Coughcod Senior 12,5 mg/10 mg/125 mg/50 mg/5 ml Syrup

COUGHCOD SENIOR is used for the temporary relief of cough.

Do not take for longer than directed by your pharmacist or doctor. Taking COUGHCOD SENIOR regularly for a long time can lead to addiction, which might make you feel restless and irritable when you stop taking the medicine.

Do not take COUGHCOD SENIOR:

• If you are hypersensitive (allergic) to mepyramine maleate, codeine phosphate, ephedrine hydrochloride, ammonium chloride, sodium citrate or any of the other ingredients of COUGHCOD SENIOR (listed in section 6).
• If you have high blood pressure.
• If you have severe asthma attacks or severe breathing problems.
• If you are dependent on alcohol.
• If you have a head injury or have a condition in which the pressure in your brain is raised (may cause painful eyes, changes in vision or headache behind the eyes).
• If you have heart failure or any other heart conditions, including any narrowing of the arteries and irregular heartbeats.
• If you have high pressure in your eye or eyes (glaucoma).
• If you have a liver or kidney condition.
• If you are taking medicines to treat depression called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days. MAOIs are medicines such as moclobemide, phenelzine or tranylcypromine.
• If you are constipated or have any condition that may cause constipation or where constipation should be avoided such as if you have paralysis (non-movement) of the bowel muscles.
• If you are at risk of blocked intestines.
• If you are suffering from severe diarrhoea (including diarrhoea caused by poisoning).
• If your doctor has informed you that you are a rapid metaboliser of codeine into morphine or if you have CYP2D6 enzyme deficiency.
• If you are prone to experiencing fits (convulsions).
• In patients who are comatose (although a comatose patient may appear awake, they are unable to consciously feel, speak, hear, or move).
• If you have an overactive thyroid gland which can cause increased appetite, weight loss or sweating.
• If you have a prostate gland enlargement.
• If you have phaeochromocytoma (tumour of adrenal gland).
• If you are under 18 years of age and have had your tonsils or adenoids removed to correct a sleeping disorder.
• If you are under 12 years of age.
• If you are pregnant or breastfeeding your baby (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

Take special care with COUGHCOD SENIOR: Exceeding the prescribed dose, together with prolonged and continuous use of COUGHCOD SENIOR, may lead to dependency and addiction.

• Do not take COUGHCOD SENIOR for longer than directed by your doctor and do not exceed the recommended dose as this can lead to dependency and addiction.
• Taking COUGHCOD SENIOR regularly for a long time can lead to addiction, which might cause you the feel restless and irritable when you stop taking COUGHCOD SENIOR.
• You should not take COUGHCOD SENIOR if you have breathing problems or suffer from asthma, avoid use during an acute asthma attack.
• If you suffer from low blood pressure or shock.
• You should not take COUGHCOD SENIOR if you are undergoing an operation using anaesthetics.
• COUGHCOD SENIOR should be given with care to patients with diseased adrenal glands (overactive/underactive thyroid) and diabetes.
• If you suffer from gall bladder disease or gall stones.
• If you suffer from bowel disorders like an obstruction in your stomach or gut (for example, because of an ulcer).
• If you suffer from muscle weakness (myasthenia gravis).
• If you suffer from alcoholism, substance abuse or dependence or mental illness.
• If you are elderly as you are more likely to experience side effects.
• If you are having an allergen skin test as COUGHCOD SENIOR may affect the results.
• If you are taking corticosteroids (medicines used to relieve swelling in a variety of conditions), aminophylline (a medicine used to treat serious lung problems) and other similar medicines, or medicines that make you pass more urine than usual (diuretics), you may be at risk from developing low levels of potassium in your body (see section Other medicines and COUGHCOD SENIOR).
• If you struggle to pass urine (urinary retention).
• If you have blockage or narrowing of an artery in the arms or legs (occlusive vascular disorders) including arteriosclerosis, which causes thick, stiff blood vessels, or aneurysms (bulges on the blood vessels).
• If you suffer from chest pain related to the heart (angina).
• If your doctor has told you that your blood is alkaline (opposite of acidic), known as metabolic or respiratory alkalosis.
• If you have low blood levels of calcium (hypocalcaemia).
• If you have low levels of stomach acid (hypochlorhydria).
• If you have a hormonal disorder that leads to high blood pressure (aldosteronism).

