Lamera

Package leaflet: Information for the user

Lamera 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 entire 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lamera is and what it is used for

Lamera 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 known as 'calcium antagonists'. Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing and consequently reducing blood pressure as well.
The combined action of these two substances helps prevent the narrowing of blood vessels, allowing blood vessels to relax and blood pressure to decrease.
Lamera is used for the treatment of high blood pressure in patients whose blood pressure is not sufficiently controlled by olmesartan medoxomil or amlodipine alone.

2. What you need to know before taking Lamera

Do not take Lamera
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 may be allergic, speak with your doctor before taking Lamera.
If you are more than three months pregnant (it is better to avoid taking Lamera 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, impaired bile secretion, or a blockage in the flow of bile from the gallbladder (e.g. caused by gallstones), or if you develop 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 (e.g. 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 Lamera.
Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g. 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 (e.g. potassium) at regular intervals.
See also the information under the section ‘Do not take Lamera’.
Tell your doctor if you also have any of the following health conditions:
kidney problems or a 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;
elevated potassium levels in the blood;
adrenal gland disorders (glands that produce hormones located above the kidneys).
Tell your doctor if you experience severe, prolonged diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with antihypertensive treatment.
As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with circulatory problems 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 you might become pregnant). Lamera 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 (under 18 years of age)
Lamera is not recommended for children and adolescents under 18 years of age.

Other medicines and Lamera
Tell 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 Lamera. Your doctor may need to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections ‘Do not take Lamera’ 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 Lamera may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Lamera 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, reduce swelling and other symptoms of inflammation, including arthritis) taken together with Lamera may increase the risk of kidney failure. The effect of Lamera may be reduced by NSAIDs.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, as it may reduce the effect of Lamera. Your doctor may advise you to take Lamera at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion or stomach acidity), as the effect of Lamera may be slightly reduced.
Medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir) or for treating fungal infections (e.g. ketoconazole, itraconazole).
Diltiazem, verapamil (medicines used for heart rhythm problems 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 (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 a transplanted organ.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Lamera with food and drinks
Lamera can be taken with or without food. Swallow the tablet with liquid (such as a glass of water). If possible, take your daily dose at the same time each day, for example at breakfast.
People taking Lamera 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 Lamera.

Elderly
If you are over 65 years old, your doctor will regularly monitor your blood pressure with each dose increase to ensure that your blood pressure does not become too low.

Patients of black ethnicity
As with other similar medicines, the antihypertensive effect of Lamera 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 you might become pregnant). Your doctor will usually advise you to stop taking Lamera before starting pregnancy or as soon as you find out you are pregnant, and will recommend another medicine instead of Lamera. Lamera 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 Lamera, inform and see 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. Lamera is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are 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 treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Lamera 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 Lamera

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 Lamera is one tablet daily.
The tablets can be taken with or without food. Swallow the tablets with 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 Lamera than you should
If you take more tablets than you should, 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 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 breathlessness, which
may develop within 24–48 hours after ingestion.
If you forget to take Lamera
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 Lamera
It is important to continue taking Lamera 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 will experience 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:

During treatment with Lamera, allergic reactions may occur that 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 Lamera and contact your doctor immediately.

Lamera 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 Lamera, contact your doctor immediately and lie down.

Frequency not known: If you notice yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Lamera for a long time, contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with treatment for high blood pressure.

Other possible side effects of Lamera:

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

Uncommon (may affect less than 1 in 100 people):
Dizziness upon standing up; lack of energy; tingling or numbness in the hands or feet; vertigo; awareness of heartbeat; rapid heartbeat; low blood pressure with symptoms such as dizziness or light-headedness; 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 an erection; weakness.

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

Rare (may affect less than 1 in 1000 people):
Hypersensitivity to the medicine; facial flushing and feeling of warmth; itchy, red welts (urticaria); swelling of the face.

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

Olmesartan medoxomil

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

Uncommon (may affect less than 1 in 100 people):
Reduced number of a type of blood cell called platelets, which may lead to easier bruising or prolonged bleeding time; rapid-onset allergic reactions affecting the whole body, causing breathing difficulties or a sudden drop in blood pressure that may even lead to fainting (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with hives; facial swelling; muscle pain; feeling unwell.

Rare (may affect less than 1 in 1000 people):
Swelling of the face, mouth and/or larynx (site of the 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 less than 1 in 10 people):
Abdominal pain; nausea; swollen ankles; drowsiness; facial flushing and feeling of warmth; vision disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness; shortness of breath.

Uncommon (may affect less than 1 in 100 people):
Restless sleep; sleep disturbances; mood disturbances including feeling anxious; depression; irritability; tremor; altered taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; runny or stuffy nose; hair loss; small red or purple spots on the skin due to minor bleeding (purpura); skin discolouration; excessive sweating; skin rash; itching; itchy, red welts (urticaria); joint or muscle pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain, feeling unwell; weight gain or weight loss.

Rare (may affect less than 1 in 1000 people):
Confusion.

Very rare (may affect less than 1 in 10,000 people):
Reduced number of white blood cells in the blood, which may increase the risk of infections; reduced 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 the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach lining; gum swelling; 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 rash, hives, redness of the skin over the entire body, severe itching, blistering, peeling and swelling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis), inflammation of mucous membranes, 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 Lamera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "Exp".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lamera contains
The active substances are olmesartan medoxomil and amlodipine (as besylate).
Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

The other components are:
Tablet core
Microcrystalline cellulose
Sodium croscarmellose
Anhydrous colloidal silica
Magnesium stearate

Coating
Polyvinyl alcohol
Macrogol 3350
Talc
Titanium dioxide (E171)
Red iron oxide (E172) (only for film-coated tablets 40 mg/10 mg)
Yellow iron oxide (E172) (only for film-coated tablets 40 mg/5 mg and 40 mg/10 mg)

Description of the appearance of Lamera and contents of the pack
Lamera 20 mg/5 mg: white, round, biconvex, film-coated tablets, with "L" engraved on one side and smooth on the other, with a diameter of 6.1 mm.
Lamera 40 mg/5 mg: yellow, round, biconvex, film-coated tablets, with "I" engraved on one side and smooth on the other, with a diameter of 8.1 mm.
Lamera 40 mg/10 mg: brownish-red, round, biconvex, film-coated tablets, with "H" engraved on one side and smooth on the other, with a diameter of 8.1 mm.

Lamera film-coated tablets are available in packs of 14, 28, 30, 56, 90, 98, 10x28 and 10x30 film-coated tablets, and in packs of 10, 50 and 500 film-coated tablets in perforated blister packs for single-dose administration.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed S.r.l.,
Via G. Mazzini 20,
20123 Milano,
Italy

Manufacturer
Genepharm S.A.,
18th km Marathonos Avenue,
15351 Pallini Attiki,
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Amlodipina + Olmesartan medoxomilo / Genepharm
Italy: Lamera