Nobligan 50 mg, Nobligan 100 mg Tramadol Hydrochloride Capsules Hard
What Nobligan Is And What Nobligan Used For?
Tramadol – the active substance in Nobligan – is a painkiller that belongs to the class of opioids that work on the central nervous system. Tramadol has an analgesic effect by affecting specific nerve cells in the spinal cord and brain. Nobligan used for to treat moderate to severe pain.
What You Need To Know Before Using Nobligan?
Do Not Use Nobligan
- If you are allergic to Nobligan 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 also taking MAOIs (certain medicines to treat depression or Parkinson’s disease ) or have taken such medicines in the last 14 days before treatment with Nobligan (see ‘Other medicines and Nobligan’)
- 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:
- 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 tend to have epileptic seizures or seizures
- If you are suffering from depression and are taking antidepressant medicines, as some of them may interact with tramadol (see “Other medicines and Nobligan”)
- If you have impaired liver or kidney function
Epileptic seizures have occurred in patients taking the recommended dose of tramadol. The risk may increase if the dose of tramadol exceeds the recommended upper daily dose (400 mg).
Note that Nobligan can cause physical and mental dependence. When Nobligan is taken longer, the effect may decrease, and a higher dose may be necessary ( tolerance development ).
Patients with a tendency to drug abuse or dependence should only be treated with Nobligan for short periods and under strict medical supervision.
Nobligan tramadol is converted in the liver by an enzyme. Some people have a variation of this enzyme, which can affect different people differently. 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 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 of getting 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:
- Extreme fatigue
- Loss of appetite
- Severe abdominal pain
- Nausea
- Vomiting
- Low blood pressure
This may be a sign of adrenal insufficiency (low cortisol levels). 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 or if they have affected you before.
Children And Young People:
Tramadol is not recommended for children and adolescents with respiratory problems as tramadol poisoning symptoms may worsen in these children.
Other Drugs And Nobligan:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines. Nobligan should not be taken with MAOIs (certain medicines for depression or Parkinson’s disease ).
The analgesic effect of Nobligan 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 may then need to adjust your Nobligan dosering. The risk of side effects is increasing.
- If you also take other painkillers such as morphine and codeine (also as cough medicine), and alcohol. You may feel drowsy and faint. Tell your doctor if this happens.
- Concomitant use of Nobligan and sedatives or medicines for sleep disorders (e.g., 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 together with sedatives, the nobligan dosering and treatment time should be limited by your doctor. Tell your doctor if you are taking any sedatives, and 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 take 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 simultaneously. Your doctor will tell you if Nobligan is right for you.
- If you take certain antidepressant medicines, Nobligan may interact with these medicines. You may develop serotonergic syndrome (see section 4, “Possible side effects”).
- If you take coumarin-type anticoagulants (blood-thinning medicines) such as warfarin with Nobligan. The effect of these medicines on the coagulation capacity of the blood may be affected, and bleeding may occur.
Nobligan With Food And Alcohol:
Do not drink alcohol during treatment with this medicine, as alcohol may increase the effect of Nobligan.
Pregnancy, Breastfeeding And Fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 during pregnancy. Long-term treatment during pregnancy can lead to habituation in the unborn child, which can result in the child experiencing withdrawal symptoms after birth.
Therefore, if you are pregnant, your doctor will only prescribe Nobligan if necessary. Tramadol is excreted in human milk. You should, therefore, not take Nobligan more than one occasion during breastfeeding.
Alternatively, if you take Nobligan more than one single once, you should stop breastfeeding. Human-based experience does not indicate that tramadol affects female or male fertility.
Driving And Using Machines:
Nobligan can cause drowsiness, dizziness, and blurred vision, impairing 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 can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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 Hard Capsules Contain Sodium:
This medicine contains less than 1 mmol (23 mg) sodium per capsule, i.e., essentially ‘sodium-free.’
How To Use Nobligan?
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 sensitivity. Generally, you should take the lowest dose that provides pain relief. You should not take more than 8 hard capsules (equivalent to 400 mg 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 or 2 hard capsules (equivalent to 50 or 100 mg tramadol hydrochloride) 3-4 times daily.
