Package Leaflet: Information for the User

Diltiazem Aristo 60 mg Tablets EFG

Diltiazem

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Diltiazem Aristo

3. How to take Diltiazem Aristo

4. Possible side effects

5. Storage of Diltiazem Aristo

6. Contents of the pack and additional information

Diltiazem is a calcium antagonist that produces a potent vasodilatory action on blood vessels. It also decreases the heart's oxygen requirements.

This medication is used for:

• Treatment of ischemic cardiopathy: a heart disease in which arteries are unable to supply sufficient oxygen
• Prevention of angina pectoris: a type of ischemic cardiopathy that manifests with chest pain and pressure.
• Treatment of mild to moderate essential hypertension (elevated blood pressure)

Do not take Diltiazem Aristo

• if you are allergic to diltiazem or any of the other ingredients of this medication (listed in section 6).
• if you have heart rhythm or conduction disorders, such as:

• sinus node dysfunction

• third-degree atrioventricular block if you do not have a pacemaker

• severe bradycardia (less than 40 beats per minute)

• if you have a severe heart disease called left ventricular heart failure with pulmonary edema.
• if you need to receive an intravenous administration of dantrolene (a medication used in muscle contraction alterations) (see “Use of Diltiazem Aristo with other medications”)
• if you are already taking a medication containing lomitapida used for the treatment of high cholesterol levels (see section: "Taking Diltiazem with other medications”).
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Aristo.

• if you have heart rhythm disorders such as bradycardia (slow heart rate) or first-degree atrioventricular block,
• if you have a history of heart failure, new difficulty breathing, 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.
• if you have a severe liver or kidney disease, or if you are over 65 years old. In these cases, diltiazem blood levels may be higher. Your doctor may need to monitor you more closely and even perform periodic control examinations,
• if you are to undergo surgery under general anesthesia while on treatment with this medication.

Use of Diltiazem Aristo with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

For safety reasons, the concomitant use of dantrolene (a medication used in muscle contraction alterations) and diltiazem is contraindicated.

It is especially important to inform your doctor if you take any of the following medications:

• Alpha and beta blockers (used to treat high blood pressure)
• Amiodarone and digoxin (medications for the treatment of abnormal heart rhythms)
• Nitrate derivatives (used in heart diseases)
• Ciclosporin (used in organ transplants)
• Carbamazepine (for the treatment of epilepsy)
• Cimetidine and ranitidine (used in the treatment of stomach ulcers)
• Simvastatin, pravastatin, and other statins (used to reduce the amount of cholesterol and other fatty substances in the blood)
• Medications containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increased risk and severity of liver-related side effects.

Taking Diltiazem Aristo 60 mg with food and drinks

The Diltiazem Aristo 60 mg tablet should be swallowed whole, not chewed, and with the help of a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you intend to become pregnant, consult your doctor or pharmacist before using this medication.

Diltiazem Aristo 60 mg is contraindicated during pregnancy.

Diltiazem Aristo 60 mg passes into breast milk, so taking this medication is contraindicated in breastfeeding women.

Driving and operating machines

At the start of treatment and when increasing the dose, you may be affected in your ability to drive and operate machines due to a decrease in reaction capacity. This is also important if you consume alcohol at the same time. Therefore, do not drive oruse potentially hazardous machinery until you check how you tolerate the medication.

Important information about some of the components of Diltiazem Aristo

Thismedication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Diltiazem Aristo 60 mg is administered orally.

The recommended dose is:

• Coronary heart disease: 3 tablets a day, preferably before main meals. The dose may be increased or decreased, always under medical criteria.
• Hypertension: Treatment of mild to moderate hypertension should begin with half a tablet of 60 mg 3 times a day, and in case of severe hypertension with 1 tablet 3 times a day at most. If necessary, the dose can be increased to 2 tablets 3 times a day at most. In prolonged treatments, the dose can be reduced to half a tablet of 60 mg 3 times a day.

The Diltiazem Aristo 60 mg tablet should be swallowed whole, without chewing, and with the help of a glass of water.

If you take more Diltiazem Aristo than you should

The symptoms of an overdose of this medication are: pronounced hypotension (very low blood pressure), leading to collapse, and severe disturbances of the heart rhythm.

If you take more tablets than you should, inform your doctor or go immediately to the emergency service of a hospital. Bring the packaging of the medication with you. This is so that the doctor knows what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, irregular heartbeats, difficulty speaking, confusion, decreased renal function, coma, and sudden death.

If you take more Diltiazem Aristo than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Diltiazem Aristo

Do not take a double dose to compensate for the missed doses, wait for the next dose to take your next tablet and then continue with the usual schedule.

If you interrupt treatment with Diltiazem Aristo

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Diltiazem Aristo may produce adverse effects, although not all people will experience them.

The possible adverse effects due to the use of Diltiazem Aristo are as follows:

• Frequent (≥1/100 to <1)swelling in the legs, general discomfort, headache, drowsiness, dizziness, skin redness, itching.

• Possibly Frequent (≥1/1,000 to <1)heart rhythm alterations such as slow heart rate, palpitations, syncope, heart failure, low blood pressure; nausea, gas, abdominal pain, burning sensation, diarrhea, constipation, liver function alterations (elevated transaminases), insomnia, hallucinations, depression.

• Rare (≥1/10,000 to <1)gum alterations after prolonged treatments.

• Very Rare (<1)severe allergic reactions, increased blood sugar, sexual dysfunction, skin alterations (erythema multiforme, including rare cases of Stevens-Johnson syndrome, exfoliative dermatitis, generalized acute pustular exanthematous dermatitis).

• Unknown Frequency (cannot be estimated from available data): A condition in which the body's defense system attacks normal tissue, causing symptoms such as inflamed joints, fatigue, and skin eruptions (called "lupus-like syndrome").

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, website:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of that medication.

This medication does not require special conservation conditions.

Keep this medication out of the sight and reach of children.

Do not use Diltiazem Aristo after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Diltiazem Aristo Composition

- The active ingredient is diltiazem. Each tablet contains 60 mg of diltiazem hydrochloride.

- The other components (excipients) are: lactose monohydrate, hydroxypropylmethylcellulose, calcium phosphate dibasic, hydroxypropylcellulose, talc, magnesium stearate, carbomer 934 P4.

Appearance of the product and contents of the packaging

The tablets are white, cylindrical, with beveled edges, and have a notch on one face.

Diltiazem Aristo 60 mg tablets EFG are presented in boxes containing 30 tablets, 60 tablets, and 500 tablets (clinical packaging) in a double-layer PVC/aluminum blister.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

Responsible for Manufacturing

LABORATORIOS ALCALÁ FARMA, S.L.

Ctra. M-300, Km. 29,920

28802 Alcalá de Henares (MADRID) or LABORATORIOS ALTER, S.A. Mateo Inurria, 30- 28036 Madrid

Or

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30- 28036 Madrid

Or

LABORATORIOS MEDICAMENTOS INTERNACIONALES S.A. (MEDINSA)

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

This leaflet was approved in: April 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/