What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0735.


Pregabalin Ranbaxy 50mg, 75mg, 100mg, 150mg, 225mg and 300mg Capsules, Hard

Package leaflet: Information for the patient

Pregabalin Ranbaxy 50 mg capsules, hard

Pregabalin Ranbaxy 75 mg capsules, hard

Pregabalin Ranbaxy 100 mg capsules, hard

Pregabalin Ranbaxy 150 mg capsules, hard

Pregabalin Ranbaxy 225 mg capsules, hard

Pregabalin 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 Pregabalin Ranbaxy is and what it is used for
2. What you need to know before you take Pregabalin Ranbaxy
3. How to take Pregabalin Ranbaxy
4. Possible side effects
5. How to store Pregabalin Ranbaxy
6. Contents of the pack and other information

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

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

Generalised Anxiety Disorder:

Pregabalin 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 Pregabalin Ranbaxy

Do not take Pregabalin Ranbaxy

  • 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 Ranbaxy.

  • 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 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.
  • 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 Ranbaxy

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 which have sedative effects (including opioids), pregabalin 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 is taken together with medicines containing:

  • Oxycodone – (used as a pain-killer)
  • Lorazepam – (used for treating anxiety)
  • Alcohol

Pregabalin Ranbaxy may be taken with oral contraceptives.

Pregabalin Ranbaxy with food, drink and alcohol

Pregabalin Ranbaxy capsules may be taken with or without food.

It is advised not to drink alcohol while taking pregabalin.

Pregnancy, breast-feeding and fertility

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.

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.

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.

Pregabalin Ranbaxy contains sodium and mannitol

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

Mannitol may have a mild laxative effect.

3. How to take Pregabalin Ranbaxy

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

Swallow the capsule whole with water.

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

If you take more Pregabalin Ranbaxy than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin Ranbaxy 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 Pregabalin Ranbaxy

It is important to take your Pregabalin 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 Pregabalin Ranbaxy

Do not stop taking Pregabalin 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 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 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 Pregabalin Ranbaxy and contact a doctor or go to the nearest hospital immediately, as you may need urgent medical attention.

  • Hypersensitivity (uncommon, may affect up to 1 in 100 people) and allergic reactions (which may include swollen face, swollen tongue, difficulty breathing, itchiness) (rare, may affect up to 1 in 1,000 people).
  • Serious skin reaction characterized by rash, blisters, peeling skin and pain (rare, may affect up to 1 in 1,000 people).
    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 with nausea and vomiting) (rare, may affect up to 1 in 1,000 people).

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, 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, spasm in neck
  • 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, abnormal uncontrolled movements of the limbs, 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, heart failure
  • Flushing, hot flushes
  • Difficulty breathing, dry nose, nasal congestion
  • Cough, 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, vision loss
  • Dilated pupils, cross eyes
  • Inflammation of the eyes (keratitis)
  • Cold sweat, tightness of the throat, swollen tongue
  • Difficulty in swallowing
  • Slow or reduced movement of the 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 behaviour
  • Jaundice (yellowing of the skin and eyes)

Very rare (may affect up to 1 in 10,000 people)

  • Liver failure
  • Inflammation of the liver (hepatitis)

The following adverse reaction has been reported in the post-marketing experience

  • Trouble breathing, shallow breaths

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pregabalin 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/bottle/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 should be used within 30 days
  • 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 Ranbaxy contains

The active substance is pregabalin.

Pregabalin Ranbaxy 50 mg: Each capsule, hard contains 50 mg of pregabalin.

Pregabalin Ranbaxy 75 mg: Each capsule, hard contains 75 mg of pregabalin.

Pregabalin Ranbaxy 100 mg: Each capsule, hard contains 100 mg of pregabalin.

Pregabalin Ranbaxy 150 mg: Each capsule, hard contains 150 mg of pregabalin.

Pregabalin Ranbaxy 225 mg: Each capsule, hard contains 225 mg of pregabalin.

Pregabalin Ranbaxy 300 mg: Each capsule, hard contains 300 mg of pregabalin.

The other excipients are:

Capsules content:

Mannitol, talc

Capsules shell:

Gelatin, titanium dioxide (E171), purified water, 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 Pregabalin 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 14.0-14.8 mm

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 15.3-16.3 mm.

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 17.0-18.2 mm.

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 '0' 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/Al/PVC//Al blister

For 50, 100, 150, 225 and 300 mg

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

For 75 mg

Pack sizes: 14, 21, 56, 70, 84, 98, 100 or 112 capsules, hard

PVC//Al blister

For 50, 100 and 225 mg:

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

For 75 mg

Pack sizes: 14, 21, 28, 56, 70, 84, 98, 100 or 112 capsules, hard

For 150 and 300mg

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

HDPE bottle with child resistance closure (PP)

For 50, 75, 100, 150, 225mg and 300 mg:

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
5th floor
Hyde Park
Hayes 3
11 Millington Road
Hayes
UB3 4AZ
United Kingdom

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Terapia SA
124 Fabricii Street
400 632 Cluj-Napoca
Romania

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

France: PREGABALINE SUN 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg gélule

Germany: PREGABALIN BASICS 25 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 225 mg, 250 mg, 275 mg, 300 mg Hartkapseln

Poland: Tabagine

Romania: Pregabalină Terapia 75 mg, 125 mg, 150 mg, 175 mg, 250 mg, 275 mg, 300 mg capsule

Spain: Pregabalina SUN 25 mg, 75 mg, 150 mg, 300 mg cápsulas duras EFG

The Netherlands: Pregabaline SUN 75 mg, 150 mg, 300 mg harde capsules

United Kingdom: Pregabalin Ranbaxy 50 mg, 75 mg, 100 mg, 150 mg, 225 mg, 300 mg Capsules, Hard

This leaflet was last revised in December 2020.