- Children
- Nobligan capsules 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 extending the time between doses.
- Liver or kidney disease ( insufficiency ) / dialysis patients
- In patients with hepatic and renal impairment, tramadol excretion may be slow. If this applies to you, your doctor may prescribe an extended dosing interval. Nobligan is not recommended for patients with severe hepatic and renal impairment.
How And When Should You Take The Nobligan?
For oral use.
The capsules should be swallowed whole, not divided or chewed, along with enough fluid.
You can take Nobligan both on an empty stomach and at mealtime.
How Long Should You Take The Nobligan?
Your doctor may decide that an interruption must be made for some time and then resume treatment. You should not take Nobligan for 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 and in what dose.
If you think that the effect of Nobligan is too strong or too weak, talk to your doctor or pharmacist.
If You Use More Nobligan Than You Should
Contact a doctor or hospital for risk assessment and advice if you have ingested too much medicine.
After very high doses:
- Pupil decrease
- Vomiting
- Drop in blood pressure
- Palpitations
- Collapse
- Disturbance of consciousness
- Coma (deep unconsciousness)
- Epileptic seizures
- Difficulty breathing
- Respiratory arrest may occur
In these cases, a doctor must be called immediately!
If You Forget To Take Nobligan:
If you forget to take the capsules, the pain will likely return. Do not take a double dose to compensate for a forgotten dose, but continue to take the capsules as before.
If You Stop Using Nobligan:
The pain will likely return if you stop or stop Nobligan treatment too soon. 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, 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).
Patients who have been treated with Nobligan for a long time and who have suddenly stopped their treatment may suffer from withdrawal symptoms and experience that they do not feel well. They may feel anxious, anxious, nervous, or shivering.
They may be hyperactive, have difficulty sleeping, or have gastrointestinal disorders. Very rarely, panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and tinnitus can occur. Unusual symptoms from the central nervous system have been observed in very rare cases, such as mental confusion, delusion, change in one’s perception of personality (depersonalization), change in perception of reality (derealization), and persecution mania ( paranoia). Talk to your doctor if you get any of these side effects after stopping your treatment with Nobligan.
Ask your doctor or pharmacist if you have any further questions about using this product.
Possible Nobligan Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them.
You should see a doctor immediately if you get symptoms such as a swollen face, tongue, and throat, difficulty swallowing, hives, or difficulty breathing.
The most common side effects with Nobligan treatment 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 under physical exertion.
- Nausea
- Stomach upset:
- Feeling of pressure in the stomach
- Bloating
- Diarrhea
- skin reactions, e.g.,
- 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 (e.g., itching , tingling, numbness), tremors, epileptic seizures, muscle twitching, uncoordinated movements, transient loss of consciousness (syncope), speech difficulties.
- Epileptic seizures had 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
- Nightmares
- Psychological disorders may occur during treatment with Nobligan. 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 temporarily inhibited 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 a drug that lowers brain function is taken simultaneously, 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, e.g.,
- Anxiety
- Hallucinations
- Coma
And other symptoms such as:
- Fever
- Increased heart rate
- Unstable blood pressure
- Involuntary twitching
- Muscle stiffness
- Lack of coordination of movements
- Gastrointestinal symptoms e.g.
- Nausea
- Vomiting
- Diarrhea
(see section 2, “What you need to know before using Nobligan”).
How To Store The Nobligan?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and blister. The expiration date is the last day of the specified month.
- Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are 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.
- The other ingredients are: microcrystalline cellulose, sodium starch glycollate, anhydrous colloidal silica, magnesium stearate; The capsule shell contains gelatin, yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate.
What The Medicine Looks Like And Contents Of The Pack?
- Monochrome (pale yellow) glossy, oblong capsules.
- Nobligan hard capsules are packaged in blisters and are supplied in cartons of 20, 100, or 250 hard capsules.
- The packages with 500 hard capsules are only for dose dispensing.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Grünenthal GmbH, 52099 Aachen, Germany