Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Telmisartan; Hydrochlorothiazide
Available from:
Accord Healthcare Ireland Ltd.
ATC code:
C09DA; C09DA07
INN (International Name):
Telmisartan; Hydrochlorothiazide
Dosage:
40 mg / 12.5 milligram(s)
Pharmaceutical form:
Tablet
Therapeutic area:
Angiotensin II antagonists and diuretics; telmisartan and diuretics
Authorization status:
Not marketed
Authorization number:
PA2315/015/001
Authorization date:
2019-08-02

Package leaflet: Information for the user

Telmisartan/ Hydrochlorothiazide 80 mg/12.5 mg tablets

telmisartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Telmisartan/ Hydrochlorothiazide is and what it is used for

What you need to know before you take Telmisartan/ Hydrochlorothiazide

How to take Telmisartan/ Hydrochlorothiazide

Possible side effects

How to store Telmisartan/ Hydrochlorothiazide

Contents of the pack and other information

1.

What Telmisartan/ Hydrochlorothiazide is and what it is used for

Telmisartan/ Hydrochlorothiazide is a combination of two active substances, 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 your body which causes your blood vessels to narrow

thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the

blood vessels relax, and your blood pressure is lowered.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your

urine output to increase, leading to a lowering of your blood pressure.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead

sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms

of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure

to verify if it is within the normal range.

Telmisartan/ Hydrochlorothiazide is used to

treat high blood pressure (essential hypertension) in

adults whose blood pressure is not controlled enough when telmisartan is used alone.

2.

What you need to know before you take Telmisartan/ Hydrochlorothiazide

Do not take Telmisartan/ Hydrochlorothiazide

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 any other sulfonamide-derived medicines.

if you are more than 3 months pregnant. (It is also better to avoid Telmisartan/

Hydrochlorothiazide in early pregnancy – see pregnancy section).

if you have severe liver problems such as cholestasis or biliary obstruction (problems with

drainage of the 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 levels or high calcium levels in your

blood that do not get better with treatment.

if you have diabetes or impaired kidney function and you are treated with a blood pressure

lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan/

Hydrochlorothiazide.

Warnings and precautions

Talk to your doctor before taking Telmisartan/ Hydrochlorothiazide if you are suffering or have ever

suffered from any of the following conditions or illnesses:

Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body

water) or have salt deficiency due to diuretic therapy (water tablets), 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 disease.

Heart trouble.

Diabetes.

Gout.

Raised aldosterone levels (water and salt retention in the body along with imbalance of various

blood minerals).

Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body’s

immune system attacks the body.

If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.

Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase

the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin

from sun exposure and UV rays while taking Telmisartan/ Hydrochlorothiazide.

The active substance hydrochlorothiazide can cause an unusual reaction, resulting in a decrease

in vision and eye pain. These could be symptoms of fluid accumulation in the vascular layer of

the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours

to weeks of taking Telmisartan/ Hydrochlorothiazide. This can lead to permanent vision

impairment, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can

be at higher risk of developing this.

Talk to your doctor before taking Telmisartan/ Hydrochlorothiazide if you are taking:

any of the following medicines used to treat high blood pressure:

an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have

diabetes-related kidney problems.

aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes

(e.g. potassium) in your blood at regular intervals. See also information under the heading “Do

not take Telmisartan/ Hydrochlorothiazide”.

digoxin.

You must tell your doctor if you think you are (or might become) pregnant. Telmisartan/

Hydrochlorothiazide 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 your baby if used at that stage (see pregnancy

section).

Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms

of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness,

muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart

rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor.

You should also tell your doctor if you experience an increased sensitivity of the skin to the sun with

symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than

normal.

In case of surgery or anaesthetics, you should tell your doctor that you are taking Telmisartan/

Hydrochlorothiazide.

Telmisartan/ Hydrochlorothiazide may be less effective in lowering the blood pressure in black

patients.

Children and adolescents

The use of Telmisartan/ Hydrochlorothiazide in children and adolescents up to the age of 18 years is

not recommended.

