TELMISARTAN 40 mg /12.5 Mg Coated Tablet

Зміст інструкції

1. Telmisartan and Hydrochlorothiazide Mylan Pharma 40 mg/12.5 mg tablets
   1. What is Telmisartan and Hydrochlorothiazide Mylan Pharma and what is it used for
   2. What you need to know before taking Telmisartan and Hydrochlorothiazide Mylan Pharma
   3. How to take Telmisartan and Hydrochlorothiazide Mylan Pharma
   4. Possible side effects
   5. How to store Telmisartan and Idroclorotiazide Mylan Pharma
   6. Package Contents and Other Information

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
Read this leaflet carefully before taking this medicine as 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Telmisartan and Hydrochlorothiazide Mylan Pharma is and what it is used for
• 2. What you need to know before you take Telmisartan and Hydrochlorothiazide Mylan Pharma
• 3. How to take Telmisartan and Hydrochlorothiazide Mylan Pharma
• 4. Possible side effects
• 5. How to store Telmisartan and Hydrochlorothiazide Mylan Pharma
• 6. Contents of the pack and other information

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

Telmisartan and Hydrochlorothiazide Mylan Pharma is a combination of two active ingredients,
telmisartan and hydrochlorothiazide, in one tablet. Both of these substances help to 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 narrowing of the blood vessels, thus increasing blood pressure. Telmisartan blocks the effect of angiotensin II, causing relaxation of the blood vessels and thus reducing blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause an increase in urine flow with a consequent lowering of blood pressure.

High blood pressure, if left untreated, can damage blood vessels in many organs,
this can sometimes lead to heart attack, heart or kidney failure, stroke or blindness. Normally,
high blood pressure does not give symptoms before such damage occurs. Therefore, it is
important to have your blood pressure checked regularly to verify
if 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 totreat high blood pressure
(essential hypertension) in adults whose blood pressure is not sufficiently controlled
when telmisartan is used alone.

[For 80 mg/25 mg]:

Telmisartan and Hydrochlorothiazide Mylan Pharma is used totreat 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 by telmisartan and hydrochlorothiazide administered separately.

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

Do not take Telmisartan and Hydrochlorothiazide Mylan Pharma

• 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 any other medicine derived from sulfonamide
• If you are pregnant for more than 3 months (it is best to avoid using Telmisartan and Hydrochlorothiazide Mylan Pharma even during the early stages of pregnancy - see the Pregnancy section)
• If you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease
• If you have a severe kidney disease
• If your doctor determines that you have low potassium levels or high calcium levels in the blood that do not improve with treatment
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren. If any of the above conditions apply to you, tell your doctor or pharmacist before taking Telmisartan and Hydrochlorothiazide Mylan Pharma.

Warnings and precautions
Tell your doctor if you suffer from or have ever suffered from any of the following conditions or
diseases:

• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver diseases.
• Heart problems.
• Diabetes.
• Gout.
• Increased levels of aldosterone (retention of water and salt in the body 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 the body itself.
• if you have decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Telmisartan and Hydrochlorothiazide Mylan Pharma. If not

treated, this condition can 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” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes
• aliskiren The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Telmisartan and Hydrochlorothiazide Mylan Pharma”.
• if you are taking digoxin.
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Telmisartan and Hydrochlorothiazide Mylan Pharma.
• if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Telmisartan and Hydrochlorothiazide Mylan Pharma, see a doctor immediately.

You must tell 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
at the beginning of pregnancy and should not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if taken during this period (see the Pregnancy section).
Treatment with hydrochlorothiazide can cause an electrolyte imbalance in your body.
Typical symptoms of electrolyte imbalance include dry mouth, weakness, lethargy,
drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting,
muscle fatigue and an abnormally fast heartbeat (more than 100 beats per
minute). If you experience any of these symptoms, tell your doctor.
You should also tell your doctor if you have noticed increased sensitivity of the skin to the sun with
symptoms of sunburn (such as redness, itching, swelling, blistering) that occur
more quickly than usual.
In case of surgery or administration of anesthetics, you must inform your doctor
that you are taking Telmisartan and Hydrochlorothiazide Mylan Pharma.
Telmisartan and Hydrochlorothiazide Mylan Pharma may be less effective in reducing blood
pressure in black patients.

Children and adolescents
The use of Telmisartan and Hydrochlorothiazide Mylan Pharma in children and adolescents up to 18
years of age is not recommended.

Other medicines and Telmisartan and Hydrochlorothiazide Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the section “Do not take Telmisartan and Hydrochlorothiazide Mylan Pharma” and “Warnings and precautions”).

