Telmix plus

Package leaflet: Information for the user

Telmix Plus, 40 mg + 12.5 mg, tablets
Telmix Plus, 80 mg + 12.5 mg, tablets
Telmix Plus, 80 mg + 25 mg, tablets
Telmisartan + Hydrochlorothiazide
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Telmix Plus is and what it is used for
2. Important information before taking Telmix Plus
3. How to take Telmix Plus
4. Possible side effects
5. How to store Telmix Plus
6. Contents of the pack and other information

1. What Telmix Plus is and what it is used for

Telmix Plus is a combination medicine containing two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Both substances help control high blood pressure.
Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to widen and blood pressure to decrease.
Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics. It increases urine output, which leads to a reduction in blood pressure.
Untreated high blood pressure may damage blood vessels in various organs and may lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before such complications occur. Therefore, it is important to measure blood pressure regularly to ensure it remains within normal limits.
Telmix Plus 40 mg + 12.5 mg is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.
Telmix Plus 80 mg + 12.5 mg is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.
Telmix Plus 80 mg + 25 mg is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with Telmix Plus 80 mg + 12.5 mg, or in adults whose blood pressure has been controlled by taking telmisartan and hydrochlorothiazide as separate medicines.

2. Important information before using Telmix Plus

When not to use Telmix Plus:

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to hydrochlorothiazide or to other sulfonamide derivatives;
• after the third month of pregnancy (Telmix Plus should also be avoided during early pregnancy – see section “Pregnancy”);
• if the patient has severe liver disease, such as biliary obstruction or cholestasis (impaired bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has severe kidney disease;
• if the doctor has diagnosed low blood potassium levels or high blood calcium levels that do not improve with treatment;
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

Before taking Telmix Plus, inform your doctor or pharmacist if any of the above conditions apply to you.

Warnings and precautions

Inform your doctor if the patient has or has had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water), has low sodium levels due to diuretic (water tablet) treatment, follows a low-sodium diet, has diarrhoea or vomiting, or is undergoing haemodialysis;
• kidney disease or has had a kidney transplant;
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
• liver disease;
• heart disease;
• diabetes;
• gout;
• elevated aldosterone levels (retention of water and sodium in the body, with electrolyte imbalances);
• systemic lupus erythematosus (also known as lupus or SLE) – a disease in which the immune system attacks the body itself.

Before starting Telmix Plus, discuss with your doctor:

• if the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, especially if the patient has kidney problems related to diabetes;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section “When not to use Telmix Plus.”
  • if the patient is taking digoxin,
  • if the patient has previously had skin cancer or develops an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Telmix Plus, protect the skin from sunlight and UV radiation.
  • if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Telmix Plus. Untreated, they may lead to permanent vision loss. The risk of these adverse effects may be higher in patients who previously had an allergy to penicillin or sulfonamides.
  • if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Telmix Plus, seek immediate medical help.

Inform your doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. Telmix Plus is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).

Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body. Typical symptoms of fluid and electrolyte imbalance include: dryness of the mucous membranes in the mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (faster than 100 beats per minute). If any of these symptoms occur, inform your doctor.

Also inform your doctor if the patient experiences skin hypersensitivity to sunlight, such as sunburn (e.g. redness, itching, swelling, blistering) occurring more easily than usual.

If a surgical procedure or anaesthesia is planned, inform the doctor about taking Telmix Plus.

Telmix Plus may be less effective in lowering blood pressure in black patients.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Telmix Plus, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Telmix Plus on your own.

Children and adolescents

Telmix Plus is not recommended for use in children and adolescents under 18 years of age.

Telmix Plus and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The doctor may recommend adjusting the dose of these medicines or taking other precautions. In some cases, it may be necessary to discontinue one of the medicines.

This especially applies to concomitant use of Telmix Plus with any of the following medicines:

• lithium preparations, used in the treatment of certain types of depression;
• medicines that reduce blood potassium levels (hypokalaemia), such as other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium benzyloxypenicillin (antibiotic), salicylic acid and its derivatives;
• medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines, e.g. heparin (an anticoagulant);
• medicines whose effects are influenced by changes in blood potassium levels, such as heart medicines (e.g. digoxin), medicines used to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used to treat psychiatric disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines, e.g. certain antibiotics (sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (terfenadine);
• antidiabetic medicines (insulin or oral medicines such as metformin);
• cholestyramine and colestipol, used to reduce blood lipid levels;
• medicines that increase blood pressure, e.g. noradrenaline;
• muscle relaxants, e.g. tubocurarine;
• calcium supplements and/or vitamin D;
• anticholinergic medicines (used to treat various disorders, e.g. painful intestinal spasms, bladder spasms, asthma, locomotor disorders, muscle spasms, Parkinson’s disease, and as an adjunct during anaesthesia), e.g. atropine and biperiden;
• amantadine (used to treat Parkinson’s disease and to treat and prevent certain viral diseases);
• other medicines used to treat hypertension, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs – NSAIDs), medicines used to treat cancer, gout, or arthritis;
• ACE inhibitors or aliskiren (see also sections “When not to use Telmix Plus” and “Warnings and precautions”).

Telmix Plus may enhance the blood pressure-lowering effect of other medicines used to treat hypertension or medicines that may lower blood pressure (e.g. baclofen, amifostine). In addition, low blood pressure may be further reduced by: alcohol, barbiturates, opioids, or antidepressants. A symptom is dizziness upon standing. If dose adjustment of another medicine taken during Telmix Plus treatment is needed, consult your doctor.

NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen) may reduce the effectiveness of Telmix Plus.

Telmix Plus with food, drink and alcohol

Telmix Plus can be taken with or without food.

Avoid drinking alcohol while taking Telmix Plus. Alcohol may increase the blood pressure-lowering effect and increase the risk of dizziness or fainting.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Pregnancy

Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. Usually, the doctor will advise stopping Telmix Plus before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Telmix Plus is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Telmix Plus is not recommended during breastfeeding. The doctor may recommend alternative treatment if the patient wishes to breastfeed.

Driving and using machines

Some patients taking Telmix Plus may experience dizziness or fatigue. In such cases, do not drive or operate machinery.

Telmix Plus contains sugar (lactose) and mannitol, and sodium

If the patient has an intolerance to certain sugars, consult your doctor before using Telmix Plus.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Telmix Plus

Telmix Plus must always be taken according to the doctor's instructions. If in doubt,
consult your doctor or pharmacist.
The recommended dose of Telmix Plus for adults is one tablet daily. Try to take the tablet
at the same time each day. Telmix Plus may be taken with or between meals. Swallow the tablet
with water or a non-alcoholic drink. It is important to take Telmix Plus every day, unless
otherwise advised by your doctor.
If a patient has impaired liver function, the daily dose must not exceed 40 mg of telmisartan and
12.5 mg of hydrochlorothiazide.
Taking more Telmix Plus than recommended
Taking more tablets than recommended may cause low blood pressure and increased heart rate.
Slowed heart rate, dizziness, vomiting, and worsening of kidney function, including kidney failure,
have also been reported. Due to the presence of hydrochlorothiazide, marked lowering of blood
pressure and decreased potassium levels in the blood may occur, which could lead to nausea,
drowsiness, muscle cramps, and/or cardiac arrhythmias, particularly when used concomitantly with
drugs such as cardiac glycosides or certain antiarrhythmic agents. Seek immediate medical
advice or go to the nearest hospital emergency department.
If you miss a dose of Telmix Plus
If you miss a dose, take it as soon as possible and then return to your regular dosing schedule.
However, if more than 12 hours have passed, skip the missed dose and take your next dose at the
usual time the following day. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention.
If any of the following symptoms occur, contact your doctor immediately:

• sepsis* (commonly known as blood poisoning, a severe infection causing systemic inflammatory response),
• sudden swelling of the skin and mucous membranes (angioedema),
• blistering and peeling of the outer layers of skin (toxic epidermal necrolysis).
  The above adverse reactions are rare (occurring in fewer than 1 in 1,000 patients) or of unknown frequency (toxic epidermal necrolysis), but are extremely serious. If they occur, discontinue the medicine immediately and contact your doctor. If left untreated, these symptoms may result in death.

* An increased incidence of sepsis has been observed in individuals taking telmisartan as monotherapy; however, it cannot be excluded in patients treated with Telmix Plus. This phenomenon may be coincidental or related to a mechanism not yet understood.

Possible adverse reactions of Telmix Plus

Common adverse reactions (may occur in fewer than 1 in 10 patients):

• dizziness.

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):

• decreased blood potassium levels, anxiety, fainting, tingling and numbness (paresthesia), sensation of spinning (vestibular vertigo), increased heart rate (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath, diarrhea, dryness of the oral mucosa, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels.

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):

• lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rash, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), visual disturbances, breathing difficulties, abdominal pain, constipation, bloating (dyspepsia), nausea/vomiting, inflammation of the gastric mucosa, liver function abnormalities (more frequent in patients of Japanese origin), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain, muscle cramps, influenza-like symptoms, pain, low sodium levels, increased creatinine levels, increased blood liver enzyme activity or creatine phosphokinase.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the avascular membrane surrounding the eye – excessive fluid accumulation between the choroid and sclera or acute angle-closure glaucoma).

Adverse reactions reported for individual components may also occur during treatment with Telmix Plus, even if they were not observed during clinical trials of the combination product containing telmisartan and hydrochlorothiazide.

Telmisartan

Additional adverse reactions observed in patients receiving telmisartan alone:

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):

• upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), urinary tract infections, decreased number of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), kidney function disturbances, including acute kidney failure, fatigue, cough.

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):

• low platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, drug rash), low blood glucose levels (in patients with diabetes), gastritis, skin rash (dermatosis), osteoarthritis, tendonitis, decreased hemoglobin levels (blood protein), somnolence.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):

• progressive lung tissue fibrosis (interstitial lung disease)**

Frequency unknown (cannot be determined from available data):

• intestinal angioedema – following administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported.

** Cases of progressive lung tissue fibrosis temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.

Hydrochlorothiazide

Additional adverse reactions observed in patients receiving hydrochlorothiazide alone:

Common adverse reactions (may occur in fewer than 1 in 10 patients):

• nausea, low blood magnesium levels.

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):

• decreased platelet count, increasing the risk of bleeding or bruising, high blood calcium levels, headache.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):

• increased pH (acid-base imbalance) due to low chloride levels in blood.
• acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue, and confusion).

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• sialadenitis (inflammation of the salivary glands), decreased number (or even absence) of blood cells, including low numbers of red and white blood cells, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, sensation of "emptiness" in the head, blurred vision or yellow vision, visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the avascular membrane surrounding the eye – excessive fluid accumulation between the choroid and sclera or acute angle-closure glauka), vasculitis (necrotizing vasculitis), pancreatitis, gastritis, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering on lips, eyes or oral mucosa, skin peeling, fever (possible symptoms of erythema multiforme), fatigue, kidney inflammation or kidney function disturbances, presence of glucose in urine (glucosuria), fever, electrolyte imbalance, high blood cholesterol levels, decreased blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels (in patients with diagnosed diabetes), increased blood lipid levels, malignant skin and lip tumors (non-melanoma skin cancers).

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Telmix Plus

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after “Expiry date (EXP)” and on the blister after “EXP”. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Telmix Plus contains

• The active substances are: telmisartan and hydrochlorothiazide.

Each tablet with a strength of 40 mg + 12.5 mg contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Each tablet with a strength of 80 mg + 12.5 mg contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Each tablet with a strength of 80 mg + 25 mg contains 80 mg telmisartan and 25 mg hydrochlorothiazide.

• Other ingredients are: mannitol, sodium hydroxide, meglumine, povidone K30, magnesium stearate, sodium stearyl fumarate, lactose monohydrate, microcrystalline cellulose (PH101), iron oxide yellow (E172), iron oxide red (E 172).

What Telmix Plus looks like and contents of the pack
Telmix Plus, 40 mg + 12.5 mg, tablets
White or almost white on one side, red marbled with possible specks on the other side, biconvex, two-layer, elongated tablets with the letter T1 embossed on the red side and smooth on the other.
Telmix Plus, 80 mg + 12.5 mg
White or almost white on one side, red marbled with possible specks on the other side, biconvex, two-layer, elongated tablets with the letter T2 embossed on the red side and smooth on the other.
Telmix Plus, 80 mg + 25 mg
White or almost white on one side, yellow marbled with possible specks on the other side, biconvex, two-layer, elongated tablets with the letter T2 embossed on the yellow side and smooth on the other.
The medicine is packed in blisters made of OPA/Aluminium/PVC/Aluminium and placed in a cardboard box.
Pack contents: 7, 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland

Manufacturer/Importer
Laboratori Fundació DAU
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain