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PREGABALIN RANBAXY 75MG CAPSULES HARD

Active substance(s): PREGABALIN / PREGABALIN

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B. PACKAGE LEAFLET

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Package leaflet: Information for the user
Pregabalin Ranbaxy 50mg capsules, hard
Pregabalin Ranbaxy 75mg capsules, hard
Pregabalin Ranbaxy 100mg capsules, hard
Pregabalin Ranbaxy 150mg capsules, hard
Pregabalin Ranbaxy 225mg capsules, hard
Pregabalin Ranbaxy 300mg capsules, hard
Pregabalin
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:
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2.
3.
4.
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6.

1.

What Pregabalin Ranbaxy is and what it is used for
What you need to know before you take Pregabalin Ranbaxy
How to take Pregabalin Ranbaxy
Possible side effects
How to store Pregabalin Ranbaxy
Contents of the pack and other information

What Pregabalin Ranbaxy is and what it is used for

Pregabalin Ranbaxy belongs to a group of medicines used to treat epilepsy, neuropathic pain and
Generalised Anxiety Disorder (GAD) in adults.
Epilepsy:
Pregabalin Ranbaxy is used to treat a certain form of epilepsy (partial seizures with or without
secondary generalisation) in adults. Your doctor will prescribe Pregabalin Ranbaxy for you to help
treat your epilepsy when your current treatment is not controlling your condition. You should take
Pregabalin Ranbaxy in addition to your current treatment. Pregabalin Ranbaxy is not intended to be
used alone, but should always be used in combination with other anti-epileptic treatment.
Peripheral and central neuropathic pain:
Pregabalin is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can
cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as
hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and
needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep
disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall
quality of life.
Generalised Anxiety Disorder:
Pregabalin Ranbaxy is used to treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are
prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or
feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind
going blank, feeling irritable, having muscle tension or sleep disturbance. This is different to the
stresses and strains of everyday life.

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2.

What you need to know before you take Pregabalin Ranbaxy

Do not take Pregabalin Ranbaxy
- if you are allergic to Pregabalin or any of the other ingredients of this medicine (listed in section6).
Warnings and Precautions






















Some patients taking Pregabalin Ranbaxy have reported symptoms suggesting an allergic reaction.
These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash.
Should you experience any of these reactions, you should contact your physician immediately.
Pregabalin Ranbaxy has been associated with dizziness and somnolence, which could increase the
occurrence of accidental injury (fall) in older patients. Therefore, you should be careful until you
are used to any effect the medicine might have.
Pregabalin Ranbaxy may cause blurring or loss of vision, or other changes in eyesight, many of
which are temporary. You should immediately tell your doctor if you experience any changes in
your vision.
Some patients with diabetes who gain weight while taking Pregabalin Ranbaxy may need an
alteration in their diabetic medicines.
Certain side effects may be more common, such as sleepiness, because patients with spinal cord
injury may be taking other medicines to treat, for example, pain or spasticity, that have similar
side effects to Pregabalin Ranbaxy and the severity of these effects may be increased when taken
together.
There have been reports of heart failure in some patients when taking Pregabalin Ranbaxy; these
patients were mostly older with cardiovascular conditions. Before taking this medicine you should
tell your doctor if you have a history of heart disease.
There have been reports of kidney failure in some patients when taking Pregabalin Ranbaxy. If
while taking Pregabalin Ranbaxy you notice decreased urination, you should tell your doctor as
stopping the medicine may improve this.
A small number of people being treated with anti-epileptics such as Pregabalin Ranbaxy have had
thoughts of harming or killing themselves. If at any time you have these thoughts, immediately
contact your doctor.
When Pregabalin Ranbaxy is taken with other medicines that may cause constipation (such as
some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g.,
constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation,
especially if you are prone to this problem.
Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug
dependence. Let your doctor know if you think you need more medicine than prescribed.
There have been reports of convulsions when taking Pregabalin Ranbaxy or shortly after stopping
Pregabalin Ranbaxy. If you experience a convulsion, contact your doctor immediately.
There have been reports of reduction in brain function (encephalopathy) in some patients taking
Pregabalin Ranbaxy when they have other conditions. Tell your doctor if you have a history of any
serious medical conditions, including liver or kidney disease.

