Pregabalin 75 mg Capsules

Main information

  • Trade name:
  • Pregabalin 75 mg Capsules, Hard
  • Dosage:
  • 75 milligram(s)
  • Pharmaceutical form:
  • Capsule, hard
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pregabalin 75 mg Capsules, Hard
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Other antiepileptics; pregabalin

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA1240/022/003
  • Authorization date:
  • 04-08-2017
  • Last update:
  • 21-04-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Page 1 of 10

Package leaflet: Information for the patient

Pregabalin 25 mg capsules, hard

Pregabalin 50 mg capsules, hard

Pregabalin 75 mg capsules, hard

Pregabalin 100 mg capsules, hard

Pregabalin 150 mg capsules, hard

Pregabalin 200 mg capsules, hard

Pregabalin 225 mg capsules, hard

Pregabalin 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

What this medicine is and what it is used for

What you need to know before you take this medicine

How to take this medicine

Possible side effects

How to store this medicine

Contents of the pack and other information

1.

What this medicine is and what it is used for

Pregabalin 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 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

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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 is used to treat a certain form of epilepsy (partial seizures with or

without secondary generalisation) in adults. Your doctor will prescribe Pregabalin for

you to help treat your epilepsy when your current treatment is not controlling your

condition. You should take Pregabalin in addition to your current treatment. Pregabalin

is not intended to be used alone, but should always be used in combination with other

anti-epileptic treatment.

Generalised Anxiety Disorder: Pregabalin 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 this medicine

Do not take this medicine:

if you are allergic to the active substance or any of the other ingredients of this

medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

Some patients taking Pregabalin 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 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 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

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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; 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. If while taking Pregabalin 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

have had thoughts of harming or killing themselves. If at any time you have

these thoughts, immediately contact your doctor.

When Pregabalin 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 or shortly after

stopping Pregabalin. If you experience a convulsion, contact your doctor

immediately.

There have been reports of reduction in brain function (encephalopathy) in some

patients taking Pregabalin 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.

Taking other medicines

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

other medicines.

Pregabalin and certain other medicines may influence each other (interaction). When

taken with certain other medicines, Pregabalin may potentiate the side effects seen with

these medicines, including respiratory failure and coma. The degree of dizziness,

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sleepiness and decreased concentration may be increased if Pregabalin is taken together

with medicinal products containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin may be taken with oral contraceptives.

Taking this medicine with food, drink and alcohol

Pregabalin capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin.

Pregnancy and breast-feeding

Pregabalin 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 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 this medicine

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 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 either twice or three times a day.

For twice a day take Pregabalin once in the morning and once in the evening, at

about the same time each day. For three times a day take Pregabalin once in the

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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 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

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 until your doctor tells you to stop.

If you take more of this medicine 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 than you should. Fits have also been

reported

If you forget to take this medicine

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 this medicine

Do not stop taking Pregabalin 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 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 for a longer period of time.

If you have any further questions on the use of this medicine, ask your doctor,

pharmacist or nurse.

4.

Possible side effects

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

them.

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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.

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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, neutropaenia, 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.

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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. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353

1 6762517, Website: www.hpra.ie, email: medsafety@hpra.ie for Ireland.. By reporting

side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date refers to the last day of that month.

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 this medicine contains

The active substance is Pregabalin. Each hard capsule contains 25 mg, 50 mg, 75

mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.

The other ingredients are mannitol, maize starch, talc. The capsule shell contains

gelatin, titanium dioxide (E171). In addition, 75mg, 100mg, 200mg, 225mg and

300mg capsules contain iron oxide red (E172). The printing ink composition is

shellac (E904), propylene glycol (E1520), strong ammonia solution (E527), black iron

oxide (E172), potassium hydroxide (E525).

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What this medicine looks like and contents of the pack

25 mg capsules: White cap / White body size ‘4’ hard gelatin capsules imprinted

with ‘138’ on cap and ‘J’ on body with black ink, filled with white to off white

powder.

50 mg capsules: White cap / White body size ‘4’ hard gelatin capsules imprinted

with ‘139’ on cap and ‘J’ on body with black ink, filled with white to off white

powder.

75 mg capsules: Orange cap / White body size ‘4’ hard gelatin capsules imprinted

with ‘140’ on cap and ‘J’ on body with black ink, filled with white to off white

powder.

100 mg capsules: Orange cap / Orange body size ‘3’ hard gelatin capsules imprinted

with ‘141’ on cap and ‘J’ on body with black ink, filled with white to off white

powder.

150 mg capsules: White cap / White body size ‘2’ hard gelatin capsules imprinted

with ‘142’ on cap and ‘J’ on body with black ink, filled with white to off white

powder.

200 mg capsules: Orange cap / Orange body size ‘1’ hard gelatin capsules imprinted

with ‘143’ on cap and ‘J’ on body with black ink, filled with white to off white

powder.

225 mg capsules: Light orange cap / White body size ‘1’ hard gelatin capsules

imprinted with ‘144’ on cap and ‘J’ on body with black ink, filled with white to off

white powder.

300 mg capsules: Orange cap / White body size ‘0’ hard gelatin capsules imprinted

with ‘145’ on cap and ‘J’ on body with black ink, filled with white to off white

powder.

This medicine is available in blister packs containing 14, 21, 56, 70, 84, 100 or 112

capsules. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd,

Unit 3, Canalside,

Northbridge Road

Berkhamsted

HP4 1EG, UK

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

Email: info@bristol-labs.co.uk

Manufacturer

Bristol Laboratories Limited, Unit 5, Traynor way, Peterlee, SR8 2RU

Page 10 of 10

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

following names:

UK: Pregabalin Bristol Labs 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg , 225 mg

capsules, hard

NL: Pregabaline Bristol Labs 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg , 225 mg

harde capsules

Pregabalin axcount 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg , 225 mg

Hartkapseln

This leaflet was last revised in June 2017

To request a copy of this leaflet in Braille, large print or audio format then please

contact the marketing authorisation holder at the address (or telephone, fax, email)

above.