Olmesartan medoxomil and amlodipine Sandoz: detailed information

Package leaflet: Information for the patient

Olmesartan medoxomil and Amlodipine Sandoz 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 all of 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 other people, even if their symptoms are the same as yours, as it may 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 and Amlodipine Sandoz is and what it is used for
What you need to know before taking Olmesartan medoxomil and Amlodipine Sandoz
How to take Olmesartan medoxomil and Amlodipine Sandoz
Possible side effects
How to store Olmesartan medoxomil and Amlodipine Sandoz
Contents of the pack and other information

1. What Olmesartan medoxomil and Amlodipine Sandoz is and what it is used for

Olmesartan medoxomil and Amlodipine Sandoz contains two active 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 medicines 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 reducing vessel constriction and lowering blood pressure.
The combined action of both substances helps reduce vascular resistance, allowing blood vessels to relax and blood pressure to decrease.
Olmesartan medoxomil and Amlodipine Sandoz is used to treat high blood pressure in adult patients whose blood pressure is not sufficiently controlled by olmesartan medoxomil or amlodipine alone.

2. What you need to know before taking Olmesartan medoxomil and Amlodipine Sandoz

Do not take Olmesartan medoxomil and Amlodipine Sandoz
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 ingredients of this
medicine (listed in section 6).
If you think you are allergic, speak with your doctor before taking Olmesartan
medoxomil and Amlodipine Sandoz.
if you are more than three months pregnant (it is better to avoid taking Olmesartan
medoxomil and Amlodipine Sandoz 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 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 serious heart problems.
if blood flow from your heart is obstructed (for example, due to narrowing of the aorta (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 medoxomil and
Amlodipine Sandoz.
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 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 medoxomil and Amlodipine Sandoz”.
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 "water tablets" (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 reduction 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 are pregnant (or if there is a possibility of becoming pregnant). Olmesartan medoxomil and Amlodipine Sandoz 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
Olmesartan medoxomil and Amlodipine Sandoz is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan medoxomil and Amlodipine Sandoz
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, as they may enhance the effect of Olmesartan medoxomil and Amlodipine Sandoz. Your doctor may need 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 medoxomil and Amlodipine Sandoz” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, "water tablets" (diuretics), or heparin (used to thin the blood and prevent thrombosis). Taking these medicines together with Olmesartan medoxomil and Amlodipine Sandoz may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmesartan medoxomil and Amlodipine Sandoz 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 medoxomil and Amlodipine Sandoz may increase the risk of kidney failure. The effect of Olmesartan medoxomil and Amlodipine Sandoz may be reduced by NSAIDs.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of Olmesartan medoxomil and Amlodipine Sandoz. Your doctor may advise you to take Olmesartan medoxomil and Amlodipine Sandoz at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion or stomach acidity) may slightly reduce the effect of Olmesartan medoxomil and Amlodipine Sandoz.
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 (antibiotics).
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, sirolimus, temsirolimus, everolimus and ciclosporin (used to control your body's immune response and thus allow your body to accept transplanted organs).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Olmesartan medoxomil and Amlodipine Sandoz with food and drink
Olmesartan medoxomil and Amlodipine Sandoz can be taken with or without food.
The tablet should be swallowed 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 this medicine should not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, which could unpredictably enhance the hypotensive effect of this medicine.

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 this medicine may be somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

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 medoxomil and Amlodipine Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartan medoxomil and Amlodipine Sandoz.
This medicine 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 this medicine, inform your doctor 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 medoxomil and Amlodipine Sandoz is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

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 resolve. Consult your doctor.

Olmesartan medoxomil and Amlodipine Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 23 mg (1 mmol) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Olmesartan medoxomil and Amlodipine Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Olmesartan medoxomil and Amlodipine Sandoz 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). The tablet must not be chewed. Do not take it with grapefruit juice.
If possible, take your daily dose at the same time each day, for example with breakfast.

If you take more Olmesartan medoxomil and Amlodipine Sandoz than you should
If you take more tablets than prescribed, you may experience a drop in blood pressure with symptoms such as dizziness, increased or slowed heart rate.
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 take more tablets than prescribed or if a child accidentally swallows any, go immediately to your doctor or the nearest emergency room, taking the medicine pack or this leaflet with you.

If you forget to take Olmesartan medoxomil and Amlodipine Sandoz
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 medoxomil and Amlodipine Sandoz
It is important to continue taking this medicine 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 do occur, they are mostly mild and do not require discontinuation of treatment.
Although they do not occur in all people, the following side effects can be serious:
Severe skin reactions including severe rash, urticaria, redness of the skin all over the body, intense itching, blistering rash, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions may occur during treatment with Olmesartan medoxomil and Amlodipine Sandoz.
If this happens, stop taking Olmesartan medoxomil and Amlodipine Sandoz and contact your doctor immediately.
Olmesartan medoxomil and Amlodipine Sandoz 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 medoxomil and Amlodipine Sandoz, 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 medoxomil and Amlodipine Sandoz for a long time, contact your doctor immediately. Your doctor will evaluate the symptoms and decide how to proceed with your blood pressure medication.

