Tilodol Sr 100 Mg Prolonged-Release Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
Invodol SR 100 mg Prolonged-release Tablets Invodol SR 150 mg Prolonged-release Tablets Invodol SR 200 mg Prolonged-release Tablets
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Invodol SR is and what it is used for
2. Before you take Invodol SR
3. How to take Invodol SR
4. Possible side effects
5. How to store Invodol SR
6. Further information
Tramadol hydrochloride, the active substance in Invodol SR, is a centrally active analgesic of the opioid group. Its pain alleviating effects are attributable to its influence on specific nerve cells in the spinal cord and in the brain.
Invodol SR is used:
• in the treatment of moderately severe to severe pain.
Do not take Invodol SR
• if you are allergic (hypersensitive) to tramadol hydrochloride or any of the other ingredients of Invodol SR
• if you have acute intoxication with alcohol, sleeping agents, centrally acting painkillers, opioids or other psychotropic agents (medicines which influence mood, emotional status and disposition)
• if you are taking MAO inhibitors concomitantly (specific medicines which are used to treat abnormally depressive mood [depression] or Parkinson's disease) or have taken these in the last 14 days prior to starting treatment with Invodol SR (see “Taking other medicines”)
• if you have epilepsy and this cannot be adequately controlled by use of medicines
• asa substitute in drug withdrawal treatment.
Take special care with Invodol SR if you
• think you may already be dependent on other analgesic 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
• have a condition which involves increased cerebral pressure (possible after head injuries or in the presence of brain disorders)
• have a liver or kidney disorder
• react sensitively to opiates
• tend to be epileptic or suffer seizures.
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 maximum daily dose of 400 mg tramadol is exceeded or if you are taking medicines concomitantly which lower the seizure threshold (see “Taking other medicines”).
Please note that psychological and physical dependence can develop in patients on Invodol SR.
During long-term use, the effects of Invodol SR may weaken, with the result that it becomes necessary to use a higher dose (development of tolerance). For this reason, Invodol 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 Invodol SR and ifyou have experienced such problems in the past.
Children
Invodol SR is not suited for use in children of less than 12 years of age (see section 3 “How to take Invodol SR”).
The 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 Invodol SR”).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The analgesic effects of Invodol 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 take Invodol SR concurrently with other medicines which also depress brain function, e.g. cough medicines, some analgesics, sleeping agents, preparations used to treat anxiety states and preparations used as substitutes during drug withdrawal treatment. In these cases, there is an increased risk of depression of respiratory activity or, in extreme circumstances, there can be respiratory arrest in case of overdose
• 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 Invodol SR at the same time. Your doctor will tell you whether Invodol SR is suitable for you.
• If you are taking certain antidepressants Invodol 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 taking cimetidine (for gastric ulcers)
• 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).
Other possible interactions
Do not take Invodol SR concurrently with 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 14days prior to starting treatment with Invodol SR. It cannot be excluded that life-threatening interactions, involving effects on the central nervous system and on respiratory and cardiovascular function, could occur.
Taking Invodol SR with food and drink
Do not drink alcohol while taking Invodol SR, this could enhance the effects of the medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There is very little information regarding the safety of tramadol in human pregnancy. In general, you should not take Invodol SR if you are pregnant.
Repeated use of Invodol SR during pregnancy can lead to a dependency of the unborn child on the drug and, consequently, to withdrawal symptoms in the newborn child after birth.
Breast-feeding
Very small quantities of tramadol are excreted into breast milk. You should not take Invodol SR if you are breast-feeding.
As a rule, it is not necessary to interrupt breast-feeding after taking a single dose of tramadol. Please ask your doctor for advice.
Driving and using machines
Invodol 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.
Important information about certain ingredients of Invodol SR
This medicinal product 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.
3 How to take Invodol SR
Always take Invodol SR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The dosage 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, unless otherwise prescribed by your doctor, is:
Adults and adolescents over the age of12 years
The usual starting dose is 100 mg tramadol hydrochloride 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 medicinal product, 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 tramadol hydrochloride daily unless there are specific medical reasons for this.
Children under 12years
Invodol SR is not recommended for use in children under 12years.
Elderly patients
In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency should not take Invodol SR. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval
Note'.
The doses recommended above are guideline values only. Ifyou 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). You can take the prolonged-release tablets separately or with meals.
It is important that you do not continue to take Invodol SR for longer than absolutely necessary.
If you take more Invodol SR than you should
This will not normally have any negative consequences for you. Continue to take Invodol 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, heartfailure, feeling sleepy or drowsy (with coma in extreme cases), migraine symptoms or epileptic seizures and shallow breathing with respiratory arrest in extreme cases.
If you observe any of these symptoms or if a child accidentally takes Invodol SR, immediately contact the nearest doctor or hospital for help!
