OXYCARDIL 60 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Oxycardil 60, 60 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Oxycardil 60 and what is it used for
4. Important information before taking Oxycardil 60
   1. When not to take Oxycardil 60
   2. Warnings and precautions
   3. Taking Oxycardil 60 with food and drink
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
   6. Oxycardil 60 and other medicines
5. How to take Oxycardil 60
   1. Taking Oxycardil 60 in children
   2. Taking Oxycardil 60 in patients with renal and/or hepatic impairment
   3. Taking Oxycardil 60 in elderly patients
   4. Taking a higher dose of Oxycardil 60 than recommended
   5. Missing a dose of Oxycardil 60
   6. Duration of treatment
   7. Stopping treatment with Oxycardil 60
6. Possible side effects
   1. Reporting side effects
7. How to store Oxycardil 60
8. Contents of the packaging and other information
   1. What Oxycardil 60 contains
   2. What the packaging of Oxycardil 60 contains
   3. Marketing authorisation holder and manufacturer

Leaflet attached to the packaging: patient information

Oxycardil 60, 60 mg, film-coated tablets

Diltiazem hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Oxycardil 60 and what is it used for
• 2. Important information before taking Oxycardil 60
• 3. How to take Oxycardil 60
• 4. Possible side effects
• 5. How to store Oxycardil 60
• 6. Contents of the packaging and other information

1. What is Oxycardil 60 and what is it used for

Oxycardil 60 belongs to a group of medicines called calcium antagonists. These medicines act on smooth muscle of blood vessels and have a strong effect on the heart muscle. Oxycardil 60 is indicated for the treatment of:

• ischaemic heart disease in the form of:
• stable angina pectoris
• unstable angina pectoris
• vasospastic angina pectoris (Prinzmetal's variant)
• hypertension.

2. Important information before taking Oxycardil 60

When not to take Oxycardil 60

• sick sinus syndrome in patients without a pacemaker,
• second or third degree atrioventricular block in patients without a pacemaker,
• severe bradycardia (less than 40 heartbeats per minute),
• left ventricular heart failure with pulmonary congestion,
• concomitant intravenous administration of dantrolene,
• concomitant administration of ivabradine, used to treat certain heart conditions
• concomitant administration of a medicine containing lomitapide, used to treat high cholesterol levels (see section: "Oxycardil 60 and other medicines").

Warnings and precautions

Before starting treatment with Oxycardil 60, the patient should discuss it with their doctor or pharmacist,

• in case of left ventricular dysfunction, bradycardia or first degree atrioventricular block, caution should be exercised,
• in case of general anaesthesia, the doctor should be informed about the use of Oxycardil 60, as it may enhance the effects of anaesthetics on the heart, as well as their vasodilatory effects,
• in elderly patients and patients with renal or hepatic impairment, it is possible to increase the concentration of diltiazem in the blood, therefore patients should remain under close medical supervision; in particular, heart rate should be monitored frequently,
• in patients with a risk of intestinal obstruction, caution should be exercised, as Oxycardil 60 inhibits gastrointestinal motility,

Taking Oxycardil 60 may be associated with mood changes, including depression.

Taking Oxycardil 60 with food and drink

Tablets should be taken without chewing, before meals, with a sufficient amount of liquid (e.g. one glass of water).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before taking this medicine.
Taking Oxycardil 60 is contraindicated during pregnancy, as well as in women of childbearing age who do not use effective contraception methods. In case of necessity to use Oxycardil 60 in breastfeeding women, an alternative method of feeding the child should be used.

Driving and operating machinery

Based on the collected adverse reactions, i.e. dizziness (frequent), malaise (frequent), the ability to drive vehicles and operate machinery may be impaired, however, no studies have been conducted in this direction.

Oxycardil 60 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as medicines they plan to take.
Oxycardil 60 may enhance the effects of other medicines taken at the same time.
The patient should inform their doctor if they are taking the following medicines:

• lithium - concomitant use with Oxycardil 60 may increase the risk of lithium neurotoxicity;
• nitrates - concomitant use with Oxycardil 60 may increase the hypotensive effect and the risk of fainting (vasodilatory effect);
• theophylline - concomitant use with Oxycardil 60 may increase theophylline blood levels;
• alpha-adrenergic receptor blockers - concomitant use with Oxycardil 60 may cause or worsen hypotension, therefore the use of this combination can be considered only under close blood pressure monitoring;
• amiodarone, digoxin - concomitant use with Oxycardil 60 may increase the risk of bradycardia, therefore caution should be exercised, especially in elderly patients and when using high doses;
• beta-adrenergic receptor blockers - concomitant use with Oxycardil 60 may cause cardiac rhythm disturbances (marked bradycardia, sinoatrial block), atrioventricular conduction disturbances and heart failure;
• other antiarrhythmic medicines - concomitant use with Oxycardil 60 may increase the risk of additional adverse cardiac effects;
• carbamazepine - concomitant use with Oxycardil 60 may increase carbamazepine blood levels;
• rifampicin - concomitant use with Oxycardil 60 may increase the risk of decreased diltiazem blood levels;
• cimetidine, ranitidine - concomitant use with Oxycardil 60 may increase diltiazem blood levels;
• cyclosporin - concomitant use with Oxycardil 60 may increase cyclosporin blood levels, therefore in case of combined treatment, it is recommended to reduce the cyclosporin dose, monitor kidney function, control cyclosporin blood levels and adjust the dose;
• colchicine - concomitant use with Oxycardil 60 may increase colchicine blood levels;
• immunosuppressants (sirolimus, temsirolimus, everolimus),
• medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide levels, which may lead to an increased risk and severity of liver-related adverse reactions.

Oxycardil 60 contains lactose and sucrose; if the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Oxycardil 60 contains hydrogenated castor oil: the medicine may cause gastrointestinal disorders and diarrhoea.

3. How to take Oxycardil 60

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.
The following dosing schedule is recommended for adults.
Ischaemic heart disease
Three times a day, 1 tablet of Oxycardil 60 (corresponding to 180 mg of diltiazem hydrochloride per day). If necessary, the dose of the medicine may be increased to 360 mg of diltiazem hydrochloride per day. In case of long-term treatment with a satisfactory clinical effect, every 2-3 months the doctor may check if it is possible to reduce the dose of the medicine.
Hypertension
Three times a day, 1 tablet of Oxycardil 60 (corresponding to 180 mg of diltiazem hydrochloride per day). If necessary, the dose of the medicine may be increased to a maximum of 360 mg of diltiazem hydrochloride per day. In case of a satisfactory antihypertensive effect, the doctor may consider reducing the dose of the medicine.

Taking Oxycardil 60 in children

The safety and efficacy of Oxycardil 60 in children have not been established.

Taking Oxycardil 60 in patients with renal and/or hepatic impairment

In patients with hepatic and renal impairment, the medicine may be used with caution, especially when increasing the dose. Liver and kidney function should be regularly assessed.

Taking Oxycardil 60 in elderly patients

In elderly patients, the medicine may be used with caution, especially when increasing the dose. Treatment should start with a dose of 60 mg (see section 3: How to take Oxycardil 60).

Taking a higher dose of Oxycardil 60 than recommended

Overdose of Oxycardil 60 may lead to severe hypotension (including shock), bradycardia, heart failure, atrioventricular block or worsening of kidney function.
In case of taking a higher dose of Oxycardil 60 than recommended, the patient should immediately contact their doctor. Depending on the symptoms, the doctor will administer appropriate treatment.

Missing a dose of Oxycardil 60

In case the patient forgets to take Oxycardil 60, they should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should take the next dose at the scheduled time. A double dose should not be taken to make up for a missed dose.

Duration of treatment

Oxycardil 60 is used for long-term treatment. Stopping treatment or changing the dose of the medicine should only be done under medical supervision.

Stopping treatment with Oxycardil 60

If treatment with Oxycardil 60 is to be stopped, the medicine should be discontinued gradually, reducing the subsequent doses, especially in patients with ischaemic heart disease.

4. Possible side effects

Like all medicines, Oxycardil 60 can cause side effects, although not everybody gets them.
The frequency of side effects is presented in accordance with the MedDRA convention: very common (≥1/10); common (≥1/100 to <1>Blood and lymphatic system disorders:
Not known: thrombocytopenia
Psychiatric disorders:
Uncommon: nervousness, insomnia
Not known: mood changes (including depression)
Nervous system disorders:
Common: headache, dizziness
Not known: extrapyramidal symptoms, myoclonus (muscle twitching)
Cardiac disorders:
Common: atrioventricular block (first, second or third degree, possible bundle branch block), palpitations
Uncommon: bradycardia (reduced heart rate)
Not known: sinoatrial block, congestive heart failure
Vascular disorders:
Common: flushing, especially of the face
Uncommon: orthostatic hypotension
Not known: vasculitis (including leukocytoclastic vasculitis)
Gastrointestinal disorders:
Common: constipation, nausea, abdominal pain, dyspepsia
Uncommon: vomiting, diarrhoea
Rare: dryness of the oral mucosa
Not known: gingival hyperplasia
Hepatobiliary disorders:
Uncommon: increased liver enzyme activity (ASAT, ALAT, LDH, alkaline phosphatase)
Not known: hepatitis
Skin and subcutaneous tissue disorders:
Common: rash
Rare: urticaria
Not known: photosensitivity (including lichenoid keratosis of sun-exposed skin), angioedema, rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, rare erythema multiforme with or without fever, a condition in which the immune system attacks the body's own tissues, causing symptoms such as joint swelling, fatigue and rash (known as "lupus-like syndrome").
Reproductive system and breast disorders:
Not known: gynaecomastia
General disorders and administration site conditions:
Very common: peripheral oedema
Common: malaise

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Oxycardil 60

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Oxycardil 60 contains

• The active substance of the medicine is diltiazem hydrochloride. Each film-coated tablet contains 60 mg of diltiazem hydrochloride.
• The other ingredients are: lactose monohydrate, polyacrylate dispersion 30%, hydrogenated castor oil, aluminium hydroxide, talc, magnesium stearate. The ingredients of the coating are: hypromellose, sucrose, glycerol 85%, titanium dioxide, magnesium stearate, polysorbate 80.

What the packaging of Oxycardil 60 contains

The packaging contains 30, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Tel.: + 48 22 696 99 20
Manufacturer:
Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Date of last revision of the leaflet:April 2023