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PREGABALIN ALKEM 20 MG/ML ORAL SOLUTION

Active substance(s): PREGABALIN / PREGABALIN

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Pregabalin and certain other medicines may influence each other (interaction). When taken with certain
other medicines, Pregabalin may increase the likelihood of 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 is taken together with medicinal products containing:

Package leaflet: Information for the user
Pregabalin Alkem 20 mg/ml oral solution
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.

Pregabalin with food, drink and alcohol
Pregabalin may be taken with or without food.

Pregabalin Alkem 20 mg/ml oral solution is named as Pregabalin in this leaflet.

It is advised not to drink alcohol while taking Pregabalin.

What is in this leaflet:
1. What Pregabalin is and what it is used for
2. What you need to know before you take Pregabalin
3. How to take Pregabalin
4. Possible side effects
5. How to store Pregabalin
6. Contents of the pack and other information

Pregnancy and breast-feeding
Pregabalin 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.





Pregabalin may be taken with oral contraceptives.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Pregabalin 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.

1. What Pregabalin is and what it is used for
Pregabalin belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder
(GAD) in adults.

Pregabalin oral solution contains
Pregabalin oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) which may cause allergic reactions (possibly delayed).

Epilepsy: Pregabalin oral solution is used to treat a certain form of epilepsy (partial seizures with or
without secondary generalisation-epileptic fits starting on one specific part of the brain) in adults. Your
doctor will prescribe Pregabalin oral solution for you to help treat your epilepsy when your current
treatment is not controlling your condition. You should take Pregabalin oral solution in addition to your
current treatment. Pregabalin oral solution is not intended to be used alone, but should always be used
in combination with other anti-epileptic treatment.

3. How to take Pregabalin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Generalised Anxiety Disorder: Pregabalin oral solution 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.

Your doctor will determine what dose is appropriate for you.
Epilepsy or Generalised Anxiety Disorder:
 Take the solution as instructed by your doctor.
 The dose, which has been adjusted for you and your condition, will generally be between 150 mg (7.5
ml) and 600 mg (30 ml) each day.
 Your doctor will tell you to take Pregabalin either twice or three times a day. For twice a day take
Pregabalin once in the morning and once in the evening, at about the same time each day. For three
times a day take Pregabalin once in the morning, once in the afternoon and once in the evening, at about
the same time each day.

2. What you need to know before you take Pregabalin
Do not take Pregabalin
 if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

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Warnings and Precautions
Talk to your doctor or pharmacist before taking Pregabalin.








Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol

If you have the impression that the effect of Pregabalin is too strong or too weak, talk to your doctor or
pharmacist.

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.

Use in elderly patients
If you are an elderly patient (over 65 years of age), you should take Pregabalin normally except if you have
problems with your kidneys.

Pregabalin has been associated with dizziness and sleepiness, 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.

Use in patients with kidney problems
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your
kidneys.

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.

Administration:
Instructions for use

Some patients with diabetes who gain weight while taking pregabalin may need an alteration in
their diabetic medicines.

Pregabalin is for oral use only.


Certain side effects may be more common, such as sleepiness, because patients with spinal cord
injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side
effects to Pregabalin and the severity of these effects may be increased when taken together.



There have been reports of heart failure in some patients when taking Pregabalin; 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 you notice decreased urination, you should tell your doctor as stopping the medicine
may improve this.

3. Push the syringe plunger to the bottom of the barrel of the syringe (toward its tip) to remove excess air.
Attach the syringe to the PIBA with a slight twisting motion (Figure 3).



A small number of people being treated with anti-epileptics such as Pregabalin have had thoughts
of harming or killing themselves. If at any time you have these thoughts, immediately contact your
doctor.

4. Invert the bottle (with the syringe attached) and fill the syringe with the liquid by pulling the syringe
plunger down to just beyond the graduation mark corresponding to the quantity in millilitres (ml)
prescribed by your doctor (Figure 4). Remove air bubbles from the syringe by pushing the plunger up
to the appropriate graduation mark.



When Pregabalin 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.

1. Open the bottle: Press downward on the cap and turn it counter-clockwise (Figure 1).
2. First time use only: A Press-In Bottle Adapter (PIBA) is provided with the oral syringe. This is the
device that gets inserted into the neck of the bottle to make it easier to withdraw the solution using the
oral syringe. If the PIBA is not already in place, remove the PIBA and 5 ml oral syringe from the plastic
overwrap. With the bottle on a flat surface, insert the PIBA into the bottle neck while keeping the
PIBA's flat surface facing up and pressing on it (Figure 2).

5. Return the bottle to an upright position with the syringe still in the PIBA/bottle (Figure 5).
6. Remove the syringe from the bottle/PIBA (Figure 6).
7. Empty the contents of the syringe directly into mouth by pushing the syringe plunger to the bottom of
the syringe barrel (Figure 7).
Note: Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).



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.

[For example, a 150 mg (7.5 ml) dose will require two withdrawals from the bottle to achieve the entire
dose. Using the oral syringe, first withdraw 5 ml and empty contents of syringe directly into the mouth,
then refill the oral syringe with 2.5 ml and empty the remaining contents into the mouth.]



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.

8. Rinse the syringe by drawing water into the syringe and pushing the syringe plunger to the bottom of
the syringe barrel, at least three times (Figure 8).
9. Replace the cap on the bottle (leaving the PIBA in place in the bottle neck) (Figure 9).

Children and adolescents
The safety and efficacy in children and adolescents (under 18 years of age) has not been established
and therefore, pregabalin should not be used in this age group.
Other medicines and Pregabalin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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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 (fits)
 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 characterised by rash, blisters, peeling skin and pain)

Table 1. Oral Syringe Withdrawals to Deliver Prescribed Dose of Pregabalin
Pregabalin Dose
(mg)

Total Solution
Volume (ml)

First Syringe
Second Syringe
Withdrawal (ml) Withdrawal (ml)

25

1.25

1.25

Not required

Not required

50

2.5

2.5

Not required

Not required

75

3.75

3.75

Not required

Not required

100

5

5

Not required

Not required

150

7.5

5

2.5

Not required

200

10

5

5

Not required

225

11.25

5

5

1.25

300

15

5

5

5

Third Syringe
Withdrawal (ml)

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 take more Pregabalin than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of
Pregabalin oral solution with you. You may feel sleepy, confused, agitated, or restless as a result of taking
more Pregabalin than you should. Fits have also been reported.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.

If you forget to take Pregabalin
It is important to take your Pregabalin oral solution 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.
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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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

If you stop taking Pregabalin
Do not stop taking Pregabalin unless your doctor tells you to. If your treatment is stopped, it should be done
gradually over a minimum of 1 week.

5. How to store Pregabalin

After stopping long and short-term Pregabalin 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 for a longer period of time.

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.

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

Store below 30˚C.

4. Possible side effects

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.

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

6. Contents of the pack and other information

Very common: may affect more than 1 in 10 people
 Dizziness, drowsiness, headache

What Pregabalin oral solution contains

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 (feeling of dizziness or “spinning”), 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

The active substance is pregabalin. Each ml contains 20 mg of pregabalin.
The other ingredients are: methyl parahydroxy benzoate (E218), propyl parahydroxy benzoate (E216),
Anhydrous Sodium Dihydrogen Phosphate, disodium phosphate anhydrous (E339), sucralose (E955),
Superfex Art Maraschino cherry FL #769 {contains Flavouring ingredients in propylene glycol
(E1520)}, purified water.
What Pregabalin oral solution looks like and contents of the pack
Pregabalin oral solution is a clear colourless transparent solution in a white opaque bottle containing
473 ml of oral solution, a graduated 5 ml oral syringe and a press-in bottle adapter (PIBA) are also
supplied.
Marketing Authorisation Holder:
Alkem Pharma GmbH,
Gutenbergstraße 13,
24941 Flensburg,
Germany.

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

Manufacturer:
Wave Pharma Limited
4th floor, Cavendish House,
369 Burnt Oak
Broadway, Edgware, HA85AW
United Kingdom
Distributed by:
Ascend Laboratories (UK) Limited
United Kingdom.
This leaflet was last revised in 05/2017.

PT 2513

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

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

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