Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg film-coated tablets

Main information

  • Trade name:
  • Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg film-coated tablets
  • Dosage:
  • 20/12.5
  • Pharmaceutical form:
  • Film-coated tablet
  • Prescription type:
  • Product subject to prescription which may be renewed (B)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg film-coated tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA1390/127/001
  • Authorization date:
  • 18-08-2017
  • Last update:
  • 12-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Front Side

DUMMY

92640

DUMMY

92640

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Olmesartan Medoxomil/

Hydrochlorothiazide

20 mg/12.5 mg film-coated

tablets

Olmesartan Medoxomil/

Hydrochlorothiazide

20 mg/25 mg film-coated

tablets

Olmesartan Medoxomil/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 only. Do not pass

it on to others. It may harm them, even if their signs of illness

are the same as yours.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

1. What Olmesartan Medoxomil/Hydrochlorothiazide tablets

are and what they are used for

2. What you need to know before you take Olmesartan

Medoxomil/Hydrochlorothiazide tablets

3. How to take Olmesartan Medoxomil/Hydrochlorothiazide

tablets

4. Possible side effects

5. How to store Olmesartan Medoxomil/Hydrochlorothiazide

tablets

6. Contents of the pack and other information

1.

What Olmesartan Medoxomil/

Hydrochlorothiazide tablets are and

what they are used for

Olmesartan Medoxomil/Hydrochlorothiazide tablets contains

two active substances, olmesartan medoxomil and

hydrochlorothiazide, that are used to treat high blood pressure

(hypertension):

Olmesartan medoxomil is one of a group of medicines called

angiotensin II-receptor antagonists. It lowers blood pressure

by relaxing the blood vessels.

Hydrochlorothiazide is one of a group of medicines called

thiazide diuretics (“water tablets”). It lowers blood pressure by

helping the body to get rid of extra fluid by making your

kidneys produce more urine.

You will only be given Olmesartan

Medoxomil/Hydrochlorothiazide tablets if olmesartan

medoxomil alone has not adequately controlled your blood

pressure. When given together, the two active substances in

Olmesartan Medoxomil/Hydrochlorothiazide tablets help to

lower blood pressure more than if either of them were given

alone.

You may already be taking medicines to treat your high blood

pressure, but your doctor may want you to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets to lower it more.

High blood pressure can be controlled with medicines such as

Olmesartan Medoxomil/Hydrochlorothiazide tablets. Your

doctor has probably also recommended that you make some

changes in your lifestyle to help lower your blood pressure (for

example losing weight, giving up smoking, reducing the amount

of alcohol you drink and reducing the amount of salt in your

diet). Your doctor may also have urged you to take regular

exercise, such as walking or swimming. It is important to follow

this advice from your doctor.

2.

What you need to know before you take

Olmesartan Medoxomil/

Hydrochlorothiazide tablets

Do not take Olmesartan Medoxomil/Hydrochlorothiazide

tablets

if you are allergic to olmesartan medoxomil or

hydrochlorothiazide, or any of the other ingredients of this

medicine (listed in section 6) or substances similar to

hydrochlorothiazide (sulfonamides)

if you are more than 3 months pregnant (It is also better to

avoid Olmesartan Medoxomil/Hydrochlorothiazide tablets in

early pregnancy – see pregnancy section)

if you have severe kidney problems

if you have diabetes or impaired kidney function and you are

treated with a blood pressure lowering medicine containing

aliskiren

if you suffer from low potassium, low sodium, high calcium or

high uric acid levels in the blood (with symptoms of gout or

kidney stones) that do not get better when treated

if you suffer from severe liver problems or yellowing of the

skin and eyes (jaundice) or problems with drainage of the bile

from the gallbladder (biliary obstruction e.g. gallstones)

If you think any of these apply to you, or you are unsure, do not

take the tablets. Talk to your doctor first and follow the advice

given.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking

Olmesartan Medoxomil/Hydrochlorothiazide tablets.

Before you take the tablets, tell your doctor 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

Olmesartan Medoxomil/Hydrochlorothiazide tablets”.

Before you take the tablets, tell your doctor if you have any of

the following health problems:

Mild to moderate kidney problems or if you have had a recent

kidney transplant

Liver diseases

Heart failure or problems with your heart valves or heart

muscles

Vomiting (being sick) or diarrhoea which is severe or it goes

on for several days

Treatment with high doses of water tablets (diuretics) or if you

are on a low salt diet

Problems with your adrenal glands (e.g. primary

aldosteronism)

Diabetes

Lupus erythematosus (an autoimmune disease)

Allergies or asthma.

Contact your doctor if you experience any of the following

symptoms:

diarrhoea that is severe, persistent and causes substantial

weight loss. Your doctor may evaluate your symptoms and

decide on how to continue your blood pressure medication.

decrease in vision or eye pain. These could be symptoms of

an increase of pressure in your eye and can happen within

hours to weeks of taking Olmesartan

Medoxomil/Hydrochlorothiazide tablets. This can lead to

permanent vision impairment, if not treated.

Your doctor may want to see you more often and do some

tests if you have any of these conditions.

Olmesartan Medoxomil/Hydrochlorothiazide tablets may cause

a rise in blood fat levels and uric acid levels (the cause of gout

– painful swelling of the joints). Your doctor will probably want

to do a blood test from time to time to check these.

It may change the levels of certain chemicals in your blood

called electrolytes.

Your doctor will probably want to do a blood test from time to

time to check these.

