DILTIAZEM 90 mg Extended-Release Hard Capsule

Зміст інструкції

1. Diltiazem Sandoz 120 mg prolonged-release hard capsules, 300 mg prolonged-release hard capsules
   1. What is Diltiazem Sandoz and what is it used for
   2. What you need to know before taking Diltiazem Sandoz
   3. How to take Diltiazem Sandoz
   4. Possible side effects
   5. How to store Diltiazem Sandoz
   6. Contents of the pack and other information

Diltiazem Sandoz 120 mg prolonged-release hard capsules, 300 mg prolonged-release hard capsules

Equivalent Medicinal Product

Read this leaflet carefully before you start 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 Sandoz is and what it is used for
• 2. What you need to know before you take Diltiazem Sandoz
• 3. How to take Diltiazem Sandoz
• 4. Possible side effects
• 5. How to store Diltiazem Sandoz
• 6. Contents of the pack and other information

1. What is Diltiazem Sandoz and what is it used for

Diltiazem Sandoz contains the active ingredient diltiazem which belongs to a group of medicines called
calcium channel blockers (calcium antagonists), used for the treatment of high blood pressure.
Diltiazem Sandoz is indicated for the treatment of:

• chest pain (angina pectoris) due to exertion, a heart attack or problems with the vessels that carry blood to the heart (Prinzmetal's angina);
• in cases of mild or moderate high blood pressure

2. What you need to know before taking Diltiazem Sandoz

Do not take Diltiazem Sandoz

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (hypotension) (systolic pressure less than 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) or disturbances in cardiac conduction (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 a medicine called dantrolene (for infusion) and amiodarone (see section “Other medicines and Diltiazem Sandoz”);
• 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);
• if you are already taking a medicine 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 Sandoz”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem Sandoz.
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, if you have kidney or liver problems or if you are also taking other medicines that lower blood pressure as blood pressure may drop excessively (see “Other medicines and Diltiazem Sandoz”);
• if you are at risk of intestinal obstruction as diltiazem has effects on intestinal function;
• if you are going to have surgery, in this case inform your doctor or anesthesiologist that you are taking this medicine;
• 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 such conditions, the doctor may need to monitor kidney function.

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

Children
This medicine is not recommended for children.

Other medicines and Diltiazem Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not use this medicine in combination with:

• 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 certain heart diseases. In particular, do not use this medicine and inform your doctor if you are taking:
• 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 the doctor may adjust 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 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;
• 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 function of your heart;
• carbamazepine and phenytoin, medicines used for epilepsy; in this case the doctor will monitor the levels of carbamazepine and phenytoin in the blood;
• acetylsalicylic acid (acetylsalicylic acid/lysine acetylsalicylate), medicines used to relieve pain, fever and inflammation: an increased risk of bleeding may occur;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers, called H2-blockers, such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with Diltiazem Sandoz, 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 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 blood fluidity;
• benzodiazepines, medicines for depression such as midazolam, triazolam, as diltiazem increases the concentration of these medicines in the blood;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you, adjusting the dose of corticosteroids if necessary;
• statins, medicines used to lower cholesterol levels, as there is a risk of serious muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. Diltiazem Sandoz increases the activity of cilostazol;

Diltiazem Sandoz with drinks
Avoid taking this medicine together with grapefruit juice as this may increase
its effect. If you are taking grapefruit juice, your doctor should monitor the possible manifestation of
side effects.

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.
Pregnancy
Do not take Diltiazem Sandoz if you are pregnant, planning a pregnancy or are a woman
of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).
Breastfeeding
Do not take this medicine if you are breastfeeding, as diltiazem is excreted into
breast milk.
If you need to take Diltiazem Sandoz, stop breastfeeding.

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

Diltiazem Sandoz contains sucrose
This medicine contains sucrose, a type of sugar. If you have been diagnosed with
an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Diltiazem Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended initial dose is 90 mg twice a day. Your doctor may decide to increase this
dose to 1 capsule of 120 mg twice a day or 1 capsule of 300 mg once a day, depending on your
response to treatment.
Do not chew the capsules, but swallow them whole with a little water.
The 120 mg and 300 mg capsules are indicated for maintenance therapy.
Use particular caution, especially at the beginning of treatment.

