Diltiazem EG

Patient Information Leaflet

Diltiazem EG 60 mg tablets, 120 mg modified-release hard capsules, 180 mg modified-release hard capsules

Generic medicine
Please read all of 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 other people, even if their symptoms are the same as yours, as it may 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 EG is and what it is used for
2. What you need to know before taking Diltiazem EG
3. How to take Diltiazem EG
4. Possible side effects
5. How to store Diltiazem EG
6. Contents of the pack and other information

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

Diltiazem EG 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 EG 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 EG

Do not take Diltiazem EG

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions;
• if you have low blood pressure (systolic pressure below 90 mmHg);
• if you have acute myocardial infarction with lung complications;
• if you have an irregular heartbeat (sinoatrial syndrome) or cardiac conduction disorders (second- or third-degree atrioventricular block) and do not have a functioning pacemaker;
• if you suffer from certain cardiac conduction disorders (sinoatrial block);
• if you have a very slow heart rate (severe bradycardia, less than 40 bpm);
• if you have serious heart problems such as left ventricular failure with pulmonary congestion and congestive heart failure;
• if you are using medicines such as dantrolene and amiodarone (see section "Other medicines and Diltiazem EG");
• if you are using a medicine containing lomitapide, used to treat high cholesterol levels (see section "Other medicines and Diltiazem EG");
• if you are pregnant or breastfeeding;
• if the person to take the medicine is a child (see section "Children").

Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem EG.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as impaired left ventricular function, bradycardia, or first-degree atrioventricular block;
• 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 your kidney function;
• if you are elderly or have kidney or liver problems, especially if you are also taking other medicines that lower blood pressure;
• if you are at risk of intestinal obstruction;
• if you are undergoing surgery; in this case, inform your doctor or anaesthetist that you are taking this medicine;
• if you notice changes in mood.

Your doctor will periodically monitor your liver and kidney function during treatment, as well as your heart function, especially at the beginning of treatment.
If you have an enlarged heart (cardiomegaly) or very low blood pressure, treatment must only be initiated in a hospital setting.
Children
This medicine is not recommended for children.
Other medicines and Diltiazem EG
Inform 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 (intravenous), a medicine used for muscle spasms and to treat 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 concentrations, which could increase the likelihood and severity of liver-related adverse effects.

Use particular caution and inform your doctor if you are taking any of the following medicines:

• nitrates, medicines that dilate blood vessels. If you are taking this medicine, treatment with nitrates should be started only at gradually increasing doses;
• theophylline, a medicine used to treat asthma;
• alpha-blockers, medicines used to treat high blood pressure. In this case, you may use them together with this medicine only if your blood pressure is closely monitored;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, you may use them together with this medicine only if your heart function is closely monitored, especially at the beginning of treatment;
• cardioactive glycosides, heart medicines (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, you may use diltiazem only if your heart function is closely monitored;
• carbamazepine and phenytoin, medicines used for epilepsy;
• rifampicin, a medicine for bacterial infections, or medicines used for ulcers (H2 antagonists) such as cimetidine and ranitidine. If you start or stop treatment with these medicines during treatment with Diltiazem EG, you should be monitored by your doctor;
• cyclosporine, a medicine used to prevent organ transplant rejection;
• medicines for depression (antidepressants) such as imipramine;
• medicines used for psychiatric disorders (antipsychotics), including lithium;
• medicines used for anaesthesia (see section "Warnings and precautions").

If you are taking any of the following medicines, inform your doctor, as dose adjustment may be necessary:

• benzodiazepines, medicines for depression, such as midazolam, triazolam;
• corticosteroids, medicines used to treat inflammation;
• statins, medicines used to lower blood cholesterol; because there may be a risk of serious muscle damage (myopathy and rhabdomyolysis).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Diltiazem EG if you are pregnant or planning a pregnancy.
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 use of machines
This medicine may affect your ability to drive or operate machinery, as it may cause adverse effects such as dizziness and malaise. If this occurs, avoid driving or operating machinery.
Diltiazem EG 60 mg tablets contain castor oil and lactose
This medicine contains castor oil, which may cause gastrointestinal disturbances and diarrhoea.
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Diltiazem EG 120 mg modified-release hard capsules and Diltiazem EG 180 mg modified-release hard capsules contain sucrose
These medicines contain sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking these medicines.

3. How to take Diltiazem EG

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.

Diltiazem EG 60 mg tablets
Treatment of angina pectoris: The recommended dose is 1 tablet 3 times daily, taken at regular
intervals. If necessary, your doctor may decide to increase the dose to 2 tablets 3 times daily, depending on your condition.
Treatment of high blood pressure (hypertension): The recommended dose ranges from half to 1 tablet 3 times
daily.
The Diltiazem EG tablet cannot be divided into equal doses.
For doses not achievable with Diltiazem EG, other medicinal products containing diltiazem should be used.

Diltiazem EG 120 mg modified-release hard capsules and Diltiazem EG 180 mg modified-release hard capsules
Treatment of high blood pressure (hypertension): The recommended dose is 240 mg once daily.
To achieve a satisfactory response and determine the optimal dosage, treatment may start at 120 mg daily, increasing the dose by 60 mg or 120 mg every 2 weeks (usually the optimal dosage ranges from 240 to 360 mg daily).

Use in children
There are no data regarding the safety and efficacy of use in children. Therefore, 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 3 times daily or 1 modified-release hard capsule of 120 mg (minimum effective dose), taken once daily, at least at the beginning of therapy.
If adverse effects occur or if your heart rate drops below 50 beats per minute, the dosage should be reduced.

If you take more Diltiazem EG than you should
Symptoms of overdose include: lowering of blood pressure up to collapse, slowing of the heartbeat (sinus bradycardia with or without isorhythmic dissociation), heart problems (atrioventricular conduction disturbances), and reduced kidney function.
In case of accidental ingestion/overdose of Diltiazem EG, contact your doctor immediately or go to the nearest hospital Emergency Department. Take the medicine pack with you. This way, the doctor will know what you have taken.

If you forget to take Diltiazem EG
If you forget to take a tablet or capsule, 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 forgotten dose.

If you stop taking Diltiazem EG
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 doubts about how to use 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 (can be first-, second- or third-degree; bundle branch block may occur), palpitations;
• hot flushes;
• constipation, digestive disorders (dyspepsia), stomach pain, nausea;
• skin irritation (erythema);
• malaise.

Uncommon (may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heart rate (bradycardia);
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhoea;
• liver function abnormalities (increase in liver enzymes such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK) and lactate dehydrogenase (LDH)).

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

• memory problems (amnesia), depression, personality changes, hallucinations, somnolence;
• altered sensation in limbs (paraesthesia), ringing in the ears (tinnitus), tremor;
• heart problems (palpitations, arrhythmia, asystole, syncope, angina);
• dry mouth, altered taste, abdominal pain;
• anorexia, weight gain;
• increased need to urinate (nocturia, polyuria) and kidney problems (interstitial nephritis);
• skin reactions (urticaria, petechiae, pruritus);
• bone and joint pain;
• eye problems (amblyopia, eye irritation);
• breathing difficulties (dyspnoea);
• impotence;
• reduced muscle strength (asthenia).

Not known (frequency cannot be estimated from available data)

• blood disorders (thrombocytopenia, leucopenia, prolonged bleeding time);
• mood changes (including depression);
• movement disorders (extrapyramidal syndrome);
• heart problems such as sinoatrial block, congestive heart failure;
• inflammation of blood vessels (vasculitis, leukocytoclastic vasculitis);
• sweating;
• gum enlargement;
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycaemia);
• light sensitivity (photosensitivity, including lichenoid keratosis in sun-exposed skin areas);
• swelling of the skin and mucous membranes due to fluid accumulation (angioneurotic edema);
• skin reactions such as rash, erythema multiforme (including Stevens-Johnson syndrome and toxic epidermal necrolysis), exfoliative dermatitis, generalized acute exanthematous pustulosis, occasionally desquamative erythema with or without fever and sweating;
• 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");
• nosebleeds (epistaxis);
• breast enlargement in men (gynaecomastia).

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

5. How to store Diltiazem EG

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.
Modified-release hard capsules: store the medicine in a dry place at a temperature below 30°C.
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. Contents of the pack and other information

What Diltiazem EG contains
Diltiazem EG 60 mg tablets

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

Diltiazem EG 120 mg modified-release hard capsules

• The active substance is diltiazem hydrochloride. One capsule contains 120 mg of diltiazem hydrochloride.
• The other components are:
  • core: microgranules (maize starch, sucrose), povidone (K30), shellac, ethylcellulose, talc.
  • coating: gelatin, erythrosine (E127), indigotine (E132).

Diltiazem EG 180 mg modified-release hard capsules

• The active substance is diltiazem hydrochloride. One capsule contains 180 mg of diltiazem hydrochloride.
• The other components are:
  • core: microgranules (maize starch, sucrose), povidone (K30), shellac, ethylcellulose, talc.
  • coating: gelatin, erythrosine (E127), indigotine (E132), titanium dioxide.

Description of the appearance of Diltiazem EG and contents of the pack
Box containing 50 tablets of 60 mg.
Box containing 24 or 28 modified-release hard capsules of 120 mg.
Box containing 28 modified-release hard capsules of 180 mg.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
Doppel Farmaceutici S.r.l. – Quinto Dè Stampi – Rozzano (MI)