Signs of electrolyte changes are: thirst, dryness of the mouth,

muscle pain or cramps, tired muscles, low blood pressure

(hypotension), feeling weak, sluggish, tired, sleepy

or restless, nausea, vomiting, less need to pass

urine, a rapid heart rate. Tell your doctor if you

notice these symptoms.

As with any medicine which reduces blood

pressure, an excessive drop in blood pressure in

patients with blood flow disturbances of the heart or

brain could lead to a heart attack or stroke. Your

doctor will therefore check your blood pressure

carefully.

If you are due to have tests for parathyroid function, you should

stop taking Olmesartan Medoxomil/Hydrochlorothiazide tablets

before these tests are carried out.

You must tell your doctor if you think that you are (or might

become) pregnant.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are 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

Olmesartan Medoxomil/Hydrochlorothiazide tablets are not

recommended for children and adolescents under the age of 18.

Other medicines and Olmesartan Medoxomil/

Hydrochlorothiazide tablets

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines

In particular, tell your doctor or pharmacist about any of the

following:

Other blood pressure lowering medicines

(anti-hypertensives), as the effect of Olmesartan

Medoxomil/Hydrochlorothiazide tablets can be increased.

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 Olmesartan

Medoxomil/Hydrochlorothiazide tablets ” and “Warnings and

precautions”).

Medicines which may alter the levels of potassium in your

blood if used at the same time as Olmesartan

Medoxomil/Hydrochlorothiazide tablets . These include:

potassium supplements (as well as salt substitutes

containing potassium)

water tablets (diuretics)

heparin (for thinning the blood)

laxatives

steroids

adrenocorticotrophic hormone (ACTH)

carbenoxolone (a medicine used to treat mouth and

stomach ulcers)

penicillin G sodium (also called benzylpenicillin sodium, an

antibiotic)

certain pain killers such as aspirin or salicylates

Lithium (a medicine used to treat mood swings and some

types of depression) used at the same time as Olmesartan

Medoxomil/Hydrochlorothiazide tablets may increase the

toxicity of lithium. If you have to take lithium, your doctor will

measure your lithium blood levels.

Non-steroidal anti-inflammatory (NSAIDs) medicines

(medicines used to relieve pain, swelling and other symptoms

of inflammation, including arthritis) used at the same time as

Olmesartan Medoxomil/Hydrochlorothiazide tablets may

increase the risk of kidney failure and the effect of

Olmesartan Medoxomil/Hydrochlorothiazide tablets can be

decreased by NSAIDs.

Sleeping tablets, sedatives and anti-depressant medicines, as

using these medicines together with Olmesartan

Medoxomil/Hydrochlorothiazide tablets may cause a sudden

drop in blood pressure when standing up.

Certain medicines such as baclofen and tubocurarine, used

to relax muscles.

Amifostine and some other drugs used to treat cancers, such

as cyclophosphamide or methotrexate.

Colestyramine and colestipol, medicines for lowering blood fat

levels.

Colesevelam hydrochloride, a drug that lowers the level of

cholesterol in your blood, as the effect of

Olmesartan Medoxomil/Hydrochlorothiazide

tablets may be decreased. Your doctor may

advise you to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets at least

4 hours before colesevelam hydrochloride.

Anticholinergic agents, such as atropine and

biperiden.

Drugs such as thioridazine, chlorpromazine,

levomepromazine, trifluoperazine, cyamemazine,

sulpiride, amisulpride, pimozide, sultopride,

tiapride, droperidol or haloperidol, used to treat

certain psychiatric disorders.

Certain medicines such as quinidine, hydroquinidine,

disopyramide, amiodarone, sotalol or digitalis, used to treat

heart problems.

Medicines such as mizolastine, pentamidine, terfenadine,

dofetilide, ibutilide or erythromycin injections, which may

change the heart rhythm.

Oral anti-diabetic medicines, such as metformin, or insulin,

used to lower blood sugar.

Beta-blockers and diazoxide, medicines used to treat high

blood pressure or low blood sugar, respectively, as

Olmesartan Medoxomil/Hydrochlorothiazide tablets can

enhance their blood-sugar-increasing effect.

Methyldopa, a medicine used to treat high blood pressure.

Medicines such as noradrenaline, used to increase blood

pressure and slow heart rate.

Diphemanil, used to treat a slow heartbeat or reduce

sweating.

Medicines such as probenecid, sulfinpyrazone and

allopurinol, used to treat gout.

Calcium supplements.

Amantadine, an anti-viral drug.

Ciclosporin, a medicine used to stop rejection of organ

transplants.

Certain antibiotics called tetracyclines or sparfloxacin.

Amphotericin, a medicine used to treat fungal infections.

Certain antacids, used to treat too much stomach acid, such

as aluminium magnesium hydroxide, as the effect of

Olmesartan Medoxomil/Hydrochlorothiazide tablets can be

slightly decreased.

Cisapride, used to increase food movement in the stomach

and gut.

Halofantrine, used for malaria.

Olmesartan Medoxomil/Hydrochlorothiazide tablets with

food and drink

Olmesartan Medoxomil/Hydrochlorothiazide tablets can be

taken with or without food.

Take care when drinking alcohol while you are taking

Olmesartan Medoxomil/Hydrochlorothiazide tablets, as some

people feel faint or dizzy. If this happens to you, do not drink

any alcohol, including wine, beer or alcopops.

Black patients

As with other similar drugs the blood pressure lowering effect of

Olmesartan Medoxomil/Hydrochlorothiazide tablets are

somewhat less in black patients.

