Pregabalin Milpharm 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 Pregabalin Milpharm is and what it is used for
2. What you need to know before you take Pregabalin Milpharm
3. How to take Pregabalin Milpharm
4. Possible side effects
5. How to store Pregabalin Milpharm
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 Pregabalin Milpharm

• Some patients taking Pregabalin Milpharm 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.
• Pregabalin Milpharm 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 Milpharm 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 Milpharm; 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 Milpharm. If while taking Pregabalin Milpharm 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 Milpharm 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 Milpharm 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 Milpharm.
• There have been reports of convulsions when taking Pregabalin Milpharm or shortly after stopping Pregabalin Milpharm. If you experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Milpharm 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.
• 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.

Dependence

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

If you notice any of the following signs whilst taking Pregabalin Milpharm, 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 Milpharm and certain other medicines may influence each other (interaction). When taken with certain other medicines which have sedative effects (including opioids), Pregabalin Milpharm 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 Milpharm is taken together with medicines containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin Milpharm may be taken with oral contraceptives.

Pregabalin Milpharm capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Milpharm.

Pregabalin Milpharm should not be taken during pregnancy or when breast-feeding, unless you are told other wise 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 Milpharm 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 each 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 Pregabalin Milpharm either twice or three times a day. For twice a day take Pregabalin Milpharm once in the morning and once in the evening, at about the same time each day. For three times a day take Pregabalin Milpharm 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 Milpharm 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 Milpharm 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 Milpharm 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 Milpharm capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Milpharm than you should. Fits and unconsciousness (coma) have also been reported.

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

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: 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 capsule, hard contains 25 mg of pregabalin.

Each capsule, hard contains 50 mg of pregabalin.

Each capsule, hard contains 75 mg of pregabalin.

Each capsule, hard contains 100 mg of pregabalin.

Each capsule, hard contains 150 mg of pregabalin.

Each capsule, hard contains 200 mg of pregabalin.

Each capsule, hard contains 225 mg of pregabalin.

Each capsule, hard contains 300 mg of pregabalin.

The other ingredients are:

Capsules content: Maize starch, talc

Capsules shell: Titanium dioxide (E171), gelatin, sodium lauryl sulfate, iron oxide red (E 172) (For 75 mg, 100 mg, 200 mg, 225 mg and 300 mg)

Printing Ink: Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

Capsule, hard.

Pregabalin Milpharm 25 mg capsules, hard

White cap/white body, size “5” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘10’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 50 mg capsules, hard

White cap/white body, size “4” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘11’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 75 mg capsules, hard

Orange cap/white body, size “4” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘12’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 100 mg capsules, hard

Orange cap/Orange body, size “3” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘13’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 150 mg capsules, hard

White cap/white body, size “2” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘14’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 200 mg capsules, hard

Light orange cap/ Light orange body, size “1” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘15’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 225 mg capsules, hard

Light orange cap/ White body, size “1” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘16’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm 300 mg capsules, hard

Orange cap/ White body, size “0” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘17’ on body with black ink contains white to off-white granular powder.

Pregabalin Milpharm hard capsules are available in clear PVC/ Aluminium blisters pack and white opaque HDPE bottles with polypropylene closure.

Pack sizes:

Blister packs: 14, 21, 30, 56, 60, 84, 90, 100, 112 and 200 capsules, hard

HDPE Bottle packs:

50 mg, 75 mg, 150 mg, 200 mg, 225 mg: 30, 200, 250 and 500 capsules, hard

25 mg, 100 mg, 300 mg: 30, 200, 250 and 500 capsules, hard

Not all pack sizes may be marketed.

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