Olmesartan Medoxomil / Hydrochlorothiazide 20mg/25mg Film Coated Tablets
Package Leaflet: Information For The User
OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE 20 mg/12.5 mg AND 20 mg/25
mg FILM-COATED TABLETS
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 is and what it is used for
2. What you need to know before you take Olmesartan Medoxomil/Hydrochlorothiazide
3. How to take Olmesartan Medoxomil/Hydrochlorothiazide
4. Possible side effects
5. How to store Olmesartan Medoxomil/Hydrochlorothiazide
6. Contents of the pack and other information
1. What Olmesartan Medoxomil/Hydrochlorothiazide is and what it is used for
Olmesartan Medoxomil/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 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 if olmesartan medoxomil alone has not adequately controlled your blood pressure. When given together, the two active substances in Olmesartan Medoxomil/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 Olmesartan Medoxomil/Hydrochlorothiazide 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 Do not take Olmesartan Medoxomil/Hydrochlorothiazide if you:
• are allergic to olmesartan medoxomil, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• are allergic to substances similar to hydrochlorothiazide (sulfonamides)
• are more than 3 months pregnant. (It is also better to avoid Olmesartan Medoxomil/Hydrochlorothiazide in early pregnancy - see pregnancy section)
• have severe kidney problems
• suffer from low potassium, low sodium, high calcium or high uric acid levels in your blood (with symptoms of gout or kidney stones) that do not get better when treated
• suffer from severe liver problems or yellowing of the skin and eyes (jaundice)
• have problems with drainage of the bile from the gallbladder (biliary obstruction, e.g. gallstones)
• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
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 before taking Olmesartan Medoxomil/Hydrochlorothiazide.
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”.
Before you take the tablets, tell your doctor if you have any of the following health problems. Your doctor may want to see you more often and do some tests if you have any of these conditions:
• mild to moderate kidney problems or you have had a kidney transplant
• liver diseases
• heart failure or problems with your heart valves or heart muscles
• vomiting (being sick) or diarrhoea which is severe or goes on for several days
• treatment with high doses of water tablets (diuretics)
• 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 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.
Olmesartan Medoxomil/Hydrochlorothiazide may cause a rise in blood fat levels and uric acid levels (the cause of gout - painful swelling of the joints). Your doctor may do a blood test from time to time to check these.
This medicine may change the levels of certain substances in your blood called electrolytes. Your doctor may do a blood test from time to time to check this. 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 or a rapid heart rate. Tell your doctor if you notice these symptoms.
As with any medicine which reduces blood pressure, a large 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.
Medical test results
If you are due to have tests for parathyroid function, you should stop taking Olmesartan Medoxomil/Hydrochlorothiazide before these tests are carried out. Ask your doctor for advice before stopping treatment.
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. Olmesartan Medoxomil/Hydrochlorothiazide 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 Medoxomil/Hydrochlorothiazide is not recommended for children and adolescents under the age of 18.
Black patients
As with other similar drugs the blood pressure lowering effect of Olmesartan Medoxomil/Hydrochlorothiazide is somewhat less in black patients.
Other medicines and Olmesartan Medoxomil/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:
• medicines which may raise the levels of potassium in your blood if used at the same time as Olmesartan Medoxomil/Hydrochlorothiazide. These include:
• potassium supplements (a salt substitute which contains 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). When used at the same time as Olmesartan Medoxomil/Hydrochlorothiazide, the toxicity of lithium may be increased. 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). When used at the same time as Olmesartan Medoxomil/Hydrochlorothiazide, they may increase the risk of kidney failure. In addition the effect of Olmesartan Medoxomil/Hydrochlorothiazide can be decreased by NSAIDs
• other blood pressure lowering medicines (anti-hypertensives) as the effect of Olmesartan Medoxomil/Hydrochlorothiazide can be increased
• sleeping tablets, sedatives and anti-depressant medicines. Using these medicines together with Olmesartan Medoxomil/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 medicines such as cyclophosphamide or methotrexate - used to treat cancers
• colestyramine and colestipol - used 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 may be decreased. Your doctor may advise you to take Olmesartan Medoxomil/Hydrochlorothiazide at least 4 hours before colesevelam hydrochloride
• anticholinergic agents such as atropine and biperiden
• medicines 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 can change the heart rhythm
• oral anti-diabetic medicines such as metformin or insulin - used to lower blood sugar
• beta-blockers and diazoxide - used to treat high blood pressure and low blood sugar respectively. Olmesartan Medoxomil/Hydrochlorothiazide 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 medicine
• ciclosporin used to stop organ transplant rejection
• certain antibiotics called tetracyclines or sparfloxacin
• amphotericin used to treat fungal infections
• certain antacids such as aluminium magnesium hydroxide (used to treat too much stomach acid). The effect of Olmesartan Medoxomil/Hydrochlorothiazide can be slightly decreased
• cisapride used to increase food movement in the stomach and gut
• halofantrine used for malaria.
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’ and ‘Warnings and precautions’).
Olmesartan Medoxomil/Hydrochlorothiazide with alcohol
Take care when drinking alcohol while you are taking Olmesartan Medoxomil/Hydrochlorothiazide, as some people feel faint or dizzy. If this happens to you, do not drink any alcohol, including wine, beer or alcopops.
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 Olmesartan Medoxomil/Hydrochlorothiazide 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. Olmesartan Medoxomil/Hydrochlorothiazide 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. Olmesartan Medoxomil/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 Medoxomil/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 Medoxomil/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 Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg film-coated tablet a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose to one Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/25 mg film-coated tablet a day.
• swallow the tablet with water
• take your dose at the same time each day, for example at breakfast time
• take Olmesartan Medoxomil/Hydrochlorothiazide until your doctor tells you to stop
• the 20 mg/25 mg tablet can be divided into equal doses.
If you take more Olmesartan Medoxomil/Hydrochlorothiazide than you should
If you take more tablets than you should, or if a child accidentally swallows any tablets, go to your doctor or nearest accident and emergency (A&E) department immediately. Take your medicine pack with you.
If you forget to take Olmesartan Medoxomil/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 Medoxomil/Hydrochlorothiazide
It is important to continue to take Olmesartan Medoxomil/Hydrochlorothiazide 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.
If you experience the following, stop taking Olmesartan Medoxomil/Hydrochlorothiazide and contact your doctor immediately:
• allergic reactions that may affect the whole body with swelling of the face, mouth and/or voice box (larynx) together with itching and rash. This occurs rarely
• Olmesartan Medoxomil/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 can occur although this is uncommon. If this happens lie down flat and contact your doctor immediately.
Olmesartan Medoxomil/Hydrochlorothiazide is a combination of two active substances and the following information firstly gives the side effects reported so far with the combination (besides those mentioned above) and secondly gives those which are known about for the separate active substances.
If these side effects occur, they are often mild and you do not need to stop your treatment.
Common: may affect up to 1 in 10 people
• dizziness/light-headedness
• weakness
• headache
• tiredness
• chest pain
• swelling of the ankles, feet, legs, hands or arms.
Uncommon: may affect up to 1 in 100 people
• fluttering of the heart beat (palpitations)
• rash
• eczema
• drowsiness
• vertigo
• cough
• indigestion
• stomach pain
• feeling and being sick (nausea and vomiting)
• diarrhoea
• muscle cramps and muscular pain
• pain in joints, arms and legs
• back pain
• erection difficulties
• blood in urine.
Some changes in blood test results have also been observed uncommonly and include:
Rise in blood fat levels, rise in blood urea or uric acid, rise in creatinine, rise or fall in blood potassium levels, rise in blood calcium levels, rise in blood sugar and an increase in the level of liver function. Your doctor will know about these from a blood test and will tell you if you need to do anything.
Rare: may affect up to 1 in 1,000 people
• feeling unwell
• disturbances in consciousness
• red lumpy skin (wheals)
• acute kidney failure.
