Venlasov Xl 75 Mg Prolonged-Release Capsules

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Package leaflet: Information for the user

Venlasov XL 75 mg and 150 mg Prolonged-release Capsules

Venlafaxine Hydrochloride

IMPORTANT THINGS YOU SHOULD KNOW ABOUT VENLASOV XL

Please read all of this leaflet before you start to take your medicine as it contains important information about Venlasov XL.

• Venlasov XL is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD), social anxiety disorder (also known as social phobia) and panic disorder (panic attacks)

• Venlasov XL is not for use in children and adolescents under 18 years of age - see section 2 ‘Use in children and adolescents under 18 years of age'

If you have any concerns about how you feel, or about this medication, it is important that you talk to your doctor - even if you feel anxious or worried about doing so. You may find it helpful to tell a friend or relative that you are depressed or suffering from an anxiety disorder, and that you have been prescribed this medication; it might be useful to show them this leaflet.

• Venlasov XL may not start to work immediately. Some people taking antidepressants may feel worse before feeling better. Your doctor may ask to see you again a couple of weeks after starting your treatment and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better.

• Some people who are depressed may think of harming or killing themself. If this happens you should see your doctor or go to a hospital straight away - see in section 2 ‘Thoughts of suicide and worsening of your depression or anxiety disorder'

• If you take too many capsules it is important to seek immediate medical attention, even if you feel well, because of the risk of serious side effects

• Do not stop taking Venlasov XL or change your dose without talking to your doctor even if you feel better. If you stop taking Venlasov XL abruptly you may get withdrawal reactions - see in section 3 ‘If you stop taking Venlasov XL'

• If you have heart problems such as fast or irregular heart rate or high blood pressure you should talk to your doctor before taking Venlasov XL - see in section 2 ‘What you need to know before you take Venlasov XL'

• Taking certain other medicines with Venlasov XL may cause problems. You should tell your doctor if you are taking any other medicines - see in section 2 ‘What you need to know before you take Venlasov XL'

• See your doctor without delay if you feel restless and feel like you can't keep still, feel ‘high' or very over-excited, have jerky muscle movements which you can't control. See section 4 -‘Possible side effects' for other important information

If you are pregnant, or intend to become pregnant, or breast-feeding, you should talk to your doctor - see section 2 ‘Pregnancy and breast-feeding'

More information on all of these points is provided in the rest of this leaflet.

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

- 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.

What is in this leaflet

1. What Venlasov XL Capsules are and what they are used for

2. What you need to know before you take Venlasov XL Capsules

3. How to take Venlasov XL Capsules

4. Possible side effects

5. How to store Venlasov XL Capsules

6. Contents of the pack and other information

1. What Venlasov XL Capsules are and what they are used for

The name of this medicine is Venlasov XL 75 mg Capsules and Venlasov XL 150 mg Capsules (referred to as Venlasov XL Capsules throughout this leaflet).

Venlasov XL Capsules contain the active ingredient venlafaxine hydrochloride, which belongs to a group of medicines called antidepressants. They are one of a group of medicines called Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs). It is thought that people who are depressed may have lower levels of serotonin and noradrenaline in their brain. Whilst it is not fully understood how antidepressants work, Venlasov XL Capsules may help by increasing the levels of serotonin and noradrenaline in the brain.

Venlasov XL Capsules are used to treat adults who are suffering from the symptoms of depressive illness and anxiety disorders such as generalised anxiety disorder (GAD), social anxiety disorder (fear and avoidance of social situations) and panic disorder (panic attacks). Venlasov XL is a treatment which can relieve these symptoms and 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.

Your doctor may continue to give you Venlasov XL Capsules when you are feeling better to prevent your symptoms from returning or prevent you from becoming depressed in the future.

2. What you need to know before you take Venlasov XL Capsules

Do not take Venlasov XL Capsules

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

If any of the above apply to you, tell your doctor or pharmacist immediately, as Venlasov XL Capsules may not be suitable for you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Venlasov XL Capsules

• if you use other medicines that taken together with Venlasov XL Capsules could increase the risk of developing serotonin syndrome (see the section ‘Other medicines and Venlasov XL Capsules').

• 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 tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g., warfarin (used to prevent blood clots).

• 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.

This medicine 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 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 dental caries (tooth decay). Therefore, you should take special care with your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to Venlasov XL Capsules. Therefore, the dosage of your diabetes medicines may need to be adjusted.

If any of these apply to you, or if you are not sure, tell your doctor.

Use in children and adolescents under 18 years of age

Venlasov XL Capsules 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 Venlasov XL Capsules.

• 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 Venlasov XL Capsules

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

Your doctor should decide whether you can take Venlasov XL Capsules 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 Venlasov XL Capsules. 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 Venlasov XL Capsules').

• 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 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 Venlasov XL Capsules 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)

Taking Venlasov XL Capsules with food and drink Food

The capsules should be taken with food.

Alcohol

The combination of Venlasov XL Capsules and alcohol should be avoided.

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 for advice before taking this medicine.

Pregnancy

You should use Venlasov XL Capsules only after discussing the potential benefits and risks to your unborn child with your doctor.

Make sure your midwife and/or doctor know you are on Venlasov XL Capsules. 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.

Breast-feeding

Venlafaxine 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 operate any tools or machines until you know how this medicine affects you.

Venlasov XL Capsules contain Allura Red (E129) and Sunset Yellow (E110)

Venlasov XL 150 mg Capsules contain the colours allura red (E129) and sunset yellow (E110) which may cause allergic reactions.

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3. How to take Venlasov XL Capsules

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

Recommended dose

The usual recommended starting dose for the treatment of depression, generalised anxiety disorder and social anxiety disorder is 75 mg taken once daily. 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.

You should swallow each capsule whole with a drink of water at approximately the same time each day, either in the morning or in the evening. Do not break open, crush or chew the capsules, or put them in water before swallowing.

Venlasov XL Capsules 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 Venlasov XL Capsules').

Use in children

Venlasov XL Capsules are not recommended for use in children and adolescents (under the age of 18). See also section 2.

If you take more Venlasov XL Capsules than you should

If you realise you have taken more Venlasov XL Capsules than your doctor has recommended (or if someone else has taken some of your Venlasov XL Capsules), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

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 Venlasov XL Capsules

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten dose.

Do not take more than the daily amount of Venlasov XL Capsules that has been prescribed for you in one day.

If you stop taking Venlasov XL Capsules

Do not discontinue the treatment or reduce the dose without consulting your doctor, even if you feel better.

If your doctor thinks that you no longer need Venlasov XL Capsules, 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, tinnitus (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 Venlasov XL Capsules 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 may cause side effects, although not everybody gets them.

Serious side effects

If any of the following happen, do not take more Venlasov XL Capsules. 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.

• 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.

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

• Yellow skin or eyes, itchiness 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 Venlasov XL Capsules, If you stop taking Venlasov XL Capsules').

• 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 Venlasov 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 SAIDH)

• 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 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 Venlasov XL Capsules')

• Aggression

• Vertigo

Venlasov XL Capsules sometimes cause 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, Venlasov XL Capsules 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 Venlasov XL Capsules for a long time.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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

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

5. How to Store Venlasov XL Capsules

Do not store above 25°C. Store in the original package in order to protect from moisture.

Keep out of the sight and reach of children Do not use Venlasov XL Capsules after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not use Venlasov XL Capsules if you notice that the capsules are sticky or show any other visible signs of deterioration.

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 to protect the environment.

6. Contents of the pack and other information What Venlasov XL Capsules contain

The active substance is venlafaxine hydrochloride equivalent to 75 mg or 150 mg venlafaxine. Other ingredients are: microcrystalline cellulose, copovidone, ethylcellulose, magnesium stearate, povidone, silica- colloidal anhydrous, talc.

The capsule shell for 75mg capsules contains gelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172). The printing ink contains the following: shellac, propylene glycol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution, red iron oxide (E172).

The capsule shell for 150mg capsules contains gelatin, titanium dioxide (E171), brilliant blue FCF (E 133), allura red (E129), sunset yellow FCF (E110). The printing ink contains the following: shellac, propylene glycol, dehydrated alcohol, isopropyl alcohol, butyl alcohol, sodium hydroxide, povidone, titanium dioxide (E171).

What Venlasov XL Capsules look like and contents of the pack

The 75 mg capsules are opaque, peach coloured, prolonged-release hard capsules having red coloured, thick and thin radial circular bands on both ends of the capsules.

The 150 mg capsules are opaque, dark orange hard gelatin capsules having white coloured, thick and thin radial circular bands on both ends of the capsules.

Venlasov XL 75mg and 150mg Capsules are available in blister packs of 7, 14, 28 or 56 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Sovereign Medical,

Sovereign House Miles Gray Road Basildon Essex SS143FR

Manufacturer

Waymade Plc,

Sovereign House Miles Gray Road Basildon Essex SS143FR

The leaflet was last revised in October 2016

» SOVEREIGN GB 724-9576-APIL

Medical

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