Skip to Content

PREGABALIN KRKA 150 MG HARD CAPSULES

Active substance(s): PREGABALIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Package Leaflet: Information for the user

Rewisca® 150 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.
 The name of this medicine is Rewisca® 150 mg hard capsules but will
be referred to as Rewisca throughout the remainder of this leaflet.
 This medicine is also available in other strengths.
What is in this leaflet
1) What Rewisca is and what it is used for
2) What you need to know before you take Rewisca
3) How to take Rewisca
4) Possible side effects
5) How to store Rewisca
6) Contents of the pack and other information
1) WHAT REWISCA IS AND WHAT IT IS USED FOR
Rewisca belongs to a group of medicines used to treat epilepsy and
Generalised Anxiety Disorder (GAD) in adults.
Epilepsy: Rewisca is used to treat a certain form of epilepsy (partial
seizures with or without secondary generalisation) in adults. Your doctor
will prescribe Rewisca for you to help treat your epilepsy when your
current treatment is not controlling your condition. You should take
Rewisca in addition to your current treatment. Rewisca is not intended to
be used alone, but should always be used in combination with other
anti-epileptic treatment.
Generalised Anxiety Disorder: Rewisca 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.

 There have been reports of convulsions when taking pregabalin or
shortly after stopping pregabalin. If you experience a convulsion,
contact your doctor immediately.
 There have been reports of reduction in brain function
(encephalopathy) in some patients taking pregabalin 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, Rewisca should not be
used in this age group.
Other medicines and Rewisca
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Rewisca and certain other medicines
may influence each other (interaction). When taken with certain other
medicines, Rewisca may potentiate the side effects seen with these
medicines, including respiratory failure and coma. The degree of
dizziness, sleepiness and decreased concentration may be increased if
Rewisca is taken together with medicinal products containing:
 Oxycodone (used as a pain-killer)
 Lorazepam (used for treating anxiety)
 Alcohol
Rewisca may be taken with oral contraceptives.
Rewisca with food, drink and alcohol
Rewisca capsules may be taken with or without food.
It is advised not to drink alcohol while taking Rewisca.
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. Rewisca 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.
Driving and using machines
Rewisca may cause 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.

2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE REWISCA
3) HOW TO TAKE REWISCA
Do not take Rewisca:
 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 Rewisca.
 Some patients taking pregabalin 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 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 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.
 There have been reports of heart failure in some patients when taking
pregabalin; 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. If while taking Rewisca 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
Rewisca have had thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact your doctor.
 When Rewisca 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.

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.
Rewisca is for oral use only.
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 Rewisca either twice or three times a
day. For twice a day take Rewisca once in the morning and once in the
evening, at about the same time each day. For three times a day take
Rewisca 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 Rewisca 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
Rewisca 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.
Swallow the capsule whole with water.
Continue taking Rewisca until your doctor tells you to stop.
If you take more Rewisca than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box of Rewisca capsules with you. You may feel
sleepy, confused, agitated, or restless as a result of taking more Rewisca
than you should.

If you forget to take Rewisca
It is important to take your Rewisca 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 Rewisca
Do not stop taking Rewisca 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 Rewisca 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 Rewisca 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.
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.
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
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 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).
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 REWISCA
 Keep out of the sight and reach of children.
 Do not store above 30oC.
 Do not use Rewisca after the expiry date which is stated on the carton
and the blister. The expiry date refers to the last day of that month.
 If the capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Rewisca contains
The active ingredient is pregabalin.
Each hard capsule contains 150 mg pregabalin.
The other ingredients are:
Capsule content: pregelatinised starch and talc (E553b).
Capsule shell: titanium dioxide (E171), gelatin (E441), red iron oxide
(E172), yellow iron oxide (E172), black printing ink (shellac (E904), black
iron oxide (E172) and propylene glycol (E1520)).
What Rewisca looks like and contents of the pack
The body of the capsule is white colour, the cap of the capsule is
yellowish brown colour. Capsule cap is imprinted with black mark ‘P150’.
The content of the capsule is white to off white powder.
Capsule length: 17.2 – 18.3 mm.
Rewisca is available in printed cartons of 56 hard capsules in blister
packs.
Manufactured by
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
or
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven,
Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0606
Leaflet dated 23rd December 2015
Leaflet coded XXXXXXXXXX
Rewisca® and KRKA® are registered trademarks of
KRKA, tovarna zdravil, d.d.

POM

Package Leaflet: Information for the user

Pregabalin Krka 150 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.
 The name of this medicine is Pregabalin Krka 150 mg hard capsules
but will be referred to as Pregabalin Krka throughout the remainder of
this leaflet.
 This medicine is also available in other strengths.
What is in this leaflet
1) What Pregabalin Krka is and what it is used for
2) What you need to know before you take Pregabalin Krka
3) How to take Pregabalin Krka
4) Possible side effects
5) How to store Pregabalin Krka
6) Contents of the pack and other information
1) WHAT PREGABALIN KRKA IS AND WHAT IT IS USED FOR
Pregabalin Krka belongs to a group of medicines used to treat epilepsy
and Generalised Anxiety Disorder (GAD) in adults.
Epilepsy: Pregabalin Krka is used to treat a certain form of epilepsy
(partial seizures with or without secondary generalisation) in adults. Your
doctor will prescribe Pregabalin Krka for you to help treat your epilepsy
when your current treatment is not controlling your condition. You should
take Pregabalin Krka in addition to your current treatment. Pregabalin
Krka is not intended to be used alone, but should always be used in
combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin Krka 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.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PREGABALIN KRKA

 There have been reports of convulsions when taking pregabalin or
shortly after stopping pregabalin. If you experience a convulsion,
contact your doctor immediately.
 There have been reports of reduction in brain function
(encephalopathy) in some patients taking pregabalin 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 Krka should not
be used in this age group.
Other medicines and Pregabalin Krka
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Pregabalin Krka and certain other
medicines may influence each other (interaction). When taken with
certain other medicines, Pregabalin Krka may potentiate the side effects
seen with these medicines, including respiratory failure and coma. The
degree of dizziness, sleepiness and decreased concentration may be
increased if Pregabalin Krka is taken together with medicinal products
containing:
 Oxycodone (used as a pain-killer)
 Lorazepam (used for treating anxiety)
 Alcohol
Pregabalin Krka may be taken with oral contraceptives.
Pregabalin Krka with food, drink and alcohol
Pregabalin Krka capsules may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin Krka.
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. Pregabalin Krka 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.
Driving and using machines
Pregabalin Krka may cause 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 KRKA

Do not take Pregabalin Krka:
 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 Krka.
 Some patients taking pregabalin 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 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 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.
 There have been reports of heart failure in some patients when taking
pregabalin; 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. If while taking Pregabalin Krka 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 Krka have had thoughts of harming or killing themselves. If
at any time you have these thoughts, immediately contact your doctor.
 When Pregabalin Krka 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.

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 Krka is for oral use only.
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 Krka either twice or three
times a day. For twice a day take Pregabalin Krka once in the morning
and once in the evening, at about the same time each day. For three
times a day take Pregabalin Krka 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 Krka 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 Krka 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.
Swallow the capsule whole with water.
Continue taking Pregabalin Krka until your doctor tells you to stop.
If you take more Pregabalin Krka than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box of Pregabalin Krka capsules with you. You
may feel sleepy, confused, agitated, or restless as a result of taking more
Pregabalin Krka than you should.

If you forget to take Pregabalin Krka
It is important to take your Pregabalin Krka 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 Krka
Do not stop taking Pregabalin Krka 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 Krka 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 Krka 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.
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.
Very common (may affect more than 1 in 10 people):
 Dizziness, drowsiness, headache.

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).
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 PREGABALIN KRKA

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.

 Keep out of the sight and reach of children.
 Do not store above 30oC.
 Do not use Pregabalin Krka after the expiry date which is stated on the
carton and the blister. The expiry date refers to the last day of that
month.
 If the capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

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 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.

The other ingredients are:
Capsule content: pregelatinised starch and talc (E553b).
Capsule shell: titanium dioxide (E171), gelatin (E441), red iron oxide
(E172), yellow iron oxide (E172), black printing ink (shellac (E904), black
iron oxide (E172) and propylene glycol (E1520)).

6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Pregabalin Krka contains
The active ingredient is pregabalin.
Each hard capsule contains 150 mg pregabalin.

What Pregabalin Krka looks like and contents of the pack
The body of the capsule is white colour, the cap of the capsule is
yellowish brown colour. Capsule cap is imprinted with black mark ‘P150’.
The content of the capsule is white to off white powder.
Capsule length: 17.2 – 18.3 mm.
Pregabalin Krka is available in printed cartons of 56 hard capsules in
blister packs.
Manufactured by
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
or
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven,
Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0606
Leaflet dated 23rd December 2015
Leaflet coded XXXXXXXXXX
KRKA® is a registered trademark of KRKA, tovarna zdravil, d.d.

POM

Package Leaflet: Information for the user

Pregabalin MPT Pharma 150 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.
 The name of this medicine is Pregabalin MPT Pharma 150 mg hard
capsules but will be referred to as Pregabalin MPT Pharma throughout
the remainder of this leaflet.
 This medicine is also available in other strengths.
What is in this leaflet
1) What Pregabalin MPT Pharma is and what it is used for
2) What you need to know before you take Pregabalin MPT Pharma
3) How to take Pregabalin MPT Pharma
4) Possible side effects
5) How to store Pregabalin MPT Pharma
6) Contents of the pack and other information
1) WHAT PREGABALIN MPT PHARMA IS AND WHAT IT IS USED
FOR
Pregabalin MPT Pharma belongs to a group of medicines used to treat
epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Epilepsy: Pregabalin MPT Pharma is used to treat a certain form of
epilepsy (partial seizures with or without secondary generalisation) in
adults. Your doctor will prescribe Pregabalin MPT Pharma for you to help
treat your epilepsy when your current treatment is not controlling your
condition. You should take Pregabalin MPT Pharma in addition to your
current treatment. Pregabalin MPT Pharma is not intended to be used
alone, but should always be used in combination with other anti-epileptic
treatment.
Generalised Anxiety Disorder: Pregabalin MPT Pharma 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.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PREGABALIN MPT PHARMA
Do not take Pregabalin MPT Pharma:
 If you are allergic to pregabalin or any of the other ingredients of this
medicine (listed in section 6).

 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 or
shortly after stopping pregabalin. If you experience a convulsion,
contact your doctor immediately.
 There have been reports of reduction in brain function
(encephalopathy) in some patients taking pregabalin 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 MPT Pharma
should not be used in this age group.
Other medicines and Pregabalin MPT Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Pregabalin MPT Pharma and certain
other medicines may influence each other (interaction). When taken with
certain other medicines, Pregabalin MPT Pharma may potentiate the side
effects seen with these medicines, including respiratory failure and coma.
The degree of dizziness, sleepiness and decreased concentration may
be increased if Pregabalin MPT Pharma is taken together with medicinal
products containing:
 Oxycodone (used as a pain-killer)
 Lorazepam (used for treating anxiety)
 Alcohol
Pregabalin MPT Pharma may be taken with oral contraceptives.
Pregabalin MPT Pharma with food, drink and alcohol
Pregabalin MPT Pharma capsules may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin MPT Pharma.
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. Pregabalin MPT Pharma 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.
Driving and using machines
Pregabalin MPT Pharma may cause 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 MPT PHARMA

Warnings and precautions:
Talk to your doctor or pharmacist before taking Pregabalin MPT Pharma.
 Some patients taking pregabalin 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 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 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.
 There have been reports of heart failure in some patients when taking
pregabalin; these patients were mostly elderly with cardiovascular
conditions.

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 MPT Pharma is for oral use only.

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. If while taking Pregabalin MPT Pharma 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 MPT Pharma have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.
 When Pregabalin MPT Pharma 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.

If you are an elderly patient (over 65 years of age), you should take
Pregabalin MPT Pharma 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.

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 MPT Pharma either twice or
three times a day. For twice a day take Pregabalin MPT Pharma once
in the morning and once in the evening, at about the same time each
day. For three times a day take Pregabalin MPT Pharma 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 MPT Pharma is
too strong or too weak, talk to your doctor or pharmacist.

Swallow the capsule whole with water.
Continue taking Pregabalin MPT Pharma until your doctor tells you to
stop.
If you take more Pregabalin MPT Pharma than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box of Pregabalin MPT Pharma capsules with
you. You may feel sleepy, confused, agitated, or restless as a result of
taking more Pregabalin MPT Pharma than you should.

If you forget to take Pregabalin MPT Pharma
It is important to take your Pregabalin MPT Pharma 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 MPT Pharma
Do not stop taking Pregabalin MPT Pharma 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 MPT Pharma 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 MPT Pharma 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.
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.
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
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 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).
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 PREGABALIN MPT PHARMA
 Keep out of the sight and reach of children.
 Do not store above 30oC.
 Do not use Pregabalin MPT Pharma after the expiry date which is
stated on the carton and the blister. The expiry date refers to the last
day of that month.
 If the capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Pregabalin MPT Pharma contains
The active ingredient is pregabalin.
Each hard capsule contains 150 mg pregabalin.
The other ingredients are:
Capsule content: pregelatinised starch and talc (E553b).
Capsule shell: titanium dioxide (E171), gelatin (E441), red iron oxide
(E172), yellow iron oxide (E172), black printing ink (shellac (E904), black
iron oxide (E172) and propylene glycol (E1520)).
What Pregabalin MPT Pharma looks like and contents of the pack
The body of the capsule is white colour, the cap of the capsule is
yellowish brown colour. Capsule cap is imprinted with black mark ‘P150’.
The content of the capsule is white to off white powder.
Capsule length: 17.2 – 18.3 mm.
Pregabalin MPT Pharma is available in printed cartons of 56 hard
capsules in blister packs.
Manufactured by
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
or
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven,
Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0606
Leaflet dated 23rd December 2015
Leaflet coded XXXXXXXXXX

POM

Expand view ⇕

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.

Hide