Telmisartan and hydrochlorothiazide Sandoz

Italy
Brand name Telmisartan and hydrochlorothiazide Sandoz
Form tablets
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 042504
Manufacturer SANDOZ S.P.A.
Telmisartan and hydrochlorothiazide Sandoz tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Telmisartan and Hydrochlorothiazide Sandoz 40 mg/12.5 mg film-coated tablets, 80 mg/12.5 mg film-coated tablets, 80 mg/25 mg film-coated tablets

Equivalent 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Telmisartan and Hydrochlorothiazide Sandoz is and what it is used for
  2. What you need to know before taking Telmisartan and Hydrochlorothiazide Sandoz
  3. How to take Telmisartan and Hydrochlorothiazide Sandoz
  4. Possible side effects
  5. How to store Telmisartan and Hydrochlorothiazide Sandoz
  6. Contents of the pack and other information

1. What Telmisartan and Hydrochlorothiazide Sandoz is and what it is used for

Telmisartan and Hydrochlorothiazide Sandoz is a combination of two active substances, telmisartan and
hydrochlorothiazide, in a single tablet. Both of these substances help 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, allowing blood vessels to relax and thus reducing blood pressure.
  • Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine flow, resulting in a reduction of blood pressure.

If 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 regularly check your blood pressure to ensure it remains within the normal range.
Telmisartan and Hydrochlorothiazide Sandoz 40 mg/12.5 mg is used to treat high blood pressure
(essential hypertension) in adults whose blood pressure is not sufficiently controlled by telmisartan alone.
Telmisartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg is used to treat high blood pressure
(essential hypertension) in adults whose blood pressure is not sufficiently controlled by telmisartan alone.
Telmisartan and Hydrochlorothiazide Sandoz 80 mg/25 mg is used to treat high blood pressure
(essential hypertension) in adults whose blood pressure is not adequately controlled with Telmisartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg, or in patients who have been previously stabilized on telmisartan and hydrochlorothiazide given separately.

2. What you need to know before taking Telmisartan and Hydrochlorothiazide Sandoz

DO NOT take Telmisartan and Hydrochlorothiazide Sandoz

  • 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 Sandoz even in the early stages of pregnancy – see section “Pregnancy”)
  • if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the gallbladder) or any other serious liver disease
  • if you have severe kidney disease
  • if your doctor detects low levels of potassium or high levels of calcium in the blood that do not improve with treatment
  • if you have diabetes or reduced kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

If any of these conditions apply to you, inform your doctor or pharmacist before taking
Telmisartan and Hydrochlorothiazide Sandoz.
Warnings and precautions
Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Sandoz if you have or have ever had any of the following conditions or diseases:

  • Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy, 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 (water and salt retention in the body with imbalance of various minerals in the blood).

  • Systemic lupus erythematosus (also called “lupus” or “SLE”), a disease in which the body’s immune system attacks the body itself.

  • The active substance hydrochlorothiazide may cause an uncommon reaction leading to vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, and may occur from hours to weeks after taking telmisartan/hydrochlorothiazide. If left untreated, this condition may lead to permanent vision damage. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms.

  • If you have previously had skin cancer or if you develop an unexpected skin lesion 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 exposure and UV radiation while taking Telmisartan and Hydrochlorothiazide Sandoz.

Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Sandoz:

  • if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Telmisartan and Hydrochlorothiazide Sandoz”.
  • if you are taking digoxin, a medicine used to treat heart conditions

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Telmisartan and Hydrochlorothiazide Sandoz 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 the unborn child (see section “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, which manifests as faster onset than normal of sunburn symptoms (such as redness, itching, swelling, or blistering).
If undergoing surgery or receiving anaesthetics, inform your doctor that you are taking Telmisartan and Hydrochlorothiazide Sandoz.
Telmisartan and Hydrochlorothiazide Sandoz may be less effective in lowering blood pressure in black patients.
Children and adolescents
The use of Telmisartan and Hydrochlorothiazide Sandoz is not recommended in children and adolescents under 18 years of age.
Other medicines and Telmisartan and Hydrochlorothiazide Sandoz
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 and/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 taken concurrently with Telmisartan and Hydrochlorothiazide Sandoz:

  • Medicines containing lithium, used to treat certain types of depression.

  • Medicines associated with low potassium levels in the blood (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 potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant medicine), and other medicines such as sodium heparin (an anticoagulant).

  • Heart medicines (e.g. digoxin) or medicines used to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol).

  • Medicines for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine).

  • Certain antibiotics (e.g. sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g. terfenadine).

  • Medicines for treating diabetes (insulins or oral agents such as metformin).

  • Cholestyramine and colestipol, medicines used to lower blood fat levels.

  • Medicines to increase blood pressure, such as noradrenaline.

  • Muscle relaxants, such as tubocurarine.

  • Anticholinergic medicines (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 certain viral infections).

  • Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines used to treat cancer, gout or arthritis, calcium and/or vitamin D supplements.

  • An ACE inhibitor or aliskiren (see also the sections “Do not take Telmisartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”).

  • Digoxin, a medicine used to treat heart conditions.

Telmisartan and Hydrochlorothiazide Sandoz may enhance the effect of other medicines used to treat high blood pressure or medicines with potential blood pressure-lowering effects (e.g. baclofen, amifostine). In addition, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. Contact your doctor if you need to adjust the dose of other medicines while taking Telmisartan and Hydrochlorothiazide Sandoz.
The effect of Telmisartan and Hydrochlorothiazide Sandoz may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid and ibuprofen).
Telmisartan and Hydrochlorothiazide Sandoz and alcohol
Avoid drinking alcohol until you have spoken with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
Your doctor will normally advise you to stop taking Telmisartan and Hydrochlorothiazide Sandoz before becoming pregnant or as soon as pregnancy is detected, and will recommend an alternative medicine. Telmisartan and Hydrochlorothiazide Sandoz 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 unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Telmisartan and Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.
Driving and using machines
Some patients may experience dizziness or drowsiness when taking Telmisartan and Hydrochlorothiazide Sandoz. If you experience these effects, do not drive or operate machinery.
Telmisartan and Hydrochlorothiazide Sandoz contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Telmisartan and Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’

3. How to take Telmisartan and Hydrochlorothiazide Sandoz

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Telmisartan and Hydrochlorothiazide Sandoz is one tablet daily. Try to take the tablet at the same time each day. You may take Telmisartan and Hydrochlorothiazide Sandoz with or without food. Swallow the tablets with a little water or another non-alcoholic drink. It is important to take Telmisartan and Hydrochlorothiazide Sandoz every day unless otherwise instructed by your doctor.
If your liver is not functioning properly, the usual dose should not exceed 40 mg/12.5 mg once daily.
If you take more Telmisartan and Hydrochlorothiazide Sandoz 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 potassium levels may also occur, which can lead to nausea, drowsiness, muscle cramps and/or irregular heartbeat, particularly when used concomitantly with medicines such as digitalis or certain antiarrhythmic treatments.
Contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.
If you forget to take Telmisartan and Hydrochlorothiazide Sandoz
If you forget to take a dose, do not worry. Take it as soon as you remember, then continue as before. If you miss a tablet for one day, take your usual dose the next day. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of 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 poisoning") is a severe infection with a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), blisters and peeling of the top 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. Patients must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal. With telmisartan alone, an increased incidence of sepsis has been observed, which cannot therefore be ruled out for Telmisartan and Hydrochlorothiazide Sandoz.
Possible side effects of Telmisartan and Hydrochlorothiazide Sandoz
Common side effects (may affect up to 1 in 10 people):

  • dizziness

Uncommon side effects (may affect up to 1 in 100 people):

  • low potassium levels in the blood
  • anxiety
  • fainting (syncope)
  • numbness sensation
  • tingling sensation (paraesthesia)
  • sensation of dizziness (vertigo)
  • fast heartbeat (tachycardia)
  • heart rhythm disorders
  • low blood pressure
  • sudden drop in blood pressure upon standing
  • shortness of breath (dyspnoea)
  • diarrhoea
  • dry mouth
  • flatulence
  • back pain
  • muscle spasm
  • muscle pain
  • erectile dysfunction (inability to achieve or maintain an erection)
  • chest pain
  • increased levels of uric acid in the blood.

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

  • inflammation of the lungs (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)
  • vision disturbances
  • breathing difficulties
  • abdominal pain
  • constipation
  • bloating (dyspepsia)
  • feeling of malaise (vomiting)
  • inflammation of the stomach (gastritis)
  • abnormal liver function (Japanese patients are more likely to experience this side effect)
  • rapid swelling of the skin and mucous membranes which may also be fatal (angioedema, including fatal outcome)
  • skin redness (erythema)
  • allergic reactions such as itching or skin rash
  • increased sweating
  • skin rash (urticaria)
  • joint pain (arthralgia) and limb pain
  • muscle cramps
  • flu-like illness
  • pain
  • low sodium levels
  • increased levels of creatinine, liver enzymes or creatine phosphokinase in the blood.

Side effects reported with one of the individual components may also be potential side effects with Telmisartan and Hydrochlorothiazide Sandoz, even if they have not been observed in clinical studies with this medicine.
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), elevated potassium levels, slowed heartbeat (bradycardia), kidney damage, including acute kidney failure, feeling of weakness, cough.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood poisoning”, a severe infection with systemic inflammatory response, which may lead to death), 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 ache, eczema (a skin disorder), osteoarthritis, inflammation of 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 occurred by chance or could be related to a currently unknown mechanism.
**Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. 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):
Feeling of malaise (nausea), low magnesium levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Reduced platelets in the blood (thrombocytopenia), increasing the risk of bleeding or bruising (small red-purple spots on the skin or other tissues caused by bleeding), high calcium levels in the blood, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increased pH (disturbed acid-base balance) due to low chloride levels in the blood.
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 low 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 fluid accumulation in the vascular layer of the eye (choroidal effusion) or of acute myopia or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), inflammation of the pancreas, stomach ache, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking systemic lupus erythematosus, in which the immune system attacks the body itself); skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight, skin rash, redness of the skin, appearance of blisters on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), feeling of weakness, inflammation of the kidneys or altered kidney function, presence of glucose in the urine (glucosuria), fever, electrolyte imbalance, elevated cholesterol levels in the blood, reduced blood volume, increased 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).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C. Keep in the original blister pack to protect the medicine from moisture.
Do not use this medicine if you notice any change in its appearance.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Telmisartan and Hydrochlorothiazide Sandoz Contains
The active substances are telmisartan and hydrochlorothiazide.
Telmisartan and Hydrochlorothiazide Sandoz 40 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Telmisartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Telmisartan and Hydrochlorothiazide Sandoz 80 mg/25 mg film-coated tablets
Each film-coated tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

Other components:
Telmisartan and Hydrochlorothiazide Sandoz 40 mg/12.5 mg film-coated tablets
Tablet core: sodium hydroxide, meglumine, povidone K25 (E1201), monohydrate lactose,
povidone K30 (E1201), crospovidone (type A) (E1202), anhydrous lactose, magnesium stearate (E572)
Tablet coating: polyvinyl alcohol-alcohol units (E1203), polyethylene glycol (E1521), anhydrous colloidal silica (E551), monohydrate citric acid (E330), yellow iron oxide (E172), red iron oxide (E172)

Telmisartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg film-coated tablets
Tablet core: sodium hydroxide, meglumine, povidone K25 (E1201), monohydrate lactose,
povidone K30 (E1201), crospovidone (type A) (E1202), anhydrous lactose, magnesium stearate (E572)
Tablet coating: polyvinyl alcohol-alcohol units (E1203), polyethylene glycol (E1521), anhydrous colloidal silica (E551), monohydrate citric acid (E330)

Telmisartan and Hydrochlorothiazide Sandoz 80 mg/25 mg film-coated tablets
Tablet core: sodium hydroxide, meglumine, povidone K25 (E1201), monohydrate lactose,
povidone K30 (E1201), crospovidone (type A) (E1202), anhydrous lactose, magnesium stearate (E572)
Tablet coating: polyvinyl alcohol-alcohol units (E1203), polyethylene glycol (E1521), anhydrous colloidal silica (E551), monohydrate citric acid (E330), yellow iron oxide (E172)

For further information on lactose, see the end of section 2.

Description of the Appearance of Telmisartan and Hydrochlorothiazide Sandoz and the Contents of the Package
Telmisartan and Hydrochlorothiazide Sandoz 40 mg/12.5 mg film-coated tablets
Red, oval, biconvex film-coated tablet, engraved with "40" on one side and "12.5" on the other (12.4 x 6.2 mm).

Telmisartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg film-coated tablets
Film-coated tablet ranging from white to almost white, oval, biconvex, engraved with "80" on one side and "12.5" on the other (15.4 x 8.0 mm).

Telmisartan and Hydrochlorothiazide Sandoz 80 mg/25 mg film-coated tablets
Yellow, oval, biconvex film-coated tablet, engraved with "80" on one side and "25" on the other (15.4 x 8.0 mm).

Al/Al blisters containing 7, 14, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz SpA
Largo U. Boccioni 1
21040 Origgio VA
Italy

Responsible Manufacturers for Batch Release
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia

LEK S.A.
Administrative site
ul. Podlipie 16, 95-010 Stryków
Poland
Production site
ul. Domaniewska 50 C, 02-672 Warszawa
Poland

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany

S.C. Sandoz, S.R.L.
Str. Livezeni nr. 7A, RO-540472 Târgu-Mureș
Romania

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Netherlands
Telmisartan/Hydrochloorthiazide Sandoz 40/12.5 mg, omhulde tabletten
Telmisartan/Hydrochloorthiazide Sandoz 80/12.5 mg, omhulde tabletten
Telmisartan/Hydrochloorthiazide Sandoz 80/25 mg, omhulde tabletten

Austria
Telmisartan/Hydrochlorothiazid Sandoz 40 mg/12.5 mg – überzogene tabletten
Telmisartan/Hydrochlorothiazid Sandoz 80 mg/12.5 mg – überzogene tabletten
Telmisartan/Hydrochlorothiazid Sandoz 80 mg/25 mg – überzogene tabletten

Belgium
Telmisartan/Hydrochloorthiazide Sandoz 40/12.5 mg omhulde tablet
Telmisartan/Hydrochloorthiazide Sandoz 80/12.5 mg omhulde tablet
Telmisartan/Hydrochloorthiazide Sandoz 80/25 mg omhulde tablet

Bulgaria
Telmisartan/Hydrochlorthiazide Sandoz 40/12.5 mg coated tablets
Telmisartan/Hydrochlorthiazide Sandoz 80/12.5 mg coated tablets

Cyprus
Telmisartan/hydrochlorothiazide Sandoz 40/12.5 mg coated tablets
Telmisartan/hydrochlorothiazide Sandoz 80/12.5 mg coated tablets
Telmisartan/hydrochlorothiazide Sandoz 80/25 mg coated tablets

Czech Republic
Telmisartan/Hydrochlorothiazid Sandoz 80 mg/12.5 mg
Telmisartan/Hydrochlorothiazid Sandoz 80 mg/25 mg

Germany
Telmisartan/Hydrochlorothiazid - 1 A Pharma 40/12.5 mg überzogene tabletten
Telmisartan/Hydrochlorothiazid - 1 A Pharma 80/12.5 mg überzogene tabletten
Telmisartan/Hydrochlorothiazid - 1 A Pharma 80/25 mg überzogene tabletten

Estonia
Telmisartan/Hydrochlorothiazide Sandoz
Telmisartan/Hydrochlorothiazide Sandoz
Telmisartan/Hydrochlorothiazide Sandoz

Greece
Telmisartan / Hydrochlorothiazide Sandoz

Spain
Telmisartán/Hidroclorotiazida Placasod 40mg/12.5mg comprimidos recubiertos EFG
Telmisartán/Hidroclorotiazida Placasod 80mg/12.5mg comprimidos recubiertos EFG
Telmisartán/Hidroclorotiazida Placasod 80mg/25mg comprimidos recubiertos EFG

Finland
Telmisartan/Hydrochlorothiazide Sandoz

France
TELMISARTAN/HYDROCHLOROTHIAZIDE GNR 40 mg/12.5 mg, comprimé enrobé
TELMISARTAN/HYDROCHLOROTHIAZIDE GNR 80 mg/12.5 mg, comprimé enrobé
TELMISARTAN/HYDROCHLOROTHIAZIDE GNR 80 mg/25 mg, comprimé enrobé

Italy
Telmisartan e Idroclorotiazide Sandoz 40 mg/12.5 mg compresse rivestite
Telmisartan e Idroclorotiazide Sandoz 80 mg/12.5 mg compresse rivestite
Telmisartan e Idroclorotiazide Sandoz 80 mg/25 mg compresse rivestite

Lithuania
Telmisartan/Hydrochlorothiazide Sandoz 40mg/12.5 mg dengtos tabletės
Telmisartan/Hydrochlorothiazide Sandoz 80mg/12.5 mg dengtos tabletės
Telmisartan/Hydrochlorothiazide Sandoz 80mg/25 mg dengtos tabletės

Luxembourg
Telmisartan/Hydrochloorthiazide Sandoz 40/12.5 mg comprimé enrobé
Telmisartan/Hydrochloorthiazide Sandoz 80/12.5 mg comprimé enrobé
Telmisartan/Hydrochloorthiazide Sandoz 80/25 mg comprimé enrobé

Latvia
Telmisartan/Hydrochlorothiazide Sandoz 40 mg/12.5 mg apvalkotās tabletes
Telmisartan/Hydrochlorothiazide Sandoz 80 mg/12.5 mg apvalkotās tabletes
Telmisartan/Hydrochlorothiazide Sandoz 80 mg/25 mg apvalkotās tabletes

Poland
Telmisartan /Hydrochlorothiazide Sandoz

Portugal
Telmisartan + Hidroclorotiazida Sandoz

Slovenia
Telmisartan /hidroklorotiazid Lek 40/12.5 mg obložene tablete
Telmisartan /hidroklorotiazid Lek 80/12.5 mg obložene tablete
Telmisartan /hidroklorotiazid Lek 80/25 mg obložene tablete

Slovak Republic
Telmisartan/Hydrochlorothiazid Sandoz 80 mg/12.5 mg
Telmisartan/Hydrochlorothiazid Sandoz 80 mg/25 mg
Telmisartan/Hydrochlorothiazid Sandoz 40 mg/12.5 mg