Pregabalin Sandoz GmbH
pregabalin
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 Pregabalin Sandoz GmbH is and what it is used for
What you need to know before you take Pregabalin Sandoz GmbH
How to take Pregabalin Sandoz GmbH
Possible side effects
How to store Pregabalin Sandoz GmbH
Contents of the pack and other information
Pregabalin Sandoz GmbH belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.
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 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.
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.
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.
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 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 capsules may be taken with or without food. It is advised not to drink alcohol while taking Pregabalin Sandoz GmbH.
Pregabalin Sandoz GmbH 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 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 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.
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.
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.
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.
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dizziness, drowsiness, headache.
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.
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.
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 reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flulike symptoms (Stevens- Johnson syndrome, toxic epidermal necrolysis).
Jaundice (yellowing of the skin and eyes).
Parkinsonism, that is symptoms resembling Parkinson’s disease; such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).
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 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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).
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/PVDC//Alu blisters packed in carton.
PVC/PVDC//Alu 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 x 1, 84 x 1 or 100 x 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 x 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 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 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 x 1 or 100 x 1 hard capsules.
150 mg capsules:
Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Unit dose blisters containing 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 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 x 1 or 100 x 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 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules.
Unit dose blisters containing 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules.
HDPE bottles containing 100, 200 or 250 hard capsules. Not all pack sizes may be marketed.
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Lek Pharmaceuticals d.d. Verovškova 57
1526 Ljubljana Slovenia
Salutas Pharma GmbH Otto-von-Guericke Allee 1 D-39179 Barleben Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz nv/sa Medialaan 40
B-1800 Vilvoorde Tél/Tel.: +32 2 722 97 97
Sandoz Pharmaceuticals d.d. filialas
Šeimyniškių 3A,
LT 09312 Vilnius
Tel: +370 5 26 36 037
КЧТ Сандоз България Бул.“Никола Вапцаров“ No. 55 сгр. 4, ет. 4
1407 София
Teл.: + 359 2 970 47 47
Sandoz nv/sa Medialaan 40
B-1800 Vilvoorde Tél/Tel.: +32 2 722 97 97
Sandoz s.r.o.
Na Pankráci 1724/129
CZ-140 00 Praha 4 - Nusle
Tel: +420 225 775 111
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 København S Danmark
Tlf: + 45 6395 1000
Medical Logistics Ltd.
ADC Building, Triq L-Esportaturi Mriehel, BKR 3000
Malta
Tel: +356 2277 8000
D-83607 Holzkirchen Tel: +49 8024 908 0
NL-1327 AH Almere Tel: +31 36 5241600
Sandoz d.d. Eesti filiaal Pärnu mnt 105
EE-11312 Tallinn Tel.: +372 665 2400
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 København S Danmark
Tlf: + 45 6395 1000
Novartis (Hellas) S.A.C.I. Εθνική Οδός No 1 (12ο km) Μεταμόρφωση
GR-144 51 Αθήνα
Τηλ: +30 210 2811712
Tel: +43 5338 2000
Sandoz Farmacéutica, S.A. Centro empresarial Parque Norte Edificio Roble
C/Serrano Galvache, N°56 28033 Madrid
Spain
Tel: +34 900 456 856
Sandoz Polska Sp. z o.o. ul. Domaniewska 50C 02-672 Warszawa
Tel.: + 48 22 209 70 00
Sandoz SAS
49 avenue Georges Pompidou
F-92593 Levallois-Perret Cedex Tél: + 33 1 4964 4800
Sandoz Farmacêutica Lda. Phone: +351 21 196 40 00
10000 Zagreb
Tel: + 385 1 2353111
e-mail: upit.croatia@sandoz.com
Sandoz S.R.L.
Str. Livezeni nr.7A,
540472 Târgu Mureş
+40 21 4075160
Rowex Ltd., Bantry, Co. Cork, Ireland.
Lek farmacevtska družba d.d. Tel: +386 1 580 21 11
P75 V009
Tel: + 353 27 50077
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 København S Danmörk
Tlf: + 45 6395 1000
Sandoz d.d. organizačná zložka
Žižkova 22B
SK-811 02 Bratislava
Tel: + 421 2 50 706 111
Sandoz S.p.A
Largo Umberto Boccioni 1 I - 21040 Origgio/VA
Tel: + 39 02 96541
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 Kööpenhamina S Tanska
Puh: +358 010 6133 400
Panayiotis Hadjigeorgiou
Γιλντίζ 31, 3042
CY-000 00 Πόλη: Λεμεσός Τηλ: 00357 25372425
Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Danmark
Tlf: + 45 6395 1000
Sandoz d.d. Latvia filiāle K.Valdemāra iela 33-29 Rīga, LV1010
Tel: + 371 67892006
Sandoz GmbH Biochemiestr. 10 A-6250 Kundl
Tel: +43 5338 2000