Other medicines and Telmisartan/ Hydrochlorothiazide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. Your doctor may need to change the dose of these other medications or take other

precautions. In some cases you may have to stop taking one of the medicines. This applies especially

to the medicines listed below taken at the same time with Telmisartan/ Hydrochlorothiazide:

Lithium containing medicines to treat some types of depression.

Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, (“water

tablets”), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone),

amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G

sodium (an antibiotic), and salicylic acid and derivatives.

Medicines that may increase blood potassium levels such as potassium-sparing diuretics,

potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an

immunosuppressant drug) and other medicinal products such as heparin sodium (an

anticoagulant)

Medicines that are affected by changes of the blood potassium level such as heart medicines

(e.g. digoxin) or medicines to control the rhythm of your heart (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. sparfloxacine,

pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine).

Medicines for the treatment of diabetes (insulins or oral agents such as metformin).

Cholestyramine and colestipol, medicines for lowering blood fat levels.

Medicines to increase blood pressure, such as noradrenaline.

Muscle relaxing medicines, such as tubocurarine.

Calcium supplements and/or vitamin D supplements.

Anti-cholinergic medicines (medicines used to treat a variety of disorders such as

gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms,

Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden.

Amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain

illnesses caused by viruses).

Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-

steroidal anti-inflammatory drugs [NSAIDs]), medicines to treat

cancer, gout, or arthritis.

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not

take Telmisartan/ Hydrochlorothiazide” and “Warnings and precautions”).

Digoxin.

Telmisartan/ Hydrochlorothiazide may increase the blood pressure lowering effect of other medicines

used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen,

amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or

antidepressants. You may notice this as dizziness when standing up. You should consult with your

doctor if you need to adjust the dose of your other medicine while taking Telmisartan/

Hydrochlorothiazide.

The effect of Telmisartan/ Hydrochlorothiazide may be reduced when you take NSAIDs (non steroidal

anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen).

Telmisartan/ Hydrochlorothiazide with food and alcohol

You can take Telmisartan/ Hydrochlorothiazide with or without food.

Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall

more and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally

advise you to stop taking Telmisartan/ Hydrochlorothiazide before you become pregnant or as soon as

you know you are pregnant and will advise you to take another medicine instead of Telmisartan/

Hydrochlorothiazide. Telmisartan/ Hydrochlorothiazide is not recommended during pregnancy, and

must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if

used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan/

Hydrochlorothiazide is not recommended for mothers who are breast-feeding and your doctor may

choose another treatment for you if you wish to breast-feed.

Driving and using machines

Some people feel dizzy or tired when taking Telmisartan/ Hydrochlorothiazide. If you feel dizzy or

tired, do not drive or operate machinery.

Telmisartan/ Hydrochlorothiazide contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-

free”.

3.

How to take Telmisartan/ Hydrochlorothiazide

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended dose Telmisartan/ Hydrochlorothiazideis one tablet a day. Try to take the tablet at

the same time each day. You can take Telmisartan/ Hydrochlorothiazide with or without food. The

tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take

Telmisartan/ Hydrochlorothiazide every day until your doctor tells you otherwise.

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

If you take more Telmisartan/ Hydrochlorothiazide 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, reduced kidney function including kidney

failure, have also been reported. Due to the hydrochlorothiazide component, markedly low blood

pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness

and muscle cramps and/or irregular heartbeat associated with the concomitant use of medicinal

products such as digitalis or certain anti-arrhythmic treatments. Contact your doctor, pharmacist, or

your nearest hospital emergency department immediately.

If you forget to take Telmisartan/ Hydrochlorothiazide

If you forget to take a dose, do not worry. Take it as soon as you remember, then carry on as before. If

you do not take your tablet on one day, take your normal dose on 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called “blood poisoning”), is a severe infection with whole-body inflammatory

response, rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer

of 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 and patients should stop

taking the medicine and see their doctor immediately. If these effects are not treated they could be

fatal. Increased incidence of sepsis has been observed with telmisartan only, however it can not be

ruled out for Telmisartan/ Hydrochlorothiazide.

Possible side effects of Telmisartan/ Hydrochlorothiazide:

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

Dizziness

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

Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles

(paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low

blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea),

diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability

to get or keep an erection), chest pain, increased blood uric acid levels.

