Pentazocine 50 Mg Capsules, Hard

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Package leaflet: Information for the patient Also talk to your doctor or pharmacist before taking Pentazocine if you: Pentazocine 50 mg • Are taking a monoamine oxidase inhibitor (MAOI, a medicine used for depression e.g. capsules, hard phenelzine, isocarboxazid) or you have pentazocine hydrochloride taken one within the last 14 days. Treatment with Pentazocine should only be started This medicine contains pentazocine 2 weeks after discontinuing treatment with hydrochloride, which is an opioid, which can an MAOI cause addiction. You can get withdrawal • Have a rare tumour of the adrenal glands symptoms if you stop taking it suddenly. called a phaeochromocytoma. This may cause Read all of this leaflet carefully before headaches, sweating, palpitations, flushing you start taking this medicine because it of the face and pains in the chest or stomach contains important information for you. • Have recently had a heart attack • Keep this leaflet. You may need to read it • Have high blood pressure again. • Have severe kidney or liver disease, or you • If you have any further questions, ask your are elderly. You may need a lower dose doctor or pharmacist. • Have epilepsy • This medicine has been prescribed for you • Have a history of drug abuse, or you are only. Do not pass it on to others. It may addicted to opiate pain killers such as harm them, even if their signs of illness are morphine or diamorphine the same as yours. • Are being treated for an underactive thyroid • If you get any side effects talk to your gland doctor or pharmacist. This includes any • Have a condition which affects your adrenal possible side effects not listed in this glands leaflet. See section 4. • Have an enlarged prostate gland and have difficulty urinating What is in this leaflet: • Suffer from an inflamed bowel or other gut 1. What Pentazocine is and what it is used for disorders 2. What you need to know before you take • Suffer from swelling (inflammation) of the Pentazocine gallbladder (cholecystitis) 3. How to take Pentazocine • Suffer from inflammation if the pancreas 4. Possible side effects (pancreatitis) 5. How to store Pentazocine • Suffer from unexplained stomach pain 6. Contents of the pack and other information • Are a smoker (the effect of Pentazocine may be decreased) 1. What Pentazocine is and what it is • Have been regularly taking other pain used for relieving medicines for longer than three This medicine has been prescribed for you for months, especially if you are suffering from relieve of moderate to severe pain. headaches or headaches have become worse. It contains Pentazocine hydrochloride which belongs to a class of medicines called opioids, Other medicines and Pentazocine which are ‘pain relivers’. Tell your doctor or pharmacist if you are taking, have recently taken or might take This medicine has been prescribed to you any other medicines, especially any of the and should not be given to anyone else. following: Opioids can cause addiction and you may get • Antidepressant medicines known as withdrawal symptoms if you stop taking it Monoamine Oxidase Inhibitors (MAOI) in suddenly. Your doctor should have explained the past 2 weeks how long you will be taking it for and when it • Medicines which make you sleepy is appropriate to stop, how to do this safely. including: 2. What you need to know before you * Phenothiazines such as Trifluoperazine, used to treat anxiety, mental disorders, take Pentazocine feeling and/or being sick (nausea, Do not take Pentazocine if you: vomiting) • Are allergic to pentazocine, or any of the * Tricyclic antidepressants, used to treat other ingredients of this medicine (listed in depression such as amitriptyline section 6) * Medicines used to improve breathing • Have breathing problems for example, ability such as doxapram (respiratory respiratory depression and/or shallow stimulants) breathing (which may lead to blue lips), • Tobacco smoking may decrease the chronic bronchitis (coughing up a lot of effectiveness of Pentazocine phlegm) or asthma • Strong pain relievers such as diamorphine • Have a history of alcohol abuse (heroin), morphine and naloxone • Are recovering from a head injury, or you • Concomitant use of Pentazocine have a condition which causes increased and sedative medicines such as pressure on the brain. Symptoms include benzodiazepines or related drugs increases severe headaches, being sick, drowsiness or the risk of drowsiness, difficulties in blurred vision breathing (respiratory depression), coma • Have heart failure or suffer from and may be life threatening. Because breathlessness and swollen ankles of this, concomitant use should only be • Have porphyria (a genetic disease that can considered when other treatment options cause skin blisters, abdominal pain and are not possible. However, if your doctor brain or nervous system disorders). does prescribe Pentazocine together with Warnings and precautions sedative medicines the dose and duration Talk to your doctor or pharmacist before of concomitant treatment should be limited taking this medicine if you: by your doctor. • are or have ever been addicted to opioids, Please tell your doctor about all sedative alcohol, prescription medicines, or illegal medicines you are taking and follow your drugs. doctor’s dose recommendation closely. It • have previously suffered from withdrawal could be helpful to inform friends or relatives symptoms such as agitation, anxiety, to be aware of the signs and symptoms shaking or sweating, when you have stated above. Contact your doctor when stopped taking alcohol or drugs. experiencing such symptoms. • feel you need to take more of pentazocine Pentazocine with food and alcohol capsules to get the same level of pain relief, • These capsules should be taken after meals this may mean you are becoming tolerant to • Do not drink alcohol whilst taking this the effects of this medicine or are becoming medicine. If you drink alcohol whilst taking addicted to it. Speak to your doctor who this medicine the sedative effect may be will discuss your treatment and may change enhanced. your dose or switch you to an alternative pain reliever. Pregnancy and breast-feeding Pregnancy Taking this medicine regularly, particularly for Do not take pentazocine capsules if you are a long time, can lead to addiction. Your doctor pregnant or think you might be pregnant should have explained how long you will be unless you have discussed this with your taking it for and when it is appropriate to stop, doctor and the benefits of treatment are how to do this safely. considered to outweigh the potential harm to Rarely, increasing the dose of this medicine the baby. can make you more sensitive to pain. If this If you use pentazocine capsules during happens, you need to speak to your doctor pregnancy, your baby may become about your treatment. dependent and experience withdrawal Addiction can cause withdrawal symptoms symptoms after the birth which may need to when you stop taking this medicine. be treated. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, Breast-feeding agitation, anxiety, feeling your heartbeat Do not take pentazocine capsules while you (palpitations), increased blood pressure, are breastfeeding as pentazocine passes into feeling or being sick, diarrhoea, loss of breast milk and will affect your baby. appetite, shaking, shivering or sweating. Driving and using machines Your doctor will discuss with you how to Pentazocine may cause sedation. If affected gradually reduce your dose before stopping you should not drive or use machines. the medicine. It is important that you do not The medicine can affect your ability to drive as stop taking the medicine suddenly as you it may make you sleepy or dizzy. will be more likely to experience withdrawal • Do not drive while taking this medicine until symptoms. you know how it affects you. Opioids should only be used by those they • It is an offence to drive if this medicine are prescribed for. Do not give your medicine affects your ability to drive. to anyone else. Taking higher doses or more • However, you would not be committing an frequent doses of opioid, may increase the risk offence if: of addiction. Overuse and misuse can lead to * The medicine has been prescribed to treat overdose and/or death. a medical or dental problem and

Description Pentazocine Hydrochloride 50 mg 28 Date: 01 Sep 2020 Time: 18:43 Component Type Leaflet Pharma Code 893 No. of colours 1 Page Count 1/2

Afﬁliate Item Code 2257496 SAP No. 400001949 Colours Black Superceded Afﬁliate Item Code 2146729 Vendor Job No. 565003 Non-Print TrackWise PR No. 2257496 Trackwise Proof No. 1 Colours MA No. PL 04569/0209 Client Market United Kingdom Equate CMYK Packing Site/Printer NA Keyline/Drawing No. NA with Supplier Code LT1327AK Barcode Info NA Main Font Myriad Pro Body Text Size 10pt 3D Render ID NA Dimensions 170 x 480 mm Min Text Size used 10pt Sign-offs

v3/July 2017 * You have taken it according to the • short ‑lived hypertension (high blood instructions given by the prescriber or in pressure) the information provided with the • altered contractions of the womb medicine and • muscle tremor * It was not affecting your ability to drive • grand mal convulsions (seizures) safely • mood changes, difficulties sleeping, Talk to your doctor or pharmacist if you are nightmares, thought disturbances, not sure whether it is safe for you to drive disorientation, confusion, hallucinations while taking this medicine. (sensing things that are not real e.g. seeing Pentazocine contains sodium things) metabisulfite, which may rarely cause severe • extremes of feeling happy or sad hypersensitivity reactions and bronchospasm. • eyesight changes This medicine contains less than 1 mmol • chills sodium (23 mg) per capsule, that is to say • lack of sexual desire and impotency (failure essentially `sodium-free’. to maintain an erection) • hypothermia (low body temperature) 3. How to take Pentazocine Drug Withdrawal Always take this medicine exactly as your When you stop taking pentazocine capsules, doctor or pharmacist has told you. Check with you may experience drug withdrawal your doctor or pharmacist if you are not sure. symptoms, which include restlessness, difficulty sleeping, irritability, agitation, Your doctor should have discussed with you, anxiety, feeling your heartbeat (palpitations), how long the course of capsules will last. They increased blood pressure, feeling or being will arrange a plan for stopping treatment. sick, diarrhoea, shaking, shivering or sweating. This will outline how to gradually reduce the dose and stop taking the medicine. How do I know if I am addicted? If you notice any of the following signs whilst Swallow the capsules whole with a full taking pentazocine capsules, it could be a sign glass of water. The capsules should be that you have become addicted. taken after meals. Do not chew or crush the • You need to take the medicine for longer capsules. Your doctor will decide how much than advised by your doctor Pentazocine you should take. This will depend • You feel you need to use more than the on your condition and the severity of your pain. recommended dose The recommended dose is: • You are using the medicine for reasons other than prescribed Adults - One 50 mg capsule every four hours. • When you stop taking the medicine you feel If more pain relief is needed your doctor may unwell, and you feel better once taking the increase your dose to two 50 mg capsules medicine again every three to four hours. The maximum dose is 600 mg a day. If you notice any of these signs, it is important you talk to your doctor. Use in children and adolescents Other forms of this medicine may be more Reporting of side effects suitable for children, ask your doctor or If you get any side effects, talk to your doctor pharmacist. or pharmacist. This includes any possible side effects not listed in this leaflet. You can also Older people or patients with kidney or report side effects via the Yellow Card Scheme liver problems- Your doctor may give you at www.mhra.gov.uk/yellowcard or search for a lower dose. MHRA Yellow Card in the Google Play or Apple If you take more Pentazocine than you should App Store. By reporting side effects you can Contact your doctor or nearest hospital help provide more information on the safety emergency department immediately. Take the of this medicine. container and any remaining capsules with you. Signs of overdose include drowsiness, 5. How to store Pentazocine shallow breathing, low or high blood pressure, Keep this medicine out of the sight and fast heartbeat, hallucinations (seeing things reach of children. that are not there) coma or fits. Store below 25°C. If you forget to take Pentazocine Take the next dose at the usual time. Do not Blister packs: Store in the original package in take a double dose to make up for a forgotten order to protect from light and moisture. dose. Bottle packs: Keep the bottle tightly closed in If you stop taking Pentazocine order to protect from light and moisture. Do not suddenly stop taking this medicine. If Do not use pentazocine after the expiry date you want to stop taking this medicine, discuss which is stated on the container after ‘EXP’. this with your doctor first. They will tell you The expiry date refers to the last day of that how to do this, usually by reducing the dose month. gradually so that any unpleasant withdrawal Do not throw away any medicines via effects are kept to a minimum. Withdrawal wastewater or household waste. Ask your symptoms such as restlessness, pharmacist how to throw away medicines difficulty sleeping, irritability, agitation, you no longer use. These measures will help anxiety, feeling your heartbeat (palpitations), protect the environment. increased blood pressure, feeling or being sick, diarrhoea, 6. Contents of the pack and other shaking, shivering or sweating may occur if information you suddenly stop taking this medicine. What Pentazocine Capsules contain If you have any further questions on the use of The active substance is pentazocine this medicine, ask your doctor or pharmacist. hydrochloride. Each capsule, hard contains 4. Possible side effects 50 mg pentazocine hydrochloride. Like all medicines, this medicine can cause The other ingredients are microcrystalline side effects, although not everybody gets cellulose, pregelatinised maize starch, calcium them. If they occur, they are likely to be mild. hydrogen phosphate dihydrous sodium However, some may be serious and need metabisulfite, sodium lauril sulfate, colloidal medical attention. anhydrous, silica, magnesium stearate, croscarmellose sodium. The capsule shell If the following side effects occur, stop contains yellow iron oxide (E172), red iron taking the capsules immediately and oxide (E172), titanium dioxide (E171), black contact your doctor: iron oxide (E172) and gelatine. The printing • sore throat, fever, severe chills and ink also contains Shellac and titanium dioxide mouth ulcers. This can be due to a lack of white blood cells called granulocytes What Pentazocine Capsules look like and (agranulocytosis) contents of the pack • swelling of the face, lips, tongue or throat, Your medicine comes as a hard grey/orange difficulty in swallowing or breathing, skin capsule, marked ‘PT50’ on one side and ‘G’ on rash or itchy flushed face (allergic reaction) the other side printed in white ink. • blood changes such as a reduction in white Pentazocine is available in containers or blood cells which makes infection (with blister packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, signs such as fever) more likely 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, and • a serious skin reaction called toxic 500 capsules. epidermal necrolysis. This is rare; symptoms Not all pack sizes may be marketed. include loss of the outer layers of skin and reddening of the skin. Marketing Authorisation Holder Mylan, Other possible side effects are: Potters Bar, • Dependence and addiction (see section Hertfordshire, ‘How do I know if I am addicted?’ EN6 1TL, • light-headedness, dizziness United Kingdom. • feeling sick, vomiting, constipation • feeling drowsy Manufacturer: • sedation Generics [UK] Limited, • fainting Potters Bar, • sweating Hertfordshire, • headache EN6 1TL, • dry mouth United Kingdom. • pins and needles Gerard Laboratories, • ureteric or biliary tract spasm causing 35/36 Baldoyle Industrial Estate, abdominal cramps Grange Road, • urinary retention (difficulty passing water) Dublin 13, • itching or flushing of the skin Ireland. • rapid heartbeat or slower heartbeat This leaflet was last revised in: August 2020 • feeling your heartbeat (palpitations) • poor circulation • increased pressure on the brain • slow or shallow breathing 2257496 • collapse due to very low blood pressure LT1327AK

Description Pentazocine Hydrochloride 50 mg 28 Date: 01 Sep 2020 Time: 18:43 Component Type Leaflet Pharma Code 893 No. of colours 1 Page Count 2/2

v3/July 2017