Alzain 225 mg Capsules, Hard

• 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 on to 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.

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

• 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 Alzain.

• Some patients taking Alzain 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, 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.
• Alzain 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.
• Alzain 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 Alzain; 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 Alzain. If while taking Alzain 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 Alzain have had thoughts of harming or killing themselves or show suicidal behaviour. If at any time you have these thoughts or show such behaviour, immediately contact your doctor.
• When Alzain 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 Alzain.
• There have been reports of convulsions when taking Alzain or shortly after stopping Alzain. If you experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Alzain 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

Some people may become dependent on Alzain (a need to keep taking the medicine). They may have withdrawal effects when they stop using Alzain (see section 3, “How to take Alzain” and “If you stop taking Alzain”). If you have concerns that you may become dependent on Alzain, it is important that you consult your doctor.

If you notice any of the following signs whilst taking Alzain, 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.

Alzain and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Alzain 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 Alzain is taken together with medicines containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Alzain may be taken with oral contraceptives.

Alzain capsules may be taken with or without food.

It is advised not to drink alcohol while taking Alzain.

Alzain 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.

Alzain 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.

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

• 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 Alzain either twice or three times a day. For twice a day take Alzain once in the morning and once in the evening, at about the same time each day. For three times a day take Alzain 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 Alzain 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 Alzain 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 Alzain until your doctor tells you to stop.

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box of Alzain capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Alzain than you should. Fits and unconsciousness (coma) have also been reported.

It is important to take your Alzain 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 Alzain. If you want to stop taking Alzain, 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- or long term treatment with Alzain, 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 Alzain for a longer period of time. If you experience withdrawal effects, you should contact your doctor.

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. Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg pregabalin.
• The other ingredients are: mannitol, Co-processed corn starch (consisting of corn starch and pregelatinised corn starch), talc, gelatine, titanium dioxide (E171) and black ink, (which contains shellac, black iron oxide (E172), potassium hydroxide). The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172).

25 mg capsules White capsules, hard, size 4 (14.4 ± 0.4 mm), with “PGB 25” marked on the body.

50 mg capsules White capsules, hard, size 3 (15.8 ± 0.4 mm), with “PGB 50” marked on the body. The capsule body is marked with a black band.

75 mg capsules White and orange capsules, hard, size 4 (14.4 ± 0.4 mm), with “PGB 75” marked on the body.

100 mg capsules Orange capsules, hard, size 3 (15.8 ± 0.4 mm), with “PGB 100” marked on the body.

150 mg capsules White capsules, hard, size 2 (17.8 ± 0.4 mm), with “PGB 150” marked on the body.

200 mg capsules Light orange capsules, hard, size 1 (19.3 ± 0.4 mm), with “PGB 200” marked on the body.

225 mg capsules White and light orange capsules, hard, size 1 (19.3 ± 0.4 mm), with “PGB 225” marked on the body.

300 mg capsules White and orange capsules, hard, size 0 (21.4 ± 0.4 mm), with “PGB 300” marked on the body.

Alzain 25 mg, 50 mg, 75 mg, 100 mg, 150 mg and 200 mg are available in two pack sizes made of PVC with an aluminium foil backing: a 56 capsules pack and a 84 capsules pack.

Alzain 225 mg and 300 mg are available in one pack size made of PVC with an aluminium foil backing: a 56 capsules pack.

Not all pack sizes may be marketed.