Telmisartan 40 mg Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Telmisartan
Available from:
Accord Healthcare Ireland Ltd.
ATC code:
C09CA; C09CA07
INN (International Name):
Telmisartan
Dosage:
40 milligram(s)
Pharmaceutical form:
Tablet
Therapeutic area:
Angiotensin II antagonists, plain; telmisartan
Authorization status:
Not marketed
Authorization number:
PA2315/014/002
Authorization date:
2019-08-02

Telmisartan 20mg, 40mg and 80mg Tablets

telmisartan

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Package Leaflet: Information for the user

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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.

The full name of this medicine is Telmisartan 20mg,

40mg and 80mg Tablets but within this leaflet it will

be referred to as Telmisartan.

What is in this leaflet:

1

What Telmisartan is and what it is used for

2

What you need to know before you take

Telmisartan

3

How to take Telmisartan

4

Possible side effects

5

How to store Telmisartan

6

Contents of the pack and other information

1

What Telmisartan is and what it is used for

Telmisartan contains the active substance telmisartan

which belongs to a class of medicines known as

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.

Telmisartan tablets are used to treat essential hypertension

(high blood pressure) in adults.

‘Essential’ means that the high blood pressure is not caused

by any other condition.

High blood pressure, if not treated, can damage blood

vessels in several organs which could lead sometimes to

heart attacks, heart or kidney failure, strokes 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 is also used to reduce cardiovascular events

(i.e. heart attack or stroke) in adults who are at risk because

they have a reduced or blocked blood supply to the heart

or legs, or have had a stroke or have high risk diabetes. Your

doctor can tell you if you are at high risk for such events.

2

What you need to know before you take

Telmisartan

Do not take Telmisartan

if you are allergic to telmisartan or any other ingredients

of this medicine (listed in section 6).

if you are more than 3 months pregnant. (It is also better

to avoid Telmisartan in early pregnancy – see pregnancy

section.)

if you have severe liver problems such as cholestasis or

biliary obstruction (problems with the drainage of the bile

from the liver and gall bladder) or any other severe liver

disease.

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.

Warning and precautions

Talk to your doctor if you are suffering or have ever suffered

from any of the following conditions or illnesses:

Kidney disease or kidney transplant.

Renal artery stenosis (narrowing of the blood vessels to

one or both kidneys).

Liver disease.

Heart trouble.

Raised aldosterone levels (water and salt retention in the

body along with imbalance of various blood minerals).

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, or vomiting.

Elevated potassium levels in your blood.

Diabetes.

Talk to your doctor before taking Telmisartan:

if you are taking digoxin.

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”.

You must tell your doctor if you think you are (or might

become) pregnant. Telmisartan 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).

In case of surgery or anaesthesia, you should tell your

doctor that you are taking Telmisartan.

Telmisartan may be less effective in lowering the blood

pressure in black patients.

Children and adolescents

The use of Telmisartan in children and adolescents up to

the age of 18 years is not recommended.

Other medicines and Telmisartan

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

medicines 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

Lithium containing medicines to treat some types of

depression.

Medicines that may increase blood potassium

levels such as salt substitutes containing potassium,

potassium-sparing diuretics (certain ‘water tablets’), ACE-

inhibitors (angiotensin-converting enzyme inhibitors,

to treat high blood pressure), angiotensin II receptor

antagonists (to treat high blood pressure), NSAIDs (non

steroidal anti-inflammatory medicines, e.g. aspirin or

ibuprofen), heparin (a medicine for thinning the blood),

immunosuppressives (e.g. ciclosporin or tacrolimus), and

the antibiotic trimethoprim.

Diuretics (‘water tablets’), especially if taken in high doses

together with Telmisartan, may lead to excessive loss of

body water and low blood pressure (hypotension).

If you are taking an ACE-inhibitor or aliskiren (see also

information under the headings “Do not take Telmisartan”

and “Warnings and precautions”).

Digoxin.

