Patient leaflet - Venlasov XL 150 mg prolonged-release capsules

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. Venlasov XL Capsules are 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 noradrenaline in the brain.

Venlasov XL Capsules are 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 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’).

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 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.

Do not drink alcohol while being treated with Venlasov XL Capsules 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.

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 Venlasov XL Capsules.

You may be more likely to think like this:

if you have previously had thoughts about killing yourself or harming yourself.
UK 676-4617-02

P
Product Name	Venlasov XL
PIP Code	UK 676-4617-02
Old PIP Code	UK 675-6530-APIL
Variaion No.	0035 in-line with RLD update
Customer	Sovereign Medical
Market	UK
Language	English
	200 x 600 mm (PIL)
	8 PT
Version No.	2
Date	24/11/25
File Name	Venlasov XL UK 676-4617-PIL

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.

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’).

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

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, skip the missed dose and take only a single dose as usual. 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 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 Venlasov XL Capsules 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 may cause side effects, although not everybody gets them.

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. 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 heart beat.

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 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 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
Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see section 2 ‘Pregnancy and breast-feeding’

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 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.

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 75 mg 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 150 mg 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 75 mg and 150 mg 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, SS14 3FR

Manufacturer

Waymade Plc,