OLMESARTAN/HYDROCHLOROTHIAZIDE 40 MG / 12.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Olmesartan/Hydrochlorothiazide 40 mg/12.5 mg film-coated tablets Olmesartan/Hydrochlorothiazide 40 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/Hy­drochlorothia­zide is and what it is used for

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

• 3. How to take Olmesartan/Hy­drochlorothia­zide

• 4. Possible side effects

• 5. How to store Olmesartan/Hy­drochlorothia­zide

• 6. Contents of the pack and other information

1. what olmesartan/hydrochlorothiazide is and what it is used for

Olmesartan/Hy­drochlorothia­zide 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 Il-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/Hy­drochlorothia­zide if olmesartan medoxomil alone has not adequately controlled your blood pressure. When given together, the two active substances in Olmesartan/Hy­drochlorothia­zide 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 this medicine to lower it more.

High blood pressure can be controlled with medicines such as Olmesartan/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/hydrochlorothiazide 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 (sulphonamides).

• are more than 3 months pregnant (it is also better to avoid this medicine in early pregnancy – see pregnancy section).
• have kidney problems
• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• 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.
• suffer from moderate or 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 before taking Olmesartan/Hy­drochlorothia­zide.

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-melenoma skin cancer). Protect your skin from sun exposure and UV rays while taking this product.

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 this medicine, seek medical attention immediately.

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/Hy­drochlorothia­zide”

Before you take the tablets, tell your doctor if you have any of the following health problems:

• 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 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 weeks of taking this medicine. 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/Hy­drochlorothia­zide 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 this medicine before these tests are carried out.

If you are a sports person, this medicine could change the results of an anti-doping test to make it positive.

You must tell your doctor if you think that you are (or might become) pregnant. This medicine 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

Olmesartan/Hy­drochlorothia­zide is not recommended for children and adolescents under the age of 18.

Other medicines and Olmesartan/Hydrochlorothiazide

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/Hy­drochlorothia­zide 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/Hy­drochlorothia­zide” and “Warnings and precautions”).

• Medicines which may alter the levels of potassium in your blood if used at the same time as this medicine. 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/Hy­drochlorothia­zide 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/Hy­drochlorothia­zide may increase the risk of kidney failure and the effect of Olmesartan/Hy­drochlorothia­zide can be decreased by NSAIDs
• Sleeping tablets, sedatives and antidepressant medicines, as using these medicines together with Olmesartan/Hy­drochlorothia­zide 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/Hy­drochlorothia­zide may be decreased. Your doctor may advise you to take this medicine 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/Hy­drochlorothia­zide can enhance their blood-sugarincreasin­g 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/Hy­drochlorothia­zide can be slightly decreased
• Cisapride, used to increase food movement in the stomach and gut
• Halofantrine, used for malaria.

Olmesartan/Hydrochlorothiazide with food, drink and alcohol

Olmesartan/Hy­drochlorothia­zide can be taken with or without food.

Take care when drinking alcohol while you are taking Olmesartan/Hy­drochlorothia­zide, 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/Hy­drochlorothia­zide is somewhat less in black patients.

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 this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmesartan/Hy­drochlorothia­zide. This medicine 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 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/Hy­drochlorothia­zide is 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/Hydrochlorothiazide 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/hydrochlorothiazide

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

The recommended dose is one Olmesartan/Hy­drochlorothia­zide 40 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/Hy­drochlorothia­zide 40 mg/25 mg tablet a day.

Swallow the tablet with a sufficient amount of fluid (e.g. one glass of water). Do not chew the tablet. The score line is not intended for breaking the tablet.

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 this medicine until your doctor tells you to stop.

If you take more Olmesartan/Hydrochlorothiazide 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/Hydrochlorothiazide

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/Hydrochlorothiazide

It is important to continue to take this medicine 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 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 this medicine and contact your doctor immediately.
• Olmesartan/Hy­drochlorothia­zide 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 this medicine, contact your doctor immediately and lie down flat.

• Acute respiratory distress may occur very rarely (signs include severe shortness of breath, fever, weakness, and confusion).

These are the other side effects known about so far with olmesartan/hydrochlorothiazide:

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 in combination 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:

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 (glycosuria).

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 (sialadenitis), 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 (paraesthesia), 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), renal dysfunction.

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), acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

Not known (frequency cannot be estimated from the available data):

Skin and lip cancer (non-melanoma skin cancer), decrease in vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or 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 Yellow Card Scheme at 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 olmesartan/hydrochlorothiazide

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 pack after „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 informationthe active substances are olmesartan medoxomil and hydrochlorothiazide.

Olmesartan/Hy­drochlorothia­zide 40mg/12.5mg film-coated tablets:

Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5 mg

hydrochlorothi­azide.

Olmesartan/Hy­drochlorothia­zide 40mg/25mg film-coated tablets:

Each film-coated tablet contains 40 mg olmesartan medoxomil and 25 mg

hydrochlorothi­azide.

The other ingredients are: Lactose monohydrate, microcrystalline cellulose, crospovidone, silica, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E171), iron (III) oxides yellow/red (E172).

What Olmesartan/Hydrochlorothiazide looks like and contents of the pack

Olmesartan/Hy­drochlorothia­zide 40mg/12.5mg film-coated tablets:

Beige, oval, biconvex film-coated tablets with a length of 16.3 mm and a width of 7.8 mm and a score line on one side. The score line is not intended for breaking the tablet.

Olmesartan/Hy­drochlorothia­zide 40mg/25mg film-coated tablets:

Salmon, oval, biconvex film-coated tablets with a length of 16.3 mm and a width of 7.8 mm and a score line on one side. The score line is not intended for breaking the tablet.

The film-coated tablets are available in blister packs of oPA-Alu-PVC form foil sealed with an aluminium foil with containing 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

STADA,

Linthwaite, Huddersfield, HD7 5QH, UK

Manufacturer

STADA Azneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany

OR

Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK

This leaflet was last revised in December 2021.

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