Patient leaflet - PREGABALIN RANBAXY 300 MG CAPSULES HARD
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.
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.
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.
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 Ranbaxy 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 Ranbaxy 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 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 Pregabalin 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 Pregabalin 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 Pregabalin Ranbaxy; 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 Ranbaxy. If while taking Pregabalin 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 Pregabalin Ranbaxy have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
- When Pregabalin 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 any drug abuse or dependence. Do not take more medicine than prescribed.
- There have been reports of convulsions when
taking Pregabalin Ranbaxy or shortly after stopping Pregabalin Ranbaxy. If you experience a convulsion, contact your doctor immediately.
- There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin 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, Pregabalin Ranbaxy 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 Ranbaxy and certain other medicines may influence each other (interaction). When taken with certain other medicines, Pregabalin 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 Pregabalin Ranbaxy 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 Ranbaxy.
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.
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.
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.
Pregabalin Ranbaxy is for oral use only. 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 Ranbaxy 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 Ranbaxy 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 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 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)
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 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at : 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/PVCAl 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
PVCAl 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) 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
5” floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB34AZ
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 RANBAXY
25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg gelule
Germany: PREGABALIN BASICS 25 mg,
50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg Hartkapseln
Poland: Tabagine
Romania: Pregabalina Terapia 75 mg,
150 mg, 300 mg capsule
Spain: Pregabalina SUN 25 mg, 75 mg,
150 mg, 300 mg capsulas 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 January 2019.