Candesartan and amlodipine Doc Generici: detailed information

Patient Information Leaflet

CANDESARTAN AND AMLODIPINE DOC 8 mg/5 mg tablets, 16 mg/5 mg tablets, 16 mg/10 mg tablets

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 others, even if they have the same symptoms as you, because it could 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:

What CANDESARTAN AND AMLODIPINE DOC is and what it is used for
What you need to know before taking CANDESARTAN AND AMLODIPINE DOC
How to take CANDESARTAN AND AMLODIPINE DOC
Possible side effects
How to store CANDESARTAN AND AMLODIPINE DOC
Contents of the pack and other information

1. What CANDESARTAN E AMLODIPINA DOC is and what it is used for

CANDESARTAN E AMLODIPINA DOC contains two active substances: candesartan and amlodipine.
Both help control high blood pressure.

Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels, thereby preventing their narrowing.
Candesartan belongs to a group of substances called “angiotensin II receptor antagonists”. Angiotensin II is produced by the body and causes blood vessels to narrow, thus increasing blood pressure. Candesartan works by blocking the effect of angiotensin II. This means that both substances help counteract the narrowing of blood vessels. As a result, blood vessels relax and blood pressure is reduced.

CANDESARTAN E AMLODIPINA DOC is used to treat high blood pressure in patients whose
blood pressure is already controlled by taking candesartan and amlodipine separately
at the same doses as those contained in CANDESARTAN E AMLODIPINA DOC.

2. What you should know before taking CANDESARTAN AND AMLODIPINE DOC

Do not take CANDESARTAN AND AMLODIPINE DOC

if you are allergic to amlodipine besylate or any other calcium antagonist, candesartan cilexetil, or to any of the other ingredients of this medicine (listed in section 6).
if you suffer from severe low blood pressure (hypotension).
if you suffer from narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
if you suffer from heart failure following a heart attack.
if you are more than 3 months pregnant (see section “Pregnancy and breastfeeding”).
if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking CANDESARTAN AND AMLODIPINE DOC if you
have or have had any of the following conditions:

recent heart attack
heart failure
severe high blood pressure (hypertensive crisis)
low blood pressure (hypotension)
you are elderly and your dose needs to be increased
you have liver or kidney problems, or you are on dialysis
if you have recently undergone a kidney transplant
if you are vomiting, have recently experienced severe vomiting, or have diarrhoea
if you have a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism)
if you have ever had a stroke
if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren.

Your doctor may check your kidney function, blood pressure, and the levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the section “Do not take CANDESARTAN AND AMLODIPINE DOC”.
Contact your doctor if, after taking CANDESARTAN AND AMLODIPINE DOC, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue.
Do not stop taking CANDESARTAN AND AMLODIPINE DOC on your own.
Your doctor may need to see you more frequently and perform tests if you develop any of these conditions.
If you are about to undergo surgery, tell your doctor or dentist that you are taking CANDESARTAN AND AMLODIPINE DOC. This is because CANDESARTAN AND AMLODIPINE DOC, when combined with certain anaesthetics, may cause excessive lowering of blood pressure.
You must inform your doctor if you think you are (or may become) pregnant. CANDESARTAN AND AMLODIPINE DOC is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may endanger your baby’s life if used at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents
There is no experience with the use of CANDESARTAN AND AMLODIPINE DOC in children (under 18 years). Therefore, do not give this medicine to children or adolescents.

Other medicines and CANDESARTAN AND AMLODIPINE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
CANDESARTAN AND AMLODIPINE DOC may affect how other medicines work, and some medicines may affect CANDESARTAN AND AMLODIPINE DOC. Your doctor may need to adjust your dose or take other precautions if you are taking:

ketoconazole, itraconazole (medicines used to treat fungal infections)
ritonavir, indinavir, nelfinavir (medicines known as protease inhibitors used to treat HIV)
rifampicin, erythromycin, clarithromycin (antibiotics)
St John's wort (Hypericum perforatum)
verapamil, diltiazem (heart medicines)
dantrolene (intravenous infusion for the treatment of severe hyperthermia)
tacrolimus, sirolimus, temsirolimus, and everolimus (used to modulate the body's immune response, allowing your body to accept a transplanted organ)
simvastatin (a medicine used to reduce cholesterol)
ciclosporin (an immunosuppressant)
other medicines that help lower high blood pressure, including beta-blockers, diazoxide, ACE inhibitors, or aliskiren (also see information under “Do not take CANDESARTAN AND AMLODIPINE DOC” and “Warnings and precautions”)
non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation)
acetylsalicylic acid (a medicine to relieve pain and inflammation) if you are taking more than 3 g per day
potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood)
heparin (a medicine to thin the blood)
cotrimoxazole (an antibiotic), also known as trimethoprim and sulfamethoxazole
tablets that help you urinate (diuretics)
lithium (a medicine for mental health conditions)

CANDESARTAN AND AMLODIPINE DOC with food and drink
Grapefruit and grapefruit juice must not be consumed during treatment with CANDESARTAN AND AMLODIPINE DOC, 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 CANDESARTAN AND AMLODIPINE DOC.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan 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 are (or may become) pregnant.
Your doctor will normally advise you to stop taking CANDESARTAN AND AMLODIPINE DOC before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
CANDESARTAN AND AMLODIPINE DOC 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 your unborn baby if used after the third month of pregnancy.

Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. Inform your doctor before taking CANDESARTAN AND AMLODIPINE DOC if you are breastfeeding or about to start breastfeeding. CANDESARTAN AND AMLODIPINE DOC is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you, especially if your baby is newborn or premature.

Driving and using machines
CANDESARTAN AND AMLODIPINE DOC may have a moderate effect on your ability to drive or use machines. If you feel unwell, dizzy, tired, or experience headache after taking the tablets, do not drive or use machines and contact your doctor immediately.

CANDESARTAN AND AMLODIPINE DOC contains lactose monohydrate and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take CANDESARTAN AND AMLODIPINE DOC

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of CANDESARTAN AND AMLODIPINE DOC 8 mg/5 mg is 1 or 2 tablets per day.
The recommended dose of CANDESARTAN AND AMLODIPINE DOC 16 mg/5 mg is 1 tablet per day.
The recommended dose of CANDESARTAN AND AMLODIPINE DOC 16 mg/10 mg is 1 tablet per day. The tablet may be divided into two equal doses.
You may take CANDESARTAN AND AMLODIPINE DOC with or without food.

If you take more CANDESARTAN AND AMLODIPINE DOC than you should
Taking too many tablets could cause your blood pressure to drop, possibly dangerously. You may feel dizzy, lightheaded, faint, or weak. The drop in blood pressure could be so severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may develop up to 24–48 hours after ingestion.
If you have taken too many tablets, contact your doctor immediately.

If you forget to take CANDESARTAN AND AMLODIPINE DOC
If you forget to take a tablet, skip the missed dose completely. Take your next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking CANDESARTAN AND AMLODIPINE DOC
Your doctor will tell you how long to take the medicine. Your condition may return if you stop treatment before your doctor tells you to do so. Therefore, do not stop treatment with CANDESARTAN AND AMLODIPINE DOC without first talking to your doctor.
If you have any doubts 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 everybody gets them.
If you experience any of the following serious, very rare side effects, stop taking this medicine immediately and inform your doctor straight away:

Sudden wheezing, chest pain, breathlessness or difficulty breathing
Swelling of the eyelids, face or lips
Swelling of the tongue and throat which may cause difficulty breathing
Severe skin reactions including severe rash, hives, redness of the skin all over the body, severe itching, blistering rash, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
Heart attack, abnormal heartbeat
Inflammation of the pancreas which may cause severe stomach pain and back pain associated with a feeling of severe illness

Candesartan may cause a reduction in the number of white blood cells. Your resistance to infections may decrease, and you may notice fatigue, infection or fever. If this happens, contact your doctor. Your doctor may occasionally carry out blood tests to check whether CANDESARTAN AND AMLODIPINE DOC has affected your blood (agranulocytosis).

Other possible side effects:
Since CANDESARTAN AND AMLODIPINE DOC is a combination of two active substances, the side effects reported are related to the use of both candesartan and amlodipine.

Side effects related to the use of amlodipine
Very common (may affect more than 1 in 10 people)

Oedema (fluid retention)

Common (may affect up to 1 in 10 people)

Headache, dizziness, drowsiness (especially at the beginning of treatment)
Palpitations (awareness of heartbeat), flushing
Abdominal pain, feeling unwell (nausea)
Changes in bowel habits, diarrhoea, constipation, indigestion
Tiredness, weakness
Visual disturbances, double vision
Muscle cramps
Swelling of the ankles

Uncommon (may affect up to 1 in 100 people)

