Telmisartan and hydrochlorothiazide Doc Generici

Package leaflet: Information for the patient

TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets

Generic Medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics are and what they are used for
2. What you need to know before taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics
3. How to take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics
4. Possible side effects
5. How to store TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics
6. Contents of the pack and other information

1. What TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici is and what it is used for

TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these components helps control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartan blocks the effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine flow, thereby contributing to lowering blood pressure.

If left untreated, high blood pressure can damage blood vessels in various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. Therefore, it is important to measure your blood pressure regularly to check whether it is within the normal range.

TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by telmisartan alone.

2. What you should know before taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics

Do not take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics

• if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine
• if you are more than 3 months pregnant (it is best to avoid taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics even in early pregnancy – see section on pregnancy)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other serious liver disease
• if you have severe kidney disease
• if your doctor determines that your blood potassium levels are low or your calcium levels are high and do not improve with treatment
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

If you are in any of these conditions, inform your doctor or pharmacist before taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics.

Warnings and precautions

Talk to your doctor before taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics if you have or have had any of the following conditions or diseases:

• Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive fluid loss) or have a salt deficiency due to diuretic therapy (diuretics), a 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 problems.
• Diabetes.
• Gout.
• Increased levels of aldosterone (fluid and salt retention in the body with imbalance of various electrolytes in the blood).
• Systemic lupus erythematosus (also known as “lupus” or “SLE”), a disease in which the body’s immune system attacks the body itself.
• The active ingredient hydrochlorothiazide may cause an uncommon reaction, resulting in vision loss and eye pain. These could be symptoms of increased pressure in your eye and may occur from hours to weeks after taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics. This condition may lead to permanent vision loss if not treated.

Talk to your doctor, pharmacist, or nurse before taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics:

• if you are taking any of the following medicines used to treat high blood pressure:
  • an “ACE inhibitor” (e.g. enalapril, lisinopril, ramipril, angiotensin-converting enzyme inhibitors), particularly if you have kidney problems related to diabetes
  • aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics.”
• if you are taking digoxin.
• if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics.
• If you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to a week after taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics. If not treated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (see section on pregnancy).

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in the body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling unwell), vomiting, muscle fatigue, and abnormally fast heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

You should also inform your doctor if you experience increased skin sensitivity to sunlight, manifesting as unusually rapid onset of sunburn symptoms (such as redness, itching, swelling, blistering).

If undergoing surgery or receiving anaesthetics, inform your doctor that you are taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics.

TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics may be less effective in lowering blood pressure in black patients.

Children and adolescents

The use of TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics is not recommended in children and adolescents under 18 years of age.

Other medicines and TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to adjust the dose of these other medicines or take additional precautions. In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to the following medicines when taken concurrently with TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics:

• Medicines containing lithium used to treat certain types of depression
• Medicines associated with low blood potassium levels (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), sodium penicillin G (an 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 medicine), and other medicinal products such as sodium heparin (an anticoagulant).
• Medicines affected by changes in blood potassium levels, such as heart medicines (e.g. digoxin) or medicines to control heart rhythm (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. sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g. terfenadine).
• Medicines for the treatment of diabetes (insulin or oral agents such as metformin).
• Cholestyramine and colestipol, medicines to lower blood fat levels.
• Medicines to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (drugs used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia), such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent virus-related illnesses).
• Other substances used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for treating cancer, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the sections: “Do not take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics” and “Warnings and precautions”).
• Digoxin.

TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics may enhance the effect of other medicines used to lower blood pressure or medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).

In addition, blood pressure lowering may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience this drop in blood pressure as dizziness when standing up.

Consult your doctor if you need to adjust the dose of other medicines while taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics.

The effect of TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin and ibuprofen).

TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics with food and alcohol

You may take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics with or without food.

Avoid consuming alcohol before discussing it with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).

Your doctor will usually advise you to stop taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead. TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.

Driving and using machines

Some patients may experience dizziness or fatigue when taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics. If you experience these effects, do not drive or operate machinery.

TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

For athletes

Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Try to take the tablet at the same time each day.
You may take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici with or without food. Swallow the tablets with a little water or another non-alcoholic drink. It is important to take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici every day unless your doctor tells you otherwise.
If your liver does not function properly, the usual dose of 40 mg/12.5 mg per day must not be exceeded.

If you take more TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici than you should
If you have accidentally taken too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function including kidney failure have also been reported. Due to the presence of hydrochlorothiazide, markedly low blood pressure and low blood potassium levels may also occur, which can cause nausea, drowsiness, muscle cramps and/or irregular heartbeat, especially when taking concomitant medications such as digitalis or certain antiarrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici
If you forget to take your medicine, do not worry. Take it as soon as you remember, then continue as before. If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for the forgotten dose.

If you stop taking TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici
If you have any questions about using this medicine, consult 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 can be serious and require immediate medical treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a severe infection with a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), development of blisters and shedding of the outer layer of the 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 must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they can be fatal.
An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be ruled out for TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics.
Possible side effects of TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics:
Common side effects (may affect up to 1 in 10 people):
Dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
Low blood potassium levels, anxiety, fainting (syncope), numbness, tingling sensation (paraesthesia), sensation of spinning (vertigo), rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence (presence of intestinal gas), back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased blood uric acid levels.
Rare side effects (may affect up to 1 in 1,000 people):
Lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rash and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), altered vision, breathing difficulties, abdominal pain, constipation, abdominal swelling (dyspepsia), feeling unwell (nausea), stomach inflammation (gastritis), abnormal liver function (this side effect is more likely in Japanese patients), skin redness (erythema), allergic reactions such as itching or skin rash, increased sweating, urticaria, joint pain (arthralgia) and pain in the extremities, muscle cramps, flu-like illness, pain, low sodium levels, increased blood levels of creatinine, liver enzymes or creatine phosphokinase.
Adverse reactions reported with either of the individual components may also be potential adverse reactions with TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics, even if not observed in clinical studies with this product.
Telmisartan
In patients treated with telmisartan alone, the following additional side effects have been reported:
Uncommon side effects (may affect up to 1 in 100 people):
Upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), urinary tract infections, reduced red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), impaired kidney function including acute kidney failure, feeling of 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), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach disorder, eczema (skin disorder), osteoarthritis, tendon inflammation, decreased haemoglobin (a blood protein), drowsiness.
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 occurred by chance or could be related to a currently unknown mechanism.
**Cases of progressive scarring of lung tissue have been reported during telmisartan treatment. However, it is not known whether telmisartan was the cause.
Hydrochlorothiazide
In patients treated with hydrochlorothiazide alone, the following additional side effects have been observed:
Common side effects (may affect up to 1 in 10 people):
Malaise (nausea), low blood magnesium levels.
Rare side effects (may affect up to 1 in 1,000 people):
Reduced platelet count, increasing the risk of bleeding or bruising (small purple-red spots on the skin or other tissues due to bleeding), high blood calcium levels, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increase in pH (altered acid-base balance) due to low blood chloride levels.
Side effects of unknown frequency (frequency cannot be determined from available data):
Inflammation of the salivary glands, decreased number (or even absence) of blood cells, including reduced red and white blood cell counts, severe allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of acute myopia or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), pancreatitis, stomach disorder, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition similar to systemic lupus erythematosus, in which the immune system attacks the body itself); skin disorders such as inflammation of skin blood vessels, increased sensitivity to sunlight, skin rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, kidney inflammation or altered kidney function, glucose in urine (glycosuria), fever, electrolyte imbalance, elevated blood cholesterol levels, reduced blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or blood fat levels, skin and lip cancer (non-melanoma skin cancer). – Decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generics

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 packaging after EXP. The expiry date refers to the last day of that month.
[For Al/Al blisters]:
This medicine does not require any special storage conditions.
[For Al/PVC/PVDC blisters]:
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 40 mg/12.5: the active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 80 mg/12.5 mg: the active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 80 mg/25 mg: the active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other components are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).

Description of the appearance of TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici and package contents
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 40 mg/12.5 mg tablets are white or almost white, oval-shaped, biconvex tablets of 6.55 x 13.6 mm, marked with "TH" on one side.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 80 mg/12.5 mg tablets are white or almost white, capsule-shaped tablets of 9.0 x 17.0 mm, marked with "TH 12.5" on both sides.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 80 mg/25 mg tablets are white or almost white, oval-shaped, biconvex tablets of 9.0 x 17.0 mm, marked with "TH" on one side and "25" on the other side.

Packaging
28 tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy

Responsible manufacturers for batch release
Actavis Ltd., BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Telmisartan/hydrochlorothiazide “DOC Generici”
Italy: TELMISARTAN AND HYDROCHLOROTHIAZIDE DOC Generici