Pregnancy 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

Olmesartan Medoxomil/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

Olmesartan Medoxomil/Hydrochlorothiazide tablets.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are 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 it is used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start

breast-feeding.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are not

recommended for mothers who are breast-feeding, and your

doctor may choose another treatment for you if you wish to

breast-feed.

If you are pregnant or breast-feeding, think you may be

pregnant or are planning to have a baby, ask your doctor or

pharmacist for advice before taking this medicine.

Driving and using machines

You may feel sleepy or dizzy while being treated for your high

blood pressure. If this happens, do not drive or use machines

until the symptoms wear off. Ask your doctor for advice.

Olmesartan Medoxomil/Hydrochlorothiazide tablets

contains lactose monohydrate

This medicine contains lactose (a type of sugar). If you have

been told by your doctor that you have an intolerance to some

sugars, contact your doctor before taking this medicine.

3.

How to take Olmesartan Medoxomil/

Hydrochlorothiazide tablets

Always take this medicine exactly as your doctor or pharmacist

has told you. Check with your doctor or pharmacist if you are

not sure.

The recommended dose is one Olmesartan

Medoxomil/Hydrochlorothiazide tablets 20 mg/12.5 mg tablet a

day. However, if your blood pressure is not controlled, your

doctor may decide to change your dose to one Olmesartan

Medoxomil/Hydrochlorothiazide tablets 20 mg/25mg tablet a

day.

Swallow the tablet with water. If possible, you should take your

dose at the same time each day, for example at breakfast

time. It is important to continue to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets until your doctor tells

you to stop.

If you take more Olmesartan Medoxomil/

Hydrochlorothiazide tablets than you should

If you take more tablets than you should, or if a child

accidentally swallows one or more, go to your doctor or nearest

accident and emergency (A&E) department immediately and

take your medicine pack with you.

If you forget to take Olmesartan Medoxomil/

Hydrochlorothiazide tablets

If you forget to take a dose, take your normal dose on the

following day as usual. Do not take a double dose to make up

for a forgotten dose.

If you stop taking Olmesartan Medoxomil/

Hydrochlorothiazide tablets

It is important to continue to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets unless your doctor tells

you to stop.

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.

However, the following two side effects can be serious:

Allergic reactions that may affect the whole body, with

swelling of the face, mouth and/or voice box (larynx) together

with itching and rash may occur rarely. If this happens, stop

taking Olmesartan Medoxomil/Hydrochlorothiazide

tablets and contact your doctor immediately.

Olmesartan Medoxomil/Hydrochlorothiazide tablets can

cause the blood pressure to fall too low in susceptible

individuals or as the result of an allergic reaction.

Light-headedness or fainting may occur uncommonly. If this

happens, stop taking Olmesartan

Medoxomil/Hydrochlorothiazide tablets, contact your

doctor immediately and lie down flat.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are a

combination of two active substances and the following

information firstly gives the other side effects reported so far

with the combination Olmesartan Medoxomil/

Hydrochlorothiazide tablets (besides those already mentioned

above) and, secondly, those which are known about for the

separate active substances.

These are the other side effects known about so far with

Olmesartan Medoxomil/Hydrochlorothiazide tablets:

If these side effects occur, they are often mild and you do not

need to stop your treatment.

Common side effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, tiredness, chest pain, swelling

of ankles, feet, legs, hands or arms.

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

Fluttering of the heartbeat (palpitations), rash, eczema, vertigo,

cough, indigestion, abdominal pain, nausea, vomiting,

diarrhoea, muscle cramps and muscular pain, pain in joints,

arms and legs, back pain, erection difficulties in men, blood in

urine.

Some changes in blood test results have also been seen

uncommonly and include:

Rise in blood fat levels, rise in blood urea or uric acid, rise in

creatinine, rise or decrease in blood potassium levels, rise in

blood calcium levels, rise in blood sugar, increase in levels of

liver function. Your doctor will know about these from a blood

test and will tell you if you need to do anything.

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

Feeling unwell, disturbances in consciousness, skin lumps

(wheals), acute kidney failure.

Some changes in blood test results have also been seen in

rare cases and include:

Rise in blood urea nitrogen, decrease in haemoglobin and

haematocrit values. Your doctor will know about these from a

blood test and will tell you if you need to do anything.

Further side effects reported with use of olmesartan

medoxomil or hydrochlorothiazide alone, but not with

Olmesartan Medoxomil/Hydrochlorothiazide tablets or in a

higher frequency:

Olmesartan Medoxomil:

Common side effects (may affect up to 1 in 10 people):

Bronchitis, cough, runny or stuffy nose, sore throat, abdominal

pain, indigestion, diarrhoea, nausea, gastroenteritis, pain in the

joints or bones, back pain, blood in urine, urinary tract infection,

flu-like symptoms, pain.

Some changes in blood test results have also been seen

commonly and include:

Rise in blood fat levels, rise in blood urea or uric acid, increase

in levels of liver and muscle function.

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

Quick allergic reactions that may affect the whole body and

may cause breathing problems as well as a rapid fall of blood

pressure that may even lead to fainting (anaphylactic

reactions), swelling of the face, angina (pain or uncomfortable

feeling in the chest; known as angina pectoris), feeling unwell,

allergic skin rash, itching, exanthema (skin eruption), skin

lumps (wheals).

Some changes in blood test results have also been seen

uncommonly and include:

Reduced numbers of a type of blood cell, known as platelets

(thrombocytopenia).

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

Impaired kidney function, lack of energy.

Some changes in blood test results have also been seen rarely

and include:

Increase in blood potassium.