The effect of Telmisartan may be reduced when you take

NSAIDs (non steroidal anti-inflammatory drugs, e.g. aspirin

or ibuprofen) or corticosteroids.

Telmisartan 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.

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 before you become pregnant or as

soon as you know you are pregnant and will advise you to

take another medicine instead of Telmisartan. Telmisartan

is not recommended in early 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 is not recommended for

mothers who are breast-feeding, and your doctor may

choose another treatment for you if you wish to breast-

feed, especially if your baby is newborn, or was born

prematurely.

Driving and using machines

Some people feel dizzy or tired when taking Telmisartan.

If you feel dizzy or tired, do not drive or use machines.

Telmisartan contains sodium

This medicine contains less than 1 mmol sodium (23mg)

per tablet, that is to say essentially “sodium-free”.

3

How to take Telmisartan

Always take this medicine exactly as your doctor has told

you. Check with your doctor or pharmacist if you are not

sure.

For treatment of high blood pressure, the usual dose of

Telmisartan for most patients is one 40mg tablet once a

day to control blood pressure over the 24-hour period.

Your doctor has recommended a lower dose of one 20mg

tablet daily. Telmisartan may also be used in combination

with diuretics (‘water tablets’) such as hydrochlorothiazide

which has been shown to have an additive blood pressure

lowering effect with telmisartan.

For reduction of cardiovascular events, the usual dose

of Telmisartan is one 80mg tablet once a day. At the

beginning of the preventive therapy with Telmisartan

80mg, blood pressure should be frequently monitored.

In patients with liver problems the usual dose should not

exceed 40mg once daily.

In patients with kidney problems a lower starting dose of

20mg is recommended.

Try to take the tablet at the same time each day. You can

take Telmisartan with or without food. The tablets should

be swallowed with some water or other non-alcoholic

drink. It is important that you take Telmisartan every

day until your doctor tells you otherwise. If you have the

impression that the effect of Telmisartan is too strong or

too weak, talk to your doctor or pharmacist.

If you take more Telmisartan than you should

It is important to keep to the dose as prescribed by your

doctor. If you accidentally take too many tablets ask

your doctor what to do or contact your nearest hospital

emergency department immediately.

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Telmisartan 20mg, 40mg & 80mg Tablets PIL - UK/IE

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Actavis Malta Zejtun

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Version 2

01.11.2017

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The most common symptoms of telmisartan overdose

are low blood pressure (hypotension) and fast heartbeat

(tachycardia). Slow heartbeat (bradycardia), dizziness,

higher levels of creatinine in the blood and sudden kidney

failure have also been reported.

If you forget to take Telmisartan

If you forget to take your medicine you should take the

dose as soon as you remember on the same day. 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 stop taking Telmisartan

Take Telmisartan every day for as long as your doctor

prescribes it in order to keep your blood pressure

controlled. If you have the impression that the effect of

Telmisartan is too strong or too weak, talk to your doctor or

pharmacist.

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); these side effects are

rare (may affect up to 1 in 1,000 people) 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.

Possible side effects of telmisartan:

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

Low blood pressure (hypotension) in users treated for

reduction of cardiovascular events.

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

Urinary tract infections, upper respiratory tract infections

(e.g. sore throat, inflamed sinuses, common cold),

deficiency in red blood cells (anaemia), high potassium

levels, difficulty falling asleep, feeling sad (depression),

fainting (syncope), feeling of spinning (vertigo), slow heart

rate (bradycardia), low blood pressure (hypotension) in

users treated for high blood pressure, dizziness on standing

up (orthostatic hypotension), shortness of breath, cough,

abdominal pain, diarrhoea, discomfort in the abdomen,

bloating, vomiting, itching, increased sweating, drug rash,

back pain, muscle cramps, muscle pain (myalgia), kidney

impairment including acute kidney failure, pain in the

chest, feeling of weakness, and increased level of creatinine

in the blood.