Some changes in blood test results have also been observed rarely and include:
Rise in blood urea nitrogen, decrease in haemoglobin and haemocrit 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 the use of olmesartan medoxomil or hydrochlorothiazide alone but not with Olmesartan Medoxomil/Hydrochlorothiazide or with a higher frequency are presented below:
Olmesartan medoxomil
Common: may affect up to 1 in 10 people
• bronchitis
• cough
• runny or stuffy nose
• sore throat
• stomach pain
• indigestion
• diarrhoea
• feeling sick (nausea)
• gastroenteritis
• pain in the bones or joints
• back pain
• blood in urine
• urinary tract infection
• flu-like symptoms
• pain.
Some changes in blood test results have also been observed commonly and include:
Rise in blood fat levels, rise in blood urea or uric acid, increase in levels of liver and muscle function.
Uncommon: may affect up to 1 in 100 people
• allergic reactions that have a fast onset and may affect the whole body and may cause breathing problems as well as a rapid fall in blood pressure that may even lead to fainting (anaphylactic reaction)
• swelling of the face
• pain or uncomfortable feeling in the chest; known as angina pectoris
• feeling unwell
• allergic skin rash
• itching
• skin eruption (exanthema)
• red lumpy skin (wheals).
Some changes in blood test results have also been observed uncommonly and include:
Reduced numbers of a type of blood cell known as platelets (thrombocytopenia).
Rare: may affect up to 1 in 1,000 people
• impaired kidney function
• lack of energy.
Some changes in blood test results have also been observed rarely and include:
Increase in blood potassium.
Hydrochlorothiazide
Very common: may affect more than 1 in 10 people
• changes in blood test results including increase in blood fat and uric acid levels.
Common: may affect up to 1 in 10 people
• feeling confused
• stomach pain
• stomach upset
• bloated feeling
• diarrhoea
• feeling and being sick (nausea and vomiting)
• constipation
• excretion of glucose into the urine.
Some changes in blood test results have also been observed 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: may affect up to 1 in 100 people
• decreased or loss of appetite
• severe difficulty breathing
• anaphylactic reactions (hypersensitivity reactions)
• worsening of pre-existing myopia near/short sightedness
• redness of the skin (erythema)
• skin reactions to light
• itching
• purplish spots or patches on the skin due to small haemorrhages (purpura)
• red lumpy skin (wheals).
Rare: 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 uninterested (apathy)
• tingling and numbness
• fits (convulsions)
• objects you look at appearing yellow
• blurred vision
• dry eyes
• irregular heart beat
• inflammation of the blood vessels
• blood clots (thrombosis or embolism)
• shortness of breath (dyspnoea)
• inflammation of the lung
• fluid accumulation in the lungs
• inflammation of the pancreas
• yellowing of the skin or whites of eyes (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: 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).
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 www.mhra.gov.uk/vellowcard
Yellow Card Scheme at: safety of this medicine.
By reporting side effects you can help provide more information on the
5. How to store Olmesartan Medoxomil/Hydrochlorothiazide Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
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 contains:
• The active substances are olmesartan medoxomil and hydrochlorothiazide.
Each film-coated tablet contains 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide or 20 mg olmesartan medoxomil and 25 mg hydrochlorothiazide.
• The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone (K-30), croscarmellose sodium, magnesium stearate and macrogol.
Film-coating: Hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
What Olmesartan Medoxomil/Hydrochlorothiazide looks like and contents of the pack: Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/12.5 mg Film-coated Tablets are reddish-yellow, round and biconvex.
Olmesartan Medoxomil/Hydrochlorothiazide 20 mg/25 mg Film-coated Tablets are pinkish, round, biconvex and scored on one side.
They are available in blister packs of 14, 28, 28x1, 30, 30x1, 56, 90, 90x1, 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-StraBe 3, Blaubeuren, 89143, Germany *OR
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb, 10000, Croatia *OR
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Krakow, 31-546, Poland This leaflet was last revised in 04/2016
PL 00289/2007 PL 00289/2008
* Only the actual site of batch release will appear on the printed version of the leaflet