IRBESARTAN/HYDROCHLOROTHIAZIDE 300 MG / 25 MG TABLETS - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan/ Hydrochlorothiazide 150 mg/12.5 mg film-coated tablets Irbesartan/ Hydrochlorothiazide 300 mg/ 12.5 mg film-coated tablets Irbesartan/ Hydrochlorothiazide 300 mg/ 25 mg film-coated tablets

Irbesartan/Hy­drochlorothia­zide

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet :

• 1. What Irbesartan/Hy­drochlorothia­zide Tablets is and what it is used for

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

• 3. How to take Irbesartan/Hy­drochlorothia­zide Tablets

• 4. Possible side effects

• 5. How to store Irbesartan/Hy­drochlorothia­zide Tablets

• 6. Contents of the pack and other information

1. what irbesartan/hydrochlorothiazide tablets is and what it is used for

Irbesartan/Hy­drochlorothia­zide Tablet 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 (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan/Hy­drochlorothia­zide Tablets

if you are allergic (hypersensitive) to hydrochlorothiazide or any other sulfonamidederived 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 mellitus or impaired kidney function and you are treated with aliskiren (another medicine to treat high blood pressure).

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 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 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 taking Irbesartan/Hy­drochlorothia­zide Tablets.
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Irbesartan/Hy­drochlorothia­zide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

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

You should also tell your doctor:

• if you are on a low-salt diet
• if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hy­drochlorothia­zide Tablets)
• if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal
• if you are going to have an operation (surgery) or be given anaesthetics
• if you have changes in your vision or pain in one or both of your eyes while taking

Irbesartan/Hy­drochlorothia­zide Tablets. This could be sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue irbesartan/hy­drochlorothia­zide treatment and seek medical attention

The hydrochlorothiazide contained in this medicine could produce a positive result in an antidoping test.

Children and adolescents

Irbesartan/Hy­drochlorothia­zide Tablets should not be given to children and adolescents (under 18 years).

Other medicines and Irbesartan/Hy­drochlorothia­zide Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hy­drochlorothia­zide Tablets may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hy­drochlorothia­zide Tablets without close supervision by your doctor.

Your doctor may need to change your dose and/or to take other precautions if you are taking aliskiren.

You may need to have blood checks if you take:

• potassium supplements
• salt substitutes containing potassium
• potassium sparing medicines or other diuretics (water tablets)
• some laxatives
• medicines for the treatment of gout
• therapeutic vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral agents or insulins)
• Carbamazepine (a medicine for treatment for epilepsy).

It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.

Irbesartan/Hy­drochlorothia­zide Tablets with food and drink

Irbesartan/Hy­drochlorothia­zide Tablets can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/Hy­drochlorothia­zide Tablets, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.

Pregnancy, breast-feeding and fertility

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/Hy­drochlorothia­zide Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan/Hy­drochlorothia­zide Tablets. Irbesartan/Hy­drochlorothia­zide Tablet is not recommended during 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/Hy­drochlorothia­zide Tablet is not recommended for mothers who are breastfeeding, 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

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan/Hy­drochlorothia­zide Tablets 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/Hy­drochlorothia­zide Tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. how to take irbesartan/hydrochlorothiazide tablets

Always take Irbesartan/Hy­drochlorothia­zide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

The usual dose of Irbesartan/Hy­drochlorothia­zide Tablets is one or two 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 Tablet is 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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Irbesartan/Hy­drochlorothia­zide Tablets can cause side effects, although not everybody gets them.

Some side effects could be very serious. If you have any of the side effects below, see a doctor straight away:

• Inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting.
• Toxic epidermal necrolysis characterised by allergic skin reactions like rash, hives, swelling of the face, lips, mouth, tongue or throat, headache, cough, pain in muscles or peeling of the skin all over the body.
• Necrotizing angitis (vasculitis, cutaneous vasculitis) characterised by pain in joints and muscles, skin redness, inflammation of blood vessels.

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).

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

• diarrhoea
• 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.

Rare (may affect up to 1 in 1,000 people )

• allergic skin reactions (rash, urticaria)
• localised swelling of the face, lips and/or tongue
• short of breath

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 the carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product 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 to protect the environment.

6. contents of the pack and other information

What Irbesartan/Hy­drochlorothia­zide Tablets contains

The active substances are Irbesartan and Hydrochlorothi­azide.

Each film-coated tablet contains 150 mg Irbesartan and 12.5 mg Hydrochlorothi­azide.

Each film-coated tablet contains 300 mg of Irbesartan and 12.5 mg of Hydrochlorothi­azide.

Each film-coated tablet contains 300 mg of Irbesartan and 25 mg of Hydrochlorothiazide

The other ingredients are

Core: Carboxymethyl­cellulose calcium, colloidal silicon dioxide, povidone (PVP K29/32), sodium starch glycolate type A, talc and magnesium stearate.

Coating:

: hypromellose 15 cp (E464), lactose monohydrate, titanium Dioxide (E171) & polyethylene glycol 3000, iron oxide red (E172) & iron oxide yellow (E172)

300mg/25mg film-coated tablets : hypromellose 15 cp (E464), lactose monohydrate, titanium dioxide (E171) & polyethylene glycol 3000, iron oxide red (E172), iron oxide yellow (E172) & iron oxide black (E172)

What do Irbesartan/Hy­drochlorothia­zide Tablets look like and contents of the pack

Irbesartan/Hy­drochlorothia­zide 150 mg/12.5 mg tablets are peach coloured, oval, film coated tablets debossed with “ML 34” on one side and plain on other side.

Irbesartan/Hy­drochlorothia­zide 300 mg/12.5 mg tablets are peach coloured, oval, film coated tablets debossed with “ML 33” on one side and plain on other side.

Irbesartan/Hy­drochlorothia­zide 300 mg/25 mg tablets are pink coloured, oval, film coated tablets debossed with “ML 32” on one side and plain on other side.

The tablets are supplied in blister packs containing 28 tablets.

Marketing Authorisation Holder

Activase Pharmaceuticals Limited

11 Boumpoulinas Nicosia 1060, Cyprus

Manufacturer

Wilcare Pharma Limited

Building 6 Unit 14, Croxley, Green Business Park,

Watford, England WD18 8YH.

If you would like this leaflet in a different format or register a complaint please contact the Marketing Authorisation holder.

This leaflet was revised in June 2020

A0180–0181–0182/O/PIL/A3

8 of 7