Children and adolescents
The safety and efficacy in children and adolescents (under 18 years of age) has not been established
and therefore, Pregabalin Ranbaxy should not be used in this age group.
Other medicines and Pregabalin Ranbaxy
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pregabalin Ranbaxy and certain other medicines may influence each other (interaction). When taken
with certain other medicines, Pregabalin Ranbaxy may potentiate the side effects seen with these
medicines, including respiratory failure and coma. The degree of dizziness, sleepiness and decreased
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concentration may be increased if Pregabalin Ranbaxy is taken together with medicinal products
containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol
Pregabalin Ranbaxy may be taken with oral contraceptives.
Pregabalin Ranbaxy with food, drink and alcohol
It is advised not to drink alcohol while taking Pregabalin Ranbaxy.
Pregnancy, breast-feeding and fertility
Pregabalin Ranbaxy should not be taken during pregnancy or when breast-feeding, unless you are told
otherwise by your doctor. Effective contraception must be used by women of child-bearing potential.
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.
Driving and using machines
Pregabalin Ranbaxy may produce dizziness, sleepiness and decreased concentration. You should not
drive, operate complex machinery or engage in other potentially hazardous activities until you know
whether this medicine affects your ability to perform these activities.

3.

How to take Pregabalin Ranbaxy

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Your doctor will determine what dose is appropriate for you.
Peripheral and central neuropathic pain, Epilepsy or Generalised Anxiety Disorder:
• Take the number of capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg
and 600 mg each day.
• Your doctor will tell you to take Pregabalin Ranbaxy either twice or three times a day. For twice a
day take Pregabalin Ranbaxy once in the morning and once in the evening, at about the same time
each day. For three times a day take Pregabalin Ranbaxy once in the morning, once in the
afternoon and once in the evening, at about the same time each day.
If you have the impression that the effect of Pregabalin Ranbaxy is too strong or too weak, talk to your
doctor or pharmacist.
If you are an older patient (over 65 years of age), you should take Pregabalin Ranbaxy normally
except if you have problems with your kidneys.
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your
kidneys.
Pregabalin Ranbaxy is for oral use only. Swallow the capsule whole with water. Pregabalin Ranbaxy
capsules may be taken with or without food.
Continue taking Pregabalin Ranbaxy until your doctor tells you to stop.
If you take more Pregabalin Ranbaxy than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of
Pregabalin Ranbaxy capsules with you. You may feel sleepy, confused, agitated, or restless as a result
of taking more Pregabalin Ranbaxy than you should.
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If you forget to take Pregabalin Ranbaxy
It is important to take your Pregabalin Ranbaxy capsules regularly at the same time each day. If you
forget to take a dose, take it as soon as you remember unless it is time for your next dose. In that case,
just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you stop taking Pregabalin Ranbaxy
Do not stop taking Pregabalin Ranbaxy unless your doctor tells you to. If your treatment is stopped it
should be done gradually over a minimum of 1 week.
After stopping long and short-term Pregabalin Ranbaxy treatment, you need to know that you may
experience certain side effects. These include, trouble sleeping, headache, nausea, feeling anxious,
diarrhoea, flulike symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness.
These symptoms may occur more commonly or severely if you have been taking Pregabalin Ranbaxy
for a longer period of time.
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.
Serious side effects:
If any of the following happen, stop taking Pregabalin Ranbaxy and contact a doctor or go to the
nearest hospital immediately, as you may need urgent medical attention.





Hypersensitivity and allergic reactions (which may include swollen face, swollen tongue,
difficulty breathing, itchiness)
Serious skin reaction characterized by rash, blisters, peeling skin and pain.
If you experience swollen face or tongue or if your skin turns red and starts to blister or peel you
should seek immediate medical advice.
Inflammation of the pancreas (which includes symptoms such as severe upper stomach pain,
often with nausea and vomiting)

Other side effects:
Very common: may affect more than 1 in 10 people

Dizziness, drowsiness, headache.
Common: may affect up to 1 in 10 people

Increased appetite

Feeling of elation, confusion, disorientation, changes in sexual interest, irritability

Disturbance in attention, clumsiness, memory impairment, loss of memory tremor, difficulty
with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal

Blurred vision, double vision

Vertigo, problems with balance, fall

Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea

Difficulties with erection

Swelling of the body including extremities

Swollen abdomen

Feeling drunk, abnormal style of walking

Weight gain

Sore throat

Muscle cramp, joint pain, back pain, pain in limb, spasm in neck

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Uncommon: may affect up to 1 in 100 people

Loss of appetite, weight loss, low blood sugar, high blood sugar

Change in perception of self, restlessness, depression, agitation, mood swings, elevated mood,
aggression, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy,
problems with sexual functioning including inability to achieve a sexual climax, delayed
ejaculation, mental impairment, difficulty with thinking

Changes in eyesight, unusual eye movement, jerky movements, reduced reflexes, increased
activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on
movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to
noise, feeling unwell

Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, tunnel vision, flashes of light, eye
irritation

Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, heart
failure

Flushing, hot flushes

Difficulty breathing, dry nose

Cough, nasal congestion, swollen face, hives, itchiness, runny nose, nose bleed, snoring

