Irbesartan viatris 75 mg comprimidos efg
Introduction
Prospecto: information for the patient
Irbesartán Viatris 75 mg tablets EFG
Read this prospect carefully before starting to take this medicine, as it contains important information for you.
-Keep this prospect, as you may need to read it again.
-If you have any questions, consult your doctor or pharmacist.
-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
1.What is Irbesartán Viatris and what is it used for
2.What you need to know before starting to take Irbesartán Viatris
3.How to take Irbesartán Viatris
4.Possible side effects
5.Storage of Irbesartán Viatris
6.Contents of the package and additional information
1. What is Irbesartán Viatris and what is it used for
Irbesartán Viatris contains irbesartan, which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows the deterioration of renal function in patients with high blood pressure and type 2 diabetes.
Irbesartán Viatris is used in adult patients:
- To treat high blood pressure (essential hypertension).
To protect the kidneys in patients with high blood pressure, type 2 diabetes, and clinical evidence of altered renal function.
2. What you need to know before starting Irbesartán Viatris
Do not take Irbesartán Viatris:
- If you areallergicto irbesartán or to any of the other components of this medication (listed in section 6).
- If you aremore than 3 months pregnant.(In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
- If you have diabetes or kidney insufficiencyand are being treated witha blood pressure lowering medication that containsaliskirén.
Warnings and precautions
Consult your doctor or pharmacist before starting to takethis medication:
- If you have had or have during treatment, excessivevomiting(being sick) ordiarrhea.
- If you have been takingdiureticsor have been on alow-sodium diet.
- If you havekidney problems,including a narrowing of the kidney artery, or have had a kidney transplant.
- If you haveheart problems,including a narrowing of the heart valves, anenlargement or weakness of the heart muscle(heart failure).
- If you have a narrowing of the heart blood vessels, which can cause chest pain, for example, angina.
- If you are taking irbesartán fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function.
- If you havelow blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing, or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes.
- If you haveprimary aldosteronism(a disease related to the increase in the production of the aldosterone hormone, which causes sodium retention and this leads to an increase in blood pressure).
- If you are ofAfrican-Caribbean origin, irbesartán may not be as effective in reducing blood pressure.
- If you are taking any of the following medications used to treat high blood pressure (hypertension):
- A blood pressure lowering medication that inhibits the enzyme angiotensin-converting enzyme (ACE inhibitor), such as enalapril, lisinopril, or ramipril, particularly if you have kidney problems related to diabetes.
- Aliskirén.
Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking irbesartán. Your doctor will decide whether to continue treatment. Do not stop taking irbesartán on your own.
Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as potassium), at regular intervals.
See also the information under the heading “Do not take Irbesartán Viatris”.
Ifyou are pregnant,if you suspect you may beor ifyou plan to becomepregnant, inform your doctor. Irbesartán is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).
During treatment:
You must also inform your doctor:
- If you are to beoperated on (surgery)orif you are to receive anesthetics.
Children and adolescents
This medication should not be used in children and adolescents, as its safety and efficacy have not been fully established.
Other medications and Irbesartán Viatris
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Your doctor may need to adjust your dose and/or take other precautions:
- If you are taking ACE inhibitors or aliskirén (see also the information under the heading “Do not take Irbesartán Viatris” and “Warnings and precautions”).
You may need to have blood tests if you are taking:
- Potassium supplements.
- Sodium-free salt substitutes that contain potassium.
- Medications that save potassium (diuretics) or medications that may increase potassium levels in the blood, for example, heparin.
- Medications that contain lithium (used to treat mental health problems).
- Repaglinida (a medication used to reduce blood sugar levels).
If you are using a type of pain reliever, known as nonsteroidal anti-inflammatory drugs or COX-2 inhibitors, for example, celecoxib or aspirin, the effect of irbesartán may be reduced.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication. Your doctor will usually advise you to stop taking irbesartán before becoming pregnant, or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Irbesartán is not recommended for use at the beginning of pregnancy and should not be administered at all after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding. Irbesartán is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is a newborn or premature.
Driving and operating machinery
It is unlikely that irbesartán will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, consult your doctor before driving or operating machinery.
Irbesartán Viatris contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars (such as lactose), consult with them before taking this medication.
This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.
3. How to Take Irbesartán Viatris
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Administration Method
Irbesartán is administered orally. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Irbesartán can be taken with or without food. You should try to take your daily dose at the same time every day. It is essential to continue taking irbesartán until your doctor advises you otherwise.
- Patients with High Blood Pressure
The recommended dose is 150 mg once a day. Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once a day.
- Patients with High Blood Pressure and Type 2 Diabetes with Kidney Impairment
In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated kidney impairment is 300 mg once a day.
The doctor may advise a lower dose, especially when starting treatment if you are on hemodialysis or are 75 years or older.
The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting treatment.
Use in Children and Adolescents
Irbesartán should not be administered to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.
If You Take More Irbesartán Viatris Than You Should
If you accidentally take too many tablets, contact your doctor immediately. You may feel dizzy or that your heart is beating faster or slower.
