Giant

Italy
Brand name Giant
Form tablets, film-coated
Active substance / Dosage
OLMESARTAN MEDOXOMIL
Prescription type Prescription only
ATC code
C09DB02
Registration number 038946
Manufacturer MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

Table of Contents

Package leaflet: Information for the user

GIANT 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets

olmesartan medoxomil/amlodipine
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 could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Giant is and what it is used for

Giant contains two substances called olmesartan medoxomil and amlodipine (as amlodipine
besilate). Both are used to control hypertension.

  • Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists". These reduce blood pressure by relaxing blood vessels.
  • Amlodipine belongs to a group of substances called "calcium antagonists". Amlodipine prevents calcium from entering the vessel wall, thereby reducing vessel constriction and lowering blood pressure.

The combined action of both substances helps counteract vascular tension, allowing blood vessels to relax and reducing blood pressure.
Giant 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 Giant

Do not take Giant

  • if you are allergic to olmesartan medoxomil or amlodipine, or to a specific group of calcium antagonists called dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6). 1 of 9

If you think you may be allergic, speak with your doctor before taking Giant.

  • if you are more than three months pregnant (it is best to avoid taking Giant 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 if bile flow from the gallbladder is blocked (for example, due to gallstones), or if you develop jaundice (yellowing of the skin and eyes).
  • if your blood pressure is very low.
  • if you suffer from inadequate 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 Giant.
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 blood electrolyte levels (for example potassium) at regular intervals.
See also the information under the heading "Do not take Giant".
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.
  • Adrenal gland disorders (hormone-producing glands located above the kidneys).

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.
Contact your doctor if, after taking Giant, you experience abdominal pain, nausea, vomiting, or diarrhoea. The doctor will decide whether treatment should continue. Do not stop taking Giant on your own.
As with any medicine that lowers blood pressure, excessive reduction in 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). Giant 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
Giant is not recommended for children and adolescents under 18 years of age.

Other medicines and Giant
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including the following:

  • Other medicines that lower blood pressure may enhance the effect of Giant. Your doctor may consider it necessary to adjust the dose and/or take additional precautions. If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Giant" and "Warnings and precautions").
  • Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood and prevent thrombosis). Taking these medicines together with Giant may increase potassium levels in the blood.
  • Lithium (a medicine used to treat mood swings and certain types of depression). Taking lithium together with Giant 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 relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken together with Giant may increase the risk of kidney failure. The effect of Giant may be reduced by NSAIDs.
  • Colesevelam hydrochloride, a medicine used to lower cholesterol levels in the blood, which may reduce the effect of Giant. Your doctor may advise you to take Giant at least 4 hours before colesevelam hydrochloride.
  • Some antacids (used for indigestion or stomach acidity) may slightly reduce the effect of Giant.
  • Medicines for HIV/AIDS (for example ritonavir, indinavir, nelfinavir) or antifungal treatments (for example ketoconazole, itraconazole).
  • Diltiazem, verapamil, medicines used for heart rhythm disorders and high blood pressure.
  • Rifampicin, erythromycin, clarithromycin (antibiotics), medicines used for tuberculosis or other infections.
  • St. John’s wort (Hypericum perforatum), a herbal remedy.
  • Dantrolene (intravenous use for severe disturbances in body temperature).
  • 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 your body to accept transplanted organs.

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

Giant with food and drink
Giant 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 Giant 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 hypotensive effect of Giant.

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.

Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Giant may be somewhat reduced in patients of Black ethnicity.

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 Giant before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Giant.
Giant 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 Giant, inform your doctor and seek medical advice 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. Giant is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment 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 a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

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 Giant

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Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

  • The recommended dose of Giant is one tablet daily.
  • Tablets may 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 with grapefruit juice.
  • If possible, take your daily dose at the same time each day, for example with breakfast.

If you take more Giant than you should
If you take more tablets than you should, you may experience a drop in blood pressure with symptoms such as dizziness, increased or decreased heart rate.
If you take more tablets than prescribed 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.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.

If you forget to take Giant
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 Giant
It is important to continue taking Giant unless your doctor tells you to stop.
If you have any questions about how to use this medicine, ask 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 not occurring in everyone, the following side effects can be serious:
During treatment with Giant, 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 Giant and contact your doctor immediately.
Giant 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 Giant, contact your doctor immediately and remain lying down.
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Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Giant for a long time, contact your doctor immediately. Your doctor will evaluate the symptoms and decide how to proceed with therapy for the treatment of high blood pressure.

Other possible side effects of Giant:

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 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; cramps; pain in arms and legs; back pain; feeling of urgency to urinate; lack of interest in sex; inability to achieve or maintain erection; weakness.

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

Rare (may affect up to 1 in 1,000 people):
Hypersensitivity to the medicine; fainting; flushing and sensation of warmth in the face; red, itchy raised patches (urticaria); facial swelling.

Side effects reported with olmesartan medoxomil or amlodipine used alone,
but not with Giant or at a higher frequency:

Olmesartan medoxomil

Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; blocked 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 increase in fats (hypertriglyceridemia); increase in plasma urea or uric acid; increase in liver and muscle function test values.

Uncommon (may affect up to 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 affecting the whole body, which 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 unwell.

Rare (may affect up to 1 in 1,000 people):
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Swelling of the face, mouth and/or larynx (site of the vocal cords); acute renal failure and kidney failure; lethargy; intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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; 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 (may affect up to 1 in 100 people):
Restless sleep; sleep disturbances; mood disorders including anxiety; depression; irritability; tremors; taste disturbances; 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 minor bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy raised patches (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 1,000 people):
Confusion

Very rare (may affect up to 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 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; elevated 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 surface, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.

Not known (frequency cannot be estimated from available data):
Tremor, rigid posture, mask-like face, slow movements and 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.
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5. How to store Giant

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 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. Contents of the Pack and Other Information

What Giant 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 other components are
Tablet core: pregelatinized maize starch, silicified microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), and iron (III) oxide (E172, only in Giant 40 mg/5 mg and 40 mg/10 mg film-coated tablets).

Description of the appearance of Giant and contents of the pack
Giant 20 mg/5 mg, film-coated tablets, round, white in colour, marked on one side with the code C73;
Giant 40 mg/5 mg, film-coated tablets, round, cream-coloured, marked on one side with the code C75;
Giant 40 mg/10 mg, film-coated tablets, round, brownish in colour, marked on one side with the code C77.
Giant is available in packs of 28, 56, 98 or 10x28 film-coated tablets, and in packs of 50 and 500 film-coated tablets with a divisible blister for single dosing.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare, L-1611
Luxembourg.
Marketing authorisation holder's representative for sale: Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7, Bagno a Ripoli - Florence.

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
Laboratorios Menarini, S.A.
Alfons XII, 587
08918 Badalona (Barcelona),
Spain
Fine Foods & Pharmaceuticals NTM S.p.A.
Via Grignano, 43
24041 - Brembate (BG), Italy

This medicinal product is authorised in the European Economic Area Member States
under the following names:
Netherlands (RMS): Capenon 20 mg/5 mg, 40 mg/5 mg, 40 mg/10 mg
Italy: Giant 20 mg/5 mg, 40 mg/5 mg, 40 mg/10 mg
Spain: Capenon 20 mg/5 mg, 40 mg/5 mg, 40 mg/10 mg
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