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OLMESARTAN TORRENT 10 MG FILM-COATED TABLETS

Active substance(s): OLMESARTAN MEDOXOMIL / OLMESARTAN MEDOXOMIL

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you are not sure.

Package leaflet: Information for the user

Adults
The recommended starting dose is one 10 mg tablet once a day. However, if your blood pressure is not
controlled, your doctor may decide to change your dose up to 20 or 40 mg once a day, or prescribe
additional medicines.

Olmesartan 10 mg Film-coated Tablets
Olmesartan 20 mg Film-coated Tablets
Olmesartan 40 mg Film-coated Tablets
Olmesartan medoxomil

In patients with mild to moderate kidney disease, your dose will not be higher than 20 mg once a day.

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.

Children and adolescents from 6 to less than 18 years of age
The recommended starting dose is 10 mg once daily. If the patient’s blood pressure is not adequately
controlled, the doctor may decide to change the dose up to 20 or 40 mg once a day. In children who weigh
less than 35 kg, the dose will not be higher than 20 mg once a day.
The tablets can be taken with or without food. Swallow the tablets with a sufficient amount of water (e.g.
one glass). If possible, take your daily dose at the same time each day, for example at breakfast time.
Olmesartan 10 mg Film-coated Tablets
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

What is in this leaflet
1. What Olmesatan is and what it is used for
2. What you need to know before you take Olmesartan
3. How to take Olmesartan
4. Possible side effects
5. How to store Olmesartan
6. Contents of the pack and other information

Olmersartan 20 mg Film-coated Tablets
The tablet can be divided into equal doses.
Olmersartan 40 mg Film-coated Tablets
The tablet can be divided into equal doses.
If you take more Olmesartan than you should
If you take more tablets than you should, or if a child accidentally swallows some, go to your doctor or
nearest emergency department immediately and take your medicine pack with you.

1. What Olmesartan is and what it is used for
Olmesartan belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood
pressure by relaxing the blood vessels.

If you forget to take Olmesartan
If you forget a dose, take your normal dose on the following day as usual. Do not take a double dose to
make up for a forgotten tablet.

Olmesartan is used for the treatment of high blood pressure (also known as ‘hypertension’) in adults and
in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels
in organs such as the heart, kidneys, brain and eyes. In some cases this may lead to a heart attack, heart
or kidney failure, stroke or blindness. Usually high blood pressure has no symptoms. It is important to
have your blood pressure checked to prevent damage occurring.

If you stop taking Olmesartan
It is important to continue to take Olmesartan unless your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

High blood pressure can be controlled with medicines such as Olmesartan. 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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do
occur, they are often mild and do not require treatment to be stopped.
Although not many people may get them, the following two side effects can be serious:

2. What you need to know before you take Olmesartan

On rare occasions (may affect up to 1 in 1,000 people) the following allergic reactions, that may affect the
whole body have been reported:
Swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur
during treatment with Olmesartan. If this happens stop taking Olmesartan and contact your doctor
immediately.
Rarely (but slightly more often in older people) Olmesartan can cause the blood pressure to fall too
low in susceptible individuals or as the result of an allergic reaction. This could cause severe
light-headedness or fainting. If this occurs stop taking Olmesartan, contact your doctor
immediately and lie down flat.

Do not take Olmesartan:
if you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in
section 6).
if you are more than 3 months pregnant. (It is also better to avoid Olmesartan in early pregnancy –
see pregnancy section).
if you suffer from 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.

These are the other side effects known about so far with Olmesartan:
Common (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness, sore
throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain, pain in the chest, back, bones or
joints, infection of the urinary tract, swelling of ankles, feet, legs, hands, or arms, blood in the urine.

Warnings and precautions
Talk to your doctor before taking Olmesartan
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

Some changes in blood test results have also been seen and include the following:
increased fat levels (hypertriglyceridaemia), increased uric acid levels (hyperuricaemia), rise in blood
urea, increases in tests of liver and muscle function.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Uncommon (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), vertigo, vomiting,
weakness, feeling unwell, muscular pain, skin rash, allergic skin rash, itching, exanthema (skin eruption),
skin lumps (wheals), angina (pain or uncomfortable feeling in the chest).

See also information under the heading "Do not take Olmesartan".
Tell your doctor if you have any of the following health problems:
kidney problems
liver disease
heart failure or problems with your heart valves or heart muscle
severe vomiting, diarrhoea, treatment with high doses of water tablets (diuretics) or if you are on a
low salt diet
increased levels of potassium in your blood
problems with your adrenal glands

In blood tests a reduction of the numbers of a type of blood cell, known as platelets has been seen
(thrombocytopenia).
Rare (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, impaired kidney function, kidney failure.
Some changes in blood test results have also been seen. These include increased potassium levels
(hyperkalaemia) and increased levels of compounds related to kidney function.

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
treatment.

Additional side effect in children and adolescents:
In children, side effects are similar to those reported in adults. However, dizziness and headache are seen
more often in children, and nose bleeding is a common side effect seen in children only.

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.

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
www.mhra.gov.uk/yellow card. By reporting side effects you can help provide more information on the
safety of this medicine.

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

5. How to store Olmesartan

Elderly people
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil
to 40 mg daily, then you need to have your blood pressure regularly checked by your doctor to make sure
that your blood pressure does not become too low.

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

Black patients
As with other similar medicines the blood pressure lowering effect of Olmesartan is somewhat less in
black patients.

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 blister or bottle 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.

Children and adolescents
Olmesartan medoxomil has been studied in children and adolescents. For more information, talk to your
doctor. Olmesartan is not recommended for children from 1 year to less than 6 years and should not be
used in children under the age of 1 year as no experience is available.

6. Contents of the pack and other information
What Olmesartan contains

Other medicines and Olmesartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following
medicines:
Other blood pressure lowering medicines, as the effect of Olmesartan 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” and “Warnings and precautions”).
Potassium supplements, a salt substitute which contains potassium, water tablets (diuretics) or
heparin (for thinning the blood). Using these medicines at the same time as Olmesartan may raise
the levels of potassium in your blood.
Lithium (a medicine used to treat mood swings and some types of depression) used at the same
time as Olmesartan 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 may
increase the risk of kidney failure and the effect of Olmesartan can be decreased by NSAIDs.
Colesevelam hydrochloride, an active substance that lowers the level of cholesterol in your blood, as
the effect of Olmesartan may be decreased. Your doctor may advise you to take Olmesartan at least
4 hours before colesevelam hydrochloride.
Certain antacids (indigestion remedies), as the effect of Olmesartan can be slightly decreased.

The active substance is olmesartan medoxomil.

Olmesartan with food and drink
Olmesartan can be taken with or without food.

Olmesartan 40 mg Film-coated Tablets
White to off-white coloured, oval shaped, biconvex, film coated tablets, approx. 15.3 x 7.4 mm, with
score line on both side.

Olmersartan 10 mg Film-coated Tablets
Each film-coated tablet contains 10 mg olmesartan medoxomil.
Olmesartan 20 mg Film-coated Tablets
Each film-coated tablet contains 20 mg olmesartan medoxomil.
Olmesartan 40 mg Film-coated Tablets
Each film-coated tablet contains 40 mg olmesartan medoxomil.
The other ingredients are lactose monohydrate, low substituted hydroxy propyl cellulose, hydroxy propyl
cellulose, cellulose, microcrystalline, magnesium stearate, hypromellose, talc and titanium dioxide (E
171).
What Olmesartan looks like and contents of the pack
Olmesartan 10 mg Film-coated Tablets
White to off-white coloured, round, biconvex, film coated tablets, with a diameter of approx. 7.1 mm
debossed with S and 8 on either side of break line on one side and plain on other side.
Olmesartan 20 mg Film-coated Tablets
White to off-white coloured, round, biconvex, film coated tablets, with a diameter of approx. 8.8 mm
debossed with Y and 7 on either side of break line on one side and plain on other side.

Pregnancy and breast-feeding
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.

OPA/Al/PVC/Al blister:
Pack sizes:
10, 14, 28, 30, 50, 56, 56 (2 x 28), 84, 90, 98, 280 (10 x 28) film-coated tablets

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 before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of Olmesartan. This medicine is not
recommended in early 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.

HDPE Bottle:
HDPE bottle with 30 or 90 film-coated tablets with white opaque polypropylene child resistant closure
with induction sealing wad
HDPE bottle with 500 film-coated tablets with white opaque polypropylene continuous threaded closure
with induction sealing wad
Each bottle contains as desiccant 1 Silica gel canister.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan is not
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for
you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Pack sizes:
30, 90, 500 film-coated tablets
Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd,
Unit 4, Charlwood Court,
Merlin Centre, County Oak Way,
Crawley, West Sussex,
RH11 7XA,
United Kingdom

Olmesartan 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 medicinal product.
3. How to take Olmesartan

This leaflet was last revised in 05/2017

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

LOCATION : Indrad
SIZE

COUNTRY : UK

: 150 x 520 mm_Front/Back Side

Colour Black

Supersedes A / W No.:
CODE : 8063035-7803

DATE : 29-05-2017

REMARK : Folding Length 35 mm
SUBSTRATE :
Activities

Department

Name

Signature

Date

Prepared By Pkg.Dev
Reviewed By Pkg.Dev
Approved By Quality

This colour proof is not colour binding. Follow Pantone shade reference for actual colour matching.

8063035-7803

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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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