Benylin Forte Syrup

Benylin Forte is a medicine which is used to help relieve coughing in adults. The syrup contains diphenhydramine (an antihistamine) that helps relieve coughing.

Do not use Benylin Forte

• If you are hypersensitive (allergic) to diphenhydramine, codeine, ammonium chloride or any of the other ingredients of Benylin with Codeine (see What Benylin Forte contains).
• If you are taking or have taken within the last 2 weeks, monoamine oxidase inhibitors (MAOIs) for depression.
• During an acute asthma attack.
• If you are intoxicated or suffer from alcohol poisoning.
• If you suffer from head injuries or increased pressure inside your skull (causing symptoms such as headache, nausea, vomiting, confusion, double vision).
• If you have liver or kidney disease.
• If you are under the age of 18 years.
• If you know that you metabolise codeine very rapidly into morphine.
• If you are pregnant or breastfeeding.

Warnings and precautions

Take special care with Benylin Forte

• Benylin Forte may lead to drowsiness and affect your concentration. Do not use it with another medicine which also causes drowsiness.
• If you suffer from fits (seizures).
• If you have a head injury or increased pressure in your skull.
• If you are elderly.
• If you have a problem of medicine abuse (now or in the past). Benylin Forte contains codeine which may cause dependence or addiction.
• If you have a family history of substance abuse.
• If you suffer from any mental health disorder.
• If you suffer from any respiratory diseases such as emphysema (lungs are enlarged and damaged), persistent inflammation of the bronchi (chronic bronchitis) or acute or persistent bronchial asthma, water on the lungs or blocked airway disease.
• If you have a persistent cough accompanied by excessive, mucus (phlegm) unless you are advised to use Benylin Forte under the supervision of your doctor.
• If you have glaucoma (increased pressure in your eye), difficulty urinating, an enlarged prostate gland.
• If you have difficulty to empty your bladder.
• If you have a liver disease or diseases of the heart and blood vessels.
• If you suffer from or suddenly develop any sleep - related breathing problems. You should inform your doctor before using Benylin Forte if this applies to you or if this happens while using Benylin Forte.
• If you are severely overweight (obese).
• If you have an underactive thyroid (hypothyroidism).
• If your adrenal glands are not working properly (adrenocortical insufficiency).
• If you are in shock.
• If you suffer from a blocked bowel causing symptoms such as abdominal pain, vomiting (being sick) bloating, passing gas (intestinal obstruction), or you are at risk of developing problems with your bowel movements (paralytic ileus). You should stop taking Benylin Forte and inform your doctor if you experience abdominal pain.
• If you suffer from a condition called myasthenia gravis (a muscle disorder causing weakness).

Benylin Forte contains alcohol. Avoid alcohol when you take Benylin Forte.

Benylin Forte can affect the outcome of skin tests that are performed. Stop using Benylin Forte and tell your doctor immediately if you experience any of the following

• If you notice any of the following side effects, you must stop using Benylin Forte and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness.
• If you notice a combination of the following side effects, you must stop using Benylin Forte and seek immediate medical advice: nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.
• If you notice any of the following side effects, you must stop using Benylin Forte and seek immediate medical advice: low libido (sex drive), loss of sexual ability in men, absence of menstruation in women or infertility (signs of androgen deficiency).
• If you notice any of the following side effects, you must stop using Benylin Forte and seek immediate medical advice: agitation, restlessness, confusion, rapid heart rate, high blood pressure, dilated pupils (signs of serotonin syndrome).

Do not share medicines prescribed for you with any other person. For oral use only. Shake the bottle before use. DO NOT USE MORE THAN THE RECOMMENDED DOSE.

Adults 18 years and older: One to two medicine measures medicine measures (5 mL – 10 mL) every 4 hours. Use the lowest effective dose for the shortest duration. DO NOT USE FOR LONGER THAN 3 DAYS.

Children and adolescents under 18 years of age: Do not give Benylin Forte to children younger than 18 years.

Benylin Forte can be taken with or without food. If you have the impression that the effect of Benylin Forte is too strong or too weak, tell your doctor or pharmacist.

If you use more Benylin Forte than you should Signs of too much Benylin Forte can include nausea (feeling sick), vomiting (being sick), thirst, headache, fits or tremors, hallucinations, coma, low blood pressure, abnormal heart rate or difficulty in breathing. 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 a dose of Benylin Forte You should only give this medicine as required and by following the dosage instructions above carefully. If you forget to take a dose, take the next dose when needed provided that the last dose was at least 4 hours ago. Do not take a double dose to make up for the forgotten individual doses.

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

If any of the following happens, stop using Benylin Forte 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;
• Hives, rash or itching;
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Benylin Forte. 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;
• Fits (seizures);
• Changes in the way your heart beats (beating faster, slower or irregular);
• Difficulty breathing, shallow breathing (respiratory depression);
• Difficulty urinating, pain when urinating, inability to empty your bladder completely;
• Hypothermia (a medical emergency that occurs when your body loses heat faster than it can produce heat, causing a dangerously low body temperature);
• Increased pressure within your skull (a life - threatening condition that can cause symptoms such as headache, nausea, vomiting, confusion, double vision);
• Stomach pain including inflammation of your pancreas known as pancreatitis (pain of the stomach area that radiates to your back, tenderness when touching your abdomen, fever, rapid pulse, nausea, vomiting).

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

Tell your doctor if you notice any of the following: Side effect occurring frequently:

• Sedation (depressed consciousness);
• Drowsiness;
• Nausea (feeling sick), vomiting (being sick), constipation.

Side effects occurring less frequently:

• Pain in the upper, middle region of your stomach;
• Lack/loss of appetite (anorexia), increased appetite;
• Unrealistic feeling of well - being;
• Changes in your mood, being confused or agitated;
• Seeing or hearing things that do not exist;
• Difficulty falling or staying asleep (insomnia);
• Feeling irritated or nervous;
• Headache or dizziness;
• Feeling restless;
• Abnormal coordination;
• Tingling or numbness of your hands and feet (pins and needles);
• Tremors (involuntary trembling or shaking of your hands and feet);
• Blurred vision, constriction of your pupils;
• Ringing in your ears;
• Vertigo (sensation of spinning or swaying);
• Low blood pressure, dizziness or light - headedness when getting up from a lying or sitting position;
• Redness of your skin;
• Tightness of your chest, dry throat, nasal dryness;
• Dry mouth, diarrhoea, indigestion;
• Sweating, itching of your nose; irritation of your skin (dermatitis);
• muscle weakness;
• Abnormal physical weakness or lack of energy;
• Chest discomfort.

Side effects occurring with unknown frequency:

• Anaemia (fatigue, loss of energy, pale skin, cramps in your legs, difficulty with concentration).

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of Benylin Forte.

• Store at or below 30 °C.
• Store in a cool place.
• Keep the bottle in the outer carton until required for use.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the label / carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).