50 mg effervescent tablet er
tramadol hydrochloride
What Tiparol is and what it is used for
Tiparol is a morphine-like, pain-relieving drug that acts on special cells in the central nervous system (brain and spinal cord). The pain-relieving effect begins within about 1 hour and lasts up to 6 hours.
Tiparol is used to treat moderate to severe pain.
Tramadol hydrochloride contained in Tiparol may also be approved to treat other conditions not mentioned in this leaflet.
What you need to know before using Tiparol
Do not use Tiparol
- if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Also, do not use Tiparol if you are taking medicines that contain MAO inhibitors (for depression or Parkinson’s disease ) or have taken such medicine in the last 14 days.
You should also not use Tiparol if you are acutely poisoned with alcohol, sleeping pills, drugs that affect mood, mood, and emotional life (e.g. drugs for anxiety, worry, or depression), or painkillers.
Warnings and precautions
Talk to your doctor or pharmacist before using Tiparol if you:
- suspect that you are addicted to medication
- are hypersensitive to opioids (the group of painkillers to which Tiparol belongs)
- feeling weak or sleepy for no known reason (you may have a reduced level of consciousness or be in a state of shock)
- has a head injury
- have breathing difficulties
- have epilepsy or convulsions
- have any liver or kidney disease
- suffer from depression and take antidepressants because some of them can interact with tramadol (see “Other medicines and Tiparol”).
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 use Tiparol for a long time, there is a risk that you will become dependent and therefore you should not take Tiparol for longer than necessary.
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 loss of appetite.
Sleep-related breathing disorders
Tiparol can cause sleep-related breathing disorders such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low oxygen levels 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 if you experience any of the following symptoms while taking Tiparol: 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.
Treatment with Tiparol can cause dry mouth with an increased risk of tooth decay. Therefore, be extra careful with oral hygiene and brush your teeth with fluoride toothpaste 2 times a day.
Children and young people
Use in children with breathing problems
Tramadol is not recommended for children with respiratory problems, as symptoms of tramadol poisoning may be worse in these children.
Other medicines and Tiparol
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Tell the doctor if you are using other medicines while taking Tiparol. Certain medicines can affect or be affected by treatment with Tiparol, for example:
- certain medicines for epilepsy (carbamazepine)
- certain drugs that affect mood/mood and emotional life, e.g. drugs for depression ( MAO inhibitors or SSRIs )
- other drugs that lower the seizure threshold
- antibiotics (erythromycin)
- antifungal ( ketoconazole )
- blood thinners ( warfarin )
- medicine for nausea and vomiting (ondansetron)
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 Tiparol at the same time. Your doctor will tell you if Tiparol is right for you.
- if you are taking certain antidepressants. Tiparol may affect these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
You may become drowsy when taking Tiparol, especially if you simultaneously drink alcohol, or take any sleeping pills or painkillers that act on the central nervous system. You should therefore avoid this.
Simultaneous use of Tiparol and sedative drugs such as benzodiazepines or related 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 no other treatment options are possible.
If your doctor nevertheless prescribes Tiparol together with sedative drugs, the dose and duration of treatment should be limited by your doctor.
Tell your doctor if you are taking sedatives and follow your doctor’s dosage recommendations carefully. It can help to inform friends and relatives to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.
Pregnancy and breastfeeding
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.
There is a risk that the fetus will be affected. Therefore, always talk to your doctor before using Tiparol if you are pregnant.
Tramadol is excreted in breast milk. You should therefore not take Tiparol more than once during breastfeeding. Alternatively, if you take Tiparol more than once, you should stop breastfeeding.
Driving ability and use of machinery
Tiparol can impair the ability to react, which you should consider before driving a car or using 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 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 your doctor or pharmacist if you are unsure.
Tiparol contains aspartame
This medicine contains 10 mg of aspartame per effervescent tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body).
