TELMISARTAN QUALIGEN 80 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Qualigen 80 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Telmisartan Qualigen and what is it used for
2. What you need to know before taking Telmisartan Qualigen
3. How to take Telmisartan Qualigen
4. Possible side effects
5. Storage of Telmisartan Qualigen
6. Package Contents and Additional Information

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

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

Telmisartan is used totreat essential hypertension (high blood pressure) in adults. "Essential" means that high blood pressure is not due to any other cause.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or kidney or brain damage. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to regularly check your blood pressure to see 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 are at high risk of developing diabetes. Your doctor will inform you if you are at high risk of experiencing these events.

2. What you need to know before taking Telmisartan Qualigen

Do not take Telmisartan Qualigen

• if you are allergic to telmisartan or any of the other ingredients of this medication (listed in section 6).
• if you are pregnant for more than 3 months. (In any case, it is best to avoid taking this medication at the start of your 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 problems and are being treated with a blood pressure medication containing aliskiren.

If any of the above applies to you, inform your doctor or pharmacist before taking telmisartan.

Warnings and Precautions

Consult your doctor if you are suffering or have ever suffered from any of the following disorders 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 aldosterone levels (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 potassium levels in the blood.
• Diabetes.

Consult your doctor before starting to take Telmisartan Qualigen

• if you are taking any of the following medications 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 monitor 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, inform your doctor. Telmisartan is not recommended during the first trimester of pregnancy (the first 3 months) and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby, see section Pregnancy.

In case of surgery or anesthesia, inform 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 use in children and adolescents up to 18 years.

Taking Telmisartan Qualigen with Other Medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medications. This applies especially to the following medications when taken with Telmisartan:

• Medications containing lithium for treating certain types of depression.
• Medications that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, 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, can 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 NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen) or corticosteroids.

Telmisartan may increase the blood pressure-lowering effect of other medications 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Telmisartan before becoming pregnant or as soon as you become pregnant and recommend taking another blood pressure medication instead. Telmisartan is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as Telmisartan is not recommended for women during this period. Your doctor may decide to prescribe a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

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

3. How to take Telmisartan Qualigen

Follow the instructions for administration of this medication exactly as indicated by your doctor.

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 other non-alcoholic beverage. It is essential that you take Telmisartan every day until your doctor tells you otherwise. If you think the effect of Telmisartan is too strong or too weak, tell 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 daily, 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 monitored frequently.

If your liver is not functioning correctly, the usual dose should not exceed 40 mg once daily.

If you take more Telmisartan than you should

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

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

If you forget to take Telmisartan

If you forget to take a dose, do not worry. Take it as soon as you remember and 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Telmisartan can cause side effects, although not everyone gets them.

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

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

Sepsis* (often called "blood infection", a severe 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 medication and visit 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 severe infection that involves an inflammatory reaction of the whole body and can cause death), increased 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, drowsiness, vision changes, increased heart rate (tachycardia), dry mouth, stomach upset, abnormal liver function (Japanese patients are more likely 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), skin redness, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, pain in the tendons, pseudo-influenza, decrease in hemoglobin (a blood protein), increased blood uric acid levels, 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 a mechanism that is currently not known.

** 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

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

5. Storage of Telmisartan Qualigen

Keep out of the sight and reach of children.

Do not use Telmisartan Qualigen after the expiration date stated on the packaging after the abbreviation EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan Qualigen

• The active ingredient is telmisartan.

Each tablet contains 80 mg of telmisartan.

• The other ingredients are:

Mannitol (E421), meglumine, povidone (K-29/32) (E 1201), sodium hydroxide (E 524), and magnesium stearate (E 470b).

Appearance of the Product and Package Contents

Telmisartan Qualigen 80 mg tablets are white or almost white, oblong tablets with a score line on each face and marked with T80 on one face. The tablet can be divided into two equal halves.

Telmisartan Qualigen 80 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 the Last Revision of this Package Leaflet: July 2021.

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