Package leaflet: Information for the user

Actelsar HCT 40 mg/12.5 mg tablets

telmisartan/hydrochlorothiazide
Read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Actelsar HCT is and what it is used for
What you need to know before taking Actelsar HCT
How to take Actelsar HCT
Possible side effects
How to store Actelsar HCT
Contents of the pack and other information

1. What Actelsar HCT is and what it is used for

Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these substances helps control high blood pressure.

Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II, causing blood vessels to relax and thus lowering blood pressure.
Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine flow, thereby contributing to the reduction of blood pressure.

If left untreated, high blood pressure can damage blood vessels in many organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage occurs. Therefore, it is important to have regular blood pressure measurements to check whether it is within the normal range.
Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

2. What you should know before taking Actelsar HCT

Do not take Actelsar HCT

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine.
if you are more than 3 months pregnant (it is better to avoid taking Actelsar HCT even in the early stages of pregnancy – see pregnancy section).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
if you have severe kidney disease.
if your doctor determines that your blood potassium levels are low or calcium levels are high and do not improve with treatment.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of these conditions, inform your doctor or pharmacist before taking Actelsar HCT.
Warnings and precautions
Talk to your doctor before taking Actelsar HCT if you have or have had any of the following
conditions or diseases:

Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhoea, vomiting, or haemodialysis.
Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Increased levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Systemic lupus erythematosus (also called “lupus” or “SLE”), a disease in which the body’s immune system attacks the body itself.
The active ingredient hydrochlorothiazide may cause an uncommon reaction, resulting in vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may occur from hours to weeks after taking Actelsar HCT. This condition may lead to permanent vision impairment if not treated.
If you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking Actelsar HCT.
If you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Actelsar HCT, consult a doctor immediately.

Talk to your doctor before taking Actelsar HCT if you are taking:

any of the following medicines used to treat high blood pressure:
an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
aliskiren. Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "Do not take Actelsar HCT".
digoxin.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Actelsar HCT is not recommended during early pregnancy and must not be taken if you are
more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (see
pregnancy section).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in the body. Typical
symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness,
restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally
fast heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your
doctor.
You should also inform your doctor if you have noticed increased skin sensitivity to sunlight,
manifesting as faster onset than normal of sunburn symptoms (such as redness, itching, swelling, or
blistering).
If you are undergoing surgery or receiving anaesthetics, inform the doctor that you are taking Actelsar
HCT.
Actelsar HCT may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of Actelsar HCT is not recommended in children and adolescents under 18 years of age.
Other medicines and Actelsar HCT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. Your doctor may decide to adjust the dose of these other medicines or take other precautions.
In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to
the following medicines when taken concurrently with Actelsar HCT:

Medicines containing lithium used to treat certain types of depression.
Medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives.
Medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant medicine), and other medicines such as sodium heparin (an anticoagulant).
Medicines that are affected by changes in blood potassium levels, such as heart medicines (e.g. digoxin) or medicines to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g. sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g. terfenadine).
Medicines for the treatment of diabetes (insulin or oral agents such as metformin).
Cholestyramine and colestipol, medicines to lower blood fat levels.
Medicines to increase blood pressure, such as noradrenaline.
Medicines that relax muscles, such as tubocurarine.
Calcium and/or vitamin D supplements.
Anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia), such as atropine and biperiden.
Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent viral illnesses).
Other substances used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for cancer, gout, or arthritis.
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take Actelsar HCT" and "Warnings and precautions").
Digoxin.

