TELMISARTAN QUALIGEN 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Qualigen 40 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack

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

1. What is Telmisartan Qualigen and what is it used for

Telmisartan belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure is reduced.

Telmisartan is used totreat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by any other condition.

High blood pressure, if left uncontrolled, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or kidney failure, strokes, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly measure your blood pressure to check if it is within the normal range.

Telmisartan is also used toreduce cardiovascular events (e.g., heart attacks or strokes) in adults at risk because their blood supply to the heart or legs is reduced or blocked, or they have had a stroke or have a high risk of developing diabetes. Your doctor will tell you if you have a high risk of developing these events.

2. What you need to know before you take Telmisartan Qualigen

Do not take Telmisartan Qualigen

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine during the first few months 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 kidney failure and are being 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.

Warnings and precautions

Tell your doctor if you are suffering from or have ever suffered from 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 disease.
• Heart problems.
• High levels of aldosterone (water and salt retention in the body, along with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive water loss from the body) or have low salt levels due to treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Tell your doctor before starting treatment with Telmisartan Qualigen

• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Telmisartan Qualigen"

If you are pregnant, think you may be pregnant, or plan to become pregnant, tell your doctor. Telmisartan is not recommended during the first few months of pregnancy (first trimester) and should not be taken after the third month of pregnancy, as it may harm your baby, see section Pregnancy.

In case of surgery or anesthesia, tell your doctor that you are taking Telmisartan.

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

Children and adolescents

Telmisartan is not recommended for children and adolescents under 18 years.

Taking Telmisartan Qualigen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to change your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially true for the following medicines when taken with Telmisartan:

• Medicines containing lithium for treating certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory medicines (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Telmisartan, may cause excessive water loss from the body and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan Qualigen" and "Warnings and precautions").

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

Telmisartan may increase the blood-pressure-lowering effect of other medicines used to treat high blood pressure.

Taking Telmisartan with food and drink

You can take Telmisartan with or without food.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Telmisartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure. Telmisartan should not be used during the first few months of pregnancy and should not be taken after the third month of pregnancy, as it may harm your baby.

Breastfeeding

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not recommended to take Telmisartan while breast-feeding, as it is not known whether telmisartan passes into breast milk. Your doctor may decide to prescribe a different treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

Some people may feel dizzy or tired when taking Telmisartan. If you feel dizzy or tired, do not drive or use machines.

Telmisartan Qualigen contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially "sodium-free".

3. How to take Telmisartan Qualigen

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartan is one tablet per day. Try to take the tablet at the same time each day. You can take Telmisartan with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take Telmisartan every day until your doctor tells you to stop. If you think that the effect of Telmisartan is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan for most patients is one 40 mg tablet once a day to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan can also be used in combination with diuretics, such as hydrochlorothiazide, which has been shown to have an additive blood-pressure-lowering effect with Telmisartan.

For the reduction of cardiovascular events, the usual daily dose of Telmisartan is one 80 mg tablet. At the start of preventive treatment with Telmisartan 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Telmisartan

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before.

If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:

If you experience any of the following symptoms, you should see your doctor immediately:

Sepsis* (often called "blood infection", a serious infection that involves an inflammatory reaction of the whole body), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 patients) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan

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

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

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

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cells (anemia), high potassium levels, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of losing balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, symptoms of weakness, and high creatinine levels in the blood.

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

Sepsis* (often called "blood infection", a serious infection that involves an inflammatory reaction of the whole body and can cause death), increased 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, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, abnormal liver function (Japanese patients show a greater tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema, including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, pain in the tendons, flu-like illness, decrease in hemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or creatine phosphokinase in the blood.

Very rare side effects (may affect up to 1 in 10,000 patients)

Progressive scarring of lung tissue (interstitial lung disease) **.

• This may have been a chance finding or be related to an 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.

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

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 Spanish Medicines Monitoring System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storing Telmisartan Qualigen

Keep out of the sight and reach of children.

Do not use Telmisartan Qualigen after the expiry date which is stated on the carton after the abbreviation EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Telmisartan Qualigen contains

• The active substance is telmisartan.

Each tablet contains 40 mg of telmisartan.

• The other ingredients are:

Mannitol (E 421), meglumine, povidone (K-29/32) (E 1201), sodium hydroxide (E 524), and magnesium stearate (E 470b).

Appearance and packaging

Telmisartan Qualigen 40 mg tablets are white or almost white, oblong tablets with a score line on each face and marked with T40 on one face. The tablet can be divided into two equal halves.

Telmisartan Qualigen 40 mg tablets are available in packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173-Sant Cugat del Vallès (Barcelona)

Spain

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970-Sant Joan Despí (Barcelona)

Spain

Date of last revision of this leaflet: 07/2021.

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”.