Syndol Tablets

SYNDOL TABLETS are indicated for the symptomatic relief of tension headache and other somatic pain/tension states such as neuralgia, primary dysmenorrhoea and following trauma and surgery. SYNDOL TABLETS calm and soothe the patient and help allay the anxiety that can prolong or aggravate pain.

Do not take SYNDOL Tablets

• if you are hypersensitive (allergic) to codeine phosphate, doxylamine succinate, paracetamol, caffeine or any of the other ingredients of SYNDOL Tablets (listed in section 6).
• If you taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
• if you are taking other medicines containing codeine or any other paracetamol-containing medicines.
• If you suffer from shortness of breath, accompanied by a bluish discoloration of the skin especially and excessive mucous from the chest.
• After operations on the bile duct,
• if you suffer from alcoholism
• if you have had head injuries and conditions in which pressure in the head is raised. Signs of this include headaches, being sick (vomiting) and blurred eyesight.
• During an asthma attack or in heart failure secondary to chronic lung disease.
• if your kidney or liver function is severely impaired.
• 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 at risk of blocked intestine (paralytic ileus)
• if you have been told by your doctor that you are a patient who is known to break down (metabolize) medications very quickly due to a specific enzyme (CYP2D6 ultra-rapid metabolisers)
• If your child is under 12 years old.
• If you are breastfeeding
• If you are in third trimester of pregnancy.
• 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 SYNDOL TABLETS 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.

Adults and children 12 years and older: 2 tablets every 4 hours as needed. Do not exceed 8 tablets per day. DO NOT EXCEED THE RECOMMENDED DOSE.

If you take more SYNDOL TABLETS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact your nearest hospital or poison centre. Signs of overdose may include unusually pale skin, nausea, vomiting, loss of appetite, abdominal pain, pupils that may be pin-point in size, a difficulty in breathing, an increased or irregular heart rate, and loin (kidney) pain.

• Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken.

If you forget to take SYNDOL Tablets

Do not take / receive a double dose to make up for forgotten individual doses.

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

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

• swelling of the hands, feet, ankles, face, lips and 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 reaction to SYNDOL Tablets. 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:

• low number of white blood cells. Signs include: fever, chills, sore throat;
• low number of cells involved with blood clotting. Signs include: more or worse bruises than normal, small purple or red dots under your skin, nosebleeds or bleeding gums, black or bloody-looking bowel movements, red or pink urine;
• an excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes;
• low number of red blood cells, white blood cells and cells involved with blood clotting. Signs include: weakness, tiredness, skin problems such as rashes or bruising, rapid heart rate, shortness of breath;
• changes in mood, anxiety, feeling depressed, confusion;
• perceptions of having seen, heard, touched, tasted or smelled something that wasn't actually there;
• seizures;
• slowing down of the central nervous system. Signs include: slower heart rate and breathing, extreme confusion and memory loss and poor judgement;
• increased pressure in the head. Signs include headache, blurred vision, feeling less alert than usual and vomiting;
• blurred vision, constriction of the pupil of the eye;
• ringing in the ears;
• changes in the way your heart beats, drop in blood pressure when standing up making (causing light-headedness or fainting);
• yellowing of the skin, whites of the eyes and mucous membranes (jaundice);
• difficulty in urinating, inability to empty all the urine from your bladder;
• sudden drop in body temperature;
• 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.

• SYNDOL Tablets, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent:
• insomnia, deep sleep, drowsiness
• incoordination,
• dry mouth,
• nervousness,
• tremors, convulsions
• facial flushing
• Less frequent:
• Abdominal pain including risk of inflammation of pancreas, which causes severe pain in the abdomen and back.
• Frequency not known:
• Restlessness
• sores in the mouth
• Decreased libido
• Lack of energy
• Sensitivity to light
• Tingling or prickling, “pins-and-needles” sensation in the arms, hands, legs or feet
• involuntary shaking of the hands, legs, face, head or vocal cords
• thick phlegm
• heartburn, diarrhoea, stomach pain, painful muscles
• fever
• hair loss
• reddening of the face
• Allergy/anaphylaxis
• Sweating
• pain in lower back area, puss in the urine, difficulty passing urine
• constipation

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

Store all medicine out of reach of children. Store at or below 25 ºC. Do not use after expiry date stated on the label.