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PREGABALIN PHARMANEL 20 MG/ML ORAL SOLUTION

Active substance(s): PREGABALIN

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Package leaflet: Information for the user
Pregabalin Pharmanel 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.
What is in this leaflet
1.
What Pregabalin Pharmanel 20 mg/ml oral solution is and what it is used for
2.
What you need to know before you take Pregabalin Pharmanel
3.
How to take Pregabalin Pharmanel
4.
Possible side effects
5.
How to store Pregabalin Pharmanel
6.
Contents of the pack and other information
1.
What Pregabalin Pharmanel 20 mg/ml oral solution is and what it is used for
Pregabalin Pharmanel belongs to a group of medicines used to treat epilepsy and Generalised
Anxiety Disorder (GAD) in adults.
Epilepsy: Pregabalin Pharmanel 20 mg/ml 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 Pharmanel 20 mg/ml oral solution for
you to help treat your epilepsy when your current treatment is not controlling your condition. You
should take Pregabalin Pharmanel 20 mg/ml oral solution in addition to your current treatment
Pregabalin Pharmanel 20 mg/ml oral solution is not intended to be used alone, but should always be
used in combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin Pharmanel 20 mg/ml 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.
2.

What you need to know before you take Pregabalin Pharmanel 20 mg/ml oral solution

Do not take Pregabalin Pharmanel 20 mg/ml oral solution
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 Pharmanel 20 mg/ml oral solution


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.



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 Pharmanel 20 mg/ml oral solution 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 have had
thoughts of harming or killing themselves. If at any time you have these thoughts,
immediately contact your doctor.



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.



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 should not be used in this age group.
Other medicines and Pregabalin Pharmanel 20 mg/ml oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pregabalin and certain other medicines may influence each other (interaction). When taken with
certain other medicines, pregabalin 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 is taken together with medicinal products containing:

Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin Pharmanel 20 mg/ml oral solution may be taken with oral contraceptives.
Pregabalin Pharmanel 20 mg/ml oral solution with food, drink and alcohol
Pregabalin may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin Pharmanel 20 mg/ml oral solution
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.
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 Pharmanel 20 mg/ml oral solution 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.
Pregabalin Pharmanel 20 mg/ml oral solution contains
Pregabalin Pharmanel 20 mg/ml oral solution oral solution contains methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).
3.

How to take Pregabalin Pharmanel 20 mg/ml oral solution

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.
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 Pharmanel 20 mg/ml oral solution either twice or
three times a day. For twice a day take Pregabalin Pharmanel 20 mg/ml oral solution once in the
morning and once in the evening, at about the same time each day. For three times a day take
Pregabalin Pharmanel 20 mg/ml oral solution 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 Pharmanel 20 mg/ml oral solution 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 Pharmanel 20 mg/ml
oral solution 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.

Continue taking Pregabalin Pharmanel 20 mg/ml oral solution until your doctor tells you to stop.
Administration:
Instructions for use
Pregabalin Pharmanel 20 mg/ml oral solution is for oral use only.
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).

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).

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.

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).
[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.]

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).

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Table 1. Oral Syringe Withdra
awals to Deliver Prescribed Dose of Pregabalin Pharmanel 20
mg/ml oral solution
Pregabalin
Pharmanel 20
mg/ml oral solution
Dose (mg)

Total Soluti
lution
Volume (ml)

First Syringe
Withdrawal (ml)

Second Syringe
Withdrawal (ml)

Third Syringe
Withdrawal (ml)

25
50
75
100
150

1.25
2.5
3.75
5
7.5

1.25
2.5
3.75
5
5

Not required
Not required
Not required
Not required
2.5

Not required
Not required
Not required
Not required
Not required

200
225
300

10
11.25
15

5
5
5

5
5
5

Not required
1.25
5

If you take more Pregabalin Pharmanel 20 mg/ml oral solution than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of
Pregabalin Pharmanel 20 mg/ml oral solution oral solution with you. You may feel sleepy, confused,
agitated, or restless as a result of taking more Pregabalin Pharmanel 20 mg/ml oral solution than you
should.
If you forget to take Pregabalin Pharmanel 20 mg/ml oral solution
It is important to take your Pregabalin 20 mg/ml oral solution 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.
If you stop taking Pregabalin Pharmanel 20 mg/ml oral solution
Do not stop taking Pregabalin Pharmanel 20 mg/ml oral solution 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 Pharmanel 20 mg/ml oral solution 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 Pharmanel 20 mg/ml oral solution for a longer period of time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: may affect more than 1in 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 to1 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

Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis)
and a serious skin reaction characterized by rash, blisters, peeling skin and pain)
If you experience swollen face or tongue or if your skin turns red and starts to blister or peel
you should seek immediate medical advice.
Certain side effects may be more common, such as sleepiness, because patients with spinal cord
injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side
effects to Pregabalin Pharmanel 20 mg/ml oral solution and the severity of these effects may be
increased when taken together.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your 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 Pharmanel 20 mg/ml oral solution

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.
Pregabalin Pharmanel 20 mg/ml oral solution should be used within 60 days of opening the bottle.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Pregabalin Pharmanel 20 mg/ml oral solution contains
The active substance is pregabalin. Each ml contains 20 mg of pregabalin.
The other ingredients are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
sodium dihydrogen phosphate anhydrous, disodium hydrogen phosphate anhydrous, sucralose,
strawberry flavouring 10131/P, purified water.
What Pregabalin Pharmanel 20 mg/ml oral solution looks like and contents of the pack
Pregabalin Pharmanel 20 mg/ml oral solution is a clear colourless solution in a white HDPE bottle
containing 473 ml of oral solution, in a lithographed cardboard carton. The carton also contains an
oral syringe with 1.25ml graduations and a total capacity of 5mls. A press-in bottle adapter is also
included.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Genus Pharmaceuticals Limited
T/A Genus Pharmaceuticals
Linthwaite
Huddersfield
HD7 5QH
UK
Manufacturer:
One Pharma S.A

60th km N. N. R.
Athinon-Lamias,
32 009 Sximatari Voiotias
Greece

This medicinal product is authorised in the Member States of the EEA under the following
names:

Member States
PT

Proposed product name
Pregabalina STADA

ES

Pregabalina STADAGEN 20 mg
/ml solución oral EFG

IT

PREGABALIN
EUROGENERICI

UK

Pregabalin Pharmanel 20 mg/ml
oral solution

This leaflet was last revised in:
April 2016

Proposed MAH
STADA Arzneitmittel AG,
Stadastrasse 2-18, 61118 Bad
Vilbel, Germany
Laboratorio STADA, S.L.
C/ Frederic Mompou 5
08960 Sant Just Desvern
Barcelona, Spain
EG SpA
Via Pavia, 6
20136 Milano
Italy
Pharmanel Commercial
Pharmaceutical S.A.
106 Marathonos Ave., Gerakas,
Athens, 15344, Greece

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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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