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Package Leaflet: Information for the user

Pregabalin Milpharm 25 mg capsules, hard Pregabalin Milpharm 50 mg capsules, hard Pregabalin Milpharm 75 mg capsules, hard Pregabalin Milpharm 100 mg capsules, hard Pregabalin Milpharm 150 mg capsules, hard Pregabalin Milpharm 200 mg capsules, hard Pregabalin Milpharm 225 mg capsules, hard Pregabalin Milpharm 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 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 Milpharm is and what it is used for

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

3.    How to take Pregabalin Milpharm

4.    Possible side effects

5.    How to store Pregabalin Milpharm

6.    Contents of the pack and other information

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

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

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

Generalised Anxiety Disorder: Pregabalin Milpharm is used to treat Generalised Anxiety Disorder(GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control.GAD canalso 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 Milpharm

Do not take Pregabalin Milpharm

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 Milpharm

•    Some patients taking Pregabalin Milpharm 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 Milpharm 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 Milpharm 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 cordinjury 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 Milpharm; 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 Milpharm. If while taking Pregabalin Milpharm 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 Milpharm have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact yourdoctor.

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

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

•    There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Milpharm 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 Milpharm

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

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

Oxycodone - (used as a pain-killer)

Lorazepam - (used for treating anxiety)

Alcohol

Pregabalin Milpharm may be taken with oral contraceptives.

Pregabalin Milpharm with food, drink and alcohol

Pregabalin Milpharm capsules may be taken with or without food.

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

Pregnancy, breast-feeding and fertility

Pregabalin Milpharm should not be taken during pregnancy or when breastfeeding, unless you are told other wise 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 Milpharm 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 Milpharm

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 Milpharm is 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 Milpharm either twice or three times a day. For twice a day take Pregabalin Milpharm once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin Milpharm once in the morning, once in the afternoon and once in the evening, atabout the same time each day.

If you have the impression that the effect of Pregabalin Milpharm 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 Milpharm 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 Milpharm until your doctor tells you to stop.

If you take more Pregabalin Milpharm than you should

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

If you forget to take Pregabalin Milpharm

It is important to take your Pregabalin Milpharm 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 Milpharm

Do not stop taking Pregabalin Milpharm unless your doctor tells you to. If your treatment is stopped it should bedone gradually over a minimum of 1 week.

After stopping long and short-term Pregabalin Milpharm 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 Milpharm 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 may affect more than 1 in 10 people:

Dizziness, drowsiness, headache

Common side-effects may affect upto 1 in 10 people:

•    Increased appetite

•    Feeling of eiation, 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 may affect upto 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 creatine, 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 may affect upto 1 in 1000 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).

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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

The United Kingdom

Yellow Card Scheme Website:www.mhra.gov.uk/yellowcard

5. How to store Pregabalin Milpharm

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 label,carton or bottle after EXP.The expiry daterefers to the last day of that month.

This medicinal product 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 to protect the environment.

Each capsule, hard contains 200 mg of pregabalin.

Each capsule, hard contains 225 mg of pregabalin.

Each capsule, hard contains 300 mg of pregabalin.

The other ingredients are:

Capsules content: Maize starch, talc

Capsules shell: Titanium dioxide (E171), gelatin, sodium lauryl sulfate, iron oxide red (E 172) (For 75 mg, 100 mg, 200 mg, 225 mg and 300 mg)

Printing Ink: Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

What Pregabalin Milpharm looks like and contents of the pack

Capsule, hard.

Pregabalin Milpharm 25 mg capsules, hard

White cap/white body, size “5” hard gelatin capsule shells, imprinted with 'Z' on cap and '10' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 50 mg capsules, hard

White cap/white body, size “4” hard gelatin capsule shells, imprinted with 'Z' on cap and '11' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 75 mg capsules, hard

Orange cap/white body, size “4” hard gelatin capsule shells, imprinted with 'Z' on cap and '12' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 100 mg capsules, hard

Orange cap/Orange body, size “3” hard gelatin capsule shells, imprinted with 'Z' on cap and '13' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 150 mg capsules, hard

White cap/white body, size “2” hard gelatin capsule shells, imprinted with 'Z' on cap and '14' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 200 mg capsules, hard

Light orange cap/ Light orange body, size “1” hard gelatin capsule shells, imprinted with 'Z' on cap and '15' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 225 mg capsules, hard

Light orange cap/ White body, size “1” hard gelatin capsule shells, imprinted with 'Z' on cap and '16' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 300 mg capsules, hard

Orange cap/ White body, size “0” hard gelatin capsule shells, imprinted with 'Z' on cap and '17' on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm hard capsules are available in clear PVC/ Aluminium blisters pack and whiteopaque HDPE bottles with polypropylene closure.

Pack sizes:

Blister packs: 14, 21, 30, 56, 60, 84, 90, 100, 112 and 200 capsules, hard HDPE Bottle packs:

50 mg, 75 mg, 150 mg, 200 mg, 225 mg: 30, 200, 250 and 500 capsules, hard 25 mg, 100 mg, 300 mg: 30, 200, 250 and 500 capsules, hard

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta or

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium:

Bulgaria:

Germany:

Ireland:

The Netherlands:

Portugal:

Romania:

Spain:

The United Kingdom:

This leaflet was last revised in 07/2015.

6. Contents of the pack and other information

What Pregabalin Milpharm contains

The active substance is pregabalin.

Each capsule, hard contains 25 mg of pregabalin. Each capsule, hard contains 50 mg of pregabalin. Each capsule, hard contains 75 mg of pregabalin. Each capsule, hard contains 100 mg of pregabalin. Each capsule, hard contains 150 mg of pregabalin.