Olmesartan and amlodipine Pensа

Italy
Brand name Olmesartan and amlodipine Pensа
Form tablets, film-coated
Active substance / Dosage
OLMESARTAN MEDOXOMIL
Prescription type Prescription only
ATC code
C09DB02
Registration number 045398
Manufacturer TOWA PHARMACEUTICAL S.P.A.
Olmesartan and amlodipine Pensа tablets, film-coated

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olmesartan and Amlodipine PENSA 20 mg/5 mg, 40 mg/5 mg, 40 mg/10 mg

film-coated tablets
Generic 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, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olmesartan and Amlodipine PENSA is and what it is used for

Olmesartan and Amlodipine PENSA contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both help control hypertension.

  • Olmesartan medoxomil belongs to a group of medicines known as “angiotensin II receptor antagonists”. These reduce blood pressure by relaxing blood vessels.
  • Amlodipine belongs to a group of substances known as “calcium antagonists”. Amlodipine prevents calcium from entering the vessel walls, thereby reducing their constriction and lowering blood pressure. The combined action of both substances helps counteract vascular resistance, allowing blood vessels to relax and blood pressure to decrease. Olmesartan and Amlodipine PENSA is used to treat high blood pressure (also known as “arterial hypertension”) in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or amlodipine alone.

2. What you should know before taking Olmesartan and Amlodipine PENSA

Do not take Olmesartan and Amlodipine PENSA

  • if you are allergic to olmesartan medoxomil or amlodipine or to a specific group of calcium antagonists, the dihydropyridines, or to any of the other components of this medicine (listed in section 6). If you think you are allergic, speak with your doctor before taking Olmesartan and Amlodipine PENSA.
  • if you are more than three months pregnant (it is better to avoid taking Olmesartan and Amlodipine PENSA 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 its outflow from the gallbladder is blocked (for example, by gallstones), or if you develop jaundice (yellowing of the skin and eyes).
  • if your blood pressure is very low.
  • if you have poor blood supply to tissues with symptoms such as low blood pressure, weak pulse, or rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems. If blood flow from your heart is obstructed (for example, due to aortic stenosis).
  • if you have reduced cardiac output (causing shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction). Warnings and precautions Talk to your doctor or pharmacist before taking Olmesartan and Amlodipine PENSA. 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), particularly if you have kidney problems related to diabetes.
    • Aliskiren. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals. See also the section “Do not take Olmesartan and Amlodipine PENSA” Consult your doctor if you also have any of the following health conditions:
  • Kidney problems or kidney transplant.
  • 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 potassium levels in the blood.
  • Problems with the 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 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 could 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 PENSA 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 child if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents (up to 18 years)
Olmesartan and Amlodipine PENSA is not recommended for children and adolescents under 18 years of age.
Other medicines and Olmesartan and Amlodipine PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine, including any of the following:

  • Other medicines that lower blood pressure may increase the effect of Olmesartan and Amlodipine PENSA. 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 PENSA” and “Warnings and precautions”).
  • Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (to thin the blood and prevent thrombosis). Taking these medicines together with Olmesartan and Amlodipine PENSA may increase potassium levels in the blood.
  • Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmesartan and Amlodipine PENSA 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) taken together with Olmesartan and Amlodipine PENSA may increase the risk of kidney failure. The effect of Olmesartan and Amlodipine PENSA may be reduced by NSAIDs.
  • Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Olmesartan and Amlodipine PENSA. Your doctor may advise you to take Olmesartan and Amlodipine PENSA at least 4 hours before colesevelam hydrochloride.
  • Some antacids (used for indigestion or stomach acidity) may slightly reduce the effect of Olmesartan and Amlodipine PENSA.
  • Medicines 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, clarithromycin, medicines used for tuberculosis or other infections.
  • St. John’s wort (Hypericum perforatum), a herbal remedy.
  • Dantrolene (infusion for severe body temperature disturbances).
  • Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
    • Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine, used to control your body’s immune response and thus allow acceptance of transplanted organs. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Olmesartan and Amlodipine PENSA with food and drink Olmesartan and Amlodipine PENSA 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.

People taking Olmesartan and Amlodipine PENSA must not consume grapefruit or grapefruit juice, as grapefruit and its 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 PENSA.
Elderly
If you are over 65 years of age, your doctor will regularly monitor your blood pressure with each dose increase, to avoid excessive lowering.
Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan and Amlodipine PENSA may be somewhat reduced in black patients.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking Olmesartan and Amlodipine PENSA before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Olmesartan and Amlodipine PENSA. Olmesartan and Amlodipine PENSA 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 child if taken after the third month of pregnancy.
If you become pregnant while taking Olmesartan and Amlodipine PENSA, inform your doctor and see them immediately.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts. Olmesartan and Amlodipine PENSA is not recommended for women who are breastfeeding, and your doctor may choose a different treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience drowsiness, discomfort, 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 PENSA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially sodium-free.

