50 mg film-coated tablet
tramadol hydrochloride
What Tradolan is and what it is used for
Tramadol hydrochloride, the active substance in Tradolan, 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 is used to treat moderate to severe pain.
Tramadol hydrochloride contained in Tradolan may also be approved to treat other conditions not mentioned in this leaflet. 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 Tradolan
Do not use Tradolan
– if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
– if you have recently used alcohol, sleeping pills, painkillers, or psychopharmaceuticals (medicines that affect mood/mood and emotional life).
– if you are simultaneously using MAO inhibitors (certain medicines for the treatment of depression) or have taken such medicines in the last 14 days before treatment with Tradolan (see “Other medicines and Tradolan”).
– if you suffer from epilepsy that is not well controlled with treatment.
– as a substitute for drug withdrawal.
Warnings and precautions
Talk to your doctor or pharmacist before using Tradolan.
Take special care with Tradolan:
– if you suspect that you are or have been addicted to other painkillers ( opioids ).
– 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 your 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 are taking antidepressants as some of them can interact with tramadol (see “Other medicines and Tradolan”).
Sleep-related breathing disorders
Tradolan can cause sleep-related breathing disorders such as sleep apnea (breathing pause
during sleep) and sleep-related hypoxemia (low oxygen 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.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tradolan. 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
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 can cause physical and psychological dependence. When Tradolan 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 only for short periods and under strict medical supervision.
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, especially after long-term treatment, your doctor will recommend tapering the dose to reduce withdrawal symptoms.
Treatment with Tradolan can cause caries as a result of dry mouth. The teeth should be cleaned with fluoride toothpaste 2 times a day.
Inform your doctor if one or more of these problems occur during treatment with Tradolan or if they have affected you in the past.
Children
Tradolan is not suitable for children under 12 years of age.
Use in children with breathing problems
Tramadol is not recommended for children with respiratory problems as the symptoms of tramadol poisoning may be worse in these children.
Other medicines and Tradolan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tradolan should not be taken with MAO inhibitors (a type of medicine used to treat depression)
The pain-relieving effect of Tradolan 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)
– fluoxetine , paroxetine (for depression). These can also increase the risk of convulsions (see below).
Concomitant use of Tradolan and sedative drugs or drugs for sleep disorders such as benzodiazepines or similar drugs increases the risk of drowsiness, 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 the doctor prescribes Tradolan at the same time as sedative drugs, the dose and duration of treatment must be 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 good 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.
The doctor assesses whether you can use Tradolan 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. You may feel drowsy and faint. Tell the doctor if this happens.
– at the same time taking medicines that can cause convulsions (seizures), for example, certain medicines for depression or mental illness. The risk of seizures may increase. Your doctor will inform you if Tradolan is suitable for you.
– are taking certain antidepressants, as Tradolan may interact with these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
– at the same time taking coumarin-type anticoagulants (blood-thinning drugs) such as warfarin, together with Tradolan. The effect of these medicines on the blood’s ability to clot can be affected and bleeding can occur.
Tramadol with food and drink
Food does not affect the effect of Tradolan. Do not drink alcohol when using Tradolan as the side effects of this medicine can 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 insufficient information on the safety of tramadol use during pregnancy. Therefore, Tradolan should not be used during pregnancy.
Breast-feeding
Tramadol is excreted in breast milk. You should therefore not take Tradolan more than once during breastfeeding. Alternatively, if you take Tradolan 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.
How to use Tradolan
Always use 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 over 12 years of age
The usual starting dose is 1 tablet. If sufficient pain relief is not achieved after 30-60 minutes, another 1 tablet can be taken.
In acute pain conditions, 2 tablets can be taken as a starting dose. Usually, 1-2 tablets 3-4 times per day are sufficient. Your doctor can prescribe a different, more appropriate dosage of the drug if necessary.
Elderly patients
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 ( insufficiency )/dialysis patients
Patients with severe liver and/or kidney failure should not take Tradolan. 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?
The tablets should be swallowed with plenty of liquid (e.g. ½ glass of water). The tablets should not be chewed. Tradolan tablets can be taken independently of a meal.
You should not take Tradolan for 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 and at what dose.
If you feel that the effect of Tradolan is too strong or too weak, contact your doctor or pharmacist.
If you have taken too much Tradolan
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.
After very high doses, the following symptoms may occur: pupil dilation, vomiting, drop in blood pressure, heart palpitations, collapse, loss of consciousness/coma (deep unconsciousness) with fatal outcome, epileptic seizures, breathing difficulties, and respiratory arrest. In these cases, doctors must be called immediately.
If you forget to take Tradolan
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
If you stop or stop treatment with Tradolan too soon, the pain is likely to come back. 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 may feel unwell if they have been treated with tramadol for a long time and then suddenly stop the treatment. They may feel worried, anxious, nervous, 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, you should contact 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 any of the following symptoms:
– swollen face, tongue, and/or throat and/or difficulty swallowing or if you get hives along with breathing difficulties (may affect up to 1 in 1,000 users).
– respiratory depression. If the recommended dose is significantly exceeded, or if any medicine that lowers brain function is taken at the same time, the breathing rate may decrease (may affect up to 1 in 1,000 users).
– serious skin reactions such as toxic epidermal necrolysis and Steven Johnson syndrome) (may affect up to 1 in 10,000 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 may occur during treatment with Tradolan. 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).
- 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 if this is caused by tramadol.
- 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):
- dizziness
- bleeding
- elevated liver values
Frequency not known (cannot be estimated from available data):
- lowering the blood sugar level
- low sodium levels, which can cause dizziness, discomfort, muscle weakness, and confusion.
- hiccup
- Serotonergic syndrome, ma 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”).
If Tradolan is used for a long time, drug dependence may occur, although the risk is very low. If treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Tradolan).
How to store Tradolan
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Use before the expiry date which is stated on the carton/label after “Exp:” 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. 1 tablet contains 50 mg tramadol hydrochloride.
Other ingredients
– Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, povidone, magnesium stearate.
– Film coating: polyacrylate dispersion 30%, macrogol 6000, hypromellose, talc, titanium dioxide (dye E 171).
Appearance and package sizes of the medicine
Film-coated, white, round, and cupped tablet.
Aluminium/PVC blister card: Packs of 20, 100 x 1,250 tablets.
Plastic container (HDPE/PP) with child-resistant lid: Pack of 200 tablets.
Plastic container (HDPP/LDPE): Pack of 1,000 tablets (intended for dose dispensing and hospital use only).
GL Pharma GmbH, Lannach, Austria.
Agent
Nordic Drugs AB, Box 300 35, 200 61 Limhamn.