OXYCODONE HYDROCHLORIDE 10 MG CAPSULES HARD, LYNLOR 10 MG CAPSULES HARD - patient leaflet, side effects, dosage

0 How to store Lynlor

Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal.

Do not take this medicine after the expiry date which is stated on the label or carton after EXP.The expiry date refers to the last day of that month.

Do not store above 30°C.

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

0 Contents of the pack and other information

♦ The active substance is oxycodone hydrochloride.

Lynlor 5mg Capsules, hard: Each capsule contains 5mg oxycodone hydrochloride.

Lynlor 10mg Capsules, hard: Each capsule contains 10mg oxycodone hydrochloride.

Lynlor 20mg Capsules, hard: Each capsule contains 20mg oxycodone hydrochloride.

• ♦ The other i ngred ients a re: Capsule content: microcrysta II i ne cellulose magnesium stearate. Capsule shell: Gelatine, sodium laurilsulfate, titanium dioxide (El 71), iron oxide yellow (El 72), iron oxide red (El 72), indigotine (El 32). Printing ink: shellac, iron oxide black (El 72), potassium hydroxide.

What Lynlor looks like and contents of the pack

Lynlor 10mg: Hard capsules, 14.4 mm in length, with a white body marked with'1 O' and a brown cap marked with'OXYI

Lynlor 20mg: Hard capsules, 14.4 mm in length, with a light pink body marked with'20'and a brown cap marked with'OXY'.

Pack sizes: Non child resistant blisters: 56 capsules

Marketing Authorisation Holder and Manufacturer

Accord, Barnstaple, EX32 8NS, UK

This leaflet was last revised in July 2021.

If you would like a leaflet with larger text, please contact 01271 385257.

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.

What is in this leaflet

□ what lynlor is and what it is used for

0 What you need to know before you take

Lynlor

0 How to take Lynlor

Q Possible side effects

0 How to store Lynlor

0 Contents of the pack and other information

Q What Lynlor is and what it is used for

This medicine has been prescribed for you to treat severe pain, which can only be adequately managed with opioid analgesics. It contains oxycodone hydrochloride, which is a centrally acting, strong painkiller which belongs to a class of medicines called opioids. 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 doctor should have explained how long you will betaking it for, when itisappropria­tetostop,and howto do this safely.

0 What you need to know before you take Lynlor

Do not take Lynlor if you:

• ♦ are allergic to oxycodone, or any of the other ingredients of the capsules (listed in section 6)

• ♦ 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

Lynlor 5mg, 10mg and 20mg Capsules, hard

• ♦ 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 capsules if recommended by your doctor

• ♦ have ongoing problems with constipation.

Warningsand precautions

Talkto your doctor or pharmacist before taking Lynlor if you:

• ♦ a re or have ever been add icted 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 ordrugs

• ♦ feel you need to take more Lynlor to get the same level of pain relief, as this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speakto your doctor 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 with dryness, coldness and swelling [‚puffiness‘] of the skin affecting the face and limbs)

• ♦ knowyou 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 happen with 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), e.g. 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 betaking it for, when it is appropriate to stop, and how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensit ive to pain. If this ha ppens, you need to s pea k to you r doctor about yourtreatment.

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 howto 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 increasethe risk of addiction. Overuse and misuse can lead to overdose and/ or death.

Do not inject Lynlor.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 capsules. Your doctor may adjust your dose.

You may experience hormonal changes while taking these capsules. Your doctor may wantto monitorthese changes.

Children and adolescents

Lynlor has not been investigated in children under 12 years. Safety and efficacy have not been established and therefore use in children under 12 years of age is not recommended.

Other medicines and Lynlor

Taking Lynlor 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 totreat epilepsy (gabapentinoids) such as pregabalin

• ♦ medicines used to treat anxiety

• ♦ medicines used to make you feel sleepy sleep (such as benzodiazepines)

• ♦ medicines used totreat psychiatric or mental disorders (such as phenothiazines)

• ♦ anaesthetics

• ♦ muscle relaxants

• ♦ medicines used totreat 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 Lynlor if you are currently taking this type of medicine, or have taken this type of medicine in the last two weeks.

Because of this, your doctor will only prescribe Lynlor where there are no other treatment options, and only in small doses for short periods of time. If you oryourfriends, 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 Lynlor with medicines used totreat depression known as Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Continued top of next column

Norepinephrine Re-uptake Inhibitors (SNRIs) can cause a condition known as serotonin toxicity.The risk of side effects increases if you use antidepressants (such as citalopram, duloxetine escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C, seeing or hearing things that are not real (hallucinations), loss of consciousness, fast heartbeat, blood pressure changes, lack of coordination, stiffness, feeling or being sick, and diarrhoea. Contact your doctor when experiencing such symptoms, as they may reduce your dose of Lynlor.

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 totreat allergies, such as cetirizine, fexofenadine or chlorphenamine

• ♦ medicines used totreat Parkinson's disease

• ♦ antibiotics such as clarithromycin, erythromycin or telithromycin

• ♦ antifungal medicines such as ketoconazole, voriconazole, itraconazole and posaconazole

• ♦ medicines used totreat 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 totreat depression known as St. John's Wort (also known as Hypericum perforatum)

• ♦ quinidine, a medicine used totreat an irregular heartbeat.

Lynlor with food, drink and alcohol

Drinking alcohol during yourtreatment with these capsules may make you 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 notto drinkalcohol while you're taking Lynlor capsules.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Lynlor 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 tothe baby. If you use Lynlor during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Use of oxycodone during childbirth can cause breathing problems in the newborn.

Breast-feeding

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

Driving and using machines

This medicine may cause a number of side effects such as drowsiness or dizziness which may 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 Lynlor, or when changing to a higher dose.

• ♦ Do not drive while taking this medicine until you knowhow 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 your doctor or in the information provided with the medicine and

• – It was not affecting your ability to drive safely.

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

Information on sodium content

This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially'sodium-free'.

0 How to take Lynlor

Always takethis medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.Your doctor should have discussed with you how long the course of capsules will last. They will arrange a plan for stopping treatment.Th is will outline howto gradually reduce the dose and stop taking the medicine.

Adults and adolescents over 12 years

The usual starting dose is one 5mg capsule every 6 hours. However, your doctor will prescribe the appropriate dose and frequency of administration required totreat your pain.

If you find that you a re still in pain whilst taking these capsules, discuss this with your doctor.

Method of use

Lynlor capsules should be swallowed whole with a sufficient amount of liquid.

Lynlor should not betaken with alcoholic beverages.

You must only take the capsules by mouth. The capsule contents should never be injected as this may lead to serious side effects, which may be fatal (see section 2 Warnings and precautions').

Adults with renal or liver impairment

The usual starting dose is half the recommended dose for adults. Your doctor will prescribe the appropriate dose based on your clinical situation and by using a more suitable formulation if available.

Use in children

Lynlor is not recommended for children under 12 years of age.

If you take more Lynlor than you should

If you have taken more Lynlor than prescribed, you should inform your doctor or your local poison control centre immediately.The following symptoms may occur: constricted pupils, depressed breathing, muscle weakness, drowsiness and drop in blood pressure. In severe cases, circulatory collapse, mental and motor inactivity, unconsciousness, slowing of the heart rate and accumulation of water in the lungs may occur; abuse of high doses of strong opioids such as oxycodone can be fatal. In no case should you expose yourself to situations requiring elevated concentration e.g. driving a car.

If you forget to take Lynlor

If you miss a dose you should take the next dose as soon as you remember and then carry on as before. Do not take two doses within 4 hours.

Do not take a double dose to make up for forgotten capsules.

If you stop taking Lynlor

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.

□ possible side effects

Like all medicines, this medicine 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 moreslowly 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 Lynlor‘). 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.

Very common (may affect morethan 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 capsules or when your dose is increased, but it should wear off after a few days)

• ♦ Dizziness

• ♦ Headache

• ♦ Itchy skin.

Common (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 or wheezing, shortness of breath, decreased cough reflex

• ♦ Rash

• ♦ Sweating.