Package leaflet: Information for the user Pregabalin Lupin 25 mg hard capsules Pregabalin Lupin 50 mg hard capsules Pregabalin Lupin 75 mg hard capsules Pregabalin Lupin 100 mg hard capsules Pregabalin Lupin 150 mg hard capsules Preagbalin Lupin 200 mg hard capsules Pregabalin Lupin 225 mg hard capsules Pregabalin Lupin 300 mg hard capsules 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 further questions, ask your doctor or your 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 Pregabalin capsules are and what they are used for

2.    What you need to know before you take Pregabalin capsules

3.    How to take Pregabalin capsules

4.    Possible side effects

5.    How to store Pregabalin capsules

6.    Contents of the pack and other information

1. What Pregabalin capsules are and what they are used for

Pregabalin capsules belong to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.

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

Generalised Anxiety Disorder: Pregabalin capsules are 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, and 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 capsules

Do not take Pregabalin capsules

If you are allergic to pregabalin or any of the other ingredients

of this medicine (listed in section 6).

Warnings and Precautions

•    Some patients taking Pregabalin capsules 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 capsules 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 capsules 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 capsules; 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 capsules. If while taking Pregabalin capsules you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.

•    A small number of people being treated with antiepileptics such as Pregabalin capsules have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

•    When Pregabalin capsules are 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 abuse or dependence. Do not take more medicine than prescribed.

•    There have been reports of convulsions when taking Pregabalin capsules or shortly after stopping Pregabalin capsules. If you experience a convulsion, contact your doctor immediately.

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

Other medicines and Pregabalin capsules

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

Pregabalin capsules and certain other medicines may influence each other (interact). When taken with certain other medicines, Pregabalin capsules 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 Pregabalin capsules are taken together with medicinal products containing:

Oxycodone - (used as a pain-killer)

Lorazepam - (used for treating anxiety)

Alcohol

Pregabalin capsules may be taken with oral contraceptives.

Pregabalin capsules with food, drink and alcohol

Pregabalin capsules may be taken with or without food.

It is advisable not to drink alcohol while taking Pregabalin capsules.

Pregnancy and breast-feeding

Pregabalin capsules 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 capsules 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 Pregabalin capsules

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 capsules are for oral use only.

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

If you take more Pregabalin capsules than you should

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

If you forget to take Pregabalin capsules

It is important to take your Pregabalin 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 capsules

Do not stop taking Pregabalin capsules 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 capsules 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 capsules 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 side-effects which may affect more than 1 person in 10 are listed below:

Dizziness, drowsiness, headache

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

•    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 side-effects which may affect more than 1 person in 1000 are listed below:

•    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, 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, 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 side-effects which may affect less than 1 person in

1000 are listed below:

•    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 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.

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

Reporting of side effects

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 Yellow Card Scheme, website: 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 Pregabalin capsules

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.

Store below 25 °C.

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 to protect the environment.

6.    Contents of the pack and other information What Pregabalin capsules 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 pregabalin.

The other ingredients are:

pregelatinised starch, talc, gelatine, titanium dioxide (E171), sodium lauryl sulphate, black ink, (which contains shellac (E904) and black iron oxide (E172)).

The 75, 100, 200, 225 and 300 mg capsules also contain red iron oxide (El72).

Pregabalin capsules are available in PVC and aluminium foil blisters in the following pack sizes:

25mg:    1,    14, 20, 21,    50, 56, 60, 84, 100    capsules

50mg:    1,    14, 20, 21,    50, 56, 60, 84, 100    capsules

75mg:    1,    14, 20, 21,    50, 56, 60, 84, 100,    112 capsules

lOOmg: 1, 14, 20, 21, 50, 56, 60, 84, 100 capsules 150mg: 1, 14, 20, 21, 50, 56, 60, 84, 98, 100, 112, 168 capsules

200mg: 1, 14, 20, 21, 50, 56, 60, 84, 100 capsules 225mg: 1, 14, 20, 21, 50, 56, 60, 84, 100 capsules 300mg: 1, 14, 20, 21, 50, 56, 60, 84, 100, 112, 168 capsules

In addition, Pregabalin capsules are available in an HDPE bottle containing 200 capsules for the 75, 150 and 300 mg strengths.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Limited, Victoria Court, Bexton Road, Knutsford, Cheshire, WA16 0PF, United Kingdom

This leaflet was last revised in August 2015

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