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Sandoz Business use only Page 1 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) 200 MG PROLONGED RELEASE TABLET 551-031D.00 PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

[Nationally completed name, 200 mg, retard tablet]

Carbamazepine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.  Keep this leaflet. You may need to read it again.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet: 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information

1. What [Nationally completed name] is and what it is used for Carbamazepine, the active ingredient in [nationally completed name], can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders.

This medicine is used:  To treat some forms of

2. What you need to know before you take [Nationally completed name] You may only take [Nationally completed name] after a full medical examination.

Do not take [Nationally completed name]  If you are allergic (hypersensitive) to carbamazepine, to any of a related group of drugs known as tricyclic (such as or ), or to any of the other ingredients of [Nationally completed name] (listed in section 6).  If you have severe heart disease.  If you have had serious blood illnesses in the past. Sandoz Business use only Page 2 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00  If you have a disturbance in the production of porphyrin, a pigment important for liver function and blood formation (also called ‘hepatic porphyria’).  If you are also taking drugs belonging to a special group of antidepressants called monoamine- oxidase inhibitors (MAOIs).

If this applies to you, tell your doctor before taking [Nationally completed name]. If you think you may be allergic, ask your doctor for advice.

Warnings and precautions Talk to your doctor or pharmacist before taking [Nationally completed name]  If you have blood illnesses (including those caused by other drugs).  If you have ever shown unusual sensitivity (rash or any other signs of allergy) to or to any other medicines. It is important to note that if you are allergic to carbamazepine, the chances are approximately 1 in 4 (25 %) that you could also have an allergic reaction to oxcarbazepine.  If you have or have had heart, liver or kidney disease in the past.  If you have increased pressure in the eye (glaucoma).  If you were told by your physician that you suffer from a mental disorder called psychosis that may be accompanied by confusion or agitation.  If you are a woman taking a hormonal contraceptive (birth control medicine). [Nationally completed name] may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking [Nationally completed name]. This should help to prevent an unwanted pregnancy.

Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, ask your doctor or health professional.

If any of the following apply to you, tell your doctor immediately.  If an allergic reaction happens such as fever with lymph nodes swelling, rash or skin blistering, tell your doctor immediately or go to the emergency department at your nearest hospital (see Possible side effects).  If you develop serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling and accompanied by fever, tell your doctor immediately or go to the emergency department at your nearest hospital (see Possible side effects). These reactions may be more frequent in patients in some Asian countries (e.g. Taiwan, Malaysia and The Philippines) and in patients with Chinese ancestry.  If you experience an increase in the number of seizures, tell your doctor immediately.  If you notice symptoms suggestive of hepatitis, such as jaundice (yellowing of skin and eyes), tell your doctor immediately.  If at any time you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptics such as carbamazepine have had such thoughts or behaviour.

Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of carbamazepine. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza- like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread Sandoz Business use only Page 3 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00 blistering and peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first months of treatment. These serious skin reactions can be more common in people from some Asian countries. The risk of these reactions in patients of Han Chinese or Thai origin may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking carbamazepine. If you develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately. Carbamazepine may cause a multi organ hypersensitivity disorder known as DRESS; it can affect several organs such as lungs, kidneys, pancreas, heart, intestine.

If you have kidney problems or are treated with medicines that lower the sodium in your blood (e.g. diuretics) or if you are elderly, your doctor may have to measure your sodium blood levels before giving you carbamazepine.

Do not stop your treatment with [Nationally completed name] without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly.

Other medicines and [Nationally completed name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Remember also those not prescribed by a doctor. It is particularly important for [nationally completed name] since many other medicines interact with it. You may need a change in your dose or, sometimes, to stop one of the medicines.

If you are taking any of the following medicines, tell your doctor or pharmacist:  , , fluvoxamine, , paroxetine, , viloxazine, bupropion (used to help stop smoking), citalopram, , sertraline, tricyclic antidepressants (e.g. imipramine, , amitriptyline, , ), monoamine-oxidase inhibitors (MAOIs) (medicines used to treat depression)  Alprazolam, (medicines used to treat anxiety)  Corticosteroids, e.g. prednisolone, dexamethasone (used for inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pains)  Anticoagulants, such as warfarin, phenprocoumon, dicoumarol and acenocoumarol (to stop your blood clotting)  Antibiotics, such as , troleandomycin, josamycin, , ciprofloxacin, doxycycline (used to treat bacterial infections)  , , bromperidol, , , , , , , , loxapine (, used to treat mental disorder)  Painkillers, containing , , , methadone, paracetamol, phenazone (antipyrine), tramadol. Long term use of carbamazepine and paracetamol may be associated with liver toxicity.  , , , methsuximide, oxcarbazepine, phenobarbitone, , , , , , , , , , , valproic , valnoctamide and , , , , (medicines used to treat epilepsy) Sandoz Business use only Page 4 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00  Antifungals, such as itraconazole, , fluconazole, voriconazole (medicines used to treat fungal infections)  , , or digoxin (medicines for high blood pressure or heart problems)  Simvastatin, atorvastatin, lovastatin, cerivastatin, ivabradine (medicines for high )  Diuretics (water tablets), such as or hydrochlorothiazide  Cimetidine or omeprazole (medicines used to treat gastric ulcers)  Isotretinoin (medicine for the treatment of acne)  Metoclopramide (an anti-sickness medication)  (a medicine to treat glaucoma – increased pressure in the eye)  Danazol (treatment for endometriosis)  Theophylline or aminophylline (used in the treatment of asthma)  Ciclosporin (an immunosuppressant, used after transplant operations, but also sometimes in the  treatment of arthritis or psoriasis)  Everolimus, tacrolimus, sirolimus (immunosuppressants)  Herbal medicine containing St. John’s wort (Hypericum perforatum)  Indinavir, saquinavir, ritonavir (drugs to treat HIV)  Any other medicines which your doctor does not know about, including Vitamin B () supplements  such as loratadine, (medicines to treat allergy such as hay-fever, itch, etc.)  drugs such as oxybutynin, dantrolene, pancuronium  Ticlodipine (which is a platelet aggregation inhibitor)  Antineoplastics such as cisplatin, doxorubicin, imatinib, cyclophosphamide, lapatinib, temsirolimus (cancer drugs)  Rifampicin, , rifabutin (medicines used to treat tuberculosis)  Aprepitant (used to prevent vomiting)  Anthelmintics such as praziquantel and albendazole (used to treat worm infections)  Levothyroxine (used to treat hypothyroidism)  Tadalafil (used to treat inability to achieve or maintain an erection)  Hormone Replacement Therapy (HRT). Carbamazepine can make HRT less effective.

Irregularity of the menstrual period may occur in women taking hormonal contraceptives (birth control medicines) and [nationally completed name]. The hormonal contraceptive may become less effective and you should consider using other contraceptive methods.

Do not take grapefruit juice while using [nationally completed name] as it may affect the amount of medicine absorbed in your body.

[Nationally completed name] with food and drink Do not drink when you are taking [nationally completed name]. Do not drink grapefruit juice or eat grapefruit since this can increase the effect of [nationally completed name]. Other juices, like orange juice or apple juice, do not have this effect.

[Nationally completed name] in children and older people Sandoz Business use only Page 5 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00 [Nationally completed name] may be safely used in children and in elderly patients, keeping to the doctor's instructions. If necessary, special information will be given, such as on careful dosage and close observation needed (see also section 3 How to take [Nationally completed name] and section 4 Possible side effects).

Pregnancy and breast-feeding 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.

Pregnancy Carbamazepine (the active substance of [nationally completed name]) should be used during pregnancy only after a careful benefit/risk evaluation by your doctor. It is important to control epileptic seizures during pregnancy. However, there is a possible risk to your baby if you take antiepileptic medication (medicine for seizures) during pregnancy. Your doctor will discuss with you the potential risk of taking [nationally completed name] during pregnancy. Do not stop your treatment with [nationally completed name] during without first checking with your doctor.

Breast feeding Tell your doctor if you are breast-feeding. The active ingredient in [nationally completed name] passes into the breast milk. As long as your doctor agrees in your special case, and your child is closely watched for side effects, you may breast-feed your child. However, if side effects appear, e.g. if your baby gets very sleepy, stop breast-feeding and tell your doctor.

Driving and using machines [Nationally completed name] may make you feel sleepy or dizzy or may cause blurred vision, especially when starting treatment or increasing the dose. So, be careful when driving a car or working a machine or doing other activities requiring careful attention.

[Nationally completed name] contains macrogolglycerol-hydroxystearate which may cause stomach upset and diarrhoea.

3. How to take [Nationally completed name] 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 usually start [nationally completed name] at a fairly low dose which can then be increased to suit you individually. The dose needed varies between patients. You can take the tablets during, after or between meals. Swallow the tablets with a drink. If necessary you may break the tablets in half along the scored line.

How much to take Epilepsy

Starting dose Maintenance dose Sandoz Business use only Page 6 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00 Adults 100-200 mg once or twice daily 400-600 mg morning and night Children 6-10 years 100 mg once daily 100-200 mg morning and 100-400 mg at night Children 10-15 years 100 mg once daily 200-400 mg morning and 400-600 mg at night

If you take more [Nationally completed name] than you should: If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. If you experience difficulty in breathing, a fast and irregular heartbeat, loss of consciousness, fainting, shakiness, sickness and/or vomiting, your dose may be too high. Stop taking your medicine and inform your doctor without delay.

If you forget to take [Nationally completed name] If you forget to take a dose, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed one; just go back to your regular dosing timetable. Do not double the dose to make up for the forgotten dose.

If you stop taking [Nationally completed name] If you are taking [Nationally completed name], do not suddenly stop taking it without first checking with your doctor. Your doctor will tell you if and when you can stop taking this medicine (see Take special care with [Nationally completed name]).

What else should you be aware of while taking [Nationally completed name]? It is very important that your doctor checks your progress at regular visits. He or she may want to take periodic blood tests, especially when you start taking [Nationally completed name]. This is quite usual and nothing to worry about.

