Yantil retard 200 mg, tabletten met verlengde afgifte

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

Do not take YANTIL Retard:

• 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 Retard”)

Warnings and precautions

Talk to your doctor or pharmacist before taking YANTIL Retard 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 Retard”),
• 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 Retard 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 Retard

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 Retard. 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 Retard 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 Retard 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 Retard 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 Retard 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 Retard 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 Retard with food, drink and alcohol

Do not drink alcohol whilst taking YANTIL Retard 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 Retard may cause drowsiness, dizziness and blurred vision and may impair your reactions. This may especially happen when you start taking YANTIL Retard, 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 Retard 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 12 hours. Daily doses of YANTIL Retard greater than 500 mg tapentadol 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 Retard is not suitable for children and adolescents below the age of 18 years.

YANTIL Retard is for oral use.

Always swallow the tablets whole, with sufficient liquid.

Don’t chew it, break it or crush it – this could lead to overdosing, because the drug will be released into your body too quickly. 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 Retard 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 Retard

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 Retard

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, constipation, dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people): decreased appetite, anxiety, depressed mood, sleep problem, nervousness, restlessness, disturbance in attention, trembling, muscle twitches, flushing, shortness of breath, vomiting, diarrhoea, indigestion, itching, increased sweating, rash, feeling of weakness, fatigue, feeling of body temperature change, mucosal dryness, accumulation of water in the tissue (oedema).

Uncommon (may affect up to 1 in 100 people): allergic reaction to medicines, including swelling beneath the skin and hives, weight loss, disorientation, confusion, excitability (agitation), perception disturbances, abnormal dreams, euphoric mood, depressed level of consciousness, memory impairment, mental impairment, fainting, sedation, balance disorder, difficulty in speaking, numbness, abnormal sensations of the skin (e.g. tingling, prickling), abnormal vision, faster heart beat, slower heart beat, palpitations,

decreased blood pressure, abdominal discomfort, hives, delay in passing urine, frequent urination, sexual dysfunction, drug withdrawal syndrome (see “If you stop taking YANTIL Retard”), feeling abnormal, irritability.

Rare (may affect up to 1 in 1,000 people): drug dependence, thinking abnormal, epileptic fit, near fainting, coordination abnormal, dangerously slow or shallow breathing (respiratory depression), impaired gastric emptying, feeling drunk, feeling of relaxation.

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.

What YANTIL Retard contains

The active substance is tapentadol.

Each tablet contains 50 mg tapentadol (as hydrochloride).

Each tablet contains 100 mg tapentadol (as hydrochloride).

Each tablet contains 150 mg tapentadol (as hydrochloride).

Each tablet contains 200 mg tapentadol (as hydrochloride).

Each tablet contains 250 mg tapentadol (as hydrochloride).

The other ingredients are:

[50 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171).

[100 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172).

[150 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).

[200 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).

[250 mg]: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172), black iron oxide (E 172).

What YANTIL Retard looks like and contents of the pack

[50 mg]: White film-coated oblong shaped prolonged-release tablets (6.5 mm x 15 mm) marked with

Grünenthal logo on one side and “H1” on the other side.

[100 mg]: Pale yellow film-coated oblong shaped prolonged-release tablets (6.5 mm x 15 mm) marked with

Grünenthal logo on one side and “H2” on the other side.

[150 mg]: Pale pink film-coated oblong shaped prolonged-release tablets (6.5 mm x 15 mm) marked with

Grünenthal logo on one side and “H3” on the other side.

[200 mg]: Pale orange film-coated oblong shaped prolonged-release tablets (7 mm x 17 mm) marked with

Grünenthal logo on one side and “H4” on the other side.

[250 mg]: Brownish red film-coated oblong shaped prolonged-release tablets (7 mm x 17 mm) marked with

Grünenthal logo on one side and “H5” on the other side.

YANTIL Retard prolonged-release tablets are packed in blisters and are supplied in boxes of 7, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1tablets.

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, Germany, Luxembourg, Netherlands, Portugal, Spain: YANTIL retard Denmark, Finland, Norway, Sweden: YANTIL Depot

Ireland, United Kingdom: YANTIL SR

France: YANTIL LP

Italy: YANTIL

This leaflet was last approved in August 2013.