Actelsar HCT may enhance the effect of other medicines used to lower blood pressure or medicines that
have the potential to lower high blood pressure (e.g. baclofen, amifostine).
In addition, a drop in blood pressure may be worsened by alcohol, barbiturates, narcotics, or
antidepressants. You may experience this as dizziness when standing up. Contact your doctor if you need
to adjust the dose of your other medicines while taking Actelsar HCT.
The effect of Actelsar HCT may be reduced when taking NSAIDs (non-steroidal anti-inflammatory
drugs, e.g. acetylsalicylic acid and ibuprofen).
Actelsar HCT with food and alcohol
You may take Actelsar HCT with or without food.
Avoid alcohol consumption without first discussing it with your doctor. Alcohol may further reduce
blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Your doctor will usually advise you to stop taking Actelsar HCT before becoming pregnant
or as soon as you find out you are pregnant and will recommend another medicine instead of Actelsar
HCT. Actelsar HCT is not recommended during pregnancy and must not be taken if you are more than
3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or about to start breastfeeding. Actelsar HCT is not
recommended for women who are breastfeeding, and your doctor may choose another treatment if you
wish to breastfeed.
Driving and using machines
Some patients may experience dizziness or drowsiness when taking Actelsar HCT. If you experience
these effects, do not drive or operate machinery.
Actelsar HCT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Actelsar HCT

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time each day. You may take Actelsar HCT with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important to take Actelsar HCT every day until your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg/12.5 mg once daily must not be exceeded.
If you take more Actelsar HCT than you should
If you have accidentally taken too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including renal failure have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which can cause nausea, drowsiness, and muscle cramps and/or irregular heartbeat, particularly when used concomitantly with medicines such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.
If you forget to take Actelsar HCT
If you forget to take your medicine, do not worry. Take it as soon as you remember, then continue as before. If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects can be serious and require immediate medical attention:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a severe infection with a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), blistering and shedding of the outer layer of the skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis), but are extremely serious, and patients must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for Actelsar HCT.
Very rare (may affect up to 1 in 10,000): Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).
Possible side effects of Actelsar HCT:
Common (may affect up to 1 in 10):
Dizziness.
Uncommon (may affect up to 1 in 100):
Low potassium levels in the blood, anxiety, fainting (syncope), numbness, tingling sensation (paraesthesia), sensation of spinning (dizziness), rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.
Rare (may affect up to 1 in 1,000):
Lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rash, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), altered vision, difficulty breathing, abdominal pain, constipation, swelling (dyspepsia), feeling unwell (nausea), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), skin redness (erythema), allergic reactions such as itching or skin rash, increased sweating, urticaria, joint pain (arthralgia) and limb pain, muscle cramps, influenza-like illness, pain, low sodium levels, increased creatinine levels, elevated liver enzymes or creatine phosphokinase in the blood.
Adverse reactions reported with one of the individual components may also be potential adverse reactions with Actelsar HCT, even if not observed in clinical studies with this product.

Telmisartan
The following additional side effects have been reported in patients treated with telmisartan alone:
Uncommon (may affect up to 1 in 100):
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, reduced red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), renal impairment including acute renal failure, feeling of weakness, cough.
Rare (may affect up to 1 in 1,000):
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach disorder, eczema (skin disorder), osteoarthritis, tendon inflammation, decreased haemoglobin (a blood protein), drowsiness.
Very rare (may affect up to 1 in 10,000):
Progressive scarring of lung tissue (interstitial lung disease)**.
*The event may have occurred by chance or could be related to a currently unknown mechanism.
**Cases of progressive scarring of lung tissue have been reported during telmisartan treatment. However, it is not known whether telmisartan was the cause.

Hydrochlorothiazide
The following additional side effects have been reported in patients treated with hydrochlorothiazide alone:
Common (may affect up to 1 in 10):
Malaise (nausea), low magnesium levels in the blood.
Rare (may affect up to 1 in 1,000):
Reduced platelets, increasing the risk of bleeding or bruising (small purple-red spots on the skin or other tissues due to bleeding), high calcium levels in the blood, headache.
Very rare (may affect up to 1 in 10,000):
Increased pH (altered acid-base balance) due to low chloride levels in the blood.
Side effects of unknown frequency (frequency cannot be determined from available data):
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of blood cells, including reduced red and white blood cell counts, severe allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or of acute myopia or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), inflammation of the pancreas, stomach disorder, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking systemic lupus erythematosus, in which the immune system attacks the body itself); skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight, skin rash, redness of the skin, blister formation on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney inflammation or altered kidney function, glucose in urine (glucosuria), fever, electrolyte imbalance, elevated cholesterol levels in the blood, reduced blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or blood fat levels.

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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Actelsar HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box, blister, or bottle label after “EXP.”. The expiry date refers to the last day of that month. “Lot” printed on the box refers to the batch number.
For Al/Al blisters and HDPE bottles:
This medicine does not require any special storage conditions.
For Al/PVC/PVDC blisters:
Do not store above 30°C.
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 Actelsar HCT contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The excipients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).

Description of the appearance of Actelsar HCT and contents of the pack
Actelsar HCT 40 mg/12.5 mg tablets are white or almost white, 6.55 x 13.6 mm, biconvex, oval-shaped tablets, with “TH” engraved on one side.
Pack sizes
Al/Al blisters: 14, 28, 30, 56, 84, 90 and 98 tablets
Al/PVC/PVDC blisters: 28, 56, 84, 90 and 98 tablets
Bottle: 30, 90 and 250 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Iceland

Manufacturer
Actavis Ltd.
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

България
Тева Фарма ЕАД
Teл: +359 24899585

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Deutschland
ratiopharm GmbH
Tel: +49 73140202

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

España
Teva Pharma, S.L.U.
Tel: +34 913873280

France
Teva Santé
Tél: +33 155917800

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Lietuva
UAB Teva Baltics
Tel: +370 52660203

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Norge
Teva Norway AS
Tlf: +47 66775590

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

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

Package leaflet: information for the user

Actelsar HCT 80 mg/12.5 mg tablets

telmisartan/hydrochlorothiazide
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Actelsar HCT is and what it is used for
What you need to know before taking Actelsar HCT
How to take Actelsar HCT
Possible side effects
How to store Actelsar HCT
Contents of the pack and other information

1. What Actelsar HCT is and what it is used for

Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these substances helps control high blood pressure.

Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine flow, thereby contributing to lowering blood pressure.

If left untreated, high blood pressure can damage blood vessels in many organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

2. What you should know before taking Actelsar HCT

Do not take Actelsar HCT

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine.
if you are more than 3 months pregnant (it is better to avoid taking Actelsar HCT even in the early stages of pregnancy – see the pregnancy section).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver or gallbladder) or any other serious liver disease.
if you have severe kidney disease.
if your doctor finds that your blood potassium levels are low or your calcium levels are high and do not improve with treatment.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhoea, vomiting, or haemodialysis.
Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Increased levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Systemic lupus erythematosus (also known as “lupus” or “SLE”), a disease in which the body’s immune system attacks the body itself.
The active substance hydrochlorothiazide may cause an uncommon reaction, resulting in vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and may occur from hours to weeks after taking Actelsar HCT. This condition may lead to permanent vision impairment if not treated.
If you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Actelsar HCT.
If you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Actelsar HCT, consult a doctor immediately.

Talk to your doctor before taking Actelsar HCT if you are taking:

any of the following medicines used to treat high blood pressure:
an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Actelsar HCT".
digoxin.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Actelsar HCT is not recommended during early pregnancy and must not be taken if you are
more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see the pregnancy section).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in the body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally fast heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.
You should also inform your doctor if you have experienced increased sensitivity of the skin to sunlight,
manifesting as more rapid onset than usual of sunburn symptoms (such as redness, itching, swelling, or blistering).
If you are undergoing surgery or receiving anaesthetics, inform your doctor that you are taking Actelsar HCT.
Actelsar HCT may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of Actelsar HCT is not recommended in children and adolescents under 18 years of age.
Other medicines and Actelsar HCT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. Your doctor may decide to adjust the dose of these other medicines or take other precautions. In some cases, it may be necessary to discontinue one of these medicines. This particularly applies to the following medicines when taken together with Actelsar HCT:

