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RANFAXIRAN XL 75 MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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Package leaflet: Information for the user
Ranfaxiran XL 37.5mg Prolonged release Capsules, Hard
Ranfaxiran XL 75mg Prolonged release Capsules, Hard
Ranfaxiran XL 150mg 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 Ranfaxiran XL is and what it is used for
2. What you need to know before you take Ranfaxiran XL
3. How to take Ranfaxiran XL
4. Possible side effects
5. How to store Ranfaxiran XL
6. Contents of the pack and other information
1. What Ranfaxiran XL is and what it is used for
Ranfaxiran XL is an antidepressant that belongs to a group of medicines called serotonin and
norepinephrine reuptake inhibitors (SNRIs).
Ranfaxiran XL is used to treat depression in adults. It is thought that people who are
depressed 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.
Treating depression 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
Ranfaxiran XL Do not take Ranfaxiran 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 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 Ranfaxiran XL, can cause serious or even life-threatening side effects. Also,
you must wait at least 7 days after you stop taking Ranfaxiran XL before you take any
irreversible MAOI (see below “Other medicines and Ranfaxiran XL”).

Warnings and precautions
Talk to your doctor before taking Ranfaxiran XL:
• If you use other medicines that taken concomitantly with Ranfaxiran XL could increase
the risk of developing serotonin syndrome (see below below “Other medicines and
Ranfaxiran 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 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.
• If you have high cholesterol levels or they get higher during treatment with Ranfaxiran
XL.
• 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.
• If you have diabetes (your doctor may need to adjust your dose of insulin or other
antidiabetic treatment).
Ranfaxiran 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
Ranfaxiran XL
Thoughts of suicide and worsening of your depression
If you are depressed 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, and ask them
to read this leaflet. You might ask them to tell you if they think your depression 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 caries. Therefore, you should take special care in your dental hygiene.
Children and adolescents
Ranfaxiran 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
Ranfaxiran XL for patients under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed Ranfaxiran 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 Ranfaxiran XL.
Also, the long-term safety effects concerning growth, maturation and cognitive and
behavioural development of Ranfaxiran XL in this age group has not yet been
demonstrated.
Other medicines and Ranfaxiran 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 Ranfaxiran 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 Ranfaxiran XL. Tell your doctor if you have taken these
medicines within the last 14 days. (MAOIs: see above “Do not take Ranfaxiran XL”).



Some medicines when taken concomitantly with Ranfaxiran XL could increase the risk of
developing ‘Serotonin syndrome’, a potentially life-threatening condition (see section 4
“Possible side effects”).

Examples of these medicines include:
o Triptans (used for migraine)
o Other medicines to treat depression, for instance SNRIs, selective serotonin reuptake inhibitors (SSRIs), tricyclics, or medicines containing lithium
o Medicines containing linezolid, an antibiotic (used to treat infections)
o Medicines containing moclobemide, a reversible MAOI (used to treat depression)
o Medicines containing sibutramine (used for weight loss)
o Medicines containing tramadol (a pain-killer)
o Medicines containing methylene blue (used to treat high levels of methaemoglobin
in the blood)

o 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)
o Products containing St. John’s Wort (also called Hypericum perforatum, a natural
or herbal remedy used to treat mild depression)
o Products containing tryptophan (used for problems such as sleep and depression)
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 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.
The following medicines may also interact with Ranfaxiran 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, itraconazole, voriconazole, posaconazole (antifungal medicines)
Clarithromycin, telithromycin (antibiotics used to treat infections)
Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)





Haloperidol or risperidone (to treat psychiatric conditions)
Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Oral contraceptives (“the pill”)

Ranfaxiran XL with food and drink
Ranfaxiran XL should be taken with food.
You should avoid alcohol while you are taking Ranfaxiran XL.
Pregnancy and Breast-feeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor
for advice before taking this medicine.You should use Ranfaxiran XL 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 Ranfaxiran 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 Ranfaxiran XL during pregnancy, let your doctor know, as your baby might
have some symptoms when it is born. These symptoms usually begin during the first 24 hours
after the baby is born. They include include irritability, tremor, hypotonia, constant crying,

sleeping difficulties and 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.
Ranfaxiran passes into breast milk. There is a risk of an effect on the baby. There are some
reports in breast-fed babies, who experienced crying, irritability, and abnormal sleeping
patterns. 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 Ranfaxiran XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Ranfaxiran XL affects you.
3. How to take Ranfaxiran XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression 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.
Take Ranfaxiran XL 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.
Ranfaxiran XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose may need to be
different.
Do not stop taking Ranfaxiran XL without talking to your doctor (see below “If you stop taking
Ranfaxiran XL”).
If you take more Ranfaxiran XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Ranfaxiran
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 Ranfaxiran 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 Ranfaxiran XL that has been prescribed for you in one day.

If you stop taking Ranfaxiran 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 Ranfaxiran 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 Ranfaxiran XL, especially when Ranfaxiran 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 Ranfaxiran 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.
Do not be concerned if you see small white granules or balls in your stools after taking
Ranfaxiran XL. Inside Ranfaxiran XL capsules are spheroids or small white balls that contain
the venlafaxine active ingredient. These spheroids are released from the capsule into your
gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract,
venlafaxine 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
venlafaxine has been absorbed.
If any of the following happens, do not take more Ranfaxiran XL. Tell your doctor
immediately, or go to the casualty department at your nearest hospital:






Chest tightness, wheezing, trouble swallowing or breathing
Swelling of the face, throat, hands, or feet
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).

