Olpidus

Patient Information Leaflet

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

Olmesartan medoxomil/amlodipine
Equivalent 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, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olpidus is and what it is used for

Olpidus 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 known as “angiotensin II receptor
antagonists”. These reduce blood pressure by relaxing blood vessels.
Amlodipine belongs to a group of substances known as “calcium channel blockers”. Amlodipine
prevents calcium from entering the walls of blood vessels, 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.
Olpidus 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 Olpidus

Do not take Olpidus
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 Olpidus.
if you are more than 3 months pregnant (it is better to avoid taking Olpidus 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, slow 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 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 Olpidus.
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 (such as potassium) in your blood at regular intervals.
See also the information under “Do not take Olpidus”.
Consult your doctor if you also have any of the following health conditions:
Kidney problems or kidney transplant.
Liver disorders.
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 levels of potassium 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 how to proceed with 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). Olpidus 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 and breastfeeding”).
Contact your doctor if, after taking Olpidus, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Olpidus on your own.

Children and adolescents
Olpidus is not recommended for children and adolescents under 18 years of age.

Other medicines and Olpidus
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 increase the effect of Olpidus. Your doctor may consider it necessary to adjust the dosage and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also “Do not take Olpidus” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, "water tablets" (diuretics), or heparin (to thin the blood and prevent thrombosis). Taking these medicines together with Olpidus may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olpidus 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) used together with Olpidus may increase the risk of kidney failure. The effect of Olpidus may be reduced by NSAIDs.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of Olpidus. Your doctor may advise you to take Olpidus at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion or stomach acidity) may slightly reduce the effect of Olpidus.
Medicines for HIV/AIDS (for example ritonavir, indinavir, nelfinavir) or for 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 (intravenous infusion for severe disturbances in body temperature).
Simvastatin, a substance used to reduce cholesterol and fat (triglycerides) 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).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Olpidus with food and drink
Olpidus 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 this medicine 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 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, think you may be pregnant, are planning a pregnancy, or are 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). Normally, your doctor will advise you to stop taking Olpidus before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine instead of Olpidus. This medicine 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 after the third month of pregnancy.
If you become pregnant while taking this medicine, inform your doctor immediately and seek medical advice.

Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts. Olpidus 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 have resolved. Consult your doctor.

Olpidus 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 Olpidus

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 Olpidus is one tablet per day.
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 Olpidus 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 slowed heart rate.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath,
which may develop within 24–48 hours after ingestion.
If you take more tablets than prescribed or if a child accidentally ingests 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 Olpidus
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 missed dose.
If you stop taking Olpidus
It is important to continue taking this medicine unless your doctor tells you
to stop.
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 experiences them. If they do occur, they are mostly mild and do not require discontinuation of treatment.
Although they do not occur in all individuals, the following side effects can be serious:
Severe skin reactions including severe rash, hives, widespread redness of the skin, intense itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions may occur during treatment with Olpidus.
If this happens, stop taking Olpidus and contact your doctor immediately.
Olpidus may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could cause severe dizziness or fainting.
If this happens, stop taking Olpidus, 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 Olpidus treatment was started a long time ago, contact your doctor immediately, who will assess the symptoms and decide how to proceed with your blood pressure medication.

Other possible side effects of Olpidus:
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
feeling of complete lack of energy
tingling or numbness in hands or feet
vertigo
awareness of heartbeat
rapid heartbeat
low blood pressure with symptoms such as dizziness, lightheadedness
breathing difficulties
cough
nausea
vomiting
indigestion
diarrhoea
constipation
dry mouth
upper abdominal pain
rash
cramps
pain in arms and legs
back pain
feeling of urgency to urinate
reduced sexual activity
inability to maintain erection or reduced erection
weakness

Changes in blood test results 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 olmesartan medoxomil or amlodipine used alone, but not with Olpidus or at higher frequency:

Olmesartan medoxomil
Common (may affect up to 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. Blood test abnormalities such as increased fat levels (hypertriglyceridaemia); increased blood urea or uric acid levels; 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 fainting (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; rash; allergic skin rash; rash with hives, 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 the vocal cords); acute renal failure and renal failure; lethargy; intestinal angioedema: intestinal swelling presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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 disturbances (including double vision and blurred vision), awareness of heartbeat, diarrhoea, constipation, indigestion, cramps, weakness, breathing difficulties.

