50 mg capsules
tramadol hydrochloride
What Tramadol Stada is and what it is used for
Tramadol – the active ingredient in Tramadol Stada – is a painkiller that belongs to the opioid class that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.
Tramadol Stada is used for
- the treatment of moderate to severe pain.
Tramadol, contained in Tramadol Stada, 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 Stada
Do not use Tramadol Stada
- if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- in case of acute intoxication with alcohol, sleeping pills, painkillers, or psychopharmaceuticals (agents that affect mood/mood and emotional life)
- if you also use a type of antidepressant called a monoamine oxidase inhibitor ( MAOI )
- if you have used MAO inhibitors in the last two weeks before you start taking Tramadol Stada
- if you have epilepsy and your disease is not adequately controlled with medicine
- as a treatment for withdrawal symptoms in drug addiction.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol Stada:
- if you are prone to epilepsy or seizures, then the risk of having a seizure may increase. Normal doses of Tramadol Stada can cause seizures. Higher doses of Tramadol Stada may increase the risk of seizures. The risk of seizures also increases when Tramadol Stada is taken together with other medicines (see “Other medicines and Tramadol Stada”)
- if you have a head injury
- if the pressure in your head is higher than normal. This can happen after a head injury or cause by a brain disease such as a brain tumor
- if you have a shock (signs of shock include cold sweats)
- if you have breathing difficulties
- if you suffer from disturbances of consciousness (if you feel that you are passing out)
- if you suffer from liver or kidney disease
- if you think you are dependent on other painkillers (opioids er).
- if you suffer from depression and are taking antidepressants as some of them may interact with tramadol (see “Other medicines and Tramadol Stada”)
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol Stada.
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.
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”).
Sleep-related breathing disorders
Tramadol Stada 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.
Tramadol is converted into the liver by an enzyme. Some people have a variant of this enzyme and this can affect 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.
Drug addiction
Please note that Tramadol Stada can cause physical and psychological dependence. When Tramadol Stada is used for a longer period, its effect may decrease, so a higher dose must be taken ( tolerance development ).
If your doctor thinks there is a risk of you developing an addiction, the doctor will treat you with Tramadol Stada for short periods. Your doctor will also regularly check whether you need to continue taking Tramadol Stada.
Children
Tramadol Stada is not recommended for children with breathing problems, as the symptoms of tramadol poisoning may be worse in these children.
Other medicines and Tramadol Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do NOT take Tramadol Stada together with monoamine oxidase inhibitors ( MAOIs ), or two weeks before or after taking these medicines. MAO inhibitors are drugs used for depression.
The effect of Tramadol Stada can increase if:
- you also take other medicines that act on the central nervous system, e.g. sedatives, sleeping pills, or other pain relievers such as morphine and codeine (also as cough medicine)
- you drink alcohol (see also “Driving ability and use of machines”).
You may feel sleepier or faint. Talk to your doctor if this happens.
The pain-relieving effect of Tramadol Stada can be reduced and the duration of the effect can be reduced if:
- you are taking medicines containing ondansetron (for nausea)
- you also take carbamazepine (a medicine for epilepsy and mental disorders).
You should not take Tramadol Stada together with the following painkillers:
- buprenorphine
- nalbuphine
- pentazocine
The risk of side effects increases,
- if you are taking medicines that can cause convulsions (seizures), such as some antidepressants and antipsychotic medicines. The risk of having a seizure may increase if you take Tramadol Stada at the same time. Your doctor will tell you if Tramadol Stada is right for you.
- if you are taking certain antidepressants. Tramadol Stada may interact with these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
You should be careful if you also take blood-thinning drugs (eg warfarin ). Tramadol Stada can increase the bleeding time and can cause bleeding in the skin ( ecchymosis ).
If you are taking ondansetron – a medicine used to treat vomiting (nausea) – you may need to take more Tramadol Stada. Your doctor will determine your dose. Ondansetron is often used in the treatment of cancer ( chemotherapy ) or before or after surgery.
Concomitant use of Tramadol Stada 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 Tramadol Stada at the same time as sedatives or medicines for sleep disorders, the dose and duration of treatment must be limited by the doctor.
Tell your doctor if you are taking any sedative or sleep medication 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 any of these symptoms.
Tramadol Stay with food, drink, and alcohol
Do not drink alcohol when you are treated with Tramadol Stada as its effect may be enhanced. Food does not affect the effect of Tramadol Stada.
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.
