100 mg, 150 mg, 200 mg prolonged-release tablets are
tramadol hydrochloride
What Nobligan retard is and what it is used for
Tramadol – the active substance in Nobligan retard – is a painkiller that belongs to a class of opioids that act on the central nervous system. Tramadol relieves pain by acting on certain nerve cells in the spinal cord and brain.
Nobligan retard is used to treat moderate to severe pain.
Tramadol contained in Nobligan retard may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Nobligan retard
Do not take the Nobligan retard
- if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
- in case of acute poisoning with alcohol, sleeping pills, painkillers or psychotropic drugs (drugs that affect mood / mood and emotional life);
- if you are taking MAOIs (certain medicines to treat depression) at the same time or have been taking such medicines for the last 14 days (see “Other medicines and Nobligan retard”);
- if you suffer from epilepsy that is not well controlled with treatment;
- as a substitute for drug withdrawal.
Warnings and cautions
Talk to your doctor before taking Nobligan retard
- if you suspect you are addicted to other painkillers ( opioids );
- if you suffer from impaired consciousness (if you feel dizzy);
- if you are in a state of shock (cold sweats may be a sign of this);
- if you have increased pressure in the head (after head or brain injury);
- if you have difficulty breathing;
- if you have a tendency to have epileptic seizures or seizures, as the risk of seizures may increase;
- if you are suffering from depression and are taking antidepressant medicines as some of them may interact with tramadol (see “Other medicines and Nobligan retard”);
- if you have impaired liver or kidney function.
Epileptic seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when dose one of tramadol exceeds the maximum recommended daily dose (400 mg).
Note that Nobligan retardation can give rise to physical and mental dependence. When Nobligan retard is taken for a longer period, the effect may decrease and higher doses may be necessary ( tolerance development ).
Patients with a tendency to drug abuse or with drug dependence should only be treated with Nobligan retard for short periods and under strict medical supervision.
Tramadol is converted in the liver by an enzyme. Some people have a variation of this enzyme and it can affect different people in different ways. Some people may not get enough pain relief, while others are at greater risk for serious side effects. If you get any of the following side effects, stop taking this medicine and see a doctor immediately: slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, poor appetite.
Nobligan retard contains an active substance that belongs to the group opioids. Opioids can cause sleep-related respiratory disorders, e.g. central sleep apnea (shallow breathing or respiratory arrest during sleep) and sleep-related hypoxemia (too low oxygen content in the blood).
The risk of experiencing central sleep apnea depends on the dose of one of the opioids. Your doctor may consider reducing your total opioid dose if you experience central sleep apnea.
There is a small risk that you may get a so-called serotonergic syndrome, which can occur after taking tramadol in combination with certain antidepressant drugs or tramadol alone. Seek medical attention immediately if you get any of the symptoms of this serious syndrome (see section 4, “Possible side effects”).
Talk to your doctor if you experience any of the following symptoms while taking Nobligan retard:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may be a sign of adrenal insufficiency (low levels of cortisol ). Contact a doctor if you get these symptoms. Your doctor will decide if you need to take hormone replacement therapy.
Tell your doctor if one or more of these problems occur during treatment with Nobligan retard or if they have affected you before.
Children and young people
Tramadol is not recommended for children and adolescents with respiratory problems as the symptoms of tramadol poisoning may be worse in these children.
Other drugs and Nobligan retard
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Nobligan retard should not be taken with MAOIs (certain medicines used to treat depression).
The analgesic effect of Nobligan retard may be reduced and the duration of action may be shortened, if you are also taking other medicines that contain:
- carbamazepine (for epilepsy );
- ondansetron (for nausea).
Your doctor will decide if you can use Nobligan retard and at what dose.
The risk of side effects is increasing,
- if you are also using other painkillers such as morphine and codeine (also as cough medicines), and alcohol with Nobligan retard . You may feel drowsy and faint. Tell your doctor if this happens.Concomitant use of Nobligan retard and sedatives or medicines for sleep disorders (eg benzodiazepines ) increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes Nobligan retard along with sedatives, doseone and the treatment time is limited by the doctor. Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It can be good to inform friends and relatives to pay attention to the signs and symptoms described above. Contact your doctor if you experience any of these symptoms.
- if you are taking medicines that can cause seizures (seizures), such as certain antidepressants and antipsychotic medicines. The risk of having a seizure may increase if you take Nobligan retard at the same time . Your doctor will tell you if Nobligan retard is right for you.
- if you are taking certain antidepressant drugs, then Nobligan retard may interact with these drugs and you may develop serotonergic syndrome (see section 4, “Possible side effects”).
- if you are taking coumarin-type anticoagulants (blood-thinning medicines) such as warfarin with Nobligan retard . The effect of these medicines on the blood’s ability to coagulate can be affected and bleeding may occur.