Hydrochlorothiazide:

Very common side effects (may affect more than 1 in 10

people):

Changes in blood results including: Increase in blood fat and

uric acid levels.

Common side effects (may affect up to 1 in 10 people):

Feeling confused, abdominal pain, stomach upset, bloated

feeling, diarrhoea, nausea, vomiting, constipation, excretion of

glucose into the urine.

Some changes in blood results have also been seen and

include:

Increase in blood creatinine, urea, calcium and sugar levels,

decrease in blood chloride, potassium, magnesium

and sodium levels. Increase of serum amylase

(hyperamylasaemia).

Uncommon side effects (may affect up to 1 in

100 people):

Decreased or loss of appetite, severe difficulty

breathing, anaphylactic skin reactions

(hypersensitivity reactions), worsening of

pre-existing myopia erythema, skin reactions to

light, itching, purplish spots or patches on the skin due to small

haemorrhages (purpura), skin lumps (wheals).

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

Swollen and sore salivary glands, decreased number of white

blood cells, decreased number of blood platelets, anaemia,

bone marrow damage, restlessness, feeling ‘down’ or

depressed, problems sleeping, feeling un-interested (apathy),

tingling and numbness, fits (convulsions), objects you look at

appearing yellow, blurred vision, dry eyes, irregular heartbeat,

inflammation of the blood vessels, blood clots (thrombosis or

embolism), inflammation of the lung, fluid accumulation in the

lungs, inflammation of the pancreas, jaundice, infection in the

gall bladder, symptoms of lupus erythematosus (such as rash,

joint pains and cold hands and fingers), allergic skin reactions,

peeling and blistering of the skin, non-infectious inflammation of

the kidney (interstitial nephritis), fever, muscle weakness

(sometimes causing impaired movement).

Very rare side effects (may affect up to 1 in 10,000 people):

Electrolyte disturbance leading to an abnormally depleted level

of chloride in the blood (hypochloraemic alkalosis), blockage in

the gut (paralytic ileus).

Not known (frequency cannot be estimated from the

available data):

Decrease in vision or eye pain (possible signs of acute

angle-closure glaucoma).

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 the national

reporting system (see contact details below).

By reporting side effects you can help provide more information

on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace,

IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie

5.

How to store Olmesartan Medoxomil/

Hydrochlorothiazide tablets

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

This medicinal product does not require any special storage

conditions.

Do not use this medicine after the expiry date which is stated

on the carton and on the blister strip as EXP. The expiry date

refers to the last day of that month.

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 Olmesartan Medoxomil/Hydrochlorothiazide tablets

contains

The active substances of Olmesartan

Medoxomil/Hydrochlorothiazide tablets are:

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20 mg/12.5 mg: Each film-coated tablet contains 20 mg

olmesartan medoxomil and 12.5 mg hydrochlorothiazide.

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20 mg/25 mg: Each film-coated tablet contains 20 mg

olmesartan medoxomil and 25 mg hydrochlorothiazide.

The other ingredients are:

Hydroxy propyl cellulose, Lactose monohydrate, Cellulose

microcrystalline, Low substituted Hydroxy propyl cellulose,

Magnesium stearate, Hypromellose, Titanium dioxide (E171),

Macrogol 3000, Talc, Iron oxide yellow (E172), Iron oxide red

(E172)

What Olmesartan Medoxomil/Hydrochlorothiazide tablets

look like and contents of the pack

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20/12.5 mg are Reddish-Yellow, round, film-coated tablets;

debossed with “OH1” on one side and plain on other side.

Diameter approximately 8.6 mm.

Olmesartan Medoxomil/Hydrochlorothiazide tablets 20/25 mg

are Pinkish, round, film-coated tablets; debossed with “OH4” on

one side and plain on other side. Diameter approximately

8.6 mm.

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20/12.5 mg and 20/25 mg are available in Alu-Alu blister

containing 10, 14, 28, 30, 56, 84, 90, 98, 280 or 300 tablets or

in Alu-Alu perforated unit dose blisters containing 10, 28, 50 or

500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Wesseling Hungary Kft.

Budapest, Fòti ùt 56,

1047 Hungary

The medicinal product is authorized in the Member States

of the EEA under the following names:

Name of

:

Name of medicinal product

member state

Olmesartan Medoxomil/

Hydrochlorothiazide Accord 20/12.5 mg,

20/25 mg Filmtabletten

Olmesartan Medoxomil/

Hydrochlorothiazide Accord

Olmesartan Medoxomil/

Hydrochlorothiazide Accord 20/12.5 mg,

20/25 mg film-coated tablets

Olmesartan medoxomil e idroclorotiazide

Accord

Olmesartan Medoxomil/

Hydrochloorthiazide Accord 20/12,5 mg,

20/25 mg filmomhulde tabletten

Olmesartan Medoxomil/

Hydrochlorothiazide 20/12.5 mg, 20/25 mg

film-coated tablets

Olmesartán medoxomilo/Hidroclorotiazida

Accord 20/12.5 mg, 20/25 mg

comprimidos recubiertos con película

This leaflet was last approved in 05/2017.

Artwork No.

Customer

Description

Market

Language

Size

Min. Font Size

Version No.

Date

Accord

Olmesartan Medoxomil

UK-IE

English

175 x 600 mm (PIL)

4 (Page 1 of 2)

25/05/17 (Olmesartan Medoxomil-Hydro 20mg(ACC-UK-IE)PIL)

Colours Used

Pantone Black

Keyline

Prepared By

Regulatory Affairs

Checked By

Regulatory Affairs

Approved By

Quality Assurance

Back Side

DUMMY

92640

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Olmesartan Medoxomil/

Hydrochlorothiazide

20 mg/12.5 mg film-coated

tablets

Olmesartan Medoxomil/

Hydrochlorothiazide

20 mg/25 mg film-coated

tablets

Olmesartan Medoxomil/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 only. Do not pass

it on to others. It may harm them, even if their signs of illness

are the same as yours.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

1. What Olmesartan Medoxomil/Hydrochlorothiazide tablets

are and what they are used for

2. What you need to know before you take Olmesartan

Medoxomil/Hydrochlorothiazide tablets

3. How to take Olmesartan Medoxomil/Hydrochlorothiazide

tablets

4. Possible side effects

5. How to store Olmesartan Medoxomil/Hydrochlorothiazide

tablets

6. Contents of the pack and other information

1.

What Olmesartan Medoxomil/

Hydrochlorothiazide tablets are and

what they are used for

Olmesartan Medoxomil/Hydrochlorothiazide tablets contains

two active substances, olmesartan medoxomil and

hydrochlorothiazide, that are used to treat high blood pressure

(hypertension):

Olmesartan medoxomil is one of a group of medicines called

angiotensin II-receptor antagonists. It lowers blood pressure

by relaxing the blood vessels.

Hydrochlorothiazide is one of a group of medicines called

thiazide diuretics (“water tablets”). It lowers blood pressure by

helping the body to get rid of extra fluid by making your

kidneys produce more urine.

You will only be given Olmesartan

Medoxomil/Hydrochlorothiazide tablets if olmesartan

medoxomil alone has not adequately controlled your blood

pressure. When given together, the two active substances in

Olmesartan Medoxomil/Hydrochlorothiazide tablets help to

lower blood pressure more than if either of them were given

alone.

You may already be taking medicines to treat your high blood

pressure, but your doctor may want you to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets to lower it more.

High blood pressure can be controlled with medicines such as

Olmesartan Medoxomil/Hydrochlorothiazide tablets. Your

doctor has probably also recommended that you make some

changes in your lifestyle to help lower your blood pressure (for

example losing weight, giving up smoking, reducing the amount

of alcohol you drink and reducing the amount of salt in your

diet). Your doctor may also have urged you to take regular

exercise, such as walking or swimming. It is important to follow

this advice from your doctor.

2.

What you need to know before you take

Olmesartan Medoxomil/

Hydrochlorothiazide tablets

Do not take Olmesartan Medoxomil/Hydrochlorothiazide

tablets

if you are allergic to olmesartan medoxomil or

hydrochlorothiazide, or any of the other ingredients of this

medicine (listed in section 6) or substances similar to

hydrochlorothiazide (sulfonamides)

if you are more than 3 months pregnant (It is also better to

avoid Olmesartan Medoxomil/Hydrochlorothiazide tablets in

early pregnancy – see pregnancy section)

if you have severe kidney problems

if you have diabetes or impaired kidney function and you are

treated with a blood pressure lowering medicine containing

aliskiren

if you suffer from low potassium, low sodium, high calcium or

high uric acid levels in the blood (with symptoms of gout or

kidney stones) that do not get better when treated

if you suffer from severe liver problems or yellowing of the

skin and eyes (jaundice) or problems with drainage of the bile

from the gallbladder (biliary obstruction e.g. gallstones)

If you think any of these apply to you, or you are unsure, do not

take the tablets. Talk to your doctor first and follow the advice

given.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking

Olmesartan Medoxomil/Hydrochlorothiazide tablets.

Before you take the tablets, tell your doctor 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

Olmesartan Medoxomil/Hydrochlorothiazide tablets”.

Before you take the tablets, tell your doctor if you have any of

the following health problems:

Mild to moderate kidney problems or if you have had a recent

kidney transplant

Liver diseases

Heart failure or problems with your heart valves or heart

muscles

Vomiting (being sick) or diarrhoea which is severe or it goes

on for several days

Treatment with high doses of water tablets (diuretics) or if you

are on a low salt diet

Problems with your adrenal glands (e.g. primary

aldosteronism)

Diabetes

Lupus erythematosus (an autoimmune disease)

Allergies or asthma.

Contact your doctor if you experience any of the following

symptoms:

diarrhoea that is severe, persistent and causes substantial

weight loss. Your doctor may evaluate your symptoms and

decide on how to continue your blood pressure medication.

decrease in vision or eye pain. These could be symptoms of

an increase of pressure in your eye and can happen within

hours to weeks of taking Olmesartan

Medoxomil/Hydrochlorothiazide tablets. This can lead to

permanent vision impairment, if not treated.

Your doctor may want to see you more often and do some

tests if you have any of these conditions.

Olmesartan Medoxomil/Hydrochlorothiazide tablets may cause

a rise in blood fat levels and uric acid levels (the cause of gout

– painful swelling of the joints). Your doctor will probably want

to do a blood test from time to time to check these.

It may change the levels of certain chemicals in your blood

called electrolytes.

Your doctor will probably want to do a blood test from time to

time to check these.

Signs of electrolyte changes are: thirst, dryness of the mouth,

muscle pain or cramps, tired muscles, low blood pressure

(hypotension), feeling weak, sluggish, tired, sleepy

or restless, nausea, vomiting, less need to pass

urine, a rapid heart rate. Tell your doctor if you

notice these symptoms.

