Yantil 75 mg, filmomhulde tabletten

Tapentadol - the active substance in YANTIL - is a strong painkiller which belongs to the class of opioids. YANTIL is used for the treatment of moderate to severe acute pain in adults that can only be adequately managed with an opioid painkiller.

Do not take YANTIL:

• 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 paralysis of the gut
• If you have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) (see "Other medicines and YANTIL")

Warnings and precautions

Talk to your doctor or pharmacist before taking YANTIL if you:

• have slow or shallow breathing,
• suffer from increased pressure in the brain or disturbed consciousness up to coma,
• have had a head injury or brain tumors,
• have had an epileptic fit or if you have an increased risk of having epileptic fits,
• suffer from a liver or kidney disease (see “How to take YANTIL”),
• suffer from a pancreatic or biliary tract disease, including pancreatitis,
• are taking medicines referred to as mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial mu-opioid agonists (e.g. buprenorphine).

YANTIL may lead to physical and psychological addiction. If you have a tendency to abuse medicines or if you are dependent on medicines, you should only take these tablets for short periods and under strict medical supervision.

Other medicines and YANTIL

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

Your breathing may become dangerously slow or shallow (respiratory depression) if you are taking certain sleeping pills or tranquillizers (e.g. barbiturates, benzodiazepines), or pain relievers such as morphine and codeine (also as cough medicine) in combination with YANTIL. If this happens tell your doctor.

If you are taking certain CNS depressants (e.g. benzodiazepines, antipsychotics, H1-antihistamines, opioids, alcohol) in combination with YANTIL your consciousness may be decreased, you may feel drowsier or feel that you might faint. If this happens tell your doctor.

Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who took tapentadol in combination with so called serotoninergic medicines (e.g. certain medicines for the treatment of depression). Signs of serotonin syndrome may be for example confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, myoclonus and diarrhoea. Your doctor may advise you on this.

Taking YANTIL together with other types of medicines referred to as mixed mu-opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial mu-opioid agonists (e.g., buprenorphine) has not been studied. It is possible that YANTIL will not work as well if given together with one of these medicinal products. Tell your doctor in case you are currently treated with one of these medicinal products.

Taking YANTIL together with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St John’s Wort) of certain enzymes that are necessary to eliminate tapentadol from your body, may influence how well tapentadol works or may cause side effects, especially when this other medication is started or stopped. Please keep your doctor informed about all medicines you are taking.

YANTIL 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.

YANTIL with food, drink and alcohol

Do not drink alcohol whilst taking YANTIL, because some side effects such as drowsiness may be increased. Food does not influence the effect of this medicine.

Pregnancy and breast-feeding

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

Do not take these tablets:

• if you are pregnant, unless your doctor has instructed you to do so,
• during childbirth because it could lead to dangerously slow or shallow breathing (respiratory depression) in the newborn,
• during breast-feeding, because it may be excreted in the breast milk.

Driving and using machines

YANTIL may cause drowsiness, dizziness and blurred vision and may impair your reactions. This may especially happen when you start taking YANTIL, when your doctor changes your dosage or when you drink alcohol or take tranquillizers. Please ask your doctor whether it is permitted to drive a car or use machines.

YANTIL contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will adjust the dosage according to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.

Adults

The usual dose is 1 tablet every 4 to 6 hours. Daily doses greater than 700 mg tapentadol on the first day of treatment and daily doses greater than 600 mg tapentadol on the following days of treatment are not recommended.

Your doctor may prescribe a different, more appropriate dose or interval of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

Elderly patients

In elderly patients (above 65 years) usually no dose adjustment is necessary. However, the excretion of tapentadol may be delayed in some patients of this age group. If this applies to you, your doctor may recommend a different dosage regimen.

Liver and Kidney disease (insufficiency)

Patients with severe liver problems should not take these tablets. If you have moderate problems, your doctor will recommend a different dosage regimen. In case of mild liver problems, a dosage adjustment is not required.

Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, a dosage adjustment is not required.

Use in children and adolescents

YANTIL is not suitable for children and adolescents below the age of 18 years.

YANTIL is for oral use.

Swallow the tablets with sufficient liquid. You may take the tablets on an empty stomach or with meals.

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

If you take more YANTIL than you should

After taking very high doses, the following may be experienced:

• pin-point pupils, vomiting, drop in blood pressure, fast heart beat, collapse, disturbed consciousness or coma (deep unconsciousness), epileptic fits, dangerously slow or shallow breathing or stopping breathing may occur.

If this happens a doctor should be called immediately!

If you forget to take YANTIL

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

If you stop taking YANTIL

If you interrupt or stop treatment too soon, your pain is likely to return. If you wish to stop treatment, please tell your doctor first before stopping treatment.

Generally there will be no after-effects when treatment is stopped, however, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they abruptly stop taking them.

Symptoms may be:

• restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain and dilated pupils,
• irritability, anxiety, backache, joint pain, weakness, abdominal cramps, difficulty in sleeping, nausea, loss of appetite, vomiting, diarrhea, and increases in blood pressure, breathing or heart

rate.

If you experience any of these complaints after stopping treatment, please consult your doctor.

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

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects or symptoms to look out for and what to do if you are affected:

This medicine may cause allergic reactions. Symptoms may be wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching, especially those covering your whole body.

Another serious side effect is a condition where you breathe more slowly or weakly than expected. It mostly occurs in elderly and weak patients.

If you are affected by these important side effects contact a doctor immediately.

Other side effects that may occur:

Very common (may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people): decreased appetite, anxiety, confusion, hallucination, sleep problem, abnormal dreams, trembling, flushing, constipation, diarrhoea, indigestion, dry mouth, itching, increased sweating, rash, muscle cramps, feeling of weakness, fatigue, feeling of body temperature change.

Uncommon (may affect up to 1 in 100 people): depressed mood, disorientation, excitability (agitation), nervousness, restlessness, euphoric mood, disturbance in attention, memory impairment, near fainting, sedation, difficulty in controlling movements, difficulty in speaking, numbness, abnormal sensations of the skin (e.g. tingling, prickling), muscle twitches, abnormal vision, faster heart beat, palpitations, decreased blood pressure, dangerously slow or shallow breathing (respiratory depression), less oxygen in the blood, shortness of breath, abdominal discomfort, hives, sensation of heaviness, delay in passing urine, frequent urination, drug withdrawal syndrome (see “If you stop taking YANTIL”), accumulation of water in the tissue (oedema), feeling abnormal, feeling drunk, irritability, feeling of relaxation.

Rare (may affect up to 1 in 1,000 people): allergic reaction to medicines, including swelling beneath the skin and hives, thinking abnormal, epileptic fit, depressed level of consciousness, coordination abnormal, slower heartbeat, impaired gastric emptying.

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.

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

Keep this medicine out of the sight and reach of children.

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

This medicinal product does not require any special storage conditions.

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 protect the environment.

The active substance is tapentadol.

Each tablet contains 50 mg tapentadol (as hydrochloride).

Each tablet contains 75 mg tapentadol (as hydrochloride).

Each tablet contains 100 mg tapentadol (as hydrochloride).

The other ingredients are:

[50 mg]:

Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet coat: polyvinylalcohol, titanium dioxide (E 171), macrogol 3350, talc.

[75 mg]:

Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet coat: polyvinylalcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

[100 mg]:

Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet coat: polyvinylalcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What YANTIL looks like and contents of the pack

[50 mg]: White round shaped film-coated tablets of 7 mm diameter, marked with Grünenthal logo on one side and “H6” on the other side.

[75 mg]: Pale yellow round shaped film-coated tablets of 8 mm diameter, marked with Grünenthal logo on one side and “H7” on the other side.

[100 mg]: Pale pink round shaped film-coated tablets of 9 mm diameter, marked with Grünenthal logo on one side and “H8” on the other side.

YANTIL film-coated tablets are packed in blisters and are supplied in boxes of 5, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grünenthal B.V., De Corridor 21K, 3621 ZA Breukelen.

Manufacturer:

Grünenthal GmbH, Zieglerstrasse 6, D-52078 Aachen, Germany.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom: YANTIL

This leaflet was last revised in August 2013.