100 mg, 150 mg, 200 mg prolonged-release tablet
tramadol hydrochloride
What Tradolan Retard is and what it is used for
Tramadol hydrochloride, the active substance in Tradolan Retard, is an analgesic that belongs to the opioid class that acts on the central nervous system. Tramadol hydrochloride acts as a pain reliever by affecting specific nerve cells in the spinal cord and brain.
Tradolan Retard is used for the treatment of moderate to severe pain.
Tramadol hydrochloride contained in Tradolan Retard may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Tradolan Retard
Do not take Tradolan Retard
– if you are allergic to tramadol hydrochloride or any other ingredient in this medicine (listed in section 6);
– if you have recently used alcohol, sleeping pills, painkillers, or psychotropic drugs (drugs that affect mood/mood and emotional life);
– if you simultaneously use MAO inhibitors (certain medicines for the treatment of depression) or have taken such medicines in the last 14 days before treatment with Tradolan Retard (see “Other medicines and Tradolan Retard”).
– if you suffer from epilepsy that is not well controlled with treatment;
– as a substitute for drug withdrawal.
Warnings and precautions
Talk to a doctor or pharmacist before taking Tradolan Retard.
Take special care with Tradolan Retard:
– if you suspect that you are or have been addicted to other painkillers (opioids er);
– if you suffer from a reduced level of consciousness (if you feel faint);
– if you are in a state of shock (cold sweating can be a sign of this);
– if you have increased pressure in the head (after a skull or brain injury);
– if you have breathing difficulties;
– if you are prone to epileptic seizures or convulsions, as the risk of seizures may increase;
– if you have impaired liver or kidney function;
– if you suffer from depression and take antidepressants because some of them can interact with tramadol (see “Other medicines and Tradolan Retard”).
Sleep-related breathing disorders
Tradolan Retard 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 the recommended dose of tramadol. The risk may increase if the dose of tramadol exceeds the recommended upper daily dose (400 mg).
Please note that Tradolan Retard can cause physical and psychological dependence. When Tradolan Retard is taken for a longer period, the effect may decrease and higher doses may become necessary ( tolerance development ). Patients with a tendency to drug abuse or who are dependent on drugs will be treated with Tradolan Retard only for short periods and under strict medical supervision.
Extreme fatigue, 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.
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.
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 you stop taking Tramadol Retard, especially after long-term treatment, your doctor will recommend tapering the dose to reduce withdrawal symptoms.
Inform your doctor if one or more of these problems occur during treatment with Tradolan Retard or if they have affected you in the past.
Children and young people
Tradolan Retard is not suitable for children under 12 years of age.
Use in children and adolescents with breathing problems
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.
Other medicines and Tradolan Retard
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tradolan Retard should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Tradolan Retard can be reduced and the duration of action can be shortened, if you simultaneously take other medicines that contain:
– carbamazepine (for epilepsy );
– ondansetron (for nausea).
Concomitant use of Tradolan Retard and sedative drugs or drugs for sleep problems such as benzodiazepines or similar drugs increases the risk of sleepiness, breathing difficulties ( respiratory depression ), and coma, and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Tradolan Retard together with sedative drugs, the dose and duration of treatment must be limited by the doctor.
Tell your doctor about any sedative medications you take and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives to be aware of the signs and symptoms listed above. Contact a doctor if you experience such symptoms.
The doctor assesses whether you can use Tradolan Retard and with what dose.
The risk of side effects increases if you
– at the same time using sedatives, sleeping pills, other painkillers such as morphine and codeine (also as cough medicine), and alcohol with Tradolan Retard. You may feel drowsy and faint. Tell the doctor if this happens.
– taking medicines that can cause convulsions (seizures), such as certain antidepressants and antipsychotic medicines. The risk of having a seizure may increase if you take Tradolan Retard at the same time. Your doctor will tell you whether Tradolan Retard is a suitable medicine for you.
– are taking certain antidepressants, as Tradolan Retard can interact with these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
– taking anticoagulants of the coumarin type (blood-thinning drugs), eg warfarin, together with Tradolan Retard. The effect of these medicines on the blood’s ability to clot can be affected and bleeding can occur.
Tradolan Retard with food and alcohol
Food does not affect the effect of Tradolan Retard. Do not drink alcohol when using Tradolan Retard, as the side effects of this medicine may be increased.
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.
