Pregabalin Sandoz

Patient Information Leaflet: Information for the User

Pregabalin Sandoz 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules, 300 mg hard capsules

pregabalin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Pregabalin Sandoz is and what it is used for
2. What you need to know before taking Pregabalin Sandoz
3. How to take Pregabalin Sandoz
4. Possible side effects
5. How to store Pregabalin Sandoz
6. Contents of the pack and other information

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

Pregabalin Sandoz belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin Sandoz is used to treat chronic pain caused by damage to the nervous system. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsing, electric shocks, shooting pain, acute pain, cramping, discomfort, tingling, numbness, or stabbing pain. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue (tiredness), and can impact physical and social functioning and overall quality of life.
Epilepsy: Pregabalin Sandoz is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin Sandoz to help manage your epilepsy when your current treatment is not adequately controlling your condition. You will need to take Pregabalin Sandoz in addition to your existing therapy. Pregabalin Sandoz is not used as monotherapy, but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: Pregabalin Sandoz is used to treat Generalized Anxiety Disorder (GAD). Symptoms of Generalized Anxiety Disorder are characterized by excessive and prolonged anxiety and worry that are difficult to control. Generalized Anxiety Disorder may also cause restlessness or a feeling of being tense or on edge, easy fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension, or sleep disturbances. These conditions are different from the stress and pressures of everyday life.

2. What you need to know before taking Pregabalin Sandoz

Do not take Pregabalin Sandoz
if you are allergic to pregabalin or to 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.

• In some patients treated with pregabalin, symptoms indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
• Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop using pregabalin and contact your doctor immediately if you develop any symptoms related to these serious skin reactions, described in section 4.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects this medicine may have on you.
• Pregabalin Sandoz may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If you experience any visual disturbances, contact your doctor immediately.
• In some diabetic patients who gain weight during treatment with pregabalin, it may be necessary to adjust diabetes medications.
• Some side effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have side effects similar to those of pregabalin, and the severity of these effects may increase when these medicines are taken together.
• There have been reports of heart failure in some patients treated with pregabalin; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease, you must inform your doctor before starting treatment with this medicine.
• There have been reports of kidney failure in some patients treated with pregabalin. If you notice a decrease in urination during treatment with Pregabalin Sandoz, inform your doctor, as this condition may improve upon discontinuation of the medicine.
• Some patients taking antiepileptic medicines such as Pregabalin Sandoz have experienced suicidal thoughts and self-harming thoughts (hurting oneself), or have shown suicidal behaviour. If at any time you have such thoughts or exhibit such behaviour, contact your doctor immediately.
• When Pregabalin Sandoz is used together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g. constipation, intestinal obstruction or paralysis) may occur. Inform your doctor if you have constipation, especially if you are prone to this condition.
• Before taking this medicine, inform your doctor if you have a history of abuse or dependence on alcohol, prescription medicines, or illegal substances, as this may indicate that you are at higher risk of becoming dependent on Pregabalin Sandoz.
• Cases of seizures have been reported when taking pregabalin or shortly after stopping it. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking pregabalin when they have other conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of breathing difficulties have occurred. If you have neurological disorders, respiratory disorders, impaired kidney function, or are over 65 years of age, your doctor may prescribe a different dosing regimen. Inform your doctor if you experience breathing difficulties or shallow breathing.

Dependence
Some people may become dependent on Pregabalin Sandoz (i.e., feel the need to continue taking the medicine). They may experience withdrawal symptoms when they stop using Pregabalin Sandoz (see section 3, “How to take Pregabalin Sandoz” and “If you stop taking Pregabalin Sandoz”). If you are concerned about the possibility of developing dependence on Pregabalin Sandoz, talk to your doctor.
If you notice any of the following signs while taking Pregabalin Sandoz, you may have developed dependence on the medicine:

• You feel the need to take the medicine longer than recommended by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons different from those for which it was prescribed
• You have made repeated unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine, you do not feel well and feel better when you start taking it again
  If you notice any of these signs, talk to your doctor to discuss the best treatment plan for you, including when and how to safely discontinue the medicine.