Use in children
The use of Diltiazem Sandoz is not recommended in children.

Use in elderly people 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 recommended initial dose is the minimum effective dose.

If you take more Diltiazem Sandoz than you should
Symptoms of overdose are: lowering of blood pressure to the point of collapse, slowing of the
heartbeat (bradycardia) and other heart problems (atrioventricular conduction disturbances),
reduction of kidney function.
In case of accidental ingestion/intake of an excessive dose of Diltiazem Sandoz, immediately
notify your doctor or go to the Emergency Room of the nearest hospital.

If you forget to take Diltiazem Sandoz
If you forget to take a capsule, 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 a missed dose.

If you stop taking Diltiazem Sandoz
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 (dyspepsia), 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) and lactate dehydrogenase (LDH).

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

• nosebleeds (epistaxis)
• 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 urticaria, redness (erythema) generalized due to alteration of blood vessels (leucocytoclastic vasculitis), small hemorrhages under the skin (petechiae), itching;
• bone and joint pain;
• impaired vision (amblyopia) eye irritation;
• difficulty breathing (dyspnea);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• 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).

Not known(frequency cannot be estimated from available data)

• decrease in certain blood cells (platelets) and alterations in blood coagulation;
• prolongation of bleeding time;
• mood changes (including depression);
• appearance of abnormal movements that disturb gait (extrapyramidal syndrome), dizziness;
• heart problems (sinoatrial block), severe decrease in heart function (congestive heart failure), alteration of electrocardiogram results; temporary cessation of the formation of the cardiac impulse at the level of the sinus node (sinus arrest) and cessation of the heart due to the absence of the contraction phase (asystole);
• fluid retention (edema), especially in the lower limbs;
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node level) if the medicine is administered intravenously;
• sweating;
• reduction of muscle strength (asthenia);
• enlargement of the gums (gingival hyperplasia);
• inflammation of the liver (hepatitis);
• increased blood sugar levels (hyperglycemia);
• skin disorders due to sensitivity to light (photosensitivity) (including lichenoid keratosis in areas of skin exposed to the sun);
• swelling of the skin and mucous membranes due to fluid accumulation (angioedema);
• various skin diseases, with redness, blisters, scaling, pustules, sweating, sometimes accompanied by fever (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis or Lyell's syndrome, exfoliative dermatitis, acute generalized exanthematous dermatitis, desquamative erythema with or without fever);
• growth of breast tissue in men (gynecomastia);
• 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").

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: h ttps://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 Sandoz

Keep this medicine out of the 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.
Store at a temperature below 30˚C. Store in the original package to protect the
medicine from humidity.
Do not dispose of any medicine in wastewater 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 Sandoz contains

• The active ingredient is diltiazem. One capsule contains 120 mg of diltiazem hydrochloride.
• The other ingredients are: sucrose and corn starch microgranules, povidone, talc, acquacoat ECD 30, dibutyl sebacate, ethylcellulose, sucrose. Capsule composition: gelatin, titanium dioxide (E171), erythrosine (E127), indigotine (E132).

Diltiazem Sandoz 300 mg prolonged-release capsules

• The active ingredient is diltiazem. One capsule contains 300 mg of diltiazem hydrochloride.
• The other ingredients are: sucrose and corn starch microgranules, povidone, talc, acquacoat ECD 30, dibutyl sebacate, ethylcellulose, sucrose. Capsule composition: gelatin, titanium dioxide (E171), erythrosine (E127), indigotine (E132).

Description of the appearance of Diltiazem Sandoz and contents of the pack
Diltiazem Sandoz 120 mg prolonged-release capsules
Pack containing 24 capsules in PVC/AL blisters.

Diltiazem Sandoz 300 mg prolonged-release capsules
Pack containing 14 capsules in PVC/AL blisters.

Marketing Authorisation Holder
Sandoz S.p.A., Largo U. Boccioni 1, 21040, Origgio (VA) - Italy

Manufacturer
Ethypharm SA, Chemin de la Poudriere, 76120 Grand-Quevilly (Seine-Maritime), France;
Famar A.V.E., Anthoussa Avenue 7, 15344 Anthoussa Attiki, Greece.