Oxycardil 60

Patient Information Leaflet

Oxycardil 60, 60 mg, coated tablets
Diltiazemi hydrochloridum
Please read the entire leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist.

Table of contents:

1. What Oxycardil 60 is and what it is 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 pack and other information

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

Oxycardil 60 belongs to a group of medicines called calcium antagonists. These medicines act on vascular smooth muscles and also have a significant effect on cardiac muscle. Oxycardil 60 is indicated for the treatment of:

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

2. Important information before using Oxycardil 60

When not to use Oxycardil 60

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6), and in patients:
• with sick sinus syndrome without an implanted pacemaker,
• with second- or third-degree atrioventricular block without an implanted pacemaker,
• with severe bradycardia (less than 40 heartbeats per minute),
• with left ventricular heart failure with pulmonary congestion,
• receiving intravenous dantrolene,
• receiving concomitant ivabradine, used in the treatment of certain heart diseases,
• receiving concomitant medication containing lomitapide, used in the treatment of high cholesterol levels (see section: "Oxycardil 60 and other medicines").

Warnings and precautions
Before starting treatment with Oxycardil 60, discuss this with your doctor or pharmacist:

• exercise caution in case of left ventricular dysfunction, bradycardia, or first-degree atrioventricular block,
• if general anesthesia is required, inform the anesthesiologist about the use of Oxycardil 60, as it may enhance disturbances in myocardial contractility, conduction, and automaticity, as well as the vasodilatory effects of anesthetic drugs,
• in elderly patients and in patients with renal or hepatic impairment, increased plasma concentrations of diltiazem may occur; therefore, patients should remain under close medical supervision, particularly regarding heart rate monitoring,
• exercise caution in patients at risk of intestinal obstruction, as Oxycardil 60 inhibits gastrointestinal motility,
• if the patient has a history of heart failure and develops new symptoms such as dyspnea, slowed heartbeat, or low blood pressure. Since cases of kidney injury have been reported in patients with such conditions, the doctor may recommend monitoring of kidney function.

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

Taking Oxycardil 60 with food and drink
Tablets should be taken whole, without chewing, before meals, with sufficient fluid
(e.g. one glass of water).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
The use of Oxycardil 60 is contraindicated during pregnancy and in women of childbearing potential who are not using effective contraceptive methods. If it is necessary to use Oxycardil 60 during breastfeeding, alternative feeding methods for the infant should be used.

Driving and operating machinery
Based on reported adverse effects such as dizziness (frequent), malaise (frequent), the ability to drive motor vehicles and operate machinery may be impaired, although no specific studies have been conducted in this regard.

Oxycardil 60 and other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines you plan to use.
Oxycardil 60 may enhance the effects of other medicines taken simultaneously.
Inform your doctor if you are taking any of the following medicines:

• lithium – concomitant use with Oxycardil 60 may increase the risk of lithium's neurotoxic effects;
• nitrates – concomitant use with Oxycardil 60 may enhance hypotensive effects and increase 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 and alpha-adrenergic receptor antagonists may cause or worsen hypotension; therefore, this combination should be considered only under strict monitoring of arterial pressure;
• amiodarone, digoxin – concomitant use with Oxycardil 60 may increase the risk of bradycardia; therefore, caution is advised during treatment, especially in elderly patients and when high doses are used;
• beta-adrenergic receptor blockers – concomitant use with Oxycardil 60 may cause cardiac rhythm disturbances (marked bradycardia, sinus block), disturbances in sinoatrial and atrioventricular conduction, and heart failure;
• other antiarrhythmic drugs – concomitant use with Oxycardil 60 may increase the risk of additional cardiac adverse effects;
• carbamazepine – concomitant use with Oxycardil 60 may increase carbamazepine blood levels;
• rifampicin – concomitant use with Oxycardil 60 may reduce diltiazem plasma concentrations;
• cimetidine, ranitidine – concomitant use with Oxycardil 60 may increase diltiazem plasma concentrations;
• cyclosporine – concomitant use with Oxycardil 60 may increase cyclosporine blood levels; therefore, in combined therapy, it is recommended to reduce the cyclosporine dose, monitor kidney function, control cyclosporine blood levels, and adjust the dose accordingly;
• colchicine – concomitant use with Oxycardil 60 may increase colchicine blood levels;
• immunosuppressive drugs (sirolimus, temsirolimus, everolimus),
• medications containing lomitapide used in the treatment of high cholesterol levels. Diltiazem may increase lomitapide concentration, which may lead to an increased likelihood and severity of liver-related adverse effects.

Oxycardil 60 contains lactose and sucrose: if the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Oxycardil 60 contains hydrogenated castor oil: this medicine may cause indigestion and diarrhea.

3. How to use Oxycardil 60

This medicine should always be used as directed by the physician. If in doubt, consult your doctor.
The following dosing regimen is recommended for adults.
Ischaemic heart disease
Three times daily, 1 tablet of Oxycardil 60 (corresponding to 180 mg of diltiazem hydrochloride per day). If necessary, the dose may be increased to a maximum of 360 mg of diltiazem hydrochloride per day. During long-term treatment with satisfactory clinical effect, the doctor may check every 2–3 months whether dose reduction is possible.
Arterial hypertension
Three times daily, 1 tablet of Oxycardil 60 (corresponding to 180 mg of diltiazem hydrochloride per day). If necessary, the dose may be increased to a maximum of 360 mg of diltiazem hydrochloride per day. If a satisfactory antihypertensive effect is achieved, the doctor may consider reducing the dose.
Use of Oxycardil 60 in children
The safety and efficacy of this medicine in children have not been established.
Use of Oxycardil 60 in patients with impaired renal and/or hepatic function
In patients with impaired liver or kidney function, this medicine should be used with special caution, especially when increasing the dose. Liver and kidney function should be regularly monitored.
Use of Oxycardil 60 in elderly patients
In elderly patients, this medicine should be used with special caution, especially when increasing the dose. Treatment should be initiated at a dose of 60 mg (see section 3: How to use Oxycardil 60).
Use of a higher than recommended dose of Oxycardil 60
Overdose of Oxycardil 60 may lead to severe hypotension (low blood pressure), including shock, bradycardia (reduced heart rate), heart failure, atrioventricular block, or worsening of renal function.
If a higher than recommended dose of Oxycardil 60 has been taken, contact a doctor immediately. Depending on the symptoms present, the doctor will initiate appropriate treatment.
Missed dose of Oxycardil 60
If a patient forgets to take a dose of Oxycardil 60, it should be taken as soon as possible, unless it is almost time for the next dose. In that case, the next dose should be taken 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. Discontinuation or change in dosing should only be done under medical supervision.
Discontinuation of Oxycardil 60
If treatment with Oxycardil 60 is to be stopped, the medicine should be withdrawn gradually by reducing successive doses, especially in patients with ischaemic heart disease.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is presented according to the MedDRA convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (frequency cannot be estimated based on available data).

Blood and lymphatic system disorders:
Unknown: thrombocytopenia

Psychiatric disorders:
Uncommon: nervousness, insomnia
Unknown: mood changes (including depression)

Nervous system disorders:
Common: headache, dizziness
Unknown: extrapyramidal symptoms, myoclonus (muscle jerks)

Cardiac disorders:
Common: atrioventricular block (first-, second- or third-degree, including bundle branch block), palpitations
Uncommon: bradycardia (reduced heart rate)
Unknown: sinoatrial block, congestive heart failure

Vascular disorders:
Common: sudden flushing, especially of the face
Uncommon: orthostatic hypotension
Unknown: vasculitis (including leukocytoclastic vasculitis)

Gastrointestinal disorders:
Common: constipation, dyspepsia, stomach pain, nausea
Uncommon: vomiting, diarrhoea
Rare: dryness of the oral mucosa
Unknown: gingival hyperplasia

Hepatobiliary disorders:
Uncommon: increased liver enzyme activity (AspAT, AlAT, LDH, alkaline phosphatase)
Unknown: hepatitis

Skin and subcutaneous tissue disorders:
Common: rash
Rare: urticaria
Unknown: photosensitivity (including actinic lichenoid keratosis), angioedema, rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, rare desquamative erythema with or without fever, a condition in which the immune system attacks normal tissues, causing symptoms such as joint swelling, fatigue and rash (called "lupus-like syndrome").

Reproductive system and breast disorders:
Unknown: gynaecomastia

General disorders and administration site conditions:
Very common: peripheral oedema
Common: malaise

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Oxycardil 60

Store below 25ºC.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What Oxycardil 60 contains

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

What the packaging of Oxycardil 60 contains
The package 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.
Kruczkowskiego Street 8
00-380 Warsaw
Tel.: +48 22 696 99 20
Manufacturer:
Orifarm Manufacturing Poland Sp. z o.o.
Księstwa Łowickiego Street 12
99-420 Łyszkowice