Telmisartan And Hydrochlorothiazide 80mg/12.5mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN AND HYDROCHLOROTHIAZIDE 40mg/I2.5mg, 80mg/I2.5mg and 80mg/25mg
TABLETS
Telmisartan and 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 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.
What is in this leaflet:
1. What Telmisartan and Hydrochlorothiazide Tablets are and what they are used for
2. What you need to know before you take Telmisartan and Hydrochlorothiazide Tablets
3. How to take Telmisartan and Hydrochlorothiazide Tablets
4. Possible side effects
5. How to store Telmisartan and Hydrochlorothiazide Tablets
6. Contents of the pack and other information
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 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 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
• 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 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.
• 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 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.
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.
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.
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
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors that may increase blood potassium levels
• heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide)
• medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine).
• other medicines used to treat high blood pressure, steroids, painkillers, medicines to treat cancer, gout, or arthritis, and vitamin D supplements
• 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.
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).
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 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 breastfeeding. Telmisartan and Hydrochlorothiazide Tablets are 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 or tired when taking Telmisartan and Hydrochlorothiazide Tablets. If you feel dizzy or tired, DO NOT drive or operate machinery.
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 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:
Seps/s* (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. 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 fmav affect up to 1 in 10 people):
Dizziness
Uncommon side effects (may affect up to 1 in 100 peopled:
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 (mav affect up to 1 in 1.000 peoplet: 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, inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience these side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), 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, increased levels of uric acid, 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 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, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.
Rare side effects fmav affect up to 1 in 1.000 peopled
Seps/s* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which can lead to death), 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 fmav affect up to 1 in 10.000 peopled 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:
Side effects of unknown frequency (frequency cannot be estimated from the available datal:
Inflammation of the salivary gland, decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia), serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, lightheadedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of 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, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased levels of glucose, 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 the Yellow Card Scheme at: www.mhra.qov.uk/yellowcard. 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.
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 or 80mg of telmisartan and 12.5mg or 25mg 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 Limited
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hampshire RG25 3ED United Kingdom