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PREGABALIN WARREN 150 MG HARD CAPSULES

Active substance(s): PREGABALIN / PREGABALIN

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Package leaflet: Information for the user
Pregabalin Warren 25 mg hard capsules,
Pregabalin Warren 50 mg hard capsules,
Pregabalin Warren 75 mg hard capsules,
Pregabalin Warren 100 mg hard capsules,
Pregabalin Warren 150 mg hard capsules,
Pregabalin Warren 200 mg hard capsules,
Pregabalin Warren 225 mg hard capsules,
Pregabalin Warren 300 mg hard capsules
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
1.
What Pregabalin Warren is and what it is used for
2.
What you need to know before you take Pregabalin Warren
3.
How to take Pregabalin Warren
4.
Possible side effects
5.
How to store Pregabalin Warren
6.
Contents of the pack and other information

1.

What Pregabalin Warren is and what it is used for

Pregabalin Warren belongs to a group of medicines used to treat epilepsy, neuropathic pain and
Generalised Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin Warren 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.
Epilepsy: Pregabalin Warren is used to treat a certain form of epilepsy (partial seizures with or
without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Warren for you to
help treat your epilepsy when your current treatment is not controlling your condition. You should
take Pregabalin Warren in addition to your current treatment. Pregabalin Warren is not intended to be
used alone, but should always be used in combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin Warren 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 Warren

Do not take Pregabalin Warren
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Pregabalin Warren.
 Some patients taking Pregabalin Warren 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 Warren has been associated with dizziness and somnolence, which could increase the
occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until
you are used to any effect the medicine might have.
 Pregabalin Warren 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 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 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 Warren; these
patients were mostly elderly 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 Warren. If
while taking Pregabalin Warren 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 Warren have had
thoughts of harming or killing themselves. If at any time you have these thoughts, immediately
contact your doctor.
 When Pregabalin Warren 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 any
drug abuse or dependence. Do not take more medicine than prescribed.
 There have been reports of convulsions when taking Pregabalin Warren or shortly after stopping
Pregabalin Warren. If you experience a convulsion, contact your doctor immediately.
 There have been reports of reduction in brain function (encephalopathy) in some patients taking
Pregabalin Warren 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 should not be used in this age group.
Other medicines and Pregabalin Warren
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pregabalin Warren and certain other medicines may influence each other (interaction). When taken
with certain other medicines, Pregabalin Warren 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 Warren is taken together with medicinal products
containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin Warren may be taken with oral contraceptives.
Pregabalin Warren with food, drink and alcohol
Pregabalin capsules may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin.
Pregnancy and breast-feeding
Pregabalin Warren 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 Warren 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.
Pregabalin Warren contains lactose monohydrate
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before taking this medicinal product.

3.

How to take Pregabalin Warren

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Your doctor will determine what dose is appropriate for you.
Pregabalin Warren is for oral use only.
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 Warren either twice or three times a day. For twice a
day take Pregabalin Warren once in the morning and once in the evening, at about the same time
each day. For three times a day take Pregabalin Warren 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 Warren is too strong or too weak, talk to your
doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should take Pregabalin Warren 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.

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Swallow the capsule whole with water.
Continue taking Pregabalin Warren until your doctor tells you to stop.
If you take more Pregabalin Warren than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box of
Pregabalin Warren capsules with you. You may feel sleepy, confused, agitated, or restless as a result
of taking more Pregabalin Warren than you should. Fits have also been reported.
If you forget to take Pregabalin Warren
It is important to take your Pregabalin Warren 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 Warren
Do not stop taking Pregabalin Warren 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 Warren treatment, you need to know that you may
experience certain side effects. These include, trouble sleeping, headache, nausea, feeling anxious,
diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness.
These symptoms may occur more commonly or severely if you have been taking Pregabalin Warren
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.
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, decrease 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, swollen abdomen.
 Difficulties with erection.
 Swelling of the body including extremities.
 Feeling drunk, abnormal style of walking.
 Weight gain.
 Muscle cramp, joint pain, back pain, pain in limb.
 Sore throat.
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, difficulty finding
words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental
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impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning
including inability to achieve a sexual climax, delayed ejaculation.
Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of
light, 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, eye irritation.
Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes
in heart beat, heart failure.
Flushing, hot flushes.
Difficulty breathing, dry nose, nasal congestion.
Increased saliva production, heartburn, numb around mouth.
Sweating, rash, chills, fever.
Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
Breast pain.
Difficulty with or painful urination, incontinence.
Weakness, thirst, chest tightness.
Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino
transferase increased, aspartate aminotransferase increased, platelet count decreased,
neutropaenia, increase in blood creatinine, decrease in blood potassium).
Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
Painful menstrual periods.
Coldness of hands and feet.

Rare: may affect up to 1 in 1,000 people
 Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision
loss.
 Dilated pupils, cross eyes.
 Cold sweat, tightness of the throat, swollen tongue.
 Inflammation of the pancreas.
 Difficulty in swallowing.
 Slow or reduced movement of the body.
 Difficulty with writing properly.
 Increased fluid in the abdomen.
 Fluid in the lungs.
 Convulsions.
 Changes in the recording of electrical changes (ECG) in the heart which correspond to heart
rhythm disturbances.
 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 behaviour.
 Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis)
and a 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.
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 and the severity of these effects may be increased when taken together.
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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
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, website
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 Pregabalin Warren

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 carton after EXP. The expiry date
refers to the last day of that month.
Do not store above 30°C.
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 Pregabalin Warren contains
 The active substance is pregabalin. Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100
mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
 The other ingredients are: lactose monohydrate, maize starch, talc, gelatin, titanium dioxide
(E171), sodium laurilsulfate and printing ink (which contains shellac, propylene glycol, strong
ammonia solution, black iron oxide (E172), potassium hydroxide).
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172).
What Pregabalin Warren looks like and contents of the pack
25 mg capsule
White hard gelatin capsule of size “4’’ with “I’’ printed on cap and “33’’ on
body containing white to off white powder.
50 mg capsule
White hard gelatin capsule of size “3’’ with “I’’ printed on cap and “34’’ on
body containing white to off white powder.
75 mg capsule
White and orange hard gelatin capsule of size “4’’ with “I’’ printed on cap
and “35’’ on body containing white to off white powder.
100 mg capsule
Orange hard gelatin capsule of size “3’’ with “I’’ printed on cap and “36’’ on
body containing white to off white powder.
150 mg capsule
White hard gelatin capsule of size “2’’ with “I’’ printed on cap and “37’’ on
body containing white to off white powder.
200 mg capsule
Orange hard gelatin capsule of size “1’’ with “I’’ printed on cap and “38’’ on
body containing white to off white powder.
225 mg capsule
White and orange hard gelatin capsule of size “1’’ with “I’’ printed on cap
and “39’’ on body containing white to off white powder.
300 mg capsule
White and orange hard gelatin capsule of size “0’’ with “I’’ printed on cap
and “40’’ on body containing white to off white powder.

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Pregabalin Warren is available in seven pack sizes made of transparent PVC with an aluminium foil
backing: a 14 capsules pack containing 1 blister strip, a 21 capsules pack containing 1 blister strip, a
56 capsules pack containing 4 blister strips, a 70 capsules pack containing 5 blister strips, a 84
capsules pack containing 4 blister strips, a 100 capsules pack containing 10 blister strips, a 112 (2 x
56) capsules pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder:
WARREN GENERICS s.r.o.
U Staré tvrze 285/21,
196 00 Praha 9,
Czech Republic
Manufacturer:
IMUNA PHARM, a.s.
Jarková 269/17,
082 22 Šarišské Michaľany
Slovak Republic
This leaflet was last revised in December 2016.

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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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