Other possible side effects of Olmesartan medoxomil and Amlodipine Sandoz:

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
fast heartbeat
low blood pressure with symptoms such as dizziness, mental fogginess
shortness of breath
cough
nausea
vomiting
indigestion
diarrhoea
constipation
dry mouth
pain in the upper abdomen
rash
cramps
pain in arms and legs
back pain
feeling of urgency to urinate
loss of sexual desire
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 blood uric acid levels, increases in a liver function test (gamma-glutamyl transferase levels).

Rare (may affect up to 1 in 1,000 people):
hypersensitivity to the medicine
fainting
flushing and feeling of warmth in the face
red, itchy welts (urticaria)
facial swelling.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan medoxomil and Amlodipine Sandoz or with different frequency:

Olmesartan medoxomil

Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; stuffy 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 blood fats (hypertriglyceridaemia); increased blood 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 affecting the whole body, which may cause breathing difficulties and rapid drop in blood pressure, possibly leading to weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching sensation; rash; allergic skin rash; urticarial rash, facial swelling; muscle pain; feeling unwell.

Rare (may affect up to 1 in 1,000 people):
Swelling of the face, mouth and/or larynx (site of vocal cords); acute kidney failure and kidney failure; lethargy.

Amlodipine

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

Common (may affect up to 1 in 10 people):
Abdominal pain; nausea; ankle swelling; drowsiness; flushing and feeling of warmth in the face, visual disturbance (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 disorders; mood disturbances including feeling anxious; 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 small bleedings (purpura); skin discoloration; excessive sweating; rash; itching sensation; 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, feeling unwell; 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, 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 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 lining; gum overgrowth; elevated liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions (itching, rash, swelling of the face, mouth and/or larynx (site of vocal cords) together with itching and rash), severe skin reactions including intense rash, urticaria, redness of the skin over the entire body, severe itching, blistering rash, skin peeling and swelling, mucosal inflammation, sometimes life-threatening.

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

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 medoxomil and Amlodipine Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
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 medoxomil and Amlodipine Sandoz contains

The active substances are olmesartan medoxomil and amlodipine (as besilate).

20 mg/5 mg film-coated tablets:
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of
amlodipine (as besilate).
40 mg/5 mg film-coated tablets:
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of
amlodipine (as besilate).
40 mg/10 mg film-coated tablets:
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of
amlodipine (as besilate).

Other components are: Tablet core: monohydrate lactose, sodium croscarmellose, pregelatinized starch (maize), magnesium stearate, silicified microcrystalline cellulose

Tablet coating:
20 mg/5 mg film-coated tablets:
partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG
3350, talc
40 mg/5 mg film-coated tablets:
partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG
3350, talc, yellow iron oxide (E 172)
40 mg/10 mg film-coated tablets:
partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG
3350, talc, yellow iron oxide (E 172), red iron oxide (E 172)

Description of the appearance of Olmesartan medoxomil and Amlodipine Sandoz and pack contents
20 mg/5 mg film-coated tablets:
Film-coated tablet, white to pale white, round, marked with “20 5” on one side, with a diameter of approximately 7.1 mm.
40 mg/5 mg film-coated tablets:
Film-coated tablet, yellow, round, marked with “40 5” on one side, with a diameter of approximately 9.1 mm.
40 mg/10 mg film-coated tablets:
Film-coated tablet, pink, round, marked with “40 10” on one side, with a diameter of approximately 9.1 mm.
The film-coated tablets are packaged in push-through blisters made of OPA/Alu/PVC/Alu and placed in a carton box.
Pack sizes:
Blister packs: 10, 14, 28, 30, 56, 90 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria Olmesartan/Amlodipin 1A Pharma 20 mg/5 mg – Filmtabletten
Olmesartan/Amlodipin 1A Pharma 40 mg/5 mg – Filmtabletten
Olmesartan/Amlodipin 1A Pharma 40 mg/10 mg - Filmtabletten
Germany Olmesartan/Amlodipin HEXAL 20 mg/5 mg Filmtabletten
Olmesartan/Amlodipin HEXAL 40 mg/5 mg Filmtabletten
Olmesartan/Amlodipin HEXAL 40 mg/10 mg Filmtabletten
Italy Olmesartan medoxomil and Amlodipine Sandoz