ADALAT 30 mg Modified-Release Tablets

Зміст інструкції

1. Adalat Crono 20 mg modified-release tablets, 30 mg modified-release tablets, 60 mg modified-release tablets
   1. What is Adalat Crono and what is it used for
   2. What you need to know before taking Adalat Crono
   3. How to take Adalat Crono
   4. Possible side effects
   5. How to store Adalat Crono

Adalat Crono 20 mg modified-release tablets, 30 mg modified-release tablets, 60 mg modified-release tablets

Nifedipine
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Adalat Crono and what is it used for

Adalat Crono contains nifedipine as its active ingredient, which belongs to the category of calcium-antagonist medicines.
Adalat Crono is used for the treatment of the following conditions:

• exertional angina(angina pectoris), which consists of severe chest pain in the region behind the sternum, due to an insufficient supply of blood and oxygen to the heart (generally following exertion). Nifedipine works by dilating the coronary arteries, thereby increasing the supply of blood and oxygen to the heart tissue. Furthermore, as it also acts at the level of peripheral vessels, it reduces the oxygen requirement of the heart.
• high blood pressure(arterial hypertension), as it causes relaxation of blood vessels and increases the elimination of sodium and water. This results in a decrease in blood pressure, particularly marked in patients with high blood pressure.

2. What you need to know before taking Adalat Crono

Do not take Adalat Crono

• if you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6);
• if you are or suspect you are pregnant (up to the 20th week) and during breastfeeding (see “Pregnancy and breastfeeding”);
• if you are in cardiovascular shock (sudden drop in blood pressure);
• if you have a Kock pouch (“deviation” after a demolitive operation on the colon and rectum);
• if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections. In this case, the levels of nifedipine in the blood may be insufficient (see “Other medicines and Adalat Crono”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Adalat Crono.

Take special care with Adalat Crono, especially:

• If you have very low blood pressure(systolic pressure below 90 mm of mercury), if you suffer from heart failure (weak heart) or severe aortic stenosis (narrowing of a heart valve);
• If you have a severe narrowing of the gastrointestinal tract, because, as the tablet consists of a non-absorbable shell, symptoms of intestinal blockage (intestinal occlusion) may occur. Exceptionally, these shells can lead to the formation of voluminous masses in the stomach, called bezoars, which cannot be eliminated through the intestine and sometimes require surgical intervention. In single cases, blockage symptoms have also manifested in patients who had never experienced gastrointestinal disorders. If you undergo X-rays of the digestive tract with barium contrast, be aware that Adalat Crono may give images that may be falsely interpreted as polyps.
• If your liver is not functioning properly. In this case, careful monitoring may be necessary and, if your condition is severe, a reduction in the dosage of Adalat Crono may also be required.
• If you are pregnant, given that the available information does not allow excluding the possibility of undesirable effects on the unborn child and newborn. For this reason, Adalat Crono should not be used in the first 20 weeks of pregnancy (see “Do not take Adalat Crono” and “Pregnancy and breastfeeding”) and, in the following weeks, can only be used after a very careful assessment of the possible risks and expected benefits and when other therapies are not suitable or have not been effective. Your doctor will then decide whether treatment with Adalat Crono is suitable for you. If they prescribe Adalat Crono for you, they are likely to subject you to frequent blood pressure checks, especially if it is administered in association with magnesium sulfate intravenously, due to the possibility of an excessive drop in blood pressure, which can harm both you and the fetus.
• If you are breastfeeding, as nifedipine passes into breast milk. For immediate-release formulations, it is recommended to delay breastfeeding or milk expression for 3 or 4 hours after taking the medicine in order to decrease the infant's exposure to nifedipine. Since there is no data on the possible effects on the newborn, if treatment with nifedipine is necessary during this period, breastfeeding should be discontinued.

If you need to undergo a laboratory test to determine the values of vanillyl-
mandelic acid in the urine (a test to diagnose a tumor of the adrenal gland),
be aware that, in the presence of nifedipine and depending on the method used, the values may
result falsely increased.

Children and adolescents
The use of Adalat Crono is not recommended in children and adolescents under 18 years
of age, because in this population only limited data on efficacy and safety are available.

Other medicines and Adalat Crono
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Regarding Adalat Crono, be aware that:
Nifedipine is transformed in the body through a particular system of molecules
(called enzymes). If medicines that influence or
use this same system are administered in association, a reduction or an increase in
concentration in the blood, and therefore in the effect of nifedipine or the other medicine, may be observed. It may
then be necessary to adjust the dosage of nifedipine or the other
medicine and/or more frequent blood pressure monitoring.
Medicines that can modify the effect of nifedipine are:

• rifampicin(an antibiotic); never take Adalat Crono together with medicinescontaining rifampicin(see “Do not take Adalat Crono”).
• certain antibiotics belonging to the class of macrolides, such as erythromycin;
• certain medicines against AIDS, such as ritonavir, amprenavir, indinavir, nelfinavir orsaquinavir;
• certain medicines against fungal infections, such as ketoconazole, itraconazole orfluconazole;
• fluoxetine, nefazodone(medicines against depression);
• quinupristin/dalfopristin(antibiotic used for particular infections);
• phenytoin,carbamazepine, phenobarbital,valproic acid(medicines against seizures);
• cimetidine, cisapride(medicines used in stomach ulcers).

Nifedipine can modify the effect of the following medicines:

• nifedipine can accentuate the blood pressure lowering effect of other medicines that lower blood pressure.In particular, if you take beta-blockers in association, your doctor will need to monitor you carefully, as it can also worsen the heart's ability to pump blood.
• digoxin, quinidine(medicines for the heart).
• tacrolimus(medicine used against transplant rejection).

Medicines that contain the following substances do not appear to modify the
concentration of nifedipine in the blood and/or their metabolism is not affected by
nifedipine: ajmaline(medicine against arrhythmias), acetylsalicylic acidat a dose of 100 mg
(medicine against flu symptoms or to thin the blood), benazepril, doxazosin,
cilexetil candesartan, irbesartan, debrisochine, talinolol(medicines against high blood pressure), omeprazole, pantoprazole, ranitidine(medicines against heartburn), orlistat
(weight loss medicine), rosiglitazone(medicine against diabetes), triamterene-
hydrochlorothiazide(diuretic).

Adalat Crono with food and drink
Do not drink grapefruit juiceduring treatment with Adalat Crono, as it can
increase the concentration of nifedipine in the blood and prolong its effect. If you drink
grapefruit juice regularly, this effect can last for more than 3 days from
discontinuation.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Do not take Adalat Crono if you are in the first 20 weeks of pregnancy or if you are breastfeeding
(see “Do not take Adalat”).
Nifedipine should not be used during pregnancy unless the patient's clinical conditions
require treatment with nifedipine. The use of nifedipine should be reserved for women suffering from severe hypertension who have not responded to
treatment with standard therapy (see “Warnings and precautions”).
The use of nifedipine during breastfeeding is not recommended because it has been reported to
pass into breast milk and the effects of oral absorption of small amounts of nifedipine
are unknown.

Driving and operating machinery
Adalat Crono can cause dizziness or lightheadedness, especially at the beginning of
treatment or in association with alcoholic beverages. If this happens to you, do not drive
vehicles or operate machinery.

Adalat Crono contains sodium
This medicine contains sodium (the major component of table salt) in the following
quantities: 8.3 mg (20 mg tablets), 9.4 mg (30 mg tablets) or 18.8 mg (tablets
60 mg) per tablet
With the maximum daily dose of 120 mg, up to 37.6 mg per day can be taken
of sodium. This corresponds to 1.88% of the recommended daily intake of sodium
by the WHO for an adult.

3. How to take Adalat Crono

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one 30 mg coated tablet once a day, in the morning.
The safety and efficacy of Adalat Crono in children under 18 years of age has not been demonstrated.
The dose, at the doctor's discretion, may be gradually increased up to a maximum of
60 mg (one 60 mg coated tablet) in arterial hypertension or 120 mg (two
60 mg coated tablets) in angina pectoris, taking the medicine once a
day, in the morning. Your doctor may start treatment with a
20 mg tablet a day, or prescribe intermediate doses of 40 mg (20 + 20) or 50 mg
(20 + 30).
Adalat Crono is for oral use. Swallow the tablet whole with some liquid. Do
not chew and do not break the tablets. You can take Adalat Crono with or without food. Remove
the tablets from the blister only at the time of taking them.
In the Adalat Crono tablet, the medicine is contained within a non-
absorbable shell, which slowly releases the substance to be absorbed. Once the process is completed,

the empty tablet is eliminated and may be noticed in the stool.
Your doctor will determine how long you should continue treatment with Adalat Crono.

Use in elderly patients
If you are an elderly patient, a lower dosage may be necessary compared to younger
patients.

Use in patients with hepatic impairment
If your liver is not functioning properly, careful monitoring of
blood pressure may be necessary and, in severe cases, a reduction in dosage.