Use of Nobligan retard with food and alcohol
Do not drink alcohol during treatment with this drug as alcohol may potentiate the effect of Nobligan retard. Food does not affect the effect of Nobligan retard.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is very little information on the safety of using Nobligan retard during pregnancy. Therefore, you should not use Nobligan retard if you are pregnant.
Prolonged treatment during pregnancy can cause withdrawal symptoms in newborns.
Tramadol is excreted in human milk. You should therefore not take Nobligan retard on more than one
occasion during breastfeeding. Alternatively, if you take Nobligan retard more than once, you should stop breastfeeding.
Human-based experience does not indicate that tramadol affects female or male fertility.
Driving and using machines
Noble retardation can cause drowsiness, dizziness, and blurred vision and may therefore impair your ability to react. Do not drive or use vehicles, do not use power tools or machines if you feel your ability to react is affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Therefore, always read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Nobligan 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 medicine, as Nobligan retard contains lactose.
How to use Nobligan retard
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one should be adjusted according to how severe the pain is and your pain sensitivity. Generally, you should take the lowest dose one that provides pain relief. You should not take 400 mg of tramadol hydrochloride per day without a doctor’s prescription.
Unless otherwise prescribed by a doctor, the recommended dose is:
Adults and adolescents from 12 years of age:
1 Nobligan retard 100 mg tablet twice daily, preferably in the morning and in the evening (equivalent to 200 mg tramadol hydrochloride per day).
1 Nobligan retard 150 mg tablet twice daily, preferably in the morning and in the evening (equivalent to 300 mg tramadol hydrochloride per day).
1 Nobligan retard 200 mg tablet twice daily, preferably in the morning and in the evening (equivalent to 400 mg tramadol hydrochloride per day).
Your doctor may prescribe a different, more appropriate dosage of the medicine if necessary.
If necessary, the dose can be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg to 400 mg tramadol hydrochloride per day).
Children
Nobligan retard should not be given to children under 12 years of age.
Elderly people
For older people (over 75 years) it can take longer for tramadol to disappear from the body. If this affects you, your doctor may recommend that you extend the time between doses.
Severe liver or kidney disease ( insufficiency ) / dialysis
patients Patients with severe hepatic and/or renal impairment should not take Nobligan retardation. If your disability is mild or moderate, your doctor may recommend that you extend the time between doses.
How and when should you take Nobligan retard?
Nobligan retard tablets should be taken by mouth.
Nobligan retard tablets should be swallowed whole, not divided or chewed, along with enough fluid preferably in the morning and in the evening. You can take the tablets both on an empty stomach and at mealtime.
How long should you take the Nobligan retard?
You should not take Nobligan retard any longer than necessary.
If you need to be treated for a long time, your doctor will periodically check whether you should continue to take Nobligan retard and in what dose.
If you have the impression that the effect of Nobligan retard is too strong or too weak, talk to your doctor or pharmacist.
If you use more Nobligan retard than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
After very high doses, pupil decrease, vomiting, drop in blood pressure, palpitations, collapse, disturbance of consciousness, coma (deep unconsciousness), epileptic seizures, difficulty breathing, and respiratory arrest may occur. In these cases, a doctor must be called immediately!
If you forget to take the Nobligan retard
If you forget to take the tablets, the pain will likely return. Do not take a double dose to make up for a forgotten dose, but simply continue to take the tablets as before.
If you stop using Nobligan retard
If you stop or stop treatment with Nobligan retard too soon, the pain is likely to return. Contact your doctor if you wish to discontinue treatment due to unwanted effects.
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, first discuss it with your doctor, especially if you have been taking it for a long time. Your doctor will tell you when and how to stop, which can be done by gradually lowering your dose to reduce the risk of developing unnecessary side effects (withdrawal symptoms).
As a rule, there are no side effects when treatment with Nobligan retard is terminated. In rare cases, however, patients have felt unwell if they have been treated with tramadol for a long time and then abruptly discontinued treatment. They may feel anxious, anxious, nervous, or shivering. They may be hyperactive, have difficulty sleeping, or have gastrointestinal disorders. Very few people can suffer from panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and tinnitus. In very rare cases also have unusual symptoms from the central nervous system are observed, such as confusion, delusions, altered personality perception (depersonalization), altered perception of reality (derealization), and persecution mania ( paranoia ). If these symptoms occur, stop taking Nobligan retard and consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should see a doctor immediately if you get symptoms such as a swollen face, tongue, and/or throat and/or difficulty swallowing or if you get hives along with difficulty breathing.
The most common side effects with Nobligan retard are nausea and dizziness, which occur in more than 1 user in 10.
Very common: may affect more than 1 user in 10
- dizziness
- nausea
Common: may affect up to 1 in 10 users
- headache, drowsiness
- fatigue
- constipation, dry mouth , vomiting
- sweating (hyperhidrosis)
Uncommon: may affect up to 1 in 100 people
- effects on the heart and blood circulation (fast strong heartbeat, fast pulse , fainting or collapse). These side effects occur mainly in patients who are rapidly rising or sitting up or who are under physical exertion.
- nausea, stomach upset (feeling of pressure in the stomach, bloating), diarrhea
- skin reactions (eg itching , rash)
Rare: may affect up to 1 in 1,000 users
- allergic reactions (difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulatory collapse) have occurred in very rare cases
- slow pulse
- increased blood pressure
- abnormal sensations (eg itching , tingling, numbness), tremors, epileptic seizures, muscle twitching, uncoordinated movements, transient loss of consciousness (syncope), speech difficulties.
- Epileptic seizures have occurred mainly at high doses of tramadol or when tramadol was taken concomitantly with other drugs that may induce seizures.
- appetite changes
- hallucinations, confusion, sleep disorders, delirium , anxiety and nightmares
- Psychological disorders may occur during treatment with Nobligan retard . Their intensity and nature vary individually (depending on the patient’s personality and treatment time). The symptoms can occur in the form of mood swings (mostly elevated mood, temporarily irritated mood), change in activity (usually inhibited, temporarily increased) and decreased perception (changes in mind and recognition, which can lead to changed decision-making behaviors).
- drug dependence may occur
- blurred vision, pupillary reduction ( miosis ), pupil dilation ( mydriasis )
- slow breathing, shortness of breath ( dyspnoea )
- Exacerbation of asthma has been reported, however, it is not clear if this is caused by tramadol. If the recommended dose is significantly exceeded, or if a drug that lowers brain function is taken at the same time, the respiratory rate may decrease ( respiratory depression ).
- muscle weakness
- bladder problems (difficulty or pain in throwing water), decreased urine output ( dysuria )
Very rare: may affect up to 1 in 10,000 people
- elevated liver values
Has been reported: occurs an unknown number of users
- lowering blood sugar levels
- hiccup
Serotonergic syndrome, which may manifest itself as an altered state of mind (eg anxiety, hallucinations, coma ) and other symptoms such as fever, increased heart rate, unstable blood pressure, involuntary twitching, muscle stiffness, lack of coordination of movements, and/or gastrointestinal symptoms (eg nausea, vomiting, diarrhea) (see section 2 “What you need to know before using Nobligan retard”).
If treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop using Nobligan retard”)
How to store Nobligan retard
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 blister. The expiration date is the last day of the specified month.
This medicine 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.
Contents of the pack and other information
Content declaration
- The active substance is: tramadol hydrochloride.
Nobligan retard 100 mg prolonged-release tablets:
Each tablet contains 100 mg of tramadol hydrochloride.
- The other ingredients are:
Tablet core: microcrystalline cellulose, hypromellose 100,000 mPa, magnesium stearate, colloidal anhydrous silicon. - Film coating: hypromellose 6 mPa, lactose monohydrate (see section 2 “Nobligan retard contains lactose”), macrogol 6000, propylene glycol, talc, titanium dioxide (E171).
Nobligan retard 150 mg prolonged-release tablets:
Each tablet contains 150 mg of tramadol hydrochloride.
- The other ingredients are:
Tablet core: microcrystalline cellulose, hypromellose 100,000 mPa, magnesium stearate, colloidal anhydrous silicon. - Film coating: hypromellose 6 mPa, lactose monohydrate (see section 2 “Nobligan retard contains lactose”), macrogol 6000, propylene glycol, talc, titanium dioxide (E171), quinoline yellow (E104), red iron oxide (E172).
Nobligan retard 200 mg prolonged-release tablets:
Each tablet contains 200 mg of tramadol hydrochloride.
- The other ingredients are:
Tablet core: microcrystalline cellulose, hypromellose 100,000 mPa, magnesium stearate, colloidal anhydrous silicon. - Film coating: hypromellose 6 mPa, lactose monohydrate (see section 2 “Nobligan retard contains lactose”), macrogol 6000, propylene glycol, talc, titanium dioxide (E171), quinoline yellow (E104), red iron oxide (E172), brown iron oxide (E172).
What the medicine looks like and contents of the pack
Nobligan retard 100 mg prolonged-release tablets are round, biconvex, white film-coated tablets, marked with the manufacturer’s logo (underlined omega ( Ω )) on one side and “T1” on the other side.
Nobligan retard 150 mg prolonged-release tablets are round, biconvex, slightly orange film-coated tablets, marked with the manufacturer’s logo (underlined omega ( Ω )) on one side and “T2” on the other side.
Nobligan retard 200 mg prolonged-release tablets are round, biconvex, slightly brown-orange film-coated tablets, marked with the manufacturer’s logo (an underlined omega ( Ω)) on one side and “T3” on the other side.
Nobligan retard prolonged-release tablets are packaged in blisters and are supplied in cartons of 10, 20, 30, 50, 60, 100, and 150 (10×15) tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Grünenthal GmbH, 52099 Aachen, Germany