Mood changes, anxiety, depression, insomnia
Tremor, altered taste, fainting
Numbness or tingling sensation in limbs, loss of pain sensitivity
Tinnitus (ringing in the ears)
Low blood pressure
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
Cough
Dry mouth, vomiting (feeling sick)
Hair loss, increased sweating, itchy skin, red patches on the skin, skin colour changes
Urinary disorders, increased need to urinate at night, increased frequency of urination
Difficulty achieving an erection, discomfort or breast enlargement in men
Pain, feeling unwell
Joint or muscle pain, back pain
Weight gain or weight loss

Rare (may affect up to 1 in 1,000 people)

Confusion

Very rare (may affect up to 1 in 10,000 people)

Low levels of white blood cells and platelets in the blood which may lead to unusual bruising or easy bleeding (damage to red blood cells)
High blood sugar levels (hyperglycaemia)
A nerve disorder that may cause muscle weakness, twitching or numbness
Swelling of the gums
Abdominal swelling (gastritis)
Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain clinical tests
Increased muscle tension
Inflammation of blood vessels, often with skin rash
Light sensitivity

Not known (frequency cannot be estimated from the available data)

Tremor, rigid posture, mask-like face, slow movements and shuffling, unbalanced gait

Side effects related to the use of candesartan
Common (may affect up to 1 in 10 people)

Feeling dizzy/sensation of dizziness
Headache
Respiratory infection
Low blood pressure. This may make you feel faint or dizzy.
Changes in blood tests: increased potassium levels in the blood, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience fatigue, weakness, irregular heartbeat or tingling.
Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect up to 1 in 10,000 people)

Swelling of the face, lips, tongue and/or throat
Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
A reduction in red or white blood cells. You may notice fatigue, infection or fever
Rash, rash with swelling (urticaria)
Itching
Back pain, joint and muscle pain
Changes in liver function, including inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
Cough
Nausea
Changes in blood test results: reduced sodium levels in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps.

Not known (frequency cannot be estimated from the available data)

Diarrhoea

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 CANDESARTAN AND AMLODIPINE DOC

Keep this medicine out of the sight and reach of children.
Store this medicine at a temperature not exceeding 30 °C in the original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What CANDESARTAN E AMLODIPINA DOC contains

The active substances are candesartan cilexetil and amlodipine.
CANDESARTAN E AMLODIPINA DOC 8 mg/5 mg: Each tablet contains 8 mg of candesartan cilexetil and 5 mg of amlodipine (amlodipine besilate).
CANDESARTAN E AMLODIPINA DOC 16 mg/5 mg: Each tablet contains 16 mg of candesartan cilexetil and 5 mg of amlodipine (amlodipine besilate).
CANDESARTAN E AMLODIPINA DOC 16 mg/10 mg: Each tablet contains 16 mg of candesartan cilexetil and 10 mg of amlodipine (amlodipine besilate).
CANDESARTAN E AMLODIPINA DOC 8 mg/5 mg and 16 mg/5 mg: The other components are: hypromellose, lactose monohydrate, sodium croscarmellose, maize starch, triethyl citrate, magnesium stearate.
CANDESARTAN E AMLODIPINA DOC 16 mg/10 mg tablets: The other components are: lactose monohydrate, mannitol, maize starch, calcium carmellose, hydroxypropylcellulose, Macrogol 8000, stearic acid, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of CANDESARTAN E AMLODIPINA DOC and contents of the pack
CANDESARTAN E AMLODIPINA DOC 8 mg/5 mg tablets
The CANDESARTAN E AMLODIPINA DOC 8 mg/5 mg tablets are round, biconvex, white to off-white in colour, with a diameter of 6 mm ± 0.2 mm, engraved with "8" on one side and "5" on the other.

CANDESARTAN E AMLODIPINA DOC 16 mg/5 mg tablets
The CANDESARTAN E AMLODIPINA DOC 16 mg/5 mg tablets are round, two-layered tablets, white to light beige in colour, engraved with "16" on one side and "5" on the other. The tablet diameter is 8 ± 0.3 mm.

CANDESARTAN E AMLODIPINA DOC 16 mg/10 mg tablets
The CANDESARTAN E AMLODIPINA DOC 16 mg/10 mg tablets are round, biconvex, white to off-white in colour, with a diameter of 8.0 ± 0.2 mm, with a score line on both sides, imprinted with "16 16" on one side and "10 10" on the other. The tablet can be divided into equal doses.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l, Via Turati 40, 20121 Milano, Italy.

Manufacturer
ZENTIVA k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Candesartan Amlodipin DOC
Italy: CANDESARTAN E AMLODIPINA DOC