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 Pregablin Ranbaxy 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. Serious side effects:

If any of the following happen, stop taking Pregablin Ranbaxy and contact a doctor or go to the nearest hospital immediately, as you may need urgent medical attention.

•    Hypersensitivity and allergic reactions (which may include swollen face, swollen tongue, difficulty breathing, itchiness)

•    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.

•    Inflammation of the pancreas (which includes symptoms such as severe upper stomach pain, often withnauseaand vomiting)

Other side effects:

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, changes 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 withbalance, fall

•    Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea

•    Difficulties with erection

•    Swelling of the body including extremities

•    Swollen abdomen

•    Feeling drunk, abnormal style of walking

•    Weight gain

•    Sore throat

•    Muscle cramp, joint pain, back pain, pain in limb, spasm in neck

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, elevated mood, aggression, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation, mental impairment, difficulty with thinking

•    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, loss of consciousness, fainting, increased sensitivity to noise, feelingunwell

•    Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, tunnel vision, flashes of light, eye irritation

•    Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, heart failure

•    Flushing, hot flushes

•    Difficulty breathing, dry nose

•    Cough, nasal congestion, swollen face, hives, itchiness, runny nose, nose bleed, snoring

•    Increased saliva production, heartburn, numb around mouth

•    Sweating, rash, chills, fever

•    Coldness of hands and feet

•    Muscle twitching,joint swelling, muscle stiffness, pain including muscle pain, neck pain

•    Difficulty with or painful urination, incontinence

•    Weakness, thirst, chest tightness

•    Breast pain

•    Painful menstrual periods

•    Generalised swelling

•    Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased, aspartate aminotransferase increased, platelet count decreased, decrease in blood potassium, increase in blood creatinine, neutropenia).

Rare: may affect up to 1 in 1,000 people

•    Changes in heart beat

•    Abnormal sense of smell, changes in vision including swinging vision, altered perception of depth, visual brightness, visionloss

•    Dilated pupils, cross eyes

•    Inflammation of the eyes (keratitis)

•    Cold sweat, tightness of the throat, swollen tongue

•    Difficulty in swallowing

•    Slow orreducedmovementofthe body

•    Difficulty with writing properly

•    Fluid in the lungs

•    Convulsions

•    Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances

•    Increased fluid in the abdomen

•    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 behavior.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. 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 Pregablin Ranbaxy

•    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 blister/carton. The expiry date refers to the last day of that month.

•    This medicine does not require any special storage conditions

•    Bottle: Once the bottle is opened the capsules shouldbeusedwithin30days

•    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 Pregablin Ranbaxy contains

The active substance is pregabalin.

Pregablin Ranbaxy 50 mg: Each capsule, hard contains 50 mg of pregablin.

Pregablin Ranbaxy 75 mg: Each capsule, hard contains 75 mg ofpregablin.

Pregablin Ranbaxy 100 mg: Each capsule, hard contains 100 mg ofpregablin.

Pregablin Ranbaxy 150 mg: Each capsule, hard contains 150 mg ofpregablin.

Pregablin Ranbaxy 225 mg: Each capsule, hard contains 225 mg ofpregablin.

Pregablin Ranbaxy 300 mg: Each capsule, hard contains 300 mg ofpregablin.

The other excipients are Capsules content:

Mannitol, talc

Capsules shell:

Gelatin, titanium dioxide (E171), sodium lauryl sulphate

only For 75 mg, 100 mg, 225 mg and 300 mg, Iron oxide red (E172)

Printing Ink:

Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide

What Pregablin Ranbaxy looks like and contents of the pack

50 mg capsules: Hard gelatin capsules of size '2' with white opaque cap and white opaque body imprinted with black ink 'rbx' with band on cap and 'PG50' with band on body containing white to off white powder. The length of the capsule is approximately 17.0-18.2 mm.

75 mg capsules: Hard gelatin capsules of size '4' with red opaque cap and white opaque body imprinted with black ink 'rbx' on cap and 'PG75' on body containing white to off white powder. The length of the capsule is approximately 14.0-14.8mm 100 mg capsules: Hard gelatin capsules of size '3' with red opaque cap and red opaque body imprinted with black ink 'rbx' on cap and 'PG100' on body containing white to off white powder. The length of the capsule is approximately 15.3-16.3mm.

150 mg capsules: Hard gelatin capsules of size '2' with white opaque cap and white opaque body imprinted with black ink 'rbx' on cap and 'PG150' on body containing white to off white powder. The length of the capsule is approximately 17.0-18.2mm.

225 mg capsules: Hard gelatin capsules of size '1' with red opaque cap and white opaque body imprinted with black ink 'rbx' on cap and 'PG225' on body containing white to off white powder. The length of the capsule is approximately 18.6-19.7 mm.

300 mg capsules: Hard gelatin capsules of size 'O' with red opaque cap and white opaque body imprinted with black ink 'rbx' on cap and 'PG300' on body containing white to off white powder. The length of the capsule is approximately 21.0-21.8 mm.

OPA/A1/PVC//A1 blister

Pack sizes: 14, 21, 56, 84, 98 100 or 112

capsules, hard

PVC//A1 blister

For25, 50,100and225mg:

Pack sizes: 14, 21, 56, 84, 98, 100 or 112 capsules, hard.

For75,150and300mg

Pack sizes: 14, 21, 28, 56, 84, 98, 100 or 112

capsules, hard.

HDPE bottle with child resistance closure (PP).

Pack sizes: 14, 21, 30, 56, 84, 98, 100 or 112 capsules, hard

HDPE bottle with screw cap (PP).

Pack size: 500 capsules, hard

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Ranbaxy (UK) Limited Building 4, Chiswick Park,

566 Chiswick High Road,

London, W4 5YE

Manufacturer Ranbaxy Ireland Limited Spafield, Cork Road,

Cashel, Co-Tipperary,

Republic of Ireland

Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany

Terapia SA 124 Fabrici Street,

400 632 Cluj Napoca Romania

This leaflet was last revised in 08/2015.

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Package Leaflet: Information for the user

Pregablin Ranbaxy 50 mg capsules, hard Pregablin Ranbaxy 75 mg capsules, hard Pregablin Ranbaxy 100 mg capsules, hard Pregablin Ranbaxy 150 mg capsules, hard Pregablin Ranbaxy 225 mg capsules, hard Pregablin Ranbaxy 300 mg capsules, hard 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 Pregablin Ranbaxy is and what it is used for

2.    What you need to know before you take Pregablin Ranbaxy

3.    How to take Pregablin Ranbaxy

4.    Possible side effects

5.    How to store Pregablin Ranbaxy

6.    Contents of the pack and other information

1.    What Pregablin Ranbaxy is and what it is used for

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

Epilepsy:

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

Peripheral and central neuropathic pain:

Pregabalin 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 andneedles. 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.

Generalised Anxiety Disorder:

Pregablin Ranbaxy 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 Pregablin Ranbaxy

Do not take Pregablin Ranbaxy

- if you are allergic to pregablin or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

•    Some patients taking Pregablin Ranbaxy have reported symptoms suggesting an allergic reaction. These symptoms include swelling ofthe face, lips, tongue, and throat, as well as diffuse skin rash. Should you experience any of these reactions, you should contact your physician immediately.

•    Pregablin Ranbaxy has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in older patients. Therefore, you should be careful until you are used to any effect the medicine might have.

•    Pregablin Ranbaxy 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 Pregablin Ranbaxy 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 Pregablin Ranbaxy and the severity of these effects may be increased when taken together.

•    There have been reports of heart failure in some patients when taking Pregablin Ranbaxy; these patients were mostly older with cardiovascular conditions. Before taking this medicine you should tell your doctor if youhave a history of heart disease.

•    There have been reports of kidney failure in some patients when taking Pregablin Ranbaxy. If while taking Pregablin Ranbaxy 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 Pregablin Ranbaxy have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

•    When Pregablin Ranbaxy 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 Pregablin Ranbaxy or shortly after stopping Pregablin Ranbaxy. If you experience a convulsion, contact your doctor immediately.

•    There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregablin Ranbaxy 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, Pregablin Ranbaxy should not be used in this age group.

Other medicines and Pregablin Ranbaxy

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

•    Oxycodone - (used as a pain-killer)

•    Lorazepam - (used for treating anxiety)

•    Alcohol

Pregablin Ranbaxy may be taken with oral contraceptives.

Pregablin Ranbaxy with food, drink and alcohol

It is advised not to drink alcohol while taking Pregablin Ranbaxy.

Pregnancy, breast-feeding and fertility

Pregablin Ranbaxy 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

Pregablin Ranbaxy 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.

3. How to take Pregablin Ranbaxy

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.

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 Pregablin Ranbaxy either twice or three times a day. For twice a day take Pregablin Ranbaxy once in the morning and once in the evening, at about the same time each day. For three times a day take Pregablin Ranbaxy 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 Pregablin Ranbaxy 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 Pregablin Ranbaxy 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.

Pregablin Ranbaxy is for oral use only. Swallow the capsule whole with water. Pregablin Ranbaxy capsules may be taken with or without food.

Continue taking Pregablin Ranbaxy until your doctor tells you to stop.

If you take more Pregablin Ranbaxy than you should

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

If you forget to take Pregablin Ranbaxy

It is important to take your Pregablin Ranbaxy 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 Pregablin Ranbaxy

Do not stop taking Pregablin Ranbaxy 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 Pregablin Ranbaxy treatment, you need to know that you may experience certain side effects. These include, trouble sleeping, headache, nausea,