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AMPHERO XL 75MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE

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Package Leaflet: Information for the patient

Amphero XL 75 mg
Prolonged-release
Capsules, Hard
Amphero XL 150 mg
Prolonged-release
Capsules, Hard
(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
Vefamyl contains the active substance venlafaxine.
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:
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 Amphero XL
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,
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 lifethreatening 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 breastfeeding 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.

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, 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 to 75 mg per day. The maximum dose
for generalised anxiety disorder, social anxiety
disorder and panic disorder is 225 mg/day.
50063151

Description Venlafaxine Hydrochloride 150 mg,75 mg 28
Component Type Leaflet
Affiliate Item Code 1156641

Pharma Code 5204
SAP No. N/A

Superceded Affiliate Item Code 604373

Vendor Job No. 306563

TrackWise PR No. 1156641
MA No. PL 04569/13691370
Packing Site/Printer N/A

Trackwise Proof No. 3

Supplier Code 50063151

Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 03 May 2017
No. of colours
Colours

1

Time: 12:09
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 600 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v2/Oct 2016

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.
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.
Rare (may affect up to 1 in 1,000 people):
• 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).
• Severe skin reaction with the peeling of the top
layer of the skin, severe blisters and bleeding in
the skin and also in the lips, eyes, mouth, nose
and genitals.
• Chest tightness, wheezing, trouble swallowing
or breathing.
• Signs of frequent infection such as high
temperature, sore throat, flu‑like symptoms
or ulcers in your mouth or throat, tiredness,
shortness of breath, looking pale or bruising or
bleeding more easily than normal. These may
be due to reduction in certain type of blood
cells.
• Severe rash, itching, or hives (elevated patches
of red or pale skin that often itch).
• Unexplained muscle pain, tenderness or
weakness (rhabdomyolysis).
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.
• Inability to pass urine.
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.
• Psychiatric problems, such as hyperactivity and
feeling unusually overexcited.
Rare (may affect up to 1 in 1,000 people):
• Seizures or fits.
• Pain in the upper abdomen and back, feeling
or being sick which may be caused by
inflammation of pancreas (pancreatitis).
• 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.
• Coughing, wheezing, shortness of breath and
a high temperature.
Very rare (may affect up to 1 in 10,000 people):
• Prolonged bleeding – if you cut or injure
yourself, it may take slightly longer than usual
for bleeding to stop.
• Nerve problems such as movement disorders.
Not known (cannot be estimated from the
available data):
• Withdrawal effects (see the section “How
to take Amphero XL, if you stop taking
Amphero XL”).
• 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).
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.
• Insomnia.
• Sweating (including night sweats).
• Drowsiness.
• Constipation.
Common (may affect up to 1 in 10 people):
• Appetite decreased.

• Confusion; feeling separated (or detached)
from yourself; lack of orgasm; decreased libido;
nervousness; abnormal dreams.
• Tremor; a sensation of restlessness or an
inability to sit or stand still, 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.
• Rash, itching.
• Yawning.
• Agitation.
• Vomiting; 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.
• Altered taste sensation.
• Fast heartbeat.
• Shortness of breath.
• Weight gain; weight loss.
Uncommon (may affect up to 1 in 100 people):
• Hallucinations; feeling separated (or detached)
from reality; abnormal orgasm (females); lack
of feeling or emotion; feeling underexcited;
grinding of the teeth.
• Fainting; involuntary movement of the muscles;
impaired coordination and balance.
• Feeling dizzy (particularly when standing up
too quickly).
• Sensitivity to sunlight; bruising; hives, abnormal
hair loss.
• Inability to control urination.
• Over activity, racing thoughts and decreased
need for sleep (mania).
• Decrease in blood pressure.
• Changes in blood levels of liver enzymes.
• Stiffness, spasms and involuntary movements
of the muscles.
Rare (may affect up to 1 in 1,000 people):
• Excessive water intake (known as SIADH).
• Decrease in blood sodium levels.
• Disorientation and confusion often
accompanied by hallucination (delirium).
• Uncontrolled muscle spasms affecting the eyes,
head, neck and the body.
• Severe eye pain, hazy or blurred vision with
rainbow coloured circles around bright lights.
• Abnormal, rapid or irregular heartbeat, which
could lead to fainting.
Very rare (may affect up to 1 in 10,000 people):
• An increase in blood levels of a hormone called
prolactin which may lead to abnormal breast
milk production.
• Unexpected bleeding, e.g. bleeding gums,
blood in the urine or the appearance of
unexpected bruises or broken blood vessels
(broken veins).
Not known (frequency cannot be estimated from
the available data):
• Aggression.
• Vertigo.

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 May 2017
1156641
50063151

Description Venlafaxine Hydrochloride 150 mg,75 mg 28
Component Type Leaflet
Affiliate Item Code 1156641

Pharma Code 5204
SAP No. N/A

Superceded Affiliate Item Code 604373

Vendor Job No. 306563

TrackWise PR No. 1156641
MA No. PL 04569/13691370
Packing Site/Printer N/A

Trackwise Proof No. 3

Supplier Code 50063151

Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 03 May 2017
No. of colours
Colours

1

Time: 12:09
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 600 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v2/Oct 2016

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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