LONGTEC 80 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Longtec

(oxycodone hydrochloride)

This medicine contains oxycodone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Longtec 80 mg prolonged release tablets but will be referred to as Longtec throughout this leaflet. Please note that the leaflet contains information about other strengths.

In this leaflet:

1. What Longtec tablets are and what they are used for 2. What you need to know before you take Longtec tablets

• 3. How to take Longtec tablets

• 4. Possible side effects

• 5. How to store Longtec tablets

• 6. Contents of the pack and other information

• 1. What Longtec tablets are and what they are used for

This medicine has been prescribed for you for the relief of moderate to severe pain over a period of 12 hours. It contains oxycodone which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. what you need to know before you take longtec tablets

Do not take Longtec tablets if you:

• are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the tablets (listed in section 6 of this leaflet);
• have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
• have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;
• have a heart problem after long-term lung disease (cor pulmonale);
• have increased carbon dioxide levels in the blood. Symptoms may include dizziness, drowsiness, fatigue, shortness of breath and headache;
• have moderate to severe liver problems. If you have other long-term liver problems you should only take these tablets if recommended by your doctor;
• have ongoing problems with constipation;
• have a rare hereditary problem of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption;
• are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs;
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs;
• feel you need to take more tablets to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;
• are elderly or weakened;
• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;
• have myxoedema (a thyroid disorder associated with dryness, coldness and swelling or puffiness of the skin affecting the face and limbs);
• know you are suffering from a brain injury or tumour, or you have a head injury, severe headache or feel sick, as this may indicate that the pressure in your skull is increased;
• have low blood pressure (hypotension);
• have low blood volume (hypovolaemia). This can occur due to severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;
• feel very lightheaded or faint;
• have a mental disorder following use of certain medicines (toxic psychosis);
• have inflammation of the pancreas (which causes severe pain in the abdomen and back);
• have problems with your gall bladder or bile duct;
• have inflammatory bowel disease;
• have an enlarged prostate gland, which causes difficulty in passing urine (in men);
• have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), for example due to Addison’s disease;
• have severely impaired lung function. Symptoms may include breathlessness and coughing;
• have long term pain unrelated to cancer;
• have a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea;
• have kidney or liver problems.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment.

Addiction can cause withdrawal symptoms when you stop taking 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 doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Do not inject Longtec tablets. This can cause serious side effects including tissue death at the site of injection, infection, inflammation of the lungs and damage to the heart which may be fatal.

If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital that you are taking these tablets. Your doctor may adjust your dose.

You may experience hormonal changes while taking these tablets. Your doctor may want to monitor these changes.

Other medicines and Longtec

Taking Longtec tablets at the same time as other medicines that slow down the central nervous system can cause slow or difficulty breathing (respiratory depression), severe sleepiness, loss of consciousness and death. These medicines include:

• other medicines used to treat pain known as opioids (such as codeine or morphine);
• medicines used to treat epilepsy (gabapentinoids) such as pregabalin;
• medicines used to treat anxiety;
• medicines used to make you feel sleepy (such as benzodiazepines);
• medicines used to treat psychiatric or mental disorders (such as phenothiazines);
• anaesthetics;
• muscle relaxants;
• medicines used to treat high blood pressure;
• a type of medicine used to treat depression known as monoamine oxidase inhibitors (MAOIs), such as tranylcypromine, phenelzine and isocarboxazid. You should not take Longtec tablets if you are currently taking this type of medicine, or have taken this medicine in the last two weeks.

Because of this, your doctor will only prescribe Longtec tablets where there are no other treatment options, and only in small doses for short periods of time. If you or your friends, family or caregivers notice that you are having difficulty breathing or that you have become very sleepy or lost consciousness you (or they) should inform your doctor immediately.

Taking Longtec tablets with medicines used to treat depression known as Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) can cause a condition known as serotonin toxicity. The symptoms of this include agitation, seeing or hearing things that aren’t real (hallucinations), loss of consciousness, a fast heartbeat, blood pressure changes, increased body temperature, muscle twitching, lack of coordination, stiffness, feeling or being sick, or diarrhoea. If you are taking SSRI or SNRI medicines such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine your doctor may reduce your dose of Longtec tablets.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to adjust your dose:

• a type of medicine used to treat depression known as tricyclic antidepressants, such as amitriptyline, clomipramine, imipramine, lofepramine or nortriptyline;
• medicines used to treat allergies, such as cetirizine, fexofenadine or chlorphenamine;
• medicines used to treat Parkinson’s di­sease;
• antibiotics such as clarithromycin, erythromycin or telithromycin;
• antifungal medicines such as ketoconazole, voriconazole, itraconazole and posaconazole;
• medicines used to treat HIV known as protease inhibitors, such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir;
• cimetidine, a medicine used to treat stomach ulcers;
• rifampicin, a medicine used to treat tuberculosis;
• medicines used to treat seizures, fits or convulsions such as carbamazepine and phenytoin;
• a herbal remedy used to treat depression known as St. John’s Wort (also known as Hypericum perforatum);
• quinidine, a medicine used to treat an irregular heartbeat.

Taking Longtec tablets with food, drink and alcohol

Drinking alcohol during your treatment with this medicine may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended that you do not drink alcohol while you are taking Longtec tablets.

