Telmisartan Doc Generici

Package leaflet: Information for the user

TELMISARTAN DOC Generici 20 mg tablets, 40 mg tablets, 80 mg tablets

Equivalent medicine
Please read 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

TELMISARTAN DOC Generici belongs to a class of medicines known as
angiotensin II receptor antagonists. Angiotensin II is a substance in the
body that causes blood vessels to narrow, thereby increasing blood pressure.
TELMISARTAN DOC Generici blocks the effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
TELMISARTAN DOC Generici is used to treat essential hypertension (high
blood pressure) in adults. “Essential” means that the high blood pressure is not
caused by other conditions.
If left untreated, high blood pressure can damage blood vessels in many organs,
and this may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High
blood pressure usually does not produce symptoms until such damage occurs. Therefore, it is important
to have your blood pressure checked regularly to ensure it is within the normal range.
TELMISARTAN DOC Generici is also used to reduce cardiovascular
events (heart attacks or strokes) in adults who are at risk because of reduced or blocked blood flow to the heart or legs, or who have had a stroke or have high-risk diabetes. Your doctor will be able to tell you if you are at high risk for such events.

2. What you need to know before taking TELMISARTAN DOC Generici

Do not take TELMISARTAN DOC Generici

• if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant (it is better to avoid TELMISARTAN DOC Generici 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 liver and gallbladder) or any other severe liver disease
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

If any of the above conditions apply to you, inform your doctor or pharmacist before taking TELMISARTAN DOC Generici.

Warnings and precautions

Talk to your doctor if you have or have ever had any of the following conditions or diseases:

• Kidney disease or kidney transplant
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• Liver diseases
• Heart problems
• Increased levels of aldosterone (retention of water and salt in the body with imbalance of various minerals in the blood)
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy, low-salt diet, diarrhoea or vomiting
• High levels of potassium in the blood
• Diabetes

Talk to your doctor before taking TELMISARTAN DOC Generici

• 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 check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the heading “Do not take TELMISARTAN DOC Generici”.

• if you are taking digoxin

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). TELMISARTAN DOC Generici 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 unborn baby if taken during this period (see section Pregnancy).
If you are undergoing surgery or receiving anaesthetics, you must inform your doctor that you are taking TELMISARTAN DOC Generici.
Like all other angiotensin II receptor antagonists, TELMISARTAN DOC Generici may be less effective in reducing blood pressure in black patients.

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

Other medicines and TELMISARTAN DOC Generici
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 and/or take other 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 DOC Generici:

• Medicines containing lithium used to treat certain types of depression
• Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”), ACE inhibitors, angiotensin receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. ciclosporin or tacrolimus) and the antibiotic trimethoprim
• Diuretics, especially when taken at high doses together with TELMISARTAN DOC Generici, may cause excessive loss of body water and low blood pressure (hypotension)

If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take TELMISARTAN DOC Generici” and “Warnings and precautions”) or digoxin.

As with other medicines that lower blood pressure, the effect of TELMISARTAN DOC Generici may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
TELMISARTAN DOC Generici may enhance the effect of other medicines used to treat high 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 any other medicines while taking TELMISARTAN DOC Generici.

TELMISARTAN DOC Generici with food and drink
You may take TELMISARTAN DOC Generici with or without food.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking TELMISARTAN DOC Generici before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of TELMISARTAN DOC Generici. TELMISARTAN DOC Generici 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 unborn baby if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed. TELMISARTAN DOC Generici is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Some patients may experience dizziness or feel tired when taking TELMISARTAN DOC Generici. If you experience dizziness or feel tired, do not drive or use machines.

3. How to take TELMISARTAN DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of TELMISARTAN DOC Generici is one tablet daily. Try to take the tablet at the same time each day. You may take TELMISARTAN DOC Generici with or without food. Swallow the tablets with a glass of water or another non-alcoholic drink. It is important to take TELMISARTAN DOC Generici every day unless your doctor tells you otherwise. If you feel that the effect of TELMISARTAN DOC Generici is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of TELMISARTAN DOC Generici for most patients is one 40 mg tablet once daily to control blood pressure over 24 hours. However, in some cases, your doctor may recommend a lower dose of 20 mg daily or a higher dose of 80 mg. Alternatively, TELMISARTAN DOC Generici may be taken in combination with diuretics, such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect when used together with TELMISARTAN DOC Generici.

To reduce cardiovascular events, the usual dose is one 80 mg tablet of TELMISARTAN DOC Generici once daily. At the beginning of preventive treatment with TELMISARTAN DOC Generici 80 mg, blood pressure should be monitored frequently.

If you have impaired liver function, the usual dose must not exceed 40 mg daily.

If you take more TELMISARTAN DOC Generici than you should
If you have taken too many tablets by mistake, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.

If you forget to take TELMISARTAN DOC Generici
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 day's dose, take your normal dose the next day.
Do not take a double dose to make up for a forgotten tablet.

If you have any questions about how to use this medicine, ask 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 immediately contact your doctor if you experience any of the following symptoms:
Sepsis* (often called "blood infection" – a severe infection causing a systemic inflammatory response), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people), but extremely serious, and patients must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal.

Possible side effects of TELMISARTAN DOC Generici:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated to reduce cardiovascular events.

Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, respiratory tract infections (e.g., sore throat, sinusitis, cold), reduced red blood cells (anaemia), high potassium levels in the blood, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), sensation of dizziness (vertigo), slowed heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, swelling, vomiting, itching, increased sweating, drug-related skin rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute renal failure, chest pain, feeling of weakness, and increased blood creatinine levels.

Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called "blood infection" – a severe infection with systemic inflammatory response that may lead to death), increased levels of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, vision disturbances, rapid heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered liver function (patients of Japanese origin are more likely to experience this side effect), rapid swelling of the skin and mucous membranes, which may also be fatal (angioedema, including fatal outcomes), eczema (skin disorder), skin redness (urticaria), severe drug-related skin rash, joint pain (arthralgia), limb pain, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase levels 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 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.

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
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TELMISARTAN DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp." The expiry date refers to the last day of that month.
Aluminium/aluminium blisters: This medicine requires no special storage conditions.
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 DOC Generici contains

• The active substance is telmisartan: one 20 mg tablet of TELMISARTAN DOC Generici contains 20 mg of telmisartan; one 40 mg tablet of TELMISARTAN DOC Generici contains 40 mg of telmisartan; one 80 mg tablet of TELMISARTAN DOC Generici contains 80 mg of telmisartan.
• The other components are: povidone, meglumine, sodium hydroxide, mannitol, crospovidone and magnesium stearate.

Description of the appearance of TELMISARTAN DOC Generici and contents of the pack
TELMISARTAN DOC Generici are tablets.
TELMISARTAN DOC Generici 20 mg: white, round tablets with "LC" engraved on one side.
TELMISARTAN DOC Generici 40 mg: white, oval tablets with "LC" engraved on one side.
TELMISARTAN DOC Generici 80 mg: white, oval tablets with "LC" engraved on one side.
TELMISARTAN DOC Generici is supplied in blisters containing 28 tablets.
It is possible that not all pack sizes or tablet strengths are marketed.

Marketing Authorization Holder:
DOC Generici S.r.l
Via Turati 40
20121 Milan
Italy

Manufacturer responsible for batch release:
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the European Economic Area countries with the following names:
Portugal: Meldoc 20/40/80 mg Comprimidos
Italy: TELMISARTAN DOC Generici 20, 40 and 80 mg tablets

This leaflet was last updated on