Increased saliva production, heartburn, numb around mouth

Sweating, rash, chills, fever

Coldness of hands and feet

Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain

Difficulty with or painful urination, incontinence

Weakness, thirst, chest tightness

Breast pain

Painful menstrual periods

Generalised swelling

Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine
amino transferase increased, aspartate aminotransferase increased, platelet count decreased,
decrease in blood potassium, increase in blood creatinine, neutropenia).
Rare: may affect up to 1 in 1,000 people

Changes in heart beat

Abnormal sense of smell, changes in vision including swinging vision, altered perception of
depth, visual brightness, vision loss

Dilated pupils, cross eyes

Inflammation of the eyes (keratitis)

Cold sweat, tightness of the throat, swollen tongue

Difficulty in swallowing

Slow or reduced movement of the body

Difficulty with writing properly

Fluid in the lungs

Convulsions

Changes in the recording of electrical changes (ECG) in the heart which correspond to heart
rhythm disturbances

Increased fluid in the abdomen

Muscle damage

Breast discharge, abnormal breast growth, breast growth in males

Interrupted menstrual periods

Kidney failure, reduced urine volume, urinary retention

Decrease in white blood cell count

Inappropriate behavior.
Certain side effects may be more common, such as sleepiness, because patients with spinal cord
injury may be taking other medicines to treat, for example, pain or spasticity, that have similar
side effects to Pregabalin Ranbaxy and the severity of these effects may be increased when taken
together.

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Reporting of side effects
If you get any side effects, talk to your doctor or 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.






6.

How to store Pregabalin Ranbaxy
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 blister/carton. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions
Bottle: Once the bottle is opened the capsules should be used within 30 days
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.

Contents of the pack and other information

What Pregabalin Ranbaxy contains
The active substance is pregabalin.
Pregabalin Ranbaxy 50 mg: Each capsule, hard contains 50 mg of Pregabalin.
Pregabalin Ranbaxy 75 mg: Each capsule, hard contains 75 mg of Pregabalin.
Pregabalin Ranbaxy 100 mg: Each capsule, hard contains 100 mg of Pregabalin.
Pregabalin Ranbaxy 150 mg: Each capsule, hard contains 150 mg of Pregabalin.
Pregabalin Ranbaxy 225 mg: Each capsule, hard contains 225 mg of Pregabalin.
Pregabalin Ranbaxy 300 mg: Each capsule, hard contains 300 mg of Pregabalin.
The other excipients are Capsules content:
Mannitol, talc
Capsules shell:
Gelatin, titanium dioxide (E171), sodium lauryl sulphate
only For 75 mg, 100 mg, 225 mg and 300 mg, Iron oxide red (E172)
Printing Ink:
Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide
What Pregabalin Ranbaxy looks like and contents of the pack
50 mg capsules: Hard gelatin capsules of size '2' with white opaque cap and white opaque body
imprinted with black ink 'rbx' with band on cap and 'PG50' with band on body containing white to off
white powder. The length of the capsule is approximately 17.0-18.2 mm.
75 mg capsules: Hard gelatin capsules of size '4' with red opaque cap and white opaque body
imprinted with black ink 'rbx' on cap and 'PG75' on body containing white to off white powder. The
length of the capsule is approximately 14.0-14.8 mm
100 mg capsules: Hard gelatin capsules of size '3' with red opaque cap and red opaque body imprinted
with black ink 'rbx' on cap and 'PG100' on body containing white to off white powder. The length of
the capsule is approximately 15.3-16.3 mm.
150 mg capsules: Hard gelatin capsules of size '2' with white opaque cap and white opaque body
imprinted with black ink 'rbx' on cap and 'PG150' on body containing white to off white powder. The
length of the capsule is approximately 17.0-18.2 mm.
225 mg capsules: Hard gelatin capsules of size '1' with red opaque cap and white opaque body
imprinted with black ink 'rbx' on cap and 'PG225' on body containing white to off white powder. The
length of the capsule is approximately 18.6-19.7 mm.
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300 mg capsules: Hard gelatin capsules of size '0' with red opaque cap and white opaque body
imprinted with black ink 'rbx' on cap and 'PG300' on body containing white to off white powder. The
length of the capsule is approximately 21.0-21.8 mm.
OPA/Al/PVC//Al blister
Pack sizes: 14, 21, 56, 84, 98 100 or 112 capsules, hard
PVC//Al blister
For 25, 50, 100 and 225 mg:
Pack sizes: 14, 21, 56, 84, 98, 100 or 112 capsules, hard.
For 75, 150 and 300mg
Pack sizes: 14, 21, 28, 56, 84, 98, 100 or 112
capsules, hard.
HDPE bottle with child resistance closure (PP).
Pack sizes: 14, 21, 30, 56, 84, 98, 100 or 112
capsules, hard
HDPE bottle with screw cap (PP). Pack size: 500 capsules, hard
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia SA
124 Fabrici Street,
400 632 Cluj Napoca
Romania
This leaflet was last revised in August 2016.

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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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