DILTIAZEM 60 mg Модифицированные Таблетки

Содержание инструкции

1. DILTIAZEM DOC Generici 60 mg modified release tablets
   1. What is DILTIAZEM DOC Generici 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
2. DILTIAZEM DOC Generici 120 mg prolonged-release tablets, 300 mg prolonged-release tablets
   1. What is DILTIAZEM DOC Generici 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

DILTIAZEM DOC Generici 60 mg modified release tablets

Equivalent Medicinal Product
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 you take 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 is DILTIAZEM DOC Generici and what it is used for

DILTIAZEM DOC Generici contains the active ingredient 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 vessels that carry blood to the heart (Prinzmetal's angina);
• in cases of mild to moderate high blood pressure.

2. What you need to 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 heart attack with lung problems;
• if you have an irregular heartbeat (due to certain heart diseases (sick sinus syndrome) (atrioventricular block sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems possibly with lung disorders (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are using medicines such as dantrolene and amiodarone for infusion (see section “Other medicines and DILTIAZEM DOC Generici”);
• if you are already using medicines containing ivabradine for the treatment of certain heart diseases;
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and DILTIAZEM DOC Generici”);
• if you are pregnant or suspect you are pregnant, if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).

Warnings and precautions
Talk to your doctor or pharmacist before taking DILTIAZEM DOC Generici.
Talk to 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, the 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 functioning of the left ventricle, slow heartbeat (bradycardia) or other heart disorders (first-degree atrioventricular block);
• if you are elderly or if you 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 bowel obstruction, as diltiazem has effects on bowel function;
• if you are going to have surgery, in this case inform the anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct-acting oral anticoagulants (e.g.: dabigatran, rivaroxaban, apixaban) together with DILTIAZEM DOC Generici.

In some of the cases mentioned, you may be prescribed different doses than those normally used.
Your doctor will subject you to periodic checks of heart, liver, kidney function (during and
especially at the beginning of treatment) and blood sugar levels, if you suffer from diabetes mellitus, as
there is a risk of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with changes in mood, including depression.
The use of DILTIAZEM DOC Generici can cause constriction of the bronchi (bronchospasm), including a
worsening of asthma, especially in those patients who already have some difficulty breathing or after
increased dosage. During therapy with DILTIAZEM DOC Generici your doctor will subject you to checks
of 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 tell your doctor if you are taking:

• dantrolene (infusion), a medicine used for muscle spasms and for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat heart problems;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects;
• antihypertensives, medicines that lower blood pressure. If you are taking this medicine together with an antihypertensive, your doctor will carefully monitor your blood pressure;
• nitrates, medicines that dilate blood vessels. If you are taking this medicine, you can only start treatment with nitrates 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, the 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 in particular cardiac glycosides (e.g. digoxin). Take particular care especially if you are elderly or if you take high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, the doctor will closely monitor the functioning of the heart;
• carbamazepine and phenytoin, medicines used for epilepsy; in this case, the doctor will monitor the levels of carbamazepine and phenytoin in the blood;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers also called anti-H2 such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with DILTIAZEM DOC Generici, the doctor may adjust the dose of diltiazem;
• cyclosporine, a medicine used against 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 examination, as they can increase the heart effects of diltiazem such as lowering blood pressure;
• antiplatelet agents, medicines that prevent the aggregation of certain blood cells called platelets, increasing blood fluidity;
• benzodiazepines, medicines for depression, such as midazolam, triazolam, as diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you by adjusting the dose of corticosteroids, if necessary;
• statins, medicines used to lower cholesterol in the blood; because there is a risk of serious muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. DILTIAZEM DOC Generici increases the activity of cilostazol;
• DILTIAZEM DOC Generici can lead to an increase in the level of colchicine (drug used to treat gout) when administered concomitantly;
• DILTIAZEM DOC Generici can lead to an increased risk of bleeding if taken together with blood thinners such as direct-acting oral anticoagulants (e.g.: dabigatran, rivaroxaban, apixaban);
• DILTIAZEM DOC Generici can lead to a prolongation of the QT interval (alterations in the ECG such as alterations in the heartbeat and rhythm, together with symptoms of dizziness) when administered together with drugs that have the potential/are known to prolong the QT interval.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take DILTIAZEM DOC Generici if you are pregnant or planning a pregnancy. or if you are a
woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take diltiazem, stop breastfeeding.

Driving and using machines
This medicine can affect your ability to drive and operate machinery as it can cause
side effects such as malaise and dizziness. If this happens, avoid driving or using
machinery.

DILTIAZEM DOC Generici contains castor oil
This medicine contains castor oil which can cause stomach upset and diarrhea.

DILTIAZEM DOC Generici contains lactose
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take DILTIAZEM DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Use particular caution especially at the beginning of the 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 3 times a day, at regular intervals.
If necessary, your doctor may decide to increase the dose to 2 tablets 3 times a day depending on your
condition.

Treatment of high blood pressure (hypertension):the recommended dose ranges from half to 1 tablet 3 times a
day.

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

Use in elderly people and 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 3 times a day.

If you take more DILTIAZEM DOC Generici than you should
In case of accidental ingestion/taking of an excessive dose of DILTIAZEM DOC Generici, immediately
inform your doctor or go to the Emergency Room of the nearest hospital. Bring the package of the
medicine with you. This way the doctor will know what you have taken.
Symptoms of overdose are: lowering of blood pressure to the point of collapse, slowing of the
heartbeat (bradycardia) and other heart problems (disturbances in atrioventricular conduction, sinus arrest
and cardiac arrest), reduced kidney function.
An excess of fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath that may
develop up to 24-48 hours after taking it.

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 to take
the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DILTIAZEM DOC Generici
Do not abruptly stop treatment with this medicine as it may worsen heart problems such as
angina. Consult your doctor before stopping treatment.
If you have any doubts about the use of this medicine, ask 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 retention (peripheral edema).

Common(may affect up to 1 in 10 people)

• headache, 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);
• feeling of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• liver disorders with changes in blood tests related to the liver, 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 sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• 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), even at night (nocturia);
• skin irritations such as hives, widespread redness (erythema) due to changes in blood vessels (leucocytoclastic vasculitis), small hemorrhages under the skin (petechiae), itching;
• bone and joint pain;
• eye problems (amblyopia) and eye irritation;
• difficulty breathing (dyspnea)
• decreased sexual potency (impotence).

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

• kidney problems such as interstitial nephritis;
• decreased number of white blood cells (leukopenia). Frequency not known(the frequency cannot be estimated from the available data)
• decrease in certain blood cells (platelets) and changes in blood coagulation (prolonged bleeding time);
• mood changes (including depression);
• appearance of abnormal movements that disturb gait (extrapyramidal syndrome), dizziness;
• heart problems such as (sinoatrial block), severe decrease in heart function (congestive heart failure), changes in the results of the electrocardiogram; temporary cessation of impulse formation at the sinoatrial node (sinus arrest) and cardiac arrest due to absence of the contraction phase (asystole);
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node) if the medicine is administered intravenously;
• fluid retention (edema) especially in the lower limbs;
• sweating;
• enlargement of the gums (gingival hyperplasia);
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycemia);
• skin disorders due to sensitivity to light (including lichenoid keratosis in areas of skin exposed to the sun);
• swelling of the skin and mucous membranes (angioedema);
• various skin diseases, with redness, blisters, scaling, pustules, sweating sometimes accompanied by fever (multiforme erythema, Stevens-Johnson syndrome and toxic epidermal necrolysis, exfoliative dermatitis, acute generalized pustular exanthematous dermatitis, desquamative erythema with or without fever);
• growth of the breasts in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including worsening of asthma;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as swollen joints, fatigue and skin rashes (called "lupus-like syndrome");
• rash that may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruption).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatDILTIAZEM DOC Generici contains

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

Description of the appearance of DILTIAZEM DOC Generici and contents of the pack
Pack containing 50 modified-release tablets.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milano, 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).

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

Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is DILTIAZEM DOC Generici and what it is used for

DILTIAZEM DOC Generici contains the active ingredient 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 vessels that carry blood to the heart (Prinzmetal's angina);
• in cases of mild to moderate high blood pressure.

2. What you need to 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 heart attack with lung problems;
• if you have an irregular heartbeat due to certain heart diseases (sick sinus syndrome, atrioventricular block, sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems possibly with lung problems (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are using medicines such as dantrolene and amiodarone for infusion (see section “Other medicines and DILTIAZEM DOC Generici”);
• if you are using a medicine containing ivabradine for the treatment of certain heart conditions;
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and DILTIAZEM DOC Generici”);
• if you are pregnant or suspect you may be pregnant, if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).

Warnings and precautions
Talk to your doctor or pharmacist before taking DILTIAZEM DOC Generici.
Talk to 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, the 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 functioning of the left ventricle, slow heartbeat (bradycardia) or other heart disorders (first-degree atrioventricular block);
• if you are elderly or if you have kidney or liver problems;
• if you are also taking other medicines that lower blood pressure as blood pressure may be reduced excessively (see “Other medicines and DILTIAZEM DOC Generici”);
• if you are at risk of intestinal obstruction as diltiazem has effects on bowel function;
• if you are going to have surgery, in this case inform the anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with DILTIAZEM DOC Generici.

In some of the cases mentioned, different doses than those normally used may be prescribed to you.
Your doctor will subject you to periodic checks of heart, liver, kidney function (during and
especially at the beginning of treatment) and blood sugar levels, if you suffer from diabetes mellitus, as
there is a risk of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with changes in mood, including depression.
The use of DILTIAZEM DOC Generici can cause constriction of the bronchi (bronchospasm), including
worsening of asthma, particularly in patients who already have some difficulty breathing or after
increasing the dosage. During therapy with DILTIAZEM DOC Generici your doctor will subject you to checks
of 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 for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat irregular heartbeat;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects.