If you notice any of the following, seek urgent medical attention:
Common (may affect up to 1 in 10 people)
• Visual disturbance including blurred vision; dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, increased muscle
tonus
Uncommon (may affect up to 1 in 100 people)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of
internal bleeding
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
Not known (frequency cannot be estimated from the available data)
• 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
(pulmonary eosinophilia)
• 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
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual
for bleeding to stop
Withdrawal symptoms are known to occur when people stop using Ranfaxiran XL, especially
when Ranfaxiran XL are stopped suddenly or the dose is reduced too quickly. See section 3 “If
you stop taking Ranfaxiran XL”.
Other side effects
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
• 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 over-excited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary
movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of
internal bleeding
• 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; bruising;
rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• 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 platelets in your blood, leading to an increased risk of bruising or
bleeding; blood disorders which may lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin
rashes (this may be a serious allergic reaction)
• 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 Venlafaxine
tablets”)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• 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 malignant syndrome; euphoric feelings,
drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness,
spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; 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)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver
or pancreas)
• Slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash





Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Abnormal breast milk production
Changes in the recording of electrical changes (ECG) in the heart which correspond to
heart rhythm disturbances

Ranfaxiran 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 of liver
enzymes, sodium or cholesterol. More rarely, Ranfaxiran 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 Ranfaxiran
XL 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 Ranfaxiran XL
Keep this medicine out of the sight and reach of children.
This medicinal does not require any special storage conditions.
Do not use this medicine after the expiry date, which is stated on the blister or carton after
“EXP”: The expiry date refers to the last day of that 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 to protect the
environment.
.
6.

Contents of the pack and other information

What Ranfaxiran XL contains
Ranfaxiran XL 37.5 mg prolonged release capsule , hard
The active substance is venlafaxine.
Each prolonged release capsule, hard contains 42.43 mg of Venlafaxine Hydrochloride
equivalent to 37.5 mg of Venlafaxine.
Other ingredients in these capsules are:
Core Spheroid Composition: Cellulose, microcrystalline, Hypromellose,
Modified Release coating : Ethyl cellulose, Povidone (K 30), Triacetin and Talc
Capsule Shell:

Body
Iron Oxide Red (E 172)
Titanium Dioxide (E171)
Gelatin
Sodium Lauryl Sulfate
Cap
FD & C Blue 1 (E 133)
D & C Yellow 10 (E 104)
FD & C Red 40 (E 129)
Titanium Dioxide (E171)
Gelatin
Sodium Lauryl Sulfate
Ranfaxiran XL 75 mg prolonged release capsule , hard
The active substance is venlafaxine.
Each prolonged release capsule, hard contains 84.85 mg of Venlafaxine Hydrochloride
equivalent to 75 mg of Venlafaxine respectively.
Other ingredients in these capsules are:
Core Spheroid Composition: Cellulose, microcrystalline, Hypromellose,
Modified Release coating : Ethyl cellulose, Povidone (K 30), Triacetin and Talc
Capsule Shell:
Body
Iron Oxide Red (E 172)
Titanium Dioxide (E171)
Gelatin
Sodium Lauryl Sulfate
Cap
Iron Oxide Red (E 172)
Titanium Dioxide (E171)
Gelatin
Sodium Lauryl Sulfate
Ranfaxiran XL 150 mg prolonged release capsules, hard
The active substance is venlafaxine.
Each prolonged release capsule, hard contains 169.71 mg of Venlafaxine Hydrochloride

equivalent to 150 mg of Venlafaxine respectively.
Core Spheroid Composition: Cellulose, microcrystalline, Hypromellose,
Modified Release coating : Ethyl cellulose, Povidone (K 30), Triacetin and Talc
Capsule Shell:
Body
Iron Oxide Red (E172)
Iron Oxide Yellow (E 172)
Titanium Dioxide (E171)
Gelatin
Sodium Lauryl Sulfate
Cap
Iron Oxide Red (E172)
Iron Oxide Yellow (E 172)
Titanium Dioxide (E171)
Gelatin
Sodium Lauryl Sulfate
Black Printing Ink:
Shellac
Propylene glycol
Strong ammonia solution
Black iron oxide (E172)
Potassium hydroxide

What Ranfaxiran XL looks like and contents of the pack
Ranfaxiran XL is available in three strengths 37.5mg, 75mg and 150mg.
Each strength of Ranfaxiran XL has a different marking/debossing on one side and is plain
onthe other side.
Ranfaxiran XL 37.5 mg prolonged release capsule , hard
The 37.5 mg capsules are Size “2” capsule with grey opaque cap and pink opaque body
imprinted with RVn on the cap and 37.5 on the body in black ink
The 37.5 mg capsules come in packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 100
For healthcare professionals, bottles of 100 capsules are also available.
Not all pack sizes may be marketed
Ranfaxiran XL 75 mg prolonged release capsule , hard
The 75 mg capsules are Size “1” capsule with pink opaque cap and body imprinted with RVn
on the cap and 75 on the body in black ink
The 75mg capsules come in packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 100
For healthcare professionals, bottles of 100 of capsules are also available. Not all pack sizes
may be marketed
Ranfaxiran XL 150 mg prolonged release capsule , hard
The 150 mg capsules are `Size “0” capsules with caramel opaque cap and body imprinted with
RVn on the cap and 150 on the body in black ink
The 150mg capsules come in packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 100
For healthcare professionals, bottles of 100 of capsules are also available. Not all pack sizes
may be marketed
Marketing Authorisation Holder:
Ranbaxy (UK) Limited
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom

Manufacturer:
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co-Tipperary
Ireland
Cemelog –BRF Kft
2040 BudaÖrs VasÚt u.2
Hungary
Terapia S.A
124 Fabricii Street,
Cluj-Napoca 400 632,
Romania
This leaflet was last revised in May 2015.

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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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