Telmisartan and hydrochlorothiazide Mylan Pharma: detailed information

Patient Information Leaflet

Telmisartan and Hydrochlorothiazide Mylan Pharma 40 mg/12.5 mg tablets

telmisartan and hydrochlorothiazide, Telmisartan and Hydrochlorothiazide Mylan Pharma 80 mg/12.5 mg tablets
telmisartan and hydrochlorothiazide, Telmisartan and Hydrochlorothiazide Mylan Pharma 80 mg/25 mg tablets
telmisartan and hydrochlorothiazide
Generic medicine

Please read all of 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 pass it on to other people, even if they have the same symptoms as you, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Telmisartan and Hydrochlorothiazide Mylan Pharma is and what it is used for

Telmisartan and Hydrochlorothiazide Mylan Pharma is a combination of two active substances,
telmisartan and hydrochlorothiazide, in a single tablet. Both of these substances help control
high blood pressure.

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

If left untreated, high blood pressure can damage blood vessels in many organs, potentially leading to heart attack, heart or kidney failure, stroke or blindness. High blood pressure usually does not cause symptoms before such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
[For 40 mg/12.5 mg and 80 mg/12.5 mg]:
Telmisartan and Hydrochlorothiazide Mylan Pharma is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.
[For 80 mg/25 mg]:
Telmisartan and Hydrochlorothiazide Mylan Pharma is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with Telmisartan and Hydrochlorothiazide Mylan Pharma 80/12.5 mg, or in patients previously stabilized on telmisartan and hydrochlorothiazide given separately.

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

Do not take Telmisartan and Hydrochlorotiazide Mylan Pharma

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 using Telmisartan and Hydrochlorothiazide Mylan Pharma even during the early stages 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 finds that you have low levels of potassium or high levels of calcium in your blood that 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 any of the conditions listed above apply to you, inform your doctor or pharmacist before taking Telmisartan and Hydrochlorothiazide Mylan Pharma.

Warnings and precautions
Inform your doctor if you have or have ever 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 diseases.
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 called "lupus" or "SLE"), a disease in which the body's immune system attacks the body itself.
if you experience a decrease in vision or 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 a few hours to weeks after taking Telmisartan and Hydrochlorothiazide Mylan Pharma. If not treated, this condition may lead to permanent vision impairment. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.
Consult your doctor or pharmacist before taking Telmisartan and Hydrochlorothiazide Mylan Pharma:
if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly 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 Mylan Pharma".
if you are taking digoxin.
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 exposure and UV radiation while taking Telmisartan and Hydrochlorothiazide Mylan Pharma.
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 Mylan Pharma, 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 Mylan Pharma is not recommended in 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 section Pregnancy).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body.
Typical symptoms of fluid and electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally rapid heartbeat (over 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, with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than usual.
If you are undergoing surgery or receiving anaesthetics, inform your doctor that you are taking Telmisartan and Hydrochlorothiazide Mylan Pharma.
Telmisartan and Hydrochlorothiazide Mylan Pharma may be less effective in lowering blood pressure in black patients.
Children and adolescents
The use of Telmisartan and Hydrochlorothiazide Mylan Pharma in children and adolescents under 18 years of age is not recommended.
Other medicines and Telmisartan and Hydrochlorothiazide Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust the dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Telmisartan and Hydrochlorothiazide Mylan Pharma" and "Warnings and 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 Mylan Pharma:

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), and 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 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 (drugs used to treat a variety of 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 viral illnesses).
Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), and medicines for treating cancer, gout, or arthritis.
Digoxin.

Telmisartan and Hydrochlorothiazide Mylan Pharma may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines with potential blood pressure-lowering effects (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 consult your doctor if you need to adjust the dose of another medicine while taking Telmisartan and Hydrochlorothiazide Mylan Pharma.
The effect of Telmisartan and Hydrochlorothiazide Mylan Pharma may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen).
Telmisartan and Hydrochlorothiazide Mylan Pharma with food and drink
You may take Telmisartan and Hydrochlorothiazide Mylan Pharma 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 are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Telmisartan and Hydrochlorothiazide Mylan Pharma before becoming pregnant or as soon as you know you are pregnant and will recommend another medicine instead. Telmisartan and Hydrochlorothiazide Mylan Pharma is not recommended in 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 after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Telmisartan and Hydrochlorothiazide Mylan Pharma is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
Some patients may experience dizziness or fatigue while taking Telmisartan and Hydrochlorothiazide Mylan Pharma. If you experience these effects, do not drive or operate machinery.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Excipients:
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 Mylan Pharma

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Telmisartan and Hydrochlorothiazide Mylan Pharma is one tablet daily. Try to take the tablet at the same time each day. You may take Telmisartan and Hydrochlorothiazide Mylan Pharma with or without food. Swallow the tablets with a glass of water or another non-alcoholic drink. It is important to take Telmisartan and Hydrochlorothiazide Mylan Pharma every day unless your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg/12.5 mg per day must not be exceeded.