As with any medicine which reduces blood

pressure, an excessive drop in blood pressure in

patients with blood flow disturbances of the heart or

brain could lead to a heart attack or stroke. Your

doctor will therefore check your blood pressure

carefully.

If you are due to have tests for parathyroid function, you should

stop taking Olmesartan Medoxomil/Hydrochlorothiazide tablets

before these tests are carried out.

You must tell your doctor if you think that you are (or might

become) pregnant.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are 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

Olmesartan Medoxomil/Hydrochlorothiazide tablets are not

recommended for children and adolescents under the age of 18.

Other medicines and Olmesartan Medoxomil/

Hydrochlorothiazide tablets

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines

In particular, tell your doctor or pharmacist about any of the

following:

Other blood pressure lowering medicines

(anti-hypertensives), as the effect of Olmesartan

Medoxomil/Hydrochlorothiazide tablets can be increased.

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 Olmesartan

Medoxomil/Hydrochlorothiazide tablets ” and “Warnings and

precautions”).

Medicines which may alter the levels of potassium in your

blood if used at the same time as Olmesartan

Medoxomil/Hydrochlorothiazide tablets . These include:

potassium supplements (as well as salt substitutes

containing potassium)

water tablets (diuretics)

heparin (for thinning the blood)

laxatives

steroids

adrenocorticotrophic hormone (ACTH)

carbenoxolone (a medicine used to treat mouth and

stomach ulcers)

penicillin G sodium (also called benzylpenicillin sodium, an

antibiotic)

certain pain killers such as aspirin or salicylates

Lithium (a medicine used to treat mood swings and some

types of depression) used at the same time as Olmesartan

Medoxomil/Hydrochlorothiazide tablets may increase the

toxicity of lithium. If you have to take lithium, your doctor will

measure your lithium blood levels.

Non-steroidal anti-inflammatory (NSAIDs) medicines

(medicines used to relieve pain, swelling and other symptoms

of inflammation, including arthritis) used at the same time as

Olmesartan Medoxomil/Hydrochlorothiazide tablets may

increase the risk of kidney failure and the effect of

Olmesartan Medoxomil/Hydrochlorothiazide tablets can be

decreased by NSAIDs.

Sleeping tablets, sedatives and anti-depressant medicines, as

using these medicines together with Olmesartan

Medoxomil/Hydrochlorothiazide tablets may cause a sudden

drop in blood pressure when standing up.

Certain medicines such as baclofen and tubocurarine, used

to relax muscles.

Amifostine and some other drugs used to treat cancers, such

as cyclophosphamide or methotrexate.

Colestyramine and colestipol, medicines for lowering blood fat

levels.

Colesevelam hydrochloride, a drug that lowers the level of

cholesterol in your blood, as the effect of

Olmesartan Medoxomil/Hydrochlorothiazide

tablets may be decreased. Your doctor may

advise you to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets at least

4 hours before colesevelam hydrochloride.

Anticholinergic agents, such as atropine and

biperiden.

Drugs such as thioridazine, chlorpromazine,

levomepromazine, trifluoperazine, cyamemazine,

sulpiride, amisulpride, pimozide, sultopride,

tiapride, droperidol or haloperidol, used to treat

certain psychiatric disorders.

Certain medicines such as quinidine, hydroquinidine,

disopyramide, amiodarone, sotalol or digitalis, used to treat

heart problems.

Medicines such as mizolastine, pentamidine, terfenadine,

dofetilide, ibutilide or erythromycin injections, which may

change the heart rhythm.

Oral anti-diabetic medicines, such as metformin, or insulin,

used to lower blood sugar.

Beta-blockers and diazoxide, medicines used to treat high

blood pressure or low blood sugar, respectively, as

Olmesartan Medoxomil/Hydrochlorothiazide tablets can

enhance their blood-sugar-increasing effect.

Methyldopa, a medicine used to treat high blood pressure.

Medicines such as noradrenaline, used to increase blood

pressure and slow heart rate.

Diphemanil, used to treat a slow heartbeat or reduce

sweating.

Medicines such as probenecid, sulfinpyrazone and

allopurinol, used to treat gout.

Calcium supplements.

Amantadine, an anti-viral drug.

Ciclosporin, a medicine used to stop rejection of organ

transplants.

Certain antibiotics called tetracyclines or sparfloxacin.

Amphotericin, a medicine used to treat fungal infections.

Certain antacids, used to treat too much stomach acid, such

as aluminium magnesium hydroxide, as the effect of

Olmesartan Medoxomil/Hydrochlorothiazide tablets can be

slightly decreased.

Cisapride, used to increase food movement in the stomach

and gut.

Halofantrine, used for malaria.

Olmesartan Medoxomil/Hydrochlorothiazide tablets with

food and drink

Olmesartan Medoxomil/Hydrochlorothiazide tablets can be

taken with or without food.

Take care when drinking alcohol while you are taking

Olmesartan Medoxomil/Hydrochlorothiazide tablets, as some

people feel faint or dizzy. If this happens to you, do not drink

any alcohol, including wine, beer or alcopops.

Black patients

As with other similar drugs the blood pressure lowering effect of

Olmesartan Medoxomil/Hydrochlorothiazide tablets are

somewhat less in black patients.

Pregnancy 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

Olmesartan Medoxomil/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

Olmesartan Medoxomil/Hydrochlorothiazide tablets.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are 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 it is used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start

breast-feeding.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are not

recommended for mothers who are breast-feeding, and your

doctor may choose another treatment for you if you wish to

breast-feed.