Children and adolescents
The safety and efficacy of pregabalin in children and adolescents (under 18 years of age) have not been established, and therefore pregabalin should not be used in this age group.
Other medicines and Pregabalin Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Sandoz and other medicines may interact with each other. When Pregabalin Sandoz is taken together with other medicines that have sedative effects (including opioids), it may enhance these effects and could lead to respiratory failure, coma, and death.
The intensity of dizziness, somnolence, and reduced concentration may increase if Pregabalin Sandoz is taken together with other medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used to treat anxiety)
Alcohol
Pregabalin Sandoz can be taken together with oral contraceptives.
Pregabalin Sandoz with food, drinks and alcohol
Pregabalin Sandoz capsules can be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin Sandoz.
Pregnancy and breastfeeding
Pregabalin Sandoz should not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the newborn requiring medical treatment. In a study examining data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital malformations, compared with 4 out of 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (oro-facial clefts), eye, nervous system (including brain), kidney, and genital abnormalities have been reported.
Women of childbearing age must use an effective method of contraception. If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Pregabalin Sandoz may cause dizziness, somnolence, and reduced concentration. You should not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined whether this medicine affects your ability to perform these tasks.

3. How to take Pregabalin Sandoz

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.
Pregabalin Sandoz is for oral use only.

Peripheral and central neuropathic pain, epilepsy, or Generalized Anxiety Disorder:

• Take the number of capsules prescribed by your doctor.
• The appropriate dose for you and your condition generally ranges between 150 mg and 600 mg per day. Your doctor will instruct you to take Pregabalin Sandoz two or three times a day. If you take the medicine twice daily, take one dose in the morning and one in the evening, approximately at the same time each day. If you take the medicine three times daily, take one dose in the morning, one in the afternoon, and one in the evening, again at approximately the same times each day. If you feel that the effect of Pregabalin Sandoz is too strong or too weak, discuss this with your doctor or pharmacist.

If you are elderly (over 65 years of age), you should take Pregabalin Sandoz as usual, unless you have kidney problems.
Your doctor may prescribe you a different dosage and/or dose adjustment if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Pregabalin Sandoz until your doctor tells you to stop treatment.

If you take more Pregabalin Sandoz than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring the pack of Pregabalin Sandoz capsules with you. If you have taken more Pregabalin Sandoz than you should have, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin Sandoz
It is important to take Pregabalin Sandoz capsules regularly every day at the same time. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next one as scheduled. Do not take a double dose to make up for the forgotten dose.

If you stop taking Pregabalin Sandoz
Do not stop taking Pregabalin Sandoz suddenly. If you wish to stop taking Pregabalin Sandoz, speak to your doctor first. Your doctor will advise you on how to do this. If treatment is to be discontinued, it should be gradually tapered over a period of at least 1 week.

You should be aware that after stopping Pregabalin Sandoz treatment, certain undesirable effects—known as withdrawal symptoms—may occur, both in the short and long term. These include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have taken Pregabalin Sandoz for a longer period of time. If you experience withdrawal symptoms, contact your doctor.

If you have any questions about how to use 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, somnolence, headache

Common: may affect up to 1 in 10 people

• Increased appetite.
• Feeling of excitement, confusion, disorientation, decreased sexual interest, irritability.
• Attention disturbances, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Dizziness, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, abdominal distension.
• Erectile dysfunction.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, gait abnormalities.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Sore throat.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Altered perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in thinking, increased sexual interest, sexual problems including inability to achieve orgasm, delayed ejaculation.
• Visual disturbances, eye movement abnormalities, visual alterations including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
• Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation.
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Vasomotor disturbances (flushing), hot flushes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensitivity around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or painful urination, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium levels).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

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

• Altered sense of smell, sensation of visual field oscillation, altered depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatic inflammation.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Fluid accumulation in the abdomen.
• Fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) abnormalities corresponding to heart rhythm disorders.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast enlargement in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Decreased white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterised by flat, non-elevated red patches on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Jaundice (yellowing of the skin and eyes). Parkinsonism, i.e. symptoms resembling Parkinson’s disease such as tremor, bradykinesia (reduced ability to move), and rigidity (muscle stiffness).

Very rare: may affect up to 1 in 10,000 people
Liver failure.
Hepatitis (inflammation of the liver).

Not known: frequency cannot be estimated from the available data
Becoming dependent on Pregabalin Sandoz ("drug dependence").

After stopping short-term or long-term treatment with Pregabalin Sandoz, you should be aware that you may experience certain side effects, known as withdrawal effects (see "If you stop taking Pregabalin Sandoz").

If you experience swelling of the face or tongue, or if your skin turns red and blisters start to form, or if skin peeling occurs, contact your doctor immediately.

Some side effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to Pregabalin, and the severity of these effects may increase when these medicines are taken together.

The following adverse reaction has been reported during the post-marketing phase of the medicine:
breathing difficulties, shallow breathing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, container or carton after "Exp". The expiry date refers to the last day of the month.
Do not store above 25 °C.
HDPE bottles: Use within 6 months after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pregabalin Sandoz contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other ingredients are pregelatinized 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) (25 mg and 300 mg only).

Description of the appearance of Pregabalin Sandoz and package contents

Pregabalin Sandoz is available in the following pack sizes:
PVC/PVDC//aluminum blisters packed in cardboard boxes.
Unit-dose blisters in PVC/PVDC//aluminum packed in cardboard boxes.
HDPE containers with PP screw cap packed in cardboard boxes.

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, 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, 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.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
D-39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d. filialas
Tél/Tel.: +32 2 722 97 97 Tel: +370 5 26 36 037

България Luxembourg/Luxemburg
КЧТ Сандоз България Sandoz nv/sa
Teл.: + 359 2 970 47 47 Tél/Tel.: +32 2 722 97 97

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 234 142 222 Tel.: +36 1 430 2890

Danmark Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf.: + 45 63 95 10 00 Verovskova 57,
SI-1000 Ljubljana
Slovenia
Tel: +356 99644126

Deutschland Nederland
Hexal AG Sandoz B.V.
Industriestrasse 25 Hospitaaldreef 29,
D-83607 Holzkirchen NL-1315 RC Almere
Tel: +49 8024 908 0 Tel: +31 36 5241600
E-mail: [email protected] [email protected]

Eesti Norge
Sandoz d.d. Eesti filiaal Sandoz A/S
Tel.: +372 665 2400 Tlf: + 45 63 95 10 00

Ελλάδα Österreich
SANDOZ HELLAS Sandoz GmbH
ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Biochemiestr. 10
Τηλ: +30 216 600 5000 A-6250 Kundl
Tel: +43 5338 2000

España Polska
Sandoz Farmacéutica, S.A. Sandoz Polska Sp. z o.o.
Centro empresarial Parque Norte ul. Domaniewska 50C
Edificio Roble 02-672 Warszawa
C/Serrano Galvache, N°56 Tel.: + 48 22 209 70 00
28033 Madrid [email protected]
Spain
Tel: +34 900 456 856
[email protected]

France Portugal
Sandoz SAS Sandoz Farmacêutica Lda.
Tél: + 33 1 49 64 48 00 Tel: +351 211 964 000

Hrvatska România
Sandoz d.o.o. Sandoz Pharmaceuticals SRL
Maksimirska 120 Tel: +40 21 407 51 60
10000 Zagreb

Tel: + 385 1 2353111
e-mail: [email protected]

Ireland Slovenija
Rowex Ltd., Lek farmacevtska družba d.d.
Bantry, Co. Cork, Tel: +386 1 580 21 11
Ireland.
P75 V009
Tel: + 353 27 50077
e-mail: [email protected]

Ísland Slovenská republika
Sandoz A/S Sandoz d.d. organizačná zložka
Sími: + 45 63 95 10 00 Žižkova 22B
SK-811 02 Bratislava
Tel: + 421 2 48 200 600

Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: + 39 02 812 806 96 Puh/Tel: +358 10 6133 400

Κύπρος Sverige
SANDOZ HELLAS Sandoz A/S
ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. (Ελλάδα) Tel: + 45 63 95 10 00
Τηλ: +30 216 600 5000

Latvija
Sandoz d.d. Latvia filiāle
K.Valdemāra iela 33-29
Rīga, LV1010
Tel: + 371 67892006

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.