1. What Nervax is and what it is used for

Nervax belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults. Peripheral and central neuropathic pain: Nervax 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: Nervax is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Nervax for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Nervax in addition to your current treatment. Nervax is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder: Nervax 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. Before you take Nervax

Do not take Nervax

If you are allergic to pregabalin or any of the other ingredients of this medicine.

Take special care with Nervax

- 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.

- Nervax 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.

- Nervax 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 Nervax; 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 Nervax. If while taking Nervax 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 Nervax have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

- When Nervax 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 drug dependence. Let your doctor know if you think you need more medicine than prescribed.

- There have been reports of convulsions when taking Nervax or shortly after stopping Nervax. If you experience a convulsion, contact your doctor immediately.

- There have been reports of reduction in brain function (encephalopathy) in some patients taking Nervax when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.

- Pregabalin has been associated with serious, life-threatening, and fatal respiratory depression. The risk may be increased with the concomitant use of opioids and other central nervous system (CNS) depressants, and with conditions such as chronic obstructive pulmonary disease. The elderly are also at higher risk. Your health care provider should start pregabalin at the lowest dose and monitor you for symptoms of respiratory depression and sedation when co-prescribing pregabalin with an opioid or other CNS depressants (eg, benzodiazepines). Patients with underlying respiratory disease and elderly patients are also at increased risk and should be managed similarly.

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. Nervax and certain other medicines may influence each other (interaction). When taken with certain other medicines, Nervax 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 Nervax is taken together with medicinal products containing:

- Oxycodone - (used as a pain-killer).

- Lorazepam - (used for treating anxiety).

- Opioids - (used as a pain-killer) Serious respiratory depression may occur with pregabalin when co-administered with opioids and CNS depressants such as benzodiazepine. Therefore, monitor for symptoms of respiratory depression and sedation in patients who require concomitant treatment with opioids or CNS depressants.

- Alcohol.

Nervax may be taken with oral contraceptives.

Nervax with food, drink and alcohol

Nervax capsules may be taken with or without food.

It is advised not to drink alcohol while taking Nervax.

Pregnancy and breast-feeding

Nervax should not be taken during pregnancy, 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. It is not recommended to breast-feed your baby while using Nervax as it is not known if Nervax may be found in breast milk. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.

Driving and using machines

Nervax 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 Nervax

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.

Nervax 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 Nervax either twice or three times a day. For twice a day take Nervax once in the morning and once in the evening, at about the same time each day. For three times a day take Nervax 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 Nervax 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 Nervax 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 Nervax until your doctor tells you to stop.

If you take more Nervax than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box of Nervax capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Nervax than you should.

If you forget to take Nervax

It is important to take your Nervax 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 Nervax

Do not stop taking Nervax 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, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. It is not clear at this time whether these symptoms 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.

Very common side effects (may affect more than 1 person in 10):

Dizziness, drowsiness.

Common side effects (may affect more than 1 person in 100):

- Increased appetite.

- Feeling of elation, confusion, disorientation, changes in sexual interest, irritability.

- Disturbance in attention, clumsiness, memory impairment, tremor, difficulty with speaking, tingling feeling, sedation, lethargy, insomnia, fatigue, headache.

- Blurred vision, double vision.

- Vertigo, problems with balance.

- Dry mouth, constipation, vomiting, flatulence.

- Difficulties with erection.

- Swelling of the body including extremities.

- Feeling drunk, abnormal style of walking.

- Weight gain.

Uncommon side effects (may affect more than 1 person in 1000):

- Loss of appetite, low blood sugar.

- Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, loss of memory, hallucinations, abnormal dreams, panic attacks, apathy, feeling abnormal, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.

- Difficulty with thinking, numbness, changes in eyesight, unusual eye movement, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, fainting, increased sensitivity to noise.

- Dry eyes, eye swelling, eye pain, weak eyes, watery eyes.

- Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure.

- Flushing, hot flushes.

- Difficulty breathing, sore throat, dry nose.

- Swollen abdomen, increased saliva production, heartburn, numb around mouth.

- Sweating, rash, chills.

- Muscle twitching, joint swelling, muscle cramp, muscle stiffness, pain including muscle pain, joint pain, back pain, pain in limb.

- Difficulty with or painful urination, incontinence.

- Weakness, fall, thirst, chest tightness.

- Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased, aspartate aminotransferase increased, platelet count decreased).

Rare side effects (may affect less than 1 person in 1000):

- Changes in heart beat.

- Coldness of hands and feet.

- Cough, nasal congestion, runny nose, nose bleed, snoring.

- Abnormal sense of smell, changes in vision including tunnel vision, swinging vision, altered perception of depth, flashes of light, visual brightness.

- Dilated pupils, cross eyes, eye irritation.

- Fever, cold sweat, tightness of the throat.

- Inflammation of the pancreas.

- Difficulty in swallowing.

- Slow or reduced movement of the body.

- Difficulty with writing properly.

- Hives. Increased fluid in the abdomen.

- Muscle damage. Neck pain.

- Breast pain, breast discharge, abnormal breast growth.

- Painful or interrupted menstrual periods.

- High blood sugar.

- Weight loss.

- Elevated mood.

- Kidney failure, reduced urine volume.

- Changes in blood test results (decrease in blood potassium, increase in blood creatinine, decrease in white blood cell count including neutrophils).

- Inappropriate behaviour.

Additional reactions reported from post marketing experience include heart failure, changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances, fluid in the lungs, loss of consciousness, convulsions, hypersensitivity and allergic reactions (which may include swollen face, swollen tongue, difficulty breathing, itchiness, inflammation of the eyes (keratitis), vision loss and a serious skin reaction characterized by rash, blisters, peeling skin and pain), mental impairment, aggression, urinary retention, breast growth in males, diarrhea, nausea, and feeling unwell.

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Nervax

Keep out of reach of children.

Store below 30°C.

Do not use beyond the expiry date or if the product shows any sign of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use.

These measures will help to protect the environment.