What is it and how is it used?

LYRICA belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain: LYRICA is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.

Epilepsy: LYRICA 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 LYRICA for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take LYRICA in addition to your current treatment. LYRICA is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: LYRICA 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.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take LYRICA

if you are allergic (hypersensitive) to pregabalin or any of the other ingredients of Lyrica.

Take special care with LYRICA

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.

  • Some patients taking LYRICA 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.
  • LYRICA 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.
  • LYRICA 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 Lyrica; 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 Lyrica. If while taking Lyrica 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 Lyrica have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
  • When LYRICA 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 drug dependence. Let your doctor know if you think you need more medicine than prescribed.
  • There have been reports of convulsions when taking Lyrica or shortly after stopping Lyrica. If you experience a convulsion, contact your doctor immediately.
  • There have been reports of reduction in brain function (encephalopathy) in some patients taking Lyrica when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.

Taking other medicines

Before taking any new medicine with LYRICA you should talk to your doctor. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

LYRICA and certain other medicines may influence each other (interaction). When taken with certain other medicines, LYRICA 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 LYRICA is taken together with medicinal products containing:

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

LYRICA may be taken with oral contraceptives.

Taking LYRICA with food and drink

LYRICA may be taken with or without food.

It is advised not to drink alcohol while taking LYRICA

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
LYRICA should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking LYRICA.
It is not recommended to breast-feed your baby while using LYRICA as it is not known if LYRICA may be found in breast milk. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.

Driving and using machines

LYRICA 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.

Important information about some of the ingredients of LYRICA:

LYRICA oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
LYRICA oral solution contains small amounts of ethanol (alcohol), less than 100 mg/ml.

How is it used?

Always take LYRICA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you.

Peripheral and central neuropathic pain, 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 LYRICA either twice or three times a day. For twice a day take LYRICA once in the morning and once in the evening, at about the same time each day. For three times a day take LYRICA 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 LYRICA 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 LYRICA 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 LYRICA until your doctor tells you to stop.

Administration:Instructions for use

LYRICA 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 Withdrawals to Deliver Prescribed Dose of Lyrica

Lyrica Dose mg Total Solution Volume ml First Syringe Withdrawal ml Second Syringe Withdrawal ml Third Syringe 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

If you take more LYRICA than you should

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

If you forget to take LYRICA

It is important to take your LYRICA 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 LYRICA

Do not stop taking LYRICA 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 LYRICA 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. It is not clear at this time whether these symptoms occur more commonly or severely if you have been taking pregabalin for a longer period of time.

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

What are possible side effects?

Like all medicines, LYRICA can have side effects, although not everyone gets them.

Very common side-effects which may affect more than 1 person in 10 are listed below:

Dizziness, tiredness

Common side-effects which may affect more than 1 person in 100 are listed below:

  • Increased appetite
  • Feeling of elation, confusion, disorientation, changes in sexual interest, irritability
  • Disturbance in attention, clumsiness, memory impairment, tremor, difficulty with speaking, tingling feeling, sedation, lethargy, insomnia, fatigue
  • Blurred vision, double vision
  • Vertigo, problems with balance
  • Dry mouth, constipation, vomiting, flatulence
  • Difficulties with erection
  • Swelling of the body including extremities
  • Feeling drunk, abnormal style of walking
  • Weight gain
Uncommon side-effects which may affect more than 1 person in 1000 are listed below:

  • Loss of appetite, low blood sugar
  • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, loss of memory, hallucinations, abnormal dreams, panic attacks, apathy, feeling abnormal, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
  • Difficulty with thinking, numbness, changes in eyesight, unusual eye movement, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, fainting, increased sensitivity to noise
  • Dry eyes, eye swelling, eye pain, weak eyes, watery eyes
  • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure
  • Flushing, hot flushes
  • Difficulty breathing, sore throat, dry nose
  • Swollen abdomen, increased saliva production, heartburn, numb around mouth
  • Sweating, rash ,chills
  • Muscle twitching, joint swelling, muscle cramp, muscle stiffness, pain including muscle pain, joint pain, back pain, pain in limb
  • Difficulty with or painful urination, incontinence
  • Weakness, fall, thirst, chest tightness
  • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased,aspartate aminotransferase increased, platelet count decreased)

