Pregabalin Aliud Pharma 25 mg Kapsel, hård

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

22-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
pregabalin
Tillgänglig från:
ALIUD PHARMA GmbH
ATC-kod:
N03AX16
INN (International namn):
pregabalin
Dos:
25 mg
Läkemedelsform:
Kapsel, hård
Sammansättning:
pregabalin 25 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
55175
Tillstånd datum:
2017-11-06

Dokument på andra språk

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

06-11-2017

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Package leaflet: Information for the user

Pregabalin Aliud Pharma 25 mg capsules, hard

Pregabalin Aliud Pharma 50 mg capsules, hard

Pregabalin Aliud Pharma 75 mg capsules, hard

Pregabalin Aliud Pharma 100 mg capsules, hard

Pregabalin Aliud Pharma 150 mg capsules, hard

Pregabalin Aliud Pharma 200 mg capsules, hard

Pregabalin Aliud Pharma 225 mg capsules, hard

Pregabalin Aliud Pharma 300 mg capsules, hard

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 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.

What is in this leaflet

What <Product name> is and what it is used for

What you need to know before you take <Product name>

How to take <Product name>

Possible side effects

How to store <Product name>

Contents of the pack and other information

1. What <Product name> is and what it is used for

<Product name> belongs to a group of medicines used to treat epilepsy, neuropathic pain

and Generalised Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain: <Product name> 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

needles.

Peripheral

central

neuropathic

pain

also

associated

with

mood

changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and

social functioning and overall quality of life.

Epilepsy: <Product name> is used to treat a certain form of epilepsy (partial seizures with or

without secondary generalisation) in adults. Your doctor will prescribe <Product name> for

you to help treat your epilepsy when your current treatment is not controlling your condition.

You should take <Product name> in addition to your current treatment. <Product name> is

not intended to be used alone, but should always be used in combination with other

anti-epileptic treatment.

Generalised Anxiety Disorder: <Product name> 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 <Product name>

DO NOT take <Product name>

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

section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking <Product name>

Some patients taking <Product name> 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.

<Product

name>

been

associated

with

dizziness

sleepiness,

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.

<Product name> 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. The severity of these effects may be increased

when taken together.

There have been reports of heart failure in some patients when taking <Product name>;

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 <Product name>.

If while taking <Product name> 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 <Product name> have

had thoughts of harming or killing themselves. If at any time you have these thoughts,

immediately contact your doctor.

When <Product name> 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 <Product name> or shortly after

stopping

<Product

name>.

experience

convulsion,

contact

your

doctor

immediately.

There have been reports of reduction in brain function (encephalopathy) in some patients

taking <Product name> 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 <Product name>

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

medicines.

<Product name> and certain other medicines may influence each other (interaction). When

taken with certain other medicines, <Product name> may increase the side effects seen with

these medicines, including respiratory failure and coma. The degree of dizziness, sleepiness

and decreased concentration may be increased if <Product name> is taken together with

medicinal products containing:

Oxycodone – (used as a painkiller)

Lorazepam – (used for treating anxiety)

Alcohol

<Product name> may be taken with oral contraceptives.

<Product name> with food, drink and alcohol

<Product name> capsules may be taken with or without food.

It is advised not to drink alcohol while taking <Product name>.

Pregnancy and breast-feeding

<Product name> should not be taken during pregnancy or when breast-feeding, 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

<Product name> 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.

<Product name> contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicinal product.

3. How to take <Product name>

Always take this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

Dosage

Your doctor will determine what dose is appropriate for you.

Peripheral and central neuropathic pain, 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 <Product name> either twice or three times a day. For

twice a day take <Product name> once in the morning and once in the evening, at about

the same time each day. For three times a day take <Product name> 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 <Product name> is too strong or too weak, talk to

your doctor or pharmacist.

Elderly patients

If you are an elderly patient (over 65 years of age), you should take <Product name>

normally except if you have problems with your kidneys.

Patients with kidney problems

Your doctor may prescribe a different dosing schedule and/or dose if you have problems with

your kidneys.

<Product name> is for oral use only.

Swallow the capsule whole with water.

Continue taking <Product name> until your doctor tells you to stop.

If you take more <Product name> than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box of

<Product name> capsules with you. You may feel sleepy, confused, agitated, or restless as a

result of taking more <Product name> than you should. Fits have also been reported.

If you forget to take <Product name>

It is important to take your <Product name> 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 <Product name>

Do not stop taking <Product name> 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 <Product name> treatment, you need to know that you

may experience certain side effects. These include trouble sleeping, headache, nausea,

feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain,

sweating, and dizziness. These symptoms may occur more commonly or severely if you

have been taking <Product name> 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.

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.

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

attention,

clumsiness,

memory

impairment,

loss

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

cold 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, crossed 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 characterised by rash, blisters, peeling skin and

pain)

jaundice (yellowing of the skin and eyes)

Very rare: may affect up to 1 in 10,000 people

liver failure

hepatitis (inflammation of the liver)

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. The severity of these effects may be increased when taken

together.

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 <Product name>

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 and 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.

6. Contents of the pack and other information

What <Product name> contains

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: lactose monohydrate, starch, pregelatinised (maize), talc,

gelatine, titanium dioxide (E171). The 75, 100, 200, 225 and 300 mg capsules also

contain red iron oxide (E172). 50, 225 mg only: Shellac, Iron oxide black (E172),

Propylene Glycol

What <Product name> looks like and contents of the pack

25 mg capsules

White capsules, hard (approximately 14 mm).

50 mg capsules

White capsules, hard (approximately 16 mm). The body is marked with

a black circular line.

75 mg capsules

White and orange capsules, hard (approximately 14 mm).

100 mg capsules

Orange capsules, hard (approximately 16 mm).

150 mg capsules

White capsules, hard (approximately 18 mm).

200 mg capsules

Light orange capsules, hard (approximately 19 mm).

225 mg capsules

White and light orange capsules, hard (approximately 19 mm). The

body is marked with a black circular line.

300 mg capsules

White and orange capsules, hard (approximately 22 mm).

<Product name> 25 mg is available in pack sizes made of PVC with an aluminium foil

backing: 14, 21, 28, 30, 56, 60, 70, 84, 100, 200 and 210 capsules.

<Product name> 50 mg is available in pack sizes made of PVC with an aluminium foil

backing: 14, 21, 28, 30, 56, 60, 84, 100, 200 and 210 capsules.

<Product name> 75 mg, is available in pack sizes made of PVC with an aluminium foil

backing: 14, 14 (sample), 28, 30, 56, 60, 70, 100, 200 and 210 capsules.

Product name> 100 mg is available in pack sizes made of PVC with an aluminium foil

backing: 14, 21, 30, 56, 60, 84, 100, 200 and 210 capsules.

<Product name> 150 mg is available in two pack sizes made of PVC with an aluminium foil

backing: 14, 21, 28, 30, 56, 60, 70 100, 200 and 210 capsules.

Product name> 200 mg is available in pack sizes made of PVC with an aluminium foil

backing: 14, 21, 30, 56, 60, 84, 100, 200 and 210 capsules.

<Product name> 225 mg is available in two pack sizes made of PVC with an aluminium foil

backing: 14, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.

<Product name> 300 mg is available in two pack sizes made of PVC with an aluminium foil

backing: 14, 21, 28, 30, 56, 60, 70, 100, 200 and 210 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the

following names:

<[To be completed nationally]>

This leaflet was last revised in October 2017.

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