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XENALVEN XL 37.5 MG PROLONGED RELEASE CAPSULE
Active substance(s): VENLAFAXINE HYDROCHLORIDE
Prolonged release capsules
IMPORTANT THINGS YOU SHOULD KNOW
ABOUT Xenalven XL
Please read all of this leaflet before you start to take
your medicine as it contains important information
about Xenalven XL
• Xenalven XL is used to treat depression, severe and
persistent anxiety known as generalised anxiety
disorder (GAD), social anxiety disorder (also known
as social phobia) and panic disorder (panic attacks)
• Xenalven XL is not for use in children and adolescents
– see in section 2 ‘Use in children and adolescents’
• If you have any concerns about how you feel, or about
this medication, it is important that you talk to your
doctor - even if you feel anxious or worried about
doing so. You may find it helpful to tell a friend or
relative that you are depressed or suffering from an
anxiety disorder, and that you have been prescribed this
medication; it might be useful to show them this leaflet.
• Xenalven XL may not start to work immediately.
Some people taking antidepressants may feel worse
before feeling better. Your doctor may ask to see you
again a couple of weeks after you start treatment and then
regularly until you start to feel well again. Tell your
doctor if you do not start to feel better.
• Some people who are depressed may think of harming
or killing themself. If this happens you should see
your doctor or go to a hospital straight away – see in
section 2 ‘Thoughts of suicide and worsening of your
depression or anxiety disorder’
• If you take too many capsules it is important to seek
immediate medical attention, even if you feel well,
because of the risk of serious side effects
• Do not stop taking Xenalven XL or change your dose
without the advice of your doctor even if you feel
better. If you stop taking Xenalven XL abruptly you may
get withdrawal reactions – see in section 3 ‘If you stop
taking Xenalven XL’
• If you have heart problems such as fast or irregular
heart rate or high blood pressure you should talk to
your doctor before taking Xenalven XL – see in
section 2 ‘Before you take Xenalven XL’
• Taking certain other medicines with Xenalven XL
may cause problems. You should tell your doctor if
you are taking any other medicines – see in section 2
‘Before you take Xenalven XL’
• See your doctor without delay if you feel restless and
feel like you can’t keep still, feel ‘high’ or very overexcited, have jerky muscle movements which you can’t
control. See section 4 – ‘Possible side effects’ for other
• If you are pregnant, or intend to become pregnant, or
breast-feeding, you should talk to your doctor – see in
section 2 ‘Pregnancy, breast-feeding and Xenalven XL’
More information on all of these points is provided in
the rest of this leaflet.
Read all of this leaflet carefully before you start using
this medicine because it contains important information
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
• 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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet
1. What Xenalven XL Capsules are and what are they used
2. What you need to know before you take Xenalven XL
3. How to take Xenalven XL Capsules
4. Possible side effects
5. How to store Xenalven XL Capsules
6. Contents of the pack and other information
1. WHAT XENALVEN XL CAPSULES ARE AND
WHAT ARE THEY USED FOR
Xenalven XL is an antidepressant and one of a group of
medicines called serotonin noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat
depression. It is thought that people who are depressed
may have lower levels of serotonin and noradrenaline in
their brain. Whilst it is not fully understood how antidepressants work, Xenalven XL prolonged release capsules
may help to relieve the symptoms of depression by
increasing the levels of these substances in the brain.
Xenalven XL capsules is a treatment for adults with
depression. Xenalven XL capsules 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 XENALVEN XL CAPSULES.
Do not take Xenalven XL
• if you are allergic to venlafaxine or any other ingredients
of this medicine (listed in section 6).
• if you are also taking or have taken any time 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 venlafaxine can cause serious or even life-threatening side
effects. Also, you must wait at least 7 days after you stop
taking Xenalven XL before you take any MAOI (see
also the section "Taking other medicines" and the
information in that section about "Serotonin Syndrome")
Warnings and precautions
Take special care with Xenalven XL
• if you use other medicines that taken at the same time
as Xenalven XL could increase the risk of developing
serotonin syndrome (see the section “Taking other
• 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 a history of fits (seizures)
• if you have a history of low sodium levels in your blood
• 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 eg.warfarin (used to prevent blood clot)
• if your cholesterol levels get higher
• if you have been told you have an abnormal heart
• 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.
Xenalven XL may cause a sensation of restlessness or an
inability to sit or stand still. 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 Xenalven XL capsules.
Thoughts of suicide and worsening of your depression or
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.
You may be more likely to think like this:
• if you have previously had thoughts about killing or
• if you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in adults (aged less than 25 years) with
psychiatric conditions who were treated with an
If you have thoughts of harming or killing yourself at any
time, contact your doctor or go to a hospital straight
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 is reported in 10% of patients treated with
Xenalven XL. This may increase the risk of tooth decay.
Therefore, you should take special care in your dental
Your blood glucose levels may be altered due to Xenalven
XL. Therefore, the dosage of your diabetes medicines may
need to be adjusted.
Children and adolescents
Xenalven XL 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 Xenalven XL for patients under 18 because
he/she decides that this is in their best interests. If your
doctor has prescribed Xenalven 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 Xenalven XL. Also, the long-term safety effects
concerning growth, maturation and cognitive and
behavioural development of Xenalven XL in this age group
has not yet been demonstrated.
Other medicines and Xenalven XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines including
medicines obtained without a prescription.
Your doctor should decide whether you can take Xenalven
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
Xenalven XL capsules. 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
Xenalven XL Capsules”).
• Serotonin syndrome: A potentially life-threatening
condition or Neuroleptic Malignant Syndrome
(NMS)-like reactions (see the section "Possible Side
Effects"), may occur with Xenalven XL treatment,
particularly when taken with other medicines. Examples
of these medicines include:
- triptans (used for migraine)
- medicines to treat depression, for instance SNRI,
SSRIs, tricyclics, or medicines containing lithium
- medicines containing linezolid, an antibiotic (used to
- medicines containing moclobemide, a reversible MAOI
(used to treat depression)
- medicines containing sibutramine (used for weight
- medicines containing tramadol, fentanyl, tapentadol,
pethidine, or pentazocine (used to treat severe pain)
- Medicines containing methadone (used to treat opioid
drug addiction or severe pain)
- Medicines containing dextromethorphan (used to treat
- 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)
Signs and symptoms of serotonin syndrome may include a
combination of the following: 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
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
• Antibiotics such as erythromycin or moxifloxacin (used
to treat bacterial infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with Xenalven
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
• metoprolol (a beta blocker to treat high blood pressure
and heart problems)
Xenalven XL with food and alcohol
Xenalven XL should be taken with food (see section “How
to take Xenalven XL Capsules”).
You should avoid alcohol while you are taking Xenalven
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 Xenalven XL only after discussing the potential
benefits and the potential risks to your unborn child with
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 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.
Xenalven XL 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 Xenalven XL.
Driving and using machines
Venlafaxine can cause impaired judgement, thinking, and
movement and coordination as well as problems with
vision. If you are affected by any of these you should not
drive, operate machinery or take part in any activities where
such effects could put you or others at risk.
Xenalven XL contains sunset yellow, ponceau 4R red
• sunset yellow as a colouring agent – is contained in the
75 mg and 150 mg strength capsules. It may cause an
• ponceau 4R red as a colouring agent – is contained in the
37.5 mg capsules. It may cause as allergic reaction.
PACKAGE LEAFLET: INFORMATION FOR THE
sucrose – is contained in all strengths capsules. If you
have been told by your doctor that you have intolerance
to some sugars, contact your doctor before taking this
3. HOW TO TAKE XENALVEN XL CAPSULES
Always take Xenalven XL exactly as your doctor has told
you. You should 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 Xenalven 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.
Xenalven XL should be taken with food.
If you have liver or kidney problems, talk to your doctor,
since your dose of Xenalven XL may need to be different.
Do not stop taking Xenalven XL without talking to your
doctor (see the section “If you stop taking Xenalven XL”).
If you take more Xenalven XL than you should
Call your doctor or pharmacist immediately if you take
more than the amount of Xenalven XL prescribed by your
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
If you forget to take Xenalven 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 more
than the daily amount of Xenalven XL that has been
prescribed for you in one day.
If you stop taking Xenalven 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 Xenalven 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 Xenalven XL, especially
when Xenalven 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
Your doctor will advise you on how you should gradually
discontinue Xenalven 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 product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Xenalven XL can cause side effects,
although not everybody gets them.
Do not be concerned if you see small white granules or
balls in your stools after taking Xenalven XL. Inside
Xenalven XL capsules are spheroids or small white balls
that contain the Xenalven XL active ingredient. These
spheroids are released from the capsules into your
gastrointestinal tract. As the spheroids travel the length
of your gastrointestinal tract, Xenalven XL is slowly
released. The spheroid “shell” remains undissolved and
is eliminated in your stools. Therefore, even though you
may see spheroids in your stools, your dose of Xenalven
XL has been absorbed
If any of the following happen, do not take more Xenalven
XL. Tell your doctor immediately, or go to the casualty
department at your nearest hospital:
• chest tightness, wheezing, trouble swallowing or
• swelling of the face, throat, hands, or feet
• feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm
• 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 ofcoordination,
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).
Serious side effects
If you notice any signs of the following, you may need
urgent medical attention:
• A high temperature with rigid muscles, confusion or
agitation, and sweating, or if you experience jerky
muscle movements which you can't control, these may
be symptoms of serious conditions known as neuroleptic
• Euphoric feelings, drowsiness, sustained rapid eye
movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms
of serotonergic syndrome
• Unexplained muscle pain, tenderness or weakness
• Coughing, wheezing, shortness of breath and a high
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness 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, seizures or fits
• psychiatric problems, such as hyperactivity and euphoria
• treatment withdrawal (see the section “How to take
Xenalven XL Capsules, if you stop taking Xenalven XL)
• Prolonged bleeding - if you cut or injure yourself, it may
take slightly longer than usual for bleeding to stop.
Other reported side effects
Very common (may affect more than 1 in 10 people)
• Headache; dry mouth; sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased; constipation; vomiting; increased
• Feeling separated (or detached) from yourself and
reality; nervousness; confusion; abnormal dreams;
• Drowsiness; tremor; pins and needles; increased muscle
• Increase in blood pressure; flushing; palpitations
• Increased frequency in urination; difficulties passing
• Decreased libido; abnormal ejaculation/orgasm (males);
lack of orgasm; erectile dysfunction (impotence)
• Menstrual irregularities such as increased bleeding or
increased irregular bleeding
• Weakness (asthenia); fatigue, chills
• 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)
Uncommon (may affect up to 1 in 100 people)
• Bruising; black tarry stools (faeces) or blood in stools,
which can be a sign of internal bleeding
Grinding of the teeth; involuntary movement of the
• Hallucinations; feeling separated (or detached) from
• General swelling of the skin especially the face, mouth,
tongue, throat area or hands and feet and/or a raised
itchy rash (hives) may be present
• Sensitivity to sunlight; abnormal hair loss; rash
• Impaired coordination and balance; feeling dizzy
(particularly when standing up too quickly), fainting,
• Weight gain; weight loss
• Lack of feeling or emotion; agitation feeling separated
(or detached) from reality
• Inability to pass urine
• Abnormal orgasm (females)
• A sensation of restlessness or an inability to sit or stand
still; seizures or fits; feeling over-excited or euphoric.
• Shortness of breath
Rare (may affect up to 1 in 1000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for
Frequency not known
• Reduced number of platelets in your blood, leading to an
increased risk of brushing or bleeding; blood disorders
which may lead to an increased risk of infection; slight
changes in blood levels of liver enzymes; decrease in
blood sodium levels;
• Itchiness, yellow skin or eyes, dark urine, or flu-like
symptoms, which are symptoms of inflammation of the
• Excessive water intake (known as SIADH)
• Abnormal breast milk production
• Disorientation and confusion often accompanied by
• Stiffness, spasms and involuntary movements of the
• 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).
• Severe eye pain and decreased or blurred vision
• Decrease in blood pressure; abnormal, rapid or irregular
heartbeat, which could lead to fainting
• Coughing, wheezing, shortness of breath and a high
temperature, which are symptoms of inflammation of the
lungs associated with an increase in white blood cells
• Severe abdominal or back pains (which could indicate a
serious problem in the gut, liver or pancreas)
• Skin rash, which may lead to severe blistering and
peeling of the skin; itching; mild rash
• Swollen face or tongue, shortness of breath or difficulty
breathing, often with skin rashes (this may be a serious
• Unexpected bleeding e.g. bleeding gums, blood in urine
or vomit, or the appearance of unexpected bruises or
broken blood vessels (broken veins).
• Unexplained muscle pain, tenderness or weakness
Xenalven XL 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 or liver
enzymes, sodium or cholesterol. More rarely, Xenalven XL
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 Xenalven XL 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 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 XENALVEN XL CAPSULES
Keep this medicine out of the sight and reach of children.
Do not use Xenalven XL 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 30C and store in the original container to
protect from moisture.
Do not use Xenalven XL after 100 days of opening the
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
What Xenalven XL contains
- The name of your medicine is Xenalven XL 37.5 mg or
75 mg or 150 mg Prolonged release capsules. It will be
referred to as Xenalven XL Capsules throughout this
leaflet. Each prolonges release capsules contains either
37.5 mg or 75 mg or 150 mg venlafaxine hydrochloride
as an active substance.
- The other contents of the capsules are Sugar Spheres
(contains sucrose), Ethyl cellulose (E462), Hydroxy
propyl cellulose, Hypromellose (E464), Talc (E553b),
Dibutyl sebacate, Oleic acid and Colloidal anhydrous
- The capsules shell contains: Gelatin, Sodium Lauryl
sulphate, Ponceau 4R (E124), Quinoline yellow (E104)
and Titanium dioxide (E171) for 37.5 mg, Sunset yellow
(E110), Quinoline yellow (E104) and Titanium dioxide
(E171) for 75 mg, Sunset yellow (E110), Quinoline
yellow (E104), Patent blue (E131) and Titanium dioxide
(E171) for 150 mg.
Remember: This medicine is for you. Only a doctor can
prescribe it for you. Never give it to someone else. It may
harm them even if their symptoms are the same as yours.
What Xenalven XL looks like and contents of the pack
Xenalven XL Prolonged release capsules is available in
- 37.5 mg: White to off-white pellets filled in hard gelatin
capsules shells ‘size 3’ with orange cap and clear
- 75 mg: White to off-white pellets filled in hard gelatin
capsules shells ‘size 1’ with yellow cap and clear
- 150 mg: White to off-white pellets filled in hard gelatin
capsules shells ‘size 0’ with buff cap and clear transparent body.
Xenalven XL is available in a PVC/aluminium foil blister
packs of 14, 28 or 30 capsules and in HDPE bottles of 100
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Cipla (EU) Limited, Hillbrow House, Hillbrow Road,
Esher, Surrey, KT10 9NW, United Kingdom.
Cipla (EU) Limited,
20 Balderton Street, London W1K 6TL, United Kingdom
Cipla Europe NV,
Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in 09/2015.
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.