• 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.

1. What Tapimio is and what it is used for
2. What you need to know before you take Tapimio
3. How to take Tapimio
4. Possible side effects
5. How to store Tapimio
6. Contents of the pack and other information

• if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6).
• if you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia)
• if you have no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach
• if you have poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and emotions (see ‘Other medicines and Tapimio’).

Talk to your doctor or pharmacist before taking Tapimio 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 Tapimio 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.
• have slow or shallow breathing
• suffer from increased pressure in the brain or are not fully conscious
• have had a head injury or brain tumors
• suffer from liver or kidney problems (see “How to take Tapimio”)
• suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or disease of the bile duct (biliary tract disease)
• are taking medicines referred to as mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial mu-opioid agonists (e.g. buprenorphine)
• have a tendency towards epilepsy or fits or if you are taking other medicines known to increase the risk of seizures because the risk of a fit may increase.
• have a tendency to abuse medicines or if you are dependent on medicines, as Tapimio may lead to addiction.

Taking this medicine regularly, particularly for a long time, can lead to addiction. 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.

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

Sleep-related breathing disorders

Tapimio contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnoea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood).

The risk of experiencing central sleep apnoea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dose if you experience central sleep apnoea.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• The risk of side effects increases if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Tapimio at the same time. Your doctor will tell you whether Tapimio is suitable for you.
• Concomitant use of Tapimio and sedative medicines such as benzodiazepines or related medicines (certain sleeping pills or tranquillizers (e.g. barbiturates) or pain relievers such as opioids, morphine and codeine (also as cough medicine), antipsychotics, H1-antihistamines, alcohol) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor does prescribe Tapimio together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• If you are taking a type of medicine that affects serotonin levels (e.g. certain medicines to treat depression), speak to your doctor before taking Tapimio as there have been cases of “serotonin syndrome”. Serotonin syndrome is a rare, but life-threatening condition. The signs include involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension and body temperature above 38°C. Your doctor can advise you on this.
• Tapimio may not work as well if taken with opioid-like medicines (e.g. those containing pentazocine, nalbuphine or buprenorphine). Tell your doctor if you are currently being treated with one of these medicines.
• Taking Tapimio with medicines (e.g. rifampicin, phenobarbital or St John’s Wort) that affect the enzymes required to remove Tapimio from the body, may affect how well Tapimio works or may cause side effects. The effects may occur especially when the other medicine is started or stopped.
• Tapimio should not be taken together with MAO inhibitors (certain medicines for the treatment of depression). Tell your doctor if you are taking MAO inhibitors or have taken these during the last 14 days.

Do not drink alcohol whilst you are taking Tapimio, because some side effects such as drowsiness may be increased.

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

Do not take Tapimio if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Tapimio during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

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

If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking Tapimio, then do not drive, use tools or machinery.

Any such effects are more likely to occur when you start taking Tapimio, when the dose of Tapimio is changed, or when you are drinking alcohol or taking tranquilizers. Please ask your doctor before driving or using machines.

Total daily doses of Tapimio greater than 500 mg tapentadol are not recommended.

The usual dose is one capsule every 12 hours. Your doctor may prescribe a different, more appropriate dose or timing of dosing, if this is necessary for you. If you feel that the effect of these capsules is too strong or weak, talk to your doctor or pharmacist.

In elderly patients (above 65 years) usually no dose adjustment is necessary. However, your doctor may adjust your dose or time between doses if required.

Do not take Tapimio if you have severe liver or kidney problems. If you have moderate liver problems, your doctor will adjust your dose or time between doses. If you have mild liver problems or mild to moderate kidney problems, a dose adjustment is not required

Tapimio is not recommended for children and adolescents below the age of 18 years.

Tapimio is for oral use.

Swallow the capsule with a glass of water. You may take the capsule either on an empty stomach or with food.

If you have difficulty swallowing, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of cold soft food (e.g. apple sauce) and taken immediately. Do not store for future use. Drink some fluid, e.g. water, after you have swallowed the soft food containing the capsule contents.

The capsule and the capsule contents must not be crushed or chewed, as it may result in overdose due to quick release of tapentadol in your body.

This medicine may be provided in peel-off child-resistant blisters. You cannot press out the capsules through the peel-off blister and this may damage the prolonged-release capsule. Please observe the following opening instructions for the peel-off blister:

1. Tear off a single dose along the perforation line of the blister.

2. An unsealed area is now accessible which is located at the corner where the perforation lines have crossed.

3. Pull at the unsealed section to peel off the cover seal.

Do not take the capsules for longer than your doctor has told you

Taking too much Tapimio may be life-threatening. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Very high doses of Tapimio may cause the following:

• pin-point pupils in the eyes
• being sick (vomiting)
• drop in blood pressure
• fast heart beat
• altered consciousness, collapse or deep unconsciousness (coma)
• epileptic fits
• dangerously slow or shallow breathing or stopping breathing

If you forget to take the capsules, your pain is likely to return. Do not take a double dose to make up for a forgotten dose; simply continue taking the capsules as before.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber 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 experience any of these complaints after stopping Tapimio, please contact your doctor.

Do not stop taking this medicine unless your doctor tells you to. If your doctor wants you to stop taking your capsules, he/she will tell you how to do this. This may include a gradual reduction of the dose.

• This medicine may cause allergic reactions including swelling beneath the skin, hives, and in severe cases difficulty breathing, a fall in blood pressure, collapse, or shock (uncommon). Symptoms may be wheeziness, difficulty breathing, swelling of the eyelids, face or lips, or rash or itching, which may cover your whole body.
• Another serious side effect is a condition where you breathe more slowly or weakly than expected (rare). It mostly occurs in elderly and weak patients. If you are affected by these important side effects, contact a doctor immediately.

Very common (may affect more than 1 in 10 people)

• feeling sick (nausea)
• constipation
• dizziness, drowsiness, headache

Common (may affect up to 1 in 10 people)

• decreased appetite, anxiety, being sick (vomiting), diarrhoea, indigestion
• sleep problem, tiredness or exhaustion (fatigue), feeling of weakness, trembling, muscle twitches, shortness of breath
• feeling depressed, nervousness, restlessness, lack of attention
• feeling hot (flushing), increased sweating, feeling of body temperature change, dry areas like nostrils, mouth, lips, eyelids, ears, genitals and anus itching, rash
• water retention (oedema)

Uncommon (may affect up to 1 in 100 people)

• weight loss
• low awareness of time, place or identity (disorientation), confusion, excitable (agitated), disturbances in perception, abnormal dreams, forgetfulness, mental impairment
• feeling very happy (euphoria), less consciousness, fainting, sedation, feeling unsteady, difficulty in speaking, numbness
• abnormal sensations of the skin (e.g. tingling, prickling), skin reactions (hives)
• abnormal vision
• faster or slower heartbeat, palpitations, low blood pressure
• stomach discomfort, delay in passing urine, passing urine more often than usual
• sexual dysfunction
• drug withdrawal effects (see ‘If you stop taking Tapimio”)
• feeling strange, irritable

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

• thinking abnormal, epileptic fits, near fainting, uncoordinated, feeling drunk or relaxed
• delayed emptying of the stomach (impaired gastric emptying)

Not known (frequency cannot be estimated from the available data)

• delirium
• dependence and addiction (see section `How do I know if I am addicted?´)

In general, the likelihood of having suicidal thoughts and behaviour is increased in patients suffering from chronic pain. In addition, certain medicines for the treatment of depression (which have an impact on the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data from human use of tapentadol do not provide evidence for an increased risk.

Drug Withdrawal

When you stop taking Tapimio, 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.

If you notice any of the following signs whilst taking Tapimio, 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 prescriber.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is tapentadol.

• Tapimio 50 mg prolonged-release capsules, hard
  Each prolonged-release capsule contains 50 mg tapentadol (as phosphate).
• Tapimio 100 mg prolonged-release capsules, hard
  Each prolonged-release capsule contains 100 mg tapentadol (as phosphate).
• Tapimio 150 mg prolonged-release capsules, hard
  Each prolonged-release capsule contains 150 mg tapentadol (as phosphate).
• Tapimio 200 mg prolonged-release capsules, hard
  Each prolonged-release capsule contains 200 mg tapentadol (as phosphate).
• Tapimio 250 mg prolonged-release capsules, hard
  Each prolonged-release capsule contains 250 mg tapentadol (as phosphate).

The other ingredients are:

Capsules contents:

cellulose, microcrystalline; talc; ethylcellulose; povidone (K30); dibutyl sebacate.

Capsule shell:

gelatin; titanium dioxide (E171); red iron oxide (150, 200 and 250 mg strengths only) (E172); yellow iron oxide (100, 150 and 200 mg strengths only) (E172).

Tapimio 50 mg prolonged-release capsules, hard are hard capsules with white cap and white body filled with white to off-white spherical pellets. They are approximately 18.0 mm in length.

Tapimio 100 mg prolonged-release capsules, hard are hard capsules with ivory cap and ivory body filled with white to off-white spherical pellets. They are approximately 21.7 mm in length.

Tapimio 150 mg prolonged-release capsules, hard are hard capsules with light orange cap and light orange body filled with white to off-white spherical pellets. They are approximately 23.3 mm in length.

Tapimio 200 mg prolonged-release capsules, hard are hard capsules with orange cap and orange body filled with white to off-white spherical pellets. They are approximately 25.3 mm in length.

Tapimio 250 mg prolonged-release capsules, hard are hard capsules with swedish orange cap and swedish orange body filled with white to off-white spherical pellets. They are approximately 26.1 mm in length.

Tapimio 50 mg prolonged-release capsules are available in packs of 28 or 56 capsules. Not all pack sizes may be marketed.

Tapimio 100 mg, 150 mg, 200 mg and 250 mg prolonged-release capsules are available in packs of 56 capsules.

The capsules are supplied in peelable child-resistant paper/PET/aluminium-PVC/PE/PVDC perforated unit dose blisters.