Pregabalin Pfizer
pregabalin
pregabalin
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 Pregabalin Pfizer is and what it is used for
What you need to know before you take Pregabalin Pfizer
How to take Pregabalin Pfizer
Possible side effects
How to store Pregabalin Pfizer
Contents of the pack and other information
Pregabalin Pfizer belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking Pregabalin Pfizer.
Some patients taking Pregabalin Pfizer 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 Pfizer 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 Pfizer 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 Pfizer; 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 Pfizer. If while taking Pregabalin Pfizer 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 Pfizer have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
When Pregabalin Pfizer 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 Pfizer or shortly after stopping Pregabalin Pfizer. If you experience a convulsion, contact your doctor immediately.
There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Pfizer when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
There have been reports of breathing difficulties. If you have nervous system disorders, respiratory disorders, renal impairment, or you are older than 65, your doctor may prescribe you a different dosing regimen. Contact your doctor if you experience trouble breathing or shallow breaths.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregabalin Pfizer and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin Pfizer may potentiate these effects, and could lead to respiratory failure, coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Pfizer is taken together with medicines containing:
Oxycodone – (used as a pain-killer) Lorazepam – (used for treating anxiety) Alcohol
Pregabalin Pfizer may be taken with oral contraceptives.
Pregabalin Pfizer capsules may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin Pfizer.
Pregabalin Pfizer should not be taken during pregnancy or when breast-feeding, unless you are told
otherwise by your doctor. Pregabalin use during the first 3 months of pregnancy may cause birth defects in the unborn child that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin in the first 3 months of pregnancy, 6 babies in every 100 had such birth defects. This compares to 4 babies in every 100 born to women not treated with pregabalin in the study. Abnormalities of the face (orofacial clefts), the eyes, the nervous system (including the brain), kidneys and genitals have been reported.
Effective contraception must be used by women of childbearing 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.
Pregabalin Pfizer 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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.
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. Pregabalin Pfizer is for oral use only.
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 Pregabalin Pfizer either twice or three times a day. For twice a day take Pregabalin Pfizer once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin Pfizer 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 Pfizer 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 Pfizer 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 Pregabalin Pfizer until your doctor tells you to stop.
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin Pfizer capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Pfizer than you should. Fits have also been reported.
It is important to take your Pregabalin Pfizer 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.
Do not stop taking Pregabalin Pfizer 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 Pfizer 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 Pfizer for a longer period of time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dizziness, drowsiness, headache.
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.
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, 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.
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).
Jaundice (yellowing of the skin and eyes).
Parkinsonism, that is symptoms resembling Parkinson’s disease; such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).
Liver failure.
Hepatitis (inflammation of the liver).
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.
The following adverse reaction has been reported in the postmarketing experience: Trouble breathing, shallow breaths.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
This medicine does not require any special storage conditions.
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.
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: lactose monohydrate, maize starch, talc, gelatine, titanium dioxide (E171), sodium laurilsulphate, anhydrous colloidal silica, black ink, (which contains shellac, black iron oxide (E172), propylene glycol, potassium hydroxide) and water.
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172).
What Pregabalin Pfizer looks like and contents of the pack | |
25 mg capsules | White hard capsules, with “Pfizer” marked on the cap and “PGN 25” on the body. |
50 mg capsules | White hard capsules, with “Pfizer” marked on the cap and “PGN 50”on the body. The capsule body is marked with a black band. |
75 mg capsules | White and orange hard capsules with “Pfizer” marked on the cap and “PGN 75” on the body. |
100 mg capsules | Orange hard capsules, with “Pfizer” marked on the cap and “PGN 100” on the body. |
150 mg capsules | White hard capsules, with “Pfizer” marked on the cap and “PGN 150” on the body. |
200 mg capsules | Light orange hard capsules, with “Pfizer” marked on the cap and “PGN 200” on the body. |
225 mg capsules | White and light orange hard capsules, with “Pfizer” marked on the cap and “PGN 225” on the body. |
300 mg capsules | White and orange hard capsules, with “Pfizer” marked on the cap and “PGN 300” on the body. |
Pregabalin Pfizer is available in seven pack sizes made of PVC with an aluminium foil backing: a
14 capsules pack containing 1 blister strip, a 21 capsules pack containing 1 blister strip, a 56 capsules pack containing 4 blister strips, a 84 capsules pack containing 4 blister strips, a 100 capsules pack containing 10 blister strips, a 112 capsules pack containing 8 blister strips and 100 x 1 capsules as perforated unit dose blisters.
In addition, Pregabalin Pfizer is available in an HDPE bottle containing 200 capsules for the 25 mg, 75 mg, 150 mg and 300 mg strengths.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands.
Manufacturer:
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg,
Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pfizer S.A. / N.V.
Tél/Tel: +32 (0)2 554 62 11
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 4333
Pfizer S.A.
Tél/Tel: +32 (0)2 554 62 11
Pfizer spol s.r.o.
Tel: +420-283-004-111
Pfizer Kft.
Tel. + 36 1 488 37 00
Viatris ApS
Tlf: +45 28 11 69 32
Vivian Corporation Ltd. Tel: +356 21344610
Pfizer OFG Germany GmbH Tel: +49 (0)800 5500634
Pfizer bv
Tel: +31 (0)10 406 4301
Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500
Pfizer AS
Tlf: +47 67 52 61 00
UPJOHN HELLAS ΕΠΕ
Τηλ.: +30 2100 100 002
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0
Viatris Pharmaceuticals, S.L. Tel: +34 900 102 712
Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
Viatris Santé
Tél: +33 (0)4 37 25 75 00
Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
Mylan Hrvatska d.o.o. Tel: + 385 1 23 50 599
Pfizer România S.R.L. Tel: +40 (0)21 207 28 00
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161
Pfizer Luxembourg SARL,
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400
Icepharma hf.
Sími: +354 540 8000
Pfizer Luxembourg SARL, organizačná zložka Tel: +421–2–3355 5500
Viatris Pharma S.r.l.
Tel: +39 02 612 46921
Viatris Oy
Puh./Tel: +358 20 720 9555
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100
Viatris AB
Tel: +46 (0)8 630 19 00
Pfizer Luxembourg SARL filiāle Latvijā Tel: +371 670 35 775
Pfizer Limited
Tel: +44 (0)1304 616161