If you forget to take Invodol 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 Invodol SR
If you interrupt or prematurely stop treatment with Invodol SR, your pain may return. If you decide you wish to stop taking this preparation because of unpleasant side effects, please consult your doctor.
There will normally be no after-effects when you stop taking Invodol SR. However, in a few cases in which patients have been taking Invodol SR for a very long period, there have been after-effects such as restlessness, anxiety states, nervousness, insomnia, tremor or gastrointestinal upset. If you experience any of these side effects when you stop taking Invodol SR, please consult your doctor.
If you have any further questions on the use of the product, ask your doctor or pharmacist.
• changes in appetite
• abnormal skin sensations (such as tingling, pins and needles, sensation of numbness)
• tremor
• shallow breathing
• epileptic seizures
• involuntary muscle tics
• impaired coordination
• syncope
• blurred vision
• slow heart rate (bradycardia)
• increased blood pressure
• laboured breathing (dyspnoea) - Worsening of asthma has been reported, although there is no data available to show that this is directly related to treatment with tramadol hydrochloride. Shallow breathing may result if the prescribed dose is exceeded or other medicines that depress brain function are used concurrently.
• reduced muscular strength
• impaired urination or excretion of less urine than normal.
Veryrare (affects less than 1 userin 10,000):
• balance disorders
• a feeling of heat in parts of your body (heat sensation)
• elevation of liver enzymes.
Not known (frequencycannot be estimated from the available data):
• speech disorders
• widening of the pupils (mydriasis)
Although the risk is slight, dependence can develop when Invodol SR is used for longer periods. Withdrawal symptoms can develop when treatment is stopped (see section 3 “If you stop taking Invodol SR”)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Invodol SR after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
Storage conditions
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6
Like all medicines, Invodol SR can cause side effects, although not everybody gets them.
Serious side effects:
Invodol SR can occasionally cause allergic reactions, although severe allergic reactions are rare (affecting 1to10 users in 10,000). Stop taking Invodol 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 Invodol SR and contact your nearest hospital ifyou 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:
Verycommon (affects more than 1 useroflO):
• dizziness
• nausea.
Common (affects 1 to 10 users in 100):
• headache
• drowsiness
• vomiting
• constipation
• dry mouth
• sweating
• tiredness.
Uncommon (affects 1 to 10 users in 1,000):
• effects on the regulation of blood circulation (for example palpitations, increased heart rate). These side effects occur most frequently in association with upright body posture and physical exertion
• retching
• gastric complications (e. g. stomach upset, abdominal fullness)
• diarrhoea
• skin symptoms (e.g. itching, rash, rapid reddening of the skin).
Rare (affects 1 to 10 users in 10,000):
• shock reactions (sudden circulatory failure)
• hallucinations, confusion, sleep disturbances and nightmares - Psychological symptoms may occur after treatment with Invodol 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)
What Invodol SR contains
The active substance is: tramadol
hydrochloride
One Invodol SR 100 mg Prolonged-release Tablet contains 100 mg tramadol hydrochloride as 8.3 mg tramadol hydrochloride, immediate release, and 91.7 mg tramadol hydrochloride, slow release.
One Invodol SR 150 mg Prolonged-release Tablet contains 150 mg tramadol hydrochloride as 12.5 mg tramadol hydrochloride, immediate release, and 137.5 mg tramadol hydrochloride, slow release.
One Invodol SR 200 mg Prolonged-release Tablet contains 200 mg tramadol hydrochloride as 16.7 mg tramadol hydrochloride, immediate release, and 183.3 mg tramadol hydrochloride, slow release.
The other ingredients are:
Initial layer
lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, cellulose, microcrystalline, sodium starch glycollate (Type A), magnesium stearate, silica, colloidal anhydrous.
Depot layer
lactose monohydrate, hypromellose, povidone K25, magnesium stearate, silica, colloidal anhydrous, castor oil, hydrogenated, quinoline yellow, indigo carmine, aluminium hydroxide.
What Invodol SR looks like and contents of the pack
Invodol SR 100 mg Prolonged-release Tablets are white-green, round bilayer tablets coded TR/100 R on one side.
Invodol SR 150 mg Prolonged-release Tablets are white-green, round bilayer tablets coded TR/150 R on one side.
Invodol SR 200 mg Prolonged-release Tablets are white-green, round bilayer tablets coded TR/200 R on one side.
Invodol 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 Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer Salutas Pharma GmbH,
Otto-Von-Guericke-Alle 1,
D-39179 Barleben,
Germany.
Distributed bv
Ennogen Healthcare Limited Unit G4 Riverside Industrial Estate Riverside Way, Dartford Kent, DA1 5BS. UK