In some cases, it may be necessary to stop taking one of these medicines. This applies especially to the medicines listed below, taken at the same time as Telmisartan
and Hydrochlorothiazide Mylan Pharma:

• Medicines containing lithium to treat 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 (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used for the treatment of mouth ulcers), sodium penicillin G (an antibiotic) and salicylic acid and its derivatives.
• Medicines that can increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (an immunosuppressant medicine) and other medicines such as sodium heparin (anticoagulant).
• Medicines that are affected by changes in potassium levels in the blood such as medicines for the heart (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 the treatment of allergic reactions (e.g. terfenadine).
• Medicines for the treatment of diabetes (insulin or oral agents such as metformin).
• Cholestyramine and colestipol, medicines to lower cholesterol levels.
• Medicines to increase blood pressure, such as norepinephrine.
• Medicines that relax the muscles, 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 to anesthesia), such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson's disease and also used to treat or prevent diseases caused by viruses).
• Other medicines used to treat high blood pressure, corticosteroids, pain relievers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for cancer, gout or arthritis.
• Digoxin.

Telmisartan and Hydrochlorothiazide Mylan Pharma can increase the effect of reducing
blood pressure of other medicines used to treat high blood pressure or
of medicines with a potential blood pressure lowering effect (e.g. baclofen, amifostine).
In addition, low blood pressure can be worsened by alcohol, barbiturates, narcotics or
antidepressants. You may notice this in the form of dizziness when getting up. You should
consult your doctor if you need to adjust the dose of the other medicine while taking
Telmisartan and Hydrochlorothiazide Mylan Pharma.
The effect of Telmisartan and Hydrochlorothiazide Mylan Pharma may be reduced when you take
NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen).

Telmisartan and Hydrochlorothiazide Mylan Pharma with food and drink
You can take Telmisartan and Hydrochlorothiazide Mylan Pharma with or without food.
Avoid drinking alcohol before talking to your doctor. Alcohol can further reduce
blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking
Telmisartan and Hydrochlorothiazide Mylan Pharma before starting pregnancy or as soon as
you become aware of being pregnant and will advise you to take another
medicine instead of Telmisartan and Hydrochlorothiazide Mylan Pharma. Telmisartan and
Hydrochlorothiazide Mylan Pharma is not recommended at the beginning of pregnancy and should not be
taken if you are pregnant for more than 3 months as it may cause serious harm to the
baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Telmisartan and
Hydrochlorothiazide Mylan Pharma is not recommended for mothers who are breastfeeding and
your doctor may choose another treatment for you if you wish to breastfeed.

Driving and using machines
Some patients may experience dizziness or fatigue while taking Telmisartan and
Hydrochlorothiazide Mylan Pharma. If these effects occur, do not drive or use machines.
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.
Excipients:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially ‘sodium-free’.

3. How to take Telmisartan and Hydrochlorothiazide Mylan Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose of Telmisartan and Hydrochlorothiazide Mylan Pharma is one tablet a
day. Try to take the tablet every day at the same time. You can take Telmisartan and
Hydrochlorothiazide Mylan Pharma with or without food. The tablets must be swallowed with a
little water or other non-alcoholic beverage. It is important to take Telmisartan and Hydrochlorothiazide
Mylan Pharma every day until your doctor tells you otherwise.
If your liver is not functioning properly, you should not exceed the usual dose of 40
mg/12.5 mg per day.

If you take more Telmisartan and Hydrochlorothiazide Mylan Pharma than you should
If you have accidentally taken too many tablets, you may experience symptoms such as low
blood pressure and a 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 and muscle cramps and/or
irregular heartbeat associated with the concomitant use of drugs such as digoxin or certain
antiarrhythmic treatments. Contact your doctor, pharmacist, or the emergency room of the
nearest hospital immediately.

