Pregabalin Mylan
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 Mylan is and what it is used for
What you need to know before you take Pregabalin Mylan
How to take Pregabalin Mylan
Possible side effects
How to store Pregabalin Mylan
Contents of the pack and other information
Pregabalin Mylan contains the active substance pregabalin which 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 Mylan.
Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis have been reported in association with pregabalin. Stop using pregabalin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Some patients taking Pregabalin Mylan 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 Mylan 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 Mylan 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 Mylan; 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 Mylan. If while taking Pregabalin Mylan 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 Mylan have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
When Pregabalin Mylan 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 Mylan or shortly after stopping Pregabalin Mylan. If you experience a convulsion, contact your doctor immediately.
There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Mylan 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 Mylan and certain other medicines may influence each other (interaction). When taken with certain other medicines, which have sedative effects (including opioids), Pregabalin Mylan 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 Mylan is taken together with medicinal products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin Mylan may be taken with oral contraceptives.
Pregabalin Mylan capsules may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin Mylan.
Pregabalin Mylan 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 Mylan 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.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per capsule. That is to say essentially ‘sodium-free’
Always take this medicine exactly as your doctor or pharmacist 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 Mylan 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 Mylan either twice or three times a day. For twice a day take Pregabalin Mylan once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin Mylan 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 Mylan is too strong or too weak, talk to your doctor or pharmacist.
If you are an older patient (over 65 years of age), you should take Pregabalin Mylan 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 Mylan 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 Mylan capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Mylan than you should. Fits have also been reported.
It is important to take your Pregabalin Mylan 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 Mylan 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 Mylan 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 Mylan 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 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 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 aminotransferase 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
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 characterised by reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
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 side effects were 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 and blister after EXP. The expiry date refers to the last day of that month.
Blister: Store in the original package in order to protect from moisture. Bottle: Keep the bottle tightly closed in order to protect from moisture.
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 of pregabalin.
The other ingredients are: hydroxylpropylcellulose, maize starch, talc, gelatin, titanium dioxide (E171), sodium laurilsulfate, purified water, shellac, black iron oxide (E172), propylene glycol, potassium hydroxide and concentrated ammonia solution, yellow iron oxide (E172) and erythrosine (E127).
Hard capsule.
Pregabalin Mylan 25 mg hard capsule | Light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB25 in black ink on cap and body. Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 84 x 1, 100 x 1 capsules. |
Pregabalin Mylan 50 mg hard capsule | Dark peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB50 in black ink on cap and body. Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules. |
Pregabalin Mylan 75 mg hard capsule | Light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB75 in black ink on cap and body. Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules. |
Pregabalin Mylan 100 mg hard capsule | Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB100 in black ink on cap and body. Available in blister packs containing 21, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules. |
Pregabalin Mylan 150 mg hard capsule | Light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB150 in black ink on cap and body. Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules. |
Pregabalin Mylan 200 mg hard capsule | Light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB200 in black ink on cap and body. Available in blister packs containing 21, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules. |
Pregabalin Mylan 225 mg hard capsule | Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB225 in black ink on cap and body. Available in blister packs containing 14, 56, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules. |
Pregabalin Mylan 300 mg hard capsule | Light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB300 in black ink on cap and body. Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules. |
Not all pack sizes may be marketed.
DUBLIN
Ireland
Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary
McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg
v. d. Hoehe, Hessen, 61352, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Mylan bvba/sprl
Tél/Tel: + 32 (0)2 658 61 00
Mylan Healthcare UAB Tel: +370 5 205 1288
Майлан ЕООД
Teл.: +359 2 44 55 400
Mylan bvba/sprl
Tel: + 32 (0) 2 658 61 00
(Belgique/Belgien)
Mylan Healthcare CZ s.r.o. Tel: +420 222 004 400
Mylan EPD Kft
Tel: + 36 1 465 2100
Viatris ApS
Tlf: +45 28 11 69 32
V.J. Salomone Pharma Ltd. Tel: + 356 21 22 01 74
Mylan Healthcare GmbH Tel: +49 800 0700 800
Mylan BV
Tel: + 31 (0)20 426 3300
BGP Products Switzerland GmbH Eesti filiaal
Tel: +372 6363 052
Viatris AS
Tel: + 47 66 75 33 00
Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 993 6410
Arcana Arzneimittel GmbH Tel: +43 1 416 2418
Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 712
Mylan Healthcare Sp. z.o.o. Tel: + 48 22 546 64 00
Mylan S.A.S
Tel: +33 4 37 25 75 00
Mylan, Lda.
Tel: + 351 21 412 72 56
Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599
BGP Products SRL Tel: +40 372 579 000
Mylan Ireland Limited Tel: +353 1 8711600
Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
Icepharma hf
Sími: +354 540 8000
Mylan Italia S.r.l.
Tel: + 39 02 612 46921
Viatris Oy
Puh/Tel: +358 20 720 9555
Varnavas Hadjipanayis Ltd
Τηλ: +357 2220 7700
Viatris AB
Tel: + 46 (0)8 630 19 00
Mylan Healthcare SIA Tel: +371 676 055 80
Mylan IRE Healthcare Limited Tel: +353 18711600