Tiparol contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Tiparol contains sodium
This medicine contains 172 mg of sodium (the main ingredient in common/table salt) per effervescent tablet. This corresponds to 9% of the maximum recommended daily intake of sodium for adults.
The maximum recommended daily dose of Tiparol contains 1376 mg of sodium. This corresponds to 69% of the maximum recommended daily intake of sodium for adults.
Consult a doctor or pharmacist about your need for 3 or more effervescent tablets daily for a longer period, especially if you have been prescribed a low-salt (low-sodium) diet.
How to use Tiparol
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Your doctor will determine the dose to suit you.
Does one should be adjusted to the severity of your pain and your sensitivity to pain. Usually, you should take the lowest dose that provides pain relief.
The usual dose for adults and children over 12 years: 1 effervescent tablet 3 times daily.
One effervescent tablet is dissolved in about ½ glass of water.
Use for children and adolescents
Tiparol is not recommended for 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 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 Tiparol. If you have mild or moderate liver and/or kidney failure, your doctor may recommend you extend the time between doses.
If you have used too much Tiparol
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor’s or hospital for an assessment of the risk and advice.
If you have taken too large a dose, your pupils may become smaller, you may feel nauseous and vomit, and have disturbances in consciousness, convulsions, and shortness of breath.
If you forget to use Tiparol
Do not take a double dose to make up for a missed tablet.
If you stop using Tiparol
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 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.
Stop taking Tiparol and contact your doctor immediately if you experience any of the following symptoms ( angioedema )
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
The most common side effects are nausea and dizziness.
Common (may affect up to 1 in 10 users): Nausea, vomiting, dry mouth, constipation, sweating, dizziness, headache, drowsiness.
Uncommon (may affect up to 1 in 100 users): Nausea, stomach upset (stomach pressure, bloating), diarrhea, itching, skin rash. Cardiac effects in the form of palpitations and low blood pressure can occur, especially in physically stressed people.
Rare (may affect up to 1 in 1,000 people): Changes in appetite, allergic reactions (eg difficulty breathing, swelling), and worsening of asthma have been reported, however, it is not clear if this is caused by tramadol anaphylactic shock (a very severe allergic reaction ), increased blood pressure, slow pulse, difficulty urinating, muscle weakness and seizures, tremors, transient loss of consciousness (fainting), abnormal sensations (eg itching, tingling, numbness). Psychic side effects such as hallucinations, nightmares, confusion, altered mood, perception, and activity level may also occur. Blurred vision.
Has been reported (occurring in an unknown number of users):
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 (eg nausea, vomiting, diarrhea) (see section 2 “What you need to know before you take Tiparol”).
Reduction in blood sugar level. Cases of liver involvement, epileptic-like convulsions, and difficulty breathing have occurred. Hiccup.
If you experience any unpleasant side effects, you should contact a doctor for help.
As a rule, there are no side effects when treatment with Tiparol ends. However, it has happened that people who have used medicines containing tramadol for a long time became excited, anxious, nervous, had difficulty sleeping, and had tremors or stomach and intestinal disturbances when they stopped taking the medicine. Contact your doctor if you experience such side effects when you stop taking Tiparol.
How Tiparol should be stored
Store in the original packaging. Finish well. Moisture sensitive.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after the Expiry date. 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 50 mg.
- Other ingredients are anhydrous citric acid, sodium bicarbonate (E 500), anhydrous sodium sulfate (E 514), lactose monohydrate 75 mg, macrogol, anhydrous sodium carbonate (E 500), sodium cyclamate (sweetener E 952 ), povidone, aspartame (E 951), flavoring (orange ), dimethicone, anhydrous colloidal silicon dioxide (E 551), macrogol stearate, sorbic acid (E 200) and water.
Appearance and package sizes of the medicine
Effervescent tablet.
The plastic tube with 1×15, 1×20 and 4×15, 5×20 effervescent tablets respectively.
Manufacturer
Sandoz A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark