Pregabalin Mylan - patient leaflet, side effects, dosage

- 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 Mylan is and what it is used for

• 2. What you need to know before you take Pregabalin Mylan

• 3. How to take Pregabalin Mylan

• 4. Possible side effects

• 5. How to store Pregabalin Mylan

• 6. Contents of the pack and other information

1. What Pregabalin Mylan is and what it is used for

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.

Peripheral and central neuropathic pain: Pregabalin Mylan 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: Pregabalin Mylan is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Mylan for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Mylan in addition to your current treatment. Pregabalin Mylan is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: Pregabalin Mylan 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 Mylan

Do not take Pregabalin Mylan

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 Mylan.

• 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.

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 Mylan

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 with food, drink and alcohol

Pregabalin Mylan capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Mylan.

Pregnancy and breast-feeding

Pregabalin Mylan 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 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’

3. How to take Pregabalin Mylan

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.

Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:

• 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.

If you take more Pregabalin Mylan than you should

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.

If you forget to take Pregabalin Mylan

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.

If you stop taking Pregabalin Mylan

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, flulike 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.

4. Possible side effects

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

Very common: may affect more than 1 in 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 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 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

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)
• 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).

Very rare: may affecr up to 1 in 10,000 people

• Liver failure.
• Hepatitis (inflammation of the liver).

5. How to store Pregabalin Mylan

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.

6. Contents of the pack and other information

What Pregabalin Mylan contains

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).

What Pregabalin Mylan looks like and contents of the pack

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 × 1, 84 × 1, 100 × 1 capsules.
Pregabalin Mylan 50 mg	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.
hard capsule	Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 84 × 1, 100 × 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 × 1, 56 × 1, 100 × 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 × 1, 100 × 1 capsules.
Pregabalin Mylan	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.
150 mg hard capsule	Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 × 1, 56 × 1, 100 × 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 × 1, 100 × 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 × 1, 100 × 1 capsules.
Pregabalin Mylan	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.
300 mg hard capsule	Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 56 × 1, 100 × 1 capsules and in bottles containing 200 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturer

Mylan Hungary Kft, Mylan utca 1, Komarom, 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

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

België/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00

Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288

E'b.iiapiiH

MauaaH EOOfl, Tea.: +359 2 44 55 400

Luxembourg/Lu­xemburg

Mylan bvba/sprl

Tel: + 32 (0) 2 658 61 00 (Belgique/Belgien)

Česká republika

Mylan Healthcare CZ s.r.o.

Tel: +420 222 004 400

Danmark Viatris ApS Tlf: +45 28 11 69 32 Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800 Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: +372 6363 052 EZZàôa Generics Pharma Hellas EnE TnÀ: +30 210 993 6410 España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712 France Mylan S.A.S Tel: +33 4 37 25 75 00 Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599 Ireland Mylan Ireland Limited Tel: +353 1 8711600 Ísland Icepharma hf Sími: +354 540 8000 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46921

Malta V.J. Salomone Pharma Ltd. Tel: + 356 21 22 01 74 Nederland Mylan BV Tel: + 31 (0)20 426 3300 Norge Viatris AS Tel: + 47 66 75 33 00 Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418 Polska Mylan Healthcare Sp. z.o.o. Tel: + 48 22 546 64 00 Portugal Mylan, Lda. Tel: + 351 21 412 72 56 Romania BGP Products SRL Tel: +40 372 579 000 Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180 Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100 Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9555

Kùnpoç

Varnavas Hadjipanayis Ltd

TnÀ: +357 2220 7700

United Kingdom (Northern Ireland)

Mylan IRE Healthcare Limited

Tel: +353 18711600

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

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