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

Sepsis* (often called “blood poisoning”, is a severe infection

with whole-body inflammatory response which can lead to

death), increase in certain white blood cells (eosinophilia),

low platelet count (thrombocytopenia), severe allergic

reaction (anaphylactic reaction), allergic reaction (e.g. rash,

itching, difficulty breathing, wheezing, swelling of the face

or low blood pressure), low blood sugar levels (in diabetic

patients), feeling anxious, somnolence, impaired vision, fast

heartbeat (tachycardia), dry mouth, upset stomach, taste

disturbance (dysgeusia), abnormal liver function (Japanese

patients are more likely to experience this side effect),

rapid swelling of the skin and mucosa which can also lead

to death (angioedema also with fatal outcome), eczema (a

skin disorder), redness of skin, hives (urticaria), severe drug

rash, joint pain (arthralgia), pain in extremity, tendon pain,

flu-like illness, decreased haemoglobin (a blood protein),

increased levels of uric acid, increased hepatic enzymes or

creatine phosphokinase in the blood.

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 happened by chance or could be

related to a way that telmisartan works that is 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist

or nurse. This includes any possible side effects not listed in

this leaflet. You can also report side effects directly via

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more

information on the safety of this medicine.

5

How to store Telmisartan

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 or blister after “EXP”. The expiry date

refers to the last day of that month.

Al/Al blisters: Store in the original package in order to

protect from light.

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 contains

The active substance is telmisartan. Each tablet contains

20mg, 40mg or 80mg telmisartan.

The other ingredients are magnesium stearate,

croscarmellose sodium, mannitol, povidone, potassium

hydroxide.

What Telmisartan looks like and contents of the

pack

20mg tablets are white, round, flat with logo T on one side.

40mg tablets are white, oval, biconvex, with a break line

and logo T on one side. The tablet can be divided into equal

halves.

80mg tablets are white, oval, biconvex with logo T1 on one

side.

Pack sizes:

Al/Al blister packs: 14, 28, 30, 56, 84, 90, 98 and 100 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

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer

Actavis Ltd.

BLB 016

Bulebel Industrial Estate

Zejtun

Malta

This leaflet was last revised in September 2018.

If you would like a leaflet

with larger text,

please contact

+44 (0) 1271 385257.

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Originator:

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Details

Telmisartan 20mg, 40mg & 80mg Tablets PIL - UK/IE

Black

BBBA2930

S.Anson

12.09.18

18.09.18

S.Anson

190 x 500

Actavis Malta Zejtun

12.09.18

17.09.18

2

Version 2

01.11.2017

Health Products Regulatory Authority

06 August 2019

CRN008K72

Page 1 of 12

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Telmisartan 40 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 40 mg telmisartan

Excipients with known effect:

Telmisartan 40 mg tablets:

Each tablet contains 1.52 mg of sodium.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

40 mg tablets: White, oval, biconvex tablets with a break line and logo T on one side. The tablet can be divided into equal

halves.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Hypertension

Treatment of essential hypertension in adults.

Cardiovascular prevention

Reduction of cardiovascular morbidity in adults with:

- manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or

- type 2 diabetes mellitus with documented target organ damage.

4.2 Posology and method of administration

Posology

Treatment of essential hypertension

The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the

target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily.

Alternatively, telmisartan may be used in combination with thiazidetype diuretics such as hydrochlorothiazide which has been

shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be

borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment

(see section 5.1).

Cardiovascular prevention

The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in

reducing cardiovascular morbidity.

When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is

recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.

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06 August 2019

CRN008K72

Page 2 of 12

Special populations

Patients with renal impairment

Limited experience is available in patients with severe renal impairment or haemodialysis. A lower starting dose of 20 mg is

recommended in these patients (see section 4.4). No posology adjustment is required for patients with mild to moderate renal

impairment.

Patients with hepatic impairment

Telmisartan is contraindicated in patients with severe hepatic impairment (see section 4.3).

In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).

Elderly patients

No dose adjustment is necessary for elderly patients.

Paediatric population

The safety and efficacy of telmisartan in children and adolescents aged below 18 years have not been established.

Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.

Method of administration

Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.

4.3 Contraindications

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

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

- Biliary obstructive disorders

- Severe hepatic impairment

The concomitant use of Telmisartan 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 is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see

section 4.3) since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic

clearance for telmisartan. Telmisartan should be used only with caution in patients with mild to moderate 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

When Telmisartan is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum

levels is recommended. There is no experience regarding the administration of Telmisartan in patients with recent kidney

transplantation.

Intravascular hypovolaemia

Symptomatic hypotension, especially after the first dose of Telmisartan, 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

Health Products Regulatory Authority

06 August 2019

CRN008K72

Page 3 of 12

before the administration of Telmisartan . Volume and/or sodium depletion should be corrected prior to administration of

Telmisartan .

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 such as telmisartan 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 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.

Diabetic patients treated with insulin or antidiabetics

In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an approptiate blood

glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.

Hyperkalaemia

The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.

In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal

products that may increase potassium levels, and/or in patients with intercurrent events, hyperkalaemia may be fatal.

Before considering the concomitant use of medicinal products that affect the renin-angiotensin-aldosterone system, the

benefit risk ratio should be evaluated.

The main risk factors for hyperkalaemia to be considered are:

- Diabetes mellitus, renal impairment, age (> 70 years)

- Combination with one or more other medicinal products that affect the renin-angiotensin-aldosterone system and/or

potassium supplements. Medicinal products or therapeutic class of medicinal products that may provoke hyperkalaemia are

salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non

steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX‑2 inhibitors), heparin, immunosuppressives

(cyclosporin or tacrolimus), and trimethoprim.

- Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic acidosis, worsening of renal

function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia,

rhabdomyolysis, extend trauma).

Close-monitoring of serum potassium in at risk patients is recommended (see section 4.5).

Ethnic differences

As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin antagonists are apparently

less effective in lowering blood pressure in black people 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.

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06 August 2019

CRN008K72

Page 4 of 12

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

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.

As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia

(see section 4.4). The risk may increase in case of treatment combination with other medicinal products that may also provoke

hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor

antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX‑2 inhibitors), heparin,

immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).

The occurrence of hyperkalaemia depends on associated risk factors. The risk is increased in case of the above-mentioned

treatment combinations. The risk is particularly high in combination with potassium sparing-diuretics and when combined with

salt substitutes containing potassium. A combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk

provided that precautions for use are strictly followed.

Concomitant use not recommended

Potassium sparing diuretics or potassium supplements

Angiotensin II receptor antagonists such as telmisartan attenuate diuretic induced potassium loss. Potassium sparing diuretics

e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes

may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia,

they should be used with caution and with frequent monitoring of serum potassium.

Lithium

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

lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan. If

use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.

Concomitant use requiring caution

Non-steroidal anti-inflammatory medicinal products

NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX‑2 inhibitors and nonselective NSAIDs) may reduce

the antihypertensive effect 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.

Diuretics (thiazide or loop diuretics)

Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may

result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.

To be taken into account with concomitant use

Other antihypertensive agents

The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal

products.

Health Products Regulatory Authority

06 August 2019

CRN008K72

Page 5 of 12

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).

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.

Corticosteroids (systemic route)

Reduction of the antihypertensive effect.

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 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 drugs. Unless

continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed

to alternative anti‑hypertensive 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).

Breast-feeding

Because no information is available regarding the use of Telmisartan during breast-feeding, Telmisartan is not recommended

and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing

a newborn or preterm infant.

Fertility

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

4.7 Effects on ability to drive and use machines

When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally

occur when taking antihypertensive therapy such as Telmisartan.

4.8 Undesirable effects

Summary of the safety profile

Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000),

and acute renal failure.

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

placebo controlled trials in patients treated for hypertension. The incidence of adverse reactions was not dose related and

showed no correlation with gender, age or race of the patients. The safety profile of telmisartan in patients treated for the

reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.

The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension

and from post-marketing reports. The listing also takes into account serious adverse reactions and adverse reactions leading to

discontinuation reported in three clinical long-term studies including 21,642 patients treated with telmisartan for the reduction

of cardiovascular morbidity for up to six years.

Tabulated list of adverse reactions

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).

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

Infections and infestations

Uncommon:

Rare:

Urinary tract infection including cystitis, upper respiratory tract infection

including pharyngitis and sinusitis

Sepsis including fatal outcome

Blood and the lymphatic system disorders

Uncommon:

Anaemia

Rare:

Eosinophilia , thrombocytopenia

Immune system disorders

Rare:

Anaphylactic reaction , hypersensitivity

Metabolism and nutrition disorders

Uncommon:

Rare:

Hyperkalaemia

Hypoglycaemia (in diabetic patients)

Psychiatric disorders

Uncommon:

Insomnia, depression

Rare:

Anxiety

Nervous system disorders

Uncommon:

Syncope

Rare:

Somnolence

Eye disorders

Rare:

Visual disturbance

Ear and labyrinth disorders

Uncommon:

Vertigo

Cardiac disorders

Uncommon:

Bradycardia

Rare:

Tachycardia

Vascular disorders

Uncommon:

Hypotension

, orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

Uncommon:

Dyspnoea, cough

Very rare:

Interstitial lung disease

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Gastrointestinal disorders

Uncommon:

Rare:

Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting

Dry mouth, stomach discomfort, dysgeusia

Hepatobiliary disorders

Rare:

Hepatic function abnormal/liver disorder

Skin and subcutaneous tissue disorders

Uncommon:

Rare:

Pruritus, hyperhidrosis, rash

Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug

eruption, toxic skin eruption

Muscoloskeletal and connective tissue disorders

Uncommon:

Rare:

Back pain (e.g. sciatica), muscle spasms, myalgia

Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms)

Renal and urinary disorders

Uncommon:

Renal impairment including acute renal failure

General disorders and administration site conditions

Uncommon:

Rare:

Chest pain, asthenia (weakness)

Influenza-like illness

Investigations

Uncommon:

Blood creatinine increased

Rare:

Haemoglobin decreased, blood uric acid increased, hepatic enzyme

increased, blood creatine phosphokinase increased

1,2,3,4: for further descriptions, please see sub-section 4 Description of selected adverse reactions.

Description of selected adverse reactions

Sepsis

In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo. The event may be

a chance finding or related to a mechanism currently not known (see also section 5.1).

Hypotension

This adverse reaction was reported as common in patients with controlled blood pressure who were treated with telmisartan

for the reduction of cardiovascular morbidity on top of standard care.

Hepatic function abnormal / liver disorder

Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in Japanese patients.

Japanese patients are more likely to experience these adverse reactions.

Interstitial lung disease

Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of

telmisartan. However, a causal relationship has not been established.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6767836;

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

There is limited information available with regard to overdose in humans.

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Symptoms: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia

dizziness, increase in serum creatinine, and acute renal failure have also been reported.

Treatment: Telmisartan is not removed by haemodialysis. The patient should be closely monitored, and the treatment should

be symptomatic and supportive. Management depends on the time since ingestion and the severity of the symptoms.

Suggested measures include induction of emesis and / or gastric lavage. Activated charcoal may be useful in the treatment of

overdosage. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be

placed in a supine position, with salt and volume replacement given quickly.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.

Mechanism of action

Telmisartan is an orally active and specific angiotensin II receptor (type AT

) antagonist.

Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT

receptor subtype, which is

responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial agonist activity at the AT

receptor.

Telmisartan selectively binds the AT

receptor. The binding is long-lasting. Telmisartan does not show affinity for other

receptors, including AT

and other less characterised AT receptors. The functional role of these receptors is not known, nor is

the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.

Plasma aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or block ion channels.

Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.

Therefore it is not expected to potentiate bradykinin-mediated adverse effects.

In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase. The

inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.

Clinical efficacy and safety

Treatment of essential hypertension

After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours. The maximum

reduction in blood pressure is generally attained 4 to 8 weeks after the start of treatment and is sustained during long-term

therapy.

The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as

shown by ambulatory blood pressure measurements. This is confirmed by trough to peak ratios consistently above 80% seen

after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.

There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP). In this respect

data concerning diastolic blood pressure (DBP) are inconsistent.

In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate. The

contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined. The

antihypertensive efficacy of telmisartan is comparable to that of agents representative of other classes of antihypertensive

medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril,

hydrochlorothiazide, and lisinopril).

Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of

several days without evidence of rebound hypertension.

The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin

converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.

Cardiovascular prevention

ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of

telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged

55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus

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accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria),

which is a population at risk for cardiovascular events.

Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg

(n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time

of 4.5 years.

Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular death, non-fatal

myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure. The incidence of the primary endpoint

was similar in the telmisartan (16.7%) and ramipril (16.5%) groups. The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5%

CI 0.93 ‑ 1.10, p (non-inferiority) = 0.0019 at a margin of 1.13). The all-cause mortality rate was 11.6 % and 11.8 % among

telmisartan and ramipril treated patients, respectively.

Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death,

non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.90 - 1.08), p (non-inferiority) = 0.0004], the primary

endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of

ramipril vs. placebo.

TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as ONTARGET to telmisartan 80 mg

(n = 2954) or placebo (n = 2972), both given on top of standard care. The mean duration of follow up was 4 years and

8 months. No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death,

non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7% in the

telmisartan and 17.0% in the placebo groups with a hazard ratio of 0.92 (95% CI 0.81‑1.05, p = 0.22)]. There was evidence for a

benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death,

non-fatal myocardial infarction, and non-fatal stroke [0.87 (95% CI 0.76‑1.00, p = 0.048)], There was no evidence for benefit on

cardiovascular mortality (hazard ratio 1.03, 95% CI 0.85‑1.24).

Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global

Endpoint Trial) and VA NEPHRON‑D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the

combination of an ACE‑inhibitor with an angiotensin II receptor blocker.

ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes

mellitus accompanied by evidence of end-organ damage. VA NEPHRON‑D was a study in patients with type 2 diabetes

mellitus and diabetic nephropathy.

These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an

increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Given

their similar pharmacodynamic properties, these results are also relevant for other ACE‑inhibitors and angiotensin II receptor

blockers.

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

nephropathy.

ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test

the benefit of adding aliskiren to a standard therapy of an ACE‑inhibitor or an angiotensin II receptor blocker in patients with

type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of

an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren

group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and

renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.

Cough and angioedema were less frequently reported in patients treated with telmisartan than in patients treated with ramipril,

whereas hypotension was more frequently reported with telmisartan.

Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone. CV mortality and all cause

mortality were numerically higher with the combination. In addition, there was a significantly higher incidence of

hyperkalaemia, renal failure, hypotension and syncope in the combination arm. Therefore the use of a combination of

telmisartan and ramipril is not recommended in this population.

In the Prevention Regimen For Effectively avoiding Second Strokes (PRoFESS) trial in patients 50 years and older, who recently

experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70% vs. 0.49% [RR

1.43 (95% confidence interval 1.00‑ 2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan

(0.33%) vs. patients taking placebo (0.16%) [RR 2.07 (95% confidence interval 1.14 3.76)]. The observed increased occurrence

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rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently

known.

Paediatric population

The safety and efficacy of telmisartan in children and adolescents aged below 18 years have not been established.

The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients

aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or

2 mg/kg (n = 31 treated) over a four-week treatment period. By inclusion the presence of secondary hypertension was not

investigated. In some of the investigated patients the doses used were higher than those recommended in the treatment of

hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults. After adjustment

for age group effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mm Hg in the telmisartan 2 mg/kg

group, -9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and ‑6.0 (2.4) in the placebo group. The adjusted DBP changes

from baseline were ‑8.4 (1.5) mm Hg, ‑4.5 (1.6) mm Hg and ‑3.5 (2.1) mm Hg respectively. The change was dose dependent.

The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults. The

safety of long term treatment of telmisartan in children and adolescents was not evaluated.

An increase in eosinophils reported in this patient population has not been recorded in adults. Its clinical significance and

relevance is unknown.

These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in hypertensive paediatric

population.

5.2 Pharmacokinetic properties

Absorption

Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute bioavailability for telmisartan is

about 50%.

When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC

0-∞

) of

telmisartan varies from approximately 6% (40 mg dose) to approximately 19% (160 mg dose). By 3 hours after administration

plasma concentrations are similar whether telmisartan is taken fasting or with food.

Linearity/non-linearity

The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.

There is no linear relationship between doses and plasma levels. C

and to a lesser extent AUC increase disproportionately at

doses above 40 mg.

Distribution

Telmisartan is largely bound to plasma protein (> 99.5%), mainly albumin and alpha‑1 acid glycoprotein. The mean steady

state apparent volume of distribution (V

) is approximately 500 l.

Biotransformation

Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No pharmacological activity has been

shown for the conjugate.

Elimination

Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half‑life of > 20 hours. The

maximum plasma concentration (C

) and, to a smaller extent, the area under the plasma concentration-time curve (AUC)

increase disproportionately with dose. There is no evidence of clinically relevant accumulation of telmisartan taken at the

recommended dose. Plasma concentrations were higher in females than in males, without relevant influence on efficacy.

After oral (and intravenous) administration telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged

compound. Cumulative urinary excretion is < 1% of dose. Total plasma clearance (Cl

) is high (approximately 1,000 ml/min)

compared with hepatic blood flow (about 1,500 ml/min).

Special Populations

Paediatric population

The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57)

aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period. Pharmacokinetic

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objectives included the determination of the steady-state of telmisartan in children and adolescents, and investigation of

age-related differences. Although the study was too small for a meaningful assessment of the pharmacokinetics of children

under 12 years of age, the results are generally consistent with the findings in adults and confirm the non-linearity of

telmisartan, particularly for C

Gender

Gender differences in plasma concentrations were observed, C

and AUC being approximately 3‑and 2‑fold higher,

respectively, in females compared to males.

Elderly

The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.

Renal impairment

In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations was observed. However,

lower plasma concentrations were observed in patients with renal insufficiency undergoing dialysis. Telmisartan is highly bound

to plasma protein in renal-insufficient patients and cannot be removed by dialysis. The elimination half‑life is not changed in

patients with renal impairment.

Hepatic impairment

Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.

The elimination half‑life is not changed in patients with hepatic impairment.

5.3 Preclinical safety data

In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red

cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen

and creatinine), as well as increased serum potassium in normotensive animals. In dogs renal tubular dilation and atrophy were

observed. Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs. These

pharmacologically-mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme

inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.

In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.

These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists,

do not appear to have clinical significance.

No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal

development of the offsprings such as lower body weight and delayed eye opening was observed.

There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in

rats and mice.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Magnesium stearate

Croscarmellose sodium

Mannitol

Povidone

Potassium hydroxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

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6.4 Special precautions for storage

Al/Al blisters:

Store in the original package in order to protect from light.

HDPE tablet container with LDPE lid:

Keep the container tightly closed in order to protect from light.

6.5 Nature and contents of container

Al/Al blisters:

Pack sizes: 14, 28, 30, 56, 84, 90, 98 or 100 tablets.

HDPE container with LDPE lid and desiccant

Pack sizes: 30 or 250 tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Accord Healthcare Ireland Ltd.

Euro House

Euro Business Park

Little Island

Cork T45 K857

Ireland

8 MARKETING AUTHORISATION NUMBER

PA2315/014/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 2

August 2019

10 DATE OF REVISION OF THE TEXT

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