100 mg, 150 mg, 200 mg prolonged-release tablet er
tramadol hydrochloride
What Tramadol Retard Hexal is and what it is used for
Tramadol hydrochloride, the active substance in Tramadol Retard Hexal, is an analgesic drug in the opioid drug group that acts on the central nervous system. Its pain-relieving effects depend on the effect on specific nerve cells in the spinal cord and brain.
Tramadol Retard Hexal is used:
- in the treatment of moderate to severe pain.
Tramadol hydrochloride contained in Tramadol Retard Hexal may also be approved to treat 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 Tramadol Retard Hexal
Do not use Tramadol Retard Hexal
- if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
- if you have acute alcohol poisoning or poisoning with sleeping pills, centrally acting painkillers, opioids, or other psychotropic drugs (drugs that affect your mood or emotional state)
- if you are also taking MAO inhibitors (a special type of medicine used to treat depression or Parkinson’s disease ) or have taken any such medicine within the last 14 days before starting treatment with Tramadol Retard Hexal (see “Other medicines and Tramadol Retard Hexal”) “)
- if you have epilepsy and your seizures are not controlled by treatment
- as a treatment for withdrawal symptoms in drug addiction.
Warnings and precautions
Talk to your doctor before using Tramadol Retard Hexal
- if you think you may already be dependent on other painkillers ( opioids )
- if you have any effects on your consciousness (for example, if you feel unusually dizzy)
- if you are in a state of shock (cold sweat can be an indication of this)
- if you have breathing difficulties
- if you have increased pressure in the brain (e.g. after a head injury or brain disease)
- if you have any liver or kidney disease
- if you are sensitive to opiates
- if you have epilepsy or if you have seizures
- if you suffer from depression and take antidepressants because some of them can interact with tramadol (see “Other medicines and Tramadol Retard Hexal”). There is a small risk that you may get a so-called serotonin syndrome, which can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Seek immediate medical attention if you experience any of the symptoms of this serious syndrome (See section 4 “Possible side effects”).
If any of the above applies to you, talk to your doctor before you start taking this medicine.
Sleep-related breathing disorders: Tramadol Retard Hexal can cause sleep-related breathing disorders such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low oxygen content in the blood). The symptoms can be breathing pauses during sleep, awakenings during the night due to shortness of breath, difficulty maintaining sleep, or severe drowsiness during the day. Contact a doctor if you or someone else notices these symptoms. The doctor may consider lowering your dose.
Epileptic seizures have been reported in patients taking tramadol at recommended doses. This risk may increase if the recommended maximum daily dose of 400 mg tramadol hydrochloride is exceeded or if you simultaneously take medicines that lower the seizure threshold (see “Other medicines and Tramadol Retard Hexal”).
Please note that psychological and physical dependence may develop in patients using Tramadol Retard Hexal. During prolonged treatment with Tramadol Retard Hexal, the effects of the drug may decrease, which may lead to the need to use a higher dose (development of tolerance). For this reason, Tramadol Retard Hexal may only be used for shorter periods and under strict medical supervision in patients who are at risk of developing drug dependence.
Also, inform your doctor if any of these problems develop while you are taking Tramadol Retard Hexal and if you have had any such problems in the past.
Tramadol is converted into 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 of serious side effects. If you experience any of the following side effects, stop taking this medicine and see a doctor immediately: slow or shallow breathing, confusion, sleepiness, small pupils, nausea or vomiting, constipation, and poor appetite.
Talk to your doctor if you experience any of the following symptoms while using Tramadol Retard Hexal:
- extreme tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This can be a sign of adrenal cortex failure (low levels of cortisol ). Contact a doctor if you experience these symptoms. The doctor will decide if you need to take hormone replacement.
Children and young people
Tramadol Retard Hexal is not suitable for use in children under 12 years of age.
Tramadol is not recommended for children and adolescents with respiratory problems because the symptoms of tramadol poisoning may be worse in these children and adolescents.
Older
Patients over 75 years of age should be closely monitored as elimination of tramadol may take longer (see section 3 “How to use Tramadol Retard Hexal”).
Other medicines and Tramadol Retard Hexal
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Do not take Tramadol Retard Hexal at the same time as MAO inhibitors (medicines used to treat depression or Parkinson’s disease ) or if you have taken these medicines within the last 14 days before treatment with Tramadol Retard Hexal. Life-threatening interactions, e.g. effects on the central nervous system as well as respiratory and cardiovascular function cannot be excluded.
