Irbesartan/hydrochlorothiazide Brown & Burk 300 mg / 25 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Irbesartan/Hydrochlorothiazide tablets are and what they are used for

Irbesartan/Hydrochlorothiazide tablets is a combination of two active substances, irbesartan and

hydrochlorothiazide.

Irbesartan 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 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. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. The two active ingredients in

Irbesartan/Hydrochlorothiazide tablets work together to lower blood pressure further than if either was given alone.

Irbesartan/Hydrochlorothiazide tablets is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

2. What you need to know before you take Irbesartan/Hydrochlorothiazide tablets

Do not take Irbesartan/Hydrochlorothiazide tablets

! if you are allergic to irbesartan or any of the other

ingredients of this medicine (listed in section 6). ! if you are allergic to hydrochlorothiazide or any

other sulfonamide derived medicines

! if you are more than 3 months pregnant. (It is also

better to avoid Irbesartan /Hydrochlorothiazide tablets in early pregnancy - see pregnancy section) ! if you have severe liver or kidney problems ! if you have difficulty in producing urine ! if your doctor determines that you have persistently

high calcium or low potassium levels in your blood ! 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 before taking

Irbesartan/Hydrochlorothiazide tablets and if any of the following apply to you:

! if you get excessive vomiting or diarrhoea ! if you suffer from kidney problems or have a

kidney transplant

! if you suffer from heart problems

! if you suffer from liver problems

! if you suffer from diabetes

! if you develop low blood sugar levels (symptoms

may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes

! if you suffer from lupus erythematosus (also

known as lupus or SLE)

! if you suffer from primary aldosteronism (a

condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).

! if you are taking any of the following medicines used

to treat high blood pressure:

• an ACE-inhibitor (for example enalapril,

  lisinopril, ramipiril) in particular

• if you have diabetes-related kidney problems.
• aliskiren

! if you have had skin cancer or if you develop an

unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long

term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while using

Irbesartan/Hydrochlorothiazide tablets. ! If you experienced breathing or lung problems

(including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking

irbesartan/hydrochlorothiazide, seek medical attention immediately.

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/Hydrochlorothiazide tablets ".

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/ Hydrochlorothiazide tablets 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

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3. How to take Irbesartan/Hydrochlorothiazide tablets

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

Dosage

The recommended dose is one 150mg/12.5mg, 300mg/12.5mg or 300mg/25mg tablet a day or two 150mg/12.5mg or 300mg/12.5mg tablets a day. Irbesartan/Hydrochlorothiazide tablets will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide tablets.

Method of administration

Irbesartan/Hydrochlorothiazide tablets are for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take

Irbesartan/Hydrochlorothiazide tablets 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/Hydrochlorothiazide tablets until your doctor tells you otherwise.

The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.

If you take more Irbesartan/Hydrochlorothiazide tablets than you should

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take

Irbesartan/Hydrochlorothiazide tablets

Irbesartan/Hydrochlorothiazide tablets should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide tablets

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.

Serious side effects

Rare cases of allergic skin reactions (rash, urticarial), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.

If you get any of the above symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide tablets and contact your doctor immediately.

Other side effects

Side effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide tablets were:

Common side effects (may affect up to 1 in 10 people): ! nausea/vomiting

! abnormal urination

! fatigue

! dizziness (including when getting up from a lying or

sitting position)

! blood tests may show raised levels of an enzyme

that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).

If any of these side effects causes you problems,

talk to your doctor.

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

! diarrhea

! low blood pressure

! fainting

! heart rate increased

! flushing

! swelling

! sexual dysfunction (problems with sexual

performance)

! blood tests may show lowered levels of potassium

and sodium in your blood.

If any of these side effects causes you problems,

talk to your doctor.

Side effects reported since the launch of Irbesartan/Hydrochlorothiazide tablets

Some undesirable effects have been reported since the marketing of Irbesartan hydrochlorothiazide tablets.

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

Cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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

Frequency not known (cannot be estimated from the available data) : Headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.

As for any combination of two active substances, side effects associated with each individual component cannot be excluded.

Side effects associated with irbesartan alone, in addition to the side effects listed above,

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

! chest pain,

Frequency not known (can not be estimated from the available data):

! decrease in the number of platelets (a blood cell

essential for the clotting of the blood) have also been reported.

! decreased number of red blood cells (anaemia –

symptoms may include tiredness, headaches, being

short of breath when exercising, dizziness and looking pale)

! severe allergic reactions (anaphylactic shock). ! low blood sugar levels have also been reported.

Side effects associated with hydrochlorothiazide alone

Frequency not known (cannot be estimated from the available data):

Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout; skin and lip cancer (Non-melanoma skin cancer).

Very rare: Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

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 Yellow Card Scheme at

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/Hydrochlorothiazide tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on carton or blister after EXP. The expiry date refers to the last day of that month.

PVC/ACLAR-Aluminium blister packaging: Do not store above 30° C.

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 /Hydrochlorothiazide tablets contain

! The active substances are irbesartan and hydrochlorothiazide.

! Each Irbesartan/Hydrochlorothiazide 150mg/12.5mg film-coated tablet contains 150mg of irbesartan and 12.5mg hydrochlorothiazide.

! Each Irbesartan/Hydrochlorothiazide 300mg/12.5mg film-coated tablet contains 300mg of irbesartan and 12.5mg of hydrochlorothiazide.

! Each Irbesartan/Hydrochlorothiazide 300mg/25mg film-coated tablet contains 300mg of irbesartan and 25mg of hydrochlorothiazide.

The other ingredients are:

Tablet core:

150mg/ 12.5 mg and 300mg/ 25 mg film-coated tablets mannitol, sodium starch glycolate Type B, povidone K 30, polysorbate 80, Hypromellose 2910 5cps, silica colloidal anhydrous, magnesium stearate

300mg/ 12.5 mg film-coated tablets mannitol, sodium starch glycolate Type B, povidone K 30, polysorbate 80, Hypromellose 2910 5cps, silica colloidal anhydrous, magnesium stearate, iron oxide red, iron oxide yellow

Film-coat:

150mg/ 12.5 mg and 300mg/ 12.5 mg film-coated tablets Hypromellose 2910, titanium dioxide, macrogol 3350, carnauba wax, iron oxide yellow and iron oxide red

300mg/ 25 mg film-coated tablets

Hypromellose 2910, titanium dioxide, macrogol 3350, iron oxide red; carnauba wax and black iron oxide.

What Irbesartan/Hydrochlorothiazide tablets looks like and contents of the pack

Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg film-coated Tablets are Peach coloured, capsule shaped, biconvex, film-coated tablets, approximately 14 mm long and 7 mm wide, debossed with 'IH' on one face and plain on other face.

Irbesartan/Hydrochlorothiazide 300 mg/25 mg film-coated Tablets are Brick red coloured, capsule shaped, biconvex, film-coated tablets, approximately 18 mm long and 9 mm wide, debossed with 'IH1' on one face and plain on other face.

Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg film-coated Tablets are Peach coloured, capsule shaped, biconvex, film-coated tablets, approximately 18 mm long and 9 mm wide debossed with 'IH2' on one face and plain on other face.

Pack contents are 10, 14, 28, 30, 56, 84, 90 and 98 tablets in PVC/ACLAR/Aluminium blisters or Aluminium-Aluminium blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Ltd.

5 Marryat Close

Hounslow West

Middlesex

TW4 5DQ

United Kingdom

This leaflet was last revised in 01/2025.

Size: 150(L) x 500(W) mm Front Side Size: 150(L) x 500(W) mm

Back Side

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