Telmisartan and hydrochlorothiazide Alter: detailed information

Patient Information Leaflet

Telmisartan and Hydrochlorothiazide Alter 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets

telmisartan/hydrochlorothiazide
Generic medicine
Please 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 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 to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Telmisartan and Hydrochlorothiazide Alter is and what it is used for

Telmisartan and Hydrochlorothiazide Alter 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 class of medicines known as angiotensin II receptor blockers. 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 reducing blood pressure.
Hydrochlorothiazide belongs to a class 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; this 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 your blood pressure checked regularly to ensure it is within the normal range.
Telmisartan and Hydrochlorothiazide Alter is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan and hydrochlorothiazide given separately.

2. What you need to know before taking Telmisartan and Hydrochlorothiazide Alter

Do not take Telmisartan and Hydrochlorothiazide Alter:

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 Telmisartan and Hydrochlorothiazide Alter 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 and gallbladder) or any other serious liver disease.
if you have severe kidney disease or anuria (less than 100 ml of urine per day).
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.

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

Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive fluid loss) or have salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhoea, vomiting, or haemofiltration.
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 (fluid and salt retention in the body with imbalance of various electrolytes 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 Telmisartan and Hydrochlorothiazide Alter. 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 sun exposure and UV rays while taking Telmisartan and Hydrochlorothiazide Alter.

Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Alter

if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (e.g. enalapril, lisinopril, ramipril, angiotensin-converting enzyme inhibitors), 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 Telmisartan and Hydrochlorothiazide Alter”.
if you are taking digoxin.
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 Telmisartan and Hydrochlorothiazide Alter, consult a doctor immediately.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Telmisartan and Hydrochlorothiazide Alter 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 baby 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 rapid 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-than-normal onset of sunburn symptoms (such as redness, itching, swelling, or blistering).
If undergoing surgery or receiving anaesthetics, inform the doctor that you are taking Telmisartan and Hydrochlorothiazide Alter.
Telmisartan and Hydrochlorothiazide Alter may be less effective in lowering blood pressure in patients of African origin.
Talk to your doctor if, after taking Telmisartan and Hydrochlorothiazide Alter, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Telmisartan and Hydrochlorothiazide Alter on your own.
Children and adolescents
The use of Telmisartan and Hydrochlorothiazide Alter is not recommended in children and adolescents under 18 years of age.
Other medicines and Telmisartan and Hydrochlorothiazide Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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 concurrently with Telmisartan and Hydrochlorothiazide Alter:

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), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives.
Iodinated contrast agents used during imaging diagnostic procedures.
Medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines such as sodium heparin (an anticoagulant).
Medicines 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 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 (drugs 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 biperidone.
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]), and medicines for cancer, gout, or arthritis.
If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Telmisartan and Hydrochlorothiazide Alter” and “Warnings and precautions”).
Digoxin.

Telmisartan and Hydrochlorothiazide Alter may enhance the effect of other medicines used to lower high blood pressure or medicines that may potentially reduce blood pressure (e.g. baclofen, amifostine). In addition, blood pressure lowering may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience this drop in blood pressure as dizziness when standing up. Consult your doctor if you need to adjust the dose of other medicines while taking Telmisartan and Hydrochlorothiazide Alter.
The effect of Telmisartan and Hydrochlorothiazide Alter may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin and ibuprofen).
Telmisartan and Hydrochlorothiazide Alter with food and alcohol
You may take Telmisartan and Hydrochlorothiazide Alter with or without food.
Avoid alcohol unless you have discussed it with your doctor. Alcohol may further reduce 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 Telmisartan and Hydrochlorothiazide Alter before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine.
Telmisartan and Hydrochlorothiazide Alter 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 baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Telmisartan and Hydrochlorothiazide Alter is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
Some patients may experience dizziness, fainting, or a sensation of movement of the surrounding environment when taking Telmisartan and Hydrochlorothiazide Alter.
If you experience these effects, do not drive or operate machinery.
Telmisartan and Hydrochlorothiazide Alter contains sorbitol
This medicine contains 21.47 mg of sorbitol per 40 mg/12.5 mg tablet of Telmisartan and Hydrochlorothiazide Alter and 42.95 mg of sorbitol per 80 mg/12.5 mg and 80 mg/25 mg tablet of Telmisartan and Hydrochlorothiazide Alter. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
Telmisartan and Hydrochlorothiazide Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Telmisartan and Hydrochlorothiazide Alter

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Telmisartan and Hydrochlorothiazide Alter is one tablet daily. Try to take the tablet at the same time each day.
You may take Telmisartan and Hydrochlorothiazide Alter with or without food. The tablets should be swallowed whole with a glass of water or another non-alcoholic drink. It is important to take Telmisartan and Hydrochlorothiazide Alter every day unless your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg telmisartan once daily should not be exceeded.

If you take more Telmisartan and Hydrochlorothiazide Alter 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 levels of potassium in the blood may also occur, which can cause nausea, drowsiness, 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 Telmisartan and Hydrochlorothiazide Alter
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 forgotten doses.

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 will experience 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, including fatal outcomes), appearance 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 very rare (toxic epidermal necrolysis; may affect up to 1 in 10,000 people), but extremely serious. 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 Telmisartan and Hydrochlorothiazide Alter.
Possible side effects of Telmisartan and Hydrochlorothiazide Alter
Common side effects (may affect up to 1 in 10 people):
Dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
Reduced potassium levels in the blood, anxiety, fainting (syncope), numbness, tingling sensation (paresthesia), vertigo, rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence (intestinal gas), back pain, muscle spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Lung inflammation (bronchitis), sore throat, sinusitis, increased uric acid levels in the blood, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disturbances, visual disturbances, blurred vision, breathing difficulties, abdominal pain, constipation, abdominal swelling (dyspepsia), feeling of malaise (vomiting), stomach inflammation (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucous membranes which may be fatal (angioedema, including fatal outcomes), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain (arthralgia) and pain in the extremities (leg pain), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, rash, and fever), flu-like illness, pain, increased blood levels of creatinine, liver enzymes, or creatine phosphokinase.
Adverse reactions reported with one of the individual components may also be potential adverse reactions with Telmisartan and Hydrochlorothiazide Alter, even if not observed in clinical studies with this product.
Telmisartan
In patients treated with telmisartan alone, the following additional side effects have been reported:
Uncommon side effects (may affect up to 1 in 100 people):
Upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, bladder infection, red blood cell deficiency (anemia), elevated potassium levels, slowed heart rate (bradycardia), cough, kidney impairment including acute renal failure, feeling of weakness.
Rare side effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (skin disease), drug rash, toxic skin eruption, arthralgia and tendon pain (symptoms similar to tendinitis), decreased hemoglobin (a blood protein).
Very rare side effects (may affect up to 1 in 10,000 people):
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.
Not known (frequency cannot be estimated from the available data):
Intestinal angioedema: following the use of similar products, swelling in the intestine has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Hydrochlorothiazide
In patients treated with hydrochlorothiazide alone, the following additional side effects have been reported:
Very common side effects (may affect more than 1 in 10 people):
Elevated blood lipid levels.
Common side effects (may affect up to 1 in 10 people):
Malaise (nausea), low magnesium levels in the blood, reduced appetite.
Uncommon side effects (may affect up to 1 in 100 people):
Acute renal failure.
Rare side effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), 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, elevated blood glucose levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reaction, uncontrolled blood glucose levels in patients diagnosed with diabetes mellitus, sugar in the urine (glucosuria).
Very rare side effects (may affect up to 1 in 10,000 people):
Abnormal destruction of red blood cells (hemolytic anemia), inability of the bone marrow to function properly, decreased white blood cells (leukopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity), increased pH due to low chloride levels in the blood (altered acid-base balance, hypochloremic alkalosis), acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion), inflammation of the pancreas, lupus-like syndrome (a condition similar to systemic lupus erythematosus, in which the immune system attacks the body itself), inflammation of blood vessels (necrotizing vasculitis).
Not known (frequency cannot be estimated from the available data):
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), deficiency of blood cells (aplastic anemia), restlessness, dizziness, sudden-onset reduction in distance vision (acute myopia), decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), stomach discomfort, skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight, skin rash, skin redness, blistering on lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, elevated cholesterol levels in the blood, reduced blood volume, increased blood lipid levels, kidney impairment.
Low sodium levels accompanied by symptoms related to the brain or nerves (malaise, progressive disorientation, lack of interest or energy) occur in isolated cases.
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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telmisartan and Hydrochlorothiazide Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Keep the tablets in the sealed blister to protect them from moisture. This medicine does not require any special storage temperature.
Do not dispose of any medicine 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 Telmisartan and Hydrochlorothiazide Alter contains
Telmisartan and Hydrochlorothiazide Alter 40 mg/12.5 mg

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol-polyethylene glycol copolymer, sodium starch glycolate, sorbitol, magnesium stearate, yellow iron oxide (E172).

Telmisartan and Hydrochlorothiazide Alter 80 mg/12.5 mg

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol-polyethylene glycol copolymer, sodium starch glycolate, sorbitol, magnesium stearate, red iron oxide (E172).

Telmisartan and Hydrochlorothiazide Alter 80 mg/25 mg

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol-polyethylene glycol copolymer, sodium starch glycolate, sorbitol, magnesium stearate, yellow iron oxide (E172).

Description of the appearance of Telmisartan and Hydrochlorothiazide Alter and package contents
Telmisartan and Hydrochlorothiazide Alter 40 mg/12.5 mg tablets are light yellow, round in shape,
without a breakline, approximately 11 mm in diameter.
Telmisartan and Hydrochlorothiazide Alter 80 mg/12.5 mg tablets are reddish in colour, oblong in shape,
without a breakline, 17 mm x 7.5 mm.
Telmisartan and Hydrochlorothiazide Alter 80 mg/25 mg tablets are light yellow, oblong in shape,
without a breakline, 17 mm x 7.5 mm.
Pack sizes
28 tablets in blister packs
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milan, Italy

Manufacturer
Laboratorios Alter, S.A., c/ Mateo Inurria, 30 - 28036 Madrid, Spain