You should avoid drinking grapefruit juice during your treatment with this medicine.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Do not take Longtec tablets if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you take Longtec tablets during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breastfeeding

Do not take Longtec tablets while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.

Driving and using machines

These tablets may cause a number of side effects such as drowsiness or dizziness which could affect your ability to drive or use machinery (see section 4 ‘Possible side effects’ for a full list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and;
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and;
• It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Longtec tablets contain lactose

These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3. how to take longtec tablets

Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often.

Your doctor should have discussed with you how long the course of Longtec tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

Adults (over 18 years of age)

The usual starting dose is one 10 mg tablet every 12 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

Swallow your tablets whole with water. Do not crush, dissolve, or chew them.

Longtec tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.

You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock in the evening.

You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal (see section 2 ‘Warnings and precautions’).

Children

Children and adolescents under 18 years of age should not take the tablets.

Patients with kidney or liver problems

Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.

If you take more Longtec tablets than you should or if someone accidentally swallows your tablets

Call your doctor or hospital immediately. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show to the doctor.

If you forget to take your Longtec tablets

If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Longtec tablets

Do not suddenly stop taking this medicine. If you want to stop taking this medicine discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, these tablets can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. These may be signs of a serious allergic reaction.

The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect may affect up to 1 in 100 people and is more likely to occur when taking certain other medicines (see section 2 ‘Other medicines and Longtec tablets’). Tell your doctor immediately if this happens to you. You may wish to ask your friends, family or caregivers to monitor you for these signs and symptoms.

Drug withdrawal

When you stop taking Longtec tablets you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking Longtec tablets it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber;
• You feel you need to use more than the recommended dose;
• You are using the medicine for reasons other than prescribed;
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs it is important you talk to your doctor.

Very common side effects (May affect more than 1 in 10 people)

• Constipation (your doctor can prescribe a laxative to overcome this problem);
• Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem);
• Drowsiness (this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days);
• Dizziness;
• Headache;
• Itchy skin.

Common side effects (May affect up to 1 in 10 people)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea;
• Confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams;
• Difficulty in breathing, wheezing, shortness of breath, decreased cough reflex;
• Rash;
• Sweating.

Uncommon side effects (May affect up to 1 in 100 people)

• Withdrawal symptoms (see section ‚Drug withdrawal‘);
• Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste or unpleasant taste;
• A feeling of dizziness or spinning (vertigo), hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, disorientation, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, blurred or impaired vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions or spasms;
• Difficulty or pain in passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (hypogonadism, seen in a blood test);
• Fast, irregular heartbeat, palpitations, a feeling of lightheadedness, dizziness, flushing ofthe skin;
• Dehydration, thirst, chills, swelling ofthe hands, ankles or feet;
• Dry skin, severe flaking or peeling ofthe skin;
• Redness ofthe face, reduction in size ofthe pupils in the eye, high temperature;
• A need to take increasingly higher doses ofthe tablets to obtain the same level of pain relief (tolerance);
• Colicky abdominal pain or discomfort;
• A worsening of liver function tests (seen in a blood test).

Rare side effects (May affect up to 1 in 1,000 people)

• Low blood pressure or feeling faint, especially on standing up;
• A raised, itchy rash (hives).

Frequency not known (Frequency cannot be estimated from the available data)

• Dependence and addiction (see section ‘How do I know if I am addicted?’);
• An increased sensitivity to pain;
• Aggression;
• Tooth decay;
• Absence of menstrual periods;
• A blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools;
• Development of a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea;
• Long term use of Longtec during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

5. how to store longtec tabletskeep this medicine out of the sight and reach of children.accidental overdose by a child is dangerous and may be fatal.

Do not use any tablets after the expiry date which is stated on the blister and carton after EXR The expiry date refers to the last day of that month.

Do not store your tablets above 25 °C.

Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

If this medicine becomes discoloured or shows any other signs of deterioration, please contact your pharmacist who will advise you on what to do.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other informationwhat longtec tablets containthe active ingredient is oxycodone hydrochloride. each prolonged release tablet contains 72 mg of oxycodone as 80 mg oxycodone hydrochloride.

The other ingredients are lactose monohydrate, povidone, ammoniomethacrylate polymer, sorbic acid, glycerol triacetate, stearyl alcohol, talc, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol, hydroxypropyl­cellulose, iron oxide (E172), and indigo carmine (E132).

What Longtec tablets look like and the contents of the pack

The 40 mg tablets are green, round, bi-convex, film-coated tablets marked OC on one side and 40 on the other.

Each pack contains 56 tablets.

Product Licence Holder and Manufacturer

Procured from within the EU by

the Product Licence holder Orifarm UK Ltd.,

236 Jubilee House, 3 The Drive, Great Warley, Brentwood, CM13 3FR, UK

Repacked by Orifarm Supply A/S, Energivej 15, 5260 Odense S, Denmark

Manufactured by Bard Pharmaceuticals Ltd., Cambridge Science Park, Cambridge CB4 OGW, United Kingdom

Longtec 80 mg prolonged release tablets PL 45985/0548

Leaflet revision date: 20/12/2021

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