Seda Pain Tablets

SEDA PAIN contains caffeine, codeine phosphate, doxylamine succinate and paracetamol. Paracetamol acts as an analgesic (painkiller) and an antipyretic (lowers body temperature), codeine phosphate is an analgesic, doxylamine succinate is an antihistamine, and caffeine is a mild stimulant. SEDA PAIN is used for the short-term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen and aspirin alone such as headache, including muscle contraction or tension headache, migraine, neuralgia, period pain, toothache and other dental pain, muscular and rheumatic aches and pains and for pain relief following surgery or dental procedures.

Do not take SEDA PAIN:

• If you are hypersensitive (allergic) to paracetamol, codeine or other opioid analgesics, doxylamine succinate, caffeine or any of the other ingredients of SEDA PAIN (see section 6).
• If you have liver problems.
• If you have been told by your doctor that you have a metabolic disorder called acute intermittent porphyria. Signs include severe abdominal pain, constipation or diarrhoea, nausea and vomiting, and pain in your chest, legs or back.
• If you are having an asthma attack or have severe breathing problems.
• If you have recently had an operation on your bile duct (biliary tract).
• If you are an alcoholic.
• If you have had a head injury or been told by your doctor that you have increased pressure in your head. Signs of this include headaches, being sick (vomiting) and blurred eyesight.
• If you are taking medicines to treat depression called monoamine oxidase inhibitors (MAOIs) or have recently taken them in the last two weeks.
• If you are pregnant or breastfeeding your baby.
• If you are at risk of blocked intestines (paralytic ileus).
• If you are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome.
• If you have been told by your doctor that your body metabolises codeine to morphine very quickly.

Warnings and precautions

Take special care with SEDA PAIN:

• If you have high blood pressure or any heart problems.
• If you have thyroid or hormonal problems.
• If you have an enlarged prostate.
• If you have trouble to pass urine.
• If you have pressure in your eyes (glaucoma).
• If you have any bowel or abdominal problems (e.g. stomach ulcer).
• If you have had a recent operation on your gastrointestinal tract.
• If you have gall stones.
• If you have a condition known as myasthenia gravis which weakens the muscles.
• If you suffer from seizures.
• If you are in shock, have a history of medicine abuse or are emotionally not stable.
• If you have kidney problems or are elderly. You might need to reduce your dose.
• If you have asthma.
• If you develop any skin adverse reaction, such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE), treatment with SEDA PAIN must immediately be discontinued. These reactions can be life-threatening and are characterised by redness, inflamed or swollen skin, blisters, hives, itching and sometimes peeling or pain. Should you experience any of these symptoms, contact your health care provider immediately.

Do not share medicines prescribed for you with any other person. Always take SEDA PAIN 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 and children 12 years and older: Take 2 tablets every 4 hours as needed. Do not exceed 8 tablets per day.

Do not use continuously for longer than 10 days without consulting your doctor. SEDA PAIN can be taken with or without food.

If you take more SEDA PAIN than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining SEDA PAIN with you so the doctor will know what you have taken.

SEDA PAIN can have side effects. Not all side effects reported for SEDA PAIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SEDA PAIN, please consult your health care provider for advice. If any of the following happens, stop taking SEDA PAIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SEDA PAIN. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Bleeding or bruising more easily than normal.
• Frequent infections such as fever, severe chills, sore throat or mouth ulcers.
• Low number of red blood cells, white blood cells and cells involved with blood clotting (symptoms such as weakness, tiredness, skin problems such as rashes or bruising, rapid heart rate, shortness of breath).
• An excessive breakdown of red blood cells causing a type of anaemia (tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the whites of the eyes).
• Difficulty breathing, tightness of the chest (bronchospasm).
• Slowing down of the central nervous system (slower heart rate and breathing, extreme confusion and memory loss and poor judgement).
• Fits (seizures).
• Increased pressure in the head (headache, blurred vision, feeling less alert than usual and vomiting).
• Changes in the way your heart beats, such as beating faster, slower or irregular, heart palpitations.
• Severe stomach pain, which may reach to your back. This could be a sign of inflammation of your pancreas (pancreatitis).
• Yellowing of your skin, whites of your eyes and mucous membranes (jaundice).
• Skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE). These reactions can be life-threatening and are characterised by redness, inflamed or swollen skin, blisters, hives, itching and sometimes peeling or pain (sometimes accompanied by fever) (see Take special care with SEDA PAIN).
• Difficulty in urinating, inability to empty all the urine from your bladder.
• Sudden drop in body temperature (hypothermia).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Side effects occurring frequently:

• Feeling drowsy or confused.
• Changes in the way you move, talk or do regular activities (psychomotor impairment).
• Headache.
• Blurred vision.
• Thick phlegm.
• Dry mouth, nausea (feeling sick), vomiting (being sick), diarrhoea, constipation.

Side effects occurring less frequently:

• Seeing or hearing things that do not exist (hallucinations).
• Sleep problems, including difficulty falling and staying asleep (insomnia), nightmares.
• Nervousness, irritability, depression or very happy.
• Loss of appetite (anorexia).
• Dizziness.
• Tremors (involuntary trembling or shaking of hands and feet).
• Tingling or numbness of your hands and feet (pins and needles).
• Double vision.
• Vertigo (sensation of spinning or swaying).
• Ringing in your ears.
• Low blood pressure, including a drop in blood pressure when standing up (causing light-headedness or fainting).
• Shortness of breath (dyspnoea).
• Stomach pain.
• Feeling unwell or tired.

Side effects occurring with an unknown frequency:

• Restlessness, anxiety.
• Changes in mood.
• Decreased libido (sex drive).
• Lack of energy.
• Coordination problems.
• Increased sensitivity of your skin to the sun.
• Seeing flickering lights that obstructs your vision.
• Constricted pupils.
• Exacerbation of porphyria symptoms (inherited disorder where substances called porphyrins build up in your body, negatively affecting your skin or nervous system).
• Heartburn, stomach ulcer or cramps.
• Redness of your skin, small purple coloured spots caused by bleeding into the skin (purpura).
• Stiff muscles, muscle pain.
• Hair loss.
• Sweating, reddening of your face.
• Increased body temperature.

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

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. Acino Pharma (Pty) Ltd: E-mail: [email protected] Tel: 060 998 7896. By reporting side effects, you can help provide more information on the safety of SEDA PAIN.

• Store at or below 25 °C.

• Store in a dry place.

• Protect from light.

• Store all medicines out of reach of children.

• Do not use after the expiry date printed on the container.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).