Pregabalin Sandoz 300 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalin Sandoz 25 mg hard capsules EFG

Pregabalin Sandoz 50 mg hard capsules EFG

Pregabalin Sandoz 75 mg hard capsules EFG

Pregabalin Sandoz 100 mg hard capsules EFG

Pregabalin Sandoz 150 mg hard capsules EFG

Pregabalin Sandoz 200 mg hard capsules EFG

Pregabalin Sandoz 225 mg hard capsules EFG

Pregabalin Sandoz 300 mg hard capsules EFG

pregabalin

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the 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 adverse effects
5. How to store Pregabalin Sandoz
6. Contents of the pack and other information

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

Pregabalina 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: Pregabalina Sandoz is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, continuous pain, tingling, numbness, or pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue, and may affect physical and social activities and overall quality of life.

Epilepsy: Pregabalina Sandoz is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalina Sandoz when your current treatment does not adequately control your condition. You should take Pregabalina Sandoz in addition to your current treatment. Pregabalina Sandoz must not be used as monotherapy, but always in combination with other antiepileptic treatments.

Generalized anxiety disorder: Pregabalina Sandoz is used to treat generalized anxiety disorder (GAD). Symptoms of GAD include excessive and prolonged anxiety and worry that are difficult to control. GAD may also cause restlessness or a feeling of being keyed up or on edge, easy fatigue, difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stress and worries of normal life.

2. What you need to know before taking Pregabalina Sandoz

Do not take Pregabalina 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 starting to take Pregabalina Sandoz.

• Some patients treated with Pregabalina Sandoz have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread skin rash. If you experience any of these symptoms, you must seek immediate medical attention.

• Serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek immediate medical help if you notice any symptoms related to these serious skin reactions described in section 4.

• Pregabalina Sandoz 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.

• Pregabalina Sandoz may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any visual disturbances, you must inform your doctor immediately.

• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.

• Certain adverse effects, such as somnolence, may be more frequent in patients with spinal cord injury, as they may be taking other medications for conditions such as pain or spasticity (tight or rigid muscles), which have similar adverse effects to Pregabalina Sandoz; thus, the intensity of these effects may increase when taken together.

• Cases of heart failure have been reported in some patients treated with Pregabalina Sandoz. Most of these patients were elderly with cardiovascular disease. Before using this medicine, you must inform your doctor if you have a history of heart disease.

• Cases of renal failure have been reported in some patients treated with Pregabalina Sandoz. If during treatment with Pregabalina Sandoz you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of the treatment may improve this condition.

• Some patients taking antiepileptic medicines such as Pregabalina Sandoz have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or have shown such behavior, contact your doctor as soon as possible.

• When Pregabalina Sandoz is taken together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal paralysis) may occur. Inform your doctor if you suffer from constipation, especially if you are prone to this problem.

• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean you are at higher risk of becoming dependent on Pregabalina Sandoz.

• Seizures have been reported during treatment with Pregabalina Sandoz or shortly after discontinuation of treatment with Pregabalina Sandoz. If you experience seizures, contact your doctor immediately.

• Cases of reduced brain function (encephalopathy) have been reported in some patients taking Pregabalina Sandoz who also had other medical conditions. Inform your doctor if you have a history of serious illness, including liver or kidney disease.

• Cases of difficulty breathing have been reported. If you have nervous system disorders, respiratory disorders, renal impairment, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience breathing difficulties or shallow breathing.

Dependence

Some people may become dependent on Pregabalina Sandoz (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop using Pregabalina Sandoz (see section 3, “How to take Pregabalina Sandoz” and “If you stop taking Pregabalina Sandoz”). If you are concerned about possibly becoming dependent on Pregabalina Sandoz, it is important to consult your doctor.

If you notice any of the following signs while taking Pregabalina Sandoz, it could be a sign that you have become dependent:

• You feel the need to take the medicine for longer than recommended by your doctor.
• You feel you need to take more than the recommended dose.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better again once you take it again.

If you notice any of these signs, speak with your doctor to discuss the best treatment plan for you, including when it is appropriate to stop treatment and how to do so safely.

Children and adolescents

The safety and efficacy have not been established in children and adolescents (under 18 years of age), therefore pregabalin should not be used in this age group.

Other medicines and Pregabalina Sandoz

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

Pregabalina Sandoz and certain medicines may interact with each other. When Pregabalina Sandoz is used together with certain medicines that have sedative effects (including opioids), these effects may be enhanced and may lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if Pregabalina Sandoz is taken together with other medicines containing:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

Pregabalina Sandoz can be taken with oral contraceptives.

Taking Pregabalina Sandoz with food, drinks, and alcohol

Pregabalina Sandoz capsules can be taken with or without food.

You are advised not to drink alcohol during treatment with Pregabalina Sandoz.

Pregnancy and breastfeeding

You should not take Pregabalina Sandoz during pregnancy or breastfeeding unless your doctor has specifically instructed you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the fetus that require medical treatment. In a study reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of every 100 babies had such congenital malformations. This compares with 4 out of every 100 babies born to women not treated with pregabalin in the study. Malformations reported include those of the face (cleft lip/palate), eyes, nervous system (including the brain), kidneys, and genitals.

Women of childbearing potential should use an effective method of contraception. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pregabalina Sandoz may cause dizziness, drowsiness, and reduced concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform these activities.

3. How to take Pregabaline Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabaline Sandoz is for oral use only.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules as directed by your doctor.
• The dose, adjusted for you and your condition, is generally between 150 mg and 600 mg daily.

Your doctor will instruct you to take Pregabaline Sandoz two or three times a day. If twice daily, take Pregabaline Sandoz once in the morning and once at night, approximately at the same time each day.

If three times daily, take Pregabaline Sandoz in the morning, at midday, and at night, approximately at the same time each day.

If you feel that the effect of Pregabaline Sandoz is too strong or too weak, consult your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Pregabaline Sandoz as usual, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.

Swallow the capsule whole with water.

Continue taking Pregabaline Sandoz until your doctor tells you to stop.

If you take more Pregabaline Sandoz than you should

Call your doctor or go to the nearest emergency room immediately. Take the pack or bottle of Pregabaline Sandoz capsules with you. As a result of taking more Pregabaline Sandoz than you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabaline Sandoz

It is important that you take Pregabaline Sandoz 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, continue with your next dose as normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabaline Sandoz

Do not stop taking Pregabaline Sandoz suddenly. If you wish to stop taking Pregabaline Sandoz, speak to your doctor first. He or she will tell you how to do so. If you are going to discontinue treatment, this should be done gradually over a minimum of one week.

After ending short- or long-term treatment with Pregabaline Sandoz, you should be aware that you may experience certain adverse effects, known as withdrawal effects. These effects include sleep problems, headache, nausea, feelings of anxiety, diarrhoea, flu-like symptoms, seizures, restlessness, thoughts of self-harm or suicide, depression, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking Pregabaline Sandoz for a longer period of time. If you experience withdrawal effects, you should contact your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 euphoria, confusion, disorientation, decreased sex drive, irritability
• Attention disturbance, lack of coordination, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen
• Difficulty in erection
• Swelling of the body including limbs
• Feeling of drunkenness, disturbances in gait
• 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, high blood sugar levels
• Altered perception of self, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sex drive, sexual problems including inability to reach climax, delayed ejaculation
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, movement-related tremor, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise
• Dry eyes, eye swelling, eye pain, tired eyes, watery eyes, eye irritation
• Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Flushing, hot flushes
• Difficulty breathing, dry nose, nasal congestion
• Increased saliva production, burning, numbness around the mouth
• Sweating, rash, chills, fever
• Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Breast pain
• Difficulty or pain when urinating, inability to control urine
• Weakness, thirst, chest tightness
• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, low blood potassium)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
• Painful menstrual periods
• Feeling cold in hands and feet

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

• Altered sense of smell, oscillating vision, depth perception disturbance, visual brightness, vision loss
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Inflammation of the pancreas
• Difficulty swallowing
• Slow or reduced body movement
• Difficulty writing properly
• Increased fluid in the abdominal area
• Fluid in the lungs
• Seizures
• Changes in electrocardiogram (ECG) corresponding to disturbances in heart rhythm
• Muscle damage
• Milk secretion, abnormal breast growth, breast enlargement in men
• Interruption of menstrual periods
• Kidney failure, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by flat, non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. 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, symptoms resembling Parkinson's disease such as tremor, bradykinesia (reduced ability to move), and muscle rigidity

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

• Liver failure
• Hepatitis (inflammation of the liver)

Frequency not known: cannot be estimated from available data

• Becoming dependent on Pregabalina Sandoz (“drug dependence”)

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

If you experience swelling of the face or tongue, or if your skin becomes red with blisters or peeling, seek immediate medical attention.

Certain adverse effects, such as drowsiness, may be more frequent because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (tight or rigid muscles), which have adverse effects similar to those of Pregabalina, so the intensity of these effects may increase when taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 pack, container or carton after EXP/CAD. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

High-density polyethylene bottles: Use within 6 months after first opening.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pregabalin Sandoz

• 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 components are pregelatinized corn starch, corn starch, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172) (all dose presentations except 150 mg), red iron oxide (E172) (all dose presentations except 50 mg and 150 mg), black iron oxide (E172) (only 25 mg and 300 mg).

Appearance of the product and contents of the pack

25 mg capsules	Opaque pale yellowish-brown cap and body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to almost white powder.
50 mg capsules	Opaque light yellow cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to almost white powder.
75 mg capsules	Opaque red cap and opaque white body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to almost white powder.
100 mg capsules	Opaque red cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to almost white powder.
150 mg capsules	Opaque white cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to almost white powder.
200 mg capsules	Opaque pale orange cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to almost white powder.
225 mg capsules	Opaque pale orange cap and opaque white body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to almost white powder.
300 mg capsules	Opaque red cap and opaque pale yellowish-brown body, capsule size 0 (21.7 mm x 7.6 mm), filled with white to almost white powder.

Pregabalin Sandoz is available in the following presentations:

PVC/PVDC//Aluminum blisters packed in a carton box.

Single-dose PVC/PVDC//Aluminum blisters packed in a carton box.

High-density polyethylene bottle with polypropylene screw cap, packed in a carton box.

25 mg capsules:

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

Single-dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules.

High-density polyethylene bottles containing 200 hard capsules.

50 mg capsules:

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

Single-dose blisters containing 84 x 1 hard capsules.

High-density polyethylene bottles containing 200 hard capsules.

75 mg capsules:

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

Single-dose blisters containing 14x1, 56x1, 84x1, 100x1 or 210x1 (3 x 70) hard capsules.

High-density polyethylene bottles containing 100, 200 or 250 hard capsules.

100 mg capsules:

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

Single-dose blisters containing 84x1 or 100x1 hard capsules.

150 mg capsules:

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

Single-dose blisters containing 56x1, 84x1, 100x1 or 210x1 (3 x 70) hard capsules.

High-density polyethylene bottles containing 100, 200 or 250 hard capsules.

200 mg capsules:

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

Single-dose blisters containing 84x1 or 100x1 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.

Single-dose blisters containing 56x1, 84x1 (2 x 42), 100 x 1, 100x1 (2 x 50) or 210x1 (3 x 70) hard capsules.

High-density polyethylene bottles containing 100, 200 or 250 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

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

Belgium/Belgium/Belgium Sandoz nv/sa Medialaan 40 B-1800 Vilvoorde Tel/Tel.: +32 2 722 97 97 [email protected]	Lithuania Sandoz Pharmaceuticals d.d. branch Šeimyniškių 3A, LT 09312 Vilnius Tel: +370 5 26 36 037 [email protected]
	Luxembourg/Luxembourg Sandoz nv/sa Medialaan 40 B-1800 Vilvoorde Tel/Tel.: +32 2 722 97 97 [email protected]
Czech Republic Sandoz s.r.o. Na Pankráci 1724/129 CZ-140 00 Praha 4 - Nusle Tel: +420 225 775 111 [email protected]	Hungary Sandoz Hungária Kft. Tel.: +36 1 430 2890
Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Tlf: +45 6395 1000 [email protected]	Malta Sandoz Pharmaceuticals d.d. Verovskova 57, SI-1000 Ljubljana Slovenia Tel: +356 21222872
Germany Hexal AG Industriestrasse 25 D-83607 Holzkirchen Tel: +49 8024 908 0 E-mail: [email protected]	Netherlands Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel: +31 36 5241600 [email protected]
Estonia Sandoz d.d. Estonian branch Pärnu mnt 105 EE-11312 Tallinn Tel.: +372 665 2400 [email protected]	Norway Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Tlf: +45 6395 1000 [email protected]
Greece Novartis (Hellas) A.E.B.E. Tel: +30 210 281 17 12	Austria Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel: +43 5338 2000
Spain Sandoz Farmacéutica, S.A. Parque Norte Business Center Roble Building C/Serrano Galvache, No. 56 28033 Madrid Spain Tel: +34 900 456 856 [email protected]	Poland Sandoz Polska Sp. z o.o. ul. Domaniewska 50C 02-672 Warszawa Tel.: +48 22 209 70 00 [email protected]
France Sandoz SAS 49 avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tel: +33 1 4964 4800	Portugal Sandoz Farmacêutica Lda. Phone: +351 21 196 40 00
Croatia Sandoz d.o.o. Maksimirska 120 10000 Zagreb Tel: +385 1 2353111 e-mail: [email protected]	Romania Sandoz S.R.L. Str. Livezeni no. 7A, 540472 Târgu Mureș +40 21 4075160
Ireland Rowex Ltd., Bantry, Co. Cork, Ireland. P75 V009 Tel: +353 27 50077 e-mail: [email protected]	Slovenia Lek farmacevtska družba d.d. Tel: +386 1 580 21 11
Iceland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Tlf: +45 6395 1000 [email protected]	Slovak Republic Sandoz d.d. organizational unit Žižkova 22B SK-811 02 Bratislava Tel: +421 2 50 706 111
Italy Sandoz S.p.A Largo Umberto Boccioni 1 I - 21040 Origgio/VA Tel: +39 02 96541	Finland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Copenhagen S Denmark Puh: +358 010 6133 400 [email protected]
Cyprus Sandoz Pharmaceuticals d.d. Verovskova 57, SI-1000 Ljubljana Slovenia Tel: +357 22 69 0690	Sweden Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Stockholm S Sweden Tlf: +45 6395 1000 [email protected]
Latvia Sandoz d.d. Latvia branch K. Valdemāra iela 33-29 Riga, LV1010 Tel: +371 67892006	United Kingdom (Northern Ireland) Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel: +43 5338 2000

Date of the most recent review of this leaflet: June 2023

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.