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

• antihypertensives, medicines that lower blood pressure. If you are taking this medicine together with an antihypertensive, your doctor will carefully 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, the doctor will carefully 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 in particular cardiac glycosides (e.g., digoxin). Take particular care especially if you are elderly or if you take high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, the doctor will carefully monitor heart function;
• carbamazepine and phenytoin, medicines used for epilepsy; in this case, the doctor will monitor the levels of carbamazepine and phenytoin in the blood;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers, also called H2 antagonists such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with DILTIAZEM DOC Generici, the doctor may modify the dose of DILTIAZEM DOC Generici;
• cyclosporine, a medicine used against 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 examination, as they may increase the effects on the heart of diltiazem such as lowering blood pressure;
• antiplatelet agents, medicines that prevent the aggregation of certain blood cells called platelets, increasing the fluidity of the blood;
• benzodiazepines, medicines for depression, such as midazolam, triazolam, as diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you, modifying the dose of corticosteroids 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 when walking. DILTIAZEM DOC Generici increases the activity of cilostazol;
• DILTIAZEM DOC Generici may lead to an increase in the level of colchicine (drug used to treat gout) when administered concomitantly;
• DILTIAZEM DOC Generici may lead to an increased risk of bleeding if taken together with blood thinners such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
• DILTIAZEM DOC Generici may lead to a prolongation of the QT (alterations in the ECG such as alterations in the heartbeat and rhythm, together with symptoms of dizziness) when administered together with drugs that have the potential/are known to prolong the QT interval. Pregnancy and breastfeedingIf you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Do not take DILTIAZEM DOC Generici if you are pregnant, are planning a pregnancy or are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).

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

Driving and operating machinery
This medicine may affect your ability to drive and operate machinery as it may cause
side effects such as feeling unwell and dizziness. If this happens, avoid driving and using
machinery.

DILTIAZEM DOC Generici contains castor oil
This medicine contains hydrogenated castor oil which may cause stomach upset and diarrhoea.

3. How to take DILTIAZEM DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Use particular caution especially at the beginning of the 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.

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
120 mg tablets per day.
The dose may be increased to one 300 mg tablet per day, based on your health condition and your
sensitivity to this medicine.
This medicine is indicated for maintenance therapy.

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

Use in elderly people and 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 per day.

If you take more DILTIAZEM DOC Generici than you should
In case of accidental ingestion/intake of an excessive dose of DILTIAZEM DOC Generici, immediately
inform your doctor or go to the emergency room of the nearest hospital. Bring with you the package of the
medicine. This way the doctor will know what you have taken.
The symptoms of overdose are: lowering of blood pressure to collapse, slowing of the
heartbeat (bradycardia) and other heart rhythm problems (atrioventricular conduction disturbances,
sinus arrest and cardiac arrest), reduced kidney function.
An excess of fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath that may
develop up to 24-48 hours after taking it.

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 to take
the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DILTIAZEM DOC Generici
Do not suddenly stop the treatment with this medicine because it may worsen heart problems such as
angina. Consult your doctor before stopping the treatment.
If you have any doubts 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 retention (peripheral edema).

Common(may affect up to 1 in 10 people)

• headache, 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);
• feeling of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• liver disorders with changes in liver-related blood tests, such as aspartate transaminase (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 sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• chest pain (angina), irregular heartbeat (arrhythmia) which may cause 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) even at night (nocturia);
• skin irritations such as hives, widespread redness (erythema) due to changes in blood vessels (leucocytoclastic vasculitis), small hemorrhages under the skin (petechiae), itching;
• bone and joint pain;
• vision impairment (amblyopia), eye irritation;
• difficulty breathing (dyspnea);
• decreased sexual potency (impotence). Very rare(may affect up to 1 in 10,000 people)
• kidney problems such as interstitial nephritis;
• decreased number of white blood cells (leukopenia).

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

• decrease in certain blood cells (platelets) and changes in blood coagulation (prolonged bleeding time);
• mood changes (including depression);
• appearance of abnormal movements that disrupt gait (extrapyramidal syndrome), dizziness;
• heart problems (sinoatrial block), severe decrease in heart function (congestive heart failure), changes in electrocardiogram results, temporary cessation of cardiac impulse formation at the sinoatrial node (sinus arrest) and cessation of the heart due to the absence of the contraction phase (asystole);
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node) if the medicine is administered intravenously;
• fluid retention (edema) especially in the lower limbs;
• sweating;
• enlargement of the gums (gingival hyperplasia);
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycemia);
• skin disorders due to light sensitivity (including lichenoid keratosis in areas of skin exposed to the sun);
• swelling of the skin and mucous membranes (angioedema);
• various skin diseases, with redness, blisters, scaling, pustules, sweating sometimes accompanied by fever (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, exfoliative dermatitis, acute generalized pustular exanthematous dermatitis, desquamative erythema with or without fever);
• growth of breast tissue in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including worsening of asthma;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as swollen joints, fatigue and skin rashes (called "lupus-like syndrome");
• rash that may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruption).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DILTIAZEM DOC Generici contains

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

Description of the appearance of DILTIAZEM DOC Generici and contents of the pack
DILTIAZEM DOC Generici 120 mg prolonged-release tablets:
Pack containing 24 tablets.

DILTIAZEM DOC Generici 300 mg prolonged-release tablets:
Pack containing 14 tablets.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milano, 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).