Biotech Gabapentin Capsules

BIOTECH GABAPENTIN is used to treat epilepsy.

Do not take BIOTECH GABAPENTIN if:

• You are hypersensitive (allergic) to gabapentin or any of the ingredients of BIOTECH GABAPENTIN (listed in section 6);
• you or your child is under the age of 12 years;
• you are pregnant, trying for a baby, or breastfeeding.

Warnings and precautions

Some people taking BIOTECH GABAPENTIN get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin (see section 4).

If you experience any of the following symptoms, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• fever, rash and/ or itching;
• feeling faint or dizzy.

These are all very serious side effects. If you have them, you may have had a serious reaction to BIOTECH GABAPENTIN. You may need urgent medical attention or hospitalisation.

Do not share medicines prescribed for you with any other person. Always take BIOTECH GABAPENTIN exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with BIOTECH GABAPENTIN will last as well as the dose of BIOTECH GABAPENTIN to start with and how to increase it.

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

• Always swallow the capsules whole with plenty of water.
• Continue taking BIOTECH GABAPENTIN until your doctor tells you to stop.

If you have the impression that the effect of BIOTECH GABAPENTIN is too strong or too weak, tell your doctor or pharmacist.

If you take more BIOTECH GABAPENTIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose include dizziness, double vision, slurred speech, drowsiness, lethargy and mild diarrhoea.

If you forget to take BIOTECH GABAPENTIN

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

If you stop taking BIOTECH GABAPENTIN

Do not suddenly stop taking BIOTECH GABAPENTIN. If you want to stop taking BIOTECH GABAPENTIN, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually over a minimum of 1 week.

After stopping a short or long-term treatment with BIOTECH GABAPENTIN, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects can include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling abnormal, dizziness, and feeling generally unwell. These effects usually occur within 48 hours after stopping BIOTECH GABAPENTIN. experience withdrawal effects, you should contact your doctor.

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

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

• 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);
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• severe skin reactions that require immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction);
• BIOTECH GABAPENTIN capsules may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash when you get this type of reaction. It may cause you to be hospitalised or to stop BIOTECH GABAPENTIN capsules;
• persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas);
• patients and caregivers should seek medical attention immediately if some 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 difficult breathing
• Unresponsiveness, which means 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.

These are all very serious side effects. If you have them, you may have had a serious reaction to BIOTECH GABAPENTIN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Viral infection;
• pneumonia, respiratory infection, urinary tract infection, inflammation of the ear or other infections;
• low white blood cell counts;
• anorexia, increased appetite;
• anger towards others, confusion, mood or mental changes, depression, anxiety, nervousness, difficulty with thinking;
• clumsiness or unsteadiness (ataxia), drowsiness, dizziness, lack of coordination;
• convulsions, jerky movements, slurred speech, loss on memory, trembling or shaking (tremor), trouble in sleeping, headache, sensation such as pins and needles, decreased sensation (numbness), difficulty with coordination, continuous, uncontrolled back and forth and/or rolling eye movement (nystagmus), increased, decreased or absent reflexes;
• vision abnormalities including blurred or double vision;
• vertigo;
• low blood pressure, high blood pressure, dilatation of blood vessels;
• difficulty breathing, bronchitis, sore throat, cough, runny nose;
• vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dryness of mouth and throat, flatulence;
• facial swelling, bruises, rash, itchy skin, acne;
• joint pain, muscle ache or pain, back pain, twitching;
• difficulties with erection (impotence);
• fatigue (feeling tired), fever, swelling of hands, feet or lower legs, difficulty with walking, weakness of loss of strength, pain, feeling unwell, flu-like symptoms;
• decrease in white blood cells, increase in weight or accidental injury, fracture, abrasion.

Less frequent side effects:

• Allergic reactions such as hives;
• increase and decrease in blood glucose levels (most often observed in patients with diabetes);
• agitation (a state of chronic restlessness and unintentional and purposeless motions);
• decreased movement, mental impairment; loss of consciousness;
• rapid heartbeat;
• trouble breathing, shallow breaths (respiratory depression);
• difficulty swallowing;
• frequent urination;
• swelling that may involve the face, trunk and limbs;
• abnormal blood test results suggesting problems with the liver or fall.

After marketing BIOTECH GABAPENTIN, the following side effects have been reported. Frequency unknown:

• Decreased platelets (blood clotting cells);
• low blood sodium level;
• chest pain;
• ringing in the ears;
• inflammation of the liver, yellowing of the skin and eyes (jaundice);
• adverse events following the abrupt discontinuation of BIOTECH GABAPENTIN (anxiety, difficulty sleeping, feeling sick, pain, sweating);
• change in blood test results (creatine phosphokinase increased);
• breakdown of muscle fibers (rhabdomyolysis);
• problems with abnormal/ involuntary movements such as writhing, jerking, movements and stiffness;
• suicidal ideation and behaviour;
• hallucinations;
• becoming dependent on BIOTECH GABAPENTIN (‘medicine dependence’);
• acute kidney failure, incontinence;
• increased breast tissue, breast enlargement;
• problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.

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

Store at or below 25 ºC in a dry place. Store all medicines out of reach of children. Do not use the capsules after the expiry date shown on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).