Patient leaflet - Pregabalin Noumed 200 mg capsules
1. What Pregabalin 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 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 Pregabalin
Do not take Pregabalin
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.
Serious skin rashes including Stevens-Johnson syndrome, 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.
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 or shown suicidal behaviour. 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 on prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on Pregablin. 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.
Dependence
Some people may become dependent on Pregablin (a need to keep taking the medicine). They may have withdrawal effects when they stop using Pregablin (see section 3, “How to take Pregablin” and “If you stop taking Pregablin”). If you have concerns that you may become dependent on Pregablin, it is important that you consult your doctor.
If you notice any of the following signs whilst taking Pregablin, 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
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 may be taken with oral contraceptives.
Pregabalin with food, drink and alcohol
Pregabalin may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin.
Pregnancy and breast-feeding
If you are pregnant, or think you may be pregnant, you must tell your doctor straight away
and discuss possible risks the medicine you are taking might pose to your unborn baby.
If you are planning to become pregnant you should discuss your treatment with your doctor as
early as possible before you become pregnant.
You should not stop your treatment without discussing this with your doctor.
Pregabalin 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 childbearing 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.
Pregabalin contains mannitol
Pregabalin contains mannitol, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Pregabalin
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 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 Pregabalin than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take your pack or bottle of Pregabalin with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin than you should. Fits and unconsciousness (coma) have also been reported.
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 Pregabalin
Do not suddenly stop taking Pregabalin unless your doctor tells you to. 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 long and short-term Pregabalin treatment, 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 symptoms may occur more commonly or severely if you have been taking Pregabalin 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 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
amino transferase increased, aspartate aminotransferase increased, platelet count decreased, neutropenia, 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 a serious skin reaction 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 flulike 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 Pregablin (‘drug dependence’).
After stopping a short or long-term treatment with Pregabalin, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Pregabalin”). 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 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
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the carton and blister 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 Pregabalin capsules contains
The active substance of Pregabalin capsule is pregabalin.
Each hard capsule contains either 25 mg, or 50 mg, or 75 mg, or 100 mg, or 150 mg, or 200 mg, or 225 mg or 300 mg of pregabalin.
The other ingredients are: mannitol, maize starch and talc.
The capsule shell contains:
25mg/50mg/150mg: gelatin and titanium dioxide (E171).
75mg/100mg/200mg/225mg/300mg: gelatin, titanium dioxide (E171) and iron oxide red (E172). The printing ink is composed of shellac (E904), propylene glycol (E1520), black iron oxide (E172), potassium hydroxide (E525).
What Pregabalin capsules looks like and contents of the pack
25 mg capsules: White cap / White body size ‘4’ hard gelatin capsules imprinted with ‘P’ on cap and ‘25’ 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 ‘P’ on cap and ‘50’ 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 ‘P’ on cap and ‘75’ 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 ‘P’ on cap and ‘100’ 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 ‘P’ on cap and ‘150’ 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 ‘P’ on cap and ‘200’ 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 ‘P’ on cap and ‘225’ 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 ‘P’ on cap and ‘300’ on body with black ink, filled with white to off white powder. Pregabalin capsules are available in transparent PVC/ Aluminium blisters, Aluminium/Aluminium blisters pack and white opaque 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: 30, 200, 250 and 500 capsules, hard.
Not all pack sizes may be marketed.
This leaflet was last revised in February 2024.
Other sources of information
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Please be ready to give the following information:
Product Name: Reference number:
Pregabalin Noumed 25 mg capsules PL44041/0065
Pregabalin Noumed 50 mg capsules PL44041/0066
Pregabalin Noumed 75 mg capsules PL44041/0067
Pregabalin Noumed 100 mg capsules PL44041/0068
Pregabalin Noumed 150 mg capsules PL44041/0069
Pregabalin Noumed 200 mg capsules PL44041/0070
Pregabalin Noumed 225 mg capsules PL44041/0071
Pregabalin Noumed 300 mg capsules PL44041/0072
Marketing Authorisation Holder and Manufacturer:
NOUMED LIFE SCIENCES LIMITED
Noumed House, Shoppenhangers Road,
Maidenhead, Berkshire, SL6 2RB, UK
LPRE00/06