OXYCARDIL 120 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Oxycardi 120, 120 mg, prolonged-release 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 120 and what is it used for
4. Important information before taking Oxycardil 120
   1. When not to take Oxycardil 120
   2. Warnings and precautions
   3. Taking Oxycardil 120 with food and drink
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Oxycardil 120 and other medicines
5. How to take Oxycardil 120
   1. Taking Oxycardil 120 in children
   2. Taking Oxycardil 120 in patients with renal and/or hepatic impairment
   3. Taking Oxycardil 120 in elderly patients
   4. Taking a higher than recommended dose of Oxycardil 120
   5. Missing a dose of Oxycardil 120
   6. Duration of treatment
   7. Stopping treatment with Oxycardil 120
6. Possible side effects
   1. Reporting side effects
7. How to store Oxycardil 120
8. Contents of the packaging and other information
   1. What Oxycardil 120 contains
   2. What the packaging of Oxycardil 120 contains
   3. Marketing authorisation holder and manufacturer

Leaflet attached to the packaging: patient information

Oxycardi 120, 120 mg, prolonged-release 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 120 and what is it used for
• 2. Important information before taking Oxycardil 120
• 3. How to take Oxycardil 120
• 4. Possible side effects
• 5. How to store Oxycardil 120
• 6. Contents of the packaging and other information

1. What is Oxycardil 120 and what is it used for

Oxycardil 120 is a medicine containing 120 mg of diltiazem hydrochloride. Oxycardil 120 belongs to a group of medicines called calcium antagonists. These medicines act on the smooth muscles of blood vessels and have a strong effect on the heart muscle. Oxycardil 120 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 120

When not to take Oxycardil 120

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6), and in patients with:
• 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 diseases,
• concomitant administration of a medicine containing lomitapide, used to treat high cholesterol levels (see section: "Oxycardil 120 and other medicines").

Warnings and precautions

Before starting treatment with Oxycardil 120, 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 120, as it may enhance the effects of anaesthetics on the heart muscle, as well as the vasodilating effect of anaesthetics,
• in elderly patients and patients with renal or hepatic impairment, it is possible to increase the concentration of diltiazem in the blood, so 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 120 inhibits gastrointestinal motility,
• if the patient has a history of heart failure, new symptoms of shortness of breath, slow heart rate or low blood pressure have occurred. Because cases of kidney damage have been reported in patients with these conditions, the doctor may recommend monitoring kidney function.

Taking Oxycardil 120 may be associated with mood changes, including depression.

Taking Oxycardil 120 with food and drink

Tablets should be taken without chewing, before meals, washed down 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. The use of Oxycardil 120 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 120 in breastfeeding women, an alternative method of feeding the child should be used.

Driving and using machines

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

Oxycardil 120 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Oxycardil 120 may enhance the effects of other medicines taken at the same time. The doctor should be informed if the patient is taking the following medicines:

• lithium - concomitant use with Oxycardil 120 may increase the risk of lithium neurotoxicity;
• nitrates - concomitant use with Oxycardil 120 may increase the hypotensive effect and the risk of fainting (vasodilating effect);
• theophylline - concomitant use with Oxycardil 120 may increase theophylline levels in the blood;
• alpha-adrenergic receptor blockers - concomitant use with Oxycardil 120 may cause or worsen hypotension, so the use of this combination can only be considered under close blood pressure monitoring;
• amiodarone, digoxin - concomitant use with Oxycardil 120 may increase the risk of bradycardia, so caution should be exercised, especially in elderly patients and when using high doses;
• beta-adrenergic receptor blockers - concomitant use with Oxycardil 120 may cause cardiac rhythm disturbances (marked bradycardia, sinoatrial block), conduction disturbances and heart failure;
• other antiarrhythmic medicines - concomitant use with Oxycardil 120 may increase the risk of adverse cardiac effects;
• carbamazepine - concomitant use with Oxycardil 120 may increase carbamazepine levels in the blood;
• rifampicin - concomitant use with Oxycardil 120 may increase the risk of decreased diltiazem levels in the blood;
• cimetidine, ranitidine - concomitant use with Oxycardil 120 may increase diltiazem levels in the blood;
• cyclosporin - concomitant use with Oxycardil 120 may increase cyclosporin levels in the blood, so it is recommended to reduce the cyclosporin dose, monitor kidney function, control cyclosporin levels in the blood and adjust the dose;
• colchicine - concomitant use with Oxycardil 120 may increase colchicine levels in the blood;
• 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 120 contains lactose and sucrose; if the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Oxycardil 120 contains hydrogenated castor oil: the medicine may cause gastrointestinal disorders and diarrhoea.

3. How to take Oxycardil 120

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
The following dosage schedule is recommended for adults.
Ischaemic heart disease
In ischaemic heart disease, 180-360 mg of diltiazem hydrochloride is usually taken per day in 1 or 2 divided doses. The maximum recommended daily dose is 360 mg. In case of long-term treatment with a satisfactory clinical effect, it is recommended to check every 2-3 months whether it is possible to reduce the dose of the medicine.
Hypertension
Depending on the individual patient's condition, 120-360 mg of diltiazem hydrochloride is usually taken per day in 1 or 2 divided doses. The maximum recommended daily dose is 360 mg. In case of achieving a satisfactory antihypertensive effect, it is worth considering the possibility of reducing the dose of the medicine.

Taking Oxycardil 120 in children

The safety and efficacy of Oxycardil 120 in children have not been established.

Taking Oxycardil 120 in patients with renal and/or hepatic impairment

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

Taking Oxycardil 120 in elderly patients

In elderly patients, the medicine may only be used with caution, especially when increasing the dose. Treatment should be started with a dose of 60 mg (in the form of coated tablets, 2-3 times a day).

Taking a higher than recommended dose of Oxycardil 120

Overdose of Oxycardil 120 may lead to severe hypotension (including shock), bradycardia, heart failure, atrioventricular block, or worsening of kidney function.
In case of taking a higher than recommended dose of Oxycardil 120, the patient should immediately consult their doctor. Depending on the symptoms, the doctor will administer appropriate treatment.

Missing a dose of Oxycardil 120

In case the patient forgets to take Oxycardil 120, 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 120 is used for long-term treatment. Stopping treatment or changing the dosage of the medicine should only be done under medical supervision.

Stopping treatment with Oxycardil 120

If treatment with Oxycardil 120 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 120 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, vomiting
Uncommon: 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 solar dermatitis), angioedema, 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 120

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 120 contains

• The active substance of the medicine is diltiazem hydrochloride. Each tablet contains 120 mg of diltiazem hydrochloride in the form of immediate release.
• 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 120 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