PATIENT LEAFLET: INFORMATION FOR THE PATIENT

OLMESARTAN DOC Generici 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Equivalent Medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OLMESARTAN DOC Generici is and what it is used for

OLMESARTAN DOC Generici belongs to a class of medicines called angiotensin II receptor antagonists. These medicines reduce blood pressure by relaxing blood vessels.
OLMESARTAN DOC Generici is used to treat high blood pressure (also known as "arterial hypertension"). 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 attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms. It is important to measure your blood pressure regularly to help prevent damage.
High blood pressure can be controlled with medicines such as OLMESARTAN DOC Generici. Your doctor has likely also recommended that you 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 DOC Generici

Do not take OLMESARTAN DOC Generici

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 3 months pregnant (it is best to avoid taking OLMESARTAN DOC Generici 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

Warnings and precautions
Talk to your doctor or pharmacist before taking OLMESARTAN DOC Generici.
Consult 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), especially if you have kidney problems related to diabetes
aliskiren

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (for example potassium) in your blood at regular intervals.
See also the section “Do not take OLMESARTAN DOC Generici”.
Consult your doctor if you also have any of the following health problems:

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
elevated levels of potassium in the blood
adrenal gland disorders

Inform your doctor if you develop severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). OLMESARTAN DOC Generici is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).

Children and adolescents
The use of OLMESARTAN DOC Generici is not recommended in children and adolescents under 18 years of age.

Other medicines and OLMESARTAN DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines.
In particular, inform your doctor or pharmacist about each of the following medicines:

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

Elderly patients
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, your blood pressure must be regularly monitored by your doctor to prevent it from dropping too much.

Black patients
As with other similar medicines, the blood pressure-lowering effect of OLMESARTAN DOC Generici is somewhat reduced in black patients.

Taking OLMESARTAN DOC Generici with food and drink
OLMESARTAN DOC Generici can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking OLMESARTAN DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of OLMESARTAN DOC Generici. OLMESARTAN DOC Generici is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your unborn child if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. OLMESARTAN DOC Generici 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 was born prematurely.

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breast-feeding, ask your doctor or pharmacist for advice before taking this 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 resolve. Consult your doctor.

OLMESARTAN DOC Generici contains lactose.
This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take OLMESARTAN DOC Generici

Take this medicine exactly as your doctor has told you. If you are unsure, 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 mg or 40 mg once daily, or prescribe additional 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.

If you take more OLMESARTAN DOC Generici than you should
If you take more tablets than prescribed, or if a child accidentally ingests any, go immediately to your doctor or the nearest hospital emergency department, taking the medicine package with you.

If you forget to take OLMESARTAN DOC Generici
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 dose.

If you stop taking OLMESARTAN DOC Generici
It is important to continue taking OLMESARTAN DOC Generici until your doctor tells you to stop.

If you have any doubts about how to use OLMESARTAN DOC Generici, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If they do occur, they are mostly mild and do not require discontinuation of treatment.
Although they do not occur in everyone, the following two side effects can be serious:
rarely, the following allergic reactions affecting the whole body have been reported during treatment with OLMESARTAN DOC Generici:
swelling of the face, mouth and/or larynx (the area of the vocal cords), associated with itching and skin rash. If this occurs, stop taking OLMESARTAN DOC Generici and contact your doctor immediately.
Rarely (but slightly more frequently in elderly patients), OLMESARTAN DOC Generici 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 occurs, stop taking OLMESARTAN DOC Generici, contact your doctor immediately and remain lying down.

The following are the other side effects known so far with OLMESARTAN DOC Generici:

Common side effects (may affect up to 1 in 10 people)
Dizziness, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, fatigue, throat irritation, stuffy or runny nose, bronchitis, flu-like symptoms, cough, chest, back, bone or joint pain, urinary tract infections, swelling of ankles, feet, legs, hands or arms, blood in urine.
Some laboratory test abnormalities have also been reported, including:
increased blood fats (hypertriglyceridaemia), increased blood uric acid (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 rapid drop in blood pressure that may lead to fainting (anaphylactic reactions), facial swelling, vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, rash (skin eruption), skin blisters (wheals), angina (pain or discomfort in the chest).
Blood tests have shown a reduction in the number of a type of blood cell normally present, called platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people)
Lack of energy, muscle cramps, impaired kidney function, kidney failure.
Some laboratory test abnormalities have also been observed, including increased potassium levels (hyperkalaemia) and increased levels of substances related to kidney function.

Additional side effects in children and adolescents
Side effects in children are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a common side effect only in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.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 DOC Generici

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 DOC Generici contains
The active substance is: olmesartan medoxomil
The other components are:
Tablet core: microcrystalline cellulose, lactose monohydrate,
hydroxypropylcellulose, low-substituted hydroxypropylcellulose and magnesium stearate.
Tablet coating: titanium dioxide (E 171), hypromellose 6cP, lactose monohydrate,
macrogol 3350 and triacetin.
Description of the appearance of OLMESARTAN DOC Generici and package contents
OLMESARTAN DOC Generici 10 mg: white, round, biconvex film-coated tablets, 6.5 mm in diameter, with "OL 10" engraved on one side.
OLMESARTAN DOC Generici 20 mg: white, round, biconvex film-coated tablets, 8.5 mm in diameter, with "OL 20" engraved on one side.
OLMESARTAN DOC Generici 40 mg: white, oval, biconvex film-coated tablets, 15x7 mm in size, with "OL 40" engraved on one side.
OLMESARTAN DOC Generici film-coated tablets are available in packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l, Via Turati 40, 20121 Milano, Italy
Manufacturer
Actavis Ltd., BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta