Patient leaflet - Irbesartan 150 mg film-coated tablets
1. What Irbesartan is and what it is used for
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan is used in adult patients § to treat high blood pressure (essential
hypertension)
§ to protect the kidney in patients with
high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
2. What you need to know before you take Irbesartan
Do not take Irbesartan :
§ if you are allergic to irbesartan 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 Irbesartanin early pregnancy – see pregnancy section) § if you have diabetes or impaired
kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Warnings and precautions
Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Irbesartan. Your doctor will decide on further treatment. Do not stop taking Irbesartan on your own.
Talk to your doctor before taking Irbesartan and if any of the following apply to you:
§ if you get excessive vomiting or
diarrhoea
§ if you suffer from kidney problems § if you suffer from heart problems § if you receive Irbesartan for diabetic
kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function § if you develop low blood sugar levels
(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, ushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes
§ if you are going to have an operation
(surgery) or be given anaesthetics
§ 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 Irbesartan ”
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan 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).
Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Other medicines and Irbesartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan ” and “Warnings and precautions”).
You may need to have blood checks if you take:
§ potassium supplements
§ salt substitutes containing potassium § potassium-sparing medicines (such as certain diuretics)
§ medicines containing lithium
§ repaglinide (medication used for lowering blood sugar levels)
If you take certain painkillers, called non-steroidal anti-in ammatory drugs, the effect of irbesartan may be reduced.
Irbesartan with food and drink
Irbesartan can be taken with or without food. Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan . Irbesartan 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. Irbesartan 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. Driving and using machines
Irbesartan is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines. Irbesartan contains sodium
This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially 'sodium free'.
3. How to take Irbesartan
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Method of administration
Irbesartan is for oral use. Swallow the tablets with a sufficient amount of uid (e.g. one glass of water). You can take Irbesartan with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan until your doctor tells you otherwise.
145 mm
§ Patients with high blood pressure: The usual dose is 150 mg once a day. The
dose may later be increased to 300 mg once daily depending on blood pressure response.
§ Patients with high blood pressure and type 2 diabetes with kidney disease:
In patients with high blood pressure and
type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease. The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Use in children and adolescents
Irbesartan should not be given to children or adolescents under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
If you take more Irbesartan than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan
If you accidentally miss a daily dose, just take the next dose as normal. DO NOT take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria (hives)), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan and contact your doctor immediately.
The frequency of the side effects listed below is de ned using the following convention: Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Side effects reported in clinical studies for patients treated with irbesartan were: Very common (may affect more than 1 in 10 people):
§ if you suffer from high blood pressure and
type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Common (may affect up to 1 in 10 people): · dizziness
- feeling sick/vomiting
fatigue and blood tests may show raised
levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
In patients with high blood pressure and type 2 diabetes with kidney disease the following side effects were also reported:
dizziness when getting up from a lying or
sitting position
low blood pressure when getting up from
a lying or sitting position
- pain in joints or muscles
decreased levels of a protein in the red
blood cells (haemoglobin)
Uncommon (may affect up to 1 in 100 people):
- heart rate increased
- ushing
- cough
- diarrhoea
- indigestion/heartburn
sexual dysfunction (problems with sexual
performance)
- chest pain.
Rare
(may affect up to 1 in 1,000 people): · Intestinal angioedema: a swelling in the
gut presenting with symptoms like abdominal pain, nausea, vomiting and
diarrhoea.
Some undesirable effects have been reported since marketing of irbesartan.
Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, in ammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock) and low blood sugar levels.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
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 lea et. 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.
5. How to store Irbesartan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Irbesartan lm-coated tablets contain:
§ The active substance is Irbesartan.
Irbesartan lm-coated tablets contain 150 milligrams (mg) or 300 mg of Irbesartan.
§ The other core ingredients are mannitol
(E421), croscarmellose sodium, colloidal anhydrous silica (E551), poloxamer 188, magnesium stearate (E572) and for the lm-coating opadry white 03B28796 which contains hypromellose (E464), titanium dioxide (E171) and macrogol. What Irbesartan lm-coated tablets look like and contents of the pack
§ The 150 mg tablets are white to off-white coloured, oval shaped, biconvex, lm-coated tablets with “U” debossed on one side and “I” debossed on the other side. The tablet is approximately 4.8 mm thick, 12.5 mm long and 6.5 mm wide. § The 300 mg tablets are white to off-white coloured, oval shaped, biconvex, lm-coated tablets with “U” debossed on one side and plain on the other side. The tablet is approximately 5.6 mm thick, 15.7 mm long and 8.1 mm wide. The 150 mg and 300 mg tablets are supplied in white opaque PVC/PVdC-Aluminium blister packs of 10, 14, 28, 30, 56, 84, 90 or 98. Not all pack sizes will be marketed. Marketing Authorisation Holder and Manufacturer
This lea et was last revised in 04/2026.
XXXXXXXX Ipca Laboratories UK Ltd.
Unit 97-98, Silverbriar,
Sunderland Enterprise Park East
Sunderland, SR5 2TQ
United Kingdom