Pregabalin Medical Valley

Document: Pregabalin Medical Valley capsule, hard ENG PL change

Package Leaflet: Information For The User

Pregabalin Medical Valley 25 mg hard capsules,

Pregabalin Medical Valley 50 mg hard capsules,

Pregabalin Medical Valley 75 mg hard capsules,

Pregabalin Medical Valley 100 mg hard capsules,

Pregabalin Medical Valley 150mg hard capsules,

Pregabalin Medical Valley 200 mg hard capsules,

Pregabalin Medical Valley 300 mg hard capsules,

pregabalin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or your 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.

What is in this leaflet:

What Pregabalin Medical Valley is and what it is used for

What you need to know before you take Pregabalin Medical Valley

How to take Pregabalin Medical Valley

Possible side effects

How to store Pregabalin Medical Valley

Contents of the pack and other information

1. What Pregabalin Medical Valley is and what it is used for

Pregabalin Medical Valley belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.

Epilepsy: Pregabalin Medical Valley is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Medical Valley for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Medical Valley in addition to your current treatment. Pregabalin Medical Valley is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.

Generalised Anxiety Disorder:Pregabalin Medical Valley 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.

2. What you need to know before you take Pregabalin Medical Valley

Do not take Pregabalin Medical Valley

If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Some patients taking Pregabalin Medical Valley 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 Medical Valley 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 Medical Valley 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.

There have been reports of heart failure in some patients when taking Pregabalin Medical Valley; 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 Medical Valley. If while taking Pregabalin Medical Valley you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.

A small number of people being treated with anti-epileptics such as Pregabalin Medical Valley have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

When Pregabalin Medical Valley 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 you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence. Do not take more medicine than prescribed.

There have been reports of convulsions when taking Pregabalin Medical Valley or shortly after stopping Pregabalin Medical Valley.If you experience a convulsion, contact your doctor immediately.

There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Medical Valley when they have other conditions. Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.

Children and adolescents

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.

Other medicines and Pregabalin Medical Valley

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregabalin Medical Valley and certain other medicines may influence each other (interaction). When taken with certain other medicines, Pregabalin Medical Valley may potentiate the side effects seen with these medicines, including respiratory failure and coma. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Medical Valley is taken together with medicinal products containing:

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin Medical Valley may be taken with oral contraceptives.

Pregabalin Medical Valley with food, drink and alcohol

Pregabalin Medical Valley capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Medical Valley.

Pregnancy and breast-feeding

Pregabalin Medical Valley should not be taken during pregnancy, unless you are told otherwise by your doctor. 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.

Driving and using machines

Pregabalin Medical Valley 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.

Pregabalin Medical Valley contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Pregabalin Medical Valley

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you.

Pregabalin Medical Valley is for oral use only.

Epilepsy or Generalised Anxiety Disorder:

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

If you take more Pregabalin Medical Valley than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of Pregabalin Medical Valley capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Medical Valley than you should.

If you forget to take Pregabalin Medical Valley

It is important to take your Pregabalin Medical Valley 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.

If you stop taking Pregabalin Medical Valley

Do not stop taking Pregabalin Medical Valley 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 and short-term Pregabalin Medical Valley treatment, you need to know that you may experience certain side effects. These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flulike symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more commonly or severely if you have been taking Pregabalin Medical Valley for a longer period of time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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:

Increased appetite
Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability
Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
Blurred vision, double vision
Vertigo, problems with balance, fall
Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen
Difficulties with erection
Swelling of the body including extremities
Feeling drunk, abnormal style of walking
Weight gain
Muscle cramp, joint pain, back pain, pain in limb
Sore throat

Uncommon: may affect up to 1 in 100 people:

Loss of appetite, weight loss, low blood sugar, high blood sugar.
Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart beat, heart failure.
Flushing, hot flushes.
Difficulty breathing, dry nose, nasal congestion.
Increased saliva production, heartburn, numb around mouth.
Sweating, rash, chills, fever.
Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
Breast pain.
Difficulty with or painful urination, incontinence.
Weakness, thirst, chest tightness.
Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased, aspartate aminotransferase increased, platelet count decreased, neutropenia, increase in blood creatinine, decrease in blood potassium).
Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring. Painful menstrual periods.
Coldness of hands and feet.

