Side Effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment: • blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction. Very common (may affect more than 1 in 10 people) side effects are: • Feeling dizzy or sleepy. Common (may affect up to 1 in 10 people) side effects are: • Feeling unsteady or having a sensation of spinning or floating; • Feeling sick or vomiting; • Headache; • Diarrhoea; • Seeing double or blurred vision; • Difficulty in concentration; • Feeling low in energy or tired; • Shaking; • Skin rash; • Blood tests showing that you have low levels of sodium in your blood; • Decrease of appetite; • Difficulty in sleeping; • Difficulty in coordinating movements (ataxia); • Weight increase. Uncommon (may affect up to 1 in 100 people) side effects are: • Clumsiness; • Allergy; • Constipation; • Seizures; • Underactive thyroid gland. Symptoms include decreased level of thyroid hormone levels (seen in blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature; • Liver problems; • High blood pressure or severe increase in blood pressure; • Low blood pressure or a fall in blood pressure on standing up; • Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells; • Dehydration; • Eye movement changes, fuzzy vision or red eye; • Having falls; • Thermal burn; • Poor memory or forgetfulness; • Crying, feeling depressed, nervous or confused, lack of interest or emotion; • Inability to speak or write or understand spoken or written language; • Agitation; • Attention deficit/ hyperactivity disorder; • Irritability; • Mood changes or hallucinations; • Difficulty in speaking; • Nosebleed; • Chest pain; • Tingling and/or feeling numb in any part of your body; • Migraine; • Burning sensation; • Abnormal sense of touch; • Disturbances in the sense of smell; • Ringing in the ears; • Hearing difficulty; • Swelling in your legs and arms; • Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth; • Charcoal (dark) stool; • Inflamed gums or toothache; • Sweating or having dry skin; • Itching; • Skin changes (e.g. red skin); • Hair loss; • Urinary tract infection; • Feeling generally weak, unwell or having chills; • Weight loss; • Muscle pain, pain in limbs, muscular weakness; • Bone metabolism disorder; • Increased bone proteins; • Flushing, cold limbs; • Slower or irregular heart beat; • Feeling extremely sleepy; • Sedation; • Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramping; • Medicine toxicity; • Anxiety. Not known (frequency cannot be estimated from available data) side effects are: • Reduction in blood platelets which increases risk of bleeding or bruising; • Severe pain in the back and stomach (caused by inflamation of the pancreas); • Reduction in white blood cells which makes infections more likely; • Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis); • Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome); • Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs; • Urticaria (skin rash with itching). • The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur. There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related antiepileptics medicines like carbamazepine and oxcarbazepine. Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.