Nurika 150 mg Capsules

NURIKA belongs to a group of medicines used to treat neuropathic pain, which is a long lasting pain caused by damage to the nerves, in adults which can be caused by diabetes or shingles (a viral infection which causes a painful skin rash).

Do not take NURIKA:

• If you are hypersensitive (allergic) to pregabalin or any of the other ingredients of NURIKA (see section 6).

Warnings and precautions:

Take special care with NURIKA:

• NURIKA may cause an allergic reaction. Please inform your doctor immediately if you experience any of the following symptoms: swelling of the face, lips, tongue and throat, as well as a skin rash.
• Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis have been reported in association with pregabalin. Stop using NURIKA and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions as described in section 4.
• NURIKA may cause dizziness and drowsiness which can cause accidental falls particularly in the elderly. NURIKA can also cause loss of consciousness, confusion and mental impairment. Therefore care should be taken until you know how NURIKA affects you.
• Please inform your doctor if you are taking any anti-depressant medicines, since they may cause breathing problems if taken with NURIKA.
• When treatment with NURIKA is stopped, withdrawal symptoms may occur with symptoms such as inability to sleep, headache, nausea (feeling sick), loose stools, anxiety, flu symptoms, nervousness, depression, thoughts of harming or killing yourself, pain, fits (seizures), increased sweating and dizziness. Please inform your doctor if you experience any of these symptoms.
• If you suffer from any kidney disease or kidney failure or if while taking NURIKA you notice decreased urination, you should notify your doctor.
• Please inform your doctor if you have any heart problems such as congestive heart failure, especially if you are elderly.
• Please inform your doctor if you have diabetes and you gain weight while taking NURIKA, since the dose of your diabetic medicines may need to be adjusted.
• NURIKA may cause blurring or loss of vision, or temporary changes in your eyesight. You should tell your doctor immediately if you experience any changes in your vision.
• If you are taking NURIKA due to a spinal cord injury, side effects such as drowsiness may be increased (see section 4 - POSSIBLE SIDE EFFECTS). This may be caused by other medicines needed to treat this condition which may have similar side effects as NURIKA. If any of these apply to you, your doctor may need to monitor you more closely while you are taking NURIKA.
• If you develop thoughts of harming or killing yourself while taking NURIKA contact your doctor immediately.
• Please inform your doctor if you are taking other medicines which can cause constipation such as pain-relieving medicines containing codeine or morphine, since constipation can occur with NURIKA, especially in females and the elderly.
• Before you take NURIKA you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence problems.
• Before you take NURIKA please tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease which can cause a brain condition known as encephalopathy.
• There have been reports of breathing difficulties with NURIKA. If you have nervous system disorders, respiratory (breathing) disorders, renal (kidney) impairment, or you are older than 65 years, your doctor may prescribe a different dosing regimen for you. Contact your doctor if you experience trouble breathing or shallow breaths.
• Please inform your doctor if you are taking medicines known as opioids (used to treat severe pain) since NURIKA may increase the degree of dizziness, sleepiness and decreased concentration and may even cause death when taken together.

Other medicines and NURIKA:

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Do not share medicines prescribed for you with any other person. Always take NURIKA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

• Your doctor will determine the appropriate dose according to your specific needs.
• NURIKA is for oral use and can be taken with or without food.
• Take the capsules as instructed by your doctor. Swallow the capsule whole with water.
• Your doctor may adjust your dose after 3 to 7 days depending on your condition. If you have the impression that the effect of NURIKA is too strong or too weak, tell your doctor or pharmacist.

If you take more NURIKA than you should:

You may feel sleepy, confused, depressed, agitated, restless or get fits or collapse as a result of taking more NURIKA than you should. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of NURIKA:

If you forget to take a dose of NURIKA, take it as soon as you remember, unless it is time for your next dose. In that case, continue to take the next capsule at the usual time. Do not take a double dose to make up for a forgotten dose.

Effects when treatment with NURIKA is stopped:

Do not stop taking NURIKA unless your doctor tells you to. If your treatment with NURIKA is stopped, it should be done gradually over a minimum of 1 week. After stopping NURIKA treatment, you may experience symptoms such as difficulty in sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, nervousness, depression, thoughts of harming or killing yourself, pain, increased sweating and dizziness. If you have any further questions on the use of NURIKA, ask your doctor or pharmacist.

NURIKA can have side effects. Not all side effects reported for NURIKA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NURIKA, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking NURIKA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• serious skin reactions characterised 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)
• swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious reaction to NURIKA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• irregular heartbeat or shortness of breath, excessive tiredness and swelling of the legs (indicative of heart failure)
• decreased urination
• seizures (fits)
• yellowing of the eyes or skin. These are all serious side effects. You may need urgent medical attention.

Patients and caregivers should seek medical attention immediately if someone experiences symptoms of respiratory problems, because these can be life-threatening. Symptoms to watch for include:

• confusion or disorientation, unusual dizziness or light-headedness, extreme sleepiness or lethargy
• slowed, shallow or difficulty breathing
• unresponsiveness (when a person does not answer or react normally or you cannot wake them up)
• bluish-coloured or tinted skin, especially on the lips, fingers and toes.

The following side effects may occur frequently:

• increased appetite
• confusion, decreased sexual drive, irritability, disorientation
• dizziness, drowsiness, impaired muscle co-ordination, decreased attention, impaired memory, tremor, difficulty speaking, pins and needles, lack of energy
• blurred or double vision
• dry mouth, constipation, vomiting, flatulence, nausea (feeling ill), loose stools, bloating
• erectile dysfunction
• fatigue, feeling drunk, swelling of the body, abnormal style of walking, falls, feeling abnormal
• increased weight
• difficulty sleeping
• headache, memory loss, numbness, balance disorder
• muscle cramps, joint pain, back pain, pain in limbs, neck spasm.

The following side effects may occur less frequently:

• loss of appetite/weight loss, decreased blood glucose levels
• inability to reach sexual climax, restlessness, feeling depressed, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, increased sexual drive, panic attack, elevated mood, aggression, parkinsonism that is symptoms resembling Parkinson’s disease such as tremor, bradykinesia (decreased ability to move) and rigidity (muscle stiffness)
• decreased concentration, involuntary eye movement, speech disorder, muscle twitching, reduced reflexes, hyperactivity, sensitive skin, loss of taste, burning sensation, decreased or loss of consciousness, fainting, reduced muscle movement, loss of smell, difficulty writing, mental impairment, feeling unwell
• dry eye, eye swelling, eye pain, watery eyes, light sensitivity, eye irritation, visual disturbances
• increased hearing sensitivity
• hot flushes, high or low blood pressure, coldness in the hands and feet
• short breath, nasal dryness, cough, nasal congestion, nose bleeds, runny nose, snoring, throat tightness
• increased saliva, heartburn, numbness around the mouth, difficulty swallowing, swollen tongue, fluid accumulation in the abdomen, inflamed pancreas (which can cause severe upper abdominal pain, nausea and vomiting)
• joint swelling, muscle pain, muscle stiffness, neck pain
• difficulty urinating
• delayed ejaculation, sexual dysfunction, abnormal or no menstruation, breast pain, breast discharge, enlarged breasts
• weakness, thirst, chest tightness, swelling of the skin, fever, chills
• decreased weight.

The following side effects may also occur:

• reversible loss of ability to move your body
• trouble breathing, shallow breaths.

After stopping a short or long-term treatment with NURIKA, you may experience certain side effects, known as withdrawal effects (see Effects when treatment with NURIKA is stopped). If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects:

If you get side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of NURIKA.

Store at or below 25 °C in the original container. Keep blisters in the outer carton until required for use. Keep bottles well closed. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems. Do not use after the expiry date stated on the box, label or blister.