Diltiazem Doc Generici

Package leaflet: Information for the patient

DILTIAZEM DOC Generici 60 mg modified release tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DILTIAZEM DOC Generici is and what it is used for

DILTIAZEM DOC Generici contains the active substance diltiazem hydrochloride, which belongs to a group of medicines called calcium channel blockers (calcium antagonists), used to treat high blood pressure.
DILTIAZEM DOC Generici is indicated for the treatment of:

• chest pain (angina pectoris) due to physical exertion, heart attack, or problems with the blood vessels supplying the heart (Prinzmetal's angina);
• mild to moderate high blood pressure.

2. What you need to know before taking DILTIAZEM DOC Generics

Do not take DILTIAZEM DOC Generics

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure below 90 mmHg);
• if you have acute heart attack with lung complications;
• if you have an irregular heartbeat due to certain heart conditions (sinoatrial node syndrome) (atrioventricular block, sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, less than 40 beats per minute);
• if you have severe heart problems possibly associated with lung disorders (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are using medicines such as dantrolene and amiodarone by infusion (see section “Other medicines and DILTIAZEM DOC Generics”);
• if you are already using medicines containing ivabradine for the treatment of certain heart conditions;
• if you are using a medicine containing lomitapide, used to treat high cholesterol levels (see section “Other medicines and DILTIAZEM DOC Generics”);
• if you are pregnant or suspect you might be, if you are breastfeeding, or if you are a woman of childbearing age and are not using contraceptive medication.

Warnings and precautions
Talk to your doctor or pharmacist before taking DILTIAZEM DOC Generics.
Speak with your doctor if you have a history of heart failure, unusual shortness of breath, slow heartbeat, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions; your doctor may need to monitor kidney function.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as reduced left ventricular function, slow heartbeat (bradycardia), or other heart disorders (first-degree atrioventricular block);
• if you are elderly or have kidney or liver problems;
• if you are also taking other medicines that lower blood pressure, as blood pressure could drop excessively (see “Other medicines and DILTIAZEM DOC Generics”);
• if you are at risk of intestinal obstruction, since diltiazem affects intestinal function;
• if you are undergoing surgery, inform the anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with DILTIAZEM DOC Generics.

In some of the cases listed above, you may be prescribed different doses than those normally used.
Your doctor will perform periodic checks of your heart, liver, and kidney function (during and especially at the beginning of treatment), and blood sugar levels if you have diabetes mellitus, as there is a risk of increased blood glucose.
Calcium antagonists, such as diltiazem, may be associated with mood changes, including depression.
The use of DILTIAZEM DOC Generics may cause bronchoconstriction (bronchospasm), including worsening of asthma, particularly in patients who already have breathing difficulties or after dose escalation. During treatment with DILTIAZEM DOC Generics, your doctor will monitor your respiratory function.
Children
This medicine is not recommended for children.
Other medicines and DILTIAZEM DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, do not use this medicine and inform your doctor if you are taking:

• dantrolene (infusion), a medicine used for muscle spasms and for treating a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat heart problems;
• medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could increase the likelihood and severity of liver-related adverse effects;
• antihypertensives, medicines that reduce blood pressure. If you are taking this medicine together with an antihypertensive, your doctor will closely monitor your blood pressure;
• nitrates, medicines that dilate blood vessels. If you are taking this medicine, treatment with nitrates should be initiated only at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, your doctor will closely monitor heart function, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers (see section 4.8);
• heart medicines in general, and particularly cardioactive glycosides (e.g., digoxin). Exercise particular caution, especially if you are elderly or taking high doses of diltiazem;
• medicines used for heart rhythm disorders (antiarrhythmics). In this case, your doctor will closely monitor heart function;
• carbamazepine and phenytoin, medicines used for epilepsy; in this case, your doctor will monitor blood levels of carbamazepine and phenytoin;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers, known as H2 blockers, such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with DILTIAZEM DOC Generics, your doctor may adjust the dose of diltiazem;
• cyclosporine, a medicine used to prevent organ transplant rejection;
• medicines for depression (antidepressants), such as imipramine and tricyclic antidepressants;
• medicines used for mental disorders (antipsychotics), including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examinations, as they may enhance the effects of diltiazem on the heart, such as lowering blood pressure;
• antiplatelet agents, medicines that prevent aggregation of certain blood cells called platelets, thereby increasing blood fluidity;
• benzodiazepines, medicines for anxiety or sleep disorders, such as midazolam, triazolam, since diltiazem increases blood concentrations of these drugs;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you and adjust the corticosteroid dose if necessary;
• statins, medicines used to lower blood cholesterol; because there may be a risk of serious muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. DILTIAZEM DOC Generics increases the activity of cilostazol;
• DILTIAZEM DOC Generics may increase colchicine levels (a medicine used to treat gout) when administered concomitantly;
• DILTIAZEM DOC Generics may increase the risk of bleeding when taken together with blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
• DILTIAZEM DOC Generics may cause QT prolongation (ECG changes such as alterations in heartbeat and rhythm, along with symptoms of dizziness) when administered together with medicines that have the potential or are known to prolong the QT interval.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take DILTIAZEM DOC Generics if you are pregnant or planning a pregnancy, or if you are a woman of childbearing age and are not using contraceptive medication.
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take diltiazem, discontinue breastfeeding.
Driving and using machines
This medicine may affect your ability to drive or operate machinery because it may cause adverse effects such as malaise and dizziness. If this occurs, avoid driving or operating machinery.
DILTIAZEM DOC Generics contains castor oil
This medicine contains castor oil, which may cause gastrointestinal disturbances and diarrhea.
DILTIAZEM DOC Generics contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take DILTIAZEM DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Exercise particular caution, especially at the beginning of treatment.
Take the tablet every day at the same time, preferably before or during meals. Do not chew the tablets; swallow them whole with a little liquid.

