Venlafaxine 37.5 mg / 5 ml oral solution – patient leaflet, side effects, dosage

1.What Venlafaxine Oral Solution is and what it is used for

The full name of your medicine isVenlafaxine 37.5mg/5ml Oral Solution. In this leaflet the shorter nameVenlafaxine is used. Venlafaxine contains the active substance venlafaxine hydrochloride.

Venlafaxine 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.

Venlafaxine is a treatment for adults with depression.Treating depression 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 Venlafaxine Oral Solution

Do not takeVenlafaxine:

• If you are allergic toVenlafaxine or any of the other ingredients of this medicine (listed in section 6).The signs of an allergic reaction may include swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, severe itching of your skin with raised lumps

• If you are taking or have recently 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 other medicines, including Venlafaxine, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine before you take any irreversible MAOI (see also section ‘Other medicines andVenlafaxine’). Warnings and precautions

Talk to your doctor or pharmacist before takingVenlafaxine

• If you use other medicines that taken together withVenlafaxine could increase the risk of developing serotonin syndrome (see section

  ‘Other medicines andVenlafaxine’)

• 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 are diabetic, as your insulin or oral antidiabetic dosage may need to be changed
• 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), or if you are pregnant (see 'Pregnancy and breast-feeding').

• If your cholesterol levels get higher
• 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.

If any of these conditions apply to you, please talk with your doctor before takingVenlafaxine.

Venlafaxine 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 withVenlafaxine 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 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 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 is getting worse, or if they are worried about changes in your behaviour.

Dry Mouth

Dry mouth is reported in 10% of patients treated withVenlafaxine.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 toVenlafaxine.Therefore, the dosage of your diabetes medicines may need to be adjusted. Sexual problems

Medicines likeVenlafaxine (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

Venlafaxine should normally not be used in children 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 prescribeVenlafaxine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribedVenlafaxine for a patient under 18 and 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. Also, long term safety effects concerning growth, maturation and cognitive and behavioural development ofVenlafaxine in this age group has not yet been demonstrated.

Other medicines andVenlafaxine

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 takeVenlafaxine 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 withVenlafaxine.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’)

• Serotonin syndrome:

  Serotonin syndrome, a potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section ‘Possible side effects’), may occur withVenlafaxine 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, a reversable 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) ■ 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
  • Products containing St-JohnsWart (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression) ■ Products containing tryptophan (used for problems such as sleep or depression).

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 enzymes (determined by blood test).

Tell your doctor immediately or go to the 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 antibacterial infections)
• Antihistamines (used to treat allergy).

The following medicines may also interact withVenlafaxine 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 with food drink and alcohol

• Venlafaxine should be taken with food (see section 3 ‘How to takeVenlafaxine’)
• Do not drink alcohol while being treated withVenlafaxine. 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. 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 useVenlafaxine only after discussing the potential benefits and the potential risks to your unborn child with your doctor
• Make sure your midwife and/or doctor know you are onVenlafaxine.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 breath 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 takeVenlafaxine 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 takingVenlafaxine 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 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 withVenlafaxine. Driving or using machines

Do not drive or use any tools or machines until you know howVenlafaxine affects you.

Venlafaxine contains liquid maltitol, sodium methyl and ethyl hydroxybenzoate

• Liquid maltitol (2.00g/5ml) - a type of sugar. If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
• Sodium methyl and sodium ethyl hydroxybenzoate.These may cause an allergic reaction.This allergy may happen some time after starting the medicine.
• This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially sodium free.

3. How to take Venlafaxine Oral Solution

Always take this medicine exactly as your doctor has told you.You should check with your doctor or your pharmacist if you are not sure. The recommended dose is 75 mg (10 ml) per day in divided doses, two or three times a day.

The dose can be raised by your doctor gradually and if needed, even up to a maximum dose of 375 mg (50 ml) daily for depression. If low doses are required, the 37.5 mg/5 ml strength product is the most suitable presentation.

Continued overleaf Venlafaxine 37.5mg/5ml Oral Solution

Package leaflet: Information for the user

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16.01.2026

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Venlafaxine O

37.5

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If high doses are required, the 75 mg/5 ml strength product is the most suitable presentation.

TakeVenlafaxine at approximately the same time each day, in the morning and in the evening.

Venlafaxine should be taken with food.

If you have liver or kidney problems, talk to your doctor, since your dose ofVenlafaxine may need to be different. Do not stop takingVenlafaxine without talking to your doctor (see the section ‘if you stop takingVenlafaxine’). Taking this medicine

• This medicine contains 37.5 mg of venlafaxine as hydrochloride in each 5 ml of solution.

• Take this medicine by mouth.

  • Always use the syringe supplied in the pack.
  • This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes.There is further information in the SmPC, ask your doctor, pharmacist or nurse for this information.
  • Instructions for use via NG or PEG tube:
  • ensure the tube is clear before taking the medicine 2. flush the tube with a minimum of 5mL of water 3. administer the medicine gently and slowly into the tube, with a suitable measuring device
  • flush the tube again with a minimum of 5mL of water. A 10mL flush volume should be used for large bore size tubes (18 Fr). Measuring your dose

Instructions for use of the syringe

1. 1. To open the bottle, press the cap down and turn it anti-clockwise (figure 1).
2. 2. Put the syringe adaptor into the bottle neck (figure 2).
3. 3. Take the syringe and put it into the adaptor opening (figure 3).
4. 4. Turn the bottle upside down (figure 4).
5. 5.

   Fill the syringe with a small amount of solution by pulling

   the plunger down (figure 4A).Then push the plunger upward

   in order to remove any possible bubbles (figure 4B). Finally,

   pull the plunger down to the graduation mark corresponding

   to the quantity in millilitres (ml) prescribed by your doctor.

   The top flat edge of the piston should be in line with the

   graduation mark you are measuring to (Figure 4C).

6. 6. Turn the bottle the right way up (Figure 5A).
7. 7. Remove the syringe from the adaptor (Figure 5B).
8. 8.

   Put the end of the syringe into your mouth and push the

   plunger slowly back in to take the medicine.

9. 9.

   Wash the syringe with water and let it dry before you use

   it again (Figure 6).

10. 10.

    Close the bottle with the plastic screw cap - leave the

    syringe adaptor in the bottle.

If you take moreVenlafaxine than you should

Call your doctor or pharmacist immediately if you take more

than the amount ofVenlafaxine prescribed by your doctor.

Overdose can be life-threatening, especially with concomitant

use of alcohol and/or certain medicines (see “Other medicines

andVenlafaxine”).

The symptoms of a possible overdose may include a rapid heart

beat, changes in levels of alertness (ranging from sleepiness to

coma), blurred vision, seizures or fits, and vomiting.

If you forget to takeVenlafaxine

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 more than the daily amount of

Venlafaxine that has been prescribed for you in one day.

If you stop takingVenlafaxine

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 needVenlafaxine, he/she may ask you to reduce your dose slowly, before stopping treatment altogether. Side effects are known to occur when people stop usingVenlafaxine, especially whenVenlafaxine 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 will gradually discontinueVenlafaxine 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 product, 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 moreVenlafaxine. 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 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).

• 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, shortness of breath and 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 problem, 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 excited
• Withdrawal effects (see the section ‘How to takeVenlafaxine, if you stop takingVenlafaxine’)
• Prolonged bleeding – if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. 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 teeth
• Fainting; involuntary movements of the muscles; impaired co-ordination and balance
• Feeling dizzy (particularly when standing up to 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)

• Seizure 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) ■ Inflammation and scarring of the lung (interstitial lung disease).

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 duringVenlafaxine therapy or early after treatment discontinuation (see section 2,What you need to know before you takeVenlafaxine) ■ Aggression
• Vertigo
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see 'Pregnancy and breast-feeding' in section 2 for more information.

Venlafaxine 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,Venlafaxine 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 takingVenlafaxine for a long time.

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can always report side effects directly via theYellow card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRAYellow 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 Venlafaxine Oral Solution

• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use 30 days after you first open it.
• Do not use this medicine after the expiry date (month, year) which is stated on the label after EXP.The expiry date refers to the last day of that month.
• Do not useVenlafaxine if you notice anything wrong with the medicine.Talk to your doctor or pharmacist. ■ 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

WhatVenlafaxine Oral Solution contains

• The active substance is venlafaxine hydrochloride. Each 5 ml of oral solution contains 37.5 mg of venlafaxine (as hydrochloride). ■ The other ingredients are citric acid monohydrate (E330), di-sodium hydrogen phosphate anhydrous, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), sucralose (E955), liquid maltitol and purified water. WhatVenlafaxine Oral Solution looks like and contents of the pack

Venlafaxine is a clear, colourless to almost colourless liquid. It comes in a brown glass bottle holding 150 ml of solution with a 10 ml syringe and bottle adaptor.

The Marketing Authorisation Holder and Manufacturer is

Rosemont Pharmaceuticals Ltd,Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

Tel: + 44 (0) 113 244 1400

This leaflet was last revised in 01/2026

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Regulatory Approval JOB SPECIFICATION

16.01.2026

DBO

Venlafaxine Oral Solution

37.5mg/5ml

150ml

150ml

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N/A

UKL504

640 x 170mm

170 x 40mm

Yes

N/A