Pregnancy
There is little information about the safety of using Tramadol Stada during pregnancy.
This medicine may harm your unborn baby. If you are planning to become pregnant or are already pregnant
- you should not use Tramadol Stada, unless your doctor tells you to. Your doctor will decide whether you should take tramadol Stada.
If your doctor decides that you should take Tramadol Stada during pregnancy, you will only receive a single dose. You should not take Tramadol Stada for an extended period while you are pregnant. This can affect your unborn child who may experience withdrawal symptoms.
Breast-feeding
Tramadol is excreted in breast milk. You should therefore not take Tramadol Stada more than once during breastfeeding. Alternatively, if you take Tramadol Stada more than once, you should stop breastfeeding.
Driving ability and use of machinery
Tramadol Stada can cause drowsiness, dizziness, and blurred vision and therefore affect your ability to react. If you feel that your ability to react is impaired, do not drive a car or other vehicle, and do not use electric tools or machines.
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 may 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 your doctor or pharmacist if you are unsure.
Tramadol Stada contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost “sodium-free”.
How to use Tramadol Stada
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Should one be adjusted to the severity of your pain and your pain sensitivity?
Usually, you should take the lowest dose that provides pain relief.
Do not dose more often than every 4 hours.
The pain-relieving effect of Tramadol Stada will last for 4 to 8 hours, depending on how severe your pain is.
Your doctor will treat you with Tramadol Stada for short periods with regular breaks in the treatment. This minimizes the risk of you developing a dependency (see “Warnings and precautions”).
Do not take more than a total of 400 mg tramadol hydrochloride (8 hard capsules of Tramadol Stada) per day unless your doctor has specifically prescribed it.
Use for children up to 12 years
Children up to 12 years of age should not take Tramadol Stada capsules. Other forms of Tramadol Stada are available which are more suitable for young children.
Adults and children over 12 years of age
The usual dose is 1 – 2 capsules of Tramadol Stada (equivalent to 50 – 100 mg tramadol hydrochloride) 3 to 4 times per day.
If the pain-relieving effect is not sufficient 30 – 60 minutes after taking 1 capsule (50 mg) of Tramadol Stada, you can take another 1 capsule of Tramadol Stada (50 mg).
If you have severe pain, your doctor will decide whether you should take 2 capsules of Tramadol Stada (equivalent to 100 mg tramadol hydrochloride). If your pain is still not relieved, your doctor will increase your dose of Tramadol Stada until adequate pain relief is achieved.
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/dialysis patients
Patients with severe liver and/or kidney failure should not take Tramadol Stada. If you have mild or moderate liver and/or kidney failure, your doctor may recommend you extend the time between doses.
Mode of administration
You should swallow Tramadol Stada hard capsules whole with water. Do not crush or chew the capsules. Take Tramadol Stada between meals.
The capsules are packed in a blister intended to be difficult for children to open. To get the capsules out undamaged, push the nail or a sharp object down through the aluminum foil along the long side of the capsule before pushing the capsule out.
Duration of treatment
Your doctor will tell you how long to take Tramadol Stada.
Use for children and adolescents
Children up to 12 years of age should not take Tramadol Stada capsules. Other forms of Tramadol Stada are available which are more suitable for young children.
If you have used too much Tramadol Stada
If you have taken an extra dose by mistake, this will not usually cause any adverse effects. You must take the next dose as directed.
After ingestion of very large doses, pupil dilation, vomiting, drop in blood pressure, rapid heartbeat, collapse, loss of consciousness and even coma (deep unconsciousness), epileptic seizures and breathing difficulties and even respiratory arrest can occur. If this occurs, contact your doctor or go to the nearest emergency room immediately!
Remember to take the packaging and any remaining capsules with you.
Your doctor will treat your overdose symptoms.
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 use Tramadol Stada
If you forget to take the capsules, you are likely to get the pain back. If you forget to take a dose of Tramadol Stada, take the next dose as usual. Do not take a double dose to make up for a missed dose.
If you forget to take a dose, take the next one as soon as you remember. Then continue as before. Do not take double doses to make up for missed doses. If you are concerned, ask your doctor or pharmacist for advice.
If you stop using Tramadol Stada
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).
