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The product code(s) for this leaflet is: PLGB 53835/0007.
Vecicom 50, 100, 150, 200 and 250mg Prolonged-release Tablets
Vecicom 50 mg Prolonged-release Tablets
Vecicom 100 mg Prolonged-release Tablets
Vecicom 150 mg Prolonged-release Tablets
Vecicom 200 mg Prolonged-release Tablets
Vecicom 250 mg Prolonged-release Tablets
tapentadol
1. What Vecicom Prolonged-release Tablets are and what they are used for
2. What you need to know before you take Vecicom Prolonged-release Tablets
3. How to take Vecicom Prolonged-release Tablets
4. Possible side effects
5. How to store Vecicom Prolonged-release Tablets
6. Contents of the pack and other information
Tapentadol - the active substance in Vecicom Prolonged-release Tablets - is a strong painkiller which belongs to a group of medicines called opioids. Vecicom Prolonged-release Tablets are used in adults to treat severe long-term pain that can only be adequately managed with an opioid painkiller.
Talk to your doctor or pharmacist before taking Vecicom Prolonged-release Tablets if you:
Sleep-related breathing disorders
Vecicom Prolonged-release Tablets are an opioid painkiller.
Opioids can cause sleep-related breathing disorders, such as shallow/pauses in breathing during sleep (sleep apnoea) and low level of oxygen in the blood during sleep (sleep related hypoxaemia).
The risk of sleep apnoea depends on the dose of opioids.
If you experience this, your doctor may decrease your dose.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
Your doctor will tell you which medicines are safe to take with Vecicom Prolonged-release Tablets.
Please keep your doctor informed about all medicines you are taking.
Do not drink alcohol whilst you are taking Vecicom Prolonged-release Tablets, because some side effects such as drowsiness may be increased. You can take Vecicom Prolonged-release Tablets with or without food.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Vecicom Prolonged-release Tablets:
If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking Vecicom Prolonged-release Tablets, then do not drive, use tools or machinery.
Any such effects are more likely to occur when you start taking Vecicom Prolonged-release Tablets, when the dose of Vecicom Prolonged-release Tablets is changed, or when you drink alcohol or take tranquilizers.
Please ask your doctor before driving a car or using machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will change the dose and time between doses of Vecicom Prolonged-release Tablets according to your pain level and your needs. Generally, the lowest pain-relieving dose should be taken.
The usual dose is 1 tablet every 12 hours.
Total daily doses of Vecicom Prolonged-release Tablets greater than 500 mg tapentadol are not recommended.
Your doctor may prescribe a different, more appropriate dose or time between doses if this is necessary for you.
If you feel that the effect of these tablets is too strong or weak, talk to your doctor or pharmacist.
Vecicom Prolonged-release Tablets are for oral use.
Swallow the tablet with a glass of water. You may take the tablet either on an empty stomach or with food. The score line is not intended for breaking the tablet. Swallow whole. Do not break, crush, or chew the tablet, as it may result in overdose due to the quick release of tapentadol in your body.
The empty shell of the tablet may not be digested completely and thus be seen in a stool. This should not worry you, as the drug (active substance) of the tablet has already been absorbed in your body and what you see is just the empty shell.
In elderly patients (above 65 years) usually no dose adjustment is necessary. However, your doctor may adjust your dose or time between doses if required.
Do not take Vecicom Prolonged-release Tablets if you have severe liver or kidney problems.
If you have moderate liver problems, your doctor will adjust your dose or time between doses.
If you have mild liver problems or mild to moderate kidney problems, a dose adjustment is not required.
Vecicom Prolonged-release Tablets are not recommended for children and adolescents below the age of 18 years.
Do not take the tablets for longer than your doctor has told you.
Taking too much Vecicom Prolonged-release Tablets may be life-threatening. Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Very high doses of Vecicom Prolonged-release Tablets may cause the following:
If you forget to take the tablets, your pain is likely to return.
Do not take a double dose to make up for a forgotten dose; simply continue taking the tablets as before.
If you interrupt or stop treatment too soon, your pain is likely to return. If you wish to stop treatment, please tell your doctor first before stopping treatment.
Generally, there will be no withdrawal effects when treatment is stopped.
However, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they suddenly stop taking them.
Symptoms may be:
If you experience any of these complaints after stopping Vecicom Prolonged-release Tablets, please contact your doctor.
Do not stop taking this medicine unless your doctor tells you to.
If your doctor wants you to stop taking your tablets, he/she will tell you how to do this. This may include a gradual reduction of the dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you are affected by these important side effects contact a doctor immediately.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Unknown
In general, the likelihood of having suicidal thoughts and behaviour is increased in patients suffering from chronic pain. In addition, certain medicines for the treatment of depression (which have an impact on the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data from human use of tapentadol do not provide evidence for an increased risk of suicidal thoughts or behaviour.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Vecicom 50 mg Prolonged-release Tablets are white, oblong, biconvex film-coated tablets (6.2 mm x 13.2 mm) with score lines on both sides.
Vecicom 100 mg Prolonged-release Tablets are light yellow, oblong, biconvex film-coated tablets (6.7 mm x 14.2 mm) with score lines on both sides.
Vecicom 150 mg Prolonged-release Tablets are light pink, oblong, biconvex film-coated tablets (7.2 mm x 15.2 mm) with score lines on both sides.
Vecicom 200 mg Prolonged-release Tablets are yellow, oblong, biconvex film-coated tablets (7.7 mm x 16.2 mm) with score lines on both sides.
Vecicom 250 mg Prolonged-release Tablets are reddish brown, oblong, biconvex film-coated tablets (8.7 mm x 18.2 mm) with score lines on both sides.
Vecicom Prolonged-release Tablets are available in child resistant aluminium-PVC/PE/PVDC perforated unit dose blisters.
Packs with 20x1, 24x1, 28x1, 30x1, 50x1, 54x1, 56x1, 60x1, 100x1 Prolonged-release Tablets.
Not all pack sizes may be marketed.
POM CD
If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected]
This leaflet was last revised in November 2022
CEL00073