Before having any kind of surgery, including dental or emergency treatment, tell the doctor in charge that you are taking [Nationally completed name].

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. These side effects are often mild and occur more often early in treatment and usually wear off after a few days of treatment.

Some side effects can be serious Stop taking [nationally completed name] and tell your doctor straight away if you notice: Sandoz Business use only Page 7 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00  Serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth or skin peeling accompanied by fever. These reactions may be more frequent in patients of Chinese or Thai origin.  Mouth ulcers or unexplained bruising or bleeding  Sore throat or high temperature, or both  Yellowing of your skin or the whites of your eyes  Swollen ankles, feet or lower legs  Any signs of nervous illness or confusion  Pain in your joints and muscles, a rash across the bridge of the nose and cheeks and problems with breathing (these may be the signs of a rare reaction known as lupus erythematosus)  Fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be the signs of a multi-organ sensitivity disorder)  Bronchospasm with wheezing and coughing, difficulty in breathing, feeling faint, rash, itching or facial swelling (these may be the signs of a severe allergic reaction)  Pain in the area near the stomach. Other possible side effects Very common side effects (may affect more than 1 in 10 people)  Leucopenia (a reduced number of the cells which fight infection making it easier to catch infections);  dizziness and tiredness; feeling unsteady or finding it difficult to control movements;  feeling or being sick; changes in liver levels (usually without any symptoms);  skin reactions which may be severe.

Common side effects (may affect up to 1 in 10 people)  Changes in the blood including an increased tendency to bruise or bleed;  fluid retention and swelling; weight increase;  low sodium in the blood which might result in confusion;  headache; double or blurred vision; dry mouth.

Uncommon side effects (may affect up to 1 in 100 people)  Abnormal involuntary movements including tremor or tics; abnormal eye movements;  diarrhoea; constipation.

Rare side effects (may affect up to 1 in 1,000 people)  Inflammation of the protective membrane surrounding the brain (aseptic meningitis)  disease of the lymph glands; increase of white blood cells, loss of appetite, folic acid deficiency;  a generalised allergic reaction including rash, joint pain, fever, problems with the kidneys and other organs;  hallucinations; depression;; restlessness; aggression; agitation; confusion; speech disorders; numbness or tingling in the hands and feet; muscle weakness;  problems with eye movements  high blood pressure (which may make you feel dizzy, with a flushed face, headache, fatigue and nervousness); low blood pressure (the symptoms of which are feeling faint, light headed, dizzy, confused, having blurred vision); changes to heart beat; Sandoz Business use only Page 8 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00  stomach pain; liver problems including jaundice;  symptoms of lupus erythematosus.

Very rare side effects (may affect up to 1 in 10,000 people)  Changes to the composition of the blood including anaemia; porphyria;;  swelling of the breasts and discharge of milk which may occur in both male and females;abnormal thyroid function tests;  taste disturbances; conjunctivitis; glaucoma; cataracts;  hearing disorders;  heart failure, low or irregular heart beats  heart and circulatory problems including deep vein thrombosis (DVT), the symptoms of which could include tenderness, pain, swelling, warmth, skin discoloration and prominent superficial veins;  lung or breathing problems;  stomach pain, inflammation of mouth and tongue, taste disturbances  severe skin reactions including Stevens-Johnson syndrome (These reactions may be more frequent in patients of Chinese or Thai origin); sore mouth or tongue;  liver failure;  increased sensitivity of the skin to sunlight; alterations in skin pigmentation; acne; excessive sweating; hair loss; increased hair growth on the body and face;  muscle pain or spasm;  osteomalacia (softening or weakening of bones, which may be noticed as pain on walking and bowing of the long bones in the legs); osteoporosis (bone pain, thinning or weakening of bones, lack of Vitamin D), increased blood fat levels;  sexual difficulties which may include reduced male fertility, loss of libido or impotence;  kidney failure; blood spots in the urine; increased or decreased desire to pass urine or difficulty in passing urine.  Increase levels of cholesterol

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store [Nationally completed name]

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month. Sandoz Business use only Page 9 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00

Do not store above 25 °C. Store in the original package.

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 [nationally completed name] contains The active substance is: carbamazepine. Each retard tablet contains 200 mg of carbamazepine. The other ingredients are: Tablet core: Colloidal anhydrous silica, solid residue of aqueous dispersion of ethylcellulose, cetylic alcohol and sodium lauryl sulphate, microcrystalline cellulose, polyacrylate dispersion 30 per cent, stearate, carmellose sodium, talc. Film coating material: Hypromellose, macrogolglycerol-hydroxystearate (Ph.Eur.), iron oxide red (E 172), iron oxide yellow (E 172), talc and titanium dioxide (E 171).

What [nationally completed name] looks like and contents of the pack Beige-orange, oval, slightly bi-convex coated tablet with a score on each side. Imprint on one side, H/C. The tablet can be divided into equal doses.

30, 50, 60, 100 and 200 tablets in colourless, transparent or white opaque PVC/PE/PVDC/aluminium blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer [To be completed nationally]

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

{Name of the Member State} {Name of the medicinal product} This leaflet was last revised in 05/2014