Olmesartan and amlodipine Doc Generici: detailed information

Patient Information Leaflet: Information for the User

OLMESARTAN AND AMLODIPINE DOC 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 other people, even if
their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What OLMESARTAN E AMLODIPINA DOC is and what it is used for

OLMESARTAN E AMLODIPINA DOC contains two substances called olmesartan medoxomil and
amlodipine (as amlodipine besylate). Both of these substances help control high blood pressure.
Olmesartan medoxomil belongs to a group of medicines known as “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.

Amlodipine belongs to a group of substances called “calcium antagonists”. Amlodipine prevents calcium from entering the walls of blood vessels, thereby preventing the vessels from constricting, and thus reducing blood pressure.

The action of both substances helps prevent blood vessel constriction, allowing the vessels to relax and blood pressure to decrease.
OLMESARTAN E AMLODIPINA DOC is used for the treatment of high blood pressure in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or amlodipine alone.

2. What you must do before taking OLMESARTAN AND AMLODIPINE DOC

Do not take OLMESARTAN AND AMLODIPINE DOC
if you are allergic to olmesartan medoxomil or amlodipine or to a specific group of calcium channel blockers, the dihydropyridines, or to any of the other ingredients of this
medicine (listed in section 6).
If you think you may be allergic, speak with your doctor before taking OLMESARTAN AND
AMLODIPINE DOC.
if you are more than three months pregnant (it is better to avoid taking OLMESARTAN AND
AMLODIPINE DOC even in the early stages of pregnancy – see section “Pregnancy and breastfeeding”)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
if you have severe liver problems, if bile secretion is impaired or bile flow from the gallbladder is blocked (for example, due to gallstones), or if you are experiencing jaundice (yellowing of the skin and eyes)
if you have very low blood pressure
if you suffer from inadequate blood supply to tissues with symptoms such as low blood pressure, weak pulse, rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart problems
if blood flow from the heart is obstructed (for example, due to aortic narrowing (aortic stenosis))
if you suffer from reduced cardiac output (causing shortness of breath or peripheral swelling) after a heart attack (acute myocardial infarction)

Warnings and precautions
Talk to your doctor or pharmacist before taking OLMESARTAN AND AMLODIPINE DOC.
Inform 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 monitor your kidney function, blood pressure, and blood electrolyte levels (for example potassium) at regular intervals.
See also the information under the heading “Do not take OLMESARTAN AND AMLODIPINE DOC”.
Inform your doctor if you also have any of the following health conditions:
Kidney problems or kidney transplant
Liver disease
Heart failure or heart valve or heart muscle problems
Severe vomiting, diarrhoea, treatment with high doses of diuretics, or if you are on a low-salt diet
Increased blood potassium levels
Problems with adrenal glands (hormone-producing glands located above the kidneys)
Inform your doctor if you develop severe and prolonged diarrhoea with significant weight loss. Your doctor will assess your symptoms and decide whether to continue this high blood pressure treatment.
As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to 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 are pregnant (or if there is a possibility of becoming pregnant). OLMESARTAN AND AMLODIPINE DOC 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 and breastfeeding”).

Children and adolescents (under 18 years)
OLMESARTAN AND AMLODIPINE DOC is not recommended for children and adolescents under 18 years of age.

Other medicines and OLMESARTAN AND AMLODIPINE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Other blood pressure-lowering medicines, as the effect of OLMESARTAN AND AMLODIPINE DOC may be increased. 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 AND AMLODIPINE DOC” and “Warnings and precautions”).

Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (to thin the blood and prevent blood clots). Taking these medicines together with OLMESARTAN AND AMLODIPINE DOC may increase blood potassium levels.

Lithium (a medicine used to treat mood swings and certain types of depression) taken together with OLMESARTAN AND AMLODIPINE DOC may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.

Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) taken together with OLMESARTAN AND AMLODIPINE DOC may increase the risk of kidney failure. The effect of OLMESARTAN AND AMLODIPINE DOC may be reduced by NSAIDs.

Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, as the effect of OLMESARTAN AND AMLODIPINE DOC may be reduced. Your doctor may advise you to take OLMESARTAN AND AMLODIPINE DOC at least 4 hours before colesevelam hydrochloride.

Some antacids (used for indigestion or stomach acidity), as the effect of OLMESARTAN AND AMLODIPINE DOC may be slightly reduced.

Medicines used for HIV/AIDS (for example ritonavir, indinavir, nelfinavir) or for treating fungal infections (for example ketoconazole, itraconazole).

Diltiazem, verapamil (medicines used for heart rhythm problems and high blood pressure).

