Painamol ® Plus 500 mg/8 mg Tablets

The name of your medicine is PAINAMOL ® PLUS. It contains paracetamol and codeine which are indicated for the relief of mild to moderate pain and for the reduction of temperature in febrile conditions.

Do not take PAINAMOL ® PLUS:

• if you are hypersensitive (allergic) to paracetamol or codeine or any other ingredients of PAINAMOL ® PLUS (listed in section 6)
• If you have asthma or another lung disease which makes breathing difficult
• If you are an alcoholic.
• If you have increase pressure in the brain, e.g following a head injury
• If you have heart failure secondary to lung disease

Warnings and precautions

Take special care with PAINAMOL ® PLUS:

• if you going to use continuously for more than 10 days without consulting your doctor
• if you are taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
• if exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction
• if you have hypothyroidism(overactive thyroid), adrenocortical insufficiency(body does not produce enough of certain hormones) or myasthenia gravis(neuromuscular disease that causes weakness in skeletal muscles)
• if you have an impaired renal function, impaired liver function,
• if you have an enlargement of the prostate
• if you have inflammation or obstructive bowel disorders.
• If you are elderly and a debilitated patients.
• if you are an alcoholic , taking anaesthetics, hypnotics and sedatives, phenothiazines, tricyclic antidepressants.
• if you are in labour as codeine may cause respiratory depression in the new born infant
• If you are allergic to tartrazine which may cause an allergic reaction
• if you suffer from life threatening skin reactions such as Stevens - Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
• if you develop a red, scaly widespread rash with bumps under he skin and/or blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).
• if you develop a skin rash, swelling of lymph nodes and increase of eosinophils (a type of white blood cells). This is known as DrugReaction with Eosinophilia and Systemic Symptoms (DRESS).
• if you develop or have a history of Fixed Drug Eruptions (FDE) (may look like round or oval patches and swelling of the skin), blistering (hives), itching.

Other medicines and PAINAMOL ® PLUS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

• medicines used to treat water retention or high blood pressure
• medicines to treat mental illness (anti - psychotics)
• medicines to prevent blood clotting, such as warfarin
• medicines to treat diarrhoea, such as loperamide and kaolin
• muscle relaxants, such as atropine
• anaesthetics or other drug~ used in surgery (such as neuromuscular blocking agents)
• medicines that affect the liver e.g. carbamazepine, phenobarbital,phenytoin (anti - epileptics) or rifampicin (antibiotic)
• naloxone or naltrexone (used to treat drug abuse or overdose)
• colestyramine (used to reduce cholesterol in the blood)
• quinidine or mexiletine (used to treat certain heart conditions)
• metoclopramide or domperidone (used to treat nausea and vomiting)
• cimetidine (used to treat stomach ulcers)
• cisapride (used to treat heart burn)
• hydroxyzine (an anti - histamine)
• probenecid (used to treat gout)
• isoniazid (used to treat tuberculosis).

Do not share medicines prescribed for you with any other person. Always take PAINAMOL ® PLUS exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

• Adults: One or two tablets every four to six hours.
• Children over 12 years: One tablet every four to six hours.
• Children 6 to 12 years: Half to one tablet every six hours.

Do not exceed an adult dose of 8 tablets per day. Do not use continuously for longer than ten (10) days without consulting your doctor.

If you have the impression that the effect of PAINAMOL ® PLUS is too strong or too weak, tell your doctor or pharmacist.

If you take more PAINAMOL ® PLUS than you should

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

If you forget to take PAINAMOL ® PLUS

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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

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

• An allergic reaction may include: Any kind of skin rash, flaking skin, boils or sore lips and mouth
• In rare cases, severe allergic reaction (anaphylactic shock) may occur which may include sudden itching of the skin, wheezing, fluttering or tightness of the chest, or collapse. These are a very serious side effects. If you have them, you may have had a serious allergic reaction to . You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Less frequent side effects:

• skin rash or itching, which may include redness, hives (red itchy bumps), blisters, pustules or peeling of the skin (Toxic Epidermal Necrolysis) and bleeding in the lips, eyes, mouth, nose and genitals (Toxic Epidermal Necrolysis or Stevens - Johnson Syndrome),
• a red, scaly, widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (Acute Generalised Exanthematous Pustulosis),
• a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells),
• Fixed Drug Eruptions (FDE) (may look like round or oval patches of redness and swelling of the skin), blistering (hives), itching.
• Agranulocytosis (low number of a type of white blood cells)
• Thrombocytopenia(low blood platelet count)
• Allergic reactions including rash, itching, difficulty in breathing including shock.
• Drug dependence
• Dizziness, light - headedness, confusion, drowsiness
• Upper abdominal pain, abdominal pain that radiates to back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).
• Some of the listed side effects may be due to the diarrhoea, such as discomfort around the middle, feeling sick or being sick, dry mouth, feeling tired, drowsy or dizzy and wind.
• constipation, nausea ,vomiting
• Urinary retention(unable to emptying all the urine from the bladder)
• Drug withdrawal syndrome
• Changes in mood
• Reslessness
• Pressure inside the skull
• Constriction of pupils of the eye
• Middle ear imbalance
• Slow heart rate,
• fast hear beat
• Low blood pressure
• Dry mouth
• Spasm in the urethra
• Muscle rigity
• Diificulty in urination, sweating

Store in a cool, dry place, at or below 25cC and protect from light. Store all medicines out of reach of children. Store in the original package. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets)