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DAVIDOL 20 MG /25 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE / OLMESARTAN MEDOXOMIL

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Package leaflet: Information for the user
Davidol 20 mg/12.5 mg
Davidol 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 Davidol is and what it is used for
2. What you need to know before you take Davidol
3. How to take Davidol
4. Possible side effects
5. How to store Davidol
6. Contents of the pack and other information
1.

What Davidol is and what it is used for

Davidol 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 Davidol if olmesartan medoxomil alone has not adequately controlled
your blood pressure. When given together, the two active substances in Davidol 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 Davidol to lower it more.
High blood pressure can be controlled with medicines such as Davidol 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 Davidol

Do not take Davidol :







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 Davidol in early
pregnancy – see pregnancy section)
if you have severe kidney problems
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 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 using Davidol.
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 Davidol. 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.

Davidol 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.
Talk to your doctor or pharmacist or nurse before using Davidol :


if you are taking any of the following medicines used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril, lisinopril, ramipril, in particular if
you have diabetes-related kidney problems
o 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 Davidol”.
If you are due to have tests for parathyroid function, you should stop taking Davidol before
these tests are carried out.
If you are a sports person, this medicine could change the results of an anti-dope test to make
it positive.
You must tell your doctor if you think that you are (or might become) pregnant. Davidol 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
Davidol is not recommended for children and adolescents under the age of 18.
Other medicines and Davidol
Tell your doctor or pharmacist if you are using, have recently used or might use any other
medicines.
In particular, tell your doctor or pharmacist about any of the following:


Medicines which may alter the levels of potassium in your blood if used at the same
time as Davidol. These include:

o
o
o
o
o
o
o
o
o































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 Davidol 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 Davidol may increase the risk of kidney failure and the effect of Davidol can
be decreased by NSAIDs
Other blood pressure lowering medicines (anti-hypertensives), as the effect of Davidol
can be increased
Sleeping tablets, sedatives and anti-depressant medicines, as using these medicines
together with Davidol 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 Davidol may be decreased. Your doctor may advise you to take
Davidol 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 Davidol 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 Davidol 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 Davidol” and “Warnings and precautions”).
Davidol with food and drink
Davidol can be taken with or without food.
Take care when drinking alcohol while you are taking Davidol, 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 Davidol 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 Davidol before you become pregnant or as soon as you
know you are pregnant and will advise you to take another medicine instead of Davidol.
Davidol 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. Davidol 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.
Davidol contains lactose
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 Davidol

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 Davidol 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 Davidol 20
mg/25 mg 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 Davidol until your
doctor tells you to stop.
If you take more Davidol 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 department immediately and take your
medicine pack with you.
If you forget to take Davidol
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 Davidol
It is important to continue to take Davidol 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 Davidol and contact your doctor immediately.
Davidol 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 Davidol, contact your doctor
immediately and lie down flat.

Davidol is a combination of two active substances and the following information firstly gives
the other side effects reported so far with the combination Davidol (besides those already
mentioned above) and, secondly, those which are known about for the separate active
substances.
These are the other side effects
medoxomil/hydrochlorothiazide:

known

about

so

far

with

Olmesartan

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 heart beat (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 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 heart beat,
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
(cannot
be
estimated
from
the
available
data):
Acute transient nearsightedness (acute myopia) and sudden loss of vision on both eyes
accompanied by ocular pain, and headache (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
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5.

How to store Davidol

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 Davidol contains
The active substances are:
Davidol 20 mg/12.5 mg: Each film-coated tablet contains 20 mg olmesartan medoxomil and
12.5 mg hydrochlorothiazide.
Davidol 20 mg/25 mg: Each film-coated tablet contains 20 mg olmesartan medoxomil and 25
mg hydrochlorothiazide.
The other ingredients are:
Lactose monohydrate*, low substituted hydroxypropylcellulose, hydroxypropylcellulose,
microcrystalline cellulose, magnesium stearate, titanium dioxide (E 171), talc, hypromellose,
iron oxide yellow (E 172), iron oxide red (E 172).

* See ‘Davidol contains lactose’ section above
What Davidol looks like and contents of the pack
Davidol 20 mg/12.5 mg film-coated tablets are pale orange colored, round, bevel edged filmcoated tablets, with ‘22’ embossed on one side, with diameter of 8.6 mm.
Davidol 20 mg/25 mg film-coated tablets are pale pink colored, round, bevel edged filmcoated tablets, with ‘24’ embossed on one side, with diameter of 8.6 mm.
They are available in blister packs of 14, 28, 30, 56, 84, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
SUBSTIPHARM DEVELOPPEMENT
24 RUE ERLANGER
75016 PARIS
FRANCE
Manufacturer
MEDREICH PLC
WARWICK HOUSE
PLANE TREE CRESCENT
FELTHAM, TW13 7HF
UNITED KINGDOM
This medicinal product is authorised in the Member States of the EEA under the
following names:
Portugal:
Davidol
Belgium:
Persatul 20 mg/12.5mg, comprimé pelliculé
Persatul 20 mg/25mg, comprimé pelliculé
United Kingdom:
Davidol 20 mg/12.5mg, film-coated tablet
Davidol 20 mg/25mg, film-coated tablet
This leaflet was last revised in 04/2017.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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