Patient leaflet - Pregabalin Jubilant 75 mg capsules hard
1. What Pregabalin Jubilant is and what it is used for
Pregabalin Jubilant 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 Jubilant 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 Jubilant is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Jubilant for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Jubilant in addition to your current treatment. Pregabalin Jubilant is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin Jubilant 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 Jubilant
Do not take Pregabalin Jubilant:
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 Jubilant:
- Some patients taking Pregabalin Jubilant 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.
- Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pregabalin. Stop using pregabalin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
- Pregabalin Jubilant 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 Jubilant 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 Jubilant; 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 Jubilant. If while taking Pregabalin Jubilant 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 Jubilant have had thoughts of harming or killing themselves or shown suicidal behaviour. If at any time you have these thoughts or shown such behaviour, immediately contact your doctor.
- When Pregabalin Jubilant 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, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you may have a greater risk of becoming dependent on Pregabalin Jubilant.
There have been reports of convulsions when taking Pregabalin Jubilant or shortly after stopping
Pregabalin Jubilant. If you experience a convulsion, contact your doctor immediately.
There have been reports of reduction in brain function (encephalopathy) in some patients taking
Pregabalin Jubilant 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.
Dependence
Some people may become dependent on Pregabalin Jubilant (a need to keep taking the medicine). They may have withdrawal effects when they stop using Pregabalin Jubilant (see section 3, “How to take Pregabalin Jubilant” and “If you stop taking Pregabalin Jubilant”). If you have concerns that you may become dependent
on Pregabalin Jubilant, it is important that you consult your doctor.
If you notice any of the following signs whilst taking Pregabalin Jubilant, it could be a sign that you have become dependent:
- You need to take the medicine for longer than advised by your prescriber
- You feel you need to take more than the recommended dose
- You are using the medicine for reasons other than prescribed
- You have made repeated, unsuccessful attempts to quit or control the use of the medicine
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
If you notice any of these, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.
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 Jubilant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregabalin Jubilant and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids Pregabalin Jubilant may potentiate the side effects and could lead to respiratory failure coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Jubilant is taken together with medicines containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin Jubilant may be taken with oral contraceptives.
Pregabalin Jubilant with food, drink and alcohol
Pregabalin Jubilant capsules may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin Jubilant.
Pregnancy and breast-feeding
Pregabalin Jubilant should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. Pregabalin use during the first 3 months of pregnancy may cause birth defects in the unborn child that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin in the first 3 months of pregnancy, 6 babies in every 100 had such birth defects. This compares to 4 babies in every 100 born to women not treated with pregabalin in the study. Abnormalities of the face (orofacial clefts), the eyes, the nervous system (including the brain), kidneys and genitals have been reported.
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 Jubilant 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 Jubilant contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Pregabalin Jubilant contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’
3. How to take Pregabalin Jubilant
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed.
Your doctor will determine what dose is appropriate for you.
Pregabalin Jubilant 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 Jubilant either twice or three times a day. For twice a day take Pregabalin Jubilant once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin Jubilant 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 Jubilant 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 Jubilant 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 Jubilant until your doctor tells you to stop.
If you take more Pregabalin Jubilant than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin Jubilant capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Jubilant than you should. Fits and unconsciousness (coma) have also been reported.
If you forget to take Pregabalin Jubilant
It is important to take your Pregabalin Jubilant 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 Jubilant
Do not suddenly stop taking Pregabalin Jubilant. If you want to stop taking Pregabalin Jubilant, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually over a minimum of 1 week.
After stopping a short or long-term treatment with Pregabalin Jubilant, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu like symptoms, convulsions, nervousness, depression,
thoughts of harming or killing yourself pain, sweating, and dizziness. These effects may occur more commonly or severely if you have been taking Pregabalin Jubilant for a longer period of time. If you experience withdrawal effects, you should contact your doctor.
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: 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 attack, 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 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, suicidal behaviour, suicidal thoughts.
- Allergic reactions which may include difficulty breathing, inflammation of the eyes (keratitis) and serious skin reactions characterized by reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Jaundice (yellowing of the skin and eyes).
Parkinsonism, that is symptoms resembling Parkinson’s disease; such as tremor, bradykinesia
(decreased ability to move), and rigidity (muscle stiffness).
Very rare: may affect up to 1 in 10,000 people
- Liver failure.
- Hepatitis (inflammation of the liver).
Not known: frequency cannot be estimated from the available data
- Becoming dependent on Pregabalin Jubilant (‘drug dependence’).
After stopping a short or long-term treatment with Pregabalin Jubilant, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Pregabalin Jubilant”).
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.
The following adverse reaction has been reported in the postmarketing experience. Trouble breathing, shallow breaths.
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 Jubilant
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, blister pack or bottle. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
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 Jubilant contains
The active substance is pregabalin. Each hard capsules contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg pregabalin
The other ingredients are lactose monohydrate, maize starch, talc, gelatin, titanium dioxide, sodium lauryl sulphate, black Ink (shellac, black iron oxide, potassium hydroxide).
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contains iron oxide red E172.
What Pregabalin Jubilant looks like and contents of the pack
Pregabalin Jubilant 25 mg hard capsules
White to off-white colored cap and body, size '4' hard gelatin capsule printed in black ink with "25" on the cap and "608" on the body.
Pregabalin Jubilant 50 mg hard capsules
White to off white colored cap and body, size '4' hard gelatin capsule printed in black ink with "50" on the cap and "609" on the body.
Pregabalin Jubilant 75 mg hard capsules
Reddish brown colored cap and white to off-white colored body, size "4" hard gelatin capsule printed in black ink with "610" on the body.
Pregabalin Jubilant 100 mg hard capsules
Reddish brown colored cap and body, size "3" hard gelatin capsule printed in black ink with "611" on the body.
Pregabalin Jubilant 150 mg hard capsules
White to off white colored cap and body, size '2' hard gelatin capsule printed in black ink with "612" on the body.
Pregabalin Jubilant 200 mg hard capsules
Peach colored cap and body, size '1' hard gelatin capsule printed in black ink with "613" on the body. Pregabalin Jubilant 225 mg hard capsules
Peach colored cap and white to off-white colored body, size '1' hard gelatin capsule printed in black ink with "614" on the body.
Pregabalin Jubilant 300 mg hard capsules Reddish brown colored cap and white to off white body, size "0" hard gelatin capsule printed in black ink with "615" on the body.
Alu-PVC blister packs of 7, 10, 12, 14, 20, 24, 28, 30, 36, 48, 50, 56, 60, 70, 72, 84, 100 and 200 hard, capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturer
Elara Pharmaservices Ltd.
5 Garden Court, Lockington Hall,
Main Street, Lockington,
Derby. DE74RH, UK
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke – Belgium
Elara Pharmaservices Ltd.
Iron Farm, 7 Grimes Gate,
Diseworth, Derby, DE742QD
United Kingdom