Pregnancy
There is very little information on the safety of tramadol use during pregnancy. Therefore, Tradolan Retard should not be used during pregnancy. Long-term treatment during pregnancy may lead to habituation in the newborn (which may lead to changes in the respiratory rate in newborns). Therefore, if you are pregnant, your doctor will only prescribe Tradolan Retard if necessary.
Breast-feeding
Tramadol is excreted in breast milk. You should therefore not take Tradolan Retard more than once during breastfeeding. Alternatively, if you take Tradolan Retard more than once, you should stop breastfeeding.
Fertility
Experience based on humans does not indicate that tramadol affects female or male fertility.
Driving ability and use of machinery
Tramadol can cause drowsiness, dizziness, and blurred vision and can therefore impair your ability to react. Do not drive a car or other vehicle, and do not use electric tools or machines if you feel that 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 increased vigilance. 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.
Tradolan Retard contains tartrazine
Tradolan Retard prolonged-release tablets 150 mg and 200 mg contain the dye tartrazine (E 102) which can cause allergic reactions.
How to use Tradolan Retard
Always take this medicine as directed by your doctor or pharmacist. 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. You should not take more than 400 mg of tramadol hydrochloride per day without a doctor’s prescription.
If the doctor has not prescribed anything else, the recommended dose is:
Adults and young people from the age of 12
Take one Tradolan Retard 100 mg tablet twice daily, preferably in the morning and in the evening (equivalent to 200 mg tramadol hydrochloride per day).
Your doctor can prescribe a different, more appropriate dosage of the drug if necessary.
If necessary, the dose can be increased up to 150 mg or 200 mg 2 times daily (equivalent to 300 mg to 400 mg tramadol hydrochloride per day).
Children
Tradolan Retard should not be given to children under 12 years of age.
Elderly patients
For elderly patients (over 75 years), it may take longer for tramadol to disappear from the body. If this applies to you, your doctor may recommend that you extend the time between doses.
Severe liver or kidney disease ( insufficiency )/dialysis patients
Patients with severe liver and/or kidney failure should not take Tradolan Retard. If you have mild or moderate liver and/or kidney failure, your doctor may recommend you extend the time between doses.
How and when should you take Tradolan Retard?
Tradolan Retard tablets 150 mg and 200 mg can be divided into two equal doses.
Tradolan Retard tablets should be swallowed whole, not chewed, together with sufficient liquid, preferably in the morning and in the evening. You can take the tablets both on an empty stomach and with meals.
You should not take Tradolan Retard longer than necessary.
If you need to be treated for a longer period, your doctor will periodically check whether you should continue to take Tradolan Retard and at what dose.
If you feel that the effect of Tradolan Retard is too strong or too weak, contact your doctor or pharmacist.
If you have used too much Tradolan Retard
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 have taken an extra dose by mistake, there will normally be no ill effects. You should take your next dose as prescribed by your doctor.
After very high doses, pupil dilation, vomiting, drop in blood pressure, palpitations, collapse, loss of consciousness, coma (deep unconsciousness), epileptic seizures, difficulty breathing, and respiratory arrest may occur. In these cases, doctors must be called immediately.
If you forget to take Tradolan Retard
If you have forgotten to take the tablets, the pain will likely return. Do not take a double dose to make up for a missed dose, but simply continue taking the tablets as before.
If you stop taking Tradolan Retard
If you interrupt or stop treatment with Tradolan Retard too soon, the pain will likely return. Contact your doctor if you wish to discontinue the 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, 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).
Patients have felt unwell if they have been treated with tramadol for a long time and then suddenly stopped the treatment. They may feel worried, anxiety, nervousness, or become shaky. They may be hyperactive, suffer from sleeping difficulties, or have stomach and intestinal disorders. Very few people can suffer from panic attacks, hallucinations, and unusual sensations such as itching, tingling, numbness, and ringing in the ears ( tinnitus ). In very rare cases, unusual central nervous system symptoms have also been observed, such as confusion, delusions, altered personality perception (depersonalization), altered perception of reality (derealization), and persecutory mania ( paranoia). If these symptoms occur after you have finished your treatment with Tradolan Retard, you should contact your doctor.
If you have further questions about this medicine, contact your doctor or pharmacist.f
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 develop symptoms such as a swollen face, tongue, and/or throat and/or difficulty swallowing or if you develop hives along with breathing difficulties.
The most common side effects during treatment with Tradolan Retard are nausea and dizziness, which occur in more than 1 in 10 users.
Very common (may affect more than 1 in 10 users):
- nausea
- dizziness
Common (may affect up to 1 in 10 users):
- headache, drowsiness
- vomiting, constipation, dry mouth
- sweating
- fatigue
Uncommon (may affect up to 1 in 100 users):
- effects on the heart and blood circulation (fast strong heartbeats, rapid pulse ). These side effects can especially occur in patients in an upright position or during physical exertion.
- retching, stomach problems (e.g. 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 (eg difficulty breathing, wheezing, severe swelling of the skin) and shock (sudden circulatory collapse) have occurred in 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), and speech difficulties.
- epileptic seizures have occurred mainly with high doses of tramadol or when tramadol was taken at the same time as other drugs that can induce seizures.
- appetite changes
- hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares
- psychological problems can occur during treatment with Tradolan Retard. Their intensity and nature vary individually (depending on the patient’s personality and treatment time). The complaints can appear in the form of mood swings (mostly elevated mood, occasionally irritated mood), change in activity (usually inhibited temporarily increased), and reduced perception (changes in mind and recognition, which can lead to altered decision-making behaviors).
- drug dependence may occur
- blurred vision, pupil reduction ( miosis ), pupil dilation ( mydriasis )
- slow breathing, shortness of breath ( dyspnoea )
- worsening of asthma has been reported, however, it is not clear whether this was caused by tramadol. If the recommended dose is significantly exceeded, or if any drug that lowers brain function is taken at the same time, the breathing rate may decrease ( respiratory depression ).
- muscle weakness
- bladder emptying problems (difficulty or painful passing water), decreased urine output ( dysuria )
Very rare (may affect up to 1 in 10,000 users):
- elevated liver values
Has been reported (occurring in an unknown number of users):
- lowering of blood sugar level
- hiccup
- Serotonergic syndrome, 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 Tradolan Retard”).
If treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Tradolan Retard “).
How Tradolan Retard should be stored
Keep this medicine out of the sight and reach of children.
Store in the outer carton (light sensitive).
Use before the expiry date which is stated on the carton after “Exp. date.” or “EXP:”. The expiration date is the last day of the specified month.
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.
Tradolan Retard 100 mg: Each prolonged-release tablet contains 100 mg of tramadol hydrochloride.
Tradolan Retard 150 mg: Each prolonged-release tablet contains 150 mg of tramadol hydrochloride.
Tradolan Retard 200 mg: Each prolonged-release tablet contains 200 mg of tramadol hydrochloride.
Other ingredients:
Tablet core:
Tradolan Retard 100 mg, 150 mg, and 200 mg: Hypromellose 15000, microcrystalline cellulose, povidone, colloidal anhydrous silica, magnesium stearate.
Film coating:
Tradolan Retard 100 mg: Makrogol 6000, hypromellose 5, titanium dioxide (dye E 171), talc, polyacrylate dispersion 30%.
Tradolan Retard 150 mg: Makrogol 6000, hypromellose 5, tartrazine varnish (dye E 102), titanium dioxide (dye E 171), talc, polyacrylate dispersion 30%.
Tradolan Retard 200 mg: Makrogol 6000, hypromellose 5, tartrazine varnish (dye E 102), talc, polyacrylate dispersion 30%.
Appearance and package sizes of the medicine
Tradolan Retard 100 mg prolonged-release tablets are white, round, cupped tablets.
Tradolan Retard 150 mg prolonged-release tablets are light yellow, oblong tablets with a score. The tablet can be divided into two equal doses.
Tradolan Retard 200 mg prolonged-release tablets are yellow, oblong tablets with a score. The tablet can be divided into two equal doses.
Tradolan Retard prolonged-release tablets are available in transparent bluish or opaque white PVC aluminum blisters of 10, 20, 30, 40, 50, 60, 100 and 100 x 1 (single dose) tablets.
500 tablets in a jar (intended for dose dispensing and hospital use).
Not all pack sizes may be marketed.
GL Pharma GmbH
Schlossplatz 1
A-8502 Lannach
This medicine is approved in the European Economic Area under the names:
Austria: Lanalget retard 100, 150, 200 mg-Filmtabletten
Denmark: Tradolan Retard prolonged-release tablet er 100, 150, 200 mg
Finland: Tradolan Retard 100, 150, 200 mg
Germany: Tramadol STADA 100, 150, 200 mg Retardtabletten
Iceland: Tramol-L 100, 150, 200 mg
Sweden: Tradolan Retard prolonged-release tablet 100, 150, 200 mg