Rare (may affect up to 1 in 1000 people):

Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a

disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and

fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia),

impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick

(vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are

more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as

itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities,

muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic

enzymes or creatine phosphokinase in the blood.

Adverse reactions reported with one of the individual components may be potential adverse reactions

with Telmisartan/ Hydrochlorothiazide, even if not observed in clinical trials with this product.

Telmisartan

In patients taking telmisartan alone the following additional side effects have been reported:

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

Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract

infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate

(bradycardia), kidney impairment including acute kidney failure, weakness, cough.

Rare (may affect up to 1 in 1000 people):

Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious

allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in

diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons,

decreased haemoglobin (a blood protein), somnolence.

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

Progressive scarring of lung tissue (interstitial lung disease)**

*The event may have happened by chance or could be related to a mechanism currently not known.

**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.

However, it is not known whether telmisartan was the cause.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone the following additional side effects have been reported:

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

Feeling sick (nausea), low blood magnesium level.

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

Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in

skin or other tissue caused by bleeding), high blood calcium level, headache.

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

Increased pH (disturbed acid-base balance) due to low blood chloride level.

Not known (frequency cannot be estimated from the available data):

Skin and lip cancer (Non-melanoma skin cancer), inflammation of the salivary gland, decreases in the

number (or even lack) of cells in the blood, including low red and white blood cell count, serious

allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite,

restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain due to

high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal

effusion), acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis

necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like

syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body’s

immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased

sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling,

fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney

function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol

levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/

urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie,

E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Telmisartan/ Hydrochlorothiazide

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 carton, blister or bottle label after

“EXP”. The expiry date refers to the last day of that month.

For Al/Al blisters and HDPE tablet container

This medicine does not require any special storage conditions.

For Al/PVC/PVDC blister

Do not store above 30ºC.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Telmisartan/ Hydrochlorothiazide contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg

telmisartan and 12.5 mg hydrochlorothiazide.

The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine,

povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).

What Telmisartan/ Hydrochlorothiazide looks like and contents of the pack

Telmisartan/ Hydrochlorothiazide 80 mg/12.5 mg tablets are white or almost white, 9.0 x 17.0 mm

capsule-shaped tablets marked with “TH 12.5” on both sides.

Pack sizes

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

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

Tablet containers: 30, 90 and 250 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Ireland Limited

Euro House

Euro Business Park

Little Island

Cork

T45 K857

Ireland

Manufacturer

Actavis Ltd

BLB016

Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This medicinal product is authorised in the Member States of the EEA under the following

names:

Ireland

Telmisartan/ Hydrochlorothiazide 80 mg/12.5 mg Tablets

United Kingdom

Telmisartan/ Hydrochlorothiazide 80 mg/12.5 mg Tablets

This leaflet was last revised in May 2020.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.

Excipients with known effect:

Telmisartan Hydrochlorothiazide 40 mg/12.5 mg tablets:

Each tablet contains 0.74 mg of sodium

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet.

Telmisartan Hydrochlorothiazide 40 mg/12.5 mg tablets are white or almost white, 6.55 x 13.6 mm oval‑shaped and biconvex

tablets marked with TH on one side.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Treatment of essential hypertension.

Telmisartan Hydrochlorothiazide fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in

adults whose blood pressure is not adequately controlled on telmisartan alone.

4.2 Posology and method of administration

Posology

Telmisartan Hydrochlorothiazide should be taken in patients whose blood pressure is not adequately controlled by telmisartan

alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose

combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.

- Telmisartan Hydrochlorothiazide 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not

adequately controlled by telmisartan 40 mg.

Special populations:

Patients with renal impairment

Periodic monitoring of renal function is advised (see section 4.4).

Patients with hepatic impairment

In patients with mild to moderate hepatic impairment the posology should not exceed Telmisartan Hydrochlorothiazide

40 mg/12.5 mg once daily. Telmisartan Hydrochlorothiazide is not indicated in patients with severe hepatic impairment.

Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).

Elderly patients

No dose adjustment is necessary.

