Telmisartan 80mg Glenmark Film-coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic (hypersensitive) to telmisartan or any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is also better to avoid Telmisartan Glenmark in early pregnancy – see pregnancy section.)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
• 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, tell your doctor or pharmacist before taking Telmisartan Glenmark

Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart trouble.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• 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, or vomiting.
• Elevated potassium levels in your blood.
• Diabetes.

Talk to your doctor before taking Telmisartan Glenmark:

• 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 Glenmark”.
• if you are taking digoxin.

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

In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Glenmark.

Telmisartan Glenmark may be less effective in lowering the blood pressure in black patients.

The use of Telmisartan Glenmark in children and adolescents up to the age of 18 years is not recommended.

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 medicines 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 Glenmark:

• Lithium containing medicines to treat some types of depression.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics ('water tablets'), especially if taken in high doses together with Telmisartan Glenmark, may lead to excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Glenmark” and “Warning and precautions”).
• Digoxin

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

Telmisartan Glenmark 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 Glenmark.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Telmisartan Glenmark before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Glenmark. Telmisartan Glenmark is not recommended in early 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. Telmisartan Glenmark is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Some people feel dizzy or tired when taking Telmisartan Glenmark. If you feel dizzy or tired, do not drive or operate machinery.

If you are intolerant to some sugars, consult your doctor before taking Telmisartan Glenmark.

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

Do not stop taking Telmisartan Glenmark without talking to your doctor.

Medicines for high blood pressure may need to be taken for the rest of your life. If you stop taking Telmisartan Glenmark your blood pressure will return to the level it was before treatment in a few days.

You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare but are extremely serious and patients should stop taking the product and see their doctor immediately. If these effects are not treated they could be fatal.

Common side effects (may affect up to 1 in 10 people):

Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

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

Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension), in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

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

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, taste disturbance (dysgeusia), abnormal liver function(Japanese patients are more likely to experience these side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.

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 happened by chance or could be related to a mechanism currently not known.

**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is telmisartan, each tablet contains 20mg/40mg/80mg telmisartan.

The other ingredients are: sodium hydroxide, povidone (K-25), meglumine, lactose monohydrate, crospovidone, ferric oxide yellow (E172), magnesium stearate.

The film-coating contains: hypromellose, titanium dioxide (E171), macrogol-400, talc, ferric oxide yellow (E172).

Telmisartan 20mg Glenmark film-coated tablets are yellow, circular shaped film coated tablets with ‘20’ engraved on one side and ‘T’ engraved on the other side.

Telmisartan 40mg Glenmark film-coated tablets are yellow, capsule shaped film coated tablets with ‘40’ engraved on one side and ‘T’ engraved on the other side.

Telmisartan 80mg Glenmark film-coated tablets are yellow, capsule shaped film coated tablets with ‘80’ engraved on one side and ‘T’ engraved on the other side.

Telmisartan Glenmark is available in blister packs containing 14, 15, 28, 30, 56, 60, 84, 90 or 98 tablets.

Not all pack sizes may be marketed in your country.