Children and adolescents

COUGHCOD SENIOR is contraindicated in children under 12 years of age. COUGHCOD SENIOR should not be given to children due to the codeine content. It can cause life-threatening adverse events including death (see section Do not take COUGHCOD SENIOR). COUGHCOD SENIOR should not be given to children and adolescents under 18 years of age who undergo surgery to remove their tonsils (tonsillectomy) or surgery to remove their adenoids (adenoidectomy) (or both).

Other medicines and COUGHCOD SENIOR

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following medicines:

• Digoxin, quinidine, or tricyclic antidepressants as it may increase the irregular heartbeat.
• Ergot alkaloids, used for migraines and oxytocin, as it increases the risk of narrowing of the blood vessels.
• Monoamine-oxidase inhibitors used for depression as fatal reactions may occur whilst taking it or within 14 days of stopping such treatment (see section Do not take COUGHCOD SENIOR).
• Alcohol or central nervous system depressants as the depressant or sedative effects may be enhanced.
• Aminoglycoside antibiotics, such as gentamicin, as the warning signs of the toxic effect on the nerve of the ear may be masked.
• Buprenorphine, naltrexone, naloxone, used to treat opioid medicine dependence.
• Mexiletine, used to treat irregular heartbeat.
• Ritonavir, used to treat HIV (a viral infection).
• Cimetidine, used to treat ulcers and indigestion.
• Medicines to treat allergies (antihistamines) that can cause drowsiness.
• Anaesthetics: medicine used to put you to sleep during surgery e.g. halothane.
• Antipsychotics (e.g. haloperidol, aripiprazole): medicines used to treat psychotic disorders.
• Hypnotics and anxiolytics (e.g. chlorpromazine, diazepam, temazepam): medicines which affect the nervous system.
• Cisapride, metoclopramide and domperidone: medicines used to treat nausea (feeling or being sick) and vomiting.
• Anticholinergics (e.g. atropine and amitriptyline): medicines which are used as premedication before operations and to treat depression, may increase the effects of COUGHCOD SENIOR.
• Antiepileptics (phenobarbitone): medicines use to treat epilepsy.
• Antihypertensives: medicines used to treat high blood pressure (e.g. guanethidine, captopril).
• Doxapram and salbutamol: medicines used to treat breathing problems.
• Xanthines (aminophylline and theophylline): medicines used to treat serious lung problems.
• Propranolol, cardiac glycosides: medicines used to treat heart problems.
• Fenfluramine and dexfenfluramine: medicines used to suppress appetite.
• Corticosteroids: a type of medicine used to relieve swelling in a variety of different conditions.
• Diuretics: medicines that make you pass more urine than usual.
• Rifampicin: an antibiotic used to treat bacterial infections, including tuberculosis.
• Urinary acidifiers (e.g. sodium citrate): medicines which can cause your urine to become more acidic.
• Urinary alkalinisers (e.g. sodium bicarbonate): medicines which can cause your urine to become less acidic.

Do not share medicines prescribed for you with any other person. Always take COUGHCOD SENIOR 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. Do not exceed the recommended dose.

The usual dosing is:

• Adults and children over 12 years: Take one to two medicines measures (5 ml to 10 ml) three times daily and at night or as prescribed.

COUGHCOD SENIOR should be used at the lowest effective dose for the shortest period. If you have the impression that the effect of COUGHCOD SENIOR is too strong or too weak, tell your doctor or pharmacist.

If you take more COUGHCOD SENIOR than you should

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

If you forget to take COUGHCOD SENIOR

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of COUGHCOD SENIOR, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

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

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

• Swelling of the 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 COUGHCOD SENIOR. 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:

• Fits (convulsions), seizures, especially in infants and children,
• inability to move both eyes in the same direction, altered level of consciousness and back pain,
• cough, difficulty breathing,
• inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis),
• liver damage (hepatotoxicity), which causes symptoms such as yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice), stomach pain in the upper right portion, tiredness, loss of appetite, nausea or vomiting,
• if you feel that you regularly need to take COUGHCOD SENIOR or if you feel that you require higher doses of COUGHCOD SENIOR to produce the same effect experienced during initial use as you may be addicted or have developed tolerance to COUGHCOD SENIOR,
• palpitations (trembling, shaking, irregular heartbeats slow or fast),
• distended abdomen, fullness, gas, abdominal spasms, diarrhoea, foul-smelling breath (due to blockage of the gut) or abdominal pain, bloating and tenderness, fever, rapid heart rate, and dehydration (due to widening of the colon),
• less urine than is normal for you, difficulty or pain in passing urine, more frequent urination, especially in the evening, greater amounts than usual, with pale urine or less frequent urination or in smaller amounts than usual, with dark coloured urine as these may be symptoms of serious kidney problems,
• mental clouding or confusion (could be due to toxicity),
• increased pressure within your head (raised intracranial pressure),
• low body temperature,
• chest pain, angina, changes in the way your heart beats, for example, if you notice it beating faster (palpitations, dysrhythmias, tachycardia), if you notice it beating slower (bradycardia), heart attack or heart failure,
• changes in blood pressure, fainting, flushing,
• narrowing of the blood vessels which in severe cases may lead to gangrene in the fingers and toes,
• strokes,
• blood disorders which are usually detected in blood tests, but may be seen as pale skin, tiredness, fever, sore throat and mouth, small red spots on the skin, bruising or prolonged bleeding after injury. Blood disorders (such as leucopenia and anaemia) may be seen with symptoms of severe chills, mouth ulcers, headache, shortness of breath and dizziness,
• swelling of the spleen (splenomegaly), which causes symptoms such as pain or fullness in the left upper abdomen that may spread to the left shoulder, feeling full without eating or after eating only a small amount from the enlarged spleen pressing on your stomach, tiredness, easy bleeding,
• low levels of potassium in the blood (hypokalaemia).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Sleepiness,
• inability to concentrate, tiredness (fatigue), headache, difficulty falling asleep (insomnia), restlessness, anxiety,
• blurred vision,
• drowsiness, unsteadiness, dizziness, lack of energy (lassitude), slowing down of thought and movement (psychomotor impairment),
• thickening of airway mucous,
• nausea, vomiting, dry mouth, constipation, increase in stomach acid coming up from the stomach into the oesophagus (acid reflux), colic.

Less frequent side effects:

• Trembling (shaking), light headedness,
• sore, tight or itchy throat, difficulty swallowing, or voice changes,
• abdominal pain, feeling of fullness (due to enlargement of the spleen),
• swollen, tender or hard lymph nodes,
• an eating disorder that causes an obsession about weight and food (anorexia),
• changes in mood, mental depression, nervousness, seeing or hearing things that are not really there (hallucinations), irritability, nightmares or unusual dreams, trouble in sleeping, trembling or uncontrolled muscle movements (ataxia),
• muscle pain,
• ringing or buzzing in the ears (tinnitus),
• sensitivity to light (photosensitivity),
• fever,
• increased blood pressure,
• pus in urine,
• changes in the number and types of your blood cells,
• diarrhoea, stomach pain,
• rapid or deep breathing, usually caused by anxiety or panic (hyperventilation),
• high concentration of sodium in the blood (hypernatremia),
• a build-up of acid in the bloodstream (acidosis),
• heartburn, thirst,
• uncontrolled muscle movements.

Side effects with an unknown frequency:

• Feeling extremely happy for no particular reason,
• feeling faint on standing up,
• small pupils (in the eye),
• vertigo (a feeling of dizziness or being lightheaded),
• facial flushing,
• stomach cramps.
• biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder),
• hyperglycaemia (abnormally high levels of glucose in the blood),
• feeling unwell or tired,
• loss of appetite,
• muscle rigidity,
• double vision or other changes in vision,
• reactions to other medications that are being used,
• increased energy, nervousness especially in the elderly and in children,
• pins and needles, abnormal or involuntary movements,
• extrapyramidal effects which include tremor, slurred speech, agitation and involuntary muscle movements,
• decreased blood pressure,
• decreased appetite,
• sweating, hair loss,
• fear, anxiety (feeling worried), insomnia (problems sleeping), confusion, psychotic states (change in the way you think or act),
• tremor (shaking movements),
• hypersalivation (producing too much saliva),
• weakness,
• drop in blood pressure when standing up,
• unusual tiredness or weakness (malaise),
• abnormally low body temperature (hypothermia),
• sexual dysfunction, erectile dysfunction, decreased potency, decreased libido,
• a condition where the pancreas becomes inflamed (swollen) over a short period of time (acute pancreatitis).

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, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/Publications/Index/8. Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of COUGHCOD SENIOR.

Store all medicines out of reach of children. Store in a cool, dark place at or below 25 °C. Keep in original packaging until required for use.

• Do not store in a bathroom.
• 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).