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PREGABALIN SCIECURE 100MG HARD CAPSULES

Active substance(s): PREGABALIN / PREGABALIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PREGABALIN SCIECURE 25 MG, 50 MG, 75 MG, 100 MG, 150 MG, 200 MG, 225 MG, 300 MG HARD CAPSULES

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 further questions, ask your doctor or your 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).
• There have been reports of convulsions when taking Pregabalin Sciecure
What is in this leaflet:
hard capsule or shortly after stopping Pregabalin Sciecure hard capsule. If you
1. What Pregabalin Sciecure hard capsule is and what it is used for.
experience a convulsion, contact your doctor immediately.
2. What you need to know before you take Pregabalin Sciecure hard capsule.
3. How to take Pregabalin Sciecure hard capsule.
• There have been reports of reduction in brain function (encephalopathy) in
4. Possible side effects.
some patients taking Pregabalin Sciecure hard capsule when they have other
5. How to store Pregabalin Sciecure hard capsule.
conditions. Tell your doctor if you have a history of any serious medical
6. Contents of the pack and other information.
conditions, including liver or kidney disease.
Children and adolescents
1. What Pregabalin Sciecure hard capsule is and what it is used for
The safety and efficacy in children and adolescents (under 18 years of age)
Pregabalin Sciecure hard capsule belongs to a group of medicines used to
has not been established and therefore, pregabalin should not be used in this
treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in
age group.
adults.
Other medicines and Pregabalin Sciecure hard capsule
Peripheral and central neuropathic pain: Pregabalin Sciecure hard
Tell your doctor or pharmacist if you are taking, have recently taken or might
capsule is used to treat long lasting pain caused by damage to the nerves. A
take any other medicines.
variety of diseases can cause peripheral neuropathic pain, such as diabetes or
Pregabalin Sciecure hard capsule and certain other medicines may influence
shingles. Pain sensations may be described as hot, burning, throbbing,
each other (interaction). When taken with certain other medicines, Pregabalin
shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and
hard capsule may potentiate the side effects seen with these medicines,
needles. Peripheral and central neuropathic pain may also be associated with
including respiratory failure and coma. The degree of dizziness, sleepiness and
mood changes, sleep disturbance, fatigue (tiredness), and can have an impact
decreased concentration may be increased if Pregabalin hard capsule is taken
on physical and social functioning and overall quality of life.
together with medicines containing:
Epilepsy: Pregabalin Sciecure hard capsule is used to treat a certain form of
Oxycodone – (used as a pain-killer).
epilepsy (partial seizures with or without secondary generalisation) in adults.
Lorazepam – (used for treating anxiety)
Your doctor will prescribe Pregabalin Sciecure hard capsule for you to help
Alcohol.
treat your epilepsy when your current treatment is not controlling your
Pregabalin Sciecure hard capsule may be taken with oral contraceptives.
condition. You should take Pregabalin Sciecure hard capsule in addition to
your current treatment. Pregabalin Sciecure hard capsule is not intended to
Pregabalin Sciecure hard capsule with food, drink and alcohol
be used alone, but should always be used in combination with other
Pregabalin hard capsule may be taken with or without food.
anti-epileptic treatment.
It is advised not to drink alcohol while taking Pregabalin Sciecure hard
capsule.
Generalised Anxiety Disorder: Pregabalin Sciecure hard capsule is used to
treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are
Pregnancy and breast-feeding
prolonged excessive anxiety and worry that are difficult to control. GAD can
Pregabalin Sciecure hard capsule should not be taken during pregnancy or
also cause restlessness or feeling keyed up or on edge, being easily fatigued
when breast-feeding, unless you are told otherwise by your doctor. Effective
(tired), having difficulty concentrating or mind going blank, feeling irritable,
contraception must be used by women of child-bearing potential. If you are
having muscle tension or sleep disturbance. This is different to the stresses
pregnant or breast-feeding, think you may be pregnant or are planning to
and strains of everyday life.
have a baby, ask your doctor or pharmacist for advice before taking this
medicine.
