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AMPHERO XL 150MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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venlafaxine

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

1. What Amphero XL is and what it is used for
Amphero 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.
Amphero XL is a treatment for adults with depression.
Amphero XL is also a treatment for adults with the
following anxiety disorders: social anxiety disorder (fear
or avoidance of social situations). 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
Amphero XL

TBC

1122111

Do not take Amphero XL
• 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 Amphero XL, can cause serious or even
life-threatening side effects. Also, you must wait at least
7 days after you stop taking Amphero XL before you take
any MAOI (see also the section “Other medicines and
Amphero XL” and the information in that section about
“Serotonin Syndrome”).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amphero XL.
• If you use other medicines that taken together with
Amphero XL could increase the risk of developing
serotonin syndrome (see the section “Other medicines
and Amphero 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 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.
Amphero XL 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 Amphero XL.
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 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
Amphero XL. Therefore, the dosage of your diabetes
medicines may need to be adjusted.
Effect on urine drug screens
If you are having a urine drug screen, taking
Amphero XL may cause positive results for
phencyclidine (PCP) or amphetamine when some test
methods are used, even though you may not be taking
PCP or amphetamine. If this happens, a more specific
test can be performed.
Children and adolescents
Amphero XL should normally not be used in children
and adolescents under the age of 18 years. Also, you
should know that patients under the age of 18 have an
increased risk of side effects such as suicide attempt,
suicidal thoughts and hostility (predominantly aggression,

Description Venlafaxine Hydrochloride 75/150 mg All

3. How to take Amphero 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 starting dose for the 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. The maximum dose for social anxiety
disorder is 225 mg/day.
Take Amphero XL 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.

Date: 19 Oct 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 604373

SAP No. N/A

Colours

Superceded Affiliate Item Code 10005341
TrackWise PR No. 604373
MA No. 04569/1369 & 1370
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 250366
Trackwise Proof No. 3
Glams Proof No. 1
Client Market UK

TBC

Amphero XL 75 mg
Prolonged-release capsules, hard
Amphero XL 150 mg
Prolonged-release capsules, hard

oppositional behaviour and anger) when they take this
class of medicines. Despite this, your doctor may prescribe
Amphero XL for patients under 18 because he/she
decides that this is in their best interests. If your doctor
has prescribed Amphero XL 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 Amphero XL. Also, the long-term safety
effects concerning growth, maturation, and cognitive
and behavioural development of Amphero XL in this age
group have not yet been demonstrated.
Other medicines and Amphero 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
Amphero XL 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 Amphero XL. 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
Amphero XL”).
• 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)
• Opioid medicines (used to treat moderate to
severe pain such as tramadol, fentanyl, tapentadol,
pethidine, methadone, pentazocine)
• 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)
• Dextromethorphan (used to treat coughs)
• Medicines containing methylene blue (used to treat
high levels of methaemoglobin in the blood or
certain types of blood poisoning)
• 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,
dofetilide (used to treat abnormal heart rhythms)
• antipsychotics such as thioridazine
• antibiotics such as erythromycin or moxifloxacin
• antihistamines (used to treat allergies).
The following medicines may also interact with
Amphero XL 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)
Amphero XL with alcohol
You should avoid alcohol while you are taking
Amphero XL.
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.
Tell your doctor if you become pregnant, or you are
trying to become pregnant. You should take 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 Amphero XL. 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, other
symptoms your baby might have when it is born is
not feeding properly, in addition to having trouble
breathing. 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
Amphero XL.
Driving and using machines
Do not drive or use any tools or machines until you
know how Amphero XL affects you.

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Package Leaflet: Information for the patient

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Amphero XL should be taken with food.
If you have liver or kidney problems, talk to your doctor,
since your dose of Amphero XL may need to be different.
Do not stop taking Amphero XL without talking to your
doctor (see the section “If you stop taking Amphero XL”).
If you take more Amphero XL than you should
Call your doctor or pharmacist immediately if you take
more than the amount of Amphero XL 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 Amphero 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 Amphero XL that
has been prescribed for you in one day.
If you stop taking Amphero 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
Amphero 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
Amphero XL, especially when Amphero XL 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 Amphero XL 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.

