Telmisartan/ Hydrochlorothiazide Brown & Burk 80 mg / 12.5 mg tablets – patient leaflet, side effects, dosage

1. What Telmisartan / hydrochlorothiazide tablets is and what it is used for

Telmisartan / hydrochlorothiazide tablets is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both 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 40 mg / 12.5 mg tablets and Telmisartan / hydrochlorothiazide 80 mg /

12.5 mg tablets is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.

Telmisartan / hydrochlorothiazide 80 mg / 25 mg tablets is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by Telmisartan / hydrochlorothiazide 80 mg / 12.5 mg tablets or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.

2. What you need to know before you take Telmisartan / hydrochlorothiazide tablets

Do not take Telmisartan / hydrochlorothiazide tablets

• if you are allergic to telmisartan or any 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

  tablets 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 or anuria (less than 100 ml urine per day). · 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 tablets.

Warnings and precautions

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

Talk to your doctor before taking Telmisartan / hydrochlorothiazide tablets 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 haemofiltration.

• 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.

• The active ingredient 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 tablets. 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.

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

  treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some type of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Telmisartan / hydrochlorothiazide tablets.

Talk to your doctor before taking Telmisartan / hydrochlorothiazide tablets:

• 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 tablets”.

    • if you are taking digoxin.

    • If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following

      hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Telmisartan / hydrochlorothiazide, seek medical attention immediately.

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

Telmisartan / hydrochlorothiazide tablets may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Telmisartan / hydrochlorothiazide tablets in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Telmisartan / hydrochlorothiazide tablets:

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 tablets:

• 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.

• Iodinated contrast product used in the context of an imaging examination.

• 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 anaesthesis) 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 tablets” and “Warnings and precautions”). · Digoxin.

Telmisartan / hydrochlorothiazide tablets 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 tablets.

The effect of Telmisartan / hydrochlorothiazide tablets may be reduced when you take NSAIDs (non-steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).

Telmisartan / hydrochlorothiazide tablets with food and alcohol.

You can take Telmisartan / hydrochlorothiazide tablets 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 tablets 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 tablets. Telmisartan / hydrochlorothiazide tablets 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 tablets 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, faint or feel like everything around you is spinning when taking Telmisartan and hydrochlorothiazide tablets. If you experience any of these effects, do not drive or operate machinery.

Telmisartan / hydrochlorothiazide tablets contains lactose and sodium.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet a day. Try to take the tablet at the same time each day. You can take Telmisartan / hydrochlorothiazide tablets 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 /

hydrochlorothiazide tablets every day until your doctor tells you otherwise.

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

If you take more Telmisartan / hydrochlorothiazide tablets 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 drugs 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 tablets

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 forgotten individual doses.

If you have 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 including fatal outcome), 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 very rare (toxic epidermal necrolysis; may affect up to 1 in 10, 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. Increased incidence of sepsis has been observed with telmisartan only, however cannot be ruled out for Telmisartan / hydrochlorothiazide tablets.

Possible side effects of Telmisartan / hydrochlorothiazide tablets:

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

Dizziness

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

Inflammation of the lung (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, increased level of uric acid, feeling sad (depression), difficulty falling asleep (insomnia), sleep disorder, impaired vision, blurred 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 (leg pain), 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 tablets, 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 side effects (may affect up to 1 in 100 people):

Dizziness, Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, infection of urinary bladder, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.

Rare side effects (may affect up to 1 in 1,000 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), drug eruption, toxic skin eruption, tendon pain (tendonitis-like-symptoms), decreased haemoglobin (a blood protein), somnolence.

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

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

Frequency 'not known':

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.

Hydrochlorothiazide

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

Very common side effects (may affect more than 1 in 10 people):

Elevated blood fat levels.

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

Feeling sick (nausea), low blood magnesium level, decreased appetite.

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

Acute kidney failure.

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

Reduction in blood platelets (thrombocytopenia), which increases risk of bleeding or bruising (small purple-red marks in skin or other tissue caused by bleeding), high blood calcium level, high blood sugar level, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess of biliary substances in the blood (cholestasis), photosensitivity reaction, uncontrolled blood levels of glucose in patients with a diagnosis of diabetes mellitus, sugars in the urine (glucosuria).

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

Abnormal breakdown of red blood cells (haemolytic anaemia), inability of the bone marrow to work properly, reduction of white blood cells (leukopenia, agranulocytosis), serious allergic reactions (e.g. hypersensitivity), increased pH (disturbed acid-base balance) due to low blood chloride level, alkalosis hypochloraemic, acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion), inflammation of the pancreas, lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body), inflammation of blood vessels (vasculitis necrotizing).

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

Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), blood cell deficiency (aplastic anaemia), decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute myopia or acute angle closure glaucoma), 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.

Low levels of sodium accompanied by symptoms relating to the brain or nerves (feeling sick, progressive disorientation, lack of interest or energy) occurs in isolated cases.

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 Yellow Card Scheme at 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 / hydrochlorothiazide tablets

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

This medicinal product does not require any special storage conditions

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 tablets contain

The active substances are telmisartan and hydrochlorothiazide.

Telmisartan / hydrochlorothiazide 40 mg / 12.5 mg tablets

Each tablet contains 40mg telmisartan and 12.5mg hydrochlorothiazide

Telmisartan / hydrochlorothiazide 80 mg / 12.5 mg tablets

Each tablet contains 80mg telmisartan and 12.5mg hydrochlorothiazide

Telmisartan / hydrochlorothiazide 80 mg / 25 mg tablets

Each tablet contains 80mg telmisartan and 25mg hydrochlorothiazide

The other ingredients are mannitol, meglumine, sodium hydroxide, povidone, crospovidone Type A, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch.

Colorants:

Ferric oxide red (E172) – For 40mg/12.5mg and 80mg/12.5mg

Ferric oxide yellow (E172) – only for 80mg/25mg

What Telmisartan / hydrochlorothiazide tablets looks like and contents of the pack

40mg/12.5mg:

Biconvex, two layered, approx. 13.0mm x 7.0mm in dimension, oval-shaped, uncoated tablets. White to off white layer is of Telmisartan which may contain red specs in between engraved with 'TH' and red to reddish pink layer is of hydrochlorothiazide part.

80mg/12.5mg

Biconvex, two layered, approx. 15.0mm x 7.0mm in dimension, oval-shaped, uncoated tablets. White to off white layer is of Telmisartan which may contain red specs in between engraved with 'TH3' and red to reddish pink layer is of hydrochlorothiazide part.

80mg/25mg:

Biconvex, two layered, approx. 16.5mm x 8.0mm in dimension, oval-shaped, uncoated tablets. White to off white layer is of Telmisartan which may contain yellow specs in between engraved with 'TH1' and light yellow to yellow layer is of hydrochlorothiazide part.

Telmisartan / hydrochlorothiazide tablets are available in blister packs containing 7, 14, 28, 56, 84 or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Brown & Burk UK Limited

5 Marryat Close

Hounslow West

Middlesex

TW4 5DQ

UK.

Manufacturer

Brown & Burk UK Ltd

5, Marryat Close

Hounslow West

Middlesex

TW4 5DQ

UK

This leaflet was last revised in 05/2026

BBUKCODE