venlafaxine 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)

Venlafaxine XL should be taken with food (see section 3 “How to take Venlafaxine XL”).

Do not drink alcohol while being treated with Venlafaxine XL. Concomitant use with alcohol can lead to extreme tiredness and unconsciousness and can make your symptoms of depression and other conditions, such as anxiety disorders worse.

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 Venlafaxine 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 Venlafaxine 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 Venlafaxine XL 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 Venlafaxine XL 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.

Venlafaxine 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.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

Overdose can be life-threatening, especially with concomitant use of alcohol and/or certain medicines (see “Other medicines and Venlafaxine XL”).

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

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 Venlafaxine XL that has been prescribed for you in one day.

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 Venlafaxine 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 Venlafaxine 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.

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 (frequency 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 Venlafaxine XL)
• Aggresion
• Vertigo
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see “Pregnancy and breast-feeding” in section 2 for more information

Venlafaxine XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Venlafaxine XL 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 Venlafaxine XL for a long time.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is venlafaxine.

Each prolonged-release tablet contains 37.5, 75, 150 or 225 mg venlafaxine (as hydrochloride).

The other ingredients are

Core: Mannitol (E421), Povidone K-90, Macrogol 400, Cellulose microcrystalline (E 460(i)), Colloidal anhydrous silica, Magnesium stearate (E 470b).

Coat: Cellulose acetate, Macrogol 400, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin.

37.5 mg prolonged-release tablets: 7 mm round, biconvex, white tablets.

75 mg prolonged-release tablets: 7.5 mm round, biconvex, white tablets.

150 mg prolonged-release tablets: 9.5 mm round, biconvex, white tablets.

225 mg prolonged-release tablets: 11 mm round, biconvex, white tablets.

Venlafaxine XL is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 100 and 500 tablets; and in plastic bottles of 10, 14, 20, 28, 30, 50, 56, 60, 100, 106 and 500 tablets.

Not all pack sizes may be marketed.