The pain-relieving effect of Tramadol Retard Hexal can be reduced and the treatment effects can be shortened if you take medicines that contain any of the following active substances:
- carbamazepine (used to treat seizures)
- pentazocine, nalbuphine or buprenorphine (pain relievers)
- ondansetron (used to treat nausea)
The risk of side effects increases
- if you take sedative medicines, such as benzodiazepines or similar medicines ( sedatives, sleeping pills ). Concomitant use of Tramadol Retard Hexal and sedative drugs or drugs for sleep problems such as benzodiazepines or similar drugs increases the risk of drowsiness, breathing difficulties ( respiratory depression ), coma, and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. If the doctor prescribes Tramadol Retard Hexal at the same time as sedative drugs, the dose should and the duration of treatment is limited by the doctor. Tell the doctor if you are taking any sedative medication and follow the doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives to be aware of the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
- if you take Tramadol Retard Hexal at the same time as other medicines that also impair brain function, e.g. other pain relievers such as morphine and codeine (also as cough medicine) and alcohol while taking Tramadol Retard Hexal. You may feel sleepier or faint. If this happens, talk to your doctor.
- if you are taking medicines that can cause seizures, such as certain antidepressants or antipsychotic medicines. The risk of having a seizure may increase if you take Tramadol Retard Hexal at the same time. Your doctor will tell you if Tramadol Retard Hexal is suitable for you.
- if you are taking certain antidepressants. Tramadol Retard Hexal may affect these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
- if you are simultaneously taking medicines that prevent the blood from clotting normally (so-called coumarin derivatives, such as warfarin ). The anti-coagulant effects of these medicines can be enhanced and larger bleeding can occur under small areas of the skin ( ecchymosis ).
Tramadol Retard Hexal with food and alcohol
Do not drink alcohol while using this medicine because alcohol can increase the effect of Tramadol Retard Hexal. Food does not affect the effect of Tramadol Retard Hexal (see section 3 “How to take Tramadol Retard Hexal”).
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 using this medicine.
- PregnancyThere is very little information regarding the safety of tramadol hydrochloride during pregnancy in humans. Therefore, you should not take Tramadol Retard Hexal if you are pregnant. Long-term use of Tramadol Retard Hexal during pregnancy can lead to withdrawal symptoms in the newborn after delivery.
- Breast-feeling tramadol is excreted in breast milk. You should therefore not take Tramadol Retard Hexal more than once during breastfeeding. Alternatively, if you take Tramadol Retard Hexal more than once, you should stop breastfeeding.
- FertilityHuman experience suggests that tramadol hydrochloride does not affect female or male fertility.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Tramadol Retard Hexal can cause, among other things
- drowsiness and dizziness
- visual disturbances (blurred vision)
and can therefore reduce your ability to react. Do not drive or use tools or machines if this happens to you or if you feel that your ability to react is impaired.
Tramadol Retard Hexal contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Tramadol Retard Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. it is almost “sodium-free”.
How to use Tramadol Retard Hexal
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Does one should be adjusted to the severity of your pain and your pain sensitivity. Usually, you should take the lowest dose that provides pain relief.
The usual dose is unless otherwise prescribed by a doctor:
Adults and young people over 12 years of age
Usual dose: Usual starting dose is 1 tablet of 100 mg twice daily, morning and evening.
If this does not provide sufficient pain relief, your doctor may increase the dose to 150 mg twice daily or 200 mg twice daily.
At least 8 hours must pass between each dose.
As a general rule, you should not take more than the smallest possible dose needed to control your pain.
Do not take more than a total of 400 mg tramadol hydrochloride daily unless there are specific medical reasons for this.
Use for children under 12 years of age
Use for children under 12 is not recommended.
Older
For elderly patients (over 75 years), it may take longer for tramadol to disappear from the body. If this concerns you, your doctor may advise you to extend the time between doses.
Severe liver or kidney failure/dialysis patients
Patients with severe liver and/or kidney failure should not take Tramadol Retard Hexal. If you have mild or moderate liver and/or kidney failure, your doctor may recommend you extend the time between doses.
Note!
The recommended dosages above are guidelines only. If you are taking the drug to manage chronic pain, you should always, if possible, strictly follow the planned treatment schedule.
This is how you take your medicine
The prolonged-release tablets should be swallowed whole together with a sufficient amount of liquid (e.g. a glass of water).
The tablets must not be split, broken, or chewed.
The notch (of the identification mark) is not intended for splitting the tablet.
You can take one prolonged-release tablet on an empty stomach or with food.
It is important that you do not continue taking Tramadol Retard Hexal for longer than is necessary.
If you have taken too much Tramadol Retard Hexal
This normally has no negative consequences for you. Continue taking Tramadol Retard Hexal as usual when your pain returns.
If you have taken too much of the drug, the following signs may occur: reduced pupils, vomiting, low blood pressure, circulatory failure, disturbances in consciousness (with coma in extreme cases), epileptic-like convulsions (seizures), and shallow breathing (with respiratory arrest in extreme cases).
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Tramadol Retard Hexal
You may notice that the pain returns. Do not take a double dose to compensate for a missed dose, but continue to take the medicine as prescribed.
If you stop taking Tramadol Retard Hexal
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, you should first discuss it with your doctor, especially if you have been taking it for a long time. The doctor will tell you when and how to stop, which can be done by gradually lowering the dose to reduce the risk of developing unnecessary side effects (withdrawal symptoms).
Withdrawal symptoms may include excitement, anxiety, nervousness, tremors, overactivity, difficulty sleeping, and gastrointestinal upset. Very few patients may have panic attacks, hallucinations, abnormal sensory sensations such as itching, tingling and numbness, and ringing in the ears. Additional unusual central nervous system symptoms, i.e. confusion, delusions, altered perception of one’s personality (depersonalization), altered perception of reality (derealization), and persecutory mania ( paranoia ), have been seen in very rare cases. If you experience any of these problems after you stop taking Tramadol Retard Hexal, talk to your doctor.
If you have any further questions about this medicine, 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 experience symptoms of an allergic reaction, e.g. swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives along with difficulty breathing.
Very common (may affect more than 1 in 10 users):
- nausea
- dizziness.
Common (may affect up to 1 in 10 users):
- headache
- drowsiness
- fatigue
- vomiting, constipation, dry mouth
- sweating.
Uncommon (may affect up to 1 in 100 users):
- effects on the regulation of blood circulation (palpitations, increased pulse, attacks of weakness, and circulatory failure). These side effects usually occur in connection with an upright position and physical activity.
- nausea
- stomach upset (eg upset stomach, bloating)
- diarrhea
- skin symptoms (e.g. itching, rash, rapid reddening of the skin).
Rare (may affect up to 1 in 1,000 users):
- allergic reactions (eg difficulty breathing, wheezing, swelling of the skin) and shock reactions (sudden circulatory failure)
- hallucinations, confusion, delirium, anxiety, sleep disturbances, and nightmares
- psychological symptoms may occur after treatment with Tramadol Retard Hexal, and the intensity and nature may vary between different individuals (depending on the personality and how long the user has been going on). These symptoms can be mood swings (usually elation, sometimes irritation), changes in the level of activity (usually decreased, sometimes increased), and changes in the cognitive abilities and senses (disturbances in sensory sensations and the ability to recognize, which can lead to inappropriate decisions).
- drug dependence may occur
- appetite changes
- abnormal sensation in the skin (eg, tingling, crawling, numbness)
- tremors
- shallow breathing; can occur if the prescribed dose is exceeded or if other drugs that inhibit brain function are used at the same time
- epileptic seizures; occurred mainly after the use of high doses of tramadol or with the simultaneous use of other drugs that can cause seizures
- involuntary muscle twitches
- impaired coordination
- fainting
- speech disorders
- blurred vision, pupil constriction, pupil dilation
- slow heart rate ( bradycardia )
- high blood pressure
- slow breathing, shortness of breath ( dyspnea ); shallow breathing may occur if the prescribed dose is exceeded or if other drugs that inhibit brain function are used at the same time
- worsening of asthma has been reported although it was not possible to establish a causal relationship with the use of the active substance tramadol
- muscle weakness
- difficulty urinating, pain when urinating, or passing less urine than normal.
Very rare (may affect up to 1 in 10,000 users):
- elevated liver enzymes.
Has been reported (occurring in an unknown number of users):
- serotonin syndrome, which may manifest as altered mental status (eg, restlessness, 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 (e.g. nausea, vomiting, diarrhea) (see section 2 “What you need to know before you take Tramadol Retard Hexal”).
- low blood sugar
- hiccup.
Tramadol Retard Hexal is associated with a risk of addiction.
Withdrawal symptoms may develop when treatment is stopped (see section 3 “If you stop taking Tramadol Retard Hexal”).
How to store Tramadol Retard Hexal
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister card after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tramadol hydrochloride.
100 mg:
Each prolonged-release tablet contains 100 mg tramadol hydrochloride.
150 mg:
Each prolonged-release tablet contains 150 mg of tramadol hydrochloride.
200 mg:
Each prolonged-release tablet contains 200 mg tramadol hydrochloride.
Other ingredients are:
Outer layer: lactose monohydrate, calcium hydrogen phosphate dihydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, colloidal anhydrous silica
Depot layer: lactose monohydrate, hypromellose, povidone K25, magnesium stearate, colloidal anhydrous silicon dioxide, hydrogenated castor oil, quinoline yellow (E104), indigo carmine (E132), aluminum hydroxide.
Appearance and package sizes of the medicine
100 mg prolonged-release tablets are flat, round, two-layered tablets with beveled edges. The outer layer is white and the depot layer is green. The tablets are marked with “TR/100 R” on one side.
150 mg prolonged-release tablets are flat, round, two-layered tablets with beveled edges. The outer layer is white and the depot layer is green. The tablets are marked with “TR/150 R” on one side.
200 mg prolonged-release tablets are flat, round, two-layered tablets with beveled edges. The outer layer is white and the depot layer is green. The tablets are marked with “TR/200 R” on one side.
Package sizes
Tramadol Retard Hexal is available in packs of 10, 20, 30, 50, 60, and 100 prolonged-release tablets in a PP/aluminum blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
HEXAL A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark