Pregabalin Sandoz GmbH - patient leaflet, side effects, dosage

- 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:

• 1. What Pregabalin Sandoz GmbH is and what it is used for

• 2. What you need to know before you take Pregabalin Sandoz GmbH

• 3. How to take Pregabalin Sandoz GmbH

• 4. Possible side effects

• 5. How to store Pregabalin Sandoz GmbH

• 6. Contents of the pack and other information

1. What Pregabalin Sandoz GmbH is and what it is used for

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

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

Generalised Anxiety Disorder: Pregabalin Sandoz GmbH 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 Sandoz GmbH

Do not take Pregabalin Sandoz GmbH

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 Pregabalin Sandoz GmbH.

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.

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 Sandoz GmbH 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 Sandoz GmbH 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 Sandoz GmbH

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

• When Pregabalin Sandoz GmbH 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 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.

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 Sandoz GmbH

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

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

Oxycodone – (used as a pain-killer)

Lorazepam – (used for treating anxiety)

Alcohol

Pregabalin Sandoz GmbH may be taken with oral contraceptives.

Pregabalin Sandoz GmbH with food, drink and alcohol

Pregabalin Sandoz GmbH capsules may be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin Sandoz GmbH.

Pregnancy and breast-feeding

Pregabalin Sandoz GmbH 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

Pregabalin Sandoz GmbH 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.

3. How to take Pregabalin Sandoz GmbH

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

If you take more Pregabalin Sandoz GmbH than you should

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

If you forget to take Pregabalin Sandoz GmbH

It is important to take your Pregabalin Sandoz GmbH 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 Sandoz GmbH

Do not stop taking Pregabalin Sandoz GmbH 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 Sandoz GmbH 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 Pregabalin Sandoz GmbH 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 aminotransferase 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).
• 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).

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.

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.

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. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Sandoz GmbH

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 blister, container or carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

HDPE bottles: Use within 6 months after first opening.

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 Pregabalin Sandoz GmbH 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 pregelatinised maize starch, maize starch, talc, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (all strengths except 150 mg), red iron oxide (E 172) (all strengths except 50 mg and 150 mg), black iron oxide (E 172) (only 25 mg and 300 mg).

What Pregabalin Sandoz GmbH looks like and contents of the pack

25 mg capsules	Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm) filled with white to nearly white coloured powder.
50 mg capsules	Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with white to nearly white coloured powder.
75 mg capsules	Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm) filled with white to nearly white coloured powder.
100 mg capsules	Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with white to nearly white coloured powder.

150 mg capsules	White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm) filled with white to nearly white coloured powder.
200 mg capsules	Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
225 mg capsules	Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
300 mg capsules	Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm) filled with white to nearly white coloured powder.

Pregabalin Sandoz GmbH is available in the following presentations:

PVC/PVDCAlu blisters packed in carton.

PVC/PVDCAlu unit dose blisters packed in carton

HDPE container with PP screw cap packed in carton.

25 mg capsules:

Blisters containing 14, 28, 56, 70, 84, 100 or 120 hard capsules.

Unit dose blisters containing 56 × 1, 84 × 1 or 100 × 1 hard capsules.

HDPE bottles containing 200 hard capsules.

50 mg capsules:

Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.

Unit dose blisters containing 84 × 1 hard capsules.

HDPE bottles containing 200 hard capsules.

75 mg capsules:

Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.

Unit dose blisters containing 14 × 1, 56 × 1, 84 × 1, 100 × 1 or 210 × 1 (3 × 70) hard capsules.

HDPE bottles containing 100, 200 or 250 hard capsules.

100 mg capsules:

Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.

Unit dose blisters containing 84 × 1 or 100 × 1 hard capsules.

150 mg capsules:

Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.

Unit dose blisters containing 56 × 1, 84 × 1, 100 × 1 or 210 × 1 (3 × 70) hard capsules.

HDPE bottles containing 100, 200 or 250 hard capsules.

200 mg capsules:

Blisters containing 21, 28, 84 or 100 hard capsules.

Unit dose blisters containing 84 × 1 or 100 × 1 hard capsules.

225 mg capsules:

Blisters containing 14, 56, 70, 84, 100 or 120 hard capsules.

300 mg capsules:

Blisters containing 14, 21, 28, 56, 70, 84 (2 × 42), 100 (2 × 50) or 120 (2 × 60) hard capsules.

Unit dose blisters containing 56 × 1, 84 × 1 (2 × 42), 100 × 1 (2 × 50) or 210 × 1 (3 × 70) hard capsules.

HDPE bottles containing 100, 200 or 250 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

For any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

Sandoz nv/sa

Medialaan 40

B-1800 Vilvoorde

Tél/Tel.: +32 2 722 97 97

Etnrapua

KHT CaHgo3 Etnrapua

Eyn.“Hukona Banuapoß“ No. 55

crp. 4, em. 4

1407 Co$ua

Ten.: + 359 2 970 47 47

Česká republika

Sandoz s.r.o.

Na Pankráci 1724/129

CZ-140 00 Praha 4 – Nusle

Tel: +420 225 775 111

Danmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Kobenhavn S

Danmark

Tlf: + 45 6395 1000

Deutschland

Hexal AG

Industriestrasse 25

D-83607 Holzkirchen

Tel: +49 8024 908 0

E-mail:

Eesti

Sandoz d.d. Eesti filiaal

Pärnu mnt 105

EE-11312 Tallinn

Tel.: +372 665 2400

contact the local representative of the Marketing

Lietuva

Sandoz Pharmaceuticals d.d. filialas

Seimyniskiu 3A,

LT 09312 Vilnius

Tel: +370 5 26 36 037

Luxembourg/Lu­xemburg

Sandoz nv/sa

Medialaan 40

B-1800 Vilvoorde

Tel/Tel.: +32 2 722 97 97

Magyarorszag

Sandoz Hungaria Kft.

Tel.: +36 1 430 2890

Malta

Medical Logistics Ltd.

ADC Building, Triq L-Esportaturi

Mriehel, BKR 3000

Malta

Tel: +356 2277 8000

Nederland

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

Tel: +31 36 5241600

Norge

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 K0benhavn S

Danmark

Tlf: + 45 6395 1000

EZZába

Novartis (Hellas) S.A.C.I.

E0vik^ 05óg No 1 (12o km)

MsTa^óppoon

GR-144 51 A0qva.

Tql: +30 210 2811712

España

Sandoz Farmacéutica, S.A.

Centro empresarial Parque Norte

Edificio Roble

C/Serrano Galvache, N°56

28033 Madrid

Spain

Tel: +34 900 456 856

France

Sandoz SAS

49 avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél: + 33 1 4964 4800

Hrvatska

Sandoz d.o.o.

Maksimirska 120

10000 Zagreb

Tel: + 385 1 2353111

e-mail:

Ireland

Rowex Ltd.,

Bantry, Co. Cork,

Ireland.

P75 V009

Tel: + 353 27 50077

e-mail:

Ísland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Kobenhavn S

Danmörk

Tlf: + 45 6395 1000

Italia

Sandoz S.p.A

Largo Umberto Boccioni 1

I – 21040 Origgio/VA

Tel: + 39 02 96541

Österreich

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Tel: +43 5338 2000

Polska

Sandoz Polska Sp. z o.o. ul. Domaniewska 50C 02–672 Warszawa

Tel.: + 48 22 209 70 00

Portugal

Sandoz Farmacéutica Lda.

Phone: +351 21 924 19 11

Romania

S.C. Sandoz S.R.L.

Str. Livezeni nr.7A, 540472 Targu Mures +40 21 4075160

Slovenija

Lek farmacevtska druzba d.d.

Tel: +386 1 580 21 11

Slovenská republika

Sandoz d.d. organizacná zlozka

Zizkova 22B

SK-811 02 Bratislava

Tel: + 421 2 50 706 111

Suomi/Finland

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Kööpenhamina S

Tanska

Puh: +358 010 6133 400

Kûnpoç

Panayiotis Hadjigeorgiou

riXvTÎZ 31, 3042

CY-000 00 nôXn: Ae^SGÔç

Tql: 00357 25372425

Sverige

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S

Danmark

Tlf: + 45 6395 1000

United Kingdom (Northern Ireland)

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Tel: +43 5338 2000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

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