WHAT IS ULTRACOD AND WHAT IT IS USED FOR Ultracod is a fixed combination containing two active ingredients - paracetamol and codeine phosphate hemihydrate (= codeine), which belongs to a group of medicines called analgesics (against pain). Ultracod is indicated for the treatment of pain of moderate to severe and can be used by adults and adolescents over 12 years in case of pain of various origins, such as headache, toothache, pain of the locomotor system or in case of painful menstruation. BEFORE YOU TAKE ULTRACOD Do not take Ultracod - If you are allergic (hypersensitive) to paracetamol, codeine or any of the other components of Ultracod; - If you have asthma or severe breathing problems; - In case of head injury and high intracranial pressure (eg following a cerebral hemorrhage or brain tumor); - In case of acute liver failure and liver injury; - If you have recently had surgery on the liver, gallbladder or duct bile (biliary tract); - If you take medicines to treat depression called MAOIs (monoamine oxidase) - If you take Medicines to treat depression or have such drugs in the last 2 weeks; - If you have paralytic ileus (bowel muscles a situation which does not allow movement food through them, resulting in intestinal blockage); - If you know that you lack the enzyme glucose 6 - phosphate. It should not be given to children under 12 years. It is not recommended for long-term treatment with Ultracod. Take special care with Ultracod This combination should not be used: - If you have acute liver damage; - If you have acute kidney damage; - If abused alcohol or psychoactive drugs or you are dependent on opiates (morphine, codeine). Alcohol dependent patients may develop liver damage if they take concomitant treatment with Ultracod. - If you suffer from impaired consciousness. Caution should be exercised: - If you suffer from chronic constipation, inflammatory or obstructive bowel disease, severe diarrhea, extreme or severe bleeding, sweating, irregular heartbeat, myasthenia gravis (disease autoimmune causing muscle weakness), if you have gallstones, if you have prostatic hypertrophy and acute abdomen. Ultracod not be administered concomitantly with other medicines containing paracetamol and codeine. In case of long term use Ultracod, liver enzymes should be monitored. Using higher doses than those recommended may cause severe liver damage risk. The drug can be addictive if used long term with higher doses. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any including medicines obtained without prescription. - Ultracod drug may potentiate the effects of other drugs that suppress the activity of the nervous, for example, sleeping pills, tranquilizers, anti-allergic drugs, antidepressants, other pain relievers. Concomitant use of Ultracod and some sleeping pills, or AEDs rifampicin (an antibiotic) can cause liver damage. - The concomitant administration of Ultracod and lamotrigine (AEDs), efficacy of lamotrigine may be reduced. - Concomitant use of Ultracod and chloramphenicol (an antibiotic) may lead to accumulation potentiation of the antibiotic in the body and its side effects. - Onset of action may be delayed Ultracod by concomitant use of substances that slow stomach evacuation (eg propantelină) or substances that reduce concentrations of cholesterol (cholestyramine). Ultracod action can be accelerated by concomitant use of substances that accelerate gastric evacuation (eg, metoclopramide or domperidone). - Oral contraceptives may reduce paracetamol. - Coadministration of codeine with expectorants (ambroxol example) should be avoided as codeine may inhibit cough reflex. - Concomitant use of acetaminophen (the active ingredient in Ultracod) and zidovudine (Antiviral medication) may lead to reduced numbers of white blood cells and damage the liver. - For long term use Ultracod in higher doses (more than 4 tablets per day) simultaneously with certain drugs that reduce blood clotting (warfarin or derivatives coumarin), there was increased bleeding. Therefore, if such treatment should be checked frequently while blood clotting. Ultracod use with food and drink Must be used before or during a meal. Drinking alcohol should be avoided during use Ultracod. Using Ultracod while alcohol abuse can cause liver damage. Pregnancy and lactation Ask your doctor or pharmacist for advice before taking any medicine. Ultracod can be used during pregnancy only if strictly necessary and only in cases where the doctor has evaluate the benefit / risk. Talk to your doctor before you start taking this medicine if you are breast-feeding. Drug passes into breast milk and nursing infants were affected in sporadic cases. Therefore, you should use the lowest dose for the shortest duration Ultracod possible (maximum up to a week). Stop treatment and contact your nearest medical center if the Your child manifested symptoms of drowsiness, reduced pupils, feeding difficulty,muscle relaxation or breathing difficulties or if you experience symptoms such as nausea, vomiting and constipation. Driving and using machines Ultracod may negatively affect ability to drive or operate machinery, reducing rapid response capability. This applies particularly with concomitant use of Ultracod with drugs that cause central nervous system depression activity (eg sleeping pills). HOW TO TAKE ULTRACOD Always take Ultracod exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Adults and adolescents over 12 years: 1 to 2 tablets up to 4 times per day (if necessary), the interval between individual doses should be between 4 and 8 hours. The maximum daily dose is 8 tablets. The tablets should be swallowed whole with sufficient liquid. Elderly: Doses are the same as for adults, however your doctor will decide if doses necessary to reduce or not. Patients with impaired liver and / or kidney: Doses should be determined by your doctor. In these patients, the dose should be reduced or the range usually of individual doses should be extended. In case of impaired renal function may be administered at than 1 tablet every 6-8 hours after the previous dose. If you take too much of Ultracod In case of overdose or accidental ingestion by a child, get medical attention immediately. Overdose may manifest as respiratory depression, drowsiness, decrease pupils, nausea, vomiting, headache, retention of urine and faeces, bruising of the skin and mucous membranes, skin cold sweating, jaundice. If you miss Ultracod Use the missed dose as soon as you realize you have forgotten. If it was near time for next dose, skip the previous dose and wait for your next. Always keep an interval at least 4 hours between individual doses. Do not take a double dose to make up the missed dose. If you stop taking Ultracod In case of sudden interruption after chronic use of doses higher than recommended Ultracod reported headaches and fatigue, muscle pain, nervousness and disorder ingestion. Problems disappear after a few days break. Therefore be used Ultracod only on medical advice. POSSIBLE SIDE EFFECTS Like all medicines, Ultracod can cause side effects, although not everybody gets them. Discontinue drug immediately and present you to the doctor without delay event of facial swelling, skin and mucous membranes or the sensation of breathlessness. The use of paracetamol and codeine (Ultracod active substances) have been reported following adverse reactions (in order of frequency): Common (may affect 1 to 10 of 100 patients): fatigue, fainting, dizziness, mild headache, decreased blood pressure, constipation and, in particular at the beginning of treatment, nausea and vomiting. Uncommon (affect 1 to 10 in 1,000): sleep disorders, itching, redness skin rash. Rare (affect 1-10 in 10,000) and country in your ears ringing, feeling short of breath, dry mouth, allergic rash. Very rare (affect less than 1 in 10,000): decrease of white cells and red blood and blood platelet, hypersensitivity (with laryngeal edema, feeling shortness of breath, sweating, nausea, low blood pressure), narrowing of the bronchi (asthma). HOW TO STORE ULTRACOD Keep out of reach and sight of children. Do not use after expiry Ultracod packaging. The expiry date refers to last day that month. This medicine does not require any special storage conditions.