Uncommon (may affect up to 1 in 100 people):
Restless sleep, sleep disturbances, mood disturbances including anxiety, depression, irritability, chills, taste disturbances, fainting, ringing in the ears (tinnitus), worsening of angina pectoris (chest pain or discomfort), irregular heartbeat, stuffy or runny nose, hair loss, small purple spots or patches on the skin due to minor bleeding (purpura), skin colour changes, excessive sweating, rash, itching, red, itchy welts (urticaria), muscle or joint pain, urinary problems, need to urinate at night, increased frequency of urination, breast enlargement in men, chest pain, pain, malaise, 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 white blood cell count, 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 levels; 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, rash, swelling of the face, mouth and/or larynx (site of the vocal cords) together with itching and rash), severe skin reactions including severe rash, hives, redness of the skin over the entire body surface, intense itching, blisters, peeling and swelling of the skin, mucosal inflammation, sometimes life-threatening.

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Olpidus

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 the carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect the medicine from moisture.
Period of validity after first opening:
Bottle: 100 days
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 Olpidus contains

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

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

• Other components (excipients) 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 hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG 3350, talc
40 mg/5 mg film-coated tablets:
partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG 3350,
talc, yellow iron oxide (E 172)
40 mg/10 mg film-coated tablets:
partially hydrolyzed 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 Olpidus and package contents
20 mg/5 mg film-coated tablets:
Film-coated tablet, white to pale white, round, imprinted 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, imprinted 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, imprinted 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/Al/PVC/Al and placed in a carton box.
Alternatively, the film-coated tablets are packaged in HDPE bottles with a child-resistant screw cap made of propylene, equipped with an induction-sealed closure or a transparent inner seal, and contain a desiccant which must not be ingested, all contained within a carton box.

Pack sizes:
Blister packs: 10, 14, 28, 30, 56, 90 and 98 film-coated tablets.
Bottles (dosages 20 mg/5 mg – 40 mg/5 mg):
28, 100, 250 film-coated tablets with a container including a desiccant weighing 1 g per bottle.
Bottles (dosage 40 mg/10 mg):
28 and 100 film-coated tablets with a container including a desiccant weighing 1 g per bottle.
250 film-coated tablets with one or two containers including a desiccant weighing 2 g per bottle (2x1 g or 1x2 g).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
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 Member States of the European Economic Area under the following names:
Austria Olmesartan/Amlodipin Sandoz 20 mg/5 mg – Filmtabletten
Olmesartan/Amlodipin Sandoz 40 mg/5 mg – Filmtabletten
Olmesartan/Amlodipin Sandoz 40 mg/10 mg – Filmtabletten
Belgium Olmesartan/Amlodipine Sandoz 20 mg/5 mg filmomhulde tabletten
Olmesartan/Amlodipine Sandoz 40 mg/5 mg filmomhulde tabletten
Olmesartan/Amlodipine Sandoz 40 mg/10 mg filmomhulde tabletten
Germany Olmesartan/Amlodipin - 1 A Pharma 20 mg/5 mg Filmtabletten
Olmesartan/Amlodipin - 1 A Pharma 40 mg/5 mg Filmtabletten
Olmesartan/Amlodipin - 1 A Pharma 40 mg/10 mg Filmtabletten
Greece Olmesartan+ Amlodipine/Sandoz
Italy Olpidus
Lithuania Olmesartan medoxomil /Amlodipine Sandoz 20 mg/5 mg plėvele dengtos tabletės
Olmesartan medoxomil /Amlodipine Sandoz 40 mg/5 mg plėvele dengtos tabletės
Olmesartan medoxomil /Amlodipine Sandoz 40 mg/10 mg plėvele dengtos tabletės
Portugal Amlodipina + Olmesartan medoxomilo Sandoz
Spain Olmesartán/Amlodipino Sandoz 20 mg/5 mg comprimidos recubiertos con película EFG
Olmesartán/Amlodipino Sandoz 40 mg/5 mg comprimidos recubiertos con película EFG
Olmesartán/Amlodipino Sandoz 40 mg/10 mg comprimidos recubiertos con película EFG