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VENLAFAXINE BRISTOL LABS XL 75 MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE POLYMORPHIC FORM B / VENLAFAXINE HYDROCHLORIDE POLYMORPHIC FORM B

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Package leaflet: Information for the patient

Majoven® XL 37.5 mg prolonged release capsules, hard
Majoven® XL 75 mg prolonged release capsules, hard
Majoven® XL 150 mg prolonged release capsules, hard
Venlafaxine (as hydrochloride)
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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
The active substance in this medicine is Venlafaxine.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. 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 this medicine
Do not take this medicine:
• If you are allergic to active substance or any of the other ingredients of this medicine
(listed in section 6).

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480 mm x 150 mm

• 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 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 MAOI (see also the
section entitled “Taking other medicines” and the information in that section about
‘Serotonin Syndrome’).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
• If you use other medicines that taken together with venlafaxine could increase the
risk of developing serotonin syndrome (see the section “Taking other medicines”);
• 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.
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.
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 tooth decay (caries). Therefore, you should take special care in your dental
hygiene.
Diabetes
Your blood glucose levels may be altered due to venlafaxine. Therefore, the dosage
of your diabetes medicines may need to be adjusted.
Children and adolescents
Venlafaxine 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 venlafaxine. Also, 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.
Taking other medicines
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 venlafaxine 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 this medicine. 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 this medicine”);
• 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 Hypericumperforatum, 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 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).
Taking this medicine with food, drink and alcohol
This medicine should be taken with food (see section 3 “How to take this medicine”).
You should avoid alcohol while you are taking Venlafaxine.

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 use venlafaxine only after discussing the potential benefits and the potential
risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows 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 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.
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 this medicine affects you.
Important information regarding the ingredients of this medicine
Majoven® XL 150 mg prolonged release capsules contain Sunset yellow (E110) and
Allura red (E129), which may cause allergic reactions.

3. How to take this medicine
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 usual recommended starting dose for treatment of depression, generalised anxiety
disorder 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.
This medicine 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.
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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 medicine. 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);

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- 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.
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;
- 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 the section “How to take this medicine, If you stop taking this
medicine”);
- 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 Majoven® 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 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 during venlafaxine therapy or early after treatment
discontinuation (see section 2, “What you need to know before you take this
medicine”);
- Aggression;
- Vertigo.
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, it 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 this
medicine 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 as below
In UK: via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.
In Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1
6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store this medicine
• Keep this medicine out of the sight and reach of children.
• Do not store above 250C. Store in the original package in order to protect from
moisture.
• Do not use this medicine after the expiry date which is stated on the label and carton
after EXP. The expiry date refers to the last day of the month.

• 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 this medicine contains
• The active substance is Venlafaxine.
• The other ingredients are:
- Capsule contents: Microcrystalline cellulose, povidone K-90D, talc, colloidal silicon
dioxide, magnesium stearate, ethyl cellulose, copovidone.
- Capsule shell (37.5 mg): Gelatin, titanium dioxide (E171), yellow iron oxide (E172),
red iron oxide (E172), black iron oxide (E172).
- Capsule shell (75 mg): Gelatin, titanium dioxide (E171), red iron oxide (E172),
black iron oxide (E172).
- Capsule shell (150 mg): Gelatin, titanium dioxide (E171), sunset yellow (E110),
allura red (E129) and brilliant blue (E133).
- Printing ink (37.5 mg and 75 mg): Shellac, propylene glycol, red iron oxide (E172).
- Printing ink (150 mg): Shellac, propylene glycol, sodium hydroxide, povidone,
titanium dioxide (E171).
What this medicine looks like and contents of the pack
• 37.5 mg: Size ‘3’ hard gelatin capsule with peach opaque cap and light grey
opaque body filled with white to off white pellets.
• 75 mg: Size ‘1’ hard gelatin capsule with peach opaque cap and peach opaque
body filled with white to off white pellets.
• 150 mg: Size ‘0’ hard gelatin capsule with dark orange cap and dark orange body
filled with white to off white pellets.
• This medicine is available in blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98,
100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax :
0044 (0)1442 873717
info@bristol-labs.co.uk
E-mail:
This leaflet was last revised in January 2017
To request a copy of this leaflet in Braille, large print or audio format, contact the
licence holder at the address (or telephone, fax, email) above.

V6 18-01-17 D1

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Do not stop taking this medicine without talking to your doctor (see the section “If you
stop taking this medicine”).
If you take more of this medicine than you should
Call your doctor or pharmacist immediately if you take more of this medicine than the
amount prescribed by your doctor.
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 this medicine
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 this medicine
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 this medicine, 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, 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 venlafaxine
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.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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