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LECAENT 225MG CAPSULES HARD

Active substance(s): PREGABALIN

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Package leaflet: Information for the user

Lecaent 25mg, 50mg, 75mg, 100mg, 150mg,
200mg, 225mg and 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
1. What Lecaent is and what it is used for
2. What you need to know before you take Lecaent
3. How to take Lecaent
4. Possible side effects
5. How to store Lecaent
6. Contents of the pack and other information
1. What Lecaent is and what it is used for
Lecaent belongs to a group of medicines used to treat epilepsy and
Generalised Anxiety Disorder (GAD) in adults.
Epilepsy: Lecaent is used to treat a certain form of epilepsy (partial
seizures with or without secondary generalisation) in adults. Your
doctor will prescribe Lecaent for you to help treat your epilepsy when
your current treatment is not controlling your condition. You should
take Lecaent in addition to your current treatment. Lecaent is not
intended to be used alone, but should always be used in combination
with other anti-epileptic treatment.
Generalised Anxiety Disorder: Lecaent 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.
Lecaent may also be prescribed to treat conditions not listed in this
leaflet. If you have any questions, ask your doctor or pharmacist.
2. What you need to know before you take Lecaent
Do not take Lecaent
• 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 Lecaent.
• Some patients taking Lecaent 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.
• Lecaent 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.
• Lecaent 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 Lecaent; 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 Lecaent. If while taking Lecaent 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
Lecaent have had thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact your doctor.
• When Lecaent 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.

Continued top of next column

• 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 Lecaent or
shortly after stopping Lecaent. If you experience a convulsion,
contact your doctor immediately.
• There have been reports of reduction in brain function
(encephalopathy) in some patients taking Lecaent 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 Lecaent
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Lecaent and certain other medicines may influence each other
(interaction). When taken with certain other medicines, Lecaent 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 Lecaent is taken together
with medicinal products containing:
Oxycodone – (used as a painkiller)
Lorazepam – (used for treating anxiety)
Alcohol
Lecaent may be taken with oral contraceptives.
Lecaent with food, drink and alcohol
Lecaent capsules may be taken with or without food.
It is advised not to drink alcohol while taking Lecaent.
Pregnancy and breast-feeding
Lecaent should not be taken during pregnancy or when breastfeeding, 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
Lecaent 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 Lecaent
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.
Lecaent 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 150mg and 600mg each day.
• Your doctor will tell you to take Lecaent either twice or three times
a day. For twice a day take Lecaent once in the morning and once in
the evening, at about the same time each day. For three times a day
take Lecaent 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 Lecaent 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
Lecaent 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 Lecaent until your doctor tells you to stop.
If you take more Lecaent than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box of Lecaent capsules with you. You may feel
sleepy, confused, agitated or restless as a result of taking more Lecaent
than you should.
If you forget to take Lecaent
It is important to take your Lecaent 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.
Continued over page

If you stop taking Lecaent
Do not stop taking Lecaent 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 Lecaent 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 Lecaent 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 attack, 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 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,
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 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.

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• Allergic reactions (which may include difficulty breathing,
inflammation of the eyes (keratitis) and a serious skin reaction
characterised by rash, blisters, peeling skin and pain).
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.
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 Lecaent
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 blister 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 Lecaent contains
• The active substance is pregabalin. Each hard capsule contains
either 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg or 300mg
pregabalin.
• The other ingredients are: mannitol, co-processed corn starch
(consisting of corn starch and pregelatinised corn starch), talc,
gelatine, titanium dioxide (E171) and black ink, (which contains
shellac, black iron oxide (E172), potassium hydroxide). The 75mg,
100mg, 200mg, 225mg and 300mg capsules also contain red iron
oxide (E172).
What Lecaent looks like and contents of the pack
25mg capsules
50mg capsules

75mg capsules

White capsules, hard, size 4 (14.4 ± 0.4 mm),
with “PGB 25” marked on the body.
White capsules, hard, size 3 (15.8 ± 0.4 mm),
with “PGB 50” marked on the body. The capsule
body is marked with a black band.
White and orange capsules, hard, size 4
(14.4 ± 0.4 mm), with “PGB 75” marked on the
body.

100mg capsules

Orange capsules, hard, size 3 (15.8 ± 0.4 mm),
with “PGB 100” marked on the body.

150mg capsules

White capsules, hard, size 2 (17.8 ± 0.4 mm),
with “PGB 150” marked on the body.

200mg capsules

225mg capsules

300mg capsules

Light orange capsules, hard, size 1
(19.3 ± 0.4 mm), with “PGB 200” marked on the
body.
White and light orange capsules, hard, size 1
(19.3 ± 0.4 mm), with “PGB 225” marked on the
body.
White and orange capsules, hard, size 0
(21.4 ± 0.4 mm), with “PGB 300” marked on the
body.

Lecaent 25mg is available in two pack sizes made of PVC with an
aluminium foil backing: a 56 capsules pack and a 84 capsules pack.
Lecaent 50mg, 100mg and 200mg is available in one pack size made of
PVC with an aluminium foil backing: a 84 capsules pack.
Lecaent 75mg, 150mg, 225mg and 300mg is available in one pack size
made of PVC with an aluminium foil backing: a 56 capsules pack.
Marketing Authorisation Holder
Caduceus Pharma Ltd
6th Floor
94 Wigmore Street
London
W1U 3RF
UK
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in October 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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