Patient leaflet - Telmisartan and Hydrochlorothiazide Crescent 40 mg/12.5 mg tablets

1. What Telmisartan and Hydrochlorothiazide

Tablets are and what they are used for

The full name of your medicine is Telmisartan and Hydrochlorothiazide 40mg/12.5mg, 80mg/12.5mg, 80mg/25mg tablets, but within the leaflet it will be referred to as Telmisartan and Hydrochlorothiazide Tablets.

Telmisartan and Hydrochlorothiazide Tablets are a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure.

Telmisartan belongs to a group of medicines called angiotensin II receptor 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. • 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 and Hydrochlorothiazide 40mg/12.5mg and 80mg/12.5mg Tablets are used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone. Telmisartan and Hydrochlorothiazide 80mg/25mg Tablets are used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled by Telmisartan and Hydrochlorothiazide Tablets 80mg/12.5mg or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.

2. What you need to know before you take

Telmisartan and Hydrochlorothiazide Tablets Do not take Telmisartan and 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 and 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 100ml 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 and Hydrochlorothiazide Tablets. Warnings and precautions

Talk to your doctor before taking this medicine if you are suffering or have ever suffered from any of the following conditions or illnesses:

low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis (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 and Hydrochlorothiazide Tablets. This can lead to permanent vision impairment, if not treated. • if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Telmisartan and Hydrochlorothiazide Tablets.

Talk to your doctor before taking Telmisartan and 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 and 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 and Hydrochlorothiazide Tablets, seek medical attention immediately.

You must tell your doctor if you think you are (or might become) pregnant. Telmisartan and Hydrochlorothiazide Tablets are 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 and Hydrochlorothiazide Tablets. Telmisartan and Hydrochlorothiazide Tablets may be less effective in lowering the blood pressure in black patients. Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Telmisartan and Hydrochlorothiazide Tablets.

Your doctor will decide on further treatment. Do not stop taking Telmisartan and Hydrochlorothiazide Tablets on your own. Children and adolescents

The use of Telmisartan and Hydrochlorothiazide Tablets in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Telmisartan and 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 and 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
medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an immunosuppressant drug) and other medicinal products such as heparin sodium (an anticoagulant).
medicines that are affected by changes of the blood potassium level such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine) and other medicines such as certain antibiotics (e.g. sparfloxacine, pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine)
medicines for the treatment of diabetes (insulins or oral agents such as metformin).
cholestyramine and colestipol, medicines for lowering blood fat levels
medicines to increase blood pressure, such as noradrenaline.
muscle relaxing medicines, such as tubocurarine.
calcium supplements and/or vitamin D supplements
Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden
amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain illnesses caused by viruses)
Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as nonsteroidal 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 and Hydrochlorothiazide Tablets” and “Warnings and precautions”)
digoxin.
Iodinated contrast product used in the context of an imaging examination.

Telmisartan and 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 and Hydrochlorothiazide Tablets.

The effect of Telmisartan and Hydrochlorothiazide Tablets may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen). Telmisartan and Hydrochlorothiazide Tablets with food and alcohol

You can take Telmisartan and 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

TELMISARTAN AND HYDROCHLOROTHIAZIDE 40mg/12.5mg, 80mg/12.5mg and 80mg/25mg TABLETS

telmisartan and hydrochlorothiazide

PACKAGE LEAFLET: INFORMATION FOR THE USER

175mm

Product: Telmisartan and Hydrochlorothiazide Tablets

Huahai
P3443T increase the risk of you becoming dizzy or feeling faint. Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Your doctor will normally advise you to stop taking Telmisartan and 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 and Hydrochlorothiazide Tablets. Telmisartan and

Hydrochlorothiazide Tablets are 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 and Hydrochlorothiazide Tablets are not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed.

Driving and using machines

Some people feel dizzy, faint, feel like everything around you is spinning or tired when taking Telmisartan and

Hydrochlorothiazide Tablets. If you feel any of these effects, DO NOT drive or operate machinery.

Information on Sodium

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

3. How to take Telmisartan and 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 of Telmisartan and Hydrochlorothiazide Tablets is one tablet a day. Try to take a tablet at the same time each day.

You can take Telmisartan and Hydrochlorothiazide Tablets with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Telmisartan and Hydrochlorothiazide Tablets every day until your doctor tells you otherwise.

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

If you take more Telmisartan and 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 and 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); blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor IMMEDIATELY. If these effects are not treated they could be fatal. Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Telmisartan and Hydrochlorothiazide Tablets.

Possible side effects of Telmisartan and 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 airways to the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired/ 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 these side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, uric acid, hepatic enzymes or creatine phosphokinase in the blood.

Adverse reactions reported with one of the individual components may be potential adverse reactions with Telmisartan and 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): Upper respiratory tract infection (e.g. sore throat, inflamed

sinuses, common cold), urinary tract infections, infection in 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), arthrosis, inflammation of the tendons/ 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, headache, high blood sugar level, 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): Increased pH (disturbed acid-base balance, alkalosis, hypochloraemic) due to low blood chloride level. 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)

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 necrotising).

Side effects of unknown frequency (frequency cannot be estimated from the available data):

Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count (aplastic anaeimia), restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) 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 the Yellow Card Scheme at: 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 and 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.

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

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 and Hydrochlorothiazide Tablets contain

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40mg of telmisartan and 12.5mg of hydrochlorothiazide.
The other ingredients are sodium hydroxide, mannitol, maize starch, cellulose microcristalline, carmellose calcium, povidone (K-29/32), silicon dioxide, sodium stearyl fumarate. What Telmisartan and Hydrochlorothiazide Tablets look like and contents of the pack

Telmisartan and Hydrochlorothiazide 40mg/12.5mg Tablets are white to off-white, oblong tablets of approximately 12.5 x 6.5 mm, debossed with “H4” on one side.

Telmisartan and Hydrochlorothiazide 80mg/12.5mg Tablets are white to off-white, oblong tablets of approximately 16.1 x 7.8 mm, debossed with “H8” on one side.

Telmisartan and Hydrochlorothiazide 80mg/25mg Tablets are white to off-white, oblong tablets of approximately 16.1 x 7.8 mm, with a break-line and debossed with “H9” on the same side. The tablet can be divided into equal doses. Telmisartan and Hydrochlorothiazide Tablets are available in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Ltd., Key House,

Sarum Hill, Basingstoke, RG21 8SR, UK.

This leaflet was last revised in 06/2025.