The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0560.
Pregabalin Dr. Reddys 25mg,50mg,75mg,100mg,150mg,200mg,225mg,300mg Capsules, Hard
Pregabalin Dr. Reddy’s 25 mg Capsules, Hard
Pregabalin Dr. Reddy’s 50 mg Capsules, Hard
Pregabalin Dr. Reddy’s 75 mg Capsules, Hard
Pregabalin Dr. Reddy’s 100 mg Capsules, Hard
Pregabalin Dr. Reddy’s 150 mg Capsules, Hard
Pregabalin Dr. Reddy’s 200 mg Capsules, Hard
Pregabalin Dr. Reddy’s 225 mg Capsules, Hard
Pregabalin Dr. Reddy’s 300 mg Capsules, Hard
1. What Pregabalin is and what it is used for
2. What you need to know before you take Pregabalin
3. How to take Pregabalin
4. Possible side effects
5. How to store Pregabalin
6. Contents of the pack and other information
Pregabalin 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 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 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 is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin 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.
Talk to your doctor or pharmacist before taking Pregabalin.
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” and “If you stop taking Pregabalin”). 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 is taken together with medicines containing:
Pregabalin may be taken with oral contraceptives.
Pregabalin capsules may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin.
Pregabalin 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. 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 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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.
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 medicines than prescribed.
Your doctor will determine what dose is appropriate for you.
Pregabalin is for oral use only.
If you have the impression that the effect of Pregabalin 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 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 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 capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin than you should. Fits have also been reported.
It is important to take your Pregabalin 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 unless your doctor tells you to. If you want to stop taking Pregabalin, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually over a minimum of 1 week.
After stopping short- and long-term Pregabalin 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, pain, sweating, and dizziness. These effects may occur more commonly or severely if you have been taking Pregabalin 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
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 Pregabalin, you need to know that you may experience certain side effects, so-called withdrawal effects (see “If you stop taking Pregabalin”).
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 or blister after EXP. 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.
25 mg capsules Opaque white coloured cap and opaque white coloured body imprinted 'RDY' on the cap and '291' on the body with black imprinting ink. Size 4 (14.4 ± 0.4 mm).
50 mg capsules Opaque white coloured cap and opaque white coloured body imprinted 'RDY' on the cap and '292' on the body with black imprinting ink. The capsule body is marked with a black band. Size 3 (15.8 ± 0.4 mm).
75 mg capsules Opaque red coloured cap and opaque white coloured body imprinted 'RDY' on the cap and '293' on the body with black imprinting ink. Size 4 (14.4 ± 0.4 mm).
100 mg capsules Opaque red coloured cap and opaque red coloured body imprinted 'RDY' on the cap and '294' on the body with black imprinting ink. Size 3 (15.8 ± 0.4 mm).
150 mg capsules Opaque white coloured cap and opaque white coloured body imprinted 'RDY' on the cap and '295' on the body with black imprinting ink. Size 2 (17.8 ± 0.4 mm).
200 mg capsules Opaque light red coloured cap and opaque light red coloured body imprinted 'RDY' on the cap and '296' on the body with black imprinting ink. Size 1 (19.3 ± 0.4 mm).
225 mg capsules Opaque light red coloured cap and opaque white coloured body imprinted 'RDY' on the cap and '297' on the body with black imprinting ink. Size 1 (19.3 ± 0.4 mm).
300 mg capsules Opaque red coloured cap and opaque white coloured body imprinted 'RDY' on the cap and '298' on the body with black imprinting ink. Size 0 (21.4 ± 0.4 mm).
Pregabalin is available in blister packs containing 14, 20, 21, 30, 56, 60, 84, 90 or 100 capsules.
Not all pack sizes may be marketed.
This leaflet was last revised in 11/2023