If you take more Adalat Cronothan you should
It is important to adhere to the dose indicated by your doctor. If you have accidentally
taken too many tablets, do not hesitate: ask your doctor what to do or contact the emergency room
of the nearest hospital.

If you forget to take Adalat Crono
If you forget to take the medicine, take it as soon as you remember on the same day. If you
happen to miss a day, take the normal dose the next day. Do not take a
double dose to make up for a missed dose.
If you are not sure what to do, consult your doctor or pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
During nifedipine trials, the following side effects have been observed:

Common side effects(may affect up to 1 in 10 people)

• headache,
• edema, including peripheral edema (general swelling or swelling of the extremities),
• vasodilation (widening of blood vessels),
• constipation,
• feeling unwell.

Uncommon side effects(may affect up to 1 in 100 people)

• allergic reaction,
• allergic edema/angioedema (swelling of the skin, face and mucous membranes, including laryngeal edema, potentially life-threatening),
• anxious reactions,
• sleep disorders,
• dizziness,
• migraine (unilateral headache),
• giddiness,
• tremor,
• visual disturbances,
• tachycardia (fast heartbeat),
• palpitations (feeling of a fast or irregular heartbeat),
• hypotension (low blood pressure),
• syncope (fainting),
• epistaxis (nosebleed),
• nasal congestion (stuffy nose),
• gastrointestinal and abdominal pain (stomach ache),
• nausea,
• dyspepsia (indigestion),
• flatulence (presence of gas in the intestine),
• dry mouth,
• transient increase in liver enzymes,
• erythema (redness of the skin),
• muscle cramps,
• joint swelling,
• polyuria (increased urine output),
• dysuria (difficulty urinating),
• erectile dysfunction (difficulty achieving and maintaining an erection),
• nonspecific pain,
• chills.

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

• pruritus (itching),
• urticaria (itching and small spots on the skin),
• skin rash,
• paresthesia/dysesthesia (altered sensitivity, e.g. tingling),
• gingival hyperplasia (gum enlargement).

Side effects with unknown frequency(frequency cannot be estimated on the basis of
available data)

• agranulocytosis (lack of certain blood cells called granulocytes),
• leukopenia (decreased number of white blood cells in the blood),
• anaphylactic/anaphylactoid reaction (severe allergic or allergic-type reaction),
• hyperglycemia (increased blood sugar level),
• hypoesthesia (decreased sensitivity),
• somnolence,
• eye pain (pain in the eyes),
• chest pain (angina pectoris),
• dyspnea (difficulty breathing, shortness of breath),
• bezoars (formation of bulky masses in the stomach),
• dysphagia (difficulty swallowing),
• intestinal obstruction (blockage of intestinal contents),
• intestinal ulcer,
• vomiting,
• gastroesophageal sphincter insufficiency (regurgitation),
• jaundice (yellowing of the skin and whites of the eyes),
• toxic epidermal necrolysis (severe skin disease),
• photoallergic reaction (skin reaction following exposure to sunlight),
• palpable purpura (a particular type of skin rash),
• arthralgia (joint pain),
• myalgia (muscle pain),
• difficulty breathing.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps to
provide more information on the safety of this medicine.

5. How to store Adalat Crono

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging
after “Exp”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in the 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 Adalat Crono contains

• The active ingredient is nifedipine. Each modified-release tablet contains: Adalat Crono 20 mg modified-release tablets 20 mg of nifedipine Adalat Crono 30 mg modified-release tablets 30 mg of nifedipine 60 mg of nifedipine Adalat Crono 60 mg modified-release tablets
• The other ingredients are:

Tablet core: polyethylene oxide, hypromellose, magnesium stearate, sodium chloride,
red iron oxide (E172).
Coating: hypromellose, red iron oxide (E172), cellulose acetate, macrogols,
hydroxypropylcellulose, titanium dioxide, propylene glycol.

Description of the appearance of Adalat Crono and contents of the pack
Adalat Crono is presented as round, pink film-coated tablets, marked
on one side with “ADALAT 20”, “ADALAT 30” or “ADALAT 60”.
Each pack contains 14 tablets in a calendar blister pack.

Marketing Authorisation Holder:
Bayer S.p.A. Viale Certosa 130 – Milan

Manufacturer:
Bayer HealthCare Manufacturing S.r.l. - via delle Groane 126, Garbagnate Milanese (MI)
Bayer AG - Leverkusen - Germany