Zanclora

Package leaflet: Information for the patient

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

1. What ZANCLORA is and what it is used for

ZANCLORA 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 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 blood pressure to decrease.
ZANCLORA is used to treat high blood pressure in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or amlodipine alone.

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

Do not take Olmesartan medoxomil and Amlodipine Macleods:

• 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 Olmesartan medoxomil and Amlodipine Macleods.
• if you are more than three months pregnant (it is also advisable to avoid taking ZANCLORA 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 outflow 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 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 Macleods.
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 medoxomil and Amlodipine Macleods”.
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 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 accompanied by 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 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). ZANCLORA 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”).
Elderly
If you are over 65 years of age, your doctor will regularly monitor your blood pressure with each dose increase to prevent it from dropping too low.
Patients of black ethnicity
As with other similar medicines, the blood pressure-lowering effect of ZANCLORA may be somewhat reduced in patients of black ethnicity.
Children and adolescents (under 18 years of age)
ZANCLORA is not recommended for children and adolescents under 18 years of age.
Other medicines and ZANCLORA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any of the following:

• Other medicines that lower blood pressure may increase the effect of ZANCLORA. 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 sections: “Do not take ZANCLORA” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with ZANCLORA may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood swings and certain types of depression) taken together with ZANCLORA 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 relieve pain, swelling, and other symptoms of inflammation, including arthritis) taken together with ZANCLORA may increase the risk of kidney failure. The effect of ZANCLORA may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of ZANCLORA. Your doctor may advise you to take ZANCLORA 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 Macleods.
• 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), substances 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 transplanted organs.

ZANCLORA with food and drink
People taking ZANCLORA must not consume grapefruit or grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, potentially leading to an unpredictable increase in the blood pressure-lowering effect of this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
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 ZANCLORA before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Olmesartan medoxomil and Amlodipine Macleods. This medicine is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month.
If you become pregnant while taking this medicine, inform your doctor immediately and seek medical advice.
Breastfeeding
If you are breastfeeding or planning to breastfeed, you must inform your doctor before taking this medicine. It has been shown that amlodipine passes into breast milk in small amounts. This medicine is not recommended for breastfeeding mothers, 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.
ZANCLORA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially ‘sodium-free’.

3. How to take ZANCLORA

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 ZANCLORA 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 ZANCLORA 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 ZANCLORA
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 ZANCLORA
It is important to keep taking this medicine 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 experiences them. If they do occur, they are mostly mild and do not require discontinuation of treatment.

Although not occurring in all people, the following side effects can be serious:

During treatment with ZANCLORA, 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 ZANCLORA and contact your doctor immediately.

ZANCLORA may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could lead to severe dizziness or fainting. If this happens, stop taking ZANCLORA, 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 ZANCLORA for some time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Other possible side effects of ZANCLORA:

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

Uncommon (may affect 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; diarrhea; constipation; dry mouth; upper abdominal pain; skin rash; cramps; pain in arms and legs; back pain; feeling of urgency to urinate; loss of sexual interest; 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, increased blood creatinine, increased blood uric acid, increased liver function tests (gamma-glutamyl transferase levels).

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

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

Olmesartan medoxomil

Common (may affect less than 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; gastrointestinal flu; diarrhea; indigestion; nausea; bone or joint pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; general pain. Laboratory test abnormalities such as increased blood 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):
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 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 hives; facial swelling; muscle pain; feeling of malaise.

Rare (may affect less than 1 in 1000 people):
Swelling of the face, mouth and/or larynx (site of the vocal cords); acute renal failure and kidney failure; lethargy.

Amlodipine

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

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

Uncommon (may affect less than 1 in 100 people):
Restless sleep; sleep disturbances; mood disorders including anxiety; depression; irritability; tremors; altered taste; 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 hemorrhages (purpura); skin discoloration; 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 weight loss.

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

Very rare (may affect less than 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 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 severe 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 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 may also report side effects directly via the national reporting system at http://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 ZANCLORA

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.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ZANCLORA contains
The active substances are olmesartan medoxomil and amlodipine (as besylate).
ZANCLORA 20 mg/5 mg
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
ZANCLORA 40 mg/5 mg
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
ZANCLORA 40 mg/10 mg
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

• Other components:

Tablet core:
Silicified microcrystalline cellulose, colloidal silicon dioxide, pregelatinized starch, croscarmellose sodium, and magnesium stearate.
Tablet coating:

• ZANCLORA 20 mg/5 mg: polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide (E171)

ZANCLORA 40 mg/5 mg:
Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), yellow iron oxide (E172)
ZANCLORA 40 mg/10 mg:
Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide, yellow iron oxide (E172).

Description of the appearance of ZANCLORA and the contents of the pack
ZANCLORA 20 mg/5 mg film-coated tablets:
White, round, biconvex film-coated tablets, marked with "L75" on one side and flat on the other.
ZANCLORA 40 mg/5 mg film-coated tablets:
Light yellow, round, biconvex film-coated tablets, marked with "L77" on one side and flat on the other.
ZANCLORA 40 mg/10 mg film-coated tablets:
Red (reddish-brown), round, biconvex film-coated tablets, marked with "L78" on one side and flat on the other.

Blister packs made of OPA/aluminum/PVC and aluminum foil.
Pack sizes contain 28, 56, or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Lithium Srl
SS 114 KM 4.600
98125 - Pistunina (ME)
Italy

Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland
Or
Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50,
90449 Nürnberg,
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
DE Olmesartan / Amlodipin Heumann 20mg/5mg, 40mg/5mg, 40 mg/10 mg filmtabletten
ES OLMESARTAN / AMLODIPINO MACLEODS 20MG/5MG, 40 MG/5 MG, 40 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
IT ZANCLORA
PT Amlodipina + Olmesartan medoxomilo Macleods