Patient Leaflet Updated 02-Sep-2024 | Tillomed Laboratories Ltd
Pregabalin Tillomed 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg Capsules, Hard
Pregabalin Tillomed 25 mg capsules, hard;
Pregabalin Tillomed 50 mg capsules, hard;
Pregabalin Tillomed 75 mg capsules, hard;
Pregabalin Tillomed 100 mg capsules, hard;
Pregabalin Tillomed 150 mg capsules, hard;
Pregabalin Tillomed 200 mg capsules, hard;
Pregabalin Tillomed 225 mg capsules, hard;
Pregabalin Tillomed 300 mg capsules, hard;
pregabalin
1. What Pregabalin Tillomed is and what it is used for
2. What you need to know before you take Pregabalin Tillomed
3. How to take Pregabalin Tillomed
4. Possible side effects
5. How to store Pregabalin Tillomed
6. Contents of the pack and other information
Pregabalin Tillomed belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin Tillomed 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.
Epilepsy: Pregabalin is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Tillomed for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take pregabalin in addition to your current treatment. Pregabalin Tillomed is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin Tillomed is used to treat Generalised Anxiety Disorder (GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This is different to the stresses and strains of everyday 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 Pregabalin Tillomed.
Dependence
Some people may become dependent on pregabalin (a need to keep taking the medicine). They may have withdrawal effects when they stop using pregabalin (see section 3, “How to take Pregabalin Tillomed” and “If you stop taking Pregabalin Tillomed”). If you have concerns that you may become dependent on pregabalin, it is important that you consult your doctor.
If you notice any of the following signs whilst taking pregabalin, 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.
Pregabalin and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), pregabalin 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 Pregabalin Tillomed is taken together with medicines containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin may be taken with oral contraceptives
Pregabalin Tillomed capsules may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin Tillomed
Pregabalin Tillomed 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 child-bearing potential. 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.
Pregabalin Tillomed 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. Do not take more medicine than prescribed.
Your doctor will determine what dose is appropriate for you.
Pregabalin Tillomed is for oral use only.
Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:
If you have the impression that the effect of Pregabalin Tillomed 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 Pregabalin Tillomed 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.
Swallow the capsule whole with water.
Continue taking Pregabalin Tillomed until your doctor tells you to stop.
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin Tillomed capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Tillomed than you should. Fits and unconsciousness (coma) have also been reported.
It is important to take your Pregabalin Tillomed capsules regularly at the same time each day. If you forget to take a dose, take it as soon as you remember 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 stop taking Pregabalin Tillomed unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week.
After stopping long or short-term Pregabalin Tillomed treatment, 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 Pregabalin Tillomed 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
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 post-marketing experience: Trouble breathing, shallow breaths.
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.
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.
Pregabalin Tillomed capsules hard is available in 8 strengths: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
The 25 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 25” with black ink and white opaque cap available in blister packs of 14, 28, 56, 84, 100 capsules.
The 50 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 50” with black ink and white opaque cap. The body is marked with black coloured ink band and is available in blister packs of 14, 21, 28, 42, 56, 84, 100 capsules.
The 75 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 75” with black ink and orange opaque cap available in blister packs of 14, 56, 70, 100 capsules.
The 100 mg capsules are hard gelatin capsules with an orange opaque body imprinted with “PGBN 100” with black ink and orange opaque cap available in blister packs of 14, 21, 56, 84, 100 capsules.
The 150 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 150” with black ink and white opaque cap. The body is marked with black coloured ink band and is available in blister packs of 14, 56, 84, 100 capsules.
The 200 mg capsules are hard gelatin capsules with a light orange opaque body imprinted with “PGBN 200” with black ink and light orange opaque cap available in blister packs of 14, 21, 56, 84, 100 capsules.
The 225 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 225” with black ink and light orange opaque cap available in blister packs of 56, 84 and 100 capsules.
The 300 mg capsules are hard gelatin capsules with a white opaque body imprinted with “PGBN 300” with black ink and orange opaque cap. The body is marked with black coloured ink band and is available in blister packs of 14, 56, 84, 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer1
This leaflet was last revised in 03/2024
1Only actual batch release site listed on printed leaflet
220 Butterfield, Great Marlings, Luton, LU2 8DL, UK
+44 (0)1480 402 402
+44 (0)1480 402 402
+44 (0)1480 402431 / +44 (0)1480 402432
http://www.tillomed.com/
+44 (0)1480 402 400
+44 (0)1480 402 400
+44 (0)1480 402431 / +44 (0)1480 402432