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Paediatric population

The safety and efficacy of Telmisartan Hydrochlorothiazide in children and adolescents aged below 18 have not been

established. No data are available.

Method of administration

Telmisartan Hydrochlorothiazide tablets are for once‑daily oral administration and should be taken with liquid, with or without

food.

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

- Hypersensitivity to other sulphonamide‑derived substances (since hydrochlorothiazide is a sulphonamide‑derived medicinal

product).

- Second and third trimesters of pregnancy (see sections 4.4 and 4.6).

- Cholestasis and biliary obstructive disorders.

- Severe hepatic impairment.

- Severe renal impairment (creatinine clearance <30 ml/min).

- Refractory hypokalaemia, hypercalcaemia.

The concomitant use of Telmisartan Hydrochlorothiazide with aliskiren‑containing products is contraindicated in patients with

diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m

) (see sections 4.5 and 5.1).

4.4 Special warnings and precautions for use

Pregnancy

Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor

antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive

treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with

angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started

(see sections 4.3 and 4.6).

Hepatic impairment

Telmisartan Hydrochlorothiazide should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic

insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile. These patients can be expected to have

reduced hepatic clearance for telmisartan.

In addition, Telmisartan Hydrochlorothiazide should be used with caution in patients with impaired hepatic function or

progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. There is no

clinical experience with Telmisartan Hydrochlorothiazide in patients with hepatic impairment.

Renovascular hypertension

There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or

stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the

renin-angiotensin-aldosterone system.

Renal impairment and kidney transplantation

Telmisartan Hydrochlorothiazide must not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min)

(see section 4.3). There is no experience regarding the administration of Telmisartan Hydrochlorothiazide in patients with

recent kidney transplantation. Experience with Telmisartan Hydrochlorothiazide is modest in the patients with mild to

moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.

Thiazide diuretic associated azotaemia may occur in patients with impaired renal function.

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Intravascular hypovolaemia

Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by

vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the

administration of Telmisartan Hydrochlorothiazide.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

There is evidence that the concomitant use of ACE‑inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of

hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the

combined use of ACE‑inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5

and 5.1).

If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to

frequent close monitoring of renal function, electrolytes and blood pressure.

ACE‑inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Other conditions with stimulation of the renin-angiotensin-aldosterone system

In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone

system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment

with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely

acute renal failure (see section 4.8).

Primary aldosteronism

Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through

inhibition of the renin-angiotensin system. Therefore, the use of Telmisartan Hydrochlorothiazide is not recommended.

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy

As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive

hypertrophic cardiomyopathy.

Metabolic and endocrine effects

Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients under insulin or

antidiabetic therapy and telmisartan treatment. Therefore, in these patients blood glucose monitoring should be considered; a

dose adjustment of insulin or antidiabetics may be required, when indicated. Latent diabetes mellitus may become manifest

during thiazide therapy.

An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg

dose contained in Telmisartan Hydrochlorothiazide, minimal or no effects were reported. Hyperuricaemia may occur or frank

gout may be precipitated in some patients receiving thiazide therapy.

Electrolyte imbalance

As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate

intervals.

Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and

hypochloraemic alkalosis). Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, asthenia, lethargy,

drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal

disturbances such as nausea or vomiting (see section 4.8).

- Hypokalaemia

Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce

diuretic‑induced hypokalaemia. The risk of hypokalaemia is greater in patients with cirrhosis of liver, in patients experiencing

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brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy

with corticosteroids or Adrenocorticotropic hormone (ACTH) (see section 4.5).

- Hyperkalaemia

Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Telmisartan

Hydrochlorothiazide, hyperkalaemia might occur. Although clinically significant hyperkalaemia has not been documented with

Telmisartan Hydrochlorothiazide, risk factors for the development of hyperkalaemia include renal insufficiency and/or heart

failure, and diabetes mellitus. Potassium‑sparing diuretics, potassium supplements or potassium‑containing salt substitutes

should be co‑administered cautiously with Telmisartan Hydrochlorothiazide (see section 4.5).

- Hyponatraemia and hypochloraemic alkalosis

There is no evidence that Telmisartan Hydrochlorothiazide would reduce or prevent diuretic‑induced hyponatraemia. Chloride

deficit is generally mild and usually does not require treatment.

- Hypercalcaemia

Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the

absence of known disorders of calcium metabolism. Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.

Thiazides should be discontinued before carrying out tests for parathyroid function.

- Hypomagnesaemia

Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia (see

section 4.5).

Non-melanoma skin cancer

An increased risk of non-melanoma skin cancer(NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] within

creasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has beenobserved in two epidemiological studies based on

the Danish National CancerRegistry. Photosensitizing actions of HCTZ could act as a possible mechanismfor NMSC.

Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions

andpromptly report any suspicious skin lesions. Possible preventive measures suchas limited exposure to sunlight and UV rays

and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk ofskin cancer.

Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of

HCTZ may also needto be reconsidered in patients who have experienced previous NMSC (see alsosection 4.8).

Ethnic differences

As with all other angiotensin II receptor antagonists, telmisartan is apparently less effective in lowering blood pressure in black

patients than in non blacks, possibly because of higher prevalence of low renin states in the black hypertensive population.

Other

As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic

cardiovascular disease could result in a myocardial infarction or stroke.

General

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma,

but are more likely in patients with such a history. Exacerbation or activation of systemic lupus erythematosus has been

reported with the use of thiazide diuretics, including hydrochlorothiazide.

Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8). If a photosensitivity reaction

occurs during treatment, it is recommended to stop the treatment. If a re‑administration of the diuretic is deemed necessary, it

is recommended to protect exposed areas to the sun or to artificial UVA.

Choroidal effusion, acute myopia and secondary angle-closure glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal effusionwith visual field defect,

acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular

pain and typically occur within hours to weeks of telmisartan hydrochlorothiazide initiation. Untreated acute angle-closure

glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.

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Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors

for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Excipient Warning:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free.

4.5 Interaction with other medicinal products and other forms of interactions

Lithium

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of

lithium with angiotensin converting enzyme inhibitors. Rare cases have also been reported with angiotensin II receptor

antagonists (including Telmisartan Hydrochlorothiazide). Co‑administration of lithium and Telmisartan Hydrochlorothiazide is

not recommended (see section 4.4). If this combination proves essential, careful monitoring of serum lithium level is

recommended during concomitant use.

Medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, corticosteroids,

ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives)

If these substances are to be prescribed with the hydrochlorothiazide‑telmisartan combination, monitoring of potassium

plasma levels is advised. These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see

section 4.4).

Medicinal products that may increase potassium levels or induce hyperkalaemia (e.g. ACE inhibitors, potassium‑sparing

diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as

heparin sodium).

If these medicinal products are to be prescribed with the hydrochlorothiazide‑telmisartan combination, monitoring of

potassium plasma levels is advised. Based on the experience with the use of other medicinal products that blunt the

renin-angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is,

therefore, not recommended (see section 4.4).

Medicinal products affected by serum potassium disturbances

Periodic monitoring of serum potassium and ECG is recommended when Telmisartan Hydrochlorothiazide is administered with

medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following

torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing

factor to torsades de pointes.

- class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide)

- class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide)

- some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride,

amisulpride, tiapride, pimozide, haloperidol, droperidol)

- others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, sparfloxacine, terfenadine,

vincamine IV)

Digitalis glycosides

Thiazide‑induced hypokalaemia or hypomagnesaemia favours the onset of digitalis‑induced arrhythmia (see section 4.4).

Digoxin

When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in

trough concentration (20%) were observed. When initiating, adjusting, and discontinuing telmisartan, monitor digoxin levels in

order to maintain levels within the therapeutic range.

Other antihypertensive agents

Telmisartan may increase the hypotensive effect of other antihypertensive agents.

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Clinical trial data has shown that dual blockade of the renin‑angiotensin-aldosterone‑system (RAAS) through the combined

use of ACE‑inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such

as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single

RAAS‑acting agent (see sections 4.3, 4.4 and 5.1).

Antidiabetic medicinal products (oral agents and insulin)

Dose adjustment of the antidiabetic medicinal products may be required (see section 4.4).

Metformin

Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional renal failure linked to

hydrochlorothiazide.

Cholestyramine and colestipol resins

Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.

Non‑steroidal anti‑inflammatory medicinal products (NSAIDs)

NSAIDs (i.e. acetylsalicylic acid at anti‑inflammatory dose regimens, COX‑2 inhibitors and non‑selective NSAIDs) may reduce

the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II

receptor antagonists.

In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal

function) the co‑administration of angiotensin II receptor antagonists and agents that inhibit cyclo‑oxygenase may result in

further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore the

combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and

consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically

thereafter.

In one study the co‑administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC

0-24

and C

ramipril and ramiprilat. The clinical relevance of this observation is not known.

Pressor amines (e.g. noradrenaline)

The effect of pressor amines may be decreased.

Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine)

The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.

Medicinal products used in the treatment for gout (e.g. probenecid, sulfinpyrazone and allopurinol)

Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric

acid. Increase in dose of probenecid or sulfinpyrazone may be necessary. Co‑administration of thiazide may increase the

incidence of hypersensitivity reactions of allopurinol.

Calcium salts

Thiazide diuretics may increase serum calcium levels due to the decreased excretion. If calcium supplements or calcium sparing

medicinal products (e.g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dose

adjusted accordingly.

Beta‑blockers and diazoxide

The hyperglycaemic effect of beta‑blockers and diazoxide may be enhanced by thiazides.

Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide‑type diuretics by decreasing

gastrointestinal motility and stomach emptying rate.

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Amantadine

Thiazides may increase the risk of adverse events caused by amantadine.

Cytotoxic agents (e.g. cyclophosphamide, methotrexate)

Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.

Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the

hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.

Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.

4.6 Fertility, pregnancy and lactation

Pregnancy

The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).

The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see

sections 4.3 and 4.4).

There are no adequate data from the use of Telmisartan Hydrochlorothiazide in pregnant women. Studies in animals have

shown reproductive toxicity (see section 5.3).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of

pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled

epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal

products. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy

should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.

When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and if

appropriate, alternative therapy should be started.

Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human

fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure,

hypotension, hyperkalaemia) (see section 5.3). Should exposure to angiotensin II receptor antagonists have occurred from the

second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections

4.3 and 4.4).

There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are

insufficient. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of

hydrochlorothiazide its use during the second and third trimester may compromise foeto‑placental perfusion and may cause

foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia. Hydrochlorothiazide should

not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and

placental hypoperfusion, without a beneficial effect on the course of the disease. Hydrochlorothiazide should not be used for

essential hypertension in pregnant women except in rare situations where no other treatment could be used.

Breast‑feeding

Because no information is available regarding the use of telmisartan during breast‑feeding, Telmisartan Hydrochlorothiazide is

not recommended and alternative treatments with better established safety profiles during breast‑feeding are preferable,

especially while nursing a newborn or preterm infant.

Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing intense diuresis can inhibit

the milk production. The use of hydrochlorothiazide during breast feeding is not recommended. If hydrochlorothiazide is used

during breast‑feeding, doses should be kept as low as possible.

Fertility

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In preclinical studies, no effects of telmisartan and hydrochlorothiazide on male and female fertility were observed.

4.7 Effects on ability to drive and use machines

Telmisartan Hydrochlorothiazide can have influence on the ability to drive and use machines. Dizziness or drowsiness may

occasionally occur when taking Telmisartan Hydrochlorothiazide.

4.8 Undesirable effects

Summary of the safety profile

The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).

The overall incidence of adverse reactions reported with Telmisartan Hydrochlorothiazide was comparable to those reported

with telmisartan alone in randomised controlled trials involving 1,471 patients randomised to receive telmisartan plus

hydrochlorothiazide (835) or telmisartan alone (636). Dose‑relationship of adverse reactions was not established and they

showed no correlation with gender, age or race of the patients.

Tabulated list of adverse reactions

Adverse reactions reported in all clinical trials and occurring more frequently (p ≤0.05) with telmisartan plus

hydrochlorothiazide than with placebo are shown below according to system organ class. Adverse reactions known to occur

with each component given singly but which have not been seen in clinical trials may occur during treatment with Telmisartan

Hydrochlorothiazide.

Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10);

common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known

(cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Infections and infestations

Rare: Bronchitis, pharyngitis, sinusitis

Immune system disorders

Rare: Exacerbation or activation of systemic lupus erythematosus

Metabolism and nutrition disorders

Uncommon: Hypokalaemia

Rare: Hyperuricaemia, hyponatraemia

Psychiatric disorders

Uncommon: Anxiety

Rare: Depression

Nervous system disorders

Common: Dizziness

Uncommon: Syncope, paraesthesia

Rare: Insomnia, sleep disorders

Eye disorders

Rare: Visual disturbance, vision blurred

Ear and labyrinth disorders

Uncommon: Vertigo

Cardiac disorders

Uncommon: Tachycardia, arrhythmias

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Vascular disorders

Uncommon: Hypotension, orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Rare: Respiratory distress (including pneumonitis and pulmonary oedema)

Gastrointestinal disorders

Uncommon: Diarrhoea, dry mouth, flatulence

Rare: Abdominal pain, constipation, dyspepsia, vomiting, gastritis

Hepatobiliary disorders

Rare: Abnormal hepatic function/liver disorder

Skin and subcutaneous tissue disorders

Rare: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria

Musculoskeletal, connective tissue and bone disorders

Uncommon: Back pain, muscle spasms, myalgia

Rare: Arthralgia, muscle cramps, pain in limb

Reproductive system and breast disorders

Uncommon: Erectile dysfunction

General disorders and administration site conditions

Uncommon: Chest pain

Rare: Influenza‑like illness, pain

Investigations

Uncommon: Blood uric acid increased

Rare: Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased

Based on post‑marketing experience

For further description, please see sub-section Description of selected adverse reactions

Additional information on individual components

Adverse reactions previously reported with one of the individual components may be potential adverse reactions with

Telmisartan Hydrochlorothiazide, even if not observed in clinical trials with this product.

Telmisartan

Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.

The overall incidence of adverse reactions reported with telmisartan (41.4 %) was usually comparable to placebo (43.9 %) in

placebo controlled trials. The following adverse reactions listed below have been accumulated from all clinical trials in patients

treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.

Infections and infestations

Uncommon: Upper respiratory tract infection, urinary tract infection including cystitis

Rare: Sepsis including fatal outcome

Blood and lymphatic system disorders

Uncommon: Anaemia

Rare: Eosinophilia, thrombocytopenia

Immune system disorders

Rare: Hypersensitivity, anaphylactic reactions

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Metabolism and nutrition disorders

Uncommon: Hyperkalaemia

Rare: Hypoglycaemia (in diabetic patients)

Cardiac disorders

Uncommon: Bradycardia

Nervous system disorder

Rare: Somnolence

Respiratory, thoracic and mediastinal disorders

Uncommon: Cough

Very rare: Interstitial lung disease

Gastrointestinal disorders

Rare: Stomach discomfort

Skin and subcutaneous tissue disorders

Rare: Eczema, drug eruption, toxic skin eruption

Musculoskeletal, connective tissue and bone disorders

Rare: Arthrosis, tendon pain

Renal and urinary disorders

Uncommon: Renal impairment (including acute renal failure)

General disorders and administration site conditions

Uncommon: Asthenia

Investigations

Rare: Haemoglobin decreased

For further description, please see sub-section Description of selected adverse reactions.

Hydrochlorothiazide

Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance (see section 4.4).

Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include:

NeoplasmsBenign, malignant and unspecified (incl cysts and polyps)

Not known: Non-melanoma skin cancer (Basalcell carcinoma and Squamous cell carcinoma)

Infections and infestations

Not known: Sialadenitis

Blood and lymphatic system disorders

Rare: Thrombocytopenia (sometimes with purpura)

Not known: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis

Immune system disorders

Not known: Anaphylactic reactions, hypersensitivity

Endocrine disorders

Not known: Diabetes mellitus inadequate control

Metabolism and nutrition disorders

Common: Hypomagnesaemia

Rare: Hypercalcaemia

Very rare: Hypochloraemic alkalosis

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