Each capsule contains 25 mg, 50 mg or 75 mg of pregabalin.
Excipients/Inactive Ingredients: The other ingredients are pregelatinised maize starch, talc (E553b) in capsule contents.
The other ingredients of 25 mg capsules are titanium dioxide (E171), gelatin (E441), black printing ink [shellac (E904), black iron oxide (E172), propylene glycol (E1520)] in capsule shell.
The other ingredients of 50 mg and 75 mg capsules are titanium dioxide (E171), gelatin (E441), yellow iron oxide (E172), black printing ink [shellac (E904), black iron oxide (E172), propylene glycol (E1520)] in capsule shell.
Rewisca belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Rewisca 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: Rewisca is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. The doctor will prescribe Rewisca to help treat epilepsy when current treatment is not controlling the condition. The patient should take Rewisca in addition to current treatment. Rewisca is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: Rewisca 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.
Always take this medicine exactly as told by the doctor. Check with the doctor or pharmacist if unsure.
The doctor will determine what dose is appropriate for the patient. Rewisca is for oral use only.
Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder: Take the number of capsules as instructed by the doctor.
The dose, which has been adjusted for the patient and the condition, will generally be between 150 mg and 600 mg each day.
The doctor will tell the patient to take Rewisca either twice or three times a day. For twice a day, Rewisca should be taken once in the morning and once in the evening, at about the same time each day. For three times a day, Rewisca should be taken once in the morning, once in the afternoon and once in the evening, at about the same time each day.
If the patient has the impression that the effect of Rewisca is too strong or too weak, he/she should talk to the doctor or pharmacist.
If the patient is elderly (over 65 years of age), he/she should take Rewisca normally except if having problems with the kidneys.
The doctor may prescribe a different dosing schedule and/or dose if having problems with the kidneys.
Swallow the capsule whole with water.
Continue taking Rewisca until the doctor tells to stop.
If the patient forgets to take Rewisca: It is important to take Rewisca capsules regularly at the same time each day. If the patient forgets to take a dose, it should be taken as soon as it is remembered unless it is time for the next dose. In that case, the patient should just carry on with the next dose as normal. A double dose should not be taken to make up for a forgotten dose.
If the patient stops taking Rewisca: Do not stop taking Rewisca unless told by the doctor. If treatment is stopped, it should be done gradually over a minimum of 1 week.
After stopping long- and short-term Rewisca treatment, the patient needs to know that certain side effects may be experienced. 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 the patient has been taking Rewisca for a longer period of time.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.
If the patient takes more Rewisca than he/she should, the patient should call the doctor or go to the nearest hospital emergency unit immediately. The patient should take the box or bottle of Rewisca capsules with him/her. The patient may feel sleepy, confused, agitated, or restless as a result of taking more Rewisca than he/she should. Fits have also been reported.
Do not take Rewisca if allergic to pregabalin or any of the other ingredients of this medicine (listed in Description).
Talk to the doctor or pharmacist before taking Rewisca.
Some patients taking Rewisca 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 any of these reactions be experienced, the patient should contact the physician immediately.
Rewisca has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, the patient should be careful until he/she is used to any effect the medicine might have.
Rewisca may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. Immediately tell the doctor if experiencing any changes in 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 Rewisca; these patients were mostly elderly with cardiovascular conditions. Before taking this medicine, the patient should tell the doctor if he/she has a history of heart disease.
There have been reports of kidney failure in some patients when taking Rewisca. If while taking Rewisca decreased urination is noticed, the patient should tell the doctor as stopping the medicine may improve this.
A small number of people being treated with anti-epileptics such as Rewisca have had thoughts of harming or killing themselves. If at any time the patient has these thoughts, he/she should immediately contact the doctor.
When Rewisca 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 the doctor if experiencing constipation, especially if prone to this problem.
Before taking this medicine, the patient should tell the doctor if he/she has a history of alcoholism or any drug abuse or dependence. The patient should not take more medicine than prescribed.
There have been reports of convulsions when taking Rewisca or shortly after stopping Rewisca. If a convulsion is experienced, contact the doctor immediately.
There have been reports of reduction in brain function (encephalopathy) in some patients taking Rewisca when they have other conditions. The patient should tell the doctor if he/she has a history of any serious medical conditions, including liver or kidney disease.
Driving and using machines: Rewisca may produce dizziness, sleepiness and decreased concentration. Do not drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicine affects the ability to perform these activities.
Use in Children: 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.
Rewisca should not be taken during pregnancy or when breast-feeding, unless told otherwise by the doctor. Effective contraception must be used by women of child-bearing potential. If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she should ask the doctor or pharmacist for advice before taking this medicine.
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 heartbeat, 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 aminotransferase 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; Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis) and a serious skin reaction characterized by rash, blisters, peeling skin and pain); Jaundice (yellowing of the skin and eyes).
Very rare (may affect up to 1 in 10,000 people): Liver failure; Hepatitis (inflammation of the liver).
If swollen face or tongue is experienced or if the skin turns red and starts to blister or peel, the patient 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.
Reporting of side effects: If any side effects occur, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. The patient can also report side effects directly via the established reporting mechanism. By reporting side effects, the patient can help provide more information on the safety of this medicine.
Other medicines and Rewisca: Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines.
Rewisca and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Rewisca 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 Rewisca is taken together with medicines containing: Oxycodone (used as a pain-killer); Lorazepam (used for treating anxiety); Alcohol.
Rewisca may be taken with oral contraceptives.
Concomitant use with opioids: Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of central nervous system (CNS) depression. In a case-control study of opioid users, those patients who took pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use alone (adjusted odds ratio [aOR] 1.68 [95% CI 1.19 - 2.36]). This increased risk was observed at low doses of pregabalin (≤300 mg, aOR 1.52 [95% CI 1.04 - 2.22] and there was a trend for a greater risk at high doses of pregabalin (>300 mg, aOR 2.51 [95% CI 1.24 - 5.06]).
Rewisca with food, drink and alcohol: Rewisca capsules may be taken with or without food.
It is advised not to drink alcohol while taking Rewisca.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
For Rewisca capsules 25 mg and 50 mg: Store below 25°C.
For Rewisca capsules 75 mg: Store below 30°C.
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
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