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
Amphero XL. 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, tongue, throat, hands, or feet
Not known (cannot be estimated from the available data):
• Chest tightness, wheezing, trouble swallowing
or breathing
• Feeling nervous or anxious, dizziness, throbbing
sensations, sudden reddening of the skin and/or a
warm feeling
• Severe 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).
Other side effects that you should tell your doctor
about include:
Common (may affect up to 1 in 10 people):
• Heart problems, such as fast or irregular heart rate,
increased blood pressure
• Nerve problems such as pins and needles
Uncommon (may affect up to 1 in 100 people):
• Vomiting blood, black (tarry) stools or blood in stools,
which can be a sign of internal bleeding
Rare (may affect up to 1 in 1,000)
• Seizures or fits
Not known (cannot be estimated from the available data)
• Coughing, wheezing, shortness of breath and a
high temperature
• Yellow skin or eyes, itchiness or dark urine, which may
be symptoms of inflammation of the liver (hepatitis)
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems such as movement disorders
• Psychiatric problems, such as hyperactivity and
euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take
Amphero XL, if you stop taking Amphero 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
Amphero 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 possible side effects include:
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• 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;
nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; increased muscle tightness
• 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)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; 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)
• Hallucinations; feeling separated (or detached) from
reality; agitation; abnormal orgasm (females); lack of
feeling or emotion; feeling underexcited; grinding of
the teeth
• A sensation of restlessness or an inability to sit or
stand still; fainting; involuntary movement of the
muscles; impaired coordination and balance; altered
taste sensation
• Fast heartbeat; feeling dizzy (particularly when
standing up too quickly)
• Sensitivity to sunlight; bruising; rash; abnormal
hair loss
• Shortness of breath
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Inability to control urination
• Over activity, racing thoughts and decreased need for
sleep (mania)
Not known (frequency cannot be estimated from the
available data)
• Reduced number of white blood cells which may lead
to an increased risk of infection
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• 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 Amphero XL)
• Disorientation and confusion often accompanied by
hallucination (delirium); aggression
• Severe eye pain
• Vertigo
• Decrease in blood pressure; abnormal, rapid or
irregular heart beat, which could lead to fainting;
unexpected bleeding, e.g. bleeding gums, blood in
the urine or the appearance of unexpected bruises or
broken blood vessels (broken veins)
• Severe abdominal or back pains (which could indicate
a serious problem in the gut, liver or pancreas)
• Changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and
peeling of the skin
• Unexplained muscle pain, tenderness or weakness
(rhabdomyolysis)
• An increase in blood levels of a hormone called
prolactin which may lead to abnormal breast
milk production
Additional side effects seen in children and adolescents
In clinical trials, the following side effects were also seen
in children and adolescents:
• Unfriendliness (hostility)
• Stomach pain
• Indigestion
• Nosebleeds
• Muscle pain
Venlafaxine sometimes causes unwanted effects that
you may not be aware of, such as increases in blood
pressure or abnormal heartbeat; slight changes in blood
levels or 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 taking
venlafaxine for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Amphero XL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the packaging after EXP. The expiry date refers
to the last day of that month.
This medicine does not require special storage conditions.
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 Amphero XL contains
The active substance is venlafaxine.
Each prolonged-release capsule, hard contains
venlafaxine hydrochloride, equivalent to 75 mg or
150 mg of venlafaxine (as the hydrochloride).
The other ingredients are:
Capsule content:
Microcrystalline cellulose, hydroxypropylcellulose, talc
Sub-coating:
Hypromellose, macrogol
Prolonged-release coating:
Ethylcellulose, hypromellose
Capsule shell:
Iron oxide red (E172), iron oxide yellow (E172), titanium
dioxide (E171), gelatin
Printing Ink:
Shellac, propylene glycol, iron oxide black (E172),
potassium hydroxide
What Amphero XL looks like and contents of the pack
[75 mg]Size 1, hard, gelatin capsule with opaque flesh
(pink) cap and body, axially printed with “MYLAN” over
“VE75” in black ink.
[150 mg]Size 0, hard, gelatin capsule with opaque dark
orange cap and body, axially printed with “MYLAN” over
“VE150” in black ink.
Aclar/PVC-Al and OPA/Al/PVC-Al blister packs of 7, 10,
14, 28, 30, 50, 56, 60, 84, 90, 98, 100 capsules and HDPE
bottles containing 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL,
United Kingdom.
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1,
Hungary.

This leaflet was last revised in
March 2015

Description Venlafaxine Hydrochloride 75/150 mg All

Date: 19 Oct 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 604373

SAP No. N/A

Colours

Superceded Affiliate Item Code 10005341
TrackWise PR No. 604373
MA No. 04569/1369 & 1370
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 250366
Trackwise Proof No. 3
Glams Proof No. 1
Client Market UK

1

604373

Time: 15:38
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
170 x 480 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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