Venlor Side Effects

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Answer the side-effect intent for venlor without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Venlor?

Venlor contains the active ingredient Venlafaxine.

• Active ingredient — Venlafaxine
• Registration number — 56/1.2/0035; 56/1.2/0036; 56/1.2/0037; 56/1.2/0038
• Registration holder — CIPLA MEDPRO (PTY) LTD

It is approved for:

• VENLOR XR TABLET contains the active ingredient called venlafaxine hydrochloride
• VENLOR XR TABLET belongs to a class of medicine known as Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) and it is used in the treatment of depression, including depression associated with anxiety
• It is also used to prevent episodes of depression from reoccurring

Common side effects of Venlor

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• increased cholesterol, loss of appetite, weight loss
• abnormal dreams, nervousness, unable to sleep, lower sex drive, anxiety, agitation, feeling like you are observing yourself from outside your body
• inability to change eye focus, dilated pupils, visual disturbances
• ringing in the ears
• irregular heartbeats you can feel, fast heartrate/pulse
• high blood pressure, hot flushes
• yawning
• decreased appetite, constipation, nausea, vomiting, loss of appetite, (diarrhoea) frequent loose watery stools, which can cause dehydration and may require hospitalisation and treatment with intravenous fluids, gas, upset stomach, abdominal pain, dry mouth
• joint pain, increased muscle tone/muscle stiffness, numbness/tingling in the hands or feet, muscle aches
• inability to pass urine, difficulties passing urine, more frequent urination
• abnormal ejaculation/orgasm (males), inability to achieve an orgasm, erectile dysfunction, sexual dysfunction
• excessive sweating (including night sweats)
• weakness (asthenia), fatigue/tiredness, headache, pain, abdominal, chest and back pain, chills, fever
• weight gain or loss

Less frequent side effects

• altered taste
• blood tests showing low blood sodium levels
• state of indifference – lack of feeling or emotion, hallucinations (seeing or hearing things which are not there), overactivity, racing thoughts and decreased need for sleep (mania), feeling overexcited or euphoric, losing touch with reality
• involuntary movements of the muscles, fits/seizures, slurred speech, loss of consciousness, impaired co-ordination and balance
• irregular heartbeat, low blood pressure when standing up from sitting down
• grinding of the teeth, inflammation of the pancreas causing pain in the upper abdomen (pancreatitis), black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding
• abnormal hair loss, bull’s eye shaped lesions, hives, sensitivity to sunlight, bruising
• abnormal liver function test results
• loss of bladder control
• difficulty in controlling movements, muscle spasm
• abnormal orgasm (female), excessive or inappropriate production of milk, menstrual changes, abnormal menstrual cycle. The following side effects have been reported but the frequency of them to occur is not known:
• 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), reduction in blood platelets which increases risk of bleeding or bruising, blood disorders
• abnormal thinking, aggression, memory loss, depression, rapid changes in mood, thinking of committing suicide
• uncontrollable movements of mouth, tongue and limbs, numbness, lockjaw
• vertigo (feeling off balance)
• low blood pressure
• sore throat, stuffy nose
• increased appetite, indigestion, belching, flatulence
• menstrual irregularities such as increased bleeding or increased irregular bleeding
• heavy vaginal bleeding shortly after birth (postpartum haemorrhage)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to venlafaxine hydrochloride or any of the other ingredients of VENLOR XR TABLET (listed in section 6)
• if you are currently being treated with medicines which fall under a class called monoamine oxidase inhibitors (such as moclobemide)
• if you have stopped taking a medicine which falls under the class of monoamine oxidase inhibitors in less than 14 days
• if you are less than 18 years of age
• if you are pregnant or breastfeeding

Use with care, and tell your doctor, if

• if you have been diagnosed with major depressive disorder
• if you have been diagnosed with an eye condition called glaucoma
• if you have a heart condition
• if you have high blood pressure
• if you have a history of seizures (fits)
• if you have a history or family history of a mood disorder
• if you have a history of excessive anger
• if you are elderly
• if you have a tendency to bleed or bruise easily
• if you have been diagnosed with high cholesterol
• if you are diabetic. Tell your doctor:
• if you develop symptoms such as an increase in heart rate, an abnormal increase in body temperature, feeling anxious, seeing things that are not there (hallucinations), nausea, vomiting and diarrhoea
• if you are taking medicines such as lithium, sibutramine, St.John’s Wort [Hypericum perforatum], fentanyl, tramadol, dextromethorphan, tapentadol, pethidine, methadone and pentazocine
• if you develop a rash or any other allergic skin reaction
• if you are taking weight loss medicines
• if you are taking diuretic medicines (such as indapamide)
• if you are taking medicines to prevent blood clots (such as warfarin)
• if you experience difficulty during sexual activity while taking VENLOR XR TABLET
• if you develop symptoms such as restlessness and an inability to sit or stand still while taking VENLOR XR TABLET
• if you develop suicidal thoughts while taking VENLOR XR TABLET. 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. 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. Studies have 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 health care provider or go to a hospital immediately. 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. Children and adolescents The safety of VENLOR XR TABLET has not been studied in children less than 18 years of age. Symptoms such as having suicidal thoughts and thoughts of self-harm may be increased in children

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist, or other health care provider for advice before taking VENLOR XR TABLET
• If you take VENLOR XR TABLET 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 VENLOR XR TABLET so they can advise you
• Pregnancy Do not take VENLOR XR TABLET if you are pregnant as it may affect your newborn
• Breastfeeding VENLOR XR TABLET passes into human milk and therefore should not be used by breastfeeding mothers
• Fertility The effect of VENLOR XR TABLET on fertility is not known

Interactions and medicines to check

The approved leaflet names these interactions.

• cimetidine (used to treat heartburn and stomach ulcers)
• ketoconazole, itraconazole, voriconazole, posaconazole (used to treat fungal infections)
• atazanavir, ritonavir, saquinavir, nelfinavir (used in the treatment of HIV/AIDS)
• clarithromycin (used in the treatment of bacterial infections)
• medicines that inhibit the CYP2D6 liver enzyme such as fluoxetine (used in the treatment of depression). VENLOR XR TABLET may reduce the effect of the following medicines:
• indinavir (used in the treatment of HIV/AIDS). VENLOR XR TABLET may increase the effect of the following medicines:
• haloperidol (used in the treatment of psychosis)
• desipramine (used in the treatment of depression)
• risperidone (used in the treatment of psychosis). When VENLOR XR TABLET is used together with the following medicines, it may increase the risk of unwanted side effects:
• quinidine, amiodarone, dotalol, dofetilide (used to treat abnormal heart rhythm)
• thioridazine (used in the treatment of psychosis)
• erythromycin, moxifloxacin (used for bacterial infections)
• some antihistamines
• lithium (used to treat mood disorders)
• medicines that fall under the class of monoamine oxidase inhibitors (such as moclobemide). VENLOR XR TABLET with food, drink, and alcohol VENLOR XR TABLET should be swallowed whole with a glass of water and should be taken with food. The tablet must not be chewed, crushed, divided, or dissolved in water. Avoid alcohol while being treated with VENLOR XR TABLET

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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