Pharma – Q Fentanyl 500 mg/10 ml/100 mg/2 ml Injection

Pharma - Q Holdings (Pty) Ltd PHARMA - Q FENTANYL 500 mg/10 ml and100 mg/2 ml INJECTION Solution for injection 500 and 100 μg Page 2 of 12 The active ingredient in Pharma-Q Fentanyl Injection is fentanyl. It belongs to a group of strong painkillers, which are also called opioids. Pharma-Q Fentanyl Injection has been provided to you for pain relief during short surgical procedures and as a medicine given before administration of an anaesthetic.

Pharma- Q Fentanyl Injection should not be administered to you: • if you are hypersensitive (allergic) to fentanyl, or any of the other ingredients of Pharma- Q Fentanyl Injection (listed in section 6). • if you have previously had an allergic reaction to Pharma-Q Fentanyl Injection or a similar painkiller. • If you suffer from abnormally slow or shallow breathing, especially in the presence of cyanosis (blue colour of the tissues, skin or gums caused by too little oxygen) and excessive mucous in the chest. • If you have suffered any head injuries and conditions in which pressure inside the skull is raised. • If you are having an acute attack of bronchial asthma (wheezing and difficulty in breathing). • If you have suffered heart failure secondary to chronic lung disease. • If you are taking mono-amine oxidase inhibitors (medicines used to treat depression) or within 14 days of stopping such treatment.

Warnings and precautions

Special care should be taken with Pharma-Q Fentanyl Injection: • Pharma-Q Fentanyl Injection will be administered only by healthcare providers specifically trained to administer anaesthetics and also trained to manage the resultant breathing problems. • Pharma-Q Fentanyl Injection may weaken breathing. This may also occur sometime after the operation. Therefore, you will remain under supervision for a while after the operation. If you experience severe drowsiness or breathing problems, tell a doctor or nurse immediately. • If you have a lung disease or breathing problems, a brain disorder, impaired thyroid, liver or kidney function: always inform your doctor of this to ensure optimal care. • If you use this medicine for a prolonged period, dependence can occur. • If you are on long term opioid therapy (medicines used for pain) or have a history of opioid abuse, you may require higher doses. • Pharma-Q Fentanyl Injection will be used with caution in patients with abnormal heart rhythms and abnormally slow pulse rate. • If you suffer from muscle rigidity associated with reduced functioning of the lungs and/or your breathing stops, sudden, uncontrolled cramps in the voice box and sudden, uncontrolled narrowing of the airways, you will be given muscle relaxants. • Pharma-Q Fentanyl Injection will be used with caution if you suffer from obstructive bowel disease and myasthenia gravis (muscle disorder causing weakness). • The depressant effects are enhanced by central nervous system depressants such as alcohol, anaesthetics, hypnotics (medicines used for sleep disorders), sedatives (medicines used to induce sleep), phenothiazines (medicines used to treat depression) and meprobamate (medicine used to treat pain).

• Pharma-Q Fentanyl Injection will be given with caution or in reduced doses if you suffer from under active thyroid, decreased functioning of the adrenal gland, impaired kidney or liver function, enlarged prostrate or shock, elderly or debilitated patients. • Repeated use of opioid painkillers may result in the medicine being less effective (you become accustomed to it). It may also lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on Pharma-Q Fentanyl Injection, it is important that you consult your healthcare provider. • Being given Pharma-Q Fentanyl Injection regularly, particularly for a long time, can lead to addiction. Your healthcare provider should have explained how long you will be given Pharma-Q Fentanyl Injection for and when it is appropriate to stop, how it is done safely. • Addiction can cause withdrawal symptoms when you are stopped being given this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your healthcare provider will discuss with you how your dose will be gradually reduced before stopping Pharma-Q Fentanyl Injection. It is important that you should not stop being given Pharma-Q Fentanyl Injection suddenly as you will be more likely to experience withdrawal symptoms. • Sometimes, increasing the dose of Pharma-Q Fentanyl Injection can make you more sensitive to pain. If this happens, you need to speak to your healthcare provider about your treatment.

Children and adolescents

Pharma-Q Fentanyl Injection should not be given to children younger than 2 years of age.

You will not be expected to give yourself Pharma-Q Fentanyl Injection. Pharma-Q Fentanyl Injection will be given to you by a doctor or nurse in hospital. Your doctor will choose the dose that is right for you. Pharma-Q Fentanyl Injection: • Your dose will be individualized according to your age, body weight, physical status, underlying medical conditions, use of other medicines and on the kind of anaesthesia you require. • Your initial dose will be reduced if you are old or debilitated. • The effects of your initial dose will be taken into account when determining your next dose. • To avoid an abnormally slow pulse rate, a small dose of an anti-cholinergic (a substance which stops the passage of certain nerve impulses) will be given into the vein just before the start of anaesthesia. • A medicine called droperidol may be given to you to prevent nausea and vomiting. • Concomitant use with droperidol may also cause a state of neurolept-analgesia and/or neurolept-anaesthesia (no pain, altered awareness and memory) so that various diagnostic or minor surgical procedures can be carried out. If you have the impression that the effect of Pharma-Q Fentanyl Injection is too strong or too weak, talk to your doctor or pharmacist.

Pharma-Q Fentanyl Injection can have side effects. Not all side effects reported for Pharma-Q Fentanyl Injection are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Pharma-Q Fentanyl Injection, please consult your health care provider for advice. If any of the following happens, stop receiving Pharma-Q Fentanyl Injection 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. These are all very serious side effects. If you have them, you may have had a serious reaction to Pharma-Q Fentanyl Injection. 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: • abnormally slow pulse rate, increased heart rate and abnormal heart rhythms. • difficulty breathing; too fast or too slow breathing. These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Frequent • feeling sick (nausea), being sick (vomiting) • muscle stiffness (which may involve your chest muscles) • involuntary, repetitive body movements • drowsiness • dizziness • problems with vision • rapid or slow heartbeats • irregular heartbeats • low or high blood pressure • pain in your veins • choking caused by cramping (spasm) of the muscles in your throat • difficulty in breathing or wheezing • stop breathing for a short period of time (apnoea) • skin rash • confusion after the operation. Less frequent • changes in blood pressure • breathing complications • breathing faster than normal • fall in body temperature below normal or chills

• headache • swelling and clotting in a vein • hiccups • mood elevation • agitation after operation. Frequency unknown • convulsions (fits or seizures) • loss of consciousness • muscle twitching • stopping of the heart (cardiac arrest) • slow or shallow breathing • itching of the skin • unusual increase in sense of smell, taste, touch, feel (e.g. feel of pain) or hearing • cough • constipation • delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares) • dependence and addiction • increased risk of abdominal pain, including pancreatitis. If you received Pharma-Q Fentanyl Injection with a tranquiliser (such as droperidol) and you notice any of the following effects, tell your doctor: • shivering and restlessness • seeing or hearing things that aren’t there (hallucinations) • unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs. Drug withdrawal: When you are stopped being given Pharma-Q Fentanyl Injection, you may experience drug withdrawal symptoms, which include nausea, vomiting, chills, restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. 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 via the “6.04 Adverse Drug Reactions Reporting Form” , found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects, you can help provide more information on the safety of Pharma-Q Fentanyl Injection.

Store all medicines out of reach of children. • Store at or below 25 °C. Protect from light. • Do not use after the expiry date stated on the ampoule or carton.