Treatment of angina pectoris: the recommended dose is 1 tablet three times a day, at regular intervals.
If necessary, your doctor may decide to increase the dose to 2 tablets three times a day, depending on your condition.

Treatment of high blood pressure (hypertension): the recommended dose ranges from half a tablet to 1 tablet three times a day.

Use in children
The use of diltiazem is not recommended in children.

Use in elderly patients and patients with kidney or liver problems
If you are elderly or have liver or kidney problems, or are taking other medicines for high blood pressure, the initial dose is half a tablet three times a day.

If you take more DILTIAZEM DOC Generici than you should
In case of accidental ingestion/overdose of DILTIAZEM DOC Generici, contact your doctor immediately or go to the Emergency Department of the nearest hospital. Take the medicine package with you. This way, the doctor will know what you have taken.
Symptoms of overdose include: low blood pressure up to circulatory collapse, slowed heart rate (bradycardia), and other heart problems (atrioventricular conduction disturbances, sinus arrest, and cardiac arrest), reduced kidney function.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take DILTIAZEM DOC Generici
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DILTIAZEM DOC Generici
Do not stop treatment with this medicine abruptly, as this may worsen heart problems such as angina. Consult your doctor before stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Very common (may affect more than 1 in 10 people)

• swelling due to fluid accumulation (peripheral oedema).

Common (may affect up to 1 in 10 people)

• headache (cephalaea), dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flushes;
• constipation, digestive disorders, stomach pain, nausea;
• skin irritations such as redness (erythema);
• general malaise.

Uncommon (may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heartbeat (bradycardia);
• sensation of dizziness when standing up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhoea;
• liver disorders with changes in liver blood tests, such as increased aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH).

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

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensation in limbs (paraesthesiae), ringing in the ears (tinnitus), tremor;
• chest pain (angina), irregular heartbeat (arrhythmia) which may lead to loss of consciousness (syncope);
• dry mouth, altered taste, abdominal pain;
• changes in blood tests such as increased creatine phosphokinase (CPK);
• loss of appetite (anorexia), weight gain;
• increased need to urinate (polyuria), including during the night (nocturia);
• skin irritations such as urticaria, generalized redness (erythema) due to blood vessel disorders (leukocytoclastic vasculitis), small bleedings under the skin (petechiae), itching;
• bone and joint pain;
• eye problems (amblyopia) and eye irritation;
• breathing difficulties (dyspnoea);
• reduced sexual function (impotence).

Very rare (may affect up to 1 in 10,000 people)

• kidney problems such as interstitial nephritis;
• decrease in the number of white blood cells (leucopenia).

Frequency not known (frequency cannot be estimated from the available data)

• decrease in certain blood cells (platelets) and disturbances in blood clotting (prolongation of bleeding time);
• mood changes (including depression);
• development of abnormal movements affecting gait (extrapyramidal syndrome), dizziness;
• heart problems such as sinoatrial block, severe reduction in heart function (congestive heart failure), changes in electrocardiogram results; temporary cessation of cardiac impulse formation at the sinus node level (sinus arrest) and cardiac arrest due to absence of the contraction phase (asystole);
• low blood pressure (hypotension), slow heart rate (bradycardia) and other heart problems (atrioventricular block at the nodal level) if the medicine is administered intravenously;
• fluid retention (oedema), especially in the lower limbs;
• sweating;
• increase in gum size (gingival hyperplasia);
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycaemia);
• skin disorders due to light sensitivity (including lichenoid keratosis in sun-exposed skin areas);
• swelling of the skin and mucous membranes (angioneurotic oedema);
• various skin diseases with redness, blisters, peeling, pustules, sweating, sometimes accompanied by fever (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, generalized acute exanthematous pustulosis, desquamative erythema with or without fever);
• breast enlargement in men (gynaecomastia);
• reduction in muscle strength (asthenia);
• bronchial constriction (bronchospasm), including worsening of asthma;
• a condition in which the body's immune system attacks normal tissues causing symptoms such as joint swelling, fatigue and skin rashes (called "lupus-like syndrome");
• rash which may appear on the skin or mouth ulcers (drug-induced lichenoid eruption).

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DILTIAZEM DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 DILTIAZEM DOC Generici contains

• The active substance is diltiazem hydrochloride. One tablet contains 60 mg of diltiazem hydrochloride.
• The other components are: lactose, hydrogenated castor oil, macrogol 6000 and magnesium stearate.

Description of the appearance of DILTIAZEM DOC Generici and pack contents
Carton containing 50 modified-release tablets.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan, Italy.
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM), Italy.
LACHIFARMA S.r.l. - Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010
Zollino (LE), Italy.

Patient Information Leaflet

DILTIAZEM DOC Generici 120 mg prolonged-release tablets, 300 mg prolonged-release tablets

Generic Medicinal Product
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DILTIAZEM DOC Generici is and what it is used for
2. What you need to know before taking DILTIAZEM DOC Generici
3. How to take DILTIAZEM DOC Generici
4. Possible side effects
5. How to store DILTIAZEM DOC Generici
6. Package contents and other information

1. What DILTIAZEM DOC Generici is and what it is used for

DILTIAZEM DOC Generici contains the active substance diltiazem hydrochloride, which belongs to a group of
medicines called calcium channel blockers (calcium antagonists), used for the treatment of high blood pressure.
DILTIAZEM DOC Generici is indicated for the treatment of:

• chest pain (angina pectoris) due to exertion, heart attack, or problems with the blood vessels supplying the heart (Prinzmetal's angina);
• mild to moderate high blood pressure.

2. What you should know before taking DILTIAZEM DOC Generici

Do not take DILTIAZEM DOC Generici

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure below 90 mmHg);
• if you have an acute myocardial infarction with lung complications;
• if you have an irregular heartbeat due to certain heart conditions (sinoatrial node syndrome, atrioventricular block, sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heart rate (severe bradycardia, less than 40 beats per minute);
• if you have severe heart problems possibly associated with lung disorders (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are taking medicines such as dantrolene and amiodarone by infusion (see section “Other medicines and DILTIAZEM DOC Generici”);
• if you are taking a medicine containing ivabradine for the treatment of certain heart conditions;
• if you are taking a medicine containing lomitapide, used to treat high cholesterol levels (see section “Other medicines and DILTIAZEM DOC Generici”);
• if you are pregnant or suspect you might be, if you are breastfeeding, or if you are a woman of childbearing potential not using contraceptive medication.

Warnings and precautions
Talk to your doctor or pharmacist before taking DILTIAZEM DOC Generici.
Speak with your doctor if you have a history of heart failure, unusual shortness of breath, slow heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions; your doctor may need to monitor your kidney function.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as reduced left ventricular function, slow heart rate (bradycardia), or other heart disorders (first-degree atrioventricular block);
• if you are elderly or have kidney or liver problems;
• if you are also taking other medicines that lower blood pressure, as blood pressure may drop excessively (see “Other medicines and DILTIAZEM DOC Generici”);
• if you are at risk of intestinal obstruction, since diltiazem affects intestinal function;
• if you are undergoing surgery; in this case, inform your anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with DILTIAZEM DOC Generici.

In some of the above cases, you may be prescribed different doses than normally used.
Your doctor will periodically monitor your heart, liver, and kidney function (during and especially at the beginning of treatment), and your blood sugar levels if you have diabetes mellitus, as there is a risk of increased blood glucose.
Calcium channel blockers such as diltiazem may be associated with mood changes, including depression.
The use of DILTIAZEM DOC Generici may cause bronchoconstriction (bronchospasm), including worsening of asthma, particularly in patients who already have breathing difficulties or after dose increases. During treatment with DILTIAZEM DOC Generici, your doctor will monitor your respiratory function.

Children
This medicine is not recommended for children.

Other medicines and DILTIAZEM DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, do not use this medicine and inform your doctor if you are taking:

• dantrolene (infusion), a medicine used for muscle spasms and to treat a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat irregular heartbeat;
• medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could increase the likelihood and severity of liver-related adverse effects.

Use special caution and inform your doctor if you are taking any of the following medicines (in some cases, your doctor may adjust the dose of diltiazem or the other medicines):

• antihypertensives, medicines that reduce blood pressure. If you are taking this medicine together with an antihypertensive, your doctor will closely monitor your blood pressure;
• nitrates, medicines that dilate blood vessels. If you are taking this medicine, nitrates will be prescribed at gradually increasing doses;
• theophylline, a medicine used for asthma;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, your doctor will closely monitor heart function, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers (see section 4.8);
• heart medicines in general, and particularly cardioactive glycosides (e.g., digoxin). Exercise particular caution, especially if you are elderly or taking high doses of diltiazem;
• medicines used for heart rhythm disorders (antiarrhythmics). In this case, your doctor will closely monitor heart function;
• carbamazepine and phenytoin, medicines used for epilepsy; in this case, your doctor will monitor blood levels of carbamazepine and phenytoin;
• rifampicin, a medicine used for bacterial infections (antibiotic);
• medicines used for stomach ulcers, also known as H2 blockers, such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with DILTIAZEM DOC Generici, your doctor may adjust the dose of DILTIAZEM DOC Generici;
• cyclosporine, a medicine used to prevent organ transplant rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for mental disorders (antipsychotics), including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examinations, as they may enhance the heart-related effects of diltiazem, such as lowering of blood pressure;
• antiplatelet agents, medicines that prevent aggregation of blood cells called platelets, thereby increasing blood fluidity;
• benzodiazepines, medicines for anxiety or depression, such as midazolam, triazolam, since diltiazem increases blood concentrations of these drugs;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you and adjust the corticosteroid dose if necessary;
• statins, medicines used to lower blood cholesterol, as there may be a risk of serious muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain during walking. DILTIAZEM DOC Generici increases the activity of cilostazol;
• DILTIAZEM DOC Generici may increase blood levels of colchicine (a medicine used to treat gout) when taken concomitantly;
• DILTIAZEM DOC Generici may increase the risk of bleeding when taken together with blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
• DILTIAZEM DOC Generici may cause QT prolongation (ECG changes such as alterations in heartbeat and rhythm, along with symptoms of dizziness) when administered together with medicines known or suspected to prolong the QT interval.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take DILTIAZEM DOC Generici if you are pregnant, planning a pregnancy, or if you are a woman of childbearing potential not using contraceptive medication.

Do not take this medicine if you are breastfeeding, as it passes into breast milk.
If you need to take diltiazem, discontinue breastfeeding.

Driving and using machines
This medicine may affect your ability to drive or use machinery, as it may cause adverse effects such as malaise and dizziness. If this occurs, avoid driving or operating machinery.

DILTIAZEM DOC Generici contains castor oil
This medicine contains hydrogenated castor oil, which may cause gastrointestinal disturbances and diarrhea.

3. How to take DILTIAZEM DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Use particular caution, especially at the beginning of treatment.
Take the tablet at the same time every day, preferably before or during meals. Do not chew the
tablets; swallow them whole with some liquid.

DILTIAZEM DOC Generici 120 mg prolonged-release tablets
Treatment of angina pectoris and high blood pressure (hypertension): the recommended dose is one
tablet every 12 hours.

DILTIAZEM DOC Generici 300 mg prolonged-release tablets
Treatment of angina pectoris and high blood pressure (hypertension): the recommended initial dose is two
tablets of 120 mg daily.
The dose may be increased to one 300 mg tablet daily, depending on your health condition and your sensitivity to this medicine.
This medicine is intended for maintenance therapy.

Use in children
The use of diltiazem in children is not recommended.

Use in elderly patients and patients with kidney or liver problems
If you are elderly or have liver or kidney problems, or are taking other medicines for high blood pressure, the initial dose is two 120 mg tablets daily.

If you take more DILTIAZEM DOC Generici than you should
In case of accidental ingestion/overdose of DILTIAZEM DOC Generici, contact your doctor immediately or go to the nearest hospital emergency department. Bring the medicine package with you. This way, the doctor will know what you have taken.
Symptoms of overdose include: low blood pressure up to collapse, slow heartbeat (bradycardia), and other heart rhythm problems (atrioventricular conduction disturbances, sinus arrest, and cardiac arrest), reduced kidney function.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after intake.

If you forget to take DILTIAZEM DOC Generici
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DILTIAZEM DOC Generici
Do not stop treatment with this medicine abruptly, as this may worsen heart conditions such as angina. Consult your doctor before stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:

Very common (may affect more than 1 in 10 people)

• swelling due to fluid accumulation (peripheral edema).

Common (may affect up to 1 in 10 people)

• headache (cephalalgia), dizziness;
• serious heart problems (such as atrioventricular block), palpitations;
• hot flushes;
• constipation, digestive disturbances, stomach pain, nausea;
• skin irritations such as redness (erythema);
• general malaise.

Uncommon (may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heartbeat (bradycardia);
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhoea;
• liver disorders with changes in liver blood tests, such as aspartate transferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or lactate dehydrogenase (LDH).

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

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensation in limbs (paraesthesiae), ringing in the ears (tinnitus), tremor;
• chest pain (angina), irregular heartbeat (arrhythmia) which may lead to loss of consciousness (syncope);
• dry mouth, altered taste, abdominal pain;
• changes in blood tests such as increased creatine phosphokinase (CPK);
• loss of appetite (anorexia), weight gain;
• increased need to urinate (polyuria), including during night-time rest (nocturia);
• skin irritations such as hives, generalized redness (erythema) due to blood vessel disorders (leukocytoclastic vasculitis), small hemorrhages under the skin (petechiae), itching;
• bone and joint pain;
• vision disturbances (amblyopia), eye irritation;
• breathing difficulties (dyspnoea);
• reduced sexual function (impotence).

Very rare (may affect up to 1 in 10,000 people)

• kidney problems such as interstitial nephritis;
• decrease in white blood cells (leucopenia).

Frequency not known (frequency cannot be estimated from the available data)

• decrease in certain blood cells (platelets) and disturbances in blood clotting (prolongation of bleeding time);
• mood changes (including depression);
• development of abnormal movements affecting gait (extrapyramidal syndrome), dizziness;
• heart problems (sinoatrial block), severe reduction in heart function (congestive heart failure), changes in electrocardiogram results, temporary cessation of cardiac impulse formation at the sinus node (sinus arrest), and cardiac arrest due to absence of contraction phase (asystole);
• low blood pressure (hypotension), slowed heart rate (bradycardia), and other heart problems (atrioventricular block at the nodal level) if the medicine is administered intravenously;
• fluid retention (edema), particularly in the lower limbs;
• sweating;
• increased gum size (gingival hyperplasia);
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycaemia);
• skin disorders due to light sensitivity (including lichenoid keratosis in sun-exposed skin areas);
• swelling of the skin and mucous membranes (angioneurotic edema);
• various skin diseases with redness, blisters, peeling, pustules, sweating, sometimes accompanied by fever (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, generalized acute exanthematous pustulosis, desquamative erythema with or without fever);
• breast enlargement in men (gynaecomastia);
• reduced muscle strength (asthenia);
• bronchial constriction (bronchospasm), including worsening of asthma;
• a condition in which the body's immune system attacks normal tissues, causing symptoms such as joint swelling, fatigue, and skin rashes (called "lupus-like syndrome");
• rash which may appear on the skin or mouth ulcers (drug-induced lichenoid eruption).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store DILTIAZEM DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What DILTIAZEM DOC Generici contains

• The active substance is diltiazem hydrochloride. One tablet contains 120 mg or 300 mg of diltiazem hydrochloride.
• The other components are: mannitol, hypromellose, ethylcellulose, hydrogenated castor oil, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of DILTIAZEM DOC Generici and pack contents
DILTIAZEM DOC Generici 120 mg prolonged-release tablets:
Carton pack containing 24 tablets.
DILTIAZEM DOC Generici 300 mg prolonged-release tablets:
Carton pack containing 14 tablets.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan, Italy.
Manufacturer
COSMO S.p.A. - Via C. Colombo, 1 - Lainate (MI).
LACHIFARMA S.r.l. - Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010
Zollino (LE).