3. How to take Olmesartan – Amlodipine PENSA

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 PENSA is one tablet daily.
  • The tablets can be taken with or without food. Swallow the tablets with some liquid (such as a glass of water). Do not chew the tablets. Do not take them with grapefruit juice.
  • If possible, take your daily dose at the same time each day, for example with breakfast.
    If you take more Olmesartan and Amlodipine PENSA than you should
    If you take more tablets than prescribed, your blood pressure may drop too low, causing symptoms such as dizziness, a fast or slow heartbeat. 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 or this leaflet with you.
    If you forget to take Olmesartan and Amlodipine PENSA
    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 PENSA
    It is important to continue taking Olmesartan and Amlodipine PENSA unless your doctor tells you to stop. If you have any doubts about using this medicine, speak to 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.

However, the following two side effects, although not occurring in all patients, can be serious:

During treatment with Olmesartan and Amlodipine PENSA, allergic reactions may occur, which can affect the entire 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 PENSA and contact your doctor immediately.

Olmesartan and Amlodipine PENSA may cause excessive lowering of blood pressure in sensitive individuals or as a consequence of an allergic reaction. This could lead to severe dizziness or fainting. If this happens, stop taking Olmesartan and Amlodipine PENSA, contact your doctor immediately, and remain lying down.

Other possible side effects of Olmesartan and Amlodipine PENSA:

Common (affects less than 1 in 10 people):
Dizziness; headache; swelling of ankles, feet, legs, hands or arms; fatigue.

Uncommon (affects less than 1 in 100 people):
Dizziness upon standing; 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, shortness of breath; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth; upper abdominal pain; skin rash; muscle cramps; pain in arms and legs; back pain; feeling of urgency to urinate; loss of sexual interest; inability to achieve or maintain an erection; weakness.

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

Rare (affects less than 1 in 1,000 people):
Hypersensitivity to the medicine; fainting; flushing and sensation of warmth in the face; red, itchy welts (urticaria); facial swelling.

Side effects reported with olmesartan medoxomil or amlodipine used alone, but not with Olmesartan and Amlodipina PENSA or at a higher frequency:

Olmesartan medoxomil

Common (affects less than 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; gastroenteritis; 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 (affects less than 1 in 100 people):
Reduction in the number of a type of blood cell called platelets, which may lead to easier bruising or prolonged bleeding time; immediate allergic reactions that may affect the whole body and may cause breathing difficulties or a rapid drop in blood pressure, possibly leading to 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 (affects less than 1 in 1,000 people):
Swelling of the face, mouth and/or larynx (site of the vocal cords); acute renal failure and renal failure; lethargy.

Amlodipine

Very common (affects more than 1 in 10 people):
Oedema (fluid retention).

Common (affects less than 1 in 10 people):
Abdominal pain; nausea; swollen ankles; drowsiness; flushing and sensation of warmth in the face; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness; shortness of breath.

Uncommon (affects less than 1 in 100 people):
Restless sleep; sleep disturbances; mood disturbances including anxiety; depression; irritability; tremors; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; stuffy or runny nose; hair loss; red spots or dots on the skin due to minor bleeding (purpura); skin discolouration; excessive sweating; skin rash; itching; red, itchy welts (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 (affects less than 1 in 1,000 people):
Confusion.

Very rare (affects less than 1 in 10,000 people):
Reduction in the number of white blood cells in the blood, which may increase the risk of infections; reduction in the number of a type of blood cell called platelets, which may lead to easier bruising or prolonged bleeding time; increased blood glucose; increased muscle stiffness or increased resistance to passive movements (hypertonia); tingling or numbness in hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum enlargement; elevated liver enzyme levels; 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 surface, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.

Not known (frequency cannot be estimated from the available data):
Tremor, rigid posture, mask-like facial expression, slow movements, and unbalanced, shuffling gait.

Reporting of side effects

If you experience any side effects, 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 PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 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. PACK CONTENTS AND OTHER INFORMATION

What Olmesartan and Amlodipine PENSA contains
The active substances are olmesartan medoxomil and amlodipine ( as besylate ).
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).
The excipients are
Tablet core
Pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate
Coating
Hypromellose, macrogol 400, titanium dioxide (E171)
Yellow iron (III) oxide (E172) (only in Olmesartan and Amlodipine PENSA 40 mg/5 mg film-coated tablets)
Red iron (III) oxide (E172) (only in Olmesartan and Amlodipine PENSA 40 mg/10 mg film-coated tablets)

Description of the appearance of Olmesartan and Amlodipine PENSA and pack contents
Olmesartan and Amlodipine PENSA 20 mg/5 mg film-coated tablets, round, white, 7 mm in diameter, marked on one side with the code O2A and a score line on the other side. The score line is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
Olmesartan and Amlodipine PENSA 40 mg/5 mg film-coated tablets, round, cream-coloured, 9 mm in diameter, marked on one side with the code OA5 and a score line on the other side. The score line is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
Olmesartan and Amlodipine PENSA 40 mg/10 mg film-coated tablets, round, brownish, marked on one side with the code OA1 and a score line on the other side. The score line is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
Olmesartan and Amlodipine PENSA is available in packs of 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
PENSA PHARMA S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Manufacturer responsible for batch release
Laboratorio CINFA, S.A.
Ctra. Olaz-Chipi, 10, Pol. Ind. Areta, Huarte
31620 Huarte-Pamplona (Navarra), Spain