If you are pregnant or breast-feeding, think you may be

pregnant or are planning to have a baby, ask your doctor or

pharmacist for advice before taking this medicine.

Driving and using machines

You may feel sleepy or dizzy while being treated for your high

blood pressure. If this happens, do not drive or use machines

until the symptoms wear off. Ask your doctor for advice.

Olmesartan Medoxomil/Hydrochlorothiazide tablets

contains lactose monohydrate

This medicine contains lactose (a type of sugar). If you have

been told by your doctor that you have an intolerance to some

sugars, contact your doctor before taking this medicine.

3.

How to take Olmesartan Medoxomil/

Hydrochlorothiazide tablets

Always take this medicine exactly as your doctor or pharmacist

has told you. Check with your doctor or pharmacist if you are

not sure.

The recommended dose is one Olmesartan

Medoxomil/Hydrochlorothiazide tablets 20 mg/12.5 mg tablet a

day. However, if your blood pressure is not controlled, your

doctor may decide to change your dose to one Olmesartan

Medoxomil/Hydrochlorothiazide tablets 20 mg/25mg tablet a

day.

Swallow the tablet with water. If possible, you should take your

dose at the same time each day, for example at breakfast

time. It is important to continue to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets until your doctor tells

you to stop.

If you take more Olmesartan Medoxomil/

Hydrochlorothiazide tablets than you should

If you take more tablets than you should, or if a child

accidentally swallows one or more, go to your doctor or nearest

accident and emergency (A&E) department immediately and

take your medicine pack with you.

If you forget to take Olmesartan Medoxomil/

Hydrochlorothiazide tablets

If you forget to take a dose, take your normal dose on the

following day as usual. Do not take a double dose to make up

for a forgotten dose.

If you stop taking Olmesartan Medoxomil/

Hydrochlorothiazide tablets

It is important to continue to take Olmesartan

Medoxomil/Hydrochlorothiazide tablets unless your doctor tells

you to stop.

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.

However, the following two side effects can be serious:

Allergic reactions that may affect the whole body, with

swelling of the face, mouth and/or voice box (larynx) together

with itching and rash may occur rarely. If this happens, stop

taking Olmesartan Medoxomil/Hydrochlorothiazide

tablets and contact your doctor immediately.

Olmesartan Medoxomil/Hydrochlorothiazide tablets can

cause the blood pressure to fall too low in susceptible

individuals or as the result of an allergic reaction.

Light-headedness or fainting may occur uncommonly. If this

happens, stop taking Olmesartan

Medoxomil/Hydrochlorothiazide tablets, contact your

doctor immediately and lie down flat.

Olmesartan Medoxomil/Hydrochlorothiazide tablets are a

combination of two active substances and the following

information firstly gives the other side effects reported so far

with the combination Olmesartan Medoxomil/

Hydrochlorothiazide tablets (besides those already mentioned

above) and, secondly, those which are known about for the

separate active substances.

These are the other side effects known about so far with

Olmesartan Medoxomil/Hydrochlorothiazide tablets:

If these side effects occur, they are often mild and you do not

need to stop your treatment.

Common side effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, tiredness, chest pain, swelling

of ankles, feet, legs, hands or arms.

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

Fluttering of the heartbeat (palpitations), rash, eczema, vertigo,

cough, indigestion, abdominal pain, nausea, vomiting,

diarrhoea, muscle cramps and muscular pain, pain in joints,

arms and legs, back pain, erection difficulties in men, blood in

urine.

Some changes in blood test results have also been seen

uncommonly and include:

Rise in blood fat levels, rise in blood urea or uric acid, rise in

creatinine, rise or decrease in blood potassium levels, rise in

blood calcium levels, rise in blood sugar, increase in levels of

liver function. Your doctor will know about these from a blood

test and will tell you if you need to do anything.

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

Feeling unwell, disturbances in consciousness, skin lumps

(wheals), acute kidney failure.

Some changes in blood test results have also been seen in

rare cases and include:

Rise in blood urea nitrogen, decrease in haemoglobin and

haematocrit values. Your doctor will know about these from a

blood test and will tell you if you need to do anything.

Further side effects reported with use of olmesartan

medoxomil or hydrochlorothiazide alone, but not with

Olmesartan Medoxomil/Hydrochlorothiazide tablets or in a

higher frequency:

Olmesartan Medoxomil:

Common side effects (may affect up to 1 in 10 people):

Bronchitis, cough, runny or stuffy nose, sore throat, abdominal

pain, indigestion, diarrhoea, nausea, gastroenteritis, pain in the

joints or bones, back pain, blood in urine, urinary tract infection,

flu-like symptoms, pain.

Some changes in blood test results have also been seen

commonly and include:

Rise in blood fat levels, rise in blood urea or uric acid, increase

in levels of liver and muscle function.

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

Quick allergic reactions that may affect the whole body and

may cause breathing problems as well as a rapid fall of blood

pressure that may even lead to fainting (anaphylactic

reactions), swelling of the face, angina (pain or uncomfortable

feeling in the chest; known as angina pectoris), feeling unwell,

allergic skin rash, itching, exanthema (skin eruption), skin

lumps (wheals).

Some changes in blood test results have also been seen

uncommonly and include:

Reduced numbers of a type of blood cell, known as platelets

(thrombocytopenia).

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

Impaired kidney function, lack of energy.

Some changes in blood test results have also been seen rarely

and include:

Increase in blood potassium.

Hydrochlorothiazide:

Very common side effects (may affect more than 1 in 10

people):

Changes in blood results including: Increase in blood fat and

uric acid levels.

Common side effects (may affect up to 1 in 10 people):

Feeling confused, abdominal pain, stomach upset, bloated

feeling, diarrhoea, nausea, vomiting, constipation, excretion of

glucose into the urine.

Some changes in blood results have also been seen and

include:

Increase in blood creatinine, urea, calcium and sugar levels,

decrease in blood chloride, potassium, magnesium

and sodium levels. Increase of serum amylase

(hyperamylasaemia).

Uncommon side effects (may affect up to 1 in

100 people):

Decreased or loss of appetite, severe difficulty

breathing, anaphylactic skin reactions

(hypersensitivity reactions), worsening of

pre-existing myopia erythema, skin reactions to

light, itching, purplish spots or patches on the skin due to small

haemorrhages (purpura), skin lumps (wheals).

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

Swollen and sore salivary glands, decreased number of white

blood cells, decreased number of blood platelets, anaemia,

bone marrow damage, restlessness, feeling ‘down’ or

depressed, problems sleeping, feeling un-interested (apathy),

tingling and numbness, fits (convulsions), objects you look at

appearing yellow, blurred vision, dry eyes, irregular heartbeat,

inflammation of the blood vessels, blood clots (thrombosis or

embolism), inflammation of the lung, fluid accumulation in the

lungs, inflammation of the pancreas, jaundice, infection in the

gall bladder, symptoms of lupus erythematosus (such as rash,

joint pains and cold hands and fingers), allergic skin reactions,

peeling and blistering of the skin, non-infectious inflammation of

the kidney (interstitial nephritis), fever, muscle weakness

(sometimes causing impaired movement).

Very rare side effects (may affect up to 1 in 10,000 people):

Electrolyte disturbance leading to an abnormally depleted level

of chloride in the blood (hypochloraemic alkalosis), blockage in

the gut (paralytic ileus).

Not known (frequency cannot be estimated from the

available data):

Decrease in vision or eye pain (possible signs of acute

angle-closure glaucoma).

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 the national

reporting system (see contact details below).

By reporting side effects you can help provide more information

on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace,

IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie

5.

How to store Olmesartan Medoxomil/

Hydrochlorothiazide tablets

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

This medicinal product does not require any special storage

conditions.

Do not use this medicine after the expiry date which is stated

on the carton and on the blister strip as EXP. The expiry date

refers to the last day of that month.

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 Olmesartan Medoxomil/Hydrochlorothiazide tablets

contains

The active substances of Olmesartan

Medoxomil/Hydrochlorothiazide tablets are:

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20 mg/12.5 mg: Each film-coated tablet contains 20 mg

olmesartan medoxomil and 12.5 mg hydrochlorothiazide.

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20 mg/25 mg: Each film-coated tablet contains 20 mg

olmesartan medoxomil and 25 mg hydrochlorothiazide.

The other ingredients are:

Hydroxy propyl cellulose, Lactose monohydrate, Cellulose

microcrystalline, Low substituted Hydroxy propyl cellulose,

Magnesium stearate, Hypromellose, Titanium dioxide (E171),

Macrogol 3000, Talc, Iron oxide yellow (E172), Iron oxide red

(E172)

What Olmesartan Medoxomil/Hydrochlorothiazide tablets

look like and contents of the pack

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20/12.5 mg are Reddish-Yellow, round, film-coated tablets;

debossed with “OH1” on one side and plain on other side.

Diameter approximately 8.6 mm.

Olmesartan Medoxomil/Hydrochlorothiazide tablets 20/25 mg

are Pinkish, round, film-coated tablets; debossed with “OH4” on

one side and plain on other side. Diameter approximately

8.6 mm.

Olmesartan Medoxomil/Hydrochlorothiazide tablets

20/12.5 mg and 20/25 mg are available in Alu-Alu blister

containing 10, 14, 28, 30, 56, 84, 90, 98, 280 or 300 tablets or

in Alu-Alu perforated unit dose blisters containing 10, 28, 50 or

500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Wesseling Hungary Kft.

Budapest, Fòti ùt 56,

1047 Hungary

The medicinal product is authorized in the Member States

of the EEA under the following names:

Name of

:

Name of medicinal product

member state

Olmesartan Medoxomil/

Hydrochlorothiazide Accord 20/12.5 mg,

20/25 mg Filmtabletten

Olmesartan Medoxomil/

Hydrochlorothiazide Accord

Olmesartan Medoxomil/

Hydrochlorothiazide Accord 20/12.5 mg,

20/25 mg film-coated tablets

Olmesartan medoxomil e idroclorotiazide

Accord

Olmesartan Medoxomil/

Hydrochloorthiazide Accord 20/12,5 mg,

20/25 mg filmomhulde tabletten

Olmesartan Medoxomil/

Hydrochlorothiazide 20/12.5 mg, 20/25 mg

film-coated tablets

Olmesartán medoxomilo/Hidroclorotiazida

Accord 20/12.5 mg, 20/25 mg

comprimidos recubiertos con película

This leaflet was last approved in 05/2017.

Artwork No.

Customer

Description

Market

Language

Size

Min. Font Size

Version No.

Date

Accord

Olmesartan Medoxomil

UK-IE

English

175 x 600 mm (PIL)

4 (Page 2 of 2)

25/05/17 (Olmesartan Medoxomil-Hydro 20mg(ACC-UK-IE)PIL)

Colours Used

Pantone Black

Keyline

Prepared By

Regulatory Affairs

Checked By

Regulatory Affairs

Approved By

Quality Assurance

INP097

10 00000 0 000000