Rare: may affect up to 1 in 1,000 people:

Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision loss.
Dilated pupils, cross eyes.
Cold sweat, tightness of the throat, swollen tongue.
Inflammation of the pancreas.
Difficulty in swallowing.
Slow or reduced movement of the body.
Difficulty with writing properly.
Increased fluid in the abdomen.
Fluid in the lungs
Convulsions
Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances Muscle damage.
Breast discharge, abnormal breast growth, breast growth in males.
Interrupted menstrual periods.
Kidney failure, reduced urine volume, urinary retention.
Decrease in white blood cell count.
Inappropriate behaviour.
Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis) and a serious skin reaction characterized by rash, blisters, peeling skin and pain).

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.

Reporting of side effects

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 national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Medical Valley

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 bottle after EXP. The expiry date refers to the last day of that month.

Do not store above 30 ºC.

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 to protect the environment.

6. Contents of the pack and other information

What Pregabalin Medical Valley contains

The active substance is pregabalin. Each hard capsule contains either 25 mg,50 mg, 75 mg, 100 mg, 150 mg, 200 mg or 300 mg pregabalin.

The other ingredients are: lactose monohydrate, maize starch, talc, gelatin and titanium dioxide (E171).

50 mg and 200 mg capsules also contain red iron oxide (E172).

75 mg, 100 mg and 300 mg capsules also contain indigo carmine (E132) and erythrosine (E171)

What Pregabalin Medical Valley looks like and contents of the pack
25 mg capsules	White hard capsules with approximate size of 14 mm.
50 mg capsules	Pink hard capsules with approximate size of 16 mm.
75 mg capsules	White and maroon hard capsules with approximate size of 14 mm.
100 mg capsules	Maroon hard capsules with approximate size of 16 mm.
150 mg capsules	White hard capsules with approximate size of 18 mm.
200 mg capsules	Pink hard capsules with approximate size of 19 mm.
300 mg capsules	White and maroon hard capsules with approximate size of 21 mm.

Pregabalin Medical Valley is available in Aluminium/Aluminium-Polyamide-PVC or Aluminium/PVC-PVDC blisters.

Pregabalin Medical Valley25 mg contains 14, 21, 56, 84, 100, 112 hard capsules or 100 x 1 hard capsules in perforated unit dose blisters.

Pregabalin Medical Valley50 mg contains 14, 21, 56, 84, 100 hard capsules or 100 x 1 hard capsules in perforated unit dose blisters

Pregabalin Medical Valley 75 mg contains 14, 56, 70, 100, 112 hard capsulesor 100 x 1 hard capsules in perforated unit dose blisters

Pregabalin Medical Valley 100 mg contains 21, 84, 100 hard capsulesor 100 x 1 hard capsules in perforated unit dose blisters

Pregabalin Medical Valley 150 mg contains 14, 56, 100, 112 hard capsulesor 100 x 1 hard capsules in perforated unit dose blisters

Pregabalin Medical Valley200 mg contains 21, 84, 100 hard capsulesor 100 x 1 hard capsules in perforated unit dose blisters

Pregabalin Medical Valley 300 mg contains 14, 56, 100, 112 hard capsulesor 100 x 1 hard capsules in perforated unit dose blisters

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Manufacturer:

Laboratorios Normon S.A.,

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid, Spain.

Laboratorios Liconsa S.A.,

Avda. Miralcampo, Nº7, PI Miralcampo,

19200- Azuqueca de Henares - Guadalajara, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in 24 February 2016