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ALZAIN 200 MG CAPSULES HARD

Active substance(s): PREGABALIN

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Package leaflet: Information for the user

Alzain 25 mg Capsules, Hard
Alzain 50 mg Capsules, Hard
Alzain 75 mg Capsules, Hard
Alzain 100 mg Capsules, Hard
Alzain 150 mg Capsules, Hard
Alzain 200 mg Capsules, Hard
Alzain 225 mg Capsules, Hard
Alzain 300 mg 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 Alzain is and what it is used for
2. What you need to know before you take Alzain
3. How to take Alzain
4. Possible side effects
5. How to store Alzain
6. Contents of the pack and other information
1.What Alzain is and what it is used for
Alzain belongs to a group of medicines used to treat epilepsy and
Generalised Anxiety Disorder (GAD) in adults.
Epilepsy: Alzain is used to treat a certain form of epilepsy (partial
seizures with or without secondary generalisation) in adults. Your
doctor will prescribe Alzain for you to help treat your epilepsy when
your current treatment is not controlling your condition. You should
take Alzain in addition to your current treatment. Alzain is not
intended to be used alone, but should always be used in combination
with other anti-epileptic treatment.

• 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 Alzain or shortly
after stopping Alzain. If you experience a convulsion, contact your
doctor immediately.
• There have been reports of reduction in brain function
(encephalopathy) in some patients taking Alzain 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 Alzain
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Alzain and certain other medicines may influence each other
(interaction). When taken with certain other medicines, Alzain 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 Alzain is taken together
with medicinal products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Alzain may be taken with oral contraceptives.

Generalised Anxiety Disorder: Alzain is used to treat Generalised
Alzain with food, drink and alcohol
Anxiety Disorder (GAD). The symptoms of GAD are prolonged
Alzain capsules may be taken with or without food.
excessive anxiety and worry that are difficult to control. GAD can also
cause restlessness or feeling keyed up or on edge, being easily fatigued It is advised not to drink alcohol while taking Alzain.
(tired), having difficulty concentrating or mind going blank, feeling
Pregnancy and breast-feeding
irritable, having muscle tension or sleep disturbance. This is different to Alzain should not be taken during pregnancy or when breast-feeding,
the stresses and strains of everyday life.
unless you are told otherwise by your doctor. Effective contraception
must be used by women of child bearing potential. If you are
2. What you need to know before you take Alzain
pregnant or breast feeding, think you may be pregnant or are
Do not take Alzain
planning to have a baby, ask your doctor or pharmacist for advice
• if you are allergic to pregabalin or any of the other ingredients of
before taking this medicine.
this medicine (listed in section 6).
Driving and using machines
Warnings and precautions
Alzain may produce dizziness, sleepiness and decreased concentration.
Talk to your doctor or pharmacist before taking Alzain.
You should not drive, operate complex machinery or engage in other
potentially hazardous activities until you know whether this medicine
• Some patients taking Alzain have reported symptoms suggesting an
affects your ability to perform these activities.
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 3. How to take Alzain
immediately.
Always take this medicine exactly as your doctor has told you. Check
• Alzain 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.

with your doctor or pharmacist if you are not sure.

• Alzain 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.

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 Alzain either twice or three times a
day. For twice a day take Alzain once in the morning and once in the
evening, at about the same time each day. For three times a day take
Alzain once in the morning, once in the afternoon and once in the
evening, at about the same time each day.

• 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 Alzain; 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 Alzain. If while taking Alzain 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
Alzain have had thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact your doctor.
• When Alzain 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.

Your doctor will determine what dose is appropriate for you.
Alzain is for oral use only.

If you have the impression that the effect of Alzain 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
Alzain 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 Alzain until your doctor tells you to stop.
If you take more Alzain than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box of Alzain capsules with you. You may feel
sleepy, confused, agitated, or restless as a result of taking more Alzain
than you should.

If you forget to take Alzain
It is important to take your Alzain 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 Alzain
Do not stop taking Alzain 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 Alzain 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 Alzain for a longer period of time.

• 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
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.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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

4. Possible side effects

By reporting side effects you can help provide more information on the
safety of this medicine.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

5. How to store Alzain

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.

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 Alzain 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: 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) and water.
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also
contain red iron oxide (E172).

What Alzain looks like and contents of the pack
25 mg
capsules

White capsules, hard, size 4 (14.4 ± 0.4 mm), with
“PGB 25” marked on the body.

75 mg
capsules

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.

100 mg
capsules
150 mg
capsules
200 mg
capsules

Orange capsules, hard, size 3 (15.8 ± 0.4 mm),
with “PGB 100” marked on the body.
White capsules, hard, size 2 (17.8 ± 0.4 mm), with
“PGB 150” marked on the body.
Light orange capsules, hard, size 1 (19.3 ±
0.4 mm), with “PGB 200” marked on the body.

225 mg
capsules

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

300 mg
capsules

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

50 mg
capsules

Alzain 25 mg and 50 mg are available in two pack sizes made of PVC
with an aluminium foil backing: a 56 capsules pack and a 84 capsules
pack.
Alzain 100 mg and 200 mg are available in one pack size made of PVC
with an aluminium foil backing: a 84 capsules pack.
Alzain 75 mg, 150 mg, 225 mg and 300 mg are available in one pack
size made of PVC with an aluminium foil backing: a 56 capsules pack.
Not all pack sizes may be marketed.
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
Distributed by
Dr. Reddy’s Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire,
HU17 0LD
United Kingdom
This leaflet was last revised in 01/2016.

DR173573

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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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