Medicines containing lithium used to treat certain types of depression.
Medicines associated with low potassium levels in the blood (hypokalaemia), such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives.
Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant medicine), and other medicines such as sodium heparin (an anticoagulant).
Medicines that are affected by changes in blood potassium levels, such as heart medicines (e.g. digoxin) or medicines to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g. sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g. terfenadine).
Medicines for treating diabetes (insulin or oral agents such as metformin).
Cholestyramine and colestipol, medicines used to lower blood fat levels.
Medicines to increase blood pressure, such as noradrenaline.
Muscle relaxants, such as tubocurarine.
Calcium and/or vitamin D supplements.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid during anaesthesia), such as atropine and biperiden.
Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent viral illnesses).
Other substances used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), cancer treatments, gout, or arthritis.
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take Actelsar HCT" and "Warnings and precautions").
Digoxin.

Actelsar HCT may enhance the effect of other medicines used to lower blood pressure or medicines that have the potential to lower high blood pressure (e.g. baclofen, amifostine).
In addition, a drop in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience this as dizziness when standing up.
You should contact your doctor if you need to adjust the dose of other medicines while taking Actelsar HCT.
The effect of Actelsar HCT may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid and ibuprofen).
Actelsar HCT with food and alcohol
You may take Actelsar HCT with or without food.
Avoid consuming alcohol without first discussing it with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Actelsar HCT before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Actelsar HCT. Actelsar HCT is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Actelsar HCT is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed.
Driving and using machines
Some patients may experience dizziness or drowsiness when taking Actelsar HCT. If you experience these effects, do not drive or operate machinery.
Actelsar HCT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Actelsar HCT

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time each day. You may take Actelsar HCT with or without food. The tablets should be swallowed with a glass of water or another non-alcoholic drink. It is important to take Actelsar HCT every day until your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg/12.5 mg once daily must not be exceeded.
If you take more Actelsar HCT than you should
If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including kidney failure have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which can cause nausea, drowsiness, muscle cramps, and/or irregular heartbeat, especially when used concomitantly with medicines such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.
If you forget to take Actelsar HCT
If you forget to take your medicine, do not worry. Take it as soon as you remember, then continue as before. If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a severe infection with systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), development of blisters and shedding of the outer layer of the skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis), but are extremely severe, and patients must stop taking the medicine and consult a doctor immediately. If left untreated, these effects can be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for Actelsar HCT.
Very rare (may affect up to 1 in 10,000): Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).
Possible side effects of Actelsar HCT:
Common (may affect up to 1 in 10):
Dizziness.
Uncommon (may affect up to 1 in 100):
Reduced potassium levels in the blood, anxiety, fainting (syncope), numbness, tingling sensation (paraesthesia), sensation of spinning (dizziness), rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.
Rare (may affect up to 1 in 1,000):
Lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rash, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), blurred vision, breathing difficulties, abdominal pain, constipation, swelling (dyspepsia), feeling unwell (nausea), inflammation of the stomach (gastritis), abnormal liver function (this side effect is more likely in Japanese patients), skin redness (erythema), allergic reactions such as itching or skin rash, increased sweating, urticaria, joint pain (arthralgia) and limb pain, muscle cramps, influenza-like illness, pain, low sodium levels, increased creatinine levels, elevated liver enzymes or creatine phosphokinase in the blood.
Adverse reactions reported with one of the individual components may also be potential adverse reactions with Actelsar HCT, even if not observed in clinical studies with this product.

Telmisartan
The following additional side effects have been observed in patients treated with telmisartan alone:
Uncommon (may affect up to 1 in 100):
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, reduced red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), renal impairment including acute renal failure, feeling of weakness, cough.
Rare (may affect up to 1 in 1,000):
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach disorder, eczema (skin disorder), osteoarthritis, tendon inflammation, decreased haemoglobin (a blood protein), somnolence.
Very rare (may affect up to 1 in 10,000):
Progressive scarring of lung tissue (interstitial lung disease)**.
*The event may have occurred by chance or could be related to a currently unknown mechanism.
**Cases of progressive scarring of lung tissue have been reported during telmisartan treatment. However, it is not known whether telmisartan was the cause.

Hydrochlorothiazide
The following additional side effects have been observed in patients treated with hydrochlorothiazide alone:
Common (may affect up to 1 in 10):
Malaise (nausea), low magnesium levels in the blood.
Rare (may affect up to 1 in 1,000):
Reduced platelet count, increasing the risk of bleeding or bruising (small purple-red spots on the skin or other tissues due to bleeding), high calcium levels in the blood, headache.
Very rare (may affect up to 1 in 10,000):
Increased pH (altered acid-base balance) due to low chloride levels in the blood.
Side effects of unknown frequency (frequency cannot be estimated from the available data):
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of blood cells, including reduced red and white blood cell counts, severe allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute myopia or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), inflammation of the pancreas, stomach disorder, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking systemic lupus erythematosus, in which the immune system attacks the body itself); skin disorders such as inflammation of skin blood vessels, increased sensitivity to sunlight, skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney inflammation or altered kidney function, glucose in the urine (glucosuria), fever, electrolyte imbalance, elevated cholesterol levels in the blood, reduced blood volume, increased glucose levels in the blood, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or blood fat levels.

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 Actelsar HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box, blister or label of the
bottle after “EXP.”. The expiry date refers to the last day of that month. “Batch”
printed on the box refers to the batch number.
For Al/Al and HDPE bottle blisters:
This medicine does not require any special storage conditions.
For Al/PVC/PVDC blisters:
Do not store above 30°C.
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 Actelsar HCT Contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The excipients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).

Description of the Appearance of Actelsar HCT and Contents of the Pack
Actelsar HCT 80 mg/12.5 mg tablets are white or almost white, 9.0 x 17.0 mm, capsule-shaped tablets, marked with “TH 12.5” on both sides.
Pack sizes
Al/Al blisters: 14, 28, 30, 56, 84, 90 and 98 tablets
Al/PVC/PVDC blisters: 14, 28, 56, 84, 90 and 98 tablets
Bottle: 30, 90 and 250 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Iceland

Manufacturer
Actavis Ltd.
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

България
Тева Фарма ЕАД
Teл: +359 24899585

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Deutschland
ratiopharm GmbH
Tel: +49 73140202

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

España
Teva Pharma, S.L.U.
Tel: +34 913873280

France
Teva Santé
Tél: +33 155917800

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Lietuva
UAB Teva Baltics
Tel: +370 52660203

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Norge
Teva Norway AS
Tlf: +47 66775590

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

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

Patient Information Leaflet: Information for the User

Actelsar HCT 80 mg/25 mg tablets

telmisartan/hydrochlorothiazide
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Actelsar HCT is and what it is used for
What you need to know before taking Actelsar HCT
How to take Actelsar HCT
Possible side effects
How to store Actelsar HCT
Contents of the pack and other information

1. What Actelsar HCT is and what it is used for

Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these substances helps control high blood pressure.

Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II, causing blood vessels to relax and thus lowering blood pressure.
Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine flow, thereby contributing to blood pressure reduction.

If untreated, high blood pressure can damage blood vessels in many organs and may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

2. What you need to know before taking Actelsar HCT

Do not take Actelsar HCT

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine.
if you are more than 3 months pregnant (it is best to avoid taking Actelsar HCT even in the early stages of pregnancy – see pregnancy section).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver or gallbladder) or any other severe liver disease.
if you have severe kidney disease.
if your doctor has determined that your blood potassium levels are low or your calcium levels are high and do not improve with treatment.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy (diuretics), low-salt diet, diarrhoea, vomiting, or haemodialysis.
Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Elevated levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Systemic lupus erythematosus (also known as “lupus” or “SLE”), a disease in which the body’s immune system attacks the body itself.
The active substance hydrochlorothiazide may cause an uncommon reaction leading to vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, and may occur from hours to weeks after taking Actelsar HCT. This condition can lead to permanent vision impairment if not treated.
If you have previously had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking Actelsar HCT.
If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Actelsar HCT, consult a doctor immediately.

Talk to your doctor before taking Actelsar HCT if you are taking:

any of the following medicines used to treat high blood pressure:
an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Actelsar HCT".
digoxin.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Actelsar HCT is not recommended during early pregnancy and must not be taken if you are
more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this
period (see section on pregnancy).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in the body. Typical
symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness,
restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally
fast heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your
doctor.
You should also inform your doctor if you notice increased skin sensitivity to sunlight, manifesting as
faster onset than normal of sunburn symptoms (such as redness, itching, swelling, blistering).
If you are undergoing surgery or receiving anaesthetics, inform the doctor that you are taking Actelsar
HCT.
Actelsar HCT may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of Actelsar HCT is not recommended in children and adolescents under 18 years of age.
Other medicines and Actelsar HCT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. Your doctor may decide to adjust the dose of these other medicines or take other precautions.
In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to the
following medicines when taken concurrently with Actelsar HCT:

Medicines containing lithium used to treat certain types of depression.
Medicines associated with low blood potassium levels (hypokalaemia) such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives.
Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant medicine), and other medicines such as sodium heparin (an anticoagulant).
Medicines that are affected by changes in blood potassium levels such as heart medicines (e.g. digoxin) or medicines to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g. sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (e.g. terfenadine).
Medicines for the treatment of diabetes (insulin or oral agents such as metformin).
Cholestyramine and colestipol, medicines used to lower blood fat levels.
Medicines to increase blood pressure, such as noradrenaline.
Medicines that relax muscles, such as tubocurarine.
Calcium supplements and/or vitamin D supplements.
Anticholinergic medicines (drugs used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia), such as atropine and biperiden.
Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent virus-related illnesses).
Other substances used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), cancer medicines, gout or arthritis medicines.
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take Actelsar HCT" and "Warnings and precautions").
Digoxin.

Actelsar HCT may enhance the effect of other medicines used to lower blood pressure or medicines that
have the potential to lower high blood pressure (e.g. baclofen, amifostine).
In addition, a drop in blood pressure may be worsened by alcohol, barbiturates, narcotics, or
antidepressants. You may experience this as dizziness when standing up.
You should contact your doctor if you need to adjust the dose of other medicines while taking Actelsar
HCT.
The effect of Actelsar HCT may be reduced when taking NSAIDs (non-steroidal anti-inflammatory
drugs, e.g. acetylsalicylic acid and ibuprofen).
Actelsar HCT with food and alcohol
You may take Actelsar HCT with or without food.
Avoid alcohol unless you have discussed it with your doctor. Alcohol may further lower blood pressure
and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your
doctor will usually advise you to stop taking Actelsar HCT before becoming pregnant or as soon as you
know you are pregnant, and will recommend another medicine instead of Actelsar HCT. Actelsar HCT is
not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as
it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Actelsar HCT is not recommended
for women who are breastfeeding, and your doctor may choose another treatment if you wish to
breastfeed.
Driving and using machines
Some patients may experience dizziness or drowsiness when taking Actelsar HCT. If these effects occur,
do not drive or operate machinery.
Actelsar HCT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Actelsar HCT

If you take more Actelsar HCT than you should
If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including renal failure have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which can cause nausea, drowsiness, and muscle cramps and/or irregular heartbeat, particularly when used concomitantly with medicines such as digoxin or certain antiarrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take Actelsar HCT
If you forget to take your medicine, do not worry. Take it as soon as you remember, then continue as before. If you miss a day’s dose, take your normal dose the next day. Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a severe infection with a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), development of blisters and shedding of the outer layer of the skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis), but extremely serious, and patients must stop taking the medicine and consult their doctor immediately. If these effects are not treated, they may be fatal. An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be excluded for Actelsar HCT.
Very rare (may affect up to 1 in 10,000): Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).
Possible side effects of Actelsar HCT:
Common (may affect up to 1 in 10):
Dizziness.
Uncommon (may affect up to 1 in 100):
Low blood potassium levels, anxiety, fainting (syncope), numbness, tingling sensation (paraesthesia), sensation of spinning (vertigo), fast heartbeat (tachycardia), low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased blood uric acid levels.
Rare (may affect up to 1 in 1,000):
Lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, rash, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), altered vision, breathing difficulties, abdominal pain, constipation, swelling (dyspepsia), feeling unwell (nausea), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain (arthralgia) and limb pain, muscle cramps, influenza-like illness, pain, low sodium levels, increased creatinine levels, elevated liver enzymes or creatine phosphokinase in the blood.
Adverse reactions reported with one of the individual components may also be potential adverse reactions with Actelsar HCT, even if not observed in clinical studies with this product.

Telmisartan
In patients treated with telmisartan alone, the following additional side effects have been observed:
Uncommon (may affect up to 1 in 100):
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, reduced red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), renal impairment including acute renal failure, feeling of weakness, cough.
Rare (may affect up to 1 in 1,000):
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood glucose levels (in diabetic patients), stomach disorder, eczema (skin disorder), osteoarthritis, tendon inflammation, decreased haemoglobin (a blood protein), somnolence.
Very rare (may affect up to 1 in 10,000):
Progressive scarring of lung tissue (interstitial lung disease)**.
*The event may have occurred by chance or could be related to a currently unknown mechanism.
**Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Hydrochlorothiazide
In patients treated with hydrochlorothiazide alone, the following additional side effects have been observed:
Common (may affect up to 1 in 10):
Malaise (nausea), low blood magnesium levels.
Rare (may affect up to 1 in 1,000):
Reduced platelet count, increasing the risk of bleeding or bruising (small purple-red spots on the skin or other tissues caused by bleeding), high blood calcium levels, headache.
Very rare (may affect up to 1 in 10,000):
Increase in pH (altered acid-base balance) due to low blood chloride levels.
Side effects of unknown frequency (frequency cannot be estimated from the available data):
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of blood cells, including reduced red blood cells and white blood cells, severe allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or lost appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or of acute myopia or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), inflammation of the pancreas, stomach disorder, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking systemic lupus erythematosus, in which the immune system attacks the body itself); skin disorders such as inflammation of skin blood vessels, increased sensitivity to sunlight, rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney inflammation or altered kidney function, glucose in urine (glucosuria), fever, electrolyte imbalance, elevated blood cholesterol levels, reduced blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or elevated blood lipid levels.

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 Actelsar HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle label after "EXP.". The expiry date refers to the last day of that month. "Batch" printed on the carton refers to the batch number.
For Al/Al blisters and HDPE bottles:
This medicine does not require any special storage conditions.
For Al/PVC/PVDC blisters:
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Actelsar HCT contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).

Description of the appearance of Actelsar HCT and package contents
Actelsar HCT 80 mg/25 mg tablets are white or almost white, 9.0 x 17.0 mm, biconvex, oval-shaped tablets, marked with “TH” on one side and “25” on the other side.
Pack sizes
Al/Al blisters: 14, 28, 30, 56, 84, 90 and 98 tablets
Al/PVC/PVDC blisters: 28, 56, 84, 90 and 98 tablets
Bottle: 30, 90 and 250 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Iceland

Manufacturer
Actavis Ltd.
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

България
Тева Фарма ЕАД
Teл: +359 24899585

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Deutschland
ratiopharm GmbH
Tel: +49 73140202

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

España
Teva Pharma, S.L.U.
Tel: +34 913873280

France
Teva Santé
Tél: +33 155917800

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Lietuva
UAB Teva Baltics
Tel: +370 52660203

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Malta
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Norge
Teva Norway AS
Tlf: +47 66775590

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

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