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The product code(s) for this leaflet is: PL 19635/0010.
Misabri PR
MISABRI PR 82.5 mg prolonged-release tablets
MISABRI PR 165 mg prolonged-release tablets
MISABRI PR 330 mg prolonged-release tablets
pregabalin
1. What Misabri PR is and what it is used for
2. What you need to know before you take Misabri PR
3. How to take Misabri PR
4. Possible side effects
5. How to store Misabri PR
6. Contents of the pack and other information
Misabri PR belongs to a group of medicines used to treat neuropathic pain in adults.
Misabri PR is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking Misabri PR.
Dependence
Some people may become dependent on pregabalin (a need to keep taking the medicine). They may have withdrawal effects when they stop using this medicine (see section 3, “How to take Misabri PR” and “If you stop taking Misabri PR”). If you have concerns that you may become dependent on this medicine, it is important that you consult your doctor.
If you notice any of the following signs whilst taking Misabri PR, it could be a sign that you have become dependent:
If you notice any of these, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.
The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Misabri PR and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Misabri PR may potentiate these effects, and could lead to respiratory failure, coma and death. The degree of dizziness, sleepiness and decreased concentration may be increased if Misabri PR is taken together with medicines containing:
Misabri PR may be taken with oral contraceptives.
You should not drink alcohol while taking Misabri PR. For information regarding treatment with Misabri PR in relation with food see section 3, “How to take Misabri PR”.
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.
This medicine should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor. Pregabalin use during the first 3 months of pregnancy may cause birth defects in the unborn child that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin in the first 3 months of pregnancy, 6 babies in every 100 had such birth defects. This compares to 4 babies in every 100 born to women not treated with pregabalin in the study. Abnormalities of the face (orofacial clefts), the eyes, the nervous system (including the brain), kidneys and genitals have been reported.
Effective contraception must be used by women of childbearing potential.
Misabri PR may produce dizziness, sleepiness and decreased concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Misabri PR is for oral use only. You should take Misabri PR once a day, in the evening, directly after an evening meal. Swallow the tablet whole with water. Do not split, crush or chew the tablet. The tablet should not be broken because this could impact its characteristics.
Your doctor will determine what dose is appropriate for you.
If you have the impression that the effect of Misabri PR is too strong or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should take this medicine normally, except if you have problems with your kidneys.
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
Continue taking Misabri PR until your doctor tells you to stop.
When switching from pregabalin immediate release to pregabalin prolonged release, like this medicine, your doctor will instruct you how to do this. He will tell you to take the following steps:
Do not switch the medicines unless your doctor tells you to do so. He will also indicate the appropriate dosage for your condition.
If you have additional questions or you are not sure, talk with your doctor.
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or container (bottle) of Misabri PR tablets with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Misabri PR than you should. Fits and unconsciousness (coma) have also been reported.
It is important to take your Misabri PR tablets regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, always after some food, unless it is time for your next dose. In that case, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose.
Do not suddenly stop taking Misabri PR. If you want to stop taking this medicine, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually. After stopping a short or long-term treatment with Misabri PR, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness. These effects may occur more commonly or severely if you have been taking Misabri PR for a longer period of time. If you experience withdrawal effects, you should contact your doctor.
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.
Very common: may affect more than 1 in 10 people
Dizziness, drowsiness, headache.
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
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
After stopping a short or long-term treatment with this medicine, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Misabri PR”).If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, you should seek immediate medical advice.
Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may be increased when taken together.
The following adverse reaction has been reported in the postmarketing experience: Trouble breathing, shallow breaths.
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 box or container (bottle). The expiry date refers to the last day of that month.
For 82.5 mg: Do not store above 30°C.
For 165 mg and 330 mg: 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.
The active substance is pregabalin. Each prolonged-release tablet contains either 82.5 mg, 165 mg or 330 mg of pregabalin.
The other ingredients are:
Misabri PR 82.5 mg prolonged-release tablet
White, oval, unscored, blank on one side and imprinted “ALV 379” on the other side with black ink, with a length of 19 mm, a width of 12 mm and thickness of approximately 7 mm.
Misabri PR 165 mg prolonged-release tablet
Yellow, oval, unscored, blank on one side and imprinted “ALV 380” on the other side with black ink, with a length of 19 mm, a width of 12 mm and thickness of approximately 7 mm.
Misabri PR 330 mg prolonged-release tablet
Pink, oval, unscored, blank on one side and imprinted “ALV 381” on the other side with black ink, with a length of 19 mm, a width of 12 mm and thickness of approximately 8 mm.
Misabri PR is available in:
Not all pack sizes may be marketed.
This leaflet was last revised in 07/2024.