Actelsar HCT 80 mg/12.5 mg tablets

Introduction

Package Leaflet: Information for the User

Actelsar HCT 80 mg/12.5 mg tablets EFG

telmisartan/hydrochlorothiazide

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.

Contents of the pack and other information

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

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

Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both active substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that makes your blood vessels narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, causing the blood vessels to relax and your blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase the amount of urine produced, leading to a decrease in your blood pressure.

High blood pressure, if left untreated, can damage the blood vessels in various organs, which can sometimes lead to a heart attack, heart failure, kidney failure, stroke, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to ensure it is within the normal range.

Actelsar HCT is used totreat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with telmisartan alone.

2. What you need to know before you take Actelsar HCT

Do not take Actelsar HCT

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or other sulfonamide-derived medicines.

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Actelsar HCT at the start of pregnancy - see section Pregnancy).
• 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 you have low potassium or high calcium levels in your blood that do not improve with treatment.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Actelsar HCT.

Warnings and precautions

Consult your doctor before starting to take Actelsar HCT if you have or have had any of the following disorders or diseases:

• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or have a deficiency of salts due to treatment with diuretics, low-sodium diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• High aldosterone levels (water and salt retention in the body along with an 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 its own body
• The active ingredient hydrochlorothiazide can cause a rare reaction, leading to decreased vision and eye pain. These symptoms can be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and can occur between hours and weeks after taking Actelsar HCT. If left untreated, it can lead to permanent vision loss.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Actelsar HCT
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Actelsar HCT, seek medical attention immediately.

Consult your doctor before starting to take Actelsar HCT if you are taking:

• any of the following medicines used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may need to check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the information under the heading "Do not take Actelsar HCT".

• digoxin

If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor. The use of Actelsar HCT is not recommended at the start of pregnancy (first 3 months) and should not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

Treatment with hydrochlorothiazide can cause an electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, somnolence, restlessness, pain or muscle cramps, nausea, vomiting, muscle fatigue, and an abnormally rapid heart rate (more than 100 beats per minute). If you experience any of these symptoms, tell your doctor.

You should also tell your doctor if you experience increased sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) that appear more quickly than usual.

If you are going to have surgery or anesthesia, tell your doctor that you are taking Actelsar HCT.

Actelsar HCT may be less effective in lowering blood pressure in black patients.

Children and adolescents

The use of Actelsar HCT is not recommended in children and adolescents up to 18 years.

Using Actelsar HCT with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, it may be necessary to stop taking one of these medicines, especially if you are taking any of the following medicines with Actelsar HCT.

• Medicines containing lithium for the treatment of certain types of depression.
• Medicines associated with low potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and acetylsalicylic acid and derivatives.
• Medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (immunosuppressive medicine), and other medicines like heparin sodium (anticoagulant).
• Medicines whose effects are affected by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines to control your heart rate (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines like certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g., terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents like metformin).

• Colestyramine and colestipol, medicines to reduce blood fat levels.
• Medicines to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) like atropine and biperiden.
• Amantadine (medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases).
• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs (NSAIDs)), medicines for treating cancer, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Actelsar HCT" and "Warnings and precautions").
• Digoxin.

Actelsar HCT may increase the ability of other medicines to lower blood pressure or medicines with potential to lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure can be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. You should tell your doctor about the need to adjust the dose of your other medicines while using Actelsar HCT.

The effect of Actelsar HCT may be reduced when using NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen).

Taking Actelsar HCT with food and alcohol

You can take Actelsar HCT with or without food.

Avoid drinking alcohol until you have talked to your doctor. Alcohol can further lower your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will normally advise you to stop taking Actelsar HCT before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine to lower your blood pressure instead. The use of Actelsar HCT is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding, as it is not recommended to take Actelsar HCT during this time. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed.

Driving and using machines

Some people feel dizzy or tired when taking Actelsar HCT. If you feel dizzy or tired, do not drive or use machines.

Actelsar HCT contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Actelsar HCT

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is one tablet per day. Try to take the tablet at the same time each day. You can take Actelsar HCT with or without food. The tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take Actelsar HCT every day until your doctor tells you to stop.

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

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 hydrochlorothiazide component, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, and muscle cramps and/or irregular heartbeat associated with the concomitant use of medicines like digitalis or certain antiarrhythmic treatments. Contact your doctor or 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 the dose as soon as you remember and then continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious and require immediate medical attention:

If you experience any of the following symptoms, you should visit your doctor immediately:

Sepsis* (frequently called "blood infection"), is a serious infection that involves an inflammatory reaction of the entire body, rapid swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis); these adverse 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 should stop taking the medicine and visit their doctor immediately. If these adverse effects are not treated, they can be fatal. An increase in the incidence of sepsis with telmisartan alone has been observed; however, it cannot be ruled out for Actelsar HCT.

Very rare (may affect up to 1 in 10,000 people): acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Possible Adverse Effects of Actelsar HCT:

Frequent (may affect up to 1 in 10 people):

Dizziness

Uncommon (may affect up to 1 in 100 people):

Decreased potassium levels in the blood, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heartbeat (tachycardia), heart rhythm disturbances, low blood pressure, sudden decrease in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to have or maintain an erection), chest pain, and increased uric acid levels in the blood.

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

Bronchitis (inflammation of the lungs), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body, causing joint pain, skin rashes, and fever), sore throat, inflammation of the paranasal sinuses, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbances, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function disorders (Japanese patients show a greater tendency to experience this adverse effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs, muscle cramps, pseudo-influenza disease, pain, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase levels in the blood.

The adverse reactions reported for one of the individual components may be potential adverse reactions of Actelsar HCT, even if they have not been observed in clinical trials with this product.

Telmisartan

The following additional adverse effects have been described in patients taking telmisartan alone:

Uncommon (may affect up to 1 in 100 people):

Upper respiratory tract infection (e.g., sore throat, sinusitis, common cold), urinary tract infections, red blood cell deficiency (anemia), high potassium levels, slow heart rate (bradycardia), kidney function disorders, including acute renal failure, weakness, cough.

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

Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug rash), low blood sugar levels (in diabetic patients), stomach upset, eczema (a skin disorder), arthrosis, tendon inflammation, decreased hemoglobin (a blood protein), drowsiness.

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

Progressive lung tissue fibrosis (interstitial lung disease)**

*This may have been a casual finding or related to a currently unknown mechanism.

**Cases of progressive lung tissue fibrosis have been reported during telmisartan treatment. However, it is unknown whether telmisartan was the cause.

Hydrochlorothiazide

The following additional adverse effects have been described in patients taking hydrochlorothiazide alone:

Frequent (may affect up to 1 in 10 people):

Nausea, low magnesium levels in the blood.

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

Decreased platelet count in the blood, which increases the risk of bleeding and bruising (small purple-red marks on the skin or other tissues caused by bleeding), high calcium levels in the blood, headache.

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

Increased pH (acid-base imbalance) due to low chloride levels in the blood.

Adverse effects of unknown frequency (cannot be estimated from available data):

Salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), decreased blood cell count, including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), 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 acute angle-closure glaucoma], blood vessel inflammation (necrotizing vasculitis), pancreatitis, stomach upset, yellowing of the skin or eyes (jaundice), pseudo-lupus syndrome (a condition that mimics systemic lupus erythematosus, in which the body's immune system attacks the body), skin disorders such as blood vessel inflammation of the skin, increased sensitivity to sunlight, skin rash, redness, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or function disorders, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar levels, difficulty controlling blood sugar levels in patients with diabetes mellitus, or fat in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Actelsar HCT

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

Do not use this medicine after the expiration date stated on the carton, blister, or label of the bottle after "EXP"/"CAD". The expiration date is the last day of the month indicated. "Lot", which is printed on the carton, refers to the batch number.

For Al/Al blisters and HDPE tablet containers, this medicine does not require special storage conditions.

For Al/PVC/PVDC blisters

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Actelsar HCT

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

Appearance and Package Contents

Actelsar HCT 80 mg/12.5 mg tablets are white or almost white, oblong, 9.00 x 17.0 mm, with "TH 12.5" engraved on both sides.

Package Sizes

Al/Al blister: 14, 28, 30, 56, 84, 90, and 98 tablets

Al/PVC/PVDC blister: 14, 28, 56, 84, 90, and 98 tablets

Tablet container: 30, 90, and 250 tablets

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

Manufacturer

Actavis Ltd.

BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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