Lenbucod 10 mg/200 mg/350 mg Film-Coated Tablets

LENBUCOD belongs to a group of medicines called analgesics which works by reducing pain. LENBUCOD is indicated for the relief of mild to moderate pain (caused by inflammation) with or without fever, for a maximum period of 5 days.

Do not take LENBUCOD:

• If you are hypersensitive (allergic) to paracetamol, ibuprofen, codeine phosphate or any of the other ingredients of LENBUCOD (listed in section 6).
• If you may have reacted to any other anti-inflammatory medicine (commonly known as NSAIDs) with sensitivity reactions like asthma, acute rhinitis (runny nose), angioedema (swelling) and urticaria (itchy skin rash).
• If you have had bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces), perforation or the formation of ulcers in your digestive tract after you have taken other NSAIDs (e.g. aspirin, or other ibuprofen-containing medicines).
• If you have an active or a history of gastrointestinal (stomach or small intestine) ulcers, perforation or bleeding that repeatedly reoccurs.
• If you have any active bleeding (including bleeding in the brain).
• If you suffer from a condition of unknown origin resulting in abnormal formation of blood cells.
• If you have or previously have had medical problems with your kidney or liver (see section 2, Other medicines and LENBUCOD).
• If you have had any cardiovascular disease (you may have had chest pain, tightness, discomfort, or shortness of breath; pain, numbness, weakness or coldness in your legs or arms if the blood vessels in those parts of your body are narrowed).
• If you have had severe heart failure secondary to chronic lung disease (e.g. chronic obstructive pulmonary disease or pneumonitis).
• If you have breathing problems (such as bronchial asthma, uncontrolled asthma, an asthma attack or spasm of your airways).
• If you have polyps (abnormal tissue growth) on the lining of the nose or sinuses associated with aspirin-induced bronchospasm (difficulty breathing).
• If you have had an operation on the biliary tract (for example your liver, gall bladder or bile ducts).
• If you regularly drink large quantities of alcohol.
• If you have previously had head injuries, or if you have a condition in which the pressure in your skull has increased.
• If you have breathing problems, especially in the presence of cyanosis (a bluish colour of the skin, nails and around the eyes), and coughing up fluid or mucus from your lungs.
• If you are taking coumarin-type blood thinners, such as warfarin to prevent blood clots.
• If you are taking medicines to treat depression or bipolar disorder called monoamine oxidase inhibitors or have taken these medicines within the last 14 days (see section 2, Other medicines and LENBUCOD).
• If you are suffering from severe dehydration due to vomiting, diarrhoea or insufficient fluid intake.
• If you are in the third trimester of pregnancy (from 28 weeks onwards).
• If you are breastfeeding.
• If you/your child are under 12 years old.
• For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.

Do not share medicines prescribed for you with any other person. Always take LENBUCOD exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure. Use the lowest effective dose for the shortest possible duration of treatment. DO NOT EXCEED THE RECOMMENDED DOSE. The usual dose for adults and children over the age of 12 years is: Take one to two (1 to 2) tablets six (6) hourly if necessary, and not more than six tablets within a twenty-four hours period. Consult your health care provider if you require further treatment after five days. LENBUCOD is contraindicated in children under 12 years of age. If you take more LENBUCOD than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Immediate medical attention is critical. Even if you do not show symptoms of an overdose, immediately go to your nearest hospital or Poison Centre.

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

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

• Swelling of the hands, feet, ankles, face, lips, tongue and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Blisters on your skin or inside your mouth, nose, vagina or bottom, as these may be due to serious allergic reactions known as Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN).
• Rapid heartbeat (also known was tachycardia), drop in blood pressure to a point of life-threatening shock.
• Mouth ulcers, cold sores and ulcers or soreness of your tongue.
• Skin lumps or hives (raised, red or white, itchy patches of skin).
• The appearance of a rash or sunburn when you have been outside (even on a cloudy day).

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

Store all medicines out of reach of children.

• Store at or below 25 ºC.
• Do not use after the expiry date stated on the container.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).