Do not take Telmisartan/Hydrochlorothiazide:

• if you are allergic to telmisartan or any of the 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 this medicine 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, do not take the tablets and tell your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking this medicine 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 fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Telmisartan/Hydrochlorothiazide. This can lead to permanent vision impairment, if not treated.

Talk to your doctor before taking Telmisartan/Hydrochlorothiazide:

• 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/Hydrochlorothiazide”

• if you are taking digoxin.
• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
  Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Telmisartan/Hydrochlorothiazide.
• If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Telmisartan/Hydrochlorothiazide, seek medical attention immediately.

You must tell your doctor if you think you are (or might become) pregnant.

Telmisartan/Hydrochlorothiazide 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 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 this medicine.

These tablets may be less effective in lowering the blood pressure in black patients.

Children and adolescents

This medicine is not recommended in children and adolescents up to the age of 18 years.

Other medicines and Telmisartan/Hydrochlorothiazide:

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/Hydrochlorothiazide:

• 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.
• Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, ciclosporin (an immunosuppressant drug) and other medicinal products such as heparin sodium (an anticoagulant)
• Medicines that are affected by changes of the blood potassium level such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (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. sparfloxacine, pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
• Cholestyramine and colestipol, medicines for lowering blood fat levels.
• Medicines to increase blood pressure, such as noradrenaline.
• Muscle relaxing medicines, such as tubocurarine. – Calcium supplements and/or vitamin D supplements.
• Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson’s disease and as an aid to anaesthesia) such as atropine and biperiden.
• Amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain illnesses caused by viruses).
• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan/Hydrochlorothiazide” and “Warnings and precautions”).
• Digoxin.

Telmisartan/Hydrochlorothiazide 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/Hydrochlorothiazide.

The effect of Telmisartan/Hydrochlorothiazide may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).

Telmisartan/Hydrochlorothiazide with food and alcohol

You can take Telmisartan/Hydrochlorothiazide with or without food. Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

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 this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Telmisartan/Hydrochlorothiazide. These 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 breast-feeding. These 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/Hydrochlorothiazide. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan/Hydrochlorothiazide contains milk sugar (lactose)

If you are intolerant to some sugars, consult your doctor before taking this medicine.