Prerica Side Effects

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

What is Prerica?

Prerica contains the active ingredient Pregabalin.

• Active ingredient — Pregabalin
• Registration number — 50/2.5/0715; 50/2.5/0716; 50/2.5/0717; 50/2.5/0718
• Registration holder — Austell Pharmaceuticals (Pty) Ltd

It is approved for:

• PRERICA is used to treat peripheral neuropathic pain (long-lasting pain caused by damage to the nerves), due to diabetes or shingles in adults

Common side effects of Prerica

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.

Frequent side effects

• inflammation of nasal passages (common cold)
• increased appetite
• feeling of elation, confusion, irritability, disorientation, sleeplessness, and changes in sexual interest
• dizziness, sleepiness, headache
• clumsiness, tremor, difficulty with speaking, forgetfulness, loss of memory, disturbance in attention, numbness or ‘pins and needles’, abnormally decreased sensitivity to stimulation
• sedation, abnormal style of walking (balance disorder), lack of energy
• blurred vision, double vision
• sensation of movement
• vomiting, nausea, constipation, diarrhoea, feeling bloated, abdominal distension, dry mouth
• muscle cramp, pain in a joint, back pain, pain in a limb, cervical spasm
• difficulties with erection
• swelling of feet and lower legs caused by fluid retention, abnormal manner of walking, falling, feeling drunk, abnormal feeling, tiredness
• weight gain

Less frequent side effects

• reduced numbers of white blood cells which may make you more likely to get infections (neutropenia)
• loss of appetite, low blood sugar
• seeing or hearing things that are not there, panic attacks, restlessness, exceeding restlessness, depression, depressed mood, elevated mood, aggression, mood swings, change in perception of self (depersonalisation), difficulty speaking, abnormal dreams, lack of feeling or emotion, loss of inhibition
• fainting, numbness, contraction of a muscle, loss of consciousness, jerky movements, difficulty of movement, dizziness on standing, tremor on movement, unusual eye movement, decreased consciousness, difficulty with thinking, speech disorder, reduced reflexes, increased sensitiveness of the skin, burning sensation, loss of taste, feeling of bodily discomfort, convulsions, perversion of the sense of smell, partial or complete loss of muscle movement, inability to write coherently, as a symptom of brain disease or damage
• vision loss, peripheral vision loss, visual disturbance, eye swelling, visual field defect, reduced visual sharpness, eye pain, eye condition that manifests itself through nonspecific symptoms such as fatigue, pain in or around the eyes, the presence of flashes of light, dry eye, watery eyes, eye irritation
• visual field disturbance, altered visual depth perception, abnormal dilation of the pupil, squinting of eye(s), visual brightness
• increased sensitivity to sound
• low blood pressure, high blood pressure, hot flushes, redness of the neck and face, feeling cold
• shortness of breath, nosebleed, cough, blocked nose, runny nose, snoring, nasal dryness, fluid in the lungs, tightness of the throat
• heartburn, increased saliva production, numbness around the mouth, abdominal swelling, inflammation of the pancreas, swollen tongue, difficulty in swallowing
• hives, excessive sweating, itching of the skin, cold sweat
• joint swelling, pain in a muscle or muscles, muscle twitching, neck pain, muscle stiffness, breakdown of muscle tissue
• problems with sexual functioning including inability to achieve a sexual climax, increased libido, difficulties with erection, delayed ejaculation, painful menstrual periods, breast pain, absence of menstrual period, breast discharge, breast enlargement, breast enlargement in men
• generalised swelling caused by fluid retention, swelling of the face, chest tightness, pain, fever, thirst, chills, weakness
• changes in blood and liver test results (increased blood creatinine phosphokinase, increased alanine amino transferase, increased blood glucose, increased aspartate aminotransferase, decreased platelet count, increased blood creatinine, decreased blood potassium, decreased white blood cell count. Unknown frequency:
• thoughts of harming or killing one-self

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 PRERICA (listed in section 6)

Use with care, and tell your doctor, if

• 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
• If you have diabetes and gain weight while you are taking PRERICA, your doctor may need to make a change in your diabetic medicines
• If you experience an allergic reaction while you are taking PRERICA, you must contact your doctor immediately. The symptoms of an allergic reaction include swelling of the face, lips, tongue, and throat, as well as a skin rash
• If you take PRERICA you may experience dizziness, sleepiness, loss of consciousness, confusion, and mental impairment. This could increase the possibility of an accidental injury (fall) if you are an elderly patient. Therefore, you should be careful until you are used to any effect caused by PRERICA
• If you take PRERICA you may experience 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
• If you notice a decrease in passing urine while taking PRERICA, you should tell your doctor. It may improve if you stop taking PRERICA
• If you are taking PRERICA, or shortly after stopping it, you may experience convulsions (including epilepsy). If this happens, contact your doctor immediately. You may also experience withdrawal symptoms after short-term or long-term treatment with PRERICA, which include difficulty in sleeping, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, hyperhidrosis and dizziness
• If you have a history of a heart disease you should tell your doctor. Heart failure has been reported in some patients when they were taking PRERICA
• If you are taking medicines for spinal cord injury, you may experience an increase in certain side effects such as sleepiness, when you are also taking PRERICA
• Some people have had thoughts to harm or kill themselves while taking medicines belonging to the same group as PRERICA for the treatment of different conditions. If you have thoughts of harming or killing yourself, at any time when you are taking PRERICA, immediately contact your doctor
• When PRERICA 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
• If you have a history of alcoholism or substance abuse or dependence, you should tell your doctor. If you think you need more PRERICA than prescribed, tell your doctor
• If you have a history of any serious medical conditions you should tell your doctor. There have been reports of reduction in brain function (encephalopathy) in some patients when they were taking PRERICA. If you are not sure whether any of the above applies to you, ask your pharmacist of your doctor

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking PRERICA
• PRERICA should not be taken during pregnancy or when breastfeeding
• Effective contraception must be used by women of child-bearing potential

Interactions and medicines to check

The approved leaflet names these interactions.

• Oxycodone (for treatment of pain)
• Lorazepam (for treatment of anxiety)
• Alcohol PRERICA may be taken with oral contraceptives. PRERICA with food, drink and alcohol PRERICA capsules may be taken with or without food. It is advised not to drink alcohol while taking PRERICA

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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