DILTIAZEM ARISTO 60 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diltiazem Aristo 60 mg Tablets EFG

Diltiazem

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Diltiazem Aristo and what is it used for
2. What you need to know before you take Diltiazem Aristo
3. How to take Diltiazem Aristo
4. Possible side effects
5. Storage of Diltiazem Aristo
6. Contents of the pack and other information

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

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

This medicine is used for:

• Treatment of ischemic heart disease: a heart condition where the arteries are not able to supply enough oxygen
• Prevention of angina pectoris: a type of ischemic heart disease that manifests with pain and pressure in the chest.
• Treatment of mild to moderate essential hypertension (high blood pressure)

2. What you need to know before you take Diltiazem Aristo

Do not take Diltiazem Aristo

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

? Sinus node dysfunction

? Atrioventricular block of II and III degree if you do not have a pacemaker

? Severe bradycardia (less than 40 beats per minute)

• if you have a severe heart condition called left ventricular insufficiency with pulmonary congestion.
• if you are to receive intravenous administration of dantrolene (a drug used in muscle contraction disorders) (see "Use of Diltiazem Aristo with other medicines")
• if you are already taking a medicine that contains lomitapide used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Aristo with other medicines").
• 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 heartbeats, 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 severe liver or kidney disease, or are over 65 years old. In these cases, diltiazem blood levels may be higher. Closer monitoring by your doctor may be necessary, and you may need to undergo periodic check-ups,
• if you are to undergo surgery under general anesthesia while being treated with this medicine.

Use of Diltiazem Aristo with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

For safety reasons, the combined use of dantrolene and diltiazem is contraindicated.

It is especially important that you inform your doctor if you are taking any of the following medicines:

• Alpha and beta blockers (used to treat high blood pressure)
• Amiodarone and digoxin (drugs for the treatment of abnormal heart rhythms)
• Nitrate derivatives (used in heart diseases)
• Cyclosporin (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 cholesterol and other fatty substances in the blood)
• Medicines that contain lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase lomitapide levels, which can lead to an increased probability 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, without chewing, and with the help of a glass of water.

Pregnancy and breastfeeding

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

Diltiazem Aristo 60 mg is contraindicated during pregnancy.

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

Driving and using machines

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

Important information about some of the ingredients of Diltiazem Aristo

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Diltiazem Aristo

Follow exactly the administration instructions of this medicine 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:

• Ischemic 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 be started with half a 60 mg tablet 3 times a day, and in cases of severe hypertension with 1 tablet 3 times a day as a maximum. If necessary, the dose can be increased to 2 tablets 3 times a day as a maximum. In prolonged treatments, the dose can be reduced to half a 60 mg tablet 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 overdose of this medicine are: pronounced hypotension (very low blood pressure), leading to collapse, and severe heart rhythm disorders.

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

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

If you forget to take Diltiazem Aristo

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

If you stop taking Diltiazem Aristo

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

4. Possible side effects

Like all medicines, Diltiazem Aristo can cause side effects, although not everybody gets them.

The possible side effects due to the use of Diltiazem Aristo are the following:

• Frequent (≥1/100 to <1>

• Uncommon (≥1/1,000 to <1>

• Rare (≥1/10,000 to <1>

• Very rare (<1>

• Frequency not known (cannot be estimated from the available data): a condition in which the body's defense system attacks normal tissue, causing symptoms such as joint inflammation, fatigue, and skin rashes (called "lupus-like syndrome").

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diltiazem Aristo

This medicine does not require special storage conditions.

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

Do not use Diltiazem Aristo after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the pack and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diltiazem Aristo

• The active ingredient is diltiazem. Each tablet contains 60 mg of diltiazem hydrochloride.
• The other ingredients (excipients) are: lactose monohydrate, hydroxypropylmethylcellulose, calcium phosphate dibasic, hydroxypropylcellulose, talc, magnesium stearate, carbomer 934 P4.

Appearance of the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/