If you forget to take Telmisartan and Hydrochlorothiazide Mylan Pharma
If you forget to take the medicine, do not worry. Take it as soon as you remember,
then continue as before. If you miss a dose for one day, take the normal dose the next
day. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask 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 attention:
You should seek immediate medical attention if you experience any of the following symptoms:
Sepsis* (often called “blood infection”), is a serious infection with inflammatory response of the entire organism, rapid swelling of the skin and mucous membranes (angioedema);
appearance of blisters and peeling of the outermost 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 a doctor immediately. If these effects
are not treated they can be fatal. An increased incidence of sepsis has been observed with
telmisartan alone, however it cannot be excluded 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):
Reduced levels of potassium in the blood, anxiety, fainting (syncope), sensation of numbness,
sensation of tingling (paresthesia), sensation of spinning (vertigo), fast heartbeat
(tachycardia), heart rhythm disorders, low blood pressure, sudden drop in
blood pressure when getting up, shortness of breath (dyspnea), diarrhea, 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):
Inflammation of the lungs (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), impaired vision, difficulty
breathing, abdominal pain, constipation, bloating (dyspepsia), feeling unwell,
inflammation of the stomach (gastritis), abnormal liver function (Japanese
patients are more likely to experience this side effect), rapid swelling of
the skin and mucous membranes which can also be fatal (angioedema with fatal outcome),
redness of the skin (erythema), allergic reactions such as itching or rash,
increased sweating, hives, joint pain (arthralgia) and pain in the extremities, muscle cramps,
flu-like illness, pain, increased levels of uric acid, low levels of
sodium, increased levels of creatinine, liver enzymes or creatine phosphokinase in the blood.
Adverse reactions reported with each of the individual components may 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
The following additional side effects have been reported in patients treated with telmisartan alone:
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, decreased red blood cells (anemia), high levels of potassium, slow heartbeat (bradycardia), kidney damage including acute renal failure, weakness,
cough.
Rare side effects (may affect up to 1 in 1,000 people):
Low number of platelets (thrombocytopenia), increase in some types of white blood cells
(eosinophilia) severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach upset,
skin disorders (including eczema, drug rash, toxic skin rash), osteoarthritis,
inflammation of the tendons, reduced hemoglobin (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 may be related to a currently unknown mechanism.
** Cases of progressive scarring of
lung tissue have been reported during the intake of telmisartan. 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 side effects (may affect up to 1 in 10 people):
Feeling unwell (nausea), low level of magnesium in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Reduction of platelets, which increases the risk of bleeding or bruising (small
purple-red spots on the skin or other tissues caused by bleeding), high level of calcium in the
blood, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increased pH (altered acid-base balance) due to a low level of chlorine in the blood.
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion).
Side effects with unknown frequency (frequency cannot be estimated based on
available data):
Inflammation of the salivary glands, reductions in the number (or even absence) of blood cells, including low number of red blood cells and white blood cells, severe allergic reactions (e.g.
hypersensitivity, anaphylactic reaction), loss or decrease of appetite, restlessness, dizziness,
blurred or yellowish vision, rapid onset of distance vision impairment (acute myopia
acute), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), or acute angle-closure glaucoma
acute), inflammation of blood vessels (necrotizing vasculitis),
inflammation of the pancreas, stomach upset, yellowing of the skin or eyes
(jaundice), lupus-like syndrome (a condition similar to a disease called systemic lupus
erythematosus in which the immune system attacks the body itself); skin disorders
such as inflammation of the blood vessels of the skin, increased sensitivity to sunlight,
rash, redness of the skin, formation of blisters on lips, eyes or
mouth, peeling of the skin, fever (possible signs of erythema multiforme), feeling of
weakness, inflammation of the kidneys or altered kidney function, glucose in the urine
(glycosuria), fever, compromised electrolyte balance, high levels of cholesterol in the blood,
reduced blood volume, increased glucose levels in the blood, difficulty controlling
blood glucose/urine glucose levels in patients diagnosed with diabetes mellitus, or fats
in the blood, skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through 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 Idroclorotiazide Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package or blister
after Exp. The expiry date refers to the last day of that month.
[ For Al/Al blisters] :
This medicine does not require any special storage conditions.
[ For Al/PVDC Tristar blisters] :
Do not store at a temperature above 30 °C.
Do not dispose of any medicine in waste water 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 Mylan Pharma contains

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The active ingredients 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 carboxymethylcellulose (type A), microcrystalline cellulose, mannitol (E421)

Description of the appearance of Telmisartan and Hydrochlorothiazide Mylan Pharma and package contents
Telmisartan and Hydrochlorothiazide Mylan Pharma 40 mg/12.5 mg tablets are white or almost white tablets, 6.55x13.6 mm, oval and biconvex in shape, with “TH” imprinted on one side.
Telmisartan and Hydrochlorothiazide Mylan Pharma 80 mg/12.5 mg tablets are white or almost white tablets, 9.0x17.0 mm, capsule-shaped, with “TH 12.5” imprinted on both sides.
Telmisartan and Hydrochlorothiazide Mylan Pharma 80 mg/25 mg tablets are white or almost white tablets, 9.0x17.0 mm, oval and biconvex in shape, with “TH” imprinted on one side and “25” on the other side.

Packs
Blisters: 28 tablets
Not all pack sizes may be marketed.

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

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