Package leaflet: Information for the patient

[Invented name] 50 mg, tablets

Chlortalidone

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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What [Invented name] is and what it is used for

Choltalidone, the active substance of [Invented name], is a diuretic which remove excess water and salt, increasing the amount of urine produced by your kidneys. In prolonged use, this medicine helps to reduce and control blood pressure.

[Invented name] is used to reduce the high blood pressure. High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.

[Invented name] is also used to treat other conditions, namely heart failure, or to reduce swelling due to the fluid accumulation that occurs with some kidney or liver diseases.

2. What you need to know before you take [Invented name]

Do not take [Invented name]: - if you are allergic to chlortalidone or other similar medicines or any of the other ingredients of this medicine (listed in section 6); If you do not know exactly which medicines to avoid, ask your family doctor or pharmacist. You should tell your doctor if you suspect or know that you have had an allergic reaction to any of these components - if you have severe kidney or liver disease - if you are unable to produce urine - if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal despite treatment - if you have ever had gout or kidney stones - if you are pregnant (see Pregnancy and Breast-feeding) - if you suffer from untreated Addison´s disease and concomitat lithium therapy

Warnings and precautions

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Talk to your doctor, pharmacist or nurse before taking [Invented name]: - if you suffer from any other liver or kidney problems; - if you suffer from a circulatory disorder or heart disease; - if you suffer from diabetes mellitus; - if you have low levels of potassium, sodium or magnesium in your blood, or high calcium blood levels; Low blood levels of potassium can cause muscle weakness, muscle spasms, or abnormal heart rhythm. Low blood levels of sodium can cause tiredness, confusion, muscle spasms, convulsions or coma. High blood levels of calcium may cause loss of appetite, tiredness ou muscle weakness - if you have high cholesterol blood levels - if you have high acid uric blood levels - if you are taking any other medicine product, please see also section “Other medicines and [Invented name]”

Talk to your doctor if any of the above warnings applies to you or have applied to you in the past. Your doctor will take this information into consideration during treatment. It is important that your doctor regularly monitor your condition to verify if the medicine is being adequate.

The determination of potassium or other minerals blood levels may be necessary, from time to time, especially if you are more than 65 years old, suffer from heart, liver or kidney disease, or if you are taking potassium supplements. Periodic determination of certain electrolytes and monitoring may be necessary to establish the onset of hyponatremia (low blood sodium concentration), hypokalemia (low potassium level), hypomagnesemia (abnormally low magnesium level) or hypercalcemia (abnormally high levels of calcium)

Children and adolescents [Invented name] can cause dizziness and affect concentration, particularly at the beggining of the treatment. Parents/guardians need to ensure that children/teenagers do not drive or work with machines until this effect have disappeared.

Other medicines and [Invented name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It may be necessary change the dose, or in certain cases, stop to take one of this medicines. This applies to medicinal products subject to medical prescription or those obtained without prescription, especially: - other treatments for high blood pressure or heart problems such as: - ACE inhibitors (for example, lisinopril) - angiotensin II receptor blockers (for example candesartan, losartan) - beta blockers (for example propranolol hydrochloride) - methyldopa, guanethidine - vasodilators (for example bosentan) - diazoxide - calcium channel blockers (for example amlodipine) - adrenocorticotropic hormone (ACTH) - used to treat a number of different conditions, including ulcerative colitis (a form of inflammatory bowel disease), Crohn's disease (a form of chronic inflammatory bowel disease) and rheumatoid arthritis - corticosteroids such as prednisolone or betamethasone - used to treat allergic and inflammatory diseases and immune reactions - cytotoxic agents such as cyclophosphamide or methotrexate - used to treat cancer - asthma treatments such as salbutamol or formoterol - amphotericin - used to treat infections - carbenoxolone - used to treat ulcers - lithium - used to treat mental illness - anticholinergics such as atropine sulphate or hyoscine (butylbromide) - for abdominal or stomach spasms or cramps - colestyramine - used to reduce cholesterol levels and prevent heart disease - amantadine - used to treat Parkinson’s disease or viral infections

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- allopurinol - used to treat gout (a complex type of arthritis) - non-steroidal anti-inflammatories (NSAIDs) such as aspirin or indometacin - used for pain relief or rheumatism - digoxin - for an irregular heartbeat - insulin and other treatments for diabetes such as chlorpropamide or glibenclamide (the dose can be readjusted) - ciclosporin - used to treat rheumatic disease or skin complaints or after a transplant - calcium salts or vitamin D - used for replacement therapy - curare derivatives

[Invented name] with food, drink and alcohol Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

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 Do not take [Invented name] if you are pregnant or trying to become pregnant (see section “Do not take [Invented name]”). Tell your doctor, immediately, if you become pregnant during treatment with [Invented name].

Breast-feeding Do not take [Invented name] if you are breast-feeding because the active substance of [Invented name] passes into breast milk and could harm your baby.

Driving and using machines Like many other medicines used to treat high blood pressure, [Invented name] may cause dizziness and affet the ability to concentrate. Before you drive a vehicle, use tools or operate machines or carry out other activities that require concentration, make sure you know how [Invented name] affects you.

[Invented name] contains lactose [Invented name] tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take [Invented name]

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor> or pharmacist if you are not sure.

High blood pressure Your doctor will prescribe you the lowest possible dose to suit your needs. Please, follow the doctor’s instructions. The treatment is started at the lowest dose and the dosage is then increased gradually. The usual dosage ranges from 12.5 mg/day to 50 mg/day. The starting dose is12.5 mg /day or 25 mg/day. The medicine should be taken at mealtime, with a little liquid, preferably in the morning. Some patients should take medicines to control high blood pressure throughout their life. It will be easier to remember to take your medicine if you get used to taking it at the same time each day.

Your doctor will prescribe additional medicines to lower blood pressure if the therapy response is insufficient.

Heart Failure

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The recommended starting dose is 25 mg/day to 50 mg/day; in severe cases it may be increased up to 100 to 200 mg/day. The usual maintenance dose is the lowest effective dose, eg 25 to 50 mg/day either daily or every other day.

Your doctor will prescribe additional medicines if the therapy response is insufficient.

Oedema (swelling due to fluid retention) Your doctor will prescribe you the lowest possible dose to suit your needs. Please, follow doctor’s instructions. It is recommended that the dose does not exceed 50 mg/day.

Use in children and adolescents The lowest effective dose should also be used in children. The dose is established by the doctor.

Elderly patients or those with kidney problems The lowest effective dose of [Invented name] is recommended in elderly patients and those with kidney problems. In elderly patients, the elimination of chlortalidone is slower than in healthy young adults, although absorption is the same. Therefore, close medical observation is indicated when treating patients of advanced age with chlortalidone, and a reduction in the recommended adult dosage may be needed. Elderly patients are more sensitive to electrolytic balance. Chlortalidone and the thiazide diuretics lose their diuretic effect when the creatinine clearance is <30ml/min.

If you take more [Invented name] than you should

If you accidentally take more [Invented name] than you should tell your doctor immediately or contact your nearest accident and emergency department. Overdose symptoms may include: - severe dizziness, fainting, coma or colapse - nausea, - irregular heartbeat - unusual tiredness, weakness and muscle cramps

If you forget to take [Invented name] If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do not take a double dose. Then go on as before. Do not take a double dose to make up for a forgotten tablet.

If you stop taking [Invented name] Signs of illness that can be expected when stopping treatment with [Invented name] There are no known signs of illness

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following effecst tell your doctor or pharmacist immediately:

Very common: low blood levels of potassium which can cause muscle weakness, muscle twitching or abnormal heartbeat

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Common: skin rash or itching, low levels of sodium which can cause tiredness, confusion, muscle twitching, fits or coma; low levels of magnesium, high blood sugar levels which can cause tiredness, weakness or feeling thirsty.

Rare: sore throat, fever or chills (signs of a blood disorder); yellowing of the skin or eyes (jaundice); sensation disorder such as tingling in hands, feet and lips; renal inflammation or inflammation of blood vessels with or without pain, fever or difficulty urinating; unusual bleeding or bruising (signs of thrombocytopenia); disturbed vision; irregular cardiac rhythm; sugar in the urine; worsening of diabetes; increased calcium in the blood which can cause agitation, sore eyes, abdominal pain; inflammation of blood vessels, generally with skin rash.

Very rare: abdominal pain with nausea, vomiting or fever (signs of pancreatitis); breathing problems (signs of pneumonitis and pulmonary oedema); inflammation of kidneys or blood vessels with or without pain; low levels of chloride in the blood, symptoms include dry mouth, thirst, gastrointestinal disturbances (including nausea, vomiting), weakness, lethargy, drowsiness, restlessness, seizures, confusion, headache, muscle pains or cramps, hypotension.

Many side effects will disappear without seriously correcting treatment. Talk to your doctor if any of the following effects persist or get worse:

Very common: increased blood levels of cholesterol; increased blood levels of uric acid

Common: dizziness, fainting on standing up; gastric pain; unusual tiredness or weakness (sometimes, a sign of potassium loss), loss of appetite; increased sensitivity of your skin to sunlight; inability to achieve erection or loss of sexual interest.

Rare: headache; vomiting; nausea; diarrhea; upset stomach; constipation; joint pain (signs of gout); increased sensitivity of your skin to sunlight.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 [Invented name]

This medicinal product does not require any special storage conditions.

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 container after “EXP”. The expiry date refers to the last day of that month.

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 [Invented name] contains

- The active substance is cholrtalidone: Each tablet of [Invented name] contains 50 mg of chlortalidone.

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- The other ingredients are cellulose microcrystalline, lactose, monohydrate, povidone, sodium starch glycolate (Type A), yellow iron oxide (E172) and magnesium stearate.

What [Invented name] looks like and contents of the pack

Yellow, circular and convex tablets without break line.

[Invented name] tablets are supplied in blister packs of 10, 20, 30, 60 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder [To be completed nationally]

Manufacturer Atlantic Pharma – Produções Farmacêuticas, S.A. Rua da Tapada Grande, n.º 2, Abrunheira 2710-089 Sintra Portugal

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}>

[To be completed nationally]

This leaflet was last revised in [To be completed nationally]

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