Rare side-effects which may affect less than 1 person in 1000 are listed below:

  • Changes in heart beat
  • Coldness of hands and feet
  • Cough, nasal congestion, runny nose, nose bleed, snoring
  • Abnormal sense of smell, changes in vision including tunnel vision, swinging vision, altered perception of depth, flashes of light, visual brightness
  • Dilated pupils, cross eyes, eye irritation
  • Fever, cold sweat, tightness of the throat
  • Inflammation of the pancreas
  • Difficulty in swallowing
  • Slow or reduced movement of the body
  • Difficulty with wrting properly
  • Hives
  • Increased fluid in the abdomen
  • Muscle damage
  • Neck pain
  • Breast pain, breast discharge, abnormal breast growth, painful or interrupted menstrual periods
  • High blood sugar
  • Weight loss
  • Elevated mood
  • Kidney failure, reduced urine volume
  • Changes in blood test results (decrease in blood potassium, increase in blood creatinine, decrease in white blood cell count including neutrophils)
  • Inappropriate behaviour

Additional reactions reported from post marketing experience include heart failure, changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances, fluid in the lungs, loss of consciousness, convulsions, hypersensitivity and allergic reactions (which may include swollen face, swollen tongue, difficulty breathing, itchiness, inflammation of the eyes (keratitis), vision loss and a serious skin reaction characterized by rash, blisters, peeling skin and pain), mental impairment, aggression, urinary retention, diarrhoea, headache, nausea, and feeling unwell.

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 LYRICA and the severity of these effects may be increased when taken together.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep LYRICA out of the reach and sight of children.

Do not use LYRICA after the expiry date which is stated on the carton or bottle.

This medicinal product does not require any special storage conditions.

Ask your pharmacist how to dispose of medicines no longer required. Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

Further information

What LYRICA 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 phosphate, anhydrous (E339), sucralose (E995), artificial strawberry flavour (contains small amounts of ethanol (alcohol) , purified water.

What LYRICA looks like and contents of the pack
Lyrica 20 mg/ml oral solution is a clear colourless solution in a white bottle containing 473 ml of oral solution, in a cardboard carton. The carton also contains, in a clear polyethylene wrap, a graduated 5 ml oral syringe and a press-in bottle adapter (PIBA).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Pfizer Limited, Sandwich, Kent, CT13 9NJ, UK.

Manufacturer:
Pfizer Service Company, Hoge Wei 10, B1930 Zaventem, Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Pfizer S.A. N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburg Pfizer S.A. TélTel 32 02 554 62 11

, . 359 2 970 4333 Magyarország PFIZER Kft. Tel. 36 1 488 37 00

eská republika Pfizer spol s.r.o. Tel 420-283-004-111 Malta V.J. Salomone Pharma Ltd. Tel 356 21220174

Danmark Pfizer ApS Tlf 45 44 20 11 00 Nederland Pfizer bv Tel 31 010 406 4301

Deutschland Pfizer Pharma GmbH Tel 49 030 550055-51000 Norge Pfizer AS Tlf 47 67 52 61 00

Eesti Pfizer Luxembourg SARL Eesti filiaal Tel 372 6 405 328 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0

Pfizer Hellas A.E. . 30 210 67 85 800 Polska Pfizer Polska Sp. z o.o. Tel. 48 22 335 61 00

España Pfizer S.A. Tel 34 91 490 99 00 Portugal Laboratórios Pfizer, Lda. Tel 351 21 423 5500

France Pfizer Tél 33 01 58 07 34 40 România Pfizer România S.R.L. Tel 40 021 207 28 00

Ireland Pfizer Healthcare Ireland Tel 1800 633 363 toll free Tel 44 01304 616161 Slovenija Pfizer Luxembourg SARL, Pfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, Ljubljana Tel 386 01 52 11 400

Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel 42123355 5500

Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 SuomiFinland Pfizer Oy Puh.Tel 358 09 43 00 40

GEO. PAVLIDES ARAOUZOS LTD. 35722818087 Sverige Pfizer AB Tel 46 08 550 520 00

Latvija Pfizer Luxembourg SARL filile Latvij Tel 371 670 35 775 United Kingdom Pfizer Limited Tel 44 01304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000

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