If you take more Telmisartan and Hydrochlorothiazide Mylan Pharma than you should
If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and a fast heartbeat. A 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 could lead to nausea, drowsiness, and muscle cramps and/or irregular heartbeat, particularly when used concomitantly with medications such as digitalis or certain antiarrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take Telmisartan and Hydrochlorothiazide Mylan Pharma
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 a forgotten dose.

If you have any doubts about how to use this medicine, ask 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 may be serious and require immediate medical treatment:
You must immediately contact your doctor if you experience any of the following symptoms:
Sepsis* (often called "blood infection"), a severe infection causing 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 are 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 ruled out for Telmisartan and Hydrochlorothiazide Mylan Pharma.
Possible side effects of Telmisartan and Hydrochlorothiazide Mylan Pharma:
Common side effects (may affect up to 1 in 10 people):
Dizziness
Uncommon side effects (may affect up to 1 in 100 people):
Low blood potassium levels, anxiety, fainting (syncope), numbness, tingling sensation (paraesthesia), sensation of spinning (vertigo), 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.
Rare side effects (may affect up to 1 in 1,000 people):
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), impaired vision, difficulty breathing, abdominal pain, constipation, swelling (dyspepsia), feeling unwell, stomach inflammation (gastritis), abnormal liver function (this side effect is more likely in Japanese patients), rapid swelling of the skin and mucous membranes which may also be fatal (fatal angioedema), skin redness (erythema), allergic reactions such as itching or skin rash, increased sweating, urticaria, joint pain (arthralgia) and limb pain, muscle cramps, flu-like illness, pain, increased uric acid levels, low sodium levels, increased creatinine, liver enzymes or creatine phosphokinase in blood.
Adverse reactions reported with each individual component may also be potential adverse reactions associated with Telmisartan and Hydrochlorothiazide Mylan Pharma, even if they have not been 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, reduced red blood cells (anaemia), high potassium levels, slow heartbeat (bradycardia), kidney damage including acute renal failure, weakness, cough.
Rare side effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), increase in certain types of white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach disorder, skin disorders (including eczema, drug rash, toxic skin rash), osteoarthritis, tendon inflammation, reduced haemoglobin (a blood protein), drowsiness.
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 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 reported:
Common side effects (may affect up to 1 in 10 people):
Malaise (nausea), low blood magnesium levels.
Rare side effects (may affect up to 1 in 1,000 people):
Reduced platelet count, increasing the risk of bleeding or bruising (small purple-red spots on the skin or other tissues due to bleeding), high blood calcium levels, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increased pH (altered acid-base balance) due to low blood chloride levels.
Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Inflammation of the salivary glands, reduced number (or even absence) of blood cells, including low 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, sudden onset of reduced distance vision (acute myopia), decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), pancreatitis, stomach disorder, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition resembling 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, skin redness, blistering of lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney inflammation or altered kidney function, glucose in urine (glycosuria), fever, disturbed electrolyte balance, 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 fat levels, skin and lip cancer (non-melanoma skin cancer).
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 the following website:
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 Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack
after Exp. The expiry date refers to the last day of that month.
[ For Al/Al blisters ] :
This medicine requires no special storage conditions.
[ For Al/PVDC Tristar 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. Pack contents and other information

What Telmisartan and Hydrochlorothiazide Mylan Pharma contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other components are: magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium carboxymethylstarch (type A), microcrystalline cellulose, mannitol (E421)

Description of the appearance of Telmisartan and Hydrochlorothiazide Mylan Pharma and contents of the pack
Telmisartan and Hydrochlorothiazide Mylan Pharma 40 mg/12.5 mg tablets are white or almost white, oval, biconvex tablets, 6.55x13.6 mm, with "TH" imprinted on one side.
Telmisartan and Hydrochlorothiazide Mylan Pharma 80 mg/12.5 mg tablets are white or almost white, capsule-shaped, biconvex tablets, 9.0x17.0 mm, with "TH 12.5" imprinted on both sides.
Telmisartan and Hydrochlorothiazide Mylan Pharma 80 mg/25 mg tablets are white or almost white, oval, biconvex tablets, 9.0x17.0 mm, with "TH" imprinted on one side and "25" on the other side.
Pack sizes
Blister packs: 28 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturers
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta