Oxycardil 120

Package leaflet: Information for the patient

Oxycardil 120, 120 mg, prolonged-release tablets
Diltiazemi hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Leaflet contents:

1. What Oxycardil 120 is and what it is 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 pack and other information

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

Oxycardil 120 is a medicine containing diltiazem hydrochloride in a dose of 120 mg. Oxycardil 120
belongs to a group of medicines called calcium antagonists. These medicines act on smooth vascular muscles
and also have a strong effect on the heart muscle. Oxycardil 120 is indicated for the treatment of:

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

2. Important information before using Oxycardil 120

When not to use Oxycardil 120

• 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 ivabradine, used in the treatment of certain heart diseases,
• receiving a medicine containing lomitapide, used in the treatment of high cholesterol levels (see section: "Oxycardil 120 with other medicines").

Warnings and precautions
Before starting treatment with Oxycardil 120, discuss this with your doctor or pharmacist,

• caution is required in patients with impaired left ventricular function, bradycardia, or first-degree atrioventricular block,
• if general anaesthesia is required, inform the doctor about taking Oxycardil 120, as it may enhance disturbances in myocardial contractility, conduction, and automaticity, as well as the vasodilatory effects of anaesthetic 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, with particular attention paid to monitoring heart rate,
• caution is required in patients at risk of intestinal obstruction, as Oxycardil 120 inhibits gastrointestinal motility,
• if the patient has a history of heart failure and develops new symptoms of dyspnoea, slowed heartbeat, or low blood pressure. Since cases of kidney damage have been reported in patients with such conditions, the doctor may recommend monitoring of kidney function.

Treatment with Oxycardil 120 may be associated with mood changes, including depression.
Taking Oxycardil 120 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 or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor before using this medicine.
The use of Oxycardil 120 is contraindicated during pregnancy, as well as in women of reproductive age who are not using effective contraceptive methods. If it is necessary to use Oxycardil 120 during breastfeeding, an alternative method of infant feeding 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 120 with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Oxycardil 120 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 120 may increase the risk of lithium's neurotoxic effects;
• nitrates – concomitant use with Oxycardil 120 may enhance hypotensive effects and increase the risk of fainting (vasodilatory effect);
• theophylline – concomitant use with Oxycardil 120 may increase theophylline blood levels;
• alpha-adrenergic receptor blockers – concomitant use with Oxycardil 120 and alpha-adrenergic receptor antagonists may induce or worsen hypotension; therefore, this combination should only be considered under strict monitoring of arterial pressure;
• amiodarone, digoxin – concomitant use with Oxycardil 120 may increase the risk of bradycardia; therefore, caution is required during treatment, especially in elderly patients and when high doses are used;
• beta-adrenergic receptor blocking agents – concomitant use with Oxycardil 120 may cause cardiac rhythm disturbances (marked bradycardia, sinus arrest), disturbances in sinoatrial and atrioventricular conduction, and heart failure;
• other antiarrhythmic drugs – concomitant use with Oxycardil 120 may increase the risk of additional cardiac adverse effects;
• carbamazepine – concomitant use with Oxycardil 120 may increase carbamazepine blood levels;
• rifampicin – concomitant use with Oxycardil 120 may reduce diltiazem plasma concentrations;
• cimetidine, ranitidine – concomitant use with Oxycardil 120 may increase diltiazem plasma concentrations;
• cyclosporine – concomitant use with Oxycardil 120 may increase cyclosporine blood levels; therefore, in combined treatment, 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 120 may increase colchicine blood levels;
• immunosuppressive drugs (sirolimus, temsirolimus, everolimus),
• medicines containing lomitapide used in the treatment of high cholesterol levels. Diltiazem may increase lomitapide concentrations, which may lead to an increased likelihood and severity of liver-related adverse effects.

Oxycardil 120 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 120 contains hydrogenated castor oil: the medicine may cause indigestion and diarrhoea.

3. How to use Oxycardil 120

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor.
The following dosage regimen is recommended for adults.
Ischaemic heart disease
For ischaemic heart disease, the usual dose is 180–360 mg of diltiazem hydrochloride per day, given in 1 or 2 divided doses. The maximum recommended daily dose is 360 mg. During long-term treatment with satisfactory clinical effect, it is recommended to check every 2–3 months whether dose reduction is possible.
Hypertension
Depending on the individual patient's condition, the usual dose is 120–360 mg of diltiazem hydrochloride per day, given in 1 or 2 divided doses. The maximum recommended daily dose is 360 mg. Once a satisfactory antihypertensive effect has been achieved, consideration should be given to the possibility of reducing the dose.
Use of Oxycardil 120 in children
The safety and efficacy of this medicine in children have not been established.
Use of Oxycardil 120 in patients with renal and/or hepatic impairment
In patients with impaired liver and/or kidney function, the medicine should be used with special caution, especially when increasing the dose. Liver and kidney function should be monitored regularly.
Use of Oxycardil 120 in elderly patients
In elderly patients, the medicine should be used with special caution, especially when increasing the dose. Treatment should be initiated at a dose of 60 mg (in the form of coated tablets administered 2–3 times daily).
Use of a higher than recommended dose of Oxycardil 120
Overdose of Oxycardil 120 may lead to severe hypotension (arterial hypotension), including shock, bradycardia (reduced heart rate), heart failure, atrioventricular block, or worsening of renal function.
In case of ingestion of a higher than recommended dose of Oxycardil 120, contact a physician immediately. Depending on the symptoms present, the physician will initiate appropriate treatment.
Missed dose of Oxycardil 120
If a patient forgets to take Oxycardil 120, the dose should be taken as soon as possible, unless it is almost time for the next scheduled dose. In that case, the patient should take the next dose at the scheduled time. A double dose must not be taken to make up for the missed dose.
Duration of treatment
Oxycardil 120 is used for long-term treatment. Discontinuation of treatment or changes in dosing must only be carried out under medical supervision.
Discontinuation of Oxycardil 120
If treatment with Oxycardil 120 is to be discontinued, 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 will experience 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); not known (frequency cannot be estimated from available data).

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 jerks)

Cardiac disorders:
Common: atrioventricular block (first-, second- or third-degree, including 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, dyspepsia, stomach pain, nausea
Uncommon: vomiting, diarrhoea
Rare: dryness of the oral mucosa
Not known: gingival hyperplasia

Hepatobiliary disorders:
Uncommon: increased liver enzyme activity (AspAT, AlAT, LDH, alkaline phosphatase)
Not known: hepatitis

Skin and subcutaneous tissue disorders:
Common: erythema
Rare: urticaria
Not known: photosensitivity (including actinic 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 exfoliative erythema with or without fever, a condition in which the immune system attacks normal body tissues, causing symptoms such as joint swelling, fatigue and rash (referred to 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 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 Adverse Drug Reactions, Office for Registration 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. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Oxycardil 120

Store below 25°C.
Keep the medicine out of the 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 stated month.

6. Contents of the pack and other information

What Oxycardil 120 contains

• The active substance is diltiazem hydrochloride. Each tablet contains 120 mg of diltiazem hydrochloride in an immediate-release form.
• The other ingredients are: monohydrate lactose, 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 pack contains
The pack 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 Warszawa
Tel.: + 48 22 696 99 20

Manufacturer:
Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice