TELMISARTAN/ HYDROCHLOROTHIAZIDE BROWN & BURK 40 MG / 12.5 MG TABLETS - patient leaflet, side effects, dosage

260 mm

150 mm

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

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

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, serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, lightheadedness, blurred or yellowing of vision, 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), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at Website: 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 i 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 I 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 I

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 'THT 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 07/2021

Artwork code

Package leaflet: Information for the patient

Telmisartan I 1 12.5 mg tablets

Telmisartan I 1 12.5 mg tablets

Telmisartan I 1 25 mg tablets

Telmisartan/hy­drochlorothia­zide

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

• Keep this leaflet. You may need to read it again.
• If you have any further guestions, 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 product is Telmisartan/hy­drochlorothia­zide Brown & Burk 40mg/12.5mg, 80mg/12.5mg and 80mg/25mg tablets but within the leaflet it will be referred to as Telmisartan/hy­drochlorothia­zide tablets

What is in this leaflet

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

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

• 3. How to take Telmisartan / hydrochlorothiazide tablets

• 4. Possible side effects

• 5. How to store Telmisartan / hydrochlorothiazide tablets

• 6. Contents of the pack and other information

1. what telmisartan i 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-ll 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 H ■ blood vessels in several organs, which could lead sometimes

• ■ o ■ to heart attack, heart or kidney failure, stroke, or blindness.

• ■ "g ■ There are usually no symptoms of high blood pressure before

• ■ “ ■ damage occurs. Thus it is important to regularly measure

• ■ e ■ blood pressure to verify if it is within the normal range.

• ■ 1X1 ■

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

260 mm

150 mm

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.

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 I 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.
• 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.

3. how to take telmisartan i 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 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/12.5 mg once a day.

If you take more Telmisartan I 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 I 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 guestions 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 freguency (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 — —

■ □■

Dizziness ZZ

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, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.

Adverse reactions reported with one of the individual components may be potential adverse reactions with Telmisartan / hydrochlorothiazide 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, 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, 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) **

* The event may have happened by chance or could be related to a mechanism currently not known. "Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

Hydrochlorothi­azide

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

Common side effects (may affect up to 1 in 10 people): Feeling sick (nausea), low blood magnesium level.

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

Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in skin or other tissue caused by bleeding), high blood calcium level, headache.

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Size: 260(L) x 360(W) mm

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