Rifampicin, erythromycin (antibiotic medicines used for tuberculosis or other infections).

St. John’s wort (Hypericum perforatum), a herbal remedy.

Dantrolene (infusion for severe disturbances in body temperature).

Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.

Tacrolimus, ciclosporin, used to control the body’s immune response and thus allow the body to accept transplanted organs.

Clarithromycin, an antibiotic medicine for bacterial infections.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

OLMESARTAN AND AMLODIPINE DOC with food and drink
OLMESARTAN AND AMLODIPINE DOC can be taken with or without food. Swallow the tablet with some liquid (such as a glass of water). If possible, take your daily dose at the same time each day, for example with breakfast.
Grapefruit and grapefruit juice must not be consumed by people taking OLMESARTAN AND AMLODIPINE DOC. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of OLMESARTAN AND AMLODIPINE DOC.

Elderly
If you are over 65 years of age, your doctor will regularly monitor your blood pressure with each dose increase, to avoid your blood pressure becoming too low.

Patients of black ethnicity
As with other similar medicines, the blood pressure-lowering effect of OLMESARTAN AND AMLODIPINE DOC may be somewhat reduced in patients of black ethnicity.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Usually, your doctor will advise you to stop taking OLMESARTAN AND AMLODIPINE DOC before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of OLMESARTAN AND AMLODIPINE DOC. OLMESARTAN AND AMLODIPINE DOC 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.
If you become pregnant while taking OLMESARTAN AND AMLODIPINE DOC, inform your doctor immediately.

Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. Inform your doctor if you are breastfeeding or planning to breastfeed. OLMESARTAN AND AMLODIPINE DOC is not recommended for breastfeeding women, and your doctor may choose another treatment if you wish to breastfeed, especially if the baby is newborn or premature.

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
You may experience drowsiness, malaise, dizziness or headache during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

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

3. How to take OLMESARTAN AND AMLODIPINE DOC

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
The recommended dose of OLMESARTAN AND AMLODIPINE DOC is one tablet daily.
The tablets can be taken with or without food. Swallow the tablet with a drink (such as a glass of water). Do not chew the tablet. Do not take it with grapefruit juice.
If possible, take your dose at the same time each day, for example with breakfast.

If you take more OLMESARTAN AND AMLODIPINE DOC than you should
If you take more tablets than prescribed, you may experience a drop in blood pressure with symptoms such as dizziness, rapid or slow heartbeat.
If you take more tablets than prescribed or if a child accidentally swallows any, go immediately to a doctor or the nearest emergency department, taking the medicine pack or this leaflet with you.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take OLMESARTAN AND AMLODIPINE DOC
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 AND AMLODIPINE DOC
It is important to continue taking OLMESARTAN AND AMLODIPINE DOC unless your doctor tells you otherwise.
If you have any doubts about how to use this medicine, 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 occur, these are mostly mild and do not require discontinuation of treatment.
Even though they do not occur in all people, the following side effects can be serious:
During treatment with OLMESARTAN AND AMLODIPINE DOC, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash. If this happens, stop taking OLMESARTAN AND AMLODIPINE DOC and contact your doctor immediately.
OLMESARTAN AND AMLODIPINE DOC may cause excessive lowering of blood pressure in sensitive individuals or as a consequence of an allergic reaction. This may cause severe dizziness or fainting. If this happens, stop taking OLMESARTAN AND AMLODIPINE DOC, contact your doctor immediately and remain lying down.
Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking OLMESARTAN AND AMLODIPINE DOC for a long time, contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with treatment for high blood pressure.

Other possible side effects with OLMESARTAN AND AMLODIPINE DOC:
Common (may affect up to 1 in 10 people):
Dizziness; headache; swelling of ankles, feet, legs, hands or arms; fatigue.

Uncommon (may affect up to 1 in 100 people):
Dizziness when standing up; lack of energy; tingling or numbness in hands or feet; vertigo; awareness of heartbeat; faster heartbeat; low blood pressure with symptoms such as dizziness, feeling of emptiness in the head, difficulty breathing; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth; pain in the upper abdomen; skin rash; cramps; pain in arms and legs; back pain; feeling of urgency to urinate; lack of sexual activity; inability to achieve or maintain erection; weakness.

Some blood test abnormalities have also been observed, including the following: increase or decrease in blood potassium levels, increase in blood creatinine levels, increase in uric acid levels, increase in liver function tests (gamma-glutamyl transferase levels).

Rare (may affect up to 1 in 1000 people):
Hypersensitivity to the medicine; facial flushing and sensation of warmth; red, itchy raised spots (urticaria); facial swelling.

Side effects reported with use of olmesartan medoxomil or amlodipine alone, but not with OLMESARTAN AND AMLODIPINE DOC or at higher frequency:

Olmesartan medoxomil
Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; blocked or runny nose; cough; abdominal pain; gastrointestinal flu; diarrhoea; indigestion; nausea; bone or joint pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; pain.
Laboratory test abnormalities such as increased fats (hypertriglyceridemia); increased plasma urea or uric acid; increased liver and muscle function test values.

Uncommon (may affect up to 1 in 100 people):
Reduction in the number of a type of blood cells called platelets, which may lead to easier bruising or prolonged bleeding time; immediate allergic reactions which may affect the whole body and may cause breathing problems as well as rapid drop in blood pressure, which may also cause weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with urticaria, facial swelling; muscle pain; feeling of malaise.

Rare (may affect up to 1 in 1000 people):
Swelling of the face, mouth and/or larynx (site of the vocal cords); acute renal failure and renal failure; lethargy.

Amlodipine
Very common (may affect more than 1 in 10 people):
Edema (fluid retention).

Common (may affect up to 1 in 10 people):
Abdominal pain; nausea; swollen ankles; drowsiness; facial flushing and sensation of warmth; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness; difficulty breathing.

Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disturbances; mood disturbances including anxiety; depression; irritability; tremors; altered taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; blocked or runny nose; hair loss; red spots or patches on the skin due to small hemorrhages (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy raised spots (urticaria); muscle or joint pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain, discomfort; weight gain or loss.

Rare (may affect up to 1 in 1000 people):
Confusion.

Very rare (may affect up to 1 in 10,000 people):
Reduction in the number of white blood cells, which may increase the risk of infections; reduction in the number of a type of blood cells called platelets, which may lead to easier bruising or prolonged bleeding time; increased blood glucose; increased muscle rigidity or increased resistance to passive movement (hypertonia); tingling or numbness in hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach lining; gum enlargement; high levels of liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions: itching, skin rash, swelling of the face, mouth and/or larynx (site of the vocal cords) together with itching and skin rash; severe skin reactions including intense skin rash, urticaria, redness of the skin over the entire body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), sometimes life-threatening.

Frequency not known:
Tremor, rigid posture, mask-like facial expression, slowed movements, shuffling and unsteady gait.
Severe skin reactions, including intense skin rash, urticaria, redness of the skin over the entire body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (toxic epidermal necrolysis).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OLMESARTAN AND AMLODIPINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and label after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any 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 E AMLODIPINA DOC contains
The active substances are olmesartan medoxomil and amlodipine.
OLMESARTAN E AMLODIPINA DOC 20 mg/5 mg: one film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
OLMESARTAN E AMLODIPINA DOC 40 mg/5 mg: one film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
OLMESARTAN E AMLODIPINA DOC 40 mg/10 mg: one film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

The other components are:
Tablet core:
Pregelatinized maize starch, silicified microcrystalline cellulose (microcrystalline cellulose with anhydrous colloidal silica), monohydrate lactose, magnesium stearate, povidone K-30.

Coating:
The white coating Opadry II 85F18422 of OLMESARTAN E AMLODIPINA DOC 20 mg/5 mg contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
The yellow coating Opadry II 85F520132 of OLMESARTAN E AMLODIPINA DOC 40 mg/5 mg contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
The brown coating Opadry II 85F565114 of OLMESARTAN E AMLODIPINA DOC 40 mg/10 mg contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of OLMESARTAN E AMLODIPINA DOC and package contents
OLMESARTAN E AMLODIPINA DOC 20 mg/5 mg: white, round, film-coated tablet, engraved with "OA1" on one side and smooth on the other. Size: diameter 6.10 mm ± 0.20 mm.
OLMESARTAN E AMLODIPINA DOC 40 mg/5 mg: white to off-white, round, film-coated tablet, engraved with "OA3" on one side and smooth on the other. Size: diameter 8.10 mm ± 0.20 mm.
OLMESARTAN E AMLODIPINA DOC 40 mg/10 mg: brownish-red, round, film-coated tablet, engraved with "OA4" on one side and smooth on the other. Size: diameter 8.10 mm ± 0.20 mm.
Blister pack OPA/Al/PVC/Al or perforated OPA/Al/PVC/Al blister containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy

Manufacturers
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona, Spain

FINE FOODS & PHARMACEUTICALS N.T.M. S.P.A.
Via Grignano, 43
24041 Brembate (BG), Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: OLMESARTAN E AMLODIPINA DOC