Telmisartan 80 mg tablets – patient leaflet, side effects, dosage

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 blockers. 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 of the ingredients of this medicine (listed in section 6).
• are more than 3 months pregnant. It is also better to avoid Telmisartan in early pregnancy – see pregnancy section.
• 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.
• 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.

Warnings and precautions

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Telmisartan. Your doctor will decide on further treatment. Do not stop taking Telmisartan on your own.

Talk to your doctor or pharmacist before taking Telmisartan 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 e.g. due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes.

Talk to your doctor or pharmacist before taking Telmisartan if you:

• are taking digoxin.

• 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 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

• 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 blockers (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 medicines, 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 may experience side effects such as fainting or a feeling of spinning (vertigo) when taking Telmisartan. If you experience these side effects, do not drive or operate machinery.

Information on sodium content

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.

Front Side

Telmisartan 20mg, 40mg and 80mg Tablets

Package leaflet: Information for the patient

Continued top of next column Continued over page

(6037816) Date : 08~01~2026, (R) 12.06.2026, 13.05.2026, 15.05.2026

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.

The recommended dose is one tablet a day. Try to take the tablet at the same time each day. You can take Telmisartan with or without food. The tablets should be swallowed whole 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.

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); severe allergic reaction (anaphylactic reaction); 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, pain in the belly, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, dizziness, feeling of weakness, and increased level of creatinine in the blood.

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

Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), 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, discomfort in the belly, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), 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, low levels of sodium.

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

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

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

Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting, and diarrhoea has been reported after the use of similar products.

* 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.

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 the 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 take 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

Telmisartan tablets contain

• 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 tablets look like and contents of the pack

20 mg tablets are 7.0 mm, white to off-white, round, flat, uncoated tablets debossed with 'KO1' on one side and plain on other side.

40 mg tablets are 5.9 x 12.0 mm, white to off-white, oval, biconvex, uncoated tablets with break line, debossed with 'KO' on either side of break line and '2' on other side of break line and plain on other side. The tablet can be divided into equal halves. 80 mg tablets are 7.3 x 15.0 mm white to off-white, oval, biconvex, uncoated tablets debossed with 'KO3' on one side and plain on other 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 Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer

Actavis Ltd.

BLB 016

Bulebel Industrial Estate

Zejtun

Malta

or

Accord Healthcare Polska Sp. z.o.o.

Ul. Lutomierska 50, 95-200, Pabianice, Poland

or

Accord Healthcare B.V.

Winthontlaan 200, 3526 KV Utrecht, The Netherlands.

This leaflet was last revised in May 2026.

If you would like a leaflet with larger text, please contact

+44 (0) 1271 385257.

Back Side

INP113 10 4938 2 6037816

Continued top of next column

(6037816) Date : 08~01~2026, (R) 12.06.2026, 13.05.2026, 15.05.2026