Lynerig 25 mg/75 mg/150 mg Capsules

LYNERIG belongs to a group of medicines used to treat neuropathic pain due to Herpes zoster infections and diabetes in adults.

Do not take LYNERIG:

• If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with LYNERIG:

• If you start taking LYNERIG and experience swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. These are symptoms of an allergic reaction, and you should contact your healthcare practitioner immediately.
• If you are taking diabetes medicine and gain weight whilst taking LYNERIG talk to your doctor as he/she may need to alter the dose of your diabetes medicine.
• LYNERIG can cause dizziness and somnolence, which can increase the occurrence of accidental injury. You should be extra cautious when taking LYNERIG until you are used to how you react to it.
• LYNERIG 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.
• LYNERIG can cause kidney failure in some patients. If you experience decreased urination whilst taking LYNERIG you should tell your doctor.
• Stopping treatment with LYNERIG after short- and long-term use may cause withdrawal symptoms such as: difficulty sleeping, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, excessive sweating and dizziness.
• If you suffer from or have a family history of heart disease you tell your doctor, before commencing treatment with LYNERIG.
• If you start treatment with LYNERIG and have thoughts of harming or killing yourself, you should immediately tell your doctor.
• LYNERIG, when taken with other medicines (certain pain medicines) may cause gastrointestinal problems (e.g. constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking LYNERIG you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence. Do not take more medicine than prescribed.
• Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease, because taking LYNERIG while suffering from such conditions.

Do not share medicines prescribed for you with any other person.

Always take LYNERIG exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with LYNERIG will last. If you have the impression that the effect of LYNERIG is too strong or too weak, talk to your doctor or pharmacist.

The usual recommended starting dose for LYNERIG is 75 mg twice daily (150 mg/day), with or without food. This dose may be increased to 150 mg twice daily after an interval of 3 to 7 days. LYNERIG is for oral use only.

If you are an elderly patient (over 65 years of age), you should take LYNERIG normally except if you have problems with your kidneys. You must discuss this with your doctor. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.

Swallow the capsule whole with water.

If you take more LYNERIG than you should

In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

You may feel sleepy, confused, agitated, or restless as a result of taking more LYNERIG than you should. Fits have also been reported.

If you missed a dose of LYNERIG

If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking LYNERIG and tell your doctor immediately or go to the casualty department at your nearest hospital if someone experiences symptoms of respiratory problems because these can be life threatening. Symptoms to watch for include:

• Confusion or disorientation,
• Unusual dizziness or lightheadedness,
• Extreme sleepiness or lethargy
• Slowed, shallow, or difficult breathing
• Unresponsiveness, which means the person does not answer or react normally or when you wake them up,
• Bluish-coloured or tinted skin, especially on the lips, fingers, and toes
• Inflammation of the eyes (keratitis) and a serious skin reaction characterized by rash, blisters, peeling skin and pain)

These are all very serious side effects. If you have them, you may have had a serious reaction to LYNERIG. 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: The following side effects occur frequently:

• jaundice (yellowing of the skin and eyes), nausea, abdominal pain, fatigue and fever
• decreased urinary output, swelling of your legs ankles and feet
• dark, reddish urine, a decreased amount of urine, weakness and muscle aches

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: Frequent side effects:

• Nausea, vomiting,
• diarrhoea constipation, flatulence,
• feeling bloated,
• dry mouth,
• increased appetite,
• mood changes, confusion, irritability, disorientation,
• difficulty sleeping,
• decreased libido.
• dizziness, excessive sleepiness, headache
• symptoms of ataxia which can be impaired balance and coordination, slurring, coordination abnormal, tremor,
• dysarthria, amnesia, memory impairment, disturbance in attention,
• tingling or prickling sensation (paraesthesia), reduced sense of touch or sensation (hypoesthesia),
• sedation, balance disorder, lethargy,
• blurred vision, double vision,
• vertigo (spinning sensation),
• muscle cramp, muscle pain, back pain, spasm
• erectile dysfunction
• changes in the way you walk, fall, feeling fatigued.
• weight gain

Less frequent side effects:

• Low white blood cell count, leaving you prone to infections,
• decreased blood sugar levels,
• anorexia
• seeing, feeling or hearing things that are not there.

Panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, increase libido, inability to orgasm, lack of interest or enthusiasm, impulsive behaviour, lack of restraint, temporary loss of consciousness, abnormal movement of lips and face, jerky movements of the muscles, dizziness postural, intention tremor, uncontrolled movements of the eye, mental impairment, speech disorder, absent reflexes, loss of taste function of the tongue, feeling unwell, convulsions, loss of ability to detect smell, decreased body movement, learning disability in the form of poor writing, peripheral vision loss, visual disturbance, eye swelling, visual field defect, eye pain, eye strain, experiencing flashes of light in the field of vision, dry eye, increase flow of tears, eye irritation, vision loss, inflammation of the cornea, altered visual depth perception, pupil dilation, visual brightness, hearing sensitivity, slow, fast, irregular or abnormal heartbeat, heart problems, increase or decrease in blood pressure, hot flushes feeling cold, shortness of breath, cough, nasal congestion and dryness, snoring, collection of fluid in the lungs, difficulty swallowing, swelling of the tongue, increased saliva production, heartburn, numb around mouth, muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain, delayed ejaculation, menstrual cramps, irregular menstruation, breast pain, breasts discharge and enlargement, development of breasts in males, chest tightness, pain, fever, thirst, chills, abnormal physical weakness or lack of energy, changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased, aspartate aminotransferase increased, platelet count decreased, neutropenia, increase in blood creatinine, decrease in blood potassium), increased bleeding tendency, low blood platelet count, resulting in severe bleeding, nosebleeds, dry mouth, indigestion, inflammation of the liver, joint pain, aching muscles including muscle cramps.

Frequency unknown side effects:

• Suicidal ideation and Suicidal behaviour

If you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via the ‘6.04 Adverse Drug reaction Reporting Form found online under SAHPRA’s publications https://www.sahpra.org.za/documents/86422f1b6.04_ARF1_Jul16_v4.pdf. By reporting side effects, you can help provide more information on the safety of this medicine.

Store at or below 25 °C. Keep the blisters in the carton until required for use. Keep HDPE containers tightly 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 (e.g. toilets).