2. What you need to know before you take Pregabalin Sciecure hard
capsule
Driving and using machines
Pregabalin Sciecure hard capsule may produce dizziness, sleepiness and
Do not take Pregabalin Sciecure hard capsule
decreased concentration. You should not drive, operate complex machinery or
If you are allergic to pregabalin or any of the other ingredients of this
engage in other potentially hazardous activities until you know whether this
medicine (listed in section 6).
medicine affects your ability to perform these activities.
Warnings and Precautions
Pregabalin Sciecure hard capsule contains lactose monohydrate
Talk to your doctor or pharmacist before taking Pregabalin Sciecure hard
Lactose is a type of sugar. If you have been told by your doctor that you have
capsule.
an intolerance to some sugars, contact your doctor before taking this
• Some patients taking Pregabalin Sciecure hard capsule have reported
medicine.
symptoms suggesting an allergic reaction. These symptoms include swelling
of the face, lips, tongue, and throat, as well as diffuse skin rash. Should you
3. How to take Pregabalin Sciecure hard capsule
experience any of these reactions, you should contact your physician
Always
take this medicine exactly as your doctor has told you. Check with
immediately.
your doctor or pharmacist if you are not sure.
• Pregabalin Sciecure hard capsule has been associated with dizziness and
Your doctor will determine what dose is appropriate for you.
somnolence, which could increase the occurrence of accidental injury (fall) in
Pregabalin Sciecure hard capsule is for oral use only.
elderly patients. Therefore, you should be careful until you are used to any
effect the medicine might have.
Peripheral and central neuropathic pain, epilepsy or Generalised
Anxiety Disorder:
• Pregabalin Sciecure hard capsule may cause blurring or loss of vision, or
• Take the number of capsules as instructed by your doctor.
other changes in eyesight, many of which are temporary. You should
• The dose, which has been adjusted for you and your condition, will
immediately tell your doctor if you experience any changes in your vision.
generally be between 150 mg and 600 mg each day.
• Some patients with diabetes who gain weight while taking pregabalin may
• Your doctor will tell you to take Pregabalin Sciecure hard capsule either
need an alteration in their diabetic medicines.
twice or three times a day. For twice a day take Pregabalin Sciecure hard
• Certain side effects may be more common, such as sleepiness, because
capsule once in the morning and once in the evening, at about the same time
patients with spinal cord injury may be taking other medicines to treat, for
each day. For three times a day take Pregabalin Sciecure hard capsule once in
example, pain or spasticity, that have similar side effects to pregabalin and
the morning, once in the afternoon and once in the evening, at about the
the severity of these effects may be increased when taken together.
same time each day.
• There have been reports of heart failure in some patients when taking
If you have the impression that the effect of Pregabalin Sciecure hard capsule
Pregabalin Sciecure hard capsule; these patients were mostly elderly with
is too strong or too weak, talk to your doctor or pharmacist.
cardiovascular conditions. Before taking this medicine you should tell
If you are an elderly patient (over 65 years of age), you should take Pregabalin
your doctor if you have a history of heart disease.
Sciecure hard capsule normally except if you have problems with your kidneys.
Your doctor may prescribe a different dosing schedule and/or dose if you have
• There have been reports of kidney failure in some patients when taking
problems with your kidneys.
Pregabalin Sciecure hard capsule. If while taking Pregabalin hard capsule you
Swallow the capsule whole with water.
notice decreased urination, you should tell your doctor as stopping the
Continue taking Pregabalin Sciecure hard capsule until your doctor tells you to
medicine may improve this.
stop.
• A small number of people being treated with anti-epileptics such as
If you take more Pregabalin Sciecure hard capsule than you should
Pregabalin Sciecure hard capsule have had thoughts of harming or killing
Call your doctor or go to the nearest hospital emergency unit immediately.
themselves. If at any time you have these thoughts, immediately contact your
Take your box of Pregabalin Sciecure hard capsule with you. You may feel
doctor.
sleepy, confused, agitated, or restless as a result of taking more Pregabalin
• When Pregabalin Sciecure hard capsule is taken with other medicines that
Sciecure hard capsule than you should. Fits have also been reported.
may cause constipation (such as some types of pain medicines) it is possible
If you forget to take Pregabalin Sciecure hard capsule
that gastrointestinal problems may occur (e.g., constipation, blocked or
It is important to take your Pregabalin Sciecure hard capsule regularly at the
paralysed bowel). Tell your doctor if you experience constipation, especially if
same time each day. If you forget to take a dose, take it as soon as you
you are prone to this problem.
remember unless it is time for your next dose. In that case, just carry on with
• Before taking this medicine you should tell your doctor if you have a history
the next dose as normal. Do not take a double dose to make up for a
of alcoholism or any drug abuse or dependence. Do not take more medicine
forgotten dose.
than prescribed.

If you stop taking Pregabalin Sciecure hard capsule
Do not stop taking Pregabalin Sciecure hard capsule 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 Sciecure hard capsule
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 Sciecure hard capsule 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 person 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
attacks, apathy, aggression, elevated mood, mental 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 heartbeat, 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 aminotransferase increased, aspartate aminotransferase
increased, platelet count decreased, neutropenia, 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 1000
• 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.
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 doctororpharmacistor nurse. This
includes any possible side effects not listed in this leaflet. You can also report
any side effects directly to the national reporting system via the internet at
www.mhra.gov.uk/yellowcard; or you can report via Freephone 0808 100
3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Pregabalin Sciecure hard capsule
• 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
or bottle. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Pregabalin hard capsule 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 pregabalin.
• The other ingredients are: lactose monohydrate, maize starch, talc, gelatin,
titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black
ink, (which contains shellac, black iron oxide (E172), propylene glycol,
potassium hydroxide).
What Pregabalin Sciecure hard capsule looks like and contents of the
pack
25 mg capsules: Hard capsules, size 4, with a white cap and a white body,
with “25” printed on the body. The pack size of 56 capsules (4×14) and 84
capsules (6×14) are registered.
50 mg capsules: Hard capsules, size 3, with a white cap and a pinkish-orange body, with “50” printed on the body. The pack size of 84 capsules
(6×14) is registered.
75 mg capsules: Hard capsules, size 4, with a brownish-red cap and a white
body with, “75” printed on the body. The pack size of 56 capsules (4×14) is
registered.
100 mg capsules: Hard capsules, size 3, with a brownish-red cap and a
brownish-red body, with “100” printed on the body. The pack size of 84
capsules (6×14) is registered.
150 mg capsules: Hard capsules, size 2, with a white cap and a white body,
with “150” printed on the body. The pack size of 56 capsules (4×14) is
registered.
200 mg capsules: Hard capsules, size 1, with a pinkish-orange cap and a
pinkish-orange body, with “200” printed on the body. The pack size of 84
capsules (6×14) is registered.
225 mg capsules: Hard capsules, size 1, with a pinkish-orange cap and a
white body, with “225” printed on the body. The pack size of 56 capsules
(4×14) is registered.
300 mg capsules: Hard capsules, size 0, with a brownish-red cap and a
white body, with “300” printed on the body. The pack size of 56 capsules
(4×14) is registered.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sciecure Pharma Limited
47 Bloomfield Close, Knaphill,
Woking, Surrey,
GU21 2BL, United Kingdom.
Manufacturer:
Tillomed Laboratories Limited
3 Howard Road, Eaton Socon,
St. Neot’s Cambridgeshire,
PE19 8ET, United Kingdom.
Pregabalin Sciecure 25 mg hard capsules MA Number: PL43801/0013
Pregabalin Sciecure 50 mg hard capsules MA Number: PL43801/0014
Pregabalin Sciecure 75 mg hard capsules MA Number: PL43801/0015
Pregabalin Sciecure 100 mg hard capsules MA Number: PL43801/0016
Pregabalin Sciecure 150 mg hard capsules MA Number: PL43801/0017
Pregabalin Sciecure 200 mg hard capsules MA Number: PL43801/0018
Pregabalin Sciecure 225 mg hard capsules MA Number: PL43801/0019
Pregabalin Sciecure 300 mg hard capsules MA Number: PL43801/0020
This leaflet was last revised in March 2017

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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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