PACKAGE LEAFLET: INFORMATION FOR THE USER

Olmesartan medoxomil Alter 10 mg, 20 mg, 40 mg film-coated tablets

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

What Olmesartan medoxomil Alter is and what it is used for
What you need to know before taking Olmesartan medoxomil Alter
How to take Olmesartan medoxomil Alter
Possible side effects
How to store Olmesartan medoxomil Alter
Contents of the pack and other information

1. What Olmesartan medoxomil Alter is and what it is used for

Olmesartan medoxomil Alter belongs to a group of medicines called angiotensin II receptor antagonists. These medicines lower blood pressure by relaxing blood vessels.
Olmesartan medoxomil Alter is used to treat high blood pressure (also known as “arterial hypertension”) in adults, and in children and adolescents from 6 to 18 years of age. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attacks, heart or kidney failure, stroke, or blindness. High blood pressure usually has no symptoms. It is important to monitor your blood pressure regularly to prevent such complications.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil Alter tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow your doctor’s advice.

2. What you need to know before taking Olmesartan medoxomil Alter

Do not take Olmesartan medoxomil Alter

if you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).
if you are more than three months pregnant (it is better to avoid Olmesartan medoxomil Alter even in the early stages of pregnancy; see section “Pregnancy”).
if you have yellowing of the skin and eyes (jaundice) or disorders affecting bile flow from the gallbladder (biliary obstruction, for example gallstones).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
Olmesartan medoxomil Alter contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

Warnings and precautions
Talk to your doctor before taking Olmesartan medoxomil Alter.
Consult your doctor before taking Olmesartan medoxomil Alter

If you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (such as potassium) at regular intervals.

See also the information under the section “Do not take Olmesartan medoxomil Alter”.
Consult your doctor if you have any of the following health conditions:

Kidney problems.
Liver disease.
Heart failure or problems with heart valves or heart muscle.
Severe vomiting, diarrhoea, treatment with high doses of diuretics, or if you are on a low-salt diet.
Increased levels of potassium in the blood.
Adrenal gland disorders.

Inform your doctor if you develop severe and prolonged diarrhoea accompanied by significant weight loss.
Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with circulatory disorders of the heart or brain may lead to a heart attack or stroke.
Your doctor will therefore carefully monitor your blood pressure.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Olmesartan medoxomil Alter is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy”).
Children and adolescents
Olmesartan medoxomil Alter has been studied in children and adolescents. For further information, consult your doctor. Olmesartan medoxomil Alter is not recommended for children aged 1 to 6 years and must not be used in children under 1 year of age due to lack of available experience.
Other medicines and Olmesartan medoxomil Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

Other medicines that lower blood pressure may increase the effect of Olmesartan medoxomil Alter: Your doctor may consider it necessary to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Olmesartan medoxomil Alter” and “Warnings and precautions”).
Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (used to thin the blood). Taking these medicines together with Olmesartan medoxomil Alter may increase blood potassium levels.
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olmesartan medoxomil Alter may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) used together with Olmesartan medoxomil Alter may increase the risk of kidney failure, and the effectiveness of Olmesartan medoxomil Alter may be reduced by NSAIDs.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Olmesartan medoxomil Alter. Your doctor may advise you to take Olmesartan medoxomil Alter at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion) may slightly reduce the effectiveness of Olmesartan medoxomil Alter.

Elderly patients
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan to 40 mg daily, your blood pressure must be regularly monitored by your doctor to prevent it from dropping too low.
Patients of black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olmesartan medoxomil Alter is somewhat reduced in patients of black ethnicity.
Taking Olmesartan medoxomil Alter with food and drink
Olmesartan medoxomil Alter can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Olmesartan medoxomil Alter before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Olmesartan medoxomil Alter. Olmesartan medoxomil Alter is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Olmesartan medoxomil Alter is not recommended for women 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 premature.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.
Olmesartan medoxomil Alter contains lactose
This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Olmesartan medoxomil Alter

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended starting dose is one 10 mg tablet once daily. However, if your
blood pressure is not controlled, your doctor may decide to increase the dose to 20 or 40
mg once daily, or may prescribe other medicines.
In patients with mild to moderate renal impairment, the dose must not exceed 20 mg once daily.
The tablets can be taken with or without food. Swallow the tablets with a sufficient amount of water (for example, a glass of water). If possible, take your daily dose at the same time each day, for example with breakfast.

Children and adolescents aged 6 to 18 years:
The recommended starting dose is 10 mg once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up to 20 or 40 mg once daily. In children weighing less than 35 kg, the dose must not exceed 20 mg once daily.

If you take more Olmesartan medoxomil Alter than you should
If you take more tablets than you should, or if a child accidentally swallows any, go immediately to your doctor or the nearest emergency department, taking the medicine pack with you.

If you forget to take Olmesartan medoxomil Alter
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Olmesartan medoxomil Alter
It is important to continue taking Olmesartan medoxomil Alter unless your doctor tells you to stop.

If you have any doubts about how to use Olmesartan medoxomil Alter, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If they do occur, they are mostly mild and do not require discontinuation of treatment.

Although not occurring in all individuals, the following two side effects can be serious:

Rarely (may affect up to 1 in 1,000 people)
The following allergic reactions affecting the whole body have been reported:
During treatment with Olmesartan medoxomil Alter, swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur. If this happens, stop taking Olmesartan medoxomil Alter and contact your doctor immediately.

Rarely (but slightly more frequently in elderly people)
Olmesartan medoxomil Alter may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could lead to severe dizziness or fainting. If this happens, stop taking Olmesartan medoxomil Alter, contact your doctor immediately, and remain lying down.

The following are the other known side effects reported so far with Olmesartan medoxomil Alter:

Common side effects (may affect up to 1 in 10 people):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, nasal secretion, bronchitis, influenza-like symptoms, cough, pain, chest, back, bone or joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.

Some laboratory test abnormalities have also been observed, including the following:
Increased blood fats (hypertriglyceridaemia), increased uric acid in blood (hyperuricaemia), increased blood urea, increased liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing difficulties or a sudden drop in blood pressure that may lead to fainting (anaphylactic reactions), dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin rash), skin blisters (wheals), angina (pain or discomfort in the chest).

Blood tests have shown a reduced number of a type of particle normally present in the blood, called platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Lack of energy, muscle cramps, reduced kidney function, kidney failure.

Some laboratory test abnormalities have also been observed. These include increased potassium levels (hyperkalaemia) and increased levels of substances related to kidney function.

Additional side effects in children and adolescents:
In children, side effects are similar to those in adults. However, dizziness and headache are more frequently observed in children, and nosebleeds are a side effect commonly seen only in children.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack
(“Exp.”). The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil Alter contains
The active substance is olmesartan medoxomil.
Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
The other components are: monohydrate lactose, microcrystalline cellulose,
low-substituted hydroxypropylcellulose, calcium stearate, maize starch, talc (E553b),
mannitol (E421), soya lecithin (E322) and titanium dioxide (E171)
(see section 2 “Olmesartan medoxomil Alter contains lactose” and “Olmesartan medoxomil
Alter contains soya lecithin”).
Description of the appearance of Olmesartan medoxomil Alter and contents of the pack
Olmesartan medoxomil Alter 10 mg: white, round, biconvex film-coated tablet, 6 mm in diameter, smooth on both sides.
Olmesartan medoxomil Alter 10 mg is available in packs of 14, 28 and 56 tablets in blisters.
Olmesartan medoxomil Alter 20 mg: white, round, biconvex film-coated tablet, 8 mm in diameter, with a score line on one side and smooth on the other. The score line is not intended to divide the tablet into equal parts.
Olmesartan medoxomil Alter 20 mg is available in packs of 14, 28, 30, 56 and 90 tablets in blisters.
Olmesartan medoxomil Alter 40 mg: white, round, biconvex film-coated tablet, 11 mm in diameter, smooth on both sides.
Olmesartan medoxomil Alter 40 mg is available in packs of 14, 28 and 56 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi 7
20144 Milano
Italy
Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria, 30 28036 Madrid
Spain
This medicinal product is authorised in the European Economic Area countries under
the following names:
Spain Olmesartan Alter 10 mg /20 mg/ 40 mg film-coated tablets EFG
Italy Olmesartan medoxomil Alter
Portugal Olmesartan medoxomil Alter 10 mg /20 mg/ 40 mg film-coated tablet MG