Pregabalin Flamingo 225 mg hard capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Pregabalin Flamingo 25 mg, 50 mg, 75 mg, 100 mg, 225 mg and 300 mg hard capsules are referred as pregabalin capsules in this leaflet.

1. What pregabalin capsules are and what they are used for
2. What you need to know before you take pregabalin capsules
3. How to take pregabalin capsules
4. Possible side effects
5. How to store pregabalin capsules
6. Contents of the pack and other information

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.

Gabapentinoids can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.

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.

• Some patients taking Pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash.
  Should you experience any of these reactions, you should contact your physician immediately.
• Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pregabalin. Stop using pregabalin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• Pregabalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to any effect the medicine might have.
• Pregabalin may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any changes in your vision.
• Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
• 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.
• There have been reports of heart failure in some patients when taking Pregabalin; these patients were mostly elderly with cardiovascular conditions. Before taking this medicine you should tell your doctor if you have a history of heart disease.
• There have been reports of kidney failure in some patients when taking Pregabalin. If while taking Pregabalin you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
• Some patients being treated with anti-epileptics such as Pregabalin have had thoughts of harming or killing themselves or shown suicidal behaviour. If at any time you have these thoughts or shown such behaviour, immediately contact your doctor.
• When Pregabalin is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on Pregabalin.
• There have been reports of convulsions when taking Pregabalin or shortly after stopping Pregabalin. If you experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
• There have been reports of breathing difficulties. If you have nervous system disorders, respiratory disorders, renal impairment, or you are older than 65, your doctor may prescribe you a different dosing regimen. Contact your doctor if you experience trouble breathing or shallow breaths.

Dependence

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Gabapentinoids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of gabapentinoids may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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:

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

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:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

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.

• Take the number of capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
• Your doctor will tell you to take Pregabalin either twice or three times a day. For twice a day take Pregabalin once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin once in the morning, once in the afternoon and once in the evening, at about the same time each day.

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 of Pregabalin capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin than you should. Fits and unconsciousness (coma) 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 suddenly stop taking Pregabalin. If you want to stop taking Pregabalin, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms such as 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 for a longer period of time. If you experience withdrawal effects, you should contact your doctor.

If you notice any of the following signs whilst taking Pregabalin capsules, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

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.

• The active substance is pregabalin

The other ingredients are pregelatinised starch, purified talc

Capsules shell for pregabalin 25 mg and 50 mg hard capsules are made of titanium dioxide (E171), gelatine and purified water.

Capsules shell for pregabalin 75mg hard capsules are made of titanium dioxide (E171) , iron oxide red (E172), gelatine and purified water.

Capsules shell for pregabalin 100mg, 225mg and 300mg hard capsules are made of titanium dioxide (E171), iron oxide red & iron oxide yellow (E172), gelatine and purified water.

The ink used to print on the capsules contains shellac (E904), black iron oxide (E171) and propylene glycol (E1520).

25mg- size "4" hard gelatin capsule, white opaque cap imprinted with “PRG” & white opaque body imprinted with “25” containing white to off-white powder or powder plug. Capsule Length: 14.40 mm

50mg- size "3" hard gelatin capsule, white opaque cap imprinted with “PRG” & white opaque body imprinted with “50”, containing white to off-white powder or powder plug. Capsule Length:15.80 mm

75mg- size "4" hard gelatin capsule, brownish red opaque cap imprinted with “PRG” & white opaque body imprinted with “75”, containing white to off-white powder or powder plug. Capsule Length: 14.40 mm

100mg- size "3" hard gelatin capsule, orange opaque cap imprinted with “PRG” & orange opaque body imprinted with “100”, containing white to off-white powder or powder plug. Capsule Length: 15.80 mm

225mg- size "1" hard gelatin capsule, white opaque cap imprinted with “PRG” & orange opaque body imprinted with “225”, containing white to off-white powder or powder plug. Capsule Length: 19.30 mm

300mg- size "0" hard gelatin capsule, opaque cap imprinted with “PRG” & white opaque body imprinted with “300”, containing white to off-white powder or powder plug. Capsule Length: 21.40 mm

These capsules are available in clear film aluminium - PVC and aluminium - PVC/PVDC blister packs of 14, 56, 84, 100, and 112 capsules.

Not all pack sizes may be marketed.

25 mg- PL 43461/0198, 50 mg- PL 43461/0199

75 mg- PL 43461/0200, 100 mg- PL 43461/0201

225 mg- PL 43461/0202, 300 mg- PL 43461/0203