Nurika Side Effects

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Answer the side-effect intent for nurika without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Nurika?

Nurika contains the active ingredient Pregabalin.

• Active ingredient — Pregabalin
• Registration number — 46/2.5/0772; 46/2.5/0773; 46/2.5/0774; 46/2.5/0775
• Registration holder — Teva Pharmaceuticals (Pty) Ltd

It is approved for:

• 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)

Common side effects of Nurika

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• 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

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

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

Use with care, and tell your doctor, if

• 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. 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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking NURIKA
• Pregnancy: NURIKA should not be used during pregnancy since safety and efficacy has not been established, therefore effective contraception must be used in women of childbearing potential
• Breastfeeding: NURIKA is excreted in breast milk therefore, breastfeeding is not recommended, since the effects on newborns/infants are unknown

Interactions and medicines to check

The approved leaflet names these interactions.

• oxycodone (strong pain medicine)
• lorazepam (medicine used to treat anxiety). The use of NURIKA with alcohol may further impair your co-ordination, therefore the consumption of alcohol while you are taking NURIKA is not advised. Taking NURIKA with food and drink: NURIKA may be taken with or without food. You should avoid alcohol while taking NURIKA

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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