What Telmimed Plus is and what it is used for
Telmimed Plus is a combination of two active substances in one tablet - telmisartan and hydrochlorothiazide. Both substances help to control high blood pressure.
Telmisartan belongs to a group of medicinal products called angiotensin II receptor antagonists. Angiotensin II is a substance formed in your body that causes blood vessels to contract, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels are relaxed and your blood pressure decreases;
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics that cause an increase in urine output, leading to a decrease in your blood pressure;
If not treated, high blood pressure can damage the blood vessels in a number of organs, which can sometimes lead to heart attacks, heart or kidney failure, stroke and blindness. Symptoms resulting from high blood pressure are usually not observed before organ damage occurs. Therefore, it is important to regularly measure blood pressure to check that it is within normal range.
Telmisad Plus is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not adequately controlled when telmisartan or hydrochlorothiazide is used alone.
2. What you need to know before you take Telmimed Plus
Do not take Telmimed Plus
if you are allergic (hypersensitive) to telmisartan or any of the other ingredients included in this medicine (described in section 6);
if you are allergic (hypersensitive) to hydrochlorothiazide or other sulphonamide-derived medicines;
if you are pregnant after the third month (better to avoid using Telmisad Plus and early pregnancy (see section Pregnancy);
if you have severe liver problems such as cholestasis or biliary obstruction (a problem with gall bladder drainage) or other severe liver disease;
if you have severe kidney disease;
if your doctor finds you have low potassium levels or high blood calcium levels that do not respond to treatment.
Tell your doctor or pharmacist before taking Telmisad Plus if any of the above applies to you.
Warnings and precautions
Talk to your doctor if you suffer or have ever suffered from any of the following conditions or illnesses:
Low blood pressure (hypotension) that may occur if you are dehydrated (excessive water loss of the body) or if you have salt deficiency due to diuretics (a dehydrating medicine), a low salt diet, diarrhea, vomiting or hemodialysis;
Kidney disease or kidney transplant;
Renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
Hepatic disease;
Cardiac disorders;
Diabetes;
Gout;
Elevated aldosterone levels (retention of water and salts in the body, accompanied by an imbalance of various minerals in the blood);
Systemic lupus erythematosus (also referred to as "lupus" or "SLE"), a disease in which the immune system attacks the body;
The active ingredient, hydrochlorothiazide, may cause an unusual reaction resulting in decreased vision and eye pain. These may be symptoms of increased intraocular pressure and may occur within hours to weeks of starting Telmised Plus. This can lead to permanent loss of vision if it is not treated.
You should tell your doctor if you think you are pregnant (or plan to become pregnant). Telmisart Plus is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your child if used during this period (see section Pregnancy).
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Typical symptoms of water-electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle aches or cramps, nausea, vomiting, muscle fatigue and palpitations (more than 100 beats per minute). You should tell your doctor if you experience any of these symptoms.
You should tell your doctor if you experience increased skin sensitivity when exposed to sun, with symptoms of sunburn (such as redness, itching, swelling, rash) that occur more often than usual.
In case of surgery or anesthesia, you should tell your doctor that you are taking Telmisamide Plus.
Telmisad Plus may be less effective in lowering blood pressure in black patients.
Children and adolescents
The use of Telmisid Plus in children and adolescents up to 18 years of age is not recommended.
Other medicines and Telmimed Plus
Tell your doctor or pharmacist if you are taking, have recently taken or can take any other medicines, including
Telmimed Plus may increase the blood pressure lowering effect of other medicines, and you should consult your doctor if it is necessary to adjust the dose of another medicine while taking Telmisamide Plus.
The effect of Telmisart Plus may be reduced when given with NSAIDs (non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen).
Pregnancy and breastfeeding
Pregnancy
You should tell your doctor if you think you are pregnant (or plan to become pregnant). Usually, your doctor will advise you to stop taking Telmisad Plus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of TelmiMed Plus. Telmisart Plus is not recommended during pregnancy and should not be taken if you are pregnant after the third month as it may cause serious harm to your child if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or intend to breast-feed. Telmisad Plus is not recommended for mothers who are breast-feeding and your doctor may have another treatment if you want to breast-feed.
Driving and using machines
Some people feel dizzy or tired when they take Telmisad Plus to treat high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.
Important information about certain ingredients of Telmmed Plus
Telmisad Plus contains milk sugar (lactose).
If you have an intolerance to some sugars, talk to your doctor before taking Telmide Plus.
3. How to take Telmimed Plus
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Telmisid Plus is one tablet a day. Try taking the tablet at the same time each day. You may take Telmmed Plus with or without food. The tablets should be swallowed with some water or other non-alcoholic beverages. It is important to take Telmisam Plus every day until your doctor advises you otherwise. If your liver does not function properly, the usual dose should not exceed 40 mg / 12.5 mg once a day.
If you take more Telmimed Plus than you should
If you accidentally take too many tablets, contact your doctor, pharmacist or the nearest emergency center immediately.
If you forget to take TelmiMed Plus
If you forget to take a dose, do not worry. Take the dose as soon as you remember and then continue taking it in the usual way. If you do not take your tablet the same day, take the usual dose the next day. Do not take a double dose to make up for the missed dose.
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 everyone gets them.
Some side effects may be serious and require immediate attention from a doctor.
Tell your doctor immediately if you experience any of the following symptoms:
Sepsis * (often referred to as "blood poisoning") is a severe infection with an inflammatory process throughout the body, rapid swelling of the skin and mucous membrane (angioedema); these side effects are rare (may affect 1 in 1,000 people) but are very serious and patients should stop taking the medicine and consult a doctor immediately. If not treated, these reactions may be fatal. An increased incidence of sepsis has only been seen with telmisartan, but can not be excluded with Telmisad Plus.
Possible side effects of Telmimed Plus:
Common side effects (may affect 1 in 10 people):
Dizziness.
Uncommon side effects may affect 1 in 100 people):
Decreased blood potassium levels, anxiety, syncope, tingling sensation and numbness (vertigo), rapid heart beat dyspnoea, diarrhea, dry mouth, gas, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to obtain or maintain an erection); chest pain, increased blood uric acid level.
Rare side effects (may affect 1 in 1,000 people):
Inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body causing joint pain, skin rash and fever), sore throat, inflamed sinuses, feeling sad (depression) , difficulty falling asleep (sleeplessness), visual disturbances, difficulty in breathing, abdominal pain, constipation, abdominal distension (dyspepsia), nausea, stomach inflammation (gastritis), hepatic dysfunction (Japanese patients are more likely to develop this undesirable resource
Hydrochlorothiazide
The following side effects have been reported in patients receiving hydrochlorothiazide alone:
Adverse reactions of unknown frequency (frequency can not be estimated from the available data):
Inflammation of the salivary glands, decreased number of blood cells, including reduced number of red and white blood cells, decreased platelet count (thrombocytopenia); severe allergic reactions (eg hypersensitivity, anaphylactic reaction), decreased or loss of appetite; dizziness, blurred vision or yellow eyesight, reduced vision and eye pain (possible signs of acute angio-glaucoma), inflammation of the blood vessels (necrotizing vasculitis), inflammation of the pancreas, irritated stomach, yellowing of the skin or eyes (jaundice) , a lupus-like syndrome (a condition resembling a disease called systemic lupus erythematosus, in which the immune system attacks the body); (such as toxic epidermal necrolysis), weakness, renal inflammation or impaired renal function, presence of glucose in the urine (glucosuria), abnormal liver function tests, fever, impaired electrolyte balance, elevated blood cholesterol levels, decreased blood volume, elevated blood glucose or lipids.
If any of the side effects gets serious, tell your doctor or pharmacist.
5. How to store Telmimed Plus
Store this medicine in a place protected from light and unobstructed for 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.
You must store your medicine in the original (sealed) package to protect the tablets from moisture and light.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines that are not being used. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Telmimed Plus contains
The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
The other ingredients are mannitol, povidone (povidone K25), crospovidone, magnesium stearate, meglumine, sodium hydroxide, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate (type A) and red iron oxide (10E172).
What Telmimed Plus looks like and contents of the pack
Telmimed Plus 80 mg / 12.5 mg are oval, two-layer, white and pink-colored tablets. Telmimed Plus is available in blisters containing 7, 10, 14, 28x1, 30, 30x1, 50, 56, 84, 90, 90x1, 98, 100, 112, 126, 140, 154, 168, 182, 196 tablets.
Not all types of packaging may be marketed in the country.