TIIODOL SR 150 MG PROLONGED-RELEASE TABLETS, INVODOL SR 150 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

What you need to know before you take Tilodol SR

Do not take Tilodol SR

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
• in acute poisoning with alcohol, sleeping agents, centrally acting painkillers, opioids or other psychotropic medicines (medicines which influence mood, emotional status and disposition)
• if you are also taking monoamine oxidase (MAO) inhibitors concomitantly (specific medicines which are used to treat abnormally depressive mood [depression] or Parkinson's di­sease) or have taken them in the last 14 days before treatment with Tilodol SR (see “Other medicines and Tilodol SR”))
• if you have epilepsy and your fits are not ade quately controlled by treatment
• as a substitute in drug withdrawal treatment.

Warnings and precautions

Talk to your doctor before taking Tilodol SR if you

• think you may already be dependent on other analgesics agents (opioids)
• have a consciousness disturbance (e.g. if you feel unusually dazed)
• are in shock (cold sweat can be an indication of this)
• have difficulty in breathing
• suffer from increased pressure in the brain (possibly after a head injury or brain disease)
• have a liver or kidney disorder
• react sensitively to opiates
• tend to be epileptic or suffer seizures (fits)

If any of the above applies to you, please talk to your doctor before starting to take this medicine.

Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased if the recommended upper daily dose limit of 400 mg Tilodol SR is exceeded or if you are taking medicines concomitantly which lower the seizure threshold (see “Other medicines and Tilodol SR”).

Please note that psychological and physical dependence can develop in patients on Tilodol SR. During long-term use, the effects of Tilodol SR may weaken, with the result that it becomes necessary to use a higher dose (development of tolerance). For this reason, Tilodol SR must be used for short periods only and under strictest medical supervision in patients at risk of developing drug dependence.

Please also inform your doctor if any of these problems develop while you are taking Tilodol SR and if you have experienced such problems in the past.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Tilodol SR is not suitable for use in children of less than 12 years of age.

Use in children with breathing problems: Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.

Elderly

Patients of more than 75 years of age should be monitored carefully as the elimination of tramadol can be prolonged (see section 3 “How to take Tilodol SR”).

Other medicines and Tilodol SR

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

Do not take Tilodol SR concurrently with monoamine oxidase (MAO) inhibitors (medicines which are used to treat abnormally depressive mood [depression] or Parkinson's di­sease) or if you have taken these in the last 14 days before treatment with Tilodol SR. It cannot be excluded that life-threatening interactions, involving effects on the central nervous system and on respiratory and cardiovascular function, could occur.

• The analgesic effects of Tilodol SR may be reduced and the duration of therapeutic effects may be shortened if you are taking medicines containing one of the following active substances: carbamazepine (used to treat epileptic seizures) pentazocine, nalbuphine or buprenorphine (painkillers)
• ondansetron (used to treat nausea)

The risk of side effects increases:

• if you are taking sedative medicines such as benzodiazepines or related medicines (e.g. tranquillizers, sleeping pills). Concomitant use of Tilodol SR and sedative medicines such as benzodiazepines or related medicines 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 Tilodol SR 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 take Tilodol SR concurrently with other medicines which also depress brain function, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tilodol SR. You may feel drowsier or feel that you might faint. If this happens tell your doctor 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 Tilodol SR at the same time. Your doctor will tell you whether Tilodol SR is suitable for you.
• if you are taking certain antidepressants. Tilodol SR may interact with these medicines 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.
• if you are concurrently taking medicines that prevent normal blood coagulation (so-called coumarin derivatives, such as warfarin). The anticoagulatory effects of these medicines can be enhanced and there can be major bleeding and haemorrhaging under small areas of the skin (ecchymosis).

Tilodol SR with food and alcohol

Do not drink alcohol while taking Tilodol SR, this could enhance the effects of this medicine.

Food does not influence the effect of Tilodol SR (see section 3 “How to take Tilodol SR”).

Pregnancy, breast-feeding and fertility

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.

Pregnancy

There is very little information regarding the safety of tramadol hydrochloride in human pregnancy. Therefore, you should not take Tilodol SR if you are pregnant.

Chronic use of Tilodol SR during pregnancy may lead to withdrawal symptoms in the newborn child after birth.

Breast-feeding

Tramadol is excreted into breast milk. For this reason, you should not take Tilodol SR more than once during breast-feeding, or alternatively, if you take Tilodol SR more than once, you should stop breast-feeding.