In case of overdose or accidental ingestion, contact your doctor or pharmacist orcall the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging and remaining tablets with you.
If You Forget to Take Irbesartán Viatris
If you accidentally forget to take a dose, simply take your normal dose when it is due again. Do not take a double dose to compensate for the missed doses.
If you have any other questions about the use of this medication, consult your doctor or pharmacist.
4. Possible Adverse Effects
Some of these side effects may be serious and may require medical attention.If you notice any of the following side effects, stop taking this medicine and inform your doctor or go immediately to the nearest hospital emergency service:
Unknown frequency(cannot be estimated from available data)
- Severe allergic reaction with symptoms such as red itchy rash, feeling dizzy or faint, localized inflammation on the face, lips, and/or tongue, which may cause difficulty breathing.
- Yellow discoloration of the skin and the white part of the eyes, intense pain in the upper stomach, and feeling sick and vomiting, which may be due to liver problems.
- Rash with purple spots and red patches caused by inflammation of small blood vessels (vasculitis).
- Increased frequency of urination, in large quantities, pale in color, or unable to urinate or with difficulty urinating, or less frequently, in which case the urine may be darker or contain blood. This may be due to kidney problems.
Other possible side effects
Very common(may affect more than 1 in 10 people)
- If you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show an increase in potassium levels.
Common(may affect up to 1 in 10 people)
- Dizziness.
- Feeling sick/vomiting.
- Feeling tired (fatigue).
- Blood tests may show elevated levels of an enzyme that measures how muscles and the heart work (creatine kinase enzyme).
- In patients with high blood pressure and type 2 diabetes with kidney impairment:
- Dizziness when standing up, from a lying or sitting position.
- Low blood pressure when standing up, from a lying or sitting position.
- Muscle or joint pain.
- Blood tests may show a decrease in levels of a protein present in red blood cells (hemoglobin).
Uncommon(may affect up to 1 in 100 people)
- Feeling that your heart is beating faster (tachycardia).
- Skin redness.
- Cough.
- Diarrhea.
- Indigestion/heartburn.
- Sexual dysfunction (alterations in sexual function).
- Chest pain.
Rare(may affect up to 1 in 1,000 people)
- Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Unknown frequency(cannot be estimated from available data)
- Appearance of petechiae or more frequent bleeding than normal, which may be due to a reduction in the number of platelets (blood cells that promote coagulation).
- Tiredness, headaches, difficulty breathing when exercising or dizziness and paleness that may be caused by a reduced number of red blood cells (anemia).
- Sensation of spinning.
- Headache.
- Alteration of taste.
- Tinnitus in the ears.
- Muscle cramps.
- Muscle and joint pain.
- Blood tests show that the liver is not functioning correctly.
- Blood tests show an increase in potassium levels in the blood.
- Low blood sugar levels.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Irbesartan Viatris
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging, label, or blister, after CAD or EXP. The expiration date is the last day of the month indicated.
The product shelf life when stored in plastic bottles is 90 days once opened.
This medication does not require special storage conditions.
Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Irbesartán Viatris:
The active ingredient is irbesartan. Each tablet contains 75 mg of irbesartan.
The other components are lactose monohydrate (see section 2 of the leaflet “Irbesartán Viatris contains lactose”), povidone, microcrystalline cellulose (E-460), croscarmellose sodium, magnesium stearate (E-572), and anhydrous colloidal silica.
Appearance of the product and contents of the package:
Round tablets, white to almost white in color, with curved sides, marked with an "M" on one side and "IN1" on the other.
Available in blister packs of 10, 14, 28, 30, 56, 57, 58, 60, 84, 90, 98, and 100 tablets.
Calendar blister packs of 14, 28, 56, 84, and 98 tablets.
Plastic bottles containing 500 and 1000 tablets.
Only some package sizes may be marketed.
Marketing authorization holder and manufacturer:
Marketing authorization holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer:
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
or
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary
or
Generics [UK] Limited
Station Close, Potters Bar,
Hertfordshire,
EN6 1TL
UK
Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:
Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain
This medicinal product is authorized in the Member States of the European Economic Area with the following names:
GermanyIrbesartan Mylan 75 mg Tabletten
BelgiumIrbesartan Mylan 75 mg tabletten
SpainIrbesartán Viatris 75 mg comprimidos EFG
FranceIRBESARTAN VIATRIS 75 mg comprimé
GreeceIrbesartan/Mylan δισκ?α 75 mg/TAB
ItalyIrbesartan Mylan 75 mg compresse
LuxembourgIrbesartan Mylan 75 mg comprimés
NorwayIrbesartan Mylan 75 mg tabletter
NetherlandsIrbesartan Mylan 75 mg tabletten
PortugalIrbesartan Mylan 75 mg comprimidos
UKIrbesartan 75 mg tablets
RomaniaIrbesartan Mylan 75 mg comprimate
SwedenIrbesartan Mylan 75 mg tabletter
Last review date of this leaflet:January 2025
Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/
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