Actelsar HCT 40 mg/12.5 mg tablets

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 to other sulfonamide-derived medicines.

• if you are more than 3 months pregnant. (In any case, it is recommended that you avoid taking Actelsar HCT during the first few months of pregnancy - see section Pregnancy).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gall bladder) 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 problems and are being treated with a blood pressure 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 taking Actelsar HCT if you have or have had any of the following conditions or diseases:

• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have low levels 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 to one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• High levels of aldosterone (water and salt retention in the body along 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 its own tissues.
• The active substance hydrochlorothiazide may 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 may appear within hours to weeks after taking Actelsar HCT. If left untreated, it may 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 taking 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), especially 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, inform your doctor. The use of Actelsar HCT is not recommended during the first few months of pregnancy (first trimester) and is contraindicated during the second and third trimesters of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

Treatment with hydrochlorothiazide may 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 fast heart rate (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

You should also inform 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, inform 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

Inform 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 (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and derivatives.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an immunosuppressive medicine), and other medicines like heparin sodium (an anticoagulant).

• Medicines whose effects may be affected by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines to control your heart rhythm (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 used 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 (a 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 may increase the effects of medicines with potential to lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. You should inform your doctor about the need to adjust the dose of your other medicines while you are using Actelsar HCT.

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

Taking Actelsar HCT with food and drink

You can take Actelsar HCT with or without food.

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

Pregnancy and breastfeeding

Pregnancy

Inform 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 advise you to take another medicine to treat your high blood pressure. The use of Actelsar HCT is not recommended during pregnancy and is contraindicated during the second and third trimesters of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are already 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 may 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

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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 another 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 daily.

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 fast heart rate. Slow heart rate, 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 heartbeats 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 miss a dose, 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 a forgotten dose.

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), blister formation and peeling of the outer skin layer (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 has been observed with telmisartan alone; 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 heartbeats (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop 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 disturbances (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.

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 disturbances 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), osteoarthritis, 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 be 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 of the skin, blister formation on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or dysfunction, 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 packaging, 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 medicines no longer required. 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 40 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 40 mg/12.5 mg tablets are white or almost white, oval, and biconvex, 6.55 x 13.6 mm in size, with "TH" engraved on one side.

Package Sizes

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

Al/PVC/PVDC blister: 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/.