If you interrupt or stop, treatment with Tramadol Stada, you are likely to get the pain back. Talk to your doctor if you want to stop treatment because of side effect
As a rule, there are no side effects when treatment with Tramadol Stada ends. However, it has happened, in rare cases, that people who have been treated with Tramadol Stada for some time felt unwell if they stopped the treatment abruptly. You may feel agitated, anxious, nervous, shaky, become hyperactive, have difficulty sleeping, and have stomach or intestinal problems. In very rare cases, you may suffer from panic attacks, hallucinations, abnormal experiences such as itching, tingling, or numbness, as well as ringing in the ears ( tinnitus ). Several unusual symptoms from the central nervous system, ie. confusion, delusions, altered self-perception, altered perception of reality, and persecutory mania ( paranoia), have occurred in very rare cases. Talk to your doctor if you experience any of these symptoms after stopping treatment with Tramadol Stada.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediately if you experience any of the following:
Symptoms of an allergic reaction such as:
- swelling of the face, arms and legs, tongue, larynx, or throat
- difficulty swallowing
- breathing difficulties
- hives and difficulty breathing.
Very common (may affect more than 1 in 10 users):
- nausea
- dizziness.
Common (may affect up to 1 in 10 users):
- vomiting
- constipation
- dry mouth
- headache
- sweating
- drowsiness
- fatigue.
Uncommon (may affect up to 1 in 100 users):
- nausea
- gastrointestinal disturbances (a feeling of pressure in the stomach, bloating)
- diarrhea
- heart/vascular problems when you can feel your heartbeats (palpitations), fast heart rhythm ( tachycardia ), dizziness or fainting when standing ( postural hypotension ), when the blood circulation is not sufficient due to that the heart does not work normally ( cardiovascular collapse). These side effects are more common if you are physically stressed, e.g. if you have just had an operation.
- skin reactions include;
- itching ( pruritus )
- rash
- hives ( urticaria ).
Rare (may affect up to 1 in 1,000 users):
- appetite changes
- slow heart rate ( bradycardia )
- elevated blood pressure
- slow or shallow breathing ( respiratory depression ). You may develop respiratory depression if:
- you take a much larger dose than the recommended one (see section 3. “If you have taken too much Tramadol Stada”)
- you are taking other medicines that affect the central nervous system (see “Other medicines and Tramadol Stada”)
- epileptic seizures. There is a greater risk of seizures:
- after high doses of Tramadol Stada, or
- after taking medicines that cause convulsions or increase the risk of convulsions, e.g. antidepressant or antipsychotic medicines (see “Intake of other medicines”).
- muscle twitching
- tingling ( paresthesia )
- tremors _ _
- psychological side effects can occur after taking tramadol and vary individually in intensity and nature depending on:
- personality
- processing time
- These include:
- mood swings, usually elation, sometimes depression
- changes in activity (usually less active, sometimes more active)
- changes in your ability to think and feel things (your cognitive and sensory capacity) such as:
- ability to make decisions
- lack of attention or understanding (perception problems)
- seeing and hearing things that are not real (hallucinations)
- confusion
- sleep difficulties
- delirium
- nightmares
- blurred vision
- muscle weakness
- bladder emptying problems or pain when urinating, less urine than normal
- uncoordinated movements
- transient loss of consciousness ( syncope )
- anxiety.
- allergic reactions (hypersensitivity) including:
- shortness of breath ( dyspnea )
- contraction of the lower airways causing breathing difficulties ( bronchospasm )
- wheezing
- angioedema/severe allergic reaction/shock with respiratory distress.
If treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Tramadol Stada”).
Very rare (may affect up to 1 in 10,000 users):
- drug addiction
- increase in liver enzyme values.
Has been reported (occurring in an unknown number of users):
- The 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 Tramadol Stada”).
- worsening of asthma has been reported, although not confirmed to be caused by tramadol
- abnormally large pupils ( mydriasis )
- speech difficulties
- decrease in blood sugar level (hypoglycemia/insulin sensitivity)
- hiccup.
How to store Tramadol Stada
Store this mouthwash out of the sight and reach of children.
Use before the expiry date stated on the packaging after “EXP”.
The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Medicines must not be thrown down the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures are to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tramadol hydrochloride. 1 capsule contains 50 mg tramadol hydrochloride.
- Other ingredients are calcium hydrogen phosphate dihydrate, magnesium stearate, colloidal anhydrous silica, gelatin, titanium dioxide (E171), and sodium lauryl sulfate.
Appearance and package sizes of the medicine
Tramadol Stada is a white, opaque, hard gelatin capsule.
Tramadol Stada is packaged in aluminum/PVC blisters.
Pack sizes (blister pack): 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 200, 250, 500 and 1000 capsules.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark