VENAXX XL 75 MG PROLONGED-RELEASE CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - VENAXX XL 75 MG PROLONGED-RELEASE CAPSULES

Venaxx XL® 75 mg prolonged-release capsules, hard

Venlafaxine

MercuryPharma

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

1. what venaxx xl is and what it is used for

Venaxx XL 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.

Venaxx XL is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized 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 venaxx xl

Do not take Venaxx XL

If you are allergic to this medicine or any of the other ingredients of this medicine (listed in section 6).
If you are 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 other medicines, including this medicine, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking this medicine before you take any MAOI (see also sections “Serotonin syndrome” and “Other medicines and Venaxx XL”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Venaxx XL If you use other medicines (e.g. buprenorphine-containing medicinal products) that taken together with this medicine could increase the risk of developing serotonin syndrome, a potentially life-threatening condition (see section “Other medicines and Venaxx XL”).

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 pregnant (see ‘Pregnancy, breast-feeding and fertility’) 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 behavior.

Medicines like Venlafaxine (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment 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. If any of these conditions apply to you, please talk with your doctor before taking Venlafaxine.

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 first starting 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 Venaxx XL.

You may be more likely to think like this:

you have previously had thoughts about killing yourself or harming yourself
you are a young adult. Information from clinical trials has shown an increased risk in suicidal behaviour in adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.

If you have thoughts about harming or killing yourself at any time, contact your doctor or go to hospital straight away. You may find it helpful to tell a close friend or relative 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 Venaxx XL. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.

Diabetes

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

Children and adolescents

Venaxx XL should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 years of age 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 Venaxx XL 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 Venaxx XL. Also, the long- term safety effects concerning growth, maturation and cognitive and behavioural development of Venaxx XL in this age group has not yet been demonstrated.

Other medicines and Venaxx XL

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 this medicine 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 Venaxx XL. Tell your doctor if you have taken these medicines within the last 14 days (MAOIs: see section “What you need to know before you take Venaxx XL”)
Serotonin syndrome,

A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

Triptans (used for migraine)
Medicines to treat depression such as 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 reversible 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)
Do not take buprenorphine-containing medical products whilst taking Venaxx XL without first talking to your doctor. These medicines may interact with Venaxx XL and you may experience symptoms of serotonin syndrome (see below). Contact your doctor when experiencing such symptoms.

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).

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 Venlafaxine 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)

Venaxx XL with food, drink and alcohol

Venaxx XL should be taken with food (see section 3 “How to take Venaxx XL”). You should avoid alcohol while you are taking Venlafaxine.

Pregnancy, breast-feeding and fertility

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 only after discussing the potential benefits and the risks to your unborn child with your doctor.

Make sure your midwife and/or doctor know you are on Venlafaxine. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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 Venaxx XL during pregnancy, in addition to having trouble breathing, another symptom your baby might have when it is born is not feeling 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.

If you take Venaxx 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 Venaxx XL so they can 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 with this medicine.

Driving and using machines

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

Venaxx XL contains sodium:

This medicinal product contains less than 1 mmol sodium (23 mg) per capsule i.e. essentially ‚sodium free‘.

3. how to take venaxx xl

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

The recommended dose is

The usual recommended starting dose for treatment of depression and social anxiety disorder is 75 mg per day. 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.

Take Venlafaxine at approximately the same time each day, either in the morning or in the evening. Capsules must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.

Venlafaxine should be taken with food.

If you have liver or kidney problems, talk to your doctor, since your dose of Venaxx XL may need to be different.

Do not stop taking this medicine without talking to your doctor (see the section “If you stop taking Venaxx XL”).

If you take more Venaxx XL than you should

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

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 forget to take Venaxx XL

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 that has been prescribed for you in one day.

If you stop taking Venaxx XL

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 Venaxx 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 this medicine 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 sensation, 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 this medicine 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 can cause side effects, although not everybody gets them.

If any of the following happen, do not take more Venlafaxine. 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.

Not known: frequency 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 which may be accompanied by a 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 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 section “How to take Venaxx XL;

If you stop taking Venaxx XL”)

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 Venlafaxine 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
Dry mouth; nausea, constipation
Sweating (including night sweats)
Insomnia.

Common: may affect up to 1 in 10 people

Decreased appetite
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
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 1000 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).

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 Venaxx XL)
Aggression
Vertigo
Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy, breast-feeding and fertility in section 2 for more information.

5. how to store venaxx xl

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton after (EXP).

The expiry date refers to the last day of that month.

Store below 30°C.

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 protect the environment.

6. contents of the pack and other information

What Venaxx XL contains

The active substance is Venlafaxine.

Each prolonged-release capsule, hard contains 75 mg or 150 mg of Venlafaxine as venlafaxine hydrochloride.

The other ingredients are:

75 mg prolonged-release capsules, hard:

Capsule content: Hypromellose, ammonio methacrylate copolymer (type B), sodium laurilsulfate, magnesium stearate Coating: Basic butylated methacrylate copolymer 12.5% Capsule shell: Gelatin, titanium dioxide (E 171), red iron oxide (E172)

Printing ink: Shellac, black iron oxide (E172), propylene glycol (E1520)

150 mg prolonged-release capsules, hard:

g ink: Shellac, black iron oxide (E172), propylene glycol (E1520)

What Venaxx XL looks like and contents of the pack

75 mg prolonged-release capsules, hard: flesh opaque -flesh opaque size 0 hard gelatin capsules containing two round, biconvex film-coated tablets, with imprint VEN on cap and 75 on body.

150 mg prolonged-release capsules, hard: scarlet opaque -scarlet opaque size 00 hard gelatin capsules containing three round, biconvex film-coated tablets, with imprint VEN on cap and 150 on body.

75 mg: 14, 28, 30, 56, 98 and 100 prolonged-release capsules, hard.

150 mg: 10, 28, 30, 56, 98 and 100 prolonged-release capsules, hard.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer:

Pharmathen SA,

Dervenakion 6, Pallini 15351, Attikis, Greece

This leaflet was last revised in April 2021.

There are a number of organisations that provide help, information and advice for people with depression and their families or carers. You may wish to contact:

Mind

(National Association for Mental Health) PO Box 277, Manchester, M60 3XN

Mind infoline: 0300 123 3393

Depression Alliance, 212 Spitfire Studios 63 – 71 Collier Street, London, N1 9BE Telephone: 0845 123 23 20

Journeys,120 – 122 Broadway

Roath, Cardiff, CF 24 1NJ

Telephone: 029 2069 2891

SANE

1st Floor, Cityside House

40 Adler Street, London

E1 1EE, SANE line: 0845 767 8000

Venaxx is the registered trademark of Mercury Pharma Group Ltd.

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