Fertility

Based on human experience tramadol hydrochloride is suggested not to influence female or male fertility.

Driving and using machines

Tilodol SR can, among other things, cause

• drowsiness and dizziness
• visual disturbance (blurred vision)

and thus can impair your ability to react. Do not drive or use any tools or machines if this occurs or if you have the feeling that your ability to react is reduced.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• 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.

Tilodol SR contains lactose

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

Tilodol SR contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.

3

How to take Tilodol SR

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

The dose should be adjusted to the intensity of your pain and your individual pain sensitivity.

In general the lowest pain-relieving dose should be taken.

The usual dose is, unless otherwise prescribed by your doctor:

Continued on the next page >>

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Adults and adolescents over the age of 12 years The usual starting dose is 100 mg Tilodol SR twice daily, taken once in the morning and once in the evening. If pain relief is insufficient, your doctor can increase the dose to 150 mg twice daily or 200 mg twice daily.

For doses not realisable/prac­ticable with this medicine, other strengths are available.

There must be a minimum interval of 8 hours between each dose.

As a general rule, you should take no more than the minimum dose you require to control your pain.

Do not take more than 400 mg Tilodol SR daily unless there are specific medical reasons for this.

Use in children under 12 years

Tilodol SR is not recommended to use in children under 12 years.

Elderly

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dose interval.

Severe liver or kidney disease (insufficiency)/di­alysis patients Patients with severe liver and/or kidney insufficiency should not take Tilodol SR. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dose interval.

Note:

The doses recommended above are guideline values only. If you are taking the preparation for the management of chronic pain, you should always, if possible, strictly follow a planned administration schedule.

Method of administration

Swallow the prolonged-release tablets whole with sufficient liquid (e. g. one glass of water). Do not divide, break or chew the tablets.

You can take the prolonged-release tablets separately or with meals.

It is important that you do not continue to take Tilodol SR for longer than absolutely necessary.

If you take more Tilodol SR than you should This will not normally have any negative consequences for you. Continue to take Tilodol SR as your pain recurs as usual.

If you have taken an excessive dose of the medicine the following signs can occur: narrowed pupils, vomiting, low blood pressure, heart failure, feeling sleepy or drowsy (with coma in extreme cases), migraine symptoms or epileptic seizures (fits) and shallow breathing with respiratory arrest in extreme cases.

If you observe any of these symptoms or if a child accidentally takes Tilodol SR, immediately contact the nearest doctor or hospital for help.

If you forget to take Tilodol SR

You may experience recurrence of pain. Do not take a double dose to make up for a forgotten dose, but continue to take the preparation as prescribed.

If you stop taking Tilodol SR

You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms). Withdrawal symptoms can be the following: You may feel agitated, anxious, nervous or shaky. You may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonaliza­tion), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stop taking Tilodol SR., please consult your doctor.

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

4

Possible side effects

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

Serious side effects:

• Tilodol SR can occasionally cause allergic reactions, although severe allergic reactions are rare (affecting 1 to 10 users in 10,000). Stop taking Tilodol SR and tell your doctor straight away if you experience any of the following symptoms of a serious allergic reaction: sudden wheezing or difficulty in breathing swelling of the face, lips or throat
• rash or itching (especially affecting your whole body)

You should stop taking Tilodol SR and contact your nearest hospital if you experience any symptoms of cardiovascular collapse, such as:

• chest pain
• irregular heart beat
• breathlessness

Epileptic seizures may occur after the use of high doses of tramadol or after concurrent use of other medicines which can themselves cause seizures or which lower the seizure threshold.

Other possible side effects:

Very common: may affect more than 1 in 10 people

• dizziness
• nausea

Common: may affect up to 1 in 10 people

• headache
• drowsiness
• vomiting
• constipation
• dry mouth
• sweating
• tiredness

Uncommon: (may affect up to 1 in 100 people)

• effects on the regulation of blood circulation (for example palpitations, increased heart rate weakness attack and circulatory failure). These side effects occur most frequently in association with upright body posture and physical exertion.
• urge to vomit (retching)
• gastric complications (e. g. stomach upset, abdominal fullness)
• diarrhoea
• skin symptoms (e.g. itching, rash, rapid reddening of the skin)
• Rare: may affect up to 1 in 1,000 people allergic reactions (e.g. difficulty in breathing, wheezing, swelling of the skin) and shock

(sudden circulatory failure)

• hallucination, confusion, delirium, anxiety, sleep disturbances and nightmares – Psychological symptoms may occur after treatment with Tilodol SR, whereby their intensity and nature can differ in the individual case (depending on personality and duration of use). These can take the form of mood changes (usually elated mood, sometimes irritable mood), changes in activity (usually reduced, sometimes increased) and changes in the cognitive and sensory abilities (changes in sensory perception and impairment of the ability to recognise, which can lead to inappropriate decisions).
• drug dependence may occur.
• changes in appetite
• abnormal skin sensations (such as tingling, pins and needles, sensation of numbness)
• tremor
• shallow breathing; may result if the prescribed dose is exceeded or other medicines that depress brain function are used concurrently
• epileptic fits; occurred mainly after the use of high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits involuntary muscle tics
• impaired coordination
• transient loss of consciousness (syncope)
• speech disorders
• blurred vision, constriction of the pupil (miosis), widening of the pupils (mydriasis)
• slow heart rate (bradycardia)
• increased blood pressure
• slow breathing, shortness of breath (dyspnoea); Shallow breathing may result if the prescribed dose is exceeded or other medicines that depress brain function are used concurrently.
• Worsening of asthma has been reported, although there is no data available to show that this is directly related to treatment with tramadol hydrochloride.
• weak muscles
• passing urine with difficulty or pain, excretion of less urine than normal

Very rare: may affect up to 1 in 10,000 people

• elevation of liver enzymes

Not known: frequency cannot be estimated from the available data

• decrease in blood sugar level

How to store Tilodol SR

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

Do not use Tilodol SR after the expiry date which is stated on the blister and the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine 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.

Contents of the pack and other information

What Tilodol SR contains

The active substance is: tramadol hydrochloride

Each Tilodol SR 100 mg Prolonged-release Tablet contains 100 mg tramadol hydrochloride.

Each Tilodol SR 150 mg Prolonged-release Tablet contains 150 mg tramadol hydrochloride.

Each Tilodol SR 200 mg Prolonged-release Tablet contains 200 mg tramadol hydrochloride.

The other ingredients are:

Initial layer

lactose monohydrate; calcium hydrogen phosphate dihydrate; maize starch; cellulose microcrystalline;

sodium starch glycolate (Type A); magnesium stearate; silica colloidal anhydrous.

Slow release layer

lactose monohydrate; hypromellose; povidone K25; magnesium stearate; silica colloidal anhydrous; castor oil hydrogenated; quinoline yellow (E104); indigo carmine (E132); aluminium hydroxide.

What Tilodol SR looks like and contents of the pack

100 mg prolonged-release tablet:

The prolonged-release Tablets are flat, round bi-layer-tablets with facet, initial layer white, slow-release layer green with one-sided identification mark “TR / 100 R”.

150 mg prolonged-release tablet:

The prolonged-release Tablets are flat, round bi-layer-tablets with facet, initial layer white, slow-release layer green with one-sided identification mark “TR / 150 R”.

200 mg prolonged-release tablet:

The prolonged-release Tablets are flat, round bi-layer-tablets with facet, initial layer white, slow-release layer green with one-sided identification mark “TR / 200 R”.

Tilodol SR is available in packs with 10, 20, 30, 50, 60 and 100 prolonged-release tablets in a PP/Aluminium blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturer

Marketing Authorisation Holder

Sandoz Limited, Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK

Manufacturer

Salutas Pharma GmbH, Otto-Von-Guericke-Alle

1, D-39179 Barleben, Germany.

This leaflet was last revised

on 06/2019

46248259 SZ89­508LT08A

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Adults and adolescents over the age of 12 years The usual starting dose is 100 mg Tilodol SR twice daily, taken once in the morning and once in the evening. If pain relief is insufficient, your doctor can increase the dose to 150 mg twice daily or 200 mg twice daily.

For doses not realisable/prac­ticable with this medicine, other strengths are available.

There must be a minimum interval of 8 hours between each dose.

As a general rule, you should take no more than the minimum dose you require to control your pain.

Do not take more than 400 mg Tilodol SR daily unless there are specific medical reasons for this.

Use in children under 12 years

Tilodol SR is not recommended to use in children under 12 years.

Elderly

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dose interval.

Severe liver or kidney disease (insufficiency)/di­alysis patients Patients with severe liver and/or kidney insufficiency should not take Tilodol SR. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dose interval.

Note:

The doses recommended above are guideline values only. If you are taking the preparation for the management of chronic pain, you should always, if possible, strictly follow a planned administration schedule.

Method of administration

Swallow the prolonged-release tablets whole with sufficient liquid (e. g. one glass of water). Do not divide, break or chew the tablets.

You can take the prolonged-release tablets separately or with meals.

It is important that you do not continue to take Tilodol SR for longer than absolutely necessary.

If you take more Tilodol SR than you should This will not normally have any negative consequences for you. Continue to take Tilodol SR as your pain recurs as usual.

If you have taken an excessive dose of the medicine the following signs can occur: narrowed pupils, vomiting, low blood pressure, heart failure, feeling sleepy or drowsy (with coma in extreme cases), migraine symptoms or epileptic seizures (fits) and shallow breathing with respiratory arrest in extreme cases.

If you observe any of these symptoms or if a child accidentally takes Tilodol SR, immediately contact the nearest doctor or hospital for help.

If you forget to take Tilodol SR

You may experience recurrence of pain. Do not take a double dose to make up for a forgotten dose, but continue to take the preparation as prescribed.

If you stop taking Tilodol SR

You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms). Withdrawal symptoms can be the following: You may feel agitated, anxious, nervous or shaky. You may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonaliza­tion), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stop taking Tilodol SR., please consult your doctor.

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

4 Possible side effects

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

Serious side effects:

• Tilodol SR can occasionally cause allergic reactions, although severe allergic reactions are rare (affecting 1 to 10 users in 10,000). Stop taking Tilodol SR and tell your doctor straight away if you experience any of the following symptoms of a serious allergic reaction: sudden wheezing or difficulty in breathing swelling of the face, lips or throat
• rash or itching (especially affecting your whole body)

You should stop taking Tilodol SR and contact your nearest hospital if you experience any symptoms of cardiovascular collapse, such as:

• chest pain
• irregular heart beat
• breathlessness

Epileptic seizures may occur after the use of high doses of tramadol or after concurrent use of other medicines which can themselves cause seizures or which lower the seizure threshold.

Other possible side effects:

Very common: may affect more than 1 in 10 people

• dizziness
• nausea

Common: may affect up to 1 in 10 people

• headache
• drowsiness
• vomiting
• constipation
• dry mouth
• sweating
• tiredness

Uncommon: (may affect up to 1 in 100 people)

• effects on the regulation of blood circulation (for example palpitations, increased heart rate weakness attack and circulatory failure). These side effects occur most frequently in association with upright body posture and physical exertion.
• urge to vomit (retching)
• gastric complications (e. g. stomach upset, abdominal fullness)
• diarrhoea
• skin symptoms (e.g. itching, rash, rapid reddening of the skin)
• Rare: may affect up to 1 in 1,000 people allergic reactions (e.g. difficulty in breathing, wheezing, swelling of the skin) and shock

(sudden circulatory failure)

• hallucination, confusion, delirium, anxiety, sleep disturbances and nightmares – Psychological symptoms may occur after treatment with Tilodol SR, whereby their intensity and nature can differ in the individual case (depending on personality and duration of use). These can take the form of mood changes (usually elated mood, sometimes irritable mood), changes in activity (usually reduced, sometimes increased) and changes in the cognitive and sensory abilities (changes in sensory perception and impairment of the ability to recognise, which can lead to inappropriate decisions).
• drug dependence may occur.
• changes in appetite
• abnormal skin sensations (such as tingling, pins and needles, sensation of numbness)
• tremor
• shallow breathing; may result if the prescribed dose is exceeded or other medicines that depress brain function are used concurrently
• epileptic fits; occurred mainly after the use of high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits involuntary muscle tics
• impaired coordination
• transient loss of consciousness (syncope)
• speech disorders
• blurred vision, constriction of the pupil (miosis), widening of the pupils (mydriasis)
• slow heart rate (bradycardia)
• increased blood pressure
• slow breathing, shortness of breath (dyspnoea); Shallow breathing may result if the prescribed dose is exceeded or other medicines that depress brain function are used concurrently.
• Worsening of asthma has been reported, although there is no data available to show that this is directly related to treatment with tramadol hydrochloride.
• weak muscles
• passing urine with difficulty or pain, excretion of less urine than normal

Very rare: may affect up to 1 in 10,000 people

• elevation of